Albutein 5%

Name: Albutein 5%

Indications and usage

Albumin (Human) U.S.P., Albutein® 5% Solution is indicated:

  1. For treatment of hypovolemic shock.1,2
  2. In conditions in which there is severe hypoalbuminemia. However, unless the pathologic condition responsible for the hypoalbuminemia can be corrected, administration of albumin can afford only symptomatic or supportive relief.
  3. As an adjunct in hemodialysis and in cardiopulmonary bypass procedures.

In those conditions in which the colloid requirement is high and there is less need for fluid, albumin should be administered as a 25% solution.

Contraindications

Albutein® 5% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume.

The use of Albutein® 5% is contraindicated in patients with a history of allergic reactions to albumin.

Adverse reactions

The most common adverse reactions include fever and chills, rash, nausea, vomiting, tachycardia and hypotension. Should an adverse reaction occur, slow or stop the infusion for a period of time which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional Albutein® 5%, material from a different lot should be used.

Albutein® 5%, particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals Inc. at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

  1. Finlayson, J.S., Albumin Products Semin Thromb Hemo, 6:85-120, 1980.
  2. Hauser, C.J., et. al., Oxygen Transport Responses to Colloids and Crystalloids in Critically Ill Surgical Patients, Surg Gyn Obs,150:811-816, June 1980.
  3. Tullis, J.L., Albumin: 1. Background and Use. 2. Guidelines for Clinical Use. JAMA 237:355-360, 460-463, 1977.
  4. Janeway, C.A., Human Serum Albumin: Historical Review in Proceedings of the Workshop on Albumin, Sgouris, J.T. and Rene A. (eds), DHEW Publication No. (NIH) 76-925, Washington, D.C., U.S. Government Printing Office, 1976, pp. 3-21.

How supplied/storage and handling

Albutein® 5% is supplied as a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). It is available in the following vial sizes:

  • 250 mL vial Albutein® 5% (NDC 68516-5214-1).
  • 500 mL vial Albutein® 5% (NDC 68516-5214-2).

Storage

Albutein® 5% is stable for three years provided that storage temperature does not exceed 30 °C. Protect from freezing.

Patient counseling information

The most common adverse reactions include fever and chills, rash, nausea, vomiting, tachycardia and hypotension. Depending on the severity of the reaction, patients should be advised to discontinue use of the product and contact their physician and/or seek immediate emergency care.

Albutein® 5% should be administered with caution to patients with low cardiac reserve.

Rapid infusion may cause vascular overload with resultant pulmonary edema. Patients should be closely monitored for signs of increased venous pressure.

A rapid rise in blood pressure following infusion necessitates careful observation of injured or postoperative patients to detect and treat severed blood vessels that may not have bled at a lower pressure.

Patients with marked dehydration require administration of additional fluids. Albutein® 5% may be administered with the usual dextrose and saline intravenous solutions. However, solutions containing protein hydrolysates or alcohol must not be infused through the same administration set in conjunction with Albutein® 5% since these combinations may cause the proteins to precipitate. See also WARNINGS AND PRECAUTIONS (5.2).

Manufactured and Distributed by:
Grifols Biologicals Inc.
Los Angeles, CA 90032, U.S.A.
U. S. License No. 1694
DATE OF REVISION: 07/2008

3028183

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 250 ML VIAL

GRIFOLS

NDC 68516-5214-1

Albumin (Human) U.S.P.

Albutein® 5%

5% 12.5 g 250 mL

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.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 500 ML VIAL

GRIFOLS

NDC 68516-5214-2

Albumin (Human) U.S.P.

Albutein® 5%

5% 25 g 500 mL

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.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 250 ML CARTON

GRIFOLS

NDC 68516-5214-1

Albumin (Human) U.S.P.

Albutein® 5%

Solution 12.5 g 250 mL

5%

Store at temperatures not exceeding 30 °C.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 500 ML CARTON

GRIFOLS

NDC 68516-5214-2

Albumin (Human) U.S.P.

Albutein® 5%

Solution 25 g 500 mL

5%

Store at temperatures not exceeding 30 °C.

ALBUTEIN 
albumin (human) injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68516-5214
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albumin Human (Albumin Human) Albumin Human 12.5 g  in 250 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride  
Sodium Caprylate  
Sodium Acetyltryptophanate  
Water  
Packaging
# Item Code Package Description
1 NDC:68516-5214-1 1 VIAL (1 VIAL) in 1 CARTON
1 250 mL in 1 VIAL
2 NDC:68516-5214-2 1 VIAL (1 VIAL) in 1 CARTON
2 500 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102478 08/15/1978
Labeler - Grifols Biologicals Inc. (096019096)
Establishment
Name Address ID/FEI Operations
Grifols Biologicals Inc. 092694538 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Grifols Biologicals Inc. 121076871 MANUFACTURE
Revised: 07/2008   Grifols Biologicals Inc.
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