Grifols Usa, Llc

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Grifols Usa, Llc Drugs

Macuvex

Macuvex

Plasbumin-5 should always be administered by intravenous infusion. The choice between the use of Plasbumin-5 and Albumin (Human) 25%, USP (Plasbumin®-25) depends upon whether the patient requires primarily volume (Plasbumin-5) or primarily colloid osmotic activity (Plasbumin-25). Below a serum oncotic level of 20 mm Hg (equal to a total serum protein concentration of 5.2 g per 100 mL) there is evidence which suggests that the risk of complications increases.(1) When the oncotic pressure drops below this level, the patient should be treated with Plasbumin-25 together with diuretics. This is especially important in high risk patients who have undergone abdominal, cardiovascular, thoracic or urologic surgery or who have acute bacteremia.

The volume administered and the speed of administration should be adapted to the response of the individual patient.

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

Hypovolemic Shock

The volume infused should be related to the estimated volume deficit and the speed of administration adapted to the response of the patient.

In neonates or infants, Plasbumin-5 may be given in large amounts.(7) The recommended dose is 10 to 20 mL/kg equivalent to 0.5 to 1.0 g albumin/kg body weight.

Burns

After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(1) This is best achieved by the intravenous administration of Plasbumin, usually as Plasbumin-25. The duration of therapy is decided by the loss of protein from burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.

Other dosage recommendations are given under the specific indications referred to above.

Preparation for Administration

Remove seal to expose stopper. Always swab stopper top immediately with suitable antiseptic prior to entering vial.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
Albutein

Albutein

For Intravenous Use Only

2.1 Dosage

Adjust the concentration, dosage and infusion rate of the albumin preparation to the patient's individual requirements.

The dose required depends on the patient's body weight, severity of injury/illness and on continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required.
Indication Dose Hypovolemia Adults: Initial dose of 20 g.If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given.Hemodilution may follow administration of Albutein 20%. Anemia resulting from hemorrhage should be corrected by administration of compatible red blood cells or compatible whole blood.For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per minute is usually indicated.For renal dialysis, the initial dose should not exceed 20 g and patients should be carefully observed for signs of fluid overload. Cardiopulmonary bypass procedures Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated. Acute nephrosis Adults: 25 g together with diuretic once a day for 7 - 10 days. Hypoalbuminemia Adults: 50 to 75 gFor pre- and post-operative hypoproteinemia: 50 to 75 g.In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL.Third space protein loss due to infection: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response. Ovarian hyperstimulation syndrome Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. Neonatal hyperbilirubinemia 1 g per kilogram body weight prior to or during exchange transfusion. Adult respiratory distress syndrome (ARDS) Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. Prevention of central volume depletion after paracentesis due to cirrhotic ascites Adults: 8 g for every 1000 mL of ascitic fluid removed.
2.2 Administration

Intravenous use only
Albutein 20% is a clear and slightly viscous solution. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is turbid or if there is sediment in the bottle. Do not freeze. Warm product to room temperature before use if large volumes are administered. Albutein 20% contains no preservatives. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion. Do not dilute with sterile water for injection. The product can be diluted in an isotonic solution (e.g., 5% Dextrose in Water or 0.9% sodium chloride) [see Warnings and Precautions (5.7)]. Adjust the infusion rate to the individual circumstances and the indication.
Albutein

Albutein

For Intravenous Use Only

2.1 Dosage

Adjust the concentration, dosage and infusion rate of the albumin preparation to the patient's individual requirements.

The dose required depends on the patient's body weight, severity of injury/illness and on continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required.
Indication Dose Hypovolemia Adults: Initial dose of 25 g.If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given.Hemodilution may follow administration of Albutein 25%. Anemia resulting from hemorrhage should be corrected by administration of compatible red blood cells or compatible whole blood.For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per minute is usually indicated.For renal dialysis, the initial dose should not exceed 25 g and patients should be carefully observed for signs of fluid overload. Cardiopulmonary bypass procedures Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated. Acute nephrosis Adults: 25 g together with diuretic once a day for 7 - 10 days. Hypoalbuminemia Adults: 50 to 75 gFor pre- and post-operative hypoproteinemia: 50 to 75 g.In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL.Third space protein loss due to infection: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response. Ovarian hyperstimulation syndrome Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. Neonatal hyperbilirubinemia 1 g per kilogram body weight prior to or during exchange transfusion. Adult respiratory distress syndrome (ARDS) Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. Prevention of central volume depletion after paracentesis due to cirrhotic ascites Adults: 8 g for every 1000 mL of ascitic fluid removed.
2.2 Administration

Intravenous use only
Albutein 25% is a clear and slightly viscous solution. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is turbid or if there is sediment in the bottle. Do not freeze. Warm product to room temperature before use if large volumes are administered. Albutein 25% contains no preservatives. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion. Do not dilute with sterile water for injection. The product can be diluted in an isotonic solution. (e.g., 5% Dextrose in Water or 0.9% sodium chloride) [see Warnings and Precautions (5.7)]. Adjust the infusion rate to the individual circumstances and the indication.
Albutein

Albutein

For Intravenous Use Only

2.1 Dosage

Adjust the concentration, dosage and infusion rate of the albumin preparation to the patient's individual requirements.

The dose required depends on the patient's body weight, severity of injury/illness and on continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required.
Indication Dose Hypovolemia Adults: Initial dose of 20 g.If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given.Hemodilution may follow administration of Albutein 5%. Anemia resulting from hemorrhage should be corrected by administration of compatible red blood cells or compatible whole blood.For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per minute is usually indicated.For renal dialysis, the initial dose should not exceed 20 g and patients should be carefully observed for signs of fluid overload. Cardiopulmonary bypass procedures Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated. Hypoalbuminemia Adults: 50 to 75 gFor pre- and post-operative hypoproteinemia: 50 to 75 g.In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL.Third space protein loss due to infection: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response. Plasma exchange The dosage and infusion rate of Albutein 5% infused should be titrated to the volume of plasma removed during the procedure.
2.2 Administration

Intravenous use only
Albutein 5% is a clear and slightly viscous solution. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is turbid or if there is sediment in the bottle. Do not freeze. Warm product to room temperature before use if large volumes are administered. Albutein 5% contains no preservatives. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion. Do not dilute with sterile water for injection [see Warnings and Precautions (5.6)]. Adjust the infusion rate to the individual circumstances and the indication. In plasma exchange, adjust the infusion rate to the rate of plasma removal.
Silver Sulfadiazine

Silver Sulfadiazine

For intravenous injection after reconstitution only
Treatment with ALPHANATE should be initiated under the supervision of a physician experienced in the treatment of hemophilia. Each vial of ALPHANATE has the antihemophilic factor (AHF) potency (FVIII:C activity) expressed in International Units (IU) FVIII/vial on the label. Additionally, ALPHANATE contains von Willebrand Factor:Ristocetin Cofactor (VWF:RCo), which is expressed in IU VWF:RCo/vial for the treatment of VWD.
2.1 Dose

Treatment and Prevention of Bleeding Episodes and Excess Bleeding During and After Surgery in Patients with Hemophilia A
Dosage and duration of treatment depend on the severity of the FVIII deficiency, the location and extent of bleeding, presence of inhibitors, and the patient’s clinical condition. Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes. Dosing requirements and frequency of dosing is calculated on the basis of an expected initial response of 2% of normal FVIII:C increase per IU FVIII:C/kg body weight administered.1The expected in vivo peak increase in FVIII level expressed as IU/dL (or % of normal) can be estimated using the following formulas:
Dosage (international units) = body weight (kg) x desired FVIII rise (IU/dL or % normal) x 0.5 (IU/kg per IU/dL)

or

IU/dL (or % of normal) = [Total Dose (IU)/body weight (kg)] x 2
Titrate dose and frequency to the patient’s clinical response, including individualized needs, severity of the deficiency, severity of the hemorrhage, presence of inhibitors, and FVIII level desired. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to ALPHANATE. Table 1 provides dosage guidelines for the control and prevention of bleeding episodes in hemophilia A patients. Dosing should aim at maintaining a plasma factor VIII activity level at or above the plasma levels (in IU/dL or in % of normal) outlined in the table. Table 1: Dosage Guidelines for Patients with Hemophilia A Type of Bleeding FVIII:C Level Required(% of normal) Doses(IU/kg) Frequency of Doses(hours) Duration of Therapy (days) Minor • Large bruises • Significant cuts or scrapes • Uncomplicated joint hemorrhage 30 15 12 (twice daily) Until hemorrhage stops and healing has been achieved (1–2 days). Moderate • Nose, mouth and gum bleeds • Dental extractions Hematuria 50 25 12 (twice daily) Until healing has been achieved (2–7 days, on average). Major • Joint hemorrhage • Muscle hemorrhage • Major trauma • Hematuria • Intracranial and   intraperitoneal bleeding 80–100 Initial: 40–50 Maintenance: 25 12 (twice daily) For at least 3–5 daysUntil healing has been achieved for up to 10 days. Intracranial hemorrhage may require prophylaxis therapy for up to 6 months. Surgery Prior to surgery: 80–100 After surgery: 60–100 40–50 30–50 Once 12 (twice daily) Prior to surgery For the next 7–10 days, or until healing has been achieved. Monitoring parameters: Monitor plasma FVIII levels periodically to evaluate individual patient response to the dosage regimen. If dosing studies have determined that a particular patient exhibits a lower/higher than expected response and shorter/longer half-life, adjust the dose and the frequency of dosing accordingly. Failure to achieve the expected plasma FVIII:C level or to control bleeding after an appropriately calculated dosage may be indicative of the development of an inhibitor (an antibody to FVIII:C). Quantitate the inhibitor level by appropriate laboratory procedures and document its presence. Treatment with AHF in such cases must be individualized.2
Treatment and Prevention of Excess Bleeding During and After Surgery or Other Invasive Procedures in Patients with von Willebrand Disease
The ratio of VWF:RCo to FVIII in ALPHANATE varies by lot, so with each new lot, check IU VWF:RCo/vial to ensure accurate dosing. Dosage and duration of treatment depend on the severity of the VWF deficiency, the location and extent of bleeding, and the patient’s clinical condition. Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes. The median incremental in vivo recoveries of VWF:RCo and FVIII:C were 3.12 (IU/dL)/(IU/kg) [mean, 3.29 ± 1.46 (IU/dL)/(IU/kg); range: 1.28 to 5.73 (IU/dL)/(IU/kg)] for VWF:RCo and 1.95 (IU/dL)/(IU/kg) [mean, 2.13 ± 0.58 (IU/dL)/(IU/kg); range: 1.33 to 3.32 (IU/dL)/(IU/kg)] for FVIII:C. Table 2 provides dosing guidelines for pediatric and adult patients with von Willebrand Disease.3-6 Table 2: Dosage Guidelines for Patients with von Willebrand Disease (Except Type 3 Subjects Undergoing Major Surgery)
a The therapeutic goal is referenced in the NHLBI Guidelines.11

