Csl Behring Ag

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Csl Behring Ag Drugs

Cytogam

Cytogam

The maximum recommended total dosage per infusion is 150 mg Ig/kg, administered according to the following schedule:
Type of Transplant Kidney Liver, Pancreas, Lung, Heart Within 72 hours of transplant: 150 mg/kg 150 mg/kg 2 weeks post transplant: 100 mg/kg 150 mg/kg 4 weeks post transplant: 100 mg/kg 150 mg/kg 6 weeks post transplant: 100 mg/kg 150 mg/kg 8 weeks post transplant: 100 mg/kg 150 mg/kg 12 weeks post transplant: 50 mg/kg 100 mg/kg 16 weeks post transplant: 50 mg/kg 100 mg/kg
Preparation for Administration

Remove the tab portion of the vial cap and clean the rubber stopper with 70% alcohol or equivalent. DO NOT SHAKE VIAL; AVOID FOAMING.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Infuse the solution only if it is colorless, free of particulate matter and not turbid.

Infusion

Infusion should begin within 6 hours after entering the vial and should be complete within 12 hours of entering the vial. Vital signs should be taken preinfusion, mid-way and post-infusion as well as before any rate increase. Cytogam should be administered through an intravenous line using an administration set that contains an in-line filter (pore size 15µ) and a constant infusion pump (i.e., IVAC pump or equivalent). A smaller in-line filter (0.2µ) is also acceptable. Pre-dilution of Cytogam before infusion is not recommended. Cytogam should be administered through a separate intravenous line. If this is not possible, Cytogam may be "piggybacked" into a pre-existing line if that line contains either Sodium Chloride Injection, USP, or one of the following dextrose solutions (with or without NaCl added): 2.5% dextrose in water, 5% dextrose in water, 10% dextrose in water, 20% dextrose in water. If a pre-existing line must be used, the Cytogam should not be diluted more than 1:2 with any of the above-named solutions. Admixtures of Cytogam with any other solutions have not been evaluated.

Initial Dose

Administer intravenously at 15 mg Ig per kg body weight per hour. If no adverse reactions occur after 30 minutes, the rate may be increased to 30 mg Ig/kg/hr; if no adverse reactions occur after a subsequent 30 minutes, then the infusion may be increased to 60 mg Ig/kg/hr (volume not to exceed 75 mL/hour). DO NOT EXCEED THIS RATE OF ADMINISTRATION. The patient should be monitored closely during and after each rate change.

Subsequent Doses

Administer at 15 mg Ig/kg/hr for 15 minutes. If no adverse reactions occur, increase to 30 mg Ig/kg/hr for 15 minutes and then increase to a maximum rate of 60 mg Ig/kg/hr (volume not to exceed 75 mL/hour). DO NOT EXCEED THIS RATE OF ADMINISTRATION. The patient should be monitored closely during each rate change.

Cytogam should be used with caution in patients with pre-existing renal insufficiency and in patients judged to be at increased risk of developing renal insufficiency (including, but not limited to those with diabetes mellitus, age greater than 65, volume depletion, paraproteinemia, sepsis and patients receiving known nephrotoxic drugs). In these cases especially, it is important to assure that patients are not volume depleted prior to Cytogam infusion. While most cases of renal insufficiency have occurred in patients receiving total doses of 350 mg Ig/kg or greater, no prospective data are presently available to identify a maximum safe dose, concentration or rate of infusion in patients determined to be at increased risk of acute renal failure. In the absence of prospective data, recommended doses should not be exceeded and the concentration and infusion rate selected should be the minimum practicable.

Potential adverse reactions are: flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, wheezing, drop in blood pressure. Minor adverse reactions have been infusion rate related – if the patient develops a minor side effect (i.e., nausea, back pain, flushing), slow the rate or temporarily interrupt the infusion. If anaphylaxis or drop in blood pressure occurs, discontinue infusion and use antidote such as diphenhydramine and adrenalin.

To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, sterile disposable syringes and needles should be used. The syringes and needles should not be reused.
Levofloxacin

Levofloxacin

As with all blood products, patients should be observed for at least 20 minutes following administration of Rhophylac.

2.1 Preparation and Handling

Rhophylac is a clear or slightly opalescent, colorless to pale yellow solution. Inspect Rhophylac visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.

