Albuminar-5

Name: Albuminar-5

Albuminar-5 Dosage

Albumin is injected into a vein through an IV. A healthcare provider will give you this injection.

Your breathing, pulse, blood pressure, electrolyte levels, kidney function, and other vital signs will be watched closely while you are receiving albumin. Your blood will also need to be tested regularly during treatment.

Drink plenty of liquids while you are being treated with albumin.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Because you will receive albumin in a clinical setting, you are not likely to miss a dose.

How is this medicine (Albuminar-5) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Headache.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.

Albuminar-5 Description

Albumin (Human) 5%, Albuminar®-5 is a sterile solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is heated at 60°C for 10 hours and stabilized with 0.004 M sodium acetyltryptophanate and 0.004 M sodium caprylate.

All Source Plasma used in the manufacture of this product was tested by FDA-licensed Nucleic Acid Tests (NAT) for HCV and HIV-1 and found to be nonreactive (negative).

An investigational NAT for HBV was also performed on all Source Plasma used in the manufacture of this product and found to be nonreactive (negative). The aim of the HBV test is to detect low levels of viral material, however, the significance of a nonreactive (negative) result has not been established.

Each 50 mL vial of 5% solution contains 2.5 grams of albumin in normal saline. Each 250 mL bottle of 5% solution contains 12.5 grams of albumin in normal saline. Each 500 mL bottle of 5% solution contains 25 grams of albumin in normal saline. The 5% solution is osmotically equivalent to citrated plasma. The pH of the solution is adjusted to 6.9 ± 0.5 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.

Albuminar®-5 is to be administered by the intravenous route.

The heat treatment step employed in the manufacture of Albuminar®-5 pasteurization of the final container at 60ºC 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 Albuminar®-5 and Albumin (Human) 25%, Albuminar®-25 with the following results.1

Pasteurization (60°C for 10 hours) Viral Reduction Studies (log10 reduction)
Virus Albumin (Human) 5%, Albuminar®-5
HIV-1 >5.44, >6.38 and >6.31
BVDV >6.01, >6.76 and >6.55
PrV >7.30, >7.68 and >7.63
EMC >7.38, >7.97 and >7.97
Virus Albumin (Human) 25%, Albuminar®-25
HIV-1 >5.50, >6.57 and >6.64
BVDV >5.99, >5.81 and >5.32
PrV >7.32, >7.20 and >7.42
EMC >7.10, >7.89 and >7.87

Albuminar-5 - Clinical Pharmacology

Albuminar®-5, being active osmotically, is useful in regulating the volume of circulating blood. It is a valuable therapeutic aid for the treatment of conditions that will be benefited by its marked osmotic effect. 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 (Human), unlike whole blood or plasma, is considered free of the danger of viral hepatitis because it is heated at 60ºC for 10 hours. It is convenient to use since no cross-matching is required and the absence of cellular elements removes the danger of sensitization with repeated infusions.

How is Albuminar-5 Supplied

Albuminar®-5 is supplied as a 5% solution in:

50 mL vials containing 2.5 grams of albumin (NDC 0053-7670-06)
250 mL bottles containing 12.5 grams of albumin (NDC 0053-7670-31)
500 mL bottles containing 25 grams of albumin (NDC 0053-7670-32)

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

Contraindications

Albumin (Human) 5%, Albuminar-5 is contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.

Warnings

Do not use if the solution is turbid or if there is a sediment in the bottle. Since the product contains no antimicrobial preservative, do not begin administration more than 4 hours after the container has been entered. Destroy unused portions to prevent the possibility of subsequent use of a solution that may have become contaminated.

Albumin (Human) U.S.P., 5%, Albuminar-5 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) 5%, Albuminar-5 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-5 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.

Adverse Reactions

The incidence of untoward reactions to Albumin (Human) 5% is low. Reports have been received of anaphylaxis, which may be severe, and hypersensitivity reactions (including urticaria, skin rash, pruritus, edema, erythema, hypotension and bronchospasm). Nausea, vomiting, increased salivation, chills and febrile reactions have also been reported (see also PRECAUTIONS ).

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