b The safety parameter is extracted from Mannucci 2009.12
Minor Surgery/Bleeding Parameter VWF:RCo Target FVIII:C Activity Levels Pre-operative/pre-procedure dose: Adults: 60 IU VWF:RCo/kg body weight. Pediatrics: 75 IU VWF:RCo/kg body weight. 40-50 IU/dL Maintenance dose: Adults: 40 to 60 IU VWF:RCo/kg body weight at 8 to 12 hour intervals as clinically needed for 1-3 days.Pediatrics: 50 to 75 IU VWF:RCo/kg body weight at 8 to 12 hour intervals as clinically needed for 1-3 days. 40-50 IU/dL Therapeutic Goal (Trough)a : >50 IU/dL >50 IU/dL Safety Monitoring: Peak and trough at least once daily Peak and trough at least once daily Safety Parameterb : Should not exceed 150 IU/dL Should not exceed 150 IU/dL Major Surgery/Bleeding Parameter VWF:RCo Target FVIII:C Activity Levels Pre-operative/pre-procedure dose: Adults: 60 IU VWF:RCo/kg body weight.Pediatrics: 75 IU VWF:RCo/kg body weight. 100 IU/dL Maintenance dose: Adults: 40 to 60 IU VWF:RCo/kg body weight at 8 to 12 hour intervals as clinically needed for at least 3-7 days.Pediatrics: 50 to 75 IU VWF:RCo/kg body weight at 8 to 12 hour intervals as clinically needed for at least 3-7 days. 100 IU/dL Therapeutic Goal (Trough)a : >50 IU/dL >50 IU/dL Safety Monitoring: Peak and trough at least daily Peak and trough at least daily Safety Parameterb: Should not exceed 150 IU/dL Should not exceed 150 IU/dL
2.2 Reconstitution
Always use aseptic technique. Ensure that concentrate (ALPHANATE) and diluent (Sterile Water for Injection, USP) are at room temperature (but not above 37 ˚C) before reconstitution. Remove the plastic flip off cap from the diluent vial. Gently swab the exposed stopper surface with a cleansing agent such as alcohol trying to avoid leaving any excess cleansing agent on the stopper. Open the Mix2Vial package by peeling away the lid (Figure 1). Leave the Mix2Vial in the clear outer packaging. Place the diluent vial upright on an even surface and hold the vial tight and pick up the Mix2Vial in its clear outer packaging. Holding the diluent vial securely, push the blue end of the Mix2Vial vertically down through the diluent vial stopper (Figure 2). While holding onto the diluent vial, carefully remove the clear outer packaging from the Mix2Vial set, ensuring the Mix2Vial remains attached to the diluent vial (Figure 3). Place the product vial upright on an even surface, invert the diluent vial with the Mix2Vial attached. While holding the product vial securely on a flat surface, push the clear end of the Mix2Vial set vertically down through the product vial stopper (Figure 4). The diluent will automatically transfer out of its vial into the product vial.NOTE: If the Mix2Vial is connected at an angle, the vacuum may be released from the product vial and the diluent will not transfer into the product vial. With the diluent and product vials still attached to the Mix2Vial, gently swirl the product vial to ensure the product is fully dissolved (Figure 5). Reconstitution requires less than 5 minutes. Do not shake the vial. Disconnect the Mix2Vial into two separate pieces (Figure 6) by holding each vial adapter and twisting counterclockwise. After separating, discard the diluent vial with the blue end of the Mix2Vial. Draw air into an empty, sterile syringe. Keeping the product vial upright with the clear end of the Mix2Vial attached, screw the disposable syringe onto the luer lock portion of the Mix2Vial device by pressing and twisting clockwise. Inject air into the product vial. While keeping the syringe plunger depressed, invert the system upside down and draw the reconstituted product into the syringe by pulling the plunger back slowly (Figure 7). When the reconstituted product has been transferred into the syringe, firmly hold the barrel of the syringe and the clear vial adapter (keeping the syringe plunger facing down) and unscrew the syringe from the Mix2Vial (Figure 8). Hold the syringe upright and push the plunger until no air is left in the syringe. Attach the syringe to a venipuncture set.NOTE: If the same patient is to receive more than one vial of concentrate, the contents of two vials may be drawn into the same syringe through a separate unused Mix2Vial set before attaching to the venipuncture set. When reconstitution procedure is strictly followed, a few small particles may occasionally remain. The Mix2Vial set will remove particles and the labeled potency will not be reduced. Discard all reconstitution equipment after use into the appropriate safety container. Do not reuse. Use the prepared drug as soon as possible within 3 hours after reconstitution.
2.3 Administration

For intravenous use after reconstitution only
Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not refrigerate after reconstitution. Store reconstituted ALPHANATE at room temperature (not to exceed 30 °C) prior to administration, but administer intravenously within three hours. Use plastic disposable syringes. Do not administer ALPHANATE at a rate exceeding 10 mL/minute. Discard any unused contents into the appropriate safety container.
Human Albumin Grifols

Human Albumin Grifols

For Intravenous Use Only

2.1 Dosage

Adjust the concentration, dosage and infusion rate of the albumin preparation to the patient's individual requirements.

The dose required depends on the patient's body weight, severity of injury/illness and on continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required.
Indication Dose Hypovolemia Adults: Initial dose of 25 g.If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given.Hemodilution may follow administration of Human Albumin Grifols 25%.Anemia resulting from hemorrhage should be corrected by administration of compatible red blood cells or compatible whole blood.For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per min is usually indicated.For renal dialysis, the initial dose should not exceed 25 g and patients should be carefully observed for signs of fluid overload. Cardiopulmonary bypass procedures Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated. Acute nephrosis Adults: 25 g together with diuretic once a day for 7 - 10 days. Hypoalbuminemia Adults: 50 to 75 gFor pre- and post-operative hypoproteinemia: 50 to 75 g.In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL.Third space protein loss due to infection: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response. Ovarian hyperstimulation syndrome Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. Neonatal hyperbilirubinemia 1 g per kilogram body weight prior to or during exchange transfusion. Adult respiratory distress syndrome (ARDS) Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. Prevention of central volume depletion after paracentesis due to cirrhotic ascites Adults: 8 g for every 1000 mL of ascitic fluid removed.
2.2 Administration

Intravenous use only
Human Albumin Grifols 25% is a clear and slightly viscous solution. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is turbid or if there is sediment in the bottle. Do not freeze. Warm product to room temperature before use if large volumes are administered. Human Albumin Grifols 25% contains no preservatives. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion. Do not dilute with sterile water for injections. The product can be diluted in an isotonic solution (e.g., 5% Dextrose in Water or 0.9% sodium chloride) [see Warnings and Precautions (5.7)]. Adjust the infusion rate to the individual circumstances and the indication.
Human Albumin Grifols

Human Albumin Grifols

For Intravenous Use Only

2.1 Dosage

Adjust the concentration, dosage and infusion rate of the albumin preparation to the patient's individual requirements.

The dose required depends on the patient's body weight, severity of injury/illness and on continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required.
Indication Dose Hypovolemia Adults: Initial dose of 20 g.If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given.Hemodilution may follow administration of Human Albumin Grifols 20%. Anemia resulting from hemorrhage should be corrected by administration of compatible red blood cells or compatible whole blood.For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per min is usually indicated.For renal dialysis, the initial dose should not exceed 20 g and patients should be carefully observed for signs of fluid overload. Cardiopulmonary bypass procedures Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated. Acute nephrosis Adults: 25 g together with diuretic once a day for 7 - 10 days. Hypoalbuminemia Adults: 50 to 75 g.For pre- and post-operative hypoproteinemia: 50 to 75 g.In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL.Third space protein loss due to infection: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response. Ovarian hyperstimulation syndrome Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. Neonatal hyperbilirubinemia 1 g per kilogram body weight prior to or during exchange transfusion. Adult respiratory distress syndrome (ARDS) Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. Prevention of central volume depletion after paracentesis due to cirrhotic ascites Adults: 8 g for every 1000 mL of ascitic fluid removed.
2.2 Administration

Intravenous use only
Human Albumin Grifols 20% is a clear and slightly viscous solution. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is turbid or if there is sediment in the bottle. Do not freeze. Warm product to room temperature before use if large volumes are administered. Human Albumin Grifols 20% contains no preservatives. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion. Do not dilute with sterile water for injection. The product can be diluted in an isotonic solution (e.g., 5% Dextrose in Water or 0.9% sodium chloride) [see Warnings and Precautions (5.7)]. Adjust the infusion rate to the individual circumstances and the indication.
Alphanine Sd

Alphanine Sd

For adult usage:

AlphaNine SD should be administered intravenously promptly following reconstitution. Administration of AlphaNine SD within three hours after reconstitution is recommended to avoid the potential ill effect of any inadvertent bacterial contamination occurring during reconstitution. Discard any unused contents into the appropriate safety container.

Each vial of AlphaNine SD is labeled with the total units expressed as International Units (IU) of Factor IX, which is referenced to the WHO International Standard. One unit approximates the activity in one mL of pooled normal human plasma.

The amount of AlphaNine SD required to establish hemostasis will vary with each patient and depend upon the circumstances. The following formula may be used as a guide in determining the number of units to be administered.16

In clinical practice there is variability between patients and their clinical response. Therefore, the Factor IX level of each patient should be monitored frequently during replacement therapy.