Prior to intravenous use, ensure that the needle-free intravenous administration system is compatible with the tip of the Rhophylac glass syringe.

Do not freeze.

Bring Rhophylac to room temperature before use.

Rhophylac is for single use only. Dispose of any unused product or waste material in accordance with local requirements.

2.2 Suppression of Rh Isoimmunization

Rhophylac should be administered by intravenous or intramuscular injection. If large doses (greater than 5 mL) are required and intramuscular injection is chosen, it is advisable to administer Rhophylac in divided doses at different sites.

Ensure the site of administration will allow the injection to reach the muscle if Rhophylac is administered intramuscularly. Consider intravenous administration if reaching the muscle is of concern [see Postmarketing Experience (6.2)]. Do not administer Rhophylac subcutaneously into the fatty tissue.

Table 1 provides dosing guidelines based on the condition being treated.
Table 1: Dosing Guidelines for Suppression of Rh Isoimmunization Indication Timing of Administration Dose* (Administer by Intravenous or Intramuscular Injection) IU, international units; mcg, micrograms. * A 1500 IU (300 mcg) dose of Rhophylac will suppress the immunizing potential of ≥15 mL of Rh 0(D)-positive RBCs. 1 † The dose of Rhophylac must be increased if the patient is exposed to >15 mL of Rh 0(D)-positive RBCs; in this case, follow the dosing guidelines for excessive fetomaternal hemorrhage. Rh-incompatible pregnancy Routine antepartum prophylaxis At Week 28-30 of gestation 1500 IU (300 mcg) Postpartum prophylaxis (required only if the newborn is Rh 0(D)-positive) Within 72 hours of birth 1500 IU (300 mcg)† Obstetric complications (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage) Within 72 hours of complication 1500 IU (300 mcg)† Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma) Within 72 hours of procedure 1500 IU (300 mcg)† Excessive fetomaternal hemorrhage (>15 mL) Within 72 hours of complication 1500 IU (300 mcg) plus: 100 IU (20 mcg) per mL fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantifiedor An additional 1500 IU (300 mcg) dose if excess transplacental bleeding cannot be quantified Incompatible transfusions Within 72 hours of exposure 100 IU (20 mcg) per 2 mL transfused blood or per 1 mL erythrocyte concentrate
2.3 ITP

For treatment of ITP, ADMINISTER RHOPHYLAC BY THE INTRAVENOUS ROUTE ONLY [see Preparation and Handling (2.1)]. Do not administer intramuscularly.

A 250 IU (50 mcg) per kg body weight dose of Rhophylac is recommended for patients with ITP. The following formula can be used to calculate the recommended amount of Rhophylac to administer:

Dose (IU) × body weight (kg) = Total IU / 1500 IU per syringe = Number of syringes

Rhophylac should be administered at a rate of 2 mL per 15 to 60 seconds.
Sildenafil

Sildenafil

For subcutaneous infusion only. Do not inject into a blood vessel.

