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 ® 20% can be used in such...
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 ...
ALBUTEIN 20% is supplied in single-use, individually laser etched vials. The following vial sizes of ALBUTEIN 20% are available: NDC Number Fill Size Grams Protein 68516-5215-1 50 mL 10 g 68516-5215-2 100 mL 20 g Each vial size label incorporates integrated hangers. Each label has a peel-off strip showing the product name and lot number. ALBUTEIN 20% is stable for three yea...
www.fda.gov/medwatchFor 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® 20% can be used in such cases.1
ALBUTEIN 20% 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 20% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.1,2,7
ALBUTEIN 20% 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 20% administration will be temporary unless the underlying disorder is reversed. 8,9,10Septic patients and patients undergoing major surgery may lose more than half of their circulating plasma volume.1,11 Treatment with ALBUTEIN 20% 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 20% can be used to maintain plasma colloid osmotic pressure.2,12,13 Protein loss from the third space due to infection (acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis) may require treatment with an infusion of albumin.14,15
ALBUTEIN 20% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.16,17
ALBUTEIN 20% is indicated for the treatment of neonatal hyperbilirubinemia. It may be used prior to or during an exchange procedure in an attempt to bind free bilirubin and enhance its excretion.18,19,20
ALBUTEIN 20% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ARDS.6,21
ALBUTEIN 20% may be used to maintain cardiovascular function following removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites.2,22,23,24
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 20%. 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. |
| Acute nephrosis | Adults: 25 g together with diuretic once a day for 7 - 10 days. |
| 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. |
| Ovarian hyperstimulation syndrome | Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. |
| Neonatal hyperbilirubinemia | 1 g per kilogram body weight prior to or during exchange transfusion. |
| Adult respiratory distress syndrome (ARDS) | Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. |
| Prevention of central volume depletion after paracentesis due to cirrhotic ascites | Adults: 8 g for every 1000 mL of ascitic fluid removed. |
Intravenous use only
ALBUTEIN 20% is a solution containing 200 g per L of total protein of which at least 95% is human albumin.
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 cardiovascular 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:
The colloid-osmotic effect of human albumin 20% is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration. Patients with marked dehydration require administration of additional fluids.
20% – 25% human albumin solutions are relatively low in electrolytes compared to 4% – 5% human albumin solutions. 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 20%; this may include:
ALBUTEIN 20% must not be diluted with sterile water for injection as this may cause hemolysis in recipients. The product can be diluted in an isotonic solution (e.g., 5% dextrose in water or 0.9% sodium chloride) [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 and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for ALBUTEIN 20%.
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 20% 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.
No clinical studies were done using ALBUTEIN 20%.
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:
ALBUTEIN 20% must not be mixed with other medicinal products.
Risk Summary
There is no data with ALBUTEIN 20% use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with ALBUTEIN 20%. It is not known whether ALBUTEIN 20% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ALBUTEIN 20% should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Risk Summary
There is no information regarding the presence of ALBUTEIN 20% in human milk, the effect on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ALBUTEIN 20% and any potential adverse effects on the breastfed infant from ALBUTEIN 20%.
No human or animal data. Use only if clearly needed.
No human or animal data. Use only if clearly needed.
ALBUTEIN 20% is a sterile, aqueous solution for single dose intravenous administration containing 20% human albumin (weight/volume). ALBUTEIN 20% 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. The colloid osmotic effect of human albumin 20% is approximately four times that of normal human plasma. A liter of ALBUTEIN 20% 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 20% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. ALBUTEIN 20% is heated at 60 °C for ten hours, a process that has the capacity to inactivate 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 20% has a corresponding hyperoncotic effect.
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, the 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 20% is supplied in single-use, individually laser etched vials.
The following vial sizes of ALBUTEIN 20% are available:
NDC Number Fill Size Grams Protein
68516-5215-1 50 mL 10 g
68516-5215-2 100 mL 20 g
Each vial size label incorporates integrated hangers. Each label has a peel-off strip showing the product name and lot number.
ALBUTEIN 20% 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 20% 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 20% 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 20% 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 introduction of steps with capacity for the inactivation and/or removal of certain viruses during the manufacturing process [see Warnings and Precautions (5.8)].
Manufactured by:
Grifols Biologicals LLC
5555 Valley Boulevard
Los Angeles, CA 90032, U.S.A.
U. S. License No. 1694
3063724
Principal Display Panel – 50 mL Vial Label
NDC 68516-5215-3 10 g / 50 mL
Albumin (Human)
U.S.P.
Albutein® 20%
Solution
20% Rx only
Precautions: Do not allow to freeze. Single dose container for intravenous administration.
Discard any unused contents and administration devices after use. In case of dehydration
administer additional fluids with or immediately following Albutein®.