For pediatric usage: See PRECAUTIONS
Treatment Guidelines for Hemorrhagic Events and Surgery in Patients Diagnosed with Hemophilia B Type of Hemorrhage or Surgical Procedure Examples Treatment Guidelines Minor Hemorrhages Bruises, cuts or scrapes, uncomplicated joint hemorrhage FIX levels should be brought to at least 20-30% (20-30 IU FIX/kg/twice daily) until hemorrhage stops and healing has been achieved (1-2 days).17,18,19 Moderate Hemorrhages Nose bleeds, mouth and gum bleeds, dental extractions, hematuria FIX levels should be brought to 25-50% (25-50 IU FIX/kg/twice daily) until healing has been achieved (2-7 days, on average).17,18,19,20,21 Major Hemorrhages Joint and muscle hemorrhages (especially in the large muscles), major trauma, hematuria, intracranial and intraperitoneal bleeding FIX levels should be brought to 50% for at least 3-5 days (30-50 IU FIX/kg/twice daily). Following this treatment period, FIX levels should be maintained at 20% (20 IU FIX/kg/twice daily) until healing has been achieved. Major hemorrhages may require treatment for up to 10 days.17,18,19,20,21 Surgery Prior to surgery, FIX should be brought to 50-100% of normal (50-100 IU FIX/kg/twice daily). For the next 7 to 10 days, or until healing has been achieved, the patient should be maintained at 50-100% FIX levels (50-100 IU FIX/kg/twice daily).17,18,19,20,21
Dosing requirements and frequency of dosing is calculated on the basis of an initial response of 1% FIX increase achieved per IU of FIX infused per kg body weight and an average half-life for FIX of 18 hours. If dosing studies have revealed that a particular patient exhibits a lower response, the dose should be adjusted accordingly.

For pediatric usage: See PRECAUTIONS

RECONSTITUTION

Use Aseptic Technique
Warm diluent (Sterile Water for Injection, USP) and concentrate (AlphaNine SD) to at least room temperature (but not above 37 °C). Remove the plastic flip off cap from the diluent vial. Gently swab the exposed stopper surface with a cleansing agent such as alcohol trying to avoid leaving any excess cleansing agent on the stopper. Open the Mix2Vial® package by peeling away the lid (Figure 1). Leave the Mix2Vial in the clear outer packaging. Place the diluent vial upright on an even surface and hold the vial tight and pick up the Mix2Vial in its clear outer packaging. Holding the diluent vial securely, push the blue end of the Mix2Vial vertically down through the diluent vial stopper (Figure 2). While holding onto the diluent vial, carefully remove the clear outer packaging from the Mix2Vial set, ensuring the Mix2Vial remains attached to the diluent vial (Figure 3). Place the product vial upright on an even surface, invert the diluent vial with the Mix2Vial attached. While holding the product vial securely on a flat surface, push the clear end of the Mix2Vial set vertically down through the product vial stopper (Figure 4). The diluent will automatically transfer out of its vial into the product vial. (NOTE: If the Mix2Vial is connected at an angle, the vacuum may be released from the product vial and the diluent will not transfer into the product vial.) With the diluent and product vials still attached to the Mix2Vial, gently swirl the product vial to ensure the product is fully dissolved (Figure 5). Reconstitution requires less than 5 minutes. Do not shake the vial. Disconnect the Mix2Vial into two separate pieces (Figure 6) by holding each vial adapter and twisting counterclockwise. After separating, discard the diluent vial with the blue end of the Mix2Vial. Draw air into an empty, sterile syringe. Keeping the product vial upright with the clear end of the Mix2Vial attached, screw the disposable syringe onto the luer lock portion of the Mix2Vial device by pressing and twisting clockwise. Inject air into the product vial. While keeping the syringe plunger depressed, invert the system upside down and draw the reconstituted product into the syringe by pulling the plunger back slowly (Figure 7). When the reconstituted product has been transferred into the syringe, firmly hold the barrel of the syringe and the clear vial adapter (keeping the syringe plunger facing down) and unscrew the syringe from the Mix2Vial (Figure 8). Hold the syringe upright and push the plunger until no air is left in the syringe. Attach the syringe to a venipuncture set. NOTE: If the same patient is to receive more than one vial of concentrate, the contents of two vials may be drawn into the same syringe through a separate unused Mix2Vial set before attaching to the venipuncture set. Use the prepared drug as soon as possible within three hours after reconstitution. After reconstitution, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. When reconstitution procedure is strictly followed, a few small particles may occasionally remain. The Mix2Vial set will remove particles and the labeled potency will not be reduced. Discard all administration equipment after use into the appropriate safety container. Do not reuse.
Profilnine

Profilnine

Dose

Each vial of Profilnine is labeled with total units expressed as International Units (IU). According to the WHO International Standard, one unit approximates the activity in one mL of normal plasma.

A 1% increase in factor IX (0.01 units) per unit administered per kg body weight can be expected1. The amount of Profilnine required to establish hemostasis will vary with each patient and circumstance. Use the following formula and example as guides in determining the number of units to be administered:
Body weight (in kg) X Desired increase in Plasma Factor IX (Percent) X 1 Units/kg = Number of Factor IX Units Required Example: 50 kg X 25 (% increase) X 1 Units/kg = 1,250 Units of factor IX
Due to variability among patients and their clinical condition, monitor the factor IX level of each patient frequently during replacement therapy.

Table 2 below provides treatment guidelines for hemorrhagic events and surgery in patients with factor IX deficiency.
Table 2: Treatment Guidelines Type of Bleeding or Surgical Procedure Factor IX Level Required, % of Normal (Dose) Frequency of Doses Duration of Therapy (Days) Minor to Moderate Hemorrhages 20-30% (20-30 IU FIX/kg) until hemorrhage stops and healing has been achieved. Every 16-24 hrs Minor: 1-2 daysModerate: 2-7 days Major Hemorrhages 30-50% (30-50 IU FIX/kg).Following this treatment period, maintain FIX levels at 20% (20 IU FIX/kg) until healing has been achieved. Every 16-24 hrs 3-10 days Surgery Prior to surgery, 30-50% (30-50 IU FIX/kg).For dental extractions, bring FIX levels to 50% immediately prior to the procedure.Maintain FIX levels at 30-50% (30-50 IU FIX/kg) until healing has been achieved. Every 16-24 hrs 7-10 days
Dosing requirements and frequency of dosing are calculated on the basis of an initial response of 1% FIX increase achieved per IU of FIX infused per kg body weight and an average half-life for FIX of 24 hours. If dosing studies reveal that a particular patient exhibits a lower response, monitor blood levels and adjust the dose accordingly.

Reconstitution

Use Aseptic Technique
Ensure that concentrate (Profilnine) and diluent (Sterile Water for Injection, USP) are at room temperature (but not above 37° C) before reconstitution. Remove the plastic flip off cap from the diluent vial. Gently swab the exposed stopper surface with a cleansing agent such as alcohol. Avoid leaving any excess cleansing agent on the stopper. Open the Mix2Vial® package by peeling away the lid (Figure 1). Leave the Mix2Vial in the clear outer packaging. Place the diluent vial upright on an even surface, hold the vial tightly, and pick up the Mix2Vial in its clear outer packaging. While holding the diluent vial securely, push the blue end of the Mix2Vial vertically down through the diluent vial stopper (Figure 2). While holding onto the diluent vial, carefully remove the clear outer packaging from the Mix2Vial set, ensuring the Mix2Vial remains attached to the diluent vial (Figure 3). Place the product vial upright on an even surface, invert the diluent vial with the Mix2Vial attached. While holding the product vial securely on a flat surface, push the clear end of the Mix2Vial set vertically down through the product vial stopper (Figure 4). The diluent will automatically transfer out of its vial into the product vial. NOTE: If the Mix2Vial is connected at an angle, the vacuum may be released from the product vial and the diluent will not transfer into the product vial. With the diluent and product vials still attached to the Mix2Vial, gently swirl the product vial to ensure the product is fully dissolved (Figure 5). Reconstitution requires less than 10 minutes. Do not shake the vial. Disconnect the Mix2Vial into two separate pieces (Figure 6) by holding each vial adapter and twisting counterclockwise. After separating, discard the diluent vial with the blue end of the Mix2Vial. Draw air into an empty, sterile syringe. Keeping the product vial upright with the clear end of the Mix2Vial attached, screw the disposable syringe onto the luer lock portion of the Mix2Vial device by pressing and twisting clockwise. Inject air into the product vial. While keeping the syringe plunger depressed, invert the system upside down and draw the reconstituted product into the syringe by pulling the plunger back slowly (Figure 7). When the reconstituted product has been transferred into the syringe, firmly hold the barrel of the syringe and the clear vial adapter (keeping the syringe plunger facing down) and unscrew the syringe from the Mix2Vial (Figure 8). Hold the syringe upright and push the plunger until no air is left in the syringe. Attach the syringe to a venipuncture set. NOTE: If the same patient is to receive more than one vial of concentrate, the contents of two vials may be drawn into the same syringe through a separate unused Mix2Vial set before attaching to the venipuncture set. After reconstitution, inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. When reconstitution procedure is strictly followed, a few small particles may occasionally remain. The Mix2Vial set will remove particles and the labeled potency will not be reduced. Do not refrigerate after reconstitution. The reconstituted product is stable for 3 hours at room temperature; use as soon as possible within 3 hours after reconstitution.
Plasmanate

Plasmanate

Dosage is based almost entirely on the nature of the individual case and response to therapy. The usual minimum effective dose in adults is 250–500 mL. As with any plasma expander, the rate should be adjusted or slowed according to the clinical response and rising blood pressure.

Administration should be by vein and preferably through an area of skin at some distance from any site of infection or trauma. Plasmanate is compatible with the usual carbohydrate and electrolyte solutions.