2.1 Preparation and Handling

Hizentra is a clear and pale yellow to light brown solution. Do not use if the solution is cloudy or contains particulates.
Prior to administration, visually inspect each vial of Hizentra for particulate matter or discoloration, whenever the solution and container permit. Do not freeze. Do not use any solution that has been frozen. Check the product expiration date on the vial label. Do not use beyond the expiration date. Do not mix Hizentra with other products. Do not shake the Hizentra vial. Use aseptic technique when preparing and administering Hizentra. The Hizentra vial is for single-use only. Discard all used administration supplies and any unused product immediately after each infusion in accordance with local requirements.
2.2 Dosage
Hizentra can be administered at regular intervals from daily up to every two weeks (biweekly). Individualize the dose based on the patient's clinical response to Hizentra therapy and serum immunoglobulin G (IgG) trough levels. Before receiving treatment with Hizentra: Ensure that patients have received Immune Globulin Intravenous (Human) (IGIV) treatment at regular intervals for at least 3 months. Obtain the patient's serum IgG trough level to guide subsequent dose adjustments (see below under Dose Adjustment).
Dosage for patients switching to Hizentra from Immune Globulin Intravenous (Human) (IGIV)
Establish the initial weekly dose of Hizentra 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. To calculate the initial weekly dose of Hizentra, divide the previous IGIV dose in grams by the number of weeks between doses during the patient's IGIV treatment (e.g., 3 or 4); then multiply this by the dose adjustment factor of 1.37. [see Pharmacokinetics (12.3, Table 8)] Initial Hizentra dose = Previous IGIV dose (in grams) × 1.37 Number of weeks between IGIV doses To convert the Hizentra dose (in grams) to milliliters (mL), multiply the calculated dose (in grams) by 5. Provided the total weekly dose is maintained, any dosing interval from daily up to biweekly can be used and will result in systemic serum IgG exposure that is comparable to the previous IGIV or weekly Hizentra treatment [see Pharmacokinetics (12.3)]. For biweekly dosing, multiply the calculated Hizentra weekly dose by 2. For frequent dosing (2 to 7 times per week), divide the calculated weekly dose by the desired number of times per week (e.g., for 3 times per week dosing, divide weekly dose by 3).
Dosage for patients switching to Hizentra from IGSC
The previous weekly IGSC dose should be maintained. For biweekly dosing, multiply the previous weekly dose by 2. For frequent dosing (2 to 7 times per week), divide the previous weekly dose by the desired number of times per week (e.g., for 3 times per week dosing, divide weekly dose by 3).
Start Hizentra treatment:
For weekly or frequent dosing, start treatment with Hizentra 1 week after the patient's last IGIV infusion or Hizentra/IGSC infusion. For biweekly dosing, start treatment 1 or 2 weeks after the last IGIV infusion or 1 week after the last weekly Hizentra/IGSC infusion.
Dose Adjustment

Over time, the dose may need to be adjusted to achieve the desired clinical response and serum IgG trough level, irrespective of the frequency of administration. To determine if a dose adjustment should be considered, measure the patient's serum IgG trough level 2 to 3 months after switching to Hizentra.

Weekly dosing: When switching from IGIV to weekly Hizentra dosing, the target serum IgG trough level is projected to be approximately 16% higher than the last trough level during prior IGIV therapy [see Pharmacokinetics (12.3)].

Biweekly dosing: When switching from IGIV to biweekly Hizentra dosing, the target serum IgG trough level is projected to be approximately 10% higher than the last IGIV trough level. When switching from weekly to biweekly Hizentra dosing, the target trough is projected to be approximately 5% lower than the last trough level on weekly therapy [see Pharmacokinetics (12.3)].

Frequent dosing: When switching from weekly dosing to more frequent Hizentra dosing, the target serum IgG trough level is projected to be approximately 3 to 4% higher than the last trough level on weekly therapy [see Pharmacokinetics (12.3)].

To adjust the dose based on trough levels, calculate the difference (in mg/dL) between the patient's serum IgG trough level and the target IgG trough level for weekly or biweekly dosing. Then find this difference in Table 1 (Column 1) and, based on the Hizentra dosing frequency (for weekly or biweekly) and the patient's body weight, locate the corresponding adjustment amount (in mL) by which to increase (or decrease) the dose. For frequent dosing, add the weekly increment from Table 1 to the weekly-equivalent dose and then divide by the number of days of dosing.

Use the patient's clinical response as the primary consideration in dose adjustment. Additional dosage increments may be indicated based on the patient's clinical response (infection frequency and severity).
Table 1: Incremental Adjustment (mL)* of the Hizentra Dose† Based on the Difference (±mg/dL) from the Target Serum IgG Trough Level Difference From Target Serum IgG Trough Level (mg/dL) Dosing Frequency Weight Adjusted Dose Increment (mL)* Weight Group >10 to 30 kg >30 to 50 kg >50 to 70 kg >70 to 90 kg >90 kg n/a, not applicable. * Incremental adjustments based on slopes of the pharmacometric model-predicted relationship between serum IgG trough level and Hizentra dose increments of 1 mg/kg per week. † Includes biweekly, weekly or frequent dosing. ‡ To determine the dose increment for frequent dosing, add the weekly increment to the weekly-equivalent dose and then divide by the number of days of dosing. 50 Weekly‡ n/a 2.5 5 5 10 Biweekly 5 5 10 10 20 100 Weekly 2.5 5 10 10 15 Biweekly 5 10 20 20 30 200 Weekly 5 10 15 20 30 Biweekly 10 20 30 40 60
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 Hizentra by 10 mL. For biweekly dosing, increase the biweekly dose by 20 mL. For 2 times per week dosing, increase the dose by 5 mL.

