Csl Behring Llc

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Csl Behring Llc Drugs

Vivaglobin

Vivaglobin

For subcutaneous infusion only. DO NOT INJECT INTO A BLOOD VESSEL.

2.1 Self-Administration

Self-administration is appropriate for some patients. If self-administration is planned, the healthcare professional should provide the patient with instructions and training for subcutaneous infusion in the home or other appropriate setting (see Patient Counseling Information [17.1] and the FDA-Approved Patient Labeling).

2.2 Preparation and Handling

Vivaglobin is a colorless to light brown solution. Do not use if the solution is cloudy (turbid) or contains particulates.
Prior to administration, bring the Vivaglobin vial(s) to room temperature. Then, visually inspect each vial for particulate matter by gently swirling the vial, and check for discoloration by holding it up to the light. Check the product expiration date on the vial label. Do not use beyond the expiration date. Do not mix Vivaglobin with other products. Do not shake the Vivaglobin vial. Use aseptic technique when preparing and administering Vivaglobin. The Vivaglobin vial is for single-use only. Discard all administration equipment and any unused product immediately after each infusion in accordance with local requirements.
2.3 Dosage

The dose should be individualized based on the patient's clinical response to Vivaglobin therapy and serum immunoglobulin (IgG) trough levels.

Begin treatment with Vivaglobin one week after the patient has received a regularly scheduled Immune Globulin Intravenous (Human) (IGIV) infusion. Prior to receiving treatment with Vivaglobin, patients need to have been receiving IGIV treatment for at least 3 months at dosing intervals of either every 3 weeks or every 4 weeks.

The initial weekly dose of Vivaglobin is established by converting the monthly IGIV dose into a weekly equivalent and increasing it using a dose adjustment factor (see Initial Weekly Dose). The goal is to achieve a systemic serum IgG exposure (area under the concentration-time curve [AUC]) not inferior to the AUC of the previous IGIV treatment (see Pharmacokinetics [12.3]).

Prior to switching treatment from IGIV to Vivaglobin, obtain the patient's serum IgG trough level to guide subsequent dose adjustment (see Dose Adjustment). After 2 to 3 months, weekly administration of Vivaglobin will lead to stable steady-state serum IgG levels with lower IgG peak levels and higher IgG trough levels compared with monthly IGIV treatment.

Initial Weekly Dose

To calculate the initial weekly dose of Vivaglobin, multiply the previous IGIV dose in grams (g) by the dose adjustment factor of 1.37, then divide this dose by the number of weeks between doses during the patient's previous IGIV treatment (i.e., 3 or 4).
IGSC weekly dose (g) = 1.37 × previous IGIV dose (g) Number of weeks between IGIV doses
To convert the Vivaglobin dose (g) to milliliters (mL), divide the dose in grams (g) by 0.16.

Dose Adjustment

Over 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 should be considered, measure the patient's serum IgG trough level on IGIV prior to switching to Vivaglobin and every 2 to 3 months after switching from IGIV to Vivaglobin.

To achieve the same AUC with Vivaglobin as with the previous IGIV treatment, follow these steps:
Estimate the target serum IgG trough level on weekly Vivaglobin treatment, which is derived as follows: Target concentration (mg/dL) during Vivaglobin treatment = the last trough level during prior IGIV treatment + 180 mg/dL In Table 1, find the additional Vivaglobin dose to be administered, based on the patient's body weight, and the difference between the target IgG concentration (mg/dL) and the observed trough level during Vivaglobin treatment. Additional dosage increments may be indicated based on the patient's clinical response (infection frequency and severity). Table 1: Adjustment (±mL) of the Weekly Vivaglobin Dose Based on the Difference (±mg/dL) From the Target Serum IgG Trough Level* 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)† * Target IgG concentration (mg/dL) during Vivaglobin treatment equals the last observed trough level during prior IGIV treatment plus 180 mg/dL. † Dose adjustment in mL is based on the slope of the serum IgG trough level response to Vivaglobin dose increments (6.1 mg/dL per increment of 1 mg/kg per week). 100 1 2 2 3 4 5 6 7 8 9 10 11 12 150 2 2 3 5 6 8 9 11 12 14 15 17 18 200 2 3 4 6 8 10 12 14 16 18 20 23 25 250 3 4 5 8 10 13 15 18 20 23 26 28 31 300 3 5 6 9 12 15 18 22 25 28 31 34 37 350 4 5 7 11 14 18 22 25 29 32 36 39 43 400 4 6 8 12 16 20 25 29 33 37 41 45 49 450 5 7 9 14 18 23 28 32 37 41 46 51 55 500 5 8 10 15 20 26 31 36 41 46 51 56 61
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 trough level is 1000 mg/dL, this results in a difference of 100 mg/dL. Therefore, increase the weekly dose of Vivaglobin by 7 mL.