Remove seal to expose stopper. Always swab stopper top immediately with suitable antiseptic prior to entering the vial.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hyperrab Sd

Hyperrab Sd

The recommended dose for HyperRAB S/D is 20 IU/kg (0.133 mL/kg) of body weight given preferably at the time of the first vaccine dose.[8,9] It may also be given through the seventh day after the first dose of vaccine is given. If anatomically feasible, up to the full dose of HyperRAB S/D should be thoroughly infiltrated in the area around the wound and the rest should be administered intramuscularly in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve. [26] HyperRAB S/D should never be administered in the same syringe or needle or in the same anatomical site as vaccine.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Rabies postexposure prophylaxis schedule—United States, 1999 [19] HDCV=human diploid cell vaccine; PCEC=purified chick embryo cell vaccine; RIG=rabies immune globulin; RVA=rabies vaccine adsorbed; IM, intramuscular * These regimens are applicable for all age groups, including children. † The deltoid area is the only acceptable site of vaccination for adults and older children. For younger children, the outer aspect of the thigh may be used. Vaccine should never be administered in the gluteal area. ‡ Day 0 is the day the first dose of vaccine is administered. § Any person with a history of preexposure vaccination with HDCV, RVA, or PCEC; prior postexposure prophylaxis with HDCV, RVA, or PCEC; or previous vaccination with any other type of rabies vaccine and a documented history of antibody response to the prior vaccination. Vaccination status Treatment Regimen* Not previously vaccinated Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water. If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds. RIG Administer 20 IU/kg body weight. If anatomically feasible, the full dose should be infiltrated around the wound(s) and any remaining volume should be administered IM at an anatomical site distant from vaccine administration.Also, RIG should not be administered in the same syringe as vaccine. Because RIG might partially suppress active production of antibody, no more than the recommended dose should be given. Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area† ), one each on days 0‡, 3, 7, 14, and 28. Previously vaccinated§ Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water. If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds. RIG RIG should not be administered. Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area† ), one each on days 0‡ and 3.
Plasbumin

Plasbumin

Plasbumin-20 should always be administered by intravenous infusion. Plasbumin-20 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Plasbumin-20 should only be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

Hypovolemic Shock — For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.

Burns — After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(2) This is best achieved by the intravenous administration of Plasbumin-20. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.

Hypoproteinemia With or Without Edema — Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Plasbumin-20 must be considered purely symptomatic or supportive (see section Situations in Which Albumin Administration is Not Warranted). (2) The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Plasbumin-20 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.

Other dosage recommendations are given under the specific indications referred to above.

Preparation for Administration

Remove seal to expose stopper. Always swab stopper top immediately with a suitable antiseptic prior to entering vial.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
Plasbumin

Plasbumin

Plasbumin-20 should always be administered by intravenous infusion. Plasbumin-20 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Plasbumin-20 should only be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

Hypovolemic Shock — For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.

Burns — After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(2) This is best achieved by the intravenous administration of Plasbumin-20. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.

Hypoproteinemia With or Without Edema — Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Plasbumin-20 must be considered purely symptomatic or supportive (see section Situations in Which Albumin Administration is Not Warranted).(2) The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Plasbumin-20 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.

Other dosage recommendations are given under the specific indications referred to above.

Preparation for Administration

Remove seal to expose stopper. Always swab stopper top immediately with a suitable antiseptic prior to entering vial.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
Plasbumin

Plasbumin

Plasbumin-5 should always be administered by intravenous infusion. The choice between the use of Plasbumin-5 and Albumin (Human) 25%, USP (Plasbumin®-25) depends upon whether the patient requires primarily volume (Plasbumin-5) or primarily colloid osmotic activity (Plasbumin-25). Below a serum oncotic level of 20 mm Hg (equal to a total serum protein concentration of 5.2 g per 100 mL) there is evidence which suggests that the risk of complications increases.(1) When the oncotic pressure drops below this level, the patient should be treated with Plasbumin-25 together with diuretics. This is especially important in high risk patients who have undergone abdominal, cardiovascular, thoracic or urologic surgery or who have acute bacteremia.

The volume administered and the speed of administration should be adapted to the response of the individual patient.

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

Hypovolemic Shock

The volume infused should be related to the estimated volume deficit and the speed of administration adapted to the response of the patient.

In neonates or infants, Plasbumin-5 may be given in large amounts.(7) The recommended dose is 10 to 20 mL/kg equivalent to 0.5 to 1.0 g albumin/kg body weight.

Burns

After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(1) This is best achieved by the intravenous administration of Plasbumin, usually as Plasbumin-25. The duration of therapy is decided by the loss of protein from burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.

Other dosage recommendations are given under the specific indications referred to above.

Preparation for Administration

Remove seal to expose stopper. Always swab stopper top immediately with suitable antiseptic prior to entering vial.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
Plasbumin

Plasbumin

Plasbumin-25 should always be administered by intravenous infusion. Plasbumin-25 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Plasbumin-25 should only be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

Hypovolemic Shock—For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.

Burns—After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(2) This is best achieved by the intravenous administration of Plasbumin-25. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.

Hypoproteinemia With or Without Edema—Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Plasbumin-25 must be considered purely symptomatic or supportive (see section Situations in Which Albumin Administration is Not Warranted).(2) The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Plasbumin-25 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.

Other dosage recommendations are given under the specific indications referred to above.

Preparation for Administration

Remove seal to expose stopper. Always swab stopper top immediately with a suitable antiseptic prior to entering vial.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
Plasbumin

Plasbumin

Plasbumin-25 should always be administered by intravenous infusion. Plasbumin-25 may be administered either undiluted or diluted in 0.9% Sodium Chloride or 5% Dextrose in Water. If sodium restriction is required, Plasbumin-25 should only be administered either undiluted or diluted in a sodium-free carbohydrate solution such as 5% Dextrose in Water.

A number of factors beyond our control could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

Hypovolemic Shock—For treatment of hypovolemic shock, the volume administered and the speed of infusion should be adapted to the response of the individual patient.

Burns—After a burn injury (usually beyond 24 hours) there is a close correlation between the amount of albumin infused and the resultant increase in plasma colloid osmotic pressure. The aim should be to maintain the plasma albumin concentration in the region of 2.5 ± 0.5 g per 100 mL with a plasma oncotic pressure of 20 mm Hg (equivalent to a total plasma protein concentration of 5.2 g per 100 mL).(2) This is best achieved by the intravenous administration of Plasbumin-25. The duration of therapy is decided by the loss of protein from the burned areas and in the urine. In addition, oral or parenteral feeding with amino acids should be initiated, as the long-term administration of albumin should not be considered as a source of nutrition.

Hypoproteinemia With or Without Edema—Unless the underlying pathology responsible for the hypoproteinemia can be corrected, the intravenous administration of Plasbumin-25 must be considered purely symptomatic or supportive (see section Situations in Which Albumin Administration is Not Warranted).(2) The usual daily dose of albumin for adults is 50 to 75 g and for children 25 g. Patients with severe hypoproteinemia who continue to lose albumin may require larger quantities. Since hypoproteinemic patients usually have approximately normal blood volumes, the rate of administration of Plasbumin-25 should not exceed 2 mL per minute, as more rapid injection may precipitate circulatory embarrassment and pulmonary edema.

Other dosage recommendations are given under the specific indications referred to above.

Preparation for Administration

Remove seal to expose stopper. Always swab stopper top immediately with a suitable antiseptic prior to entering vial.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Only 16 gauge needles or dispensing pins should be used with 20 mL vial sizes and larger. Needles or dispensing pins should only be inserted within the stopper area delineated by the raised ring. The stopper should be penetrated perpendicular to the plane of the stopper within the ring.
Flebogamma Dif

Flebogamma Dif

For Intravenous Use Only

2.1 Dosage

Treatment of Primary Immunodeficiency (PI)
Dose Initial Infusion Rate Maintenance Dose Rate(if tolerated) 300-600 mg per kg body weight (6.0-12.0 mL per kg) administered every 3-4 weeks 0.01 mL per kg per minute (0.5 mg per kg per min) Increase to 0.10 mL per kg per minute (5 mg per kg per min)
As there are significant differences in the half-life of IgG among patients with PI, the frequency and amount of immunoglobulin therapy may vary from patient to patient. Adjust the dose according to the clinical response.

Adjust the dosage over time to achieve the desired trough IgG levels and clinical responses. No randomized controlled trial data are available to determine an optimum target trough serum IgG level.

2.2 Preparation and Handling
Inspect Flebogamma 5% DIF visually for particulate matter and color prior to administration. Do not use the vial if particles are detected. Do not use if turbid. Several vials of Flebogamma 5% DIF may be pooled into an empty sterile solution container by using aseptic technique, if large doses are to be administered. Do not dilute with intravenous fluids. Do not inject other medications into intravenous tubing being used for Flebogamma 5% DIF. Infuse Flebogamma 5% DIF through a separate intravenous line. Do not add any medications or intravenous fluids to the Flebogamma 5% DIF infusion container. Do not mix IGIV products of different formulations or from different manufacturers. Discard unused contents and administration devices after use. Use promptly any vial that has been entered. Discard partially used vials. Do not save for future use because the solution contains no preservative. Do not use solution that has been frozen.
2.3 Administration

The recommended initial infusion rate of Flebogamma 5% DIF is 0.01 mL per kg body weight per minute (0.5 mg per kg per min). If the infusion is well-tolerated during the first 30 minutes, the rate may be gradually increased to a maximum of 0.10 mL per kg per minute (5 mg per kg per min).

Monitor patient vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
Flebogamma Dif

Flebogamma Dif

For Intravenous Use Only

2.1 Dosage

Treatment of Primary Immunodeficiency (PI)
Dose Initial Infusion Rate Maintenance Dose Rate(if tolerated) 300 to 600 mg/kg body weight (3.0 to 6.0 mL/kg) administered every 3 to 4 weeks 0.01 mL/kg/minute (1 mg/kg/min) 0.08 mL/kg/minute (8 mg/kg/min)
As there are significant differences in the half-life of IgG among patients with PI, the frequency and amount of immunoglobulin therapy may vary from patient to patient. Dosing should be adjusted according to the clinical response.

The dosage may be adjusted over time to achieve the desired serum trough IgG levels and clinical responses. No randomized controlled trial data are available to determine an optimum target trough serum IgG level.