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

Dosage requirements for patients switching to Hizentra from another IGSC product: If a patient on Hizentra 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 if their desired IGSC trough level is known.

Measles Exposure

Administer a minimum total weekly Hizentra dose of 200 mg/kg body weight for two consecutive weeks if a patient is at risk of measles exposure (i.e., due to an outbreak in the US or travel to endemic areas outside of the US. For biweekly dosing, one infusion of a minimum of 400 mg/kg is recommended. If a patient has been exposed to measles, ensure this minimum dose is administered as soon as possible after exposure.

2.3 Administration

Hizentra is for subcutaneous infusion only. Do not inject into a blood vessel.

Hizentra is intended for subcutaneous administration using an infusion pump. Infuse Hizentra in the abdomen, thigh, upper arm, and/or lateral hip.
Injection sites – A Hizentra dose may be infused into multiple injection sites. Use up to 4 sites simultaneously or up to 12 sites consecutively per infusion. Injection sites should be at least 2 inches apart. Change the actual site of injection with each administration. Volume – For the first infusion of Hizentra, do not exceed a volume of 15 mL per injection site. The volume may be increased to 20 mL per site for the fifth infusion and then to 25 mL per site as tolerated. Rate – For the first infusion of Hizentra, the recommended flow rate is 15 mL per hour per site. For subsequent infusions, the flow rate may be increased to 25 mL per hour per site as tolerated.
Follow the steps below and use aseptic technique to administer Hizentra.
1. Assemble supplies – Gather the Hizentra vial(s), disposable supplies (not provided with Hizentra), and other items (infusion pump, sharps or other container, patient's treatment diary/log book) needed for the infusion. 2. Clean surface – Thoroughly clean a flat surface using an alcohol wipe. 3. Wash hands – Thoroughly wash and dry hands. The use of gloves when preparing and administering Hizentra is optional. 4. Check vials – Carefully inspect each vial of Hizentra. Do not use the vial if the liquid looks cloudy, contains particles, or has changed color, if the protective cap is missing, or if the expiration date on the label has passed. 5. Transfer Hizentra from vial(s) to syringe Remove the protective cap from the vial to expose the central portion of the rubber stopper of the Hizentra vial. Clean the stopper with an alcohol wipe and allow it to dry. If using a transfer device, follow the instructions provided by the device manufacturer. If using a needle and a syringe to transfer Hizentra, follow the instructions below. Attach a sterile transfer needle to a sterile syringe. Pull back on the plunger of the syringe to draw air into the syringe that is equal to the amount of Hizentra to be withdrawn. Insert the transfer needle into the center of the vial stopper and, to avoid foaming, inject the air into headspace of the vial (not into the liquid). Withdraw the desired volume of Hizentra. When using multiple vials to achieve the desired dose, repeat this step. 6. Prepare infusion pump and tubing – Follow the manufacturer's instructions for preparing the pump, using subcutaneous administration sets and tubing, as needed. Be sure to prime the tubing with Hizentra to ensure that no air is left in the tubing. 7. Prepare injection site(s) The number and location of injection sites depends on the volume of the total dose. Infuse Hizentra into a maximum of 4 sites simultaneously; or up to 12 consecutively per infusion. Injection sites should be at least 2 inches apart. Using an antiseptic skin preparation, clean each site beginning at the center and working outward in a circular motion. Allow each site to dry before proceeding. 8. Insert needle(s) Grasp the skin between 2 fingers and insert the needle into the subcutaneous tissue. If necessary, use sterile gauze and tape or transparent dressing to hold the needle in place. Before starting the infusion, attach a sterile syringe to the end of the primed administration tubing and gently pull back on the plunger to make sure no blood is flowing back into the tubing. If blood is present, remove and discard the needle and tubing. Repeat the process beginning with step 6 (priming) using a new needle, new infusion tubing, and a different injection site. 9. Start infusion – Follow the manufacturer's instructions to turn on the infusion pump. 10. Record treatment – Remove the peel-off portion of the label from each vial used, and affix it to the patient's treatment diary/log book or scan the vial if recording the infusion electronically. 11. Clean up – After administration is complete, turn off the infusion pump. Take off the tape or dressing and remove the needle set from the infusion site(s). Disconnect the tubing from the pump. Immediately discard any unused product and all used disposable supplies in accordance with local requirements. Clean and store the pump according to the manufacturer's instructions.
For self-administration, provide the patient with instructions and training for subcutaneous infusion in the home or other appropriate setting.
Carimune Nanofiltered

Carimune Nanofiltered

It is generally advisable not to dilute plasma derivatives with other infusable drugs. Carimune® NF should be given by a separate infusion line. No other medications or fluids should be mixed with Carimune® NF preparation.