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

2.4 Administration

Vivaglobin is for subcutaneous infusion only. DO NOT INJECT INTO A BLOOD VESSEL.

Vivaglobin is for subcutaneous infusion, preferably in the abdomen, thigh, upper arm, and/or lateral hip. Multiple injection sites should be at least two inches apart, and the actual point of injection should be changed with each weekly administration.
Infusion volume – Do not exceed 15 mL per site. Divide doses greater than 15 mL and infuse into a maximum of three simultaneous sites for children weighing less than 45 kg (99 pounds), a maximum of six simultaneous sites for adults up to age 65, and a maximum of four simultaneous sites for patients 65 years of age and older. If necessary, additional sites can be used consecutively during an infusion. Infusion rate – The maximum recommended infusion rate is 20 mL per hour per site and should not exceed a total of 3.0 mg/kg/minute (1.13 mL/kg/hour) for all simultaneous injection sites combined.
Ensure that patients are not volume depleted.

Follow the steps below and use aseptic technique to administer Vivaglobin. For information about subcutaneous infusion in the home or other appropriate setting, see Patient Counseling Information (17.1).
1. Assemble supplies – Place the Vivaglobin vial(s) and all supplies needed for the infusion on a clean, flat surface. 2. Thoroughly wash and dry hands – The use of gloves when preparing and administering Vivaglobin is optional. 3. Clean the vial stopper – Remove the protective cap from the vial to expose the central portion of the rubber stopper. Clean the stopper with alcohol and allow it to dry. 4. Prepare and fill the syringe(s) – Using a sterile syringe and needle, pull back on the plunger to draw air into the syringe that is equal to the amount of Vivaglobin to be withdrawn. Then, insert the needle into the vial stopper and inject the air into the vial. Finally, withdraw the desired volume of Vivaglobin. If multiple vials are required to achieve the desired dose, repeat this step with another syringe. 5. Fill and prime the infusion pump – Follow the manufacturer's instructions for filling the pump reservoir and for 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 Vivaglobin. 6. Select the injection site(s) – The number and location of injection sites depends on the volume of the total dose. Doses greater than 15 mL should be divided and infused into multiple sites that are at least two inches apart. The recommended number of simultaneous injection sites is up to six for adults, up to three for children who weigh less than 45 kg (99 pounds) and up to four for patients ages 65 and over. If necessary, additional injection sites can be used consecutively. 7. Clean the injection site(s) – Using an antiseptic solution, clean each site beginning at the center and working outward in a circular motion. Allow each site to dry before proceeding. 8. Insert the needle – Based on the patient's body mass, grasp or spread the skin; then insert the needle into the subcutaneous tissue. 9. Check for proper placement of the needle. Vivaglobin must not be injected into a blood vessel – After inserting each needle into the subcutaneous tissue and before starting the infusion, test to make sure that a blood vessel has not been accessed accidentally. To do this, attach a sterile syringe to the end of the primed administration tubing, gently pull back on the plunger, and see if any blood is flowing back into the tubing. If blood is present, remove and discard the needle and administration tubing. Repeat steps 5 and 8 (priming and needle insertion) using a new needle, new administration tubing, and a different injection site. 10. Secure the needle to the skin – Apply sterile gauze or transparent dressing over each site to hold the needle in place. If using multiple, simultaneous injection sites, secure the Y-site connection tubing to the administration tubing. 11. Infuse Vivaglobin – Follow the manufacturer's instructions to turn on the pump. 12. Record the infusion – Remove the peel-off portion of the label from each vial used, and affix it to the patient record.
After administration, immediately discard any unused product and administration equipment in accordance with local procedures.
Zemaira

Zemaira

For Intravenous Use After Reconstitution Only.

The recommended dose of Zemaira is 60 mg/kg body weight administered once weekly. Dose ranging studies using efficacy endpoints have not been performed with Zemaira or any A1-PI product.