2.2 Preparation and Handling
Inspect Flebogamma 10% DIF visually for particulate matter and color prior to administration. Do not use the vial if particles are detected. Do not use if turbid. Several vials of Flebogamma 10% DIF may be pooled into an empty sterile solution container by using aseptic technique, if large doses are to be administered. Dilution with intravenous fluids is not recommended. Injection of other medications into intravenous tubing being used for Flebogamma 10% DIF is not recommended. Infuse Flebogamma 10% DIF through a separate intravenous line. Do not add any medications or intravenous fluids to the Flebogamma 10% DIF infusion container. Do not mix IGIV products of different formulations or from different manufacturers. Discard unused contents and administration devices after use. Any vial that has been entered should be used promptly Discard partially used vials. Do not save for future use because the solution contains no preservative. Do not use solution that has been frozen.
2.3 Administration

The recommended initial infusion rate of Flebogamma 10% DIF is 0.01 mL/kg/min (1 mg/kg/min) for the first thirty minutes. If tolerated, the rate may be gradually increased to 0.04 mL/kg/min (4 mg/kg/min) and if tolerated, gradually to a maximum of 0.08 mL/kg/min (8 mg/kg/min).

Monitor patient vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.

For the first 2-3 infusions, Flebogamma 10% DIF may be administered at infusions rates slower than recommended rates. If after administration of the first few infusions no adverse drug reactions are observed, the infusion rate for subsequent infusions may be slowly increased to the maximum rate. For patients experiencing adverse drug reactions reduce the infusion rate in subsequent infusions or administer IGIV at 5% concentration.
Gamastan Sd

Gamastan Sd

FOR INTRAMUSCULAR ADMINISTRATION ONLY. DO NOT ADMINISTER SUBCUTANEOUSLY OR INTRAVENOUSLY. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Administer GamaSTAN S/D intramuscularly (see PRECAUTIONS), preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm. Do not use the gluteal region as an injection site because of the risk of injury to the sciatic nerve.(10) Doses over 10 mL should be divided and injected into several muscle sites to reduce local pain and discomfort. An individual decision as to which muscle is injected must be made for each patient based on the volume of material to be administered. Draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel. A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hepatitis A

GamaSTAN S/D in a dose of 0.01 mL/lb (0.02 mL/kg) is recommended for household and institutional hepatitis A case contacts.

The following doses of GamaSTAN S/D are recommended for persons who plan to travel in areas where hepatitis A is common.(3)
Length of Stay Dose Volume Less than 3 months 0.02 mL/kg 3 months or longer 0.06 mL/kg (repeat every 4–6 months)
Measles (Rubeola)

Give GamaSTAN S/D in a dose of 0.11 mL/lb (0.25 mL/kg) to prevent or modify measles in a susceptible person exposed fewer than 6 days previously.(7)

To a susceptible child who is exposed to measles and who is immunocompromised, administer a dose of 0.5 mL/kg (maximum dose, 15 mL) of GamaSTAN S/D immediately.(8)

Varicella

If Varicella-Zoster Immune Globulin (Human) is unavailable, GamaSTAN S/D at a dose of 0.6 to 1.2 mL/kg, promptly given, may also modify varicella.(5) For patients at risk of thrombosis, administer GamaSTAN S/D at the lower range of the recommended dose.

Rubella

Some studies suggest that the use of GamaSTAN S/D in exposed, susceptible women can lessen the likelihood of infection and fetal damage; therefore, GamaSTAN S/D at a dose of 0.55 mL/kg may benefit those women who will not consider a therapeutic abortion.(4)
Hypertet Sd

Hypertet Sd

Routine prophylactic dosage schedule:

Adults and children 7 years and older: HyperTET S/D, 250 units should be given by deep intramuscular injection (see PRECAUTIONS). At the same time, but in a different extremity and with a separate syringe, Tetanus and Diphtheria Toxoids Adsorbed (For Adult Use) (Td) should be administered according to the manufacturer's package insert. Adults with uncertain histories of a complete primary vaccination series should receive a primary series using the combined Td toxoid. To ensure continued protection, booster doses of Td should be given every 10 years. [2]

Children less than 7 years old: In small children the routine prophylactic dose of HyperTET S/D may be calculated by the body weight (4.0 units/kg). However, it may be advisable to administer the entire contents of the syringe of HyperTET S/D (250 units) regardless of the child's size, since theoretically the same amount of toxin will be produced in the child's body by the infecting tetanus organism as it will in an adult's body. At the same time but in a different extremity and with a different syringe, Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP) or Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT), if pertussis vaccine is contraindicated, should be administered per the manufacturer's package insert.

Note: The single injection of tetanus toxoid only initiates the series for producing active immunity in the recipient. The physician must impress upon the patient the need for further toxoid injections in 1 month and 1 year. Without such, the active immunization series is incomplete. If a contraindication to using tetanus toxoid-containing preparations exists for a person who has not completed a primary series of tetanus toxoid immunization and that person has a wound that is neither clean nor minor, only passive immunization should be given using tetanus immune globulin. [2] See table under INDICATIONS AND USAGE.

Available evidence indicates that complete primary vaccination with tetanus toxoid provides long lasting protection ≥10 years for most recipients. Consequently, after complete primary tetanus vaccination, boosters-even for wound management-need be given only every 10 years when wounds are minor and uncontaminated. For other wounds, a booster is appropriate if the patient has not received tetanus toxoid within the preceding 5 years. Persons who have received at least two doses of tetanus toxoid rapidly develop antibodies. [2] The prophylactic dosage schedule for these patients and for those with incomplete or uncertain immunity is shown on the table in INDICATIONS AND USAGE.

Since tetanus is actually a local infection, proper initial wound care is of paramount importance. The use of antitoxin is adjunctive to this procedure. However, in approximately 10% of recent tetanus cases, no wound or other breach in skin or mucous membrane could be implicated. [17]

Treatment of active cases of tetanus:
Standard therapy for the treatment of active tetanus including the use of Hyper TET S/D must be implemented immediately. The dosage should be adjusted according to the severity of the infection. [7,8]
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. They should not be used if particulate matter and/or discoloration are present.

HyperTET S/D is supplied with a syringe and an attached UltraSafe® Needle Guard for your protection and convenience. Please follow instructions below for proper use of syringe and UltraSafe® Needle Guard.

Directions for Syringe Usage
Remove the prefilled syringe from the package. Lift syringe by barrel, not by plunger. Twist the plunger rod clockwise until the threads are seated. With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel. Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.] Proceed with hypodermic needle puncture. Aspirate prior to injection to confirm that the needle is not in a vein or artery. Inject the medication. Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B) Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C )
A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors it is important that this product be stored properly and that the directions be followed carefully during use.
Hyperhep B Sd

Hyperhep B Sd

Acute Exposure to Blood Containing HBsAg [15]

Table 1 summarizes prophylaxis for percutaneous (needlestick or bite), ocular, or mucous-membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure (its value beyond 7 days of exposure is unclear). If Hepatitis B Immune Globulin (Human) is indicated (see Table 1), an injection of 0.06 mL/kg of body weight should be administered intramuscularly (see PRECAUTIONS) as soon as possible after exposure and within 24 hours, if possible. Consult Hepatitis B Vaccine package insert for dosage information regarding that product.
Table 1. (adapted from [20]) Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure * Hepatitis B Immune Globulin (Human), dose 0.06 mL / kg IM. † HB Vaccine dose 20 μg IM for adults; 10 μg IM for infants or children under 10 years of age. First dose within 1 week; second and third doses, 1 and 6 months later. ‡ Less than 10 sample ratio units (SRU) by radioimmunoassay (RIA), negative by enzyme immunoassay (EIA). Exposed Person Source Unvaccinated Vaccinated HBsAg-Positive 1. Hepatitis B Immune Globulin (Human) x1 immediately* 1. Test exposed person for anti-HBs. 2. Initiate HB Vaccine Series† 2. If inadequate antibody,‡ Hepatitis B Immune Globulin (Human) (x1) immediately plus HB Vaccine booster dose, or 2 doses of HBIG,* one as soon as possible after exposure and the second 1 month later. Known Source(High Risk) 1. Initiate HB Vaccine Series 1. Test Source for HBsAg only if exposed is vaccine nonresponder; if source is HBsAg-positive, give Hepatitis B Immune Globulin (Human) x1 immediately plus HB Vaccine booster dose, or 2 doses of HBIG,* one as soon as possible after exposure and the second 1 month later. 2. Test source for HBsAg. If positive, Hepatitis B Immune Globulin (Human) x1 Low Risk HBsAg-Positive Initiate HB Vaccine series Nothing required. Unknown Source Initiate HB Vaccine series within 7 days of exposure Nothing required.
For persons who refuse Hepatitis B Vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given 1 month after the first dose.

Prophylaxis of Infants Born to HBsAg and HBeAg Positive Mothers

Efficacy of prophylactic Hepatitis B Immune Globulin (Human) in infants at risk depends on administering Hepatitis B Immune Globulin (Human) on the day of birth. It is therefore vital that HBsAg-positive mothers be identified before delivery.

Hepatitis B Immune Globulin (Human) (0.5 mL) should be administered intramuscularly (IM) to the newborn infant after physiologic stabilization of the infant and preferably within 12 hours of birth. Hepatitis B Immune Globulin (Human) efficacy decreases markedly if treatment is delayed beyond 48 hours. Hepatitis B Vaccine should be administered IM in three doses of 0.5 mL of vaccine (10 μg) each. The first dose should be given within 7 days of birth and may be given concurrently with Hepatitis B Immune Globulin (Human) but at a separate site. The second and third doses of vaccine should be given 1 month and 6 months, respectively, after the first. If administration of the first dose of Hepatitis B Vaccine is delayed for as long as 3 months, then a 0.5 mL dose of Hepatitis B Immune Globulin (Human) should be repeated at 3 months. If Hepatitis B Vaccine is refused, the 0.5 mL dose of Hepatitis B Immune Globulin (Human) should be repeated at 3 and 6 months. Hepatitis B Immune Globulin (Human) administered at birth should not interfere with oral polio and diphtheria-tetanus-pertussis vaccines administered at 2 months of age. [15]

Sexual Exposure to an HBsAg-positive Person

All susceptible persons whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and should begin the hepatitis B vaccine series if prophylaxis can be started within 14 days of the last sexual contact or if sexual contact with the infected person will continue (see Table 2 below). Administering the vaccine with HBIG may improve the efficacy of postexposure treatment. The vaccine has the added advantage of conferring long-lasting protection. [8]
Table 2. (adapted from [21]) Recommendations for Postexposure Prophylaxis for Sexual Exposure to Hepatitis B * HBIG = Hepatitis B Immune Globulin (Human) † IM = intramuscularly ‡ The first dose can be administered the same time as the HBIG dose but at a different site; subsequent doses should be administered as recommended for specific vaccine. HBIG* Vaccine Dose Recommended timing Dose Recommended timing 0.06 mL/kg IM† Single dose within 14 days of last sexual contact 1.0 mL IM† First dose at time of HBIG* treatment‡
Household Exposure to Persons with Acute HBV Infection

Prophylactic treatment with a 0.5 mL dose of Hepatitis B Immune Globulin (Human) and hepatitis B vaccine is indicated for infants <12 months of age who have been exposed to a primary care-giver who has acute hepatitis B. Prophylaxis for other household contacts of persons with acute HBV infection is not indicated unless they have had identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine. [8]

Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to 1 month preceding Hepatitis B Vaccination without impairing the active immune response from Hepatitis B Vaccination.[16]

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Administer intramuscularly. Do not inject intravenously.