Carimune® NF should be used with caution in patients with pre-existing renal insufficiency and in patients judged to be at increased risk of developing renal insufficiency (including, but not limited to those with diabetes mellitus, age greater than 65, volume depletion, paraproteinemia, sepsis, and patients receiving known nephrotoxic drugs). In these cases especially it is important to assure that patients are not volume depleted prior to Carimune® NF infusion. No prospective data are presently available to identify a maximum safe dose, concentration, and rate of infusion in patients determined to be at increased risk of acute renal failure. In the absence of prospective data, recommended doses should not be exceeded and the concentration and infusion rate selected should be the minimum practicable. For patients judged to be at risk for developing renal dysfunction, Carimune® NF should be infused at a rate less than 2 mg/kg/min.

For patients judged to be at an increased risk for thrombosis, a maximum infusion rate of less than 2 mg/kg/min for patients is recommended (see PRECAUTIONS: Thrombosis).

If side effects occur, the infusion should be stopped or slowed until the symptoms subside.

Adult and Child Substitution Therapy

The recommended dose of Carimune® NF in primary immunodeficiency is 0.4 to 0.8 g/kg of body weight administered once every three to four weeks by intravenous infusion.

The first infusion of Carimune® NF in previously untreated agammaglobulinemic or hypogammaglobulinemic patients must be given as a 3% immunoglobulin solution (see Reconstitution). Subsequent infusions may be administered at a higher concentration if the patient shows good tolerance.

An initial infusion rate of 0.5 mg/kg/min is recommended. If tolerated, after 30 minutes, the rate may be increased to 1 mg/kg/min for the next 30 minutes. Thereafter, the rate may be gradually increased in a stepwise manner up to a maximum of 3 mg/kg/min as tolerated. Refer to Table 3 for the corresponding infusion rates in mg/kg/min or mL/kg/min for all product concentrations.

The first infusion of Carimune® NF in previously untreated agammaglobulinemic and hypogammaglobulinemic patients may lead to systemic side effects. The nature of these effects has not been fully elucidated. Some of them may be due to the release of proinflammatory cytokines by activated macrophages in immunodeficient recipients.67,68 Subsequent administration of Carimune® NF to immunodeficient patients as well as to normal individuals usually does not cause further untoward side effects.

Therapy of Idiopathic Thrombocytopenic Purpura (ITP)

Induction

The recommended dose of Carimune® NF for the treatment of ITP is 0.4 g/kg of body weight on 2–5 consecutive days. An immunoglobulin solution of 6% (see Reconstitution) is recommended for use in ITP.

The recommended initial infusion rate for the treatment of ITP is 0.5 mg/kg/min. If tolerated, after 30 minutes, the rate may be increased to 1 mg/kg/min for the next 30 minutes. Thereafter, the rate may be gradually increased in a stepwise manner up to a maximum of 3 mg/kg/min as tolerated. Refer to Table 3 for the corresponding infusion rates in mg/kg/min or mL/kg/min for all product concentrations.

Acute ITP – Childhood

In acute ITP of childhood, if an initial platelet count response to the first two doses is adequate (30–50,000/µL), therapy may be discontinued after the second day of the 5 day course.35

