Human Albumin Grifols

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.

• 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.

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.

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.

• 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.

Review Date: October 4, 2017

Albumin is a highly soluble, globular protein (MW 66,500), accounting for 70 - 80% of the colloid osmotic pressure of plasma. Therefore, it is important in regulating the osmotic pressure of plasma1,2. Human Albumin Grifols® 20% supplies the oncotic equivalent of approximately 4 times its volume of human plasma. It will increase the circulating plasma volume by an amount approximately 2.5 times the volume infused within 15 minutes, if the recipient is adequately hydrated3. This extra fluid reduces hemoconcentration and decreases blood viscosity. The degree and duration of volume expansion depend upon the initial blood volume.

When treating patients with diminished blood volume, the effect of infused albumin may persist for many hours. The hemodilution lasts for a shorter time when albumin is administered to individuals with normal blood volume.

Albumin is also a transport protein and binds naturally occurring, therapeutic, and toxic materials in the circulation2.

Albumin is distributed throughout the extracellular water and more than 60% of the body albumin pool is located in the extravascular fluid compartment. The total body albumin in a 70 kg man is approximately 320 g; it has a circulating life span of 15 - 20 days, with a turnover of approximately 15 g per day1.

Human Albumin Grifols® 20% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume.

The use of Human Albumin Grifols® 20% is contraindicated in patients with a history of allergic reactions to albumin.

1. Tullis, J.L., "Albumin: 1. Background and Use, 2. Guidelines for Clinical Use". JAMA 237; 355-360, 460-463, 1977.
2. Finlayson, J.S., "Albumin Products" Seminars in Thrombosis and Hemostasis, Vol 6, pp. 85-120, 1980.
3. Janeway, C.A., "Human Serum Albumin: Historical Review" in: Proceedings of the Workshop on Albumin. Sgouris, JT and René A (eds). DHEW Publication No. (NIH) 76-925, Washington, D.C., U.S. Government Printing Office, 1976, pp. 3-21.
4. Houser, C.J., et al., "Oxygen Transport Responses to Colloids and Crystalloids in Critically III Surgical Patients". Surgery, Gynecology and Obstetrics, Vol. 150, pp. 811-816, June 1980.
5. Peters, T., J.R., "Serum Albumin" in: The Plasma Proteins, 2nd Ed., Putnam F.W. (ed), New York Academic Press, Vol 1, 133-181, 1975.
6. Tsao, Y.C., Yu V.Y.H., "Albumin in the Management of Neonatal Hyperbilirubinemia". Arch Dis Childhood, Vol. 47, pp. 250-256, 1972.

Manufactured by Instituto Grifols, S.A.
Barcelona - SPAIN
U.S. Licence No. 1181

Distributed by Grifols Biologicals, Inc.
Los Angeles - CA 90032

Revised: October 2008

3028250

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML VIAL

NDC 61953-0001-1

Albumin (Human) U.S.P. Human Albumin Grifols® 20%

10.0 g 50 mL Rx only.

Dosage and directions for administration, see package insert.

Store at temperatures not exceeding 30 °C

DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

Manufactured by Instituto Grifols, S.A. Barcelona – SPAIN U.S. License No. 1181

Distributed by Grifols Biologicals, Inc. Los Angeles – CA 90032

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 ML VIAL

NDC 61953-0001-2

Albumin (Human) U.S.P. Human Albumin Grifols® 20% 100 mL

20 g 100 mL Rx only.

CONTENTS: Each 100 mL contains 20 grams Albumin (Human) in aqueous diluent.

Osmotically equivalent to 400 mL of plasma. Sodium range 130-160 milliequivalents per liter.

Dosage and directions for administration, see package insert.

Contains no preservatives. Store at temperatures not exceeding 30 °C

DO NOT USE IF TURBID.

DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

Manufactured by Instituto Grifols, S.A. Barcelona – SPAIN U.S. License No. 1181

Distributed by Grifols Biologicals, Inc. Los Angeles – CA 90032

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML CARTON

GRIFOLS

NDC 61953-0001-1

Albumin (Human) U.S.P.

Human Albumin Grifols®

20% Solution

10.0 g 50 mL

DO NOT USE IF TURBID.

DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 ML CARTON

GRIFOLS

NDC 61953-0001-2

Albumin (Human) U.S.P.

Human Albumin Grifols®

20% Solution

20 g 100 mL

DO NOT USE IF TURBID.

DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.