Hepatitis B Immune Globulin (Human) — HyperHEP B® S/D is supplied in a syringe with an attached UltraSafe® Needle Guard for your protection and convenience, as well as in vials. Please follow instructions below for proper use of syringe and UltraSafe® Needle Guard.

Directions for Syringe Usage

Remove the prefilled syringe from the package. Lift syringe by barrel,
not by plunger.
Twist the plunger rod clockwise until the threads are seated.

With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel.

Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.]

Proceed with hypodermic needle puncture.

Aspirate prior to injection to confirm that the needle is not in a vein or artery.
Inject the medication.
Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B)

Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C)

A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Hyperrho Sd Mini-dose

Hyperrho Sd Mini-dose

NEVER ADMINISTER HYPERRHO S/D MINI-DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. ADMINISTER ONLY TO WOMEN POSTABORTION OR POSTMISCARRIAGE OF UP TO 12 WEEKS’ GESTATION. NEVER ADMINISTER TO THE NEONATE.

One syringe of HyperRHO S/D Mini-Dose provides sufficient antibody to prevent Rh sensitization to 2.5 mL Rho(D) positive packed red cells or the equivalent (5 mL) of whole blood. This dose is sufficient to provide protection against maternal Rh sensitization for women undergoing spontaneous or induced abortion of up to 12 weeks’ gestation.

Rho(D) Immune Globulin (Human) — HyperRHO® S/D Mini-Dose should be administered within 3 hours or as soon as possible following spontaneous or induced abortion. If prompt administration is not possible, HyperRHO S/D Mini-Dose should be given within 72 hours following termination of the pregnancy.

HyperRHO S/D Mini-Dose is administered intramuscularly, preferably in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve. [10]

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HyperRHO S/D Mini-Dose is supplied with a syringe and an attached UltraSafe® Needle Guard for your protection and convenience. Please follow instructions below for proper use of syringe and UltraSafe® Needle Guard.

Directions for Syringe Usage

Remove the prefilled syringe from the package. Lift syringe by barrel, not by plunger.

Twist the plunger rod clockwise until the threads are seated.

With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel.

Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.]
Proceed with hypodermic needle puncture. Aspirate prior to injection to confirm that the needle is not in a vein or artery. Inject the medication.
Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B)

Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C)

A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.
Gamunex-c

Gamunex-c

GAMUNEX-C consists of 9%–11% protein in 0.16–0.24 M glycine. The buffering capacity of GAMUNEX-C is 35.0 mEq/L (0.35 mEq/g protein). A dose of 1 g/kg body weight therefore represents an acid load of 0.35 mEq/kg body weight. The total buffering capacity of whole blood in a normal individual is 45–50 mEq/L of blood, or 3.6 mEq/kg body weight. Thus, the acid load delivered with a dose of 1 g/kg of GAMUNEX-C would be neutralized by the buffering capacity of whole blood alone, even if the dose was infused instantaneously.

2.1 Preparation and Handling
Visually inspect GAMUNEX-C for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid. Do not freeze. Do not use solutions that have been frozen. The GAMUNEX-C vial is for single use only. GAMUNEX-C contains no preservative. Use any vial that has been entered promptly. Discard partially used vials. Infuse GAMUNEX-C using a separate line by itself, without mixing with other intravenous fluids or medications the subject might be receiving. The GAMUNEX-C infusion line can be flushed with 5% dextrose in water (D5/W) or 0.9% sodium chloride for injection. If dilution is required, GAMUNEX-C may be diluted with 5% dextrose in water (D5/W). Do not dilute with saline. No other drug interactions or compatibilities have been evaluated. Content of vials may be pooled under aseptic conditions into sterile infusion bags and infused within 8 hours after pooling. Avoid simultaneous administration of GAMUNEX-C and Heparin through a single lumen delivery device due to GAMUNEX-C, Heparin incompatibilities. Flush Heparin Lock (Hep-Lock) through which GAMUNEX-C was administered with 5% dextrose in water (D5/W) or 0.9% sodium chloride for injection, and do not flush with Heparin. See table below. Additional Solutions Dilution Line Flush Delivery Device Flush 5% Dextrose in water Yes Yes Yes 0.9% Sodium Chloride No Yes Yes Heparin No No No Do not mix with immune globulin intravenous (IGIV) products from other manufacturers. Do not use after expiration date.
2.2 PI

As there are significant differences in the half-life of IgG among patients with primary humoral immunodeficiencies, the frequency and amount of immunoglobulin therapy may vary from patient to patient. The proper amount can be determined by monitoring clinical response.

Intravenous (IV) The dose of GAMUNEX-C for patients with PI is 300 to 600 mg/kg body weight (3-6 mL/kg) administered every 3 to 4 weeks. The dosage may be adjusted over time to achieve the desired trough levels and clinical responses.

The recommended initial infusion rate is 1 mg/kg/min (0.01 mL/kg/min). If the infusion is well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For patients judged to be at risk for renal dysfunction or thrombosis, administer GAMUNEX-C at the minimum infusion rate practicable. (see Warnings and Precautions [5.2, 5.4])

If a patient routinely receives a dose of less than 400 mg/kg of GAMUNEX-C every 3 to 4 weeks (less than 4 mL/kg), and is at risk of measles exposure (i.e., traveling to a measles endemic area), administer a dose of at least 400 mg/kg (4 mL/kg) just prior to the expected measles exposure. If a patient has been exposed to measles, a dose of 400 mg/kg (4 mL/kg) should be administered as soon as possible after exposure.

Subcutaneous (SC) The dose should be individualized based on the patient’s clinical response to GAMUNEX-C therapy and serum IgG trough levels. Begin treatment with GAMUNEX-C one week after the patient’s last IGIV infusion. See below under "Initial Weekly Dose". Prior to switching treatment from IGIV to GAMUNEX-C, obtain the patient’s serum IgG trough level to guide subsequent dose adjustments. See below under "Dose Adjustment".

Establish the initial weekly dose of GAMUNEX-C by converting the monthly IGIV dose into a weekly equivalent and increasing it using a dose adjustment factor. The goal is to achieve a systemic serum IgG exposure (Area Under the Concentration-Time Curve [AUC]) not inferior to that of the previous IGIV treatment. If the patient has not been previously treated with IV GAMUNEX-C, convert the monthly IGIV dose by multiplying by 1.37, then dividing this dose into weekly doses based on the patient’s previous IGIV treatment interval. Monitor the patient’s clinical response, and adjust dose accordingly.

Initial Weekly DoseTo calculate the initial weekly dose of subcutaneous administration of GAMUNEX-C, multiply the previous IGIV dose in grams by the dose adjustment factor of 1.37; then divide this by the number of weeks between doses during the patient’s IGIV treatment (i.e., 3 or 4).

Initial SC dose = 1.37 × previous IGIV dose (in grams) Number of weeks between IGIV doses

To convert the GAMUNEX-C dose (in grams) to milliliters (mL), multiply the calculated dose (in grams) by 10.

Dose AdjustmentOver time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level. To determine if a dose adjustment may be considered, measure the patient’s serum IgG trough level on IGIV and as early as 5 weeks after switching from IGIV to subcutaneous. The target serum IgG trough level on weekly SC treatment is projected to be the last IGIV trough level plus 340 mg/dL. To determine if further dose adjustments are necessary, monitor the patient’s IgG trough level every 2 to 3 months.

To adjust the dose based on trough levels, calculate the difference (in mg/dL) of the patient’s serum IgG trough level from the target IgG trough level (the last IGIV trough level + 340 mg/dL). Then find this difference in Table 1 and the corresponding amount (in mL) by which to increase or decrease the weekly dose based on the patient’s body weight. However, the patient’s clinical response should be the primary consideration in dose adjustment.
Table 1: Adjustment (±mL) of the Weekly Subcutaneous Dose Based on the Difference (±mg/dL) From the Target Serum IgG Trough Level * Dose adjustment in mL is based on the slope of the serum IgG trough level response to subcutaneous administration of GAMUNEX-C dose increments (about 6.0 mg/dL per increment of 1 mg/kg per week). Difference From Target IgG Trough Level (mg/dL) Body Weight (kg) 10 15 20 30 40 50 60 70 80 90 100 110 120 Dose Adjustment (mL per Week)* 50 1 1 2 3 3 4 5 6 7 8 8 9 10 100 2 3 3 5 7 8 10 12 13 15 17 18 20 150 3 4 5 8 10 13 15 18 20 23 25 28 30 200 3 5 7 10 13 17 20 23 27 30 33 37 40 250 4 6 8 13 17 21 25 29 33 38 42 46 50 300 5 8 10 15 20 25 30 35 40 45 50 55 60 350 6 9 12 18 23 29 35 41 47 53 58 64 70 400 7 10 13 20 27 33 40 47 53 60 67 73 80 450 8 11 15 23 30 38 45 53 60 68 75 83 90 500 8 13 17 25 33 42 50 58 67 75 83 92 100
For example, if a patient with a body weight of 70 kg has an actual IgG trough level of 900 mg/dL and the target level is 1000 mg/dL, this results in a difference of 100 mg/dL. Therefore, increase the weekly dose of subcutaneous dose by 12 mL.