2.1 Preparation and Reconstitution
Check the expiration date on the vial label and carton. Do not use Zemaira after the expiration date. Reconstitute prior to use. Reconstitute Zemaira using aseptic technique to maintain product sterility. Inspect the reconstituted solution prior to administration. The solution should be clear, colorless to slightly yellow, and free from visible particles. Administer Zemaira at room temperature within 3 hours after reconstitution. Reconstituted Zemaira may be stored at room temperature. Do not freeze the reconstituted solution.
Follow the steps below to reconstitute Zemaira:
1. Ensure that the Zemaira (green cap) vial and diluent (white cap) vial are at room temperature. 2. Remove the plastic flip-top caps from the vials. Aseptically cleanse the rubber stoppers with antiseptic solution and allow them to dry. Notes on Using the Transfer Device (Steps 3 through 7): The transfer device (Figure 1) provided in the Zemaira carton has a white (diluent) end with a double orifice and a green (Zemaira) end with a single orifice. Incorrect use of the transfer device will result in loss of vacuum and prevent transfer of the diluent, thereby prolonging or preventing reconstitution of Zemaira. The transfer device is sterile. Once the protective covers have been removed (Steps 3 and 4), do not touch the exposed ends of the spikes. Figure 1 3. Remove the protective cover from the white (diluent) end of the transfer device. Insert the white end of the transfer device into the center of the stopper of the upright diluent vial (Figure 2). Figure 2 4. Remove the protective cover from the green (Zemaira) end of the transfer device. Invert the diluent vial with the attached transfer device and, using minimum force, insert the green end of the transfer device into the center of the rubber stopper of the upright Zemaira vial (green top) (Figure 3). The flange of the transfer device should rest on the surface of the stopper so that the diluent flows into the Zemaira vial. Figure 3 5. Allow the vacuum in the Zemaira vial to pull the diluent into the Zemaira vial. 6. During diluent transfer, wet the lyophilized cake completely by gently tilting the Zemaira vial (Figure 4). Do not allow the air inlet filter to face downward. Care should be taken not to lose the vacuum, as this will prolong or prevent reconstitution. Figure 4 7. After diluent transfer is complete, the transfer device will allow filtered air into the Zemaira vial through the air filter; additional venting of the Zemaira vial is not required. When diluent transfer is complete, withdraw the transfer device from the diluent vial and discard the diluent vial and transfer device. 8. Gently swirl the Zemaira vial until the powder is completely dissolved (Figure 5). DO NOT SHAKE. Figure 5
If more than 1 vial of Zemaira is needed to achieve the required dose, use aseptic technique to transfer the reconstituted solution from the vials into the administration container (e.g., empty intravenous bag or glass bottle).

2.2 Administration
For intravenous use only. Do not mix Zemaira with other medicinal products. Administer Zemaira through a separate dedicated infusion line. Perform a visual inspection of the reconstituted solution. The solution should be clear, colorless to slightly yellow, and free from visible particles. Administer at room temperature within 3 hours after reconstitution. Filter the reconstituted solution during administration. To ensure proper filtration of Zemaira, use an intravenous administration set with a suitable 5 micron infusion filter (not supplied). Administer Zemaira intravenously at a rate of approximately 0.08 mL/kg/min as determined by the response and comfort of the patient. The recommended dosage of 60 mg/kg body weight will take approximately 15 minutes to infuse. Monitor closely the infusion rate and the patient's clinical state, including vital signs, throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient. Zemaira is for single use only. Following administration, discard any unused solution and all administration equipment in an appropriate manner as per local requirements.
Stimate

Stimate

Hemophilia A and von Willebrand's Disease (Type I)

Stimate® Nasal Spray is administered by nasal insufflation, one spray per nostril, to provide a total dose of 300 mcg. In patients weighing less than 50 kg, 150 mcg administered as a single spray provided the expected effect on Factor VIII coagulant activity, Factor VIII ristocetin cofactor activity and skin bleeding time. If Stimate® Nasal Spray is used preoperatively, it should be administered 2 hours prior to the scheduled procedure.

The necessity for repeat administration of Stimate® Nasal Spray or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. Fluid restriction should be observed, and fluid intake should be limited to a minimum, from 1 hour before desmopressin administration, until at least 24 hours after administration. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than once every 48 hours should be considered in treating each patient.

The nasal spray pump can only deliver doses of 0.1 mL (150 mcg) or multiples of 0.1 mL. If doses other than these are required, DDAVP® Injection may be used.

