Albumin human

Name: Albumin human

What is the most important information I should know about albumin?

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

Albumin side effects

Get emergency medical help if you have 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.

Dosage Forms and Strengths

Albumin (Human) 20% is supplied in

  • 10 g in 50 mL infusion bottle
  • 20 g in 100 mL infusion bottle

Do not use in individuals who are hypersensitive to albumin preparations, any ingredient in the formulation, or components of the container.

Adverse Reactions

General

The most serious events are anaphylactic shock, circulatory failure, cardiac failure, and pulmonary edema.

The most common adverse events are anaphylactoid type of reactions.

Adverse reactions for Albumin (Human) 20% normally resolve when the infusion rate is slowed down or the infusion is stopped. In case of severe reactions, the infusion should be stopped and appropriate treatment should be initiated.

Clinical Studies Experience

No clinical studies were done using Albumin (Human) 20%

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Albumin (Human) (any strength). Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency.

Table 1 Adverse reactions observed for ALBUMIN HUMAN (any strength) during post-marketing phase (in decreasing order of severity)

Observed Adverse Reactions

anaphylactic shock

cardiac failure

loss of consciousness

circulatory failure

hypersensitivity

congestive heart failure

pulmonary edema

dyspnea

hypotension

hypertension

tachycardia

bradycardia

vomiting

urticaria

angioneurotic edema

rash erythematous

confusional state

headache

chills

pyrexia

flushing

nausea

pruritus

hyperhidrosis

No drug interaction studies have been conducted.

References

  1. Tullis JL: Albumin 2.Guidelines for Clinical Use. JAMA 1977; 237:460-463
  2. Vermeulen LC et al.: A Paradigm for Consensus. Arch. Intern. Med. 1995; 155:373-379
  3. Mendez CM, McClain CJ, Marsano LS: Albumin Therapy in Clinical Practice. Nutrition in Clinical Practice 2005; 20: 314-320
  4. Janeway, C. A. "Human Serum Albumin: Historical Review" in: Proceedings of the Workshop on Albumin. DHEW Publication No. (NIH) 76-925. Sgouris, J. T. and René A. (eds.), Washington, D.C., U.S. Government Printing Office. 1976, pp 3-21.
  5. Martin GS et al.: A randomized, controlled trail of furosemide with or without albumin in hypoproteinemic patients with acute lung injury. Crit. Care Med. 2005; 33: 1681-1687
  6. Tsao YC, Yu VY: Albumin in management of neonatal hyperbilirubinaemia. Arch Dis.Child 1972;47:250-256.
  7. Practice Committee of the American Society for Reproductive Medicine. Ovarian hyperstimulation syndrome. Fertil.Steril. 2006;86:S178-S183.
  8. Aboulghar M, Evers JH, Al Inany H: Intravenous albumin for preventing severe ovarian hyperstimulation syndrome: a Cochrane review. Hum.Reprod. 2002;17:3027-3032.

How Supplied/Storage and Handling

Albumin (Human) 20% is supplied in 10 g in 50 mL or 20 g in 100 mL single use bottles.

NDC Number NDC Number Size Grams protein

Octapharma Pharmazeutika Produktionsges.m.b.H

Octapharma AB

67467-633-01

68209-633-01

50 ml

10

67467-633-02

68209-633-02

100 ml

20

Albumin (Human) 20% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture.

Store protected from light.

Do not freeze.

Do not use after expiration date.

Do not use if turbid.

Description

Albumin (Human) 25%, USP (Plasbumin-25) is made from pooled human venous plasma using the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration.

Plasbumin-25 is a 25% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.02 M sodium caprylate and 0.02 M acetyltryptophan. The approximate sodium content of the product is 145 mEq/L. It contains no preservative. Plasbumin-25 must be administered intravenously.

Each vial of Plasbumin-25 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses.

Clinical Pharmacology

Each 20 mL vial of Plasbumin-25 supplies the oncotic equivalent of approximately 100 mL citrated plasma; 50 mL supplies the oncotic equivalent of approximately 250 mL citrated plasma.

When administered intravenously to an adequately hydrated subject, the oncotic (colloid osmotic) effect of 20 mL Plasbumin-25 is such that it will draw approximately a further 70 mL of fluid from the extravascular tissues into the circulation within 15 minutes, 1 thus increasing the total blood volume and reducing both hemoconcentration and whole blood viscosity. Accordingly, the main clinical indications are for hypoproteinemic states involving reduced oncotic pressure, with or without accompanying edema. 2 Plasbumin-25 can also be used as a plasma volume expander.

Albumin is a transport protein and it may be useful in severe hemolytic disease in the neonate who is awaiting exchange transfusion. The infused albumin may reduce the level of free bilirubin in the blood. 3

This could also be of importance in acute liver failure where albumin might serve the dual role of supporting plasma oncotic pressure, as well as binding excessive plasma bilirubin. 2

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