ALBUTEIN by is a Other medication manufactured, distributed, or labeled by GRIFOLS USA, LLC, Grifols Biologicals LLC, Grifols Therapeutics LLC, INSTITUTO GRIFOLS SA. Drug facts, warnings, and ingredients follow.
For Intravenous Use Only
Dosage and infusion rate should be adjusted to the patient's individual requirements.
Indication | Dose |
Hypovolemia | Adults: Initial dose of 20 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g. (2.1) |
Cardiopulmonary bypass procedures | Adults: Initial dose of 25 g. (2.1) |
Hypoalbuminemia | Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. For burn therapy after the first 24 h: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100mL. Third space protein loss due to infection: initial dose of 50 to 100 g. (2.1) |
Plasma exchange | The dose required depends on the volume of plasma removed during the procedure. |
Do not dilute with sterile water for injection as this may cause hemolysis in recipients. (5.6)
ALBUTEIN 5% is a solution containing 50 g per L of total protein of which at least 95% is human albumin. (3)
The most common adverse reactions are anaphylactoid type reactions. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals LLC at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2018
For restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3
Acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. ALBUTEIN 5% can be used in such cases.1
ALBUTEIN 5% may be of value in the treatment of shock or hypotension in renal dialysis patients.1
Preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. Albumin also may be used in the priming fluid.4,5,6
ALBUTEIN 5% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. When albumin deficit is the result of excessive protein loss, the effect of ALBUTEIN 5% administration will be temporary unless the underlying disorder is reversed.7,8,9 Septic patients and patients undergoing major surgery may lose more than half of their circulating plasma volume.1,10 Treatment with ALBUTEIN 5% may be of value in such cases, especially when plasma colloid oncotic pressure is abnormally low.1
In the first 24 hours after thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, ALBUTEIN 5% can be used to maintain plasma colloid osmotic pressure.2,11,12 Protein loss from the third space due to infection (acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis) may require treatment with an infusion of albumin.13,14
For Intravenous Use Only
Adjust the concentration, dosage and infusion rate of the albumin preparation to the patient's individual requirements.
The dose required depends on the patient's body weight, severity of injury/illness and on continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required.
Indication | Dose |
Hypovolemia | Adults: Initial dose of 20 g. If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given. Hemodilution may follow administration of ALBUTEIN 5%. Anemia resulting from hemorrhage should be corrected by administration of compatible red blood cells or compatible whole blood. For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per minute is usually indicated. For renal dialysis, the initial dose should not exceed 20 g and patients should be carefully observed for signs of fluid overload. |
Cardiopulmonary bypass procedures | Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated. |
Hypoalbuminemia | Adults: 50 to 75 g For pre- and post-operative hypoproteinemia: 50 to 75 g. In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL. Third space protein loss due to infection: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response. |
Plasma exchange | The dosage and infusion rate of ALBUTEIN 5% infused should be titrated to the volume of plasma removed during the procedure. |
Intravenous use only
Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the infusion and implementation of appropriate medical treatment.
Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient's volume status. At the first clinical signs of fluid overload (headache, dyspnea, jugular venous distention increased blood pressure), the infusion must be slowed or stopped immediately.
Use albumin with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. Examples of such conditions are:
Monitor regularly the electrolyte status of the patient and take appropriate steps to restore or maintain the electrolyte balance when albumin is administered.
Regular monitoring of coagulation and hematology parameters is necessary if comparatively large volumes are to be replaced. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets, and erythrocytes).
Monitor regularly hemodynamic parameters during administration of Albutein 5%; this may include:
ALBUTEIN 5% must not be diluted with sterile water for injection as this may cause hemolysis in recipients [see Dosage and Administration (2.2)].
Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have been identified for ALBUTEIN 5%.
The most serious adverse reactions are anaphylactic shock, heart failure and pulmonary edema. The most common adverse reactions are anaphylactoid type reactions.
Adverse reactions to ALBUTEIN 5% normally resolve when the infusion rate is slowed or the infusion is stopped. In case of severe reactions, the infusion is stopped and appropriate treatment initiated.
