Albuminar-5

Albumin is a protein produced by the liver that circulates in plasma (the clear liquid portion of your blood). Medicinal albumin is made of plasma proteins from human blood. This medicine works by increasing plasma volume or levels of albumin in the blood.

Albumin is used to replace blood volume loss resulting from trauma such as a severe burns or an injury that causes blood loss. This medicine is also used to treat low albumin levels caused by surgery, dialysis, abdominal infections, liver failure, pancreatitis, respiratory distress, bypass surgery, ovarian problems caused by fertility drugs, and other many other conditions.

Albumin may also be used for purposes not listed in this medication guide.

You should not receive albumin if you have severe anemia (lack of red blood cells), or severe heart failure.

You should not use albumin if you are allergic to it, or if you have:

• severe anemia (lack of red blood cells); or
• severe heart failure.

If possible before you receive albumin, tell your doctor if you have:

• anemia;
• heart disease, high blood pressure;
• bleeding or blood clotting disorder such as hemophilia;
• lung problems;
• kidney disease;
• a latex allergy; or
• if you are unable to urinate.

In an emergency situation it may not be possible to tell your caregivers about your health conditions. Make sure any doctor caring for you afterward knows you have received this medicine.

Albumin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether albumin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether albumin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; cough, difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregiver right away if you have:

• a light-headed feeling, like you might pass out;
• weak or shallow breathing;
• throbbing headache, blurred vision, buzzing in your ears;
• anxiety, confusion, sweating, pale skin; or
• severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, and fast or uneven heart rate.

Common side effects may include:

• nausea, vomiting;
• fever, chills;
• fast heart rate;
• mild rash; or
• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• It is used to treat or prevent low blood volume.
• It is used to treat low blood pressure.
• It is used to replace albumin in people with low blood albumin levels.
• It is used to add back fluid after fluid loss.
• It is used to treat shock.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to albumin, blood products, or any other part of Albuminar-5 (albumin).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have anemia or a weak heart.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Albuminar-5 with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

Albuminar®-5 is contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.

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.

NDC 0053-7670-06

5%

50 mL

Albumin (Human)
USP 5%
Albuminar®-5

For Intravenous
Administration Only.

Contains 2.5 g Albumin (Human) in 50 mL of
normal saline solution. Approximately isotonic
and iso-osmotic with citrated 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

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.

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.

Each 50 mL bottle 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. Each 1000 mL bottle of 5% solution contains 50 grams of albumin in normal saline. The 5% solution is osmotically equivalent with 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. 1mEq. 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) 5%, Albuminar-5, is to be administered by the intravenous route.

The heat treatment step employed in the manufacture of Albumin (Human) 5%, Albuminar-5, 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