Maintenance – Chronic ITP

In adults and children, if after induction therapy the platelet count falls to less than 30,000/µL and/or the patient manifests clinically significant bleeding, 0.4 g/kg of body weight may be given as a single infusion. If an adequate response does not result, the dose can be increased to 0.8–1 g/kg of body weight given as a single infusion.36,69,70
Table 3: Infusion Rates for Carimune® NF Concentrations Concentration(%) Initial Infusion Rate:0.5 mg/kg/min 1 mg/kg/min 2 mg/kg/min* Maximum Infusion Rate†:3 mg/kg/min * Maximum infusion rate for patients at risk of renal dysfunction or thromboembolic events. † For patients not at risk of renal dysfunction of thromboembolic events. 3% 0.0167 mL/kg/min 0.033 mL/kg/min 0.067 mL/kg/min 0.10 mL/kg/min 6% 0.008 mL/kg/min 0.0167 mL/kg/min 0.033 mL/kg/min 0.050 mL/kg/min 9% 0.006 mL/kg/min 0.011 mL/kg/min 0.022 mL/kg/min 0.033 mL/kg/min 12% 0.004 mL/kg/min 0.008 mL/kg/min 0.016 mL/kg/min 0.025 mL/kg/min
Reconstitution

(see also pictures next page)
1. Remove the protective plastic caps from the lyophilisate (LYO) and diluent bottles and disinfect both rubber stoppers with alcohol. Remove the protective cover from one end of the transfer set and insert the exposed needle through the rubber stopper into the bottle containing the diluent (picture 1). 2a. and 2b. Remove the second protective cover from the other end of the transfer set. Grasp both bottles as shown in picture 2a, quickly plunge the diluent bottle onto the lyophilisate bottle and bring the bottles into an upright position. Only if this is done quickly and the bottles are immediately brought into an upright position can the vacuum in the lyophilisate bottle be maintained, thus speeding up reconstitution and facilitating the transfer. Allow the diluent to flow into the lyophilisate bottle (picture 2b). 3. Once the appropriate amount of diluent is transferred (see Table 4), lift the diluent bottle off the spike to release the vacuum (picture 3). This will reduce foaming and facilitate dissolution. Remove the spike. 4. Swirl vigorously but do not shake, otherwise a foam will form which is very slow to subside (picture 4). The lyophilisate dissolves within a few minutes.

To reconstitute Carimune® NF from the individual vial package, or when using other diluents or higher concentrations, Table 4 indicates the volume of sterile diluent required. Observing aseptic technique, this volume should be drawn into a sterile hypodermic syringe and needle. The diluent is then injected into the corresponding Carimune® NF vial size.
Table 4: Required Diluent Volume* Target Concentration 3 g Vial 6 g Vial 12 g Vial * In patients judged to be at increased risk of developing renal insufficiency and thromboembolic events, the concentration and infusion rate of Carimune ® NF should be the minimum practicable. † Container not large enough to permit this concentration. 3% 100 mL 200 mL † 6% 50 mL 100 mL 200 mL 9% 33 mL 66 mL 132 mL 12% 25 mL 50 mL 100 mL
If large doses of Carimune® NF are to be administered, several reconstituted vials of identical concentration and diluent may be pooled in an empty sterile glass or plastic i.v. infusion container using aseptic technique.

Carimune® NF normally dissolves within a few minutes, though in exceptional cases it may take up to 20 minutes.

DO NOT SHAKE! Excessive shaking will cause foaming.

Any undissolved particles should respond to careful rotation of the bottle. Avoid foaming. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Filtering of Carimune® NF is acceptable but not required. Pore sizes of 15 microns or larger will be less likely to slow infusion, especially with higher Carimune® NF concentrations. Antibacterial filters (0.2 microns) may be used. When reconstitution of Carimune® NF occurs outside of sterile laminar air flow conditions, administration must begin promptly with partially used vials discarded. When reconstitution is carried out in a sterile laminar flow hood using aseptic technique, administration may begin within 24 hours provided the solution has been refrigerated during that time. Do not freeze Carimune® NF solution.

PROCEED WITH INFUSION ONLY IF SOLUTION IS CLEAR AND AT APPROXIMATELY ROOM TEMPERATURE.
Privigen

Privigen

Table 1: Recommended Dosage and Administration for Privigen Indication Dose Initial infusion rate Maintenance infusion rate(as tolerated) Primary Immunodeficiency 200-800 mg/kg (2-8 mL/kg)every 3-4 weeks 0.5 mg/kg/min(0.005 mL/kg/min) Increase to8 mg/kg/min (0.08 mL/kg/min) Chronic Immune Thrombocytopenic Purpura 1 g/kg (10 mL/kg) for 2 consecutive days 0.5 mg/kg/min (0.005 mL/kg/min) Increase to 4 mg/kg/min (0.04 mL/kg/min)
2.1 Dosage for Primary Humoral Immunodeficiency (PI)

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. The proper amount can be determined by monitoring clinical response.