Because adverse reactions are reported voluntarily post-approval from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to product exposure. The following adverse reactions have been identified during post approval use of human albumin, including ALBUTEIN (all strengths) in decreasing order of significance:
Pregnancy Category C. Animal reproduction studies have not been conducted with ALBUTEIN 5%. It is also not known whether ALBUTEIN 5% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. ALBUTEIN 5% should be given to a pregnant woman only if clearly needed.
ALBUTEIN 5% is a sterile, aqueous solution for single dose intravenous administration containing 5% human albumin (weight/volume). ALBUTEIN 5% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein.
ALBUTEIN 5% is osmotically and isotonically equivalent to an equal volume of normal human plasma.
A liter of ALBUTEIN 5% solution contains 130-160 milliequivalents of sodium ion. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives.
ALBUTEIN 5% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 5% is heated at 60 °C for ten hours against the possibility of transmitting viruses.
Human Albumin accounts for more than half of the total protein in the plasma and represents about 10% of protein synthesis activity by the liver.
Human Albumin 5% is almost isooncotic to normal plasma.
The primary physiological function of albumin results from its contribution to plasma colloid oncotic pressure and transport function. Albumin stabilizes circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins. Other physiological functions include antioxidant properties, free radical scavenging and capillary membrane integrity.
Albumin is distributed throughout the extracellular space and more than 60% of the body albumin pool is located in the extravascular fluid compartment. Albumin has a circulating life span of 15-20 days, with a turnover of approximately 15 g per day.
The balance between synthesis and breakdown is normally achieved by feedback regulation.
Elimination is predominantly intracellular and due to lysosome proteases.
In healthy subjects, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion. There is considerable individual variation in the effect of albumin on plasma volume. In some patients, plasma volume can remain elevated for several hours. In critically ill patients, however, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.
ALBUTEIN 5% is supplied in single-use, individually laser etched vials.
The following vial sizes of ALBUTEIN 5% are available:
NDC Number Fill Size Grams Protein
68516-5214-5 50 mL 2.5 g
68516-5214-1 250 mL 12.5 g
68516-5214-2 500 mL 25.0 g
Each vial size label incorporates integrated hangers. Each label has a peel-off strip showing the product name and lot number.
ALBUTEIN 5% is stable for three years provided the storage temperature does not exceed 30 °C. Protect from freezing.
This product is usually given in a hospital setting.
Inform patients being treated with ALBUTEIN 5% about the risks and benefits of its use [see Adverse Reactions (6)].
Inform patients to immediately report the following signs and symptoms to their physician:
Inform patients that ALBUTEIN 5% is a derivative of human plasma and may contain infectious agents that cause disease (e.g., viruses, and theoretically, the CJD agent). Inform patients that the risk that ALBUTEIN 5% may transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing the donated plasma for certain viral agents and by the inactivation and/or removal of certain viruses during the manufacturing process [see Warnings and Precautions (5.7)].
Manufactured by:
Grifols Biologicals LLC
5555 Valley Boulevard
Los Angeles, CA 90032, U.S.A.
U. S. License No. 1694
Principal Display Panel – 50 mL Vial Label
GRIFOLS
NDC: 68516-5214-6
Albumin (Human) U.S.P
Albutein® 5%
5% 2.5 g 50 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.
Principal Display Panel – 50 mL Carton Label
GRIFOLS
NDC: 68516-5214-5
Albumin (Human) U.S.P.
Albutein® 5%
Solution 2.5 g 50 mL
5%
Store at temperatures not exceeding 30° C.
Principal Display Panel – 250 mL Vial Label
GRIFOLS
NDC: 68516-5214-3
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.
Principal Display Panel – 250 mL Carton Label
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.
Principal Display Panel – 500 mL Vial Label
GRIFOLS
NDC: 68516-5214-4
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.
Principal Display Panel – 500 mL Carton Label
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 |
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Labeler - GRIFOLS USA, LLC (048987452) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Grifols Biologicals LLC | 092694538 | manufacture(68516-5214) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Grifols Biologicals LLC | 121076871 | manufacture(68516-5214) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Grifols Therapeutics LLC | 611019113 | manufacture(68516-5214) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
INSTITUTO GRIFOLS SA | 465562213 | manufacture(68516-5214) |
Mark Image Registration | Serial | Company Trademark Application Date |
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ALBUTEIN 72417224 0964012 Live/Registered |
ABBOTT LABORATORIES 1972-03-03 |