Monitor the patient’s clinical response, and repeat the dose adjustment as needed.

Dosage requirements for patients switching to GAMUNEX-C from another Immune Globulin Subcutaneous (IGSC) product have not been studied. If a patient on GAMUNEX-C does not maintain an adequate clinical response or a serum IgG trough level equivalent to that of the previous IGSC treatment, the physician may want to adjust the dose. For such patients, Table 1 also provides guidance for dose adjustment to achieve a desired IGSC trough level.

2.3 ITP

DO NOT ADMINISTER SUBCUTANEOUSLY (see Warnings and Precautions [5.10])

GAMUNEX-C may be administered at a total dose of 2 g/kg, divided in two doses of 1 g/kg (10 mL/kg) given on two consecutive days or into five doses of 0.4 g/kg (4 mL/kg) given on five consecutive days. If after administration of the first of two daily 1 g/kg (10 mL/kg) doses, an adequate increase in the platelet count is observed at 24 hours, the second dose of 1g/kg (10 mL/kg) body weight may be withheld.

Forty-eight ITP subjects were treated with 2 g/kg GAMUNEX-C, divided in two 1 g/kg doses (10 mL/kg) given on two successive days. With this dose regimen 35/39 subjects (90%) responded with a platelet count from less than or equal to 20 x109/L to more than or equal to 50 x109/L within 7 days after treatment. The high dose regimen (1 g/kg × 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.

The recommended initial infusion rate is 1 mg/kg/min (0.01 mL/kg/min). If the infusion is well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For patients judged to be at risk for renal dysfunction or thrombosis, administer GAMUNEX-C at the minimum infusion rate practicable. (see Warnings and Precautions [5.2, 5.4])

2.4 CIDP

GAMUNEX-C may be initially administered as a total loading dose of 2 g/kg (20 mL/kg) given in divided doses over two to four consecutive days. GAMUNEX-C may be administered as a maintenance infusion of 1 g/kg (10 mL/kg) administered over 1 day or divided into two doses of 0.5 g/kg (5 mL/kg) given on two consecutive days, every 3 weeks.

The recommended initial infusion rate is 2 mg/kg/min (0.02 mL/kg/min). If the infusion is well tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/min (0.08 mL/kg/min). For patients judged to be at risk for renal dysfunction or thrombosis, administer GAMUNEX-C at the minimum infusion rate practicable. (see Warnings and Precautions [5.2, 5.4])

2.5 Administration

Administer intravenously for PI, ITP and CIDP.

GAMUNEX-C may also be administered subcutaneously for the treatment of PI.
Administer GAMUNEX-C at room temperature. Inspect GAMUNEX-C visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Do not use if turbid and/or if discoloration is observed.
Intravenous
Use only 18 gauge needles to penetrate the stopper for dispensing product from the 10 mL vial. Use 16 gauge needles or dispensing pins only with 25 mL vial sizes and larger. Insert needles or dispensing pins only once and be within the stopper area delineated by the raised ring. Penetrate the stopper perpendicular to the plane of the stopper within the ring. GAMUNEX®-C vial size Gauge of needle to penetrate stopper 10 mL 18 gauge 25, 50, 100, 200, 400 mL 16 gauge Use promptly any vial that has been opened. Discard partially used vials. If dilution is required, GAMUNEX-C may be diluted with 5% dextrose in water (D5/W). Do not dilute with saline. Infuse GAMUNEX-C using a separate line by itself, without mixing with other intravenous fluids or medications the subject might be receiving. The GAMUNEX-C infusion line can be flushed with 5% dextrose in water (D5/W) or 0.9% sodium chloride for injection.
Subcutaneous for PI Only

Instructions for Administration
Prior to use, allow the solution to reach ambient room temperature. DO NOT SHAKE. Do not use if the solution is cloudy or has particulates. Check the product expiration date on the vial. Do not use beyond the expiration date. Use aseptic technique when preparing and administering GAMUNEX-C for injection. Remove the protective cap from the vial to expose the central portion of the rubber stopper. Wipe the rubber stopper with alcohol and allow to dry. Using a sterile syringe and needle, prepare to withdraw GAMUNEX-C by first injecting air into the vial that is equivalent to the amount of GAMUNEX-C to be withdrawn. Then withdraw the desired volume of GAMUNEX-C. If multiple vials are required to achieve the desired dose, repeat this step. (Figure 1) Follow the manufacturer’s instructions for filling the pump reservoir and preparing the pump, administration tubing and Y-site connection tubing, if needed. Be sure to prime the administration tubing to ensure that no air is left in the tubing or needle by filling the tubing/needle with GAMUNEX-C. Select the number and location of injection sites. (Figure 2) Cleanse the injection site(s) with antiseptic solution using a circular motion working from the center of the site and moving to the outside. Sites should be clean, dry, and at least two inches apart. (Figure 3) Grasp the skin between two fingers and insert the needle into the subcutaneous tissue. (Figure 4) Repeat priming and needle insertion steps using a new needle, administration tubing and a new infusion site. Secure the needle in place by applying sterile gauze or transparent dressing over the site. (Figure 5) If using multiple, simultaneous injection sites, use Y-site connection tubing and secure to the administration tubing. Infuse GAMUNEX-C following the manufacturer’s instructions for the pump. (Figure 6)
Rate of Administration

Intravenous

Following initial infusion (see table below), the infusion rate may be gradually increased to a maximum of 0.08 mL/kg per minute (8 mg/kg per minute) as tolerated.
Indication Initial Infusion Rate(first 30 minutes) Maximum Infusion Rate(if tolerated) PI 1 mg/kg/min 8 mg/kg/min ITP 1 mg/kg/min 8 mg/kg/min CIDP 2 mg/kg/min 8 mg/kg/min
Monitor patient vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.

Certain severe adverse drug reactions may be related to the rate of infusion. Slowing or stopping the infusion usually allows the symptoms to disappear promptly.

Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients at risk of renal dysfunction or thrombosis, administer GAMUNEX-C at the minimum infusion rate practicable and discontinue GAMUNEX-C if renal function deteriorates.

Subcutaneous for PI Only

For PI, it is recommended that GAMUNEX-C is infused at a rate of 20 mL/hr per infusion site.

In the SC clinical study, the mean volume administered per infusion site was 34 mL (17-69 mL) and the majority of infusions were administered at a rate of 20 mL/hr per site. Multiple simultaneous infusion sites were enabled by administration tubing and Y-site connection tubing. Most subjects utilized 4 infusion sites per infusion with abdomen and thighs being the most commonly used sites. The maximum number of infusion sites is 8. Injection sites should be at least 2 inches apart.
Thrombate Iii

Thrombate Iii

Each bottle of THROMBATE III has the functional activity, in international units (IU), stated on the label of the bottle. The potency assignment has been determined with a standard calibrated against a World Health Organization antithrombin III reference preparation.

Dosage should be determined on an individual basis based on the pre-therapy plasma ATIII level, in order to increase plasma ATIII levels to the level found in normal human plasma (80-120%). Dosage of THROMBATE III can be calculated from the following formula:

The above formula is based on an expected incremental in vivo recovery above baseline levels for Antithrombin III (Human), THROMBATE III® of 1.4% per IU per kg administered.(14) Thus, if a 70 kg individual has a baseline ATIII level of 57%, in order to increase plasma ATIII to 120%, the initial THROMBATE III dose would be [(120–57) × 70]/1.4 = 3150 IU total.

However, recovery may vary, and initially levels should be drawn at baseline and 20 minutes post infusion. Subsequent doses can be calculated based on the level achieved with the first dose. These recommendations are intended only as a guide for therapy. The exact loading dose and maintenance intervals should be individualized for each patient.

It is recommended that following an initial dose of THROMBATE III, plasma levels of ATIII be initially monitored at least every 12 hours and before the next infusion of THROMBATE III to maintain plasma ATIII levels greater than 80%. In some situations, e.g., following surgery,(26) hemorrhage or acute thrombosis, and during intravenous heparin administration,(19,27–29) the half-life of Antithrombin III (Human) has been reported to be shortened. In such conditions, plasma ATIII levels should be monitored more frequently, and THROMBATE III administered as necessary.

When an infusion of THROMBATE III is indicated for a patient with hereditary deficiency to control an acute thrombotic episode or prevent thrombosis during or following surgical or obstetrical procedures, it is desirable to raise the ATIII level to normal and maintain this level for 2 to 8 days, depending on the indication for treatment, type and extent of surgery, patient’s medical condition, past history and physician’s judgment. Concomitant administration of heparin in each of these situations should be based on the medical judgment of the physician.

As a general recommendation, the following therapeutic program may be utilized as a starting program for treatment, modifying the program based on the actual plasma ATIII levels achieved:
a) An initial loading dose of THROMBATE III calculated to elevate the plasma ATIII level to 120%, assuming an expected rise over the baseline plasma ATIII level of 1.4% (functional activity) per IU per kg of THROMBATE III administered. Thus, for an individual with a body weight of 70 kg and a baseline ATIII level of 57%, the initial THROMBATE III dose would be 3150 IU: b) Measure preinfusion and 20 minutes postinfusion (peak) plasma ATIII levels following the initial loading dose, plasma ATIII level after 12 hours, then preceding the next infusion (trough level). Subsequently measure ATIII levels preceding and 20 minutes after each infusion until predictable peak and trough levels have been achieved, generally between 80%–120%. Plasma levels between 80%–120% may be maintained by administration of maintenance doses of 60% of the initial loading dose, administered every 24 hours. Adjustments in the maintenance dose and/or interval between doses should be made based on actual plasma ATIII levels achieved.
The above recommendations for dosing are provided as a general guideline for therapy only. The exact loading and maintenance dosages and dosing intervals should be individualized for each subject, based on the individual clinical conditions, response to therapy, and actual plasma ATIII levels achieved. In some situations, e.g., following surgery,(26) with hemorrhage or acute thrombosis and during intravenous heparin administration,(19,27–29) in vivo survival of infused THROMBATE III has been reported to be shortened, resulting in the need to administer THROMBATE III more frequently.

