Albuminar-25

Name: Albuminar-25

What are some things I need to know or do while I take Albuminar-25?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have your urine checked as you have been told by your doctor.
  • The doctor will watch blood pressure, heart rate, and oxygen levels closely. Talk with the doctor.
  • This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Albuminar-25 while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Albuminar-25 or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Albuminar-25. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Albuminar-25 Dosage and Administration

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.

References

  1. Data on file.

Package Label - Principal Display Panel - 100 mL Carton

NDC 0053-7680-33

25%

100 mL

Albuminar®-25
Albumin (Human)
USP 25%

For Intravenous Administration Only.

25 g in 100 mL solution osmotically equivalent to 500 mL of plasma.

Do not use if turbid.

Do not begin administration more than 4 hours after the container has been entered.

Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

RX only

Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767

CSL Behring

Albuminar-25 
albumin human solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0053-7680
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albumin Human (Albumin Human) Albumin Human 25 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride  
Sodium bicarbonate  
Sodium hydroxide  
Acetic Acid  
Packaging
# Item Code Package Description
1 NDC:0053-7680-01 1 VIAL, GLASS (VIAL) in 1 CARTON
1 20 mL in 1 VIAL, GLASS
2 NDC:0053-7680-32 1 VIAL, GLASS (VIAL) in 1 CARTON
2 50 mL in 1 VIAL, GLASS
3 NDC:0053-7680-33 1 VIAL, GLASS (VIAL) in 1 CARTON
3 100 mL in 1 VIAL, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103955 01/06/2009
Labeler - CSL Behring LLC (931896963)
Establishment
Name Address ID/FEI Operations
CSL Behring LLC 931896963 MANUFACTURE
Revised: 01/2009   CSL Behring LLC

Description

Albumin (Human) 25%, Albuminar-25 is a sterile aqueous solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours.

The plasma used in the manufacture of this product has been tested and found negative for HBV, HCV, and HIV-1 by an investigational test procedure referred to as Nucleic Acid Testing (NAT) using Polymerase Chain Reaction (PCR) Technology. Investigational testing is being performed to determine the effectiveness of NAT to detect low levels of viral material. The significance of a negative result is unknown since the effectiveness of the test has not been established.

Albumin (Human) 25%, Albuminar-25 is a solution containing in each 100 mL, 25 grams of serum albumin, osmotically equivalent to 500 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium--130-160 mEq; and potassium--n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.

Albumin (Human) 25%, Albuminar-25, is to be administered by the intravenous route.

The heat treatment step employed in the manufacture of Albumin (Human) 25%, Albuminar-25, pasteurization of the final container at 60°C for 10 hours, has been validated in a series of in vitro experiments for its capacity to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV-an enveloped virus used as a model for hepatitis C virus), Pseudorabies (PrV-a large, enveloped virus), and Encephalomyocarditis Virus (EMC - a small non-enveloped virus). For each virus studied, three independent experiments were conducted using Albumin (Human) 5%, Albuminar-5 and Albumin (Human) 25%, Albuminar-25 with the following results. 1

Pasteurization (60°C for 10 hours) Viral Reduction Studies
(log 10 reduction)
Virus Albumin (Human) 5%,
Albuminar-5
Albumin (Human) 25%,
Albuminar-25
HIV-1 >5.44, >6.38 and >6.31 >5.50, >6.57 and >6.64
BVDV >6.01, >6.76 and >6.55 >5.99, >5.81 and >5.32
PrV >7.30, >7.68 and >7.63 >7.32, >7.20 and >7.42
EMC >7.38, >7.97 and >7.97 >7.10, >7.89 and >7.87

Clinical Pharmacology

Albumin (Human) 25%, Albuminar-25 is active osmotically and is therefore important in regulating the volume of circulating blood. When injected intravenously, 50 mL of 25% albumin draws approximately 175 mL of additional fluid into the circulation within 15 minutes, except in the presence of marked dehydration. This extra fluid reduces hemoconcentration and blood viscosity. The degree of volume expansion is dependent on the initial blood volume. When the circulating blood volume has been depleted, the hemodilution following albumin administration persists for many hours. In individuals with normal blood volume, it usually lasts only a few hours.

Albumin, unlike whole blood or plasma, is considered free of the danger of homologous serum hepatitis. Albumin (Human) 25%, Albuminar-25 may be given in conjunction with other parenteral fluids such as saline, dextrose or sodium lactate. It is convenient to use since no crossmatching is required and the absence of cellular elements removes the danger of sensitization with repeated infusions.

Contraindications

Albumin (Human) 25%, Albuminar-25 may be contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.

Warnings

Infusion of protein-containing solutions such as Albuminar-25 that have been excessively or inappropriately diluted with hypotonic solutions such as sterile water for injection may result in severe hemolysis and acute renal failure. Please refer to the DOSAGE AND ADMINISTRATION section for information about the recommended diluents for Albuminar-25, which are normal saline and 5% dextrose.

Do not use if the solution is turbid. Since this product contains no antimicrobial preservative, do not begin administration more than 4 hours after the container has been entered.

Albumin (Human) U.S.P., 25%, Albuminar-25 is made from human plasma. Products made from human plasma may contain infectious agents such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses during manufacture. The manufacturing procedure for Albumin (Human) 25%, Albuminar-25 includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. Albuminar-25 is pasteurized in the final container at 60.0 +/- 0.5°C for 10 - 11 hours. Virus elimination/inactivation is also achieved by the cold alcohol fractionation process. (See DESCRIPTION section for further information on viral reduction measures). Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents cannot be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Aventis Behring at 800-504-5434. The physician should discuss the risks and benefits of this product with the patient.

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for Albumin.

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