The spray pump must be primed prior to the first use. To prime pump, press down 4 times. The bottle should be discarded after 25 sprays since the amount delivered thereafter per spray may be substantially less than 150 mcg of drug.
Mononine

Mononine

Mononine® is intended for intravenous administration only. It should be reconstituted with the volume of Sterile Water for Injection, USP supplied with the lot, and administered within three hours of reconstitution. Do not refrigerate after reconstitution. After administration, any unused solution and the administration equipment should be discarded.

As a general rule, 1 IU of Factor IX activity per kg can be expected to increase the circulating level of Factor IX by 1% [IU/dL] of normal. The following formula provides a guide to dosage calculations:
Number of Factor IX = Body Weight × desired Factor IX × 1.0 IU/kg IU required (IU) (in kg) increase (% or IU/dL normal) [per IU/dL]
The amount of Mononine® to be infused, as well as the frequency of infusions, will vary with each patient and with the clinical situation.11,12

As a general rule, the level of Factor IX required for treatment of different conditions is as follows:
Minor Spontaneous Hemorrhage, Prophylaxis Major Trauma or Surgery Desired levels of Factor IX for Hemostasis 15-25%[or IU/dL] 25-50%[or IU/dL] Initial loading dose to achieve desired level up to 20-30 IU/kg up to 75 IU/kg Frequency of dosing once; repeated in 24 hours if necessary every 18-30 hours, depending on T1/2 and measured Factor IX levels Duration of treatment once; repeated if necessary up to ten days, depending upon nature of insult
Recovery of the loading dose varies from patient to patient. Doses administered should be titrated to the patient's response. Mononine® administered in doses of ≥75 IU/kg were well tolerated (see CLINICAL PHARMACOLOGY).

In the presence of an inhibitor to Factor IX, higher doses of Mononine® might be necessary to overcome the inhibitor (see PRECAUTIONS). No data on the treatment of patients with inhibitors to Factor IX with Mononine® are available.

For information on rate of administration, see Rate of Administration, below.

Reconstitution
Warm both the diluent and Mononine® in unopened vials to room temperature [not above 37°C (98°F)]. Remove the caps from both vials to expose the central portions of the rubber stoppers. Treat the surface of the rubber stoppers with antiseptic solution and allow them to dry. Using aseptic technique, insert one end of the double-end needle into the rubber stopper of the diluent vial. Invert the diluent vial and insert the other end of the double-end needle into the rubber stopper of the Mononine® vial. Direct the diluent, which will be drawn in by vacuum, over the entire surface of the Mononine® cake. (In order to assure transfer of all the diluent, adjust the position of the tip of the needle in the diluent vial to the inside edge of the diluent stopper.) Rotate the vial to ensure complete wetting of the cake during the transfer process. Remove the diluent vial to release the vacuum, then remove the double-end needle from the Mononine® vial. Gently swirl the vial until the powder is dissolved and the solution is ready for administration. The concentrate routinely and easily reconstitutes within one minute. To assure sterility, Mononine® should be administered within three hours after reconstitution. Product should be filtered prior to use as described under Administration. Parenteral drug preparations should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Administration

Intravenous Injection

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

Plastic disposable syringes are recommended with Mononine® solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type. Please note, this concentrate is supplied with a SELF-VENTING filter spike.
Using aseptic technique, attach the vented filter spike to a sterile disposable syringe.CAUTION: The use of other, non-vented filter needles or spikes without the proper procedure may result in an air lock and prevent the complete transfer of the concentrate.CAUTION: DO NOT INJECT AIR INTO THE MONONINE® VIAL. The self-venting feature of the vented filter spike precludes the need to inject air in order to facilitate withdrawal of the reconstituted solution. The injection of air could cause partial product loss through the vent filter. Insert the vented filter spike into the stopper of the Mononine® vial, invert the vial, and position the filter spike so that the orifice is at the inside edge of the stopper. Withdraw the reconstituted solution into the syringe. Discard the filter spike. Perform venipuncture using the enclosed winged needle with microbore tubing. Attach the syringe to the luer end of the tubing.CAUTION: Use of other winged needles without microbore tubing, although compatible with the concentrate, will result in a larger retention of solution within the winged infusion set.
Rate of Administration

The rate of administration should be determined by the response and comfort of the patient; intravenous dosage administration rates of up to 225 IU/minute have been regularly tolerated without incident. When reconstituted as directed, i.e., to approximately 100 IU/mL, Mononine® should be administered at a rate of approximately 2.0 mL per minute.
Albuminar-20

Albuminar-20

Albuminar®-20 may be given intravenously without dilution or it may be diluted with normal saline or 5% dextrose before administration. 250 mL per liter gives a solution which is approximately isotonic and iso-osmotic with citrated plasma.