Antithrombin III (Human), THROMBATE III, is reconstituted with Sterile Water for Injection, USP at room temperature. THROMBATE III should be filtered through a sterile filter needle as supplied in the package prior to use, and should be administered within 3 hours following reconstitution. THROMBATE III may be infused over 10–20 minutes. THROMBATE III must be administered intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Reconstitution

Vacuum TransferNote: Aseptic technique should be carefully followed. All needles and vial tops that will come into contact with the product to be administered via the intravenous route should not come in contact with any nonsterile surface. Any contaminated needles should be discarded by placing in a puncture-proof container and new equipment should be used.
THROMBATE III and diluent should be at room temperature before reconstitution. Remove shrink band from product vial. If the shrink band is absent or shows signs of tampering, do not use the product and notify Grifols Therapeutics Inc. immediately. Remove the plastic flip tops from each vial (Fig. A). Cleanse vial tops (grey stoppers) with alcohol swab and allow surface to dry. After cleaning, do not allow anything to touch the stopper. Carefully remove the plastic sheath from the short end of the transfer needle. Insert the exposed needle into the diluent vial to the hub (Fig. B). Carefully grip the sheath of the other end of the transfer needle and twist to remove it. Invert the diluent vial and insert the attached needle into the THROMBATE III vial at a 45° angle (Fig. C). This will direct the stream of diluent against the wall of the vial and minimize foaming. The vacuum will draw the diluent into the THROMBATE III vial.* When diluent transfer is complete, remove the diluent vial and transfer needle (Fig. D). Immediately after adding the diluent, swirl continuously until completely dissolved (Fig. E). Some foaming may occur, but attempt to avoid excessive foaming. The vial should then be visually inspected for particulate matter and discoloration prior to administration. Clean the top of the vial of reconstituted THROMBATE III again with alcohol swab and let surface dry. Attach the filter needle (from the package) to sterile syringe. Withdraw the THROMBATE III solution into the syringe through the filter needle (Fig. F). Remove the filter needle from the syringe and replace with an appropriate injection or butterfly needle for administration. Discard filter needle into a puncture-proof container. If the same patient is using more than one vial of THROMBATE III, the contents of multiple vials may be drawn into the same syringe through the filter needles provided.
*If vacuum is lost in the THROMBATE III vial during reconstitution, use a sterile syringe to remove the sterile water from the diluent vial and inject it into the THROMBATE III vial, directing the stream of fluid against the wall of the vial.

Rate of Administration

The rate of administration should be adapted to the response of the individual patient, but administration of the entire dose in 10 to 20 minutes is generally well tolerated.
Prolastin-c

Prolastin-c

For intravenous use only.

2.1 Dose
The recommended dose of PROLASTIN-C is 60 mg/kg body weight administered intravenously once weekly. Dose ranging studies using efficacy endpoints have not been performed with any alpha1-proteinase inhibitor product. The label on each vial of PROLASTIN-C shows the amount of functionally active Alpha1-PI in milligrams (as determined by the capacity to neutralize porcine pancreatic elastase).
2.2 Reconstitution
Allow unopened PROLASTIN-C and diluent vials to warm up to room temperature before reconstitution. Remove the plastic flip tops from each vial. Swab the exposed stopper surfaces with alcohol and allow to dry. Remove the plastic cover from the short end of the transfer needle. Insert the exposed end of the needle through the center of the stopper in the diluent vial. Remove the cover at the other end of the transfer needle by twisting it carefully. Invert the diluent vial and insert the attached needle into the PROLASTIN-C vial at a 45° angle (Figure A below). This will direct the stream of diluent against the wall of the product vial and minimize foaming. The vacuum will draw the diluent into the PROLASTIN-C vial. Remove the diluent vial and transfer needle. Immediately after adding the diluent, swirl vigorously for 10-15 seconds to thoroughly break up cake, then swirl continuously until the powder is completely dissolved (Figure B below). Some foaming will occur, but does not affect the quality of the product. Inspect the reconstituted PROLASTIN-C visually for particulate matter and discoloration prior to pooling. A few small particles may remain after reconstitution. If particles are visible, remove by passage through a sterile filter, such as a 15 micron filter used for administering blood products (not supplied). Pool reconstituted PROLASTIN-C from several vials into an empty, sterile intravenous solution container using aseptic technique. Use the sterile filter needle provided for this purpose. Keep reconstituted solution at room temperature for administration within three hours.
2.3 Administration

Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.

Infuse PROLASTIN-C intravenously at 0.08 mL/kg/min as determined by patient response and comfort. The recommended dosage of 60 mg/kg takes approximately 15 minutes to infuse.

Infuse PROLASTIN-C separately, without mixing with other agents or diluting solutions.
Hyperrho Sd Full Dose

Hyperrho Sd Full Dose

NEVER ADMINISTER HYPERRHO S/D FULL DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. NEVER ADMINISTER TO THE NEONATE.

Pregnancy and Other Obstetric Conditions

For postpartum prophylaxis, administer one syringe of HyperRHO S/D Full Dose, preferably within 72 hours of delivery. Although a lesser degree of protection is afforded if Rh antibody is administered beyond the 72-hour period, HyperRHO S/D Full Dose may still be given. [7,14] Full-term deliveries can vary in their dosage requirements depending on the magnitude of the fetomaternal hemorrhage. One full dose syringe of HyperRHO S/D Full Dose provides sufficient antibody to prevent Rh sensitization if the volume of red blood cells that has entered the circulation is 15 mL or less. [2-4] In instances where a large (greater than 30 mL of whole blood or 15 mL red blood cells) fetomaternal hemorrhage is suspected, a fetal red cell count by an approved laboratory technique (e.g., modified Kleihauer-Betke acid elution stain technique) should be performed to determine the dosage of immune globulin required. [8,15] The red blood cell volume of the calculated fetomaternal hemorrhage is divided by 15 mL to obtain the number of syringes of HyperRHO S/D Full Dose for administration. [3,8,13] If more than 15 mL of red cells is suspected or if the dose calculation results in a fraction, administer the next higher whole number of syringes (e.g., if 1.4, give 2 syringes).

For antenatal prophylaxis, one full dose syringe of HyperRHO S/D Full Dose is administered at approximately 28 weeks’ gestation. This must be followed by another full dose, preferably within 72 hours following delivery, if the infant is Rh positive.

Following threatened abortion at any stage of gestation with continuation of pregnancy, it is recommended that a full dose of HyperRHO S/D Full Dose be given. If more than 15 mL of red cells is suspected due to fetomaternal hemorrhage, the same dose modification in No. 1 above applies.

Following miscarriage, abortion, or termination of ectopic pregnancy at or beyond 13 weeks’ gestation, it is recommended that a HyperRHO S/D Full Dose be given. If more than 15 mL of red cells is suspected due to fetomaternal hemorrhage, the same dose modification in No. 1 above applies. If pregnancy is terminated prior to 13 weeks’ gestation, where licensed, a single dose of HyperRHO® S/D Mini-Dose may be used instead of HyperRHO S/D Full Dose.

Following amniocentesis at either 15 to 18 weeks’ gestation or during the third trimester, or following abdominal trauma in the second or third trimester, it is recommended that a HyperRHO S/D Full Dose be administered. If there is a fetomaternal hemorrhage in excess of 15 mL of red cells, the same dose modification in No. 1 applies.

If abdominal trauma, amniocentesis, or other adverse event requires the administration of HyperRHO S/D Full Dose at 13 to 18 weeks’ gestation, another full dose should be given at 26 to 28 weeks. To maintain protection throughout pregnancy, the level of passively acquired anti-Rho(D) should not be allowed to fall below the level required to prevent an immune response to Rh positive red cells. The half-life of IgG is 23 to 26 days. In any case, a HyperRHO S/D Full Dose should be given within 72 hours after delivery if the baby is Rh positive. If delivery occurs within 3 weeks after the last dose, the postpartum dose may be withheld unless there is a fetomaternal hemorrhage in excess of 15 mL of red blood cells.[16]

Transfusion

In the case of a transfusion of Rho(D) positive red cells to an Rho(D) negative recipient, the volume of Rh positive whole blood administered is multiplied by the hematocrit of the donor unit giving the volume of red blood cells transfused. The volume of red blood cells is divided by 15 mL which provides the number of syringes of HyperRHO S/D Full Dose to be administered.

If the dose calculated results in a fraction, the next higher whole number of syringes should be administered (e.g., if 1.4, give 2 syringes). HyperRHO S/D Full Dose should be administered within 72 hours after an incompatible transfusion, but preferably as soon as possible.

Injection Procedure

DO NOT INJECT INTRAVENOUSLY. DO NOT INJECT NEONATE. HyperRHO S/D Full Dose is administered intramuscularly, preferably in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve. [17]
A. Single Syringe Dose INJECT ENTIRE CONTENTS OF THE SYRINGE INTO THE INDIVIDUAL INTRAMUSCULARLY. B. Multiple Syringe Dose Calculate the number of syringes of HyperRHO S/D Full Dose to be given (see Dosage section).
The total volume of HyperRHO S/D Full Dose can be given in divided doses at different sites at one time or the total dose may be divided and injected at intervals, provided the total dosage is given within 72 hours of the fetomaternal hemorrhage or transfusion. USING STERILE TECHNIQUE, INJECT THE ENTIRE CONTENTS OF THE CALCULATED NUMBER OF SYRINGES INTRAMUSCULARLY INTO THE PATIENT.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HyperRHO S/D Full Dose is supplied with a syringe and an attached UltraSafe® Needle Guard for your protection and convenience. Please follow instructions below for proper use of syringe and UltraSafe® Needle Guard.

Directions for Syringe Usage
Remove the prefilled syringe from the package. Lift syringe by barrel, not by plunger. Twist the plunger rod clockwise until the threads are seated. With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel.
Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.]
Proceed with hypodermic needle puncture. Aspirate prior to injection to confirm that the needle is not in a vein or artery. Inject the medication.
Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B)

Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C)

A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration, and biological differences in individual patients. Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.

Grifols Usa, Llc

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