Instructions: The patient and physician should discuss the risks and benefits of this product.
For information on dosage and directions for administration, see accompanying pamphlet.
Contents: Each 50 mL contains 10 grams Albumin (Human) in aqueous diluent. Osmotically
equivalent to 200 mL of plasma. Sodium range 130 - 160 milliequivalents per liter.
Contains no preservatives. Heat-treated at 60 °C for 10 hours. 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.
Grifols Biologicals LLC Los Angeles, CA 90032, USA U.S License No. 1694
Lot No.:
GRIFOLS
Albutein® 20%
10 g / 50 mL
Lot No.:
GRIFOLS
Albutein® 20%
10 g / 50 mL
Lot No.:
Expires:
3063723
Principal Display Panel – 50 mL Carton Label
NDC 68516-5215-1 10 g / 50 mL
Albumin (Human)
U.S.P.
Albutein® 20%
Solution
20%
Store at temperatures
not exceeding 30 °C.
GRIFOLS
Rx only
Precautions: Do not allow to freeze.
Single dose container for intravenous administration.
Discard any unused contents
and administration devices after use.
In case of dehydration, administer additional fluids with or immediately
following Albutein®.
Instructions: The patient and physician should discuss
the risks and benefits of this product. For
information on dosage and directions for
administration, see accompanying pamphlet.
DO NOT USE IF TURBID.
DO NOT BEGIN ADMINISTRATION MORE
THAN 4 HOURS AFTER THE CONTAINER
HAS BEEN ENTERED.
GRIFOLS
Contents:
One 50 mL vial Albumin (Human) U.S.P.
Albutein®. Each 50 mL contains 10 grams
Albumin (Human) in aqueous diluent.
Osmotically equivalent to 200 mL of plasma.
Sodium range 130 - 160 milliequivalents
per liter.
Stabilized with 0.08 millimole sodium
caprylate and 0.08 millimole sodium
acetyltryptophanate per gram of albumin.
Contains no preservatives.
Heat-treated at 60 °C for 10 hours.
Grifols Biologicals LLC
Los Angeles, CA 90032, USA
U.S License No. 1694
GRIFOLS
3063722
Principal Display Panel – 100 mL Vial Label
NDC 68516-5215-4 20 g / 100 mL
Albumin (Human)
U.S.P.
Albutein® 20%
Solution
20%
GRIFOLS Rx only
Precautions: Do not allow to freeze. Single dose container for intravenous administration.
Discard any unused contents and administration devices after use. In case of dehydration
administer additional fluids with or immediately following Albutein®.
Instructions: The patient and physician should discuss the risks and benefits of this product.
For information on dosage and directions for administration, see accompanying pamphlet.
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.
Contains no preservatives. Heat-treated at 60 °C for 10 hours.
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.
Grifols Biologicals LLC
Los Angeles, CA 90032, USA U.S License No. 1694
Lot No.:
GRIFOLS
Albutein® 20%
20 g / 100 mL
Lot No.:
GRIFOLS
Albutein® 20%
20 g / 100 mL
Lot No.:
Expires:
3063721
Principal Display Panel – 100 mL Carton Label
NDC 68516-5215-2 20 g / 100 mL
Albumin (Human)
U.S.P.
Albutein® 20%
Solution
20%
Store at temperatures not exceeding 30 °C.
GRIFOLS
Rx only
Precautions:
Do not allow to freeze.
Single dose container for intravenous
administration.
Discard any unused contents
and administration devices after use.In case of dehydration, administer additional
fluids with or immediately following Albutein®.
Instructions:
The patient and physician should discuss
the risks and benefits of this product. For
information on dosage and directions for
administration, see accompanying pamphlet.
DO NOT USE IF TURBID.
DO NOT BEGIN ADMINISTRATION MORE
THAN 4 HOURS AFTER THE CONTAINER
HAS BEEN ENTERED.
GRIFOLS
Contents:
One 100 mL vial Albumin (Human) U.S.P.
Albutein®. 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.
Stabilized with 0.08 millimole sodium caprylate
and 0.08 millimole sodium acetyltryptophanate
per gram of albumin.
Contains no preservatives.
Heat-treated at 60 °C for 10 hours.
Grifols Biologicals LLC
Los Angeles, CA 90032, USA
U.S License No. 1694
GRIFOLS
3063720
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1741295 | albumin human 20 % in 100 ML Injection | PSN | 15 |
| 1741290 | albumin human 20 % in 50 ML Injection | PSN | 15 |
| 1742220 | Albutein 20 % in 100 ML Injection | PSN | 15 |
| 1742217 | Albutein 20 % in 50 ML Injection | PSN | 15 |
| 1742220 | 100 ML albumin human, USP 200 MG/ML Injection [Albutein] | SBD | 15 |