When undiluted albumin solution is administered in patients with normal blood volume, the rate of infusion should be slow enough to prevent too rapid expansion of plasma volume.

In the treatment of shock, an initial dose of 100 mL of the 20% albumin solution is given as rapidly as tolerated. If response within 30 minutes is inadequate, an additional 100 mL of 20% albumin solution may be given. Therapy should be guided by the clinical response, blood pressure and an assessment of relative anemia. If more than 250 mL are given, or if hemorrhage has occurred, the administration of packed red blood cells may be desirable.

In severe burns, immediate therapy should include large volumes of crystalloid with lesser amounts of 20% albumin solution to maintain an adequate plasma volume and protein content. After the first 24 hours, the ratio of albumin to crystalloid may be increased to establish and maintain a plasma albumin level of about 2.5 g/100 mL or a total serum protein level of about 5.2 g/100 mL.

The infusion of Albumin (Human) as a nutrient in the treatment of chronic hypoproteinemia is not recommended. In acute hypoproteinemia 250-350 mL of 20% albumin may be required to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, the rate of administration should not be greater than 3 mL per minute to avoid circulatory embarrassment.

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

Acetaminophen And Codeine

For intravenous use after reconstitution only.

2.1 Dose

Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition.1 Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.

Each vial of Helixate FS has the recombinant factor VIII (rFVIII) potency in international units (IU, unit) stated on the label. One IU (unit), as defined by the World Health Organization standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma.

The expected in vivo peak increase in factor VIII level expressed as IU/dL (or % normal) can be estimated using the following formulas:

Dosage (units) = body weight (kg) × desired factor VIII rise (IU/dL or % of normal) × 0.5 (IU/kg per IU/dL)

or

IU/dL (or % normal) = Total Dose (IU)/body weight (kg) × 2 [IU/dL]/[IU/kg]

Titrate dose to the patient's clinical response. Patients may vary in their pharmacokinetic (e.g., half-life, in vivo recovery) and clinical responses to Helixate FS.2,3,4 Although the dose can be estimated by the calculations above, it is highly recommended that appropriate laboratory tests, including serial factor VIII activity assays, are performed [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)].

Control and Prevention of Bleeding Episodes

A guide for dosing Helixate FS for the control and prevention of bleeding episodes is provided in Table 1. The goal of treatment is to maintain a plasma factor VIII activity level at or above the plasma levels (in % of normal or in IU/dL) outlined in Table 1.
Table 1 Dosing for Control and Prevention of Bleeding Episodes Type of Bleeding Episodes Factor VIII Level Required (IU/dL or % of normal) Dose (IU/kg) Frequency of Doses (hours) Duration of Therapy (days)
Minor Early hemarthrosis, minor muscle or oral bleeds.

20 – 40

10 – 20

Repeat dose if there is evidence of further bleeding.

Until bleeding is resolved

Moderate Bleeding into muscles, bleeding into the oral cavity, definite hemarthroses, and known trauma.

30 – 60

15 – 30

12 – 24

Until bleeding is resolved

Major Gastrointestinal bleeding. Intracranial, intra-abdominal or intrathoracic bleeding, central nervous system bleeding, bleeding in the retropharyngeal or retroperitoneal spaces, or iliopsoas sheath. Fractures. Head trauma.

80 – 100

Initial: 40 – 50 Repeat: 20 – 25

8 – 12

Until bleeding is resolved

Peri-operative Management

A guide for dosing Helixate FS during surgery (perioperative management) is provided in Table 2. The goal of treatment is to maintain a plasma factor VIII activity level at or above the plasma level (in % of normal or in IU/dL) outlined in Table 2.
Table 2 Dosing for Peri-operative Management Type of Surgery Factor VIII Level Required (IU/dL or % of normal) Dose (IU/kg) Frequency of Doses (hours) Duration of Therapy (days)
Minor Including tooth extraction

30 – 60

15 – 30

12 – 24

Until bleeding is resolved.

Major Examples include tonsillectomy, inguinal herniotomy, synovectomy, total knee replacement, craniotomy, osteosynthesis, trauma.

