Albuminar-25

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with albumin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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.

• If you need to store Albuminar-25 at home, talk with your doctor, nurse, or pharmacist about how to store it.

Albuminar®-25, Albumin (Human) 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.

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.

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.

Albuminar®-25 is to be administered by the intravenous route.

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

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.

The incidence of untoward reactions to Albuminar®-25 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).

NDC 0053-7680-32

25%

50 mL

Albuminar®-25
Albumin (Human)
USP 25%

For Intravenous Administration Only.

12.5 g in 50 mL solution osmotically equivalent to 250 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

SHOCK - Albumin is indicated in the emergency treatment of shock and in other similar conditions where the restoration of blood volume is urgent. If there has been considerable loss of red blood cells, transfusion with packed red blood cells is indicated.

BURNS - Albumin or Albumin in either normal saline or dextrose is indicated to prevent marked hemoconcentration and to maintain appropriate electrolyte balance.

HYPOPROTEINEMIA with or without edema - Albumin is indicated in those clinical situations usually associated with a low concentration of plasma protein and a resulting decreased circulating blood volume. Although diuresis may occur soon after albumin administration has been instituted, best results are obtained if albumin is continued until the normal serum protein level is regained.

GENERAL

If dehydration is present additional fluids must accompany or follow the administration of albumin. Administration of large quantities of albumin should be supplemented with or replaced by packed red blood cells to combat the relative anemia which would follow such use. The quick response of blood pressure which may follow the rapid administration of concentrated albumin necessitates careful observation of the injured patient to detect bleeding points which failed to bleed at lower blood pressure. Albumin (Human) 25%, Albuminar-25 should be administered with caution to patients with low cardiac reserve or with no albumin deficiency because a rapid increase in plasma volume may cause circulatory compromise (e.g. hypertension, hypotension, or pulmonary edema). In cases of hypertension, a slower rate of administration is desired - 200 mL of albumin solution may be mixed with 300 mL of 10% dextrose solution and administered at a rate of 10 grams of albumin (100 mL) per hour.

If anaphylactic or severe anaphylactoid reactions occur, discontinue infusion immediately. Infusion rates and the patient's clinical state should be monitored closely during infusion.

INFORMATION FOR PATIENT - Some viruses, such as parvovirus B19 or hepatitis A are particularly difficult to remove or inactivate at this time. Parvovirus B19 may most seriously affect pregnant women, or immune-compromised individuals. The majority of parvovirus B19 and hepatitis A infections are acquired by environmental (community acquired) sources.

PREGNANCY CATEGORY C - Animal reproduction studies have not been conducted with Albumin (Human) 25%, Albuminar-25. It is also not known whether Albuminar-25 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Albuminar-25 should be given to a pregnant woman only if clearly needed.

PEDIATRIC USE - No clinical studies using Albumin (Human) 25%, Albuminar-25 have been conducted in pediatric patients. Safety and effectiveness in pediatric patients have not been established. However, extensive experience in patients suggests that children respond to Albumin (Human) 25%, Albuminar-25 in the same manner as adults.