The recommended dose of Privigen for patients with PI is 200 to 800 mg/kg (2 to 8 mL/kg), administered every 3 to 4 weeks. If a patient misses a dose, administer the missed dose as soon as possible, and then resume scheduled treatments every 3 or 4 weeks, as applicable.

Adjust the dosage over time to achieve the desired serum IgG trough levels and clinical responses. No randomized, controlled trial data are available to determine an optimal trough level in patients receiving immune globulin therapy.

2.2 Dosage for Chronic Immune Thrombocytopenic Purpura (ITP)

The recommended dose of Privigen for patients with chronic ITP is 1 g/kg (10 mL/kg) administered daily for 2 consecutive days, resulting in a total dosage of 2 g/kg.

Carefully consider the relative risks and benefits before prescribing the high dose regimen (e.g., 1 g/kg/day for 2 days) in patients at increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload [see Warnings and Precautions (5.8)].

2.3 Preparation and Handling
Privigen is a clear or slightly opalescent, colorless to pale yellow solution. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is cloudy, turbid, or if it contains particulate matter. DO NOT SHAKE. Do not freeze. Do not use if Privigen has been frozen. Privigen should be at room temperature (up to 25ºC [77ºF]) at the time of administration. Do not use Privigen beyond the expiration date on the product label. The Privigen vial is for single-use only. Promptly use any vial that has been entered. Privigen contains no preservative. Discard partially used vials or unused product in accordance with local requirements. Infuse Privigen using a separate infusion line. Prior to use, the infusion line may be flushed with Dextrose Injection, USP (D5W) or 0.9% Sodium Chloride for Injection, USP. Do not mix Privigen with other IGIV products or other intravenous medications. However, Privigen may be diluted with Dextrose Injection, USP (D5W). An infusion pump may be used to control the rate of administration. If large doses of Privigen are to be administered, several vials may be pooled using aseptic technique. Begin infusion within 8 hours of pooling.
2.4 Administration

Privigen is for intravenous administration only.

Monitor the patient's 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.

Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients judged to be at risk for renal dysfunction or thrombosis, administer Privigen at the minimum dose and infusion rate practicable, and discontinue Privigen administration if renal function deteriorates [see Boxed Warning, Warnings and Precautions (5.2, 5.3)].

The following patients may be at risk of developing systemic reactions (mimicking symptoms of an inflammatory response or infection) on rapid infusion of Privigen (greater than 4 mg/kg/min [0.04 mL/kg/min]): 1) those who have never received Privigen or another IgG product or who have not received it within the past 8 weeks, and 2) those who are switching from another IgG product. These patients should be started at a slow rate of infusion (e.g., 0.5 mg/kg/min [0.005 mL/kg/min] or less) and gradually increase as tolerated.
Berkley And Jensen Aspi...

Berkley And Jensen Aspirin

AlbuRx® 5, Albumin (Human) 5% solution must be administered intravenously. The venipuncture site should not be infected or traumatized, and should be prepared with standard aseptic technique. The solution is compatible with whole blood or packed red cells as well as the usual electrolyte and carbohydrate solutions intended for intravenous use. By contrast, it should not be mixed with protein hydrolysates, amino acid mixtures, or solutions containing alcohol. It is ready for use as contained in the bottle and may be given without regard to the blood group of the recipient.

Upon administration of AlbuRx® 5, Albumin (Human) 5% solution, there is a rapid increase of the plasma volume about equal to the volume infused. The initial dose for adults is 250 or 500 mL. The rate of infusion and the total volume administered are determined by the condition and response of the patient. A rate of 1–2 mL per minute is usually suitable in the absence of overt shock, whereas the capacity of the administration set is the only limit in the exsanguinated patient.

During resuscitation, constant monitoring of the patient provides the guidelines for treatment.

For children, a dose of 22 to 33 mL per kilogram body weight is usually adequate and close surveillance of the young patient is essential. Since patients – notably those with sepsis or severe multiple injuries – often need a circulating blood volume exceeding the prediction derived from their body weight, treatment should always be guided by the hemodynamic response and not by blood volume calculations or measurements.5

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

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