100

50 Pre-operatively to achieve 100% activity.

6 – 12 to keep FVIII activity in desired range

Until healing is complete.

Routine Prophylaxis in Adults

The recommended dose for routine prophylaxis is 25 units per kg of body weight three times per week.

Routine Prophylaxis in Children

The recommended dose for routine prophylaxis is 25 IU/kg of body weight every other day.5

2.2 Preparation and Reconstitution

Helixate FS is administered by intravenous injection after reconstitution. Patients should follow the specific reconstitution and administration procedures provided by their physicians.

Reconstitute and administer Helixate FS with the components provided with each package. If any component of the package is opened or damaged, do not use this component.

Product reconstitution, administration, and handling of the administration set and needles must be done with caution because percutaneous puncture with a needle contaminated with blood can transmit infectious viruses, including HIV (AIDS) and hepatitis. Place needles in a sharps container after single use. Discard all equipment, including any reconstituted Helixate FS product, in an appropriate container. Obtain immediate medical attention if injury occurs.

For any questions about the handling, reconstitution and administration of Helixate FS, contact CSL Behring Medical Affairs at 1-800-504-5434.

For instructions, patients should follow the recommendations in the FDA-Approved Patient Labeling.

The procedures below are provided as general guidelines for the reconstitution of Helixate FS.
• Work on a clean flat surface and wash hands thoroughly using soap and warm water before performing the procedures. • Reconstitute the product with the components provided with each package. If any component of the package is opened or damaged, do not use this component. • Filter the reconstituted product prior to administration to remove potential particulate matter in the solution. Filtering can be achieved by using the Mix2Vial™ vial adapter.
Vacuum Transfer and Reconstitution

1.

Prepare the product under aseptic conditions.

2.

Warm the unopened diluent and the concentrate to a temperature not to exceed 37°C or 99°F.

3.

Place the product vial, diluent vial and Mix2Vial on a flat surface.

4.

Ensure product and diluent vial flip caps are removed and the stoppers are treated with an aseptic solution and allowed to dry prior to opening the Mix2Vial package.

5.

Open the Mix2Vial package by peeling away the lid (Fig. 1).

Leave the Mix2Vial in the clear package. Place the diluent vial on an even surface and hold the vial tight. Grip the Mix2Vial together with the package and snap the blue end onto the diluent stopper (Fig. 2).

6.

Carefully remove the clear package from the Mix2Vial set. Make sure that you only pull up the package and not the Mix2Vial set (Fig. 3).

7.

With the product vial firmly on a surface, invert the diluent vial with the set attached and snap the transparent adapter onto the product vial stopper (Fig. 4). The diluent will automatically transfer into the product vial.

8.

With the diluent and product vial still attached, gently swirl the product vial to ensure the powder is fully dissolved (Fig. 5). Do not shake vial.

9.

With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the blue diluent-side of the Mix2Vial set and unscrew the set into two pieces (Fig. 6)

10.

Draw air into an empty, sterile syringe. While the product vial is upright, screw the syringe to the Mix2Vial set. Inject air into the product vial. While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly (Fig. 7).

11.

Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the syringe plunger facing down) and unscrew the syringe from the Mix2Vial set (Fig. 8). Attach the syringe to an administration set made with microbore tubing. Use of other administration sets without microbore tubing may result in a larger retention of the solution within the administration set.

12

If the same patient is to receive more than one bottle, the contents of two bottles may be drawn into the same syringe through a separate unused Mix2Vial set before attaching the vein needle.

2.3 Administration

For intravenous use after reconstitution only.
• Inspect Helixate FS visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Turbid or discolored solution should be discarded. • Store the reconstituted Helixate FS at room temperature prior to administration, but administer it within 3 hours. • Administer Helixate FS over a period of 1 to 15 minutes. Adapt the rate of administration to the response of each individual patient. Determine the pulse rate before and during administration of Helixate FS. If there is a significant increase in pulse rate, reduce the rate of administration or temporarily halt the infusion allowing the symptoms to disappear promptly.
Albuminar-25

Albuminar-25

Albuminar®-25 may be given intravenously without dilution or it may be diluted with normal saline or 5% dextrose before administration. 200 mL per liter gives a solution which is approximately isotonic and iso-osmotic with citrated plasma.

When undiluted albumin solution is administered in patients with normal blood volume, the rate of infusion should be slow enough (1 mL per minute) to prevent too rapid expansion of plasma volume.

In the treatment of shock the amount of albumin and duration of therapy must be based on the responsiveness of the patient as indicated by blood pressure, degree of pulmonary congestion, and hematocrit. The initial dose may be followed by additional albumin within 15-30 minutes if the response is deemed inadequate. If there is continued loss of protein, it may be desirable to give packed red blood cells.

In the treatment of burns an optimal regimen involving use of albumin, crystalloids, electrolytes and water has not been established. Suggested therapy during the first 24 hours includes administration of large volumes of crystalloid solution to maintain an adequate plasma volume. Continuation of therapy beyond 24 hours usually requires more albumin and less crystalloid solution to prevent marked hemoconcentration and maintain electrolyte balance. Duration of treatment varies depending upon the extent of protein loss through renal excretion, denuded areas of skin and decreased albumin synthesis. Attempts to raise the albumin level above 4.0 g/100 mL may only result in an increased rate of catabolism.

In the treatment of hypoproteinemia, 200 to 300 mL of 25% albumin may be required to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of 25% albumin should not be given faster than 100 mL in 30 to 45 minutes to avoid circulatory embarrassment. If slower administration is desired, 200 mL of 25% albumin may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL of this dextrose solution an hour.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Albuminar-5

Albuminar-5

Albuminar®-5 may be given intravenously without further dilution. This concentration is approximately isotonic and iso-osmotic with citrated plasma. Albumin (Human) in this concentration provides additional fluid for plasma volume expansion. Therefore, when it is administered to patients with normal blood volume, the rate of infusion should be slow enough to prevent too rapid expansion of plasma volume.

In the treatment of shock in an adult patient an initial dose of 500 mL of the 5% albumin solution is given as rapidly as tolerated. If response within 30 minutes is inadequate, an additional 500 mL of 5% albumin solution may be given. The 50 mL dosage form would be appropriate for pediatric use, with a dose of 10-20 mL per kg of body weight infused intravenously at a rate up to 5-10 mL per minute. Therapy should be guided by the clinical response, blood pressure and an assessment of relative anemia. If more than 1000 mL are given, or if hemorrhage has occurred, the administration of packed red blood cells may be desirable.

In severe burns, immediate therapy should include large volumes of crystalloid with lesser amounts of 5% albumin solution to maintain an adequate plasma volume. After the first 24 hours, the ratio of albumin to crystalloid may be increased to establish and maintain a plasma albumin level of about 2.5 g/100 mL or a total serum protein level of about 5.2 g/100 mL. However, an optimal regimen for the use of colloids, electrolytes and water after severe burns has not been established.

The infusion of Albumin (Human) as a nutrient in the treatment of chronic hypoproteinemia is not recommended. In acute hypoproteinemia, 5% albumin may be used in replacing the protein lost in hypoproteinemic conditions. However, if edema is present or if large amounts of albumin are lost, Albumin (Human) 25% is preferred because of the greater amount of protein in the concentrated solution.

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

Monoclate-p

Monoclate-P® is for intravenous administration only. As a general rule 1 unit of AHF activity per kg will increase the circulating AHF level by 2%.10 The following formula10 provides a guide of dosage calculations for both adult and pediatric patients:
Number of AHF = Body weight × desired Factor VIII × 0.5 IU Required (in kg) increase (% normal)
Although dosage must be individualized according to the needs of the patient (weight, severity of hemorrhage, presence of inhibitors), the following general dosages are suggested.11
MILD HEMORRHAGES - Minor hemorrhagic episodes will generally subside with a single infusion if a level of 30% or more is attained. MODERATE HEMORRHAGE AND MINOR SURGERY - For more serious hemorrhages and minor surgical procedures, the patient's Factor VIII level should be raised to 30-50% of normal, which usually requires an initial dose of 15-25 IU per kg. If further therapy is required a maintenance dose is 10-15 IU per kg every 8-12 hours. SEVERE HEMORRHAGE - In hemorrhages near vital organs (neck, throat, subperitoneal) it may be desirable to raise the Factor VIII level to 80-100% of normal which can be achieved with an initial dose of 40-50 IU per kg and a maintenance dose of 20-25 IU per kg every 8-12 hours. MAJOR SURGERY - For surgical procedures a dose of AHF sufficient to achieve a level 80-100% of normal should be given an hour prior to surgery. A second dose, half the size of the priming dose, should be given five hours after the first dose. Factor VIII levels should be maintained at a daily minimum of at least 30% for a period of 10-14 days postoperatively. Close laboratory control to maintain AHF plasma levels deemed appropriate to maintain hemostasis is recommended.
Reconstitution
Warm both the diluent and Monoclate-P® in unopened vials to room temperature [not above 37°C (98°F)]. Remove the caps from both vials to expose the central portions of the rubber stoppers. Treat the surface of the rubber stoppers with antiseptic solution and allow them to dry. Using aseptic technique, insert one end of the double-end needle into the rubber stopper of the diluent vial. Invert the diluent vial and insert the other end of the double-end needle into the rubber stopper of the Monoclate-P® vial. Direct the diluent, which will be drawn in by vacuum, over the entire surface of the Monoclate-P® cake. (In order to assure transfer of all the diluent, adjust the position of the tip of the needle in the diluent vial to the inside edge of the diluent stopper.) Rotate the vial to ensure complete wetting of the cake during the transfer process. Remove the diluent vial to release the vacuum, then remove the double-end needle, from the Monoclate-P® vial. Gently swirl the vial until the powder is dissolved and the solution is ready for administration. The concentrate routinely and easily reconstitutes within one minute. To assure sterility, Monoclate-P® should be administered within three hours after reconstitution. Parenteral drug preparations should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Administration
CAUTION: This kit contains two devices, a stainless steel 5 micron filter needle, individually labeled as a 5 micron filter needle and contained in a separate blister pack, and an all plastic 5 micron vented filter spike which is supplied with the four-item administration components blister pack, either of which may be used to withdraw the reconstituted product for administration. The withdrawal directions specific for each of these alternate devices must be followed exactly for whichever device is chosen for use as described below. Product loss or inability to withdraw product will result if the improper instructions are followed. A. Administration using the stainless steel filter needle for withdrawal
(This item is individually packaged in a separate, labeled blister pack.)

Intravenous Injection

Plastic disposable syringes are recommended with Monoclate-P® solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type.
1. Using aseptic technique, attach the filter needle to a sterile disposable syringe. 2. Draw air into the syringe equal to or greater than the contents of the vial. 3. Insert the filter needle into the stopper of the Monoclate-P ® vial, invert the vial, position the filter needle above the level of the liquid and inject all of the air into the vial. 4. Pull the filter needle back down below the level of the liquid until the tip is at the inside edge of the stopper. 5. Withdraw the reconstituted solution into the syringe being careful to always keep the tip of the needle below the level of the liquid. CAUTION: Failure to inject air into the vial, or allowing air to pass through the filter needle while filling the syringe with reconstituted solution, may cause the needle to clog. 6. Discard the filter needle. Perform venipuncture using the enclosed winged needle with microbore tubing. Attach the syringe to the luer end of the tubing. CAUTION: Use of other winged needles without microbore tubing, although compatible with the concentrate, will result in a larger retention of solution within the winged infusion set. 7. Administer solution intravenously at a rate (approximately 2 mL/minute) comfortable to the patient. B. Administration using the all plastic vented filter spike for withdrawal
(This spike is supplied in the four-item Administration Components pack.)

Intravenous Injection

Plastic disposable syringes are recommended with Monoclate-P® solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type.
1. Using aseptic technique, attach the vented filter spike to a sterile disposable syringe. CAUTION: DO NOT INJECT AIR INTO THE MONOCLATE-P ® VIAL. The self-venting feature of the vented filter spike precludes the need to inject air in order to facilitate withdrawal of the reconstituted solution. The injection of air could cause partial product loss through the vent filter. CAUTION: The use of other, non-vented filter needles or spikes without the proper procedure may result in an air lock and prevent the complete transfer of the concentrate. 2. Insert the vented filter spike into the stopper of the Monoclate-P ® vial, invert the vial, and position the filter spike so that the orifice is at the inside edge of the stopper. 3. Withdraw the reconstituted solution into the syringe. 4. Discard the filter spike. Perform venipuncture using the enclosed winged needle with microbore tubing. Attach the syringe to the luer end of the tubing. CAUTION: Use of other winged needles without microbore tubing, although compatible with the concentrate, will result in a larger retention of solution within the winged infusion set. 5. Administer solution intravenously at a rate (approximately 2 mL/minute) comfortable to the patient.

Csl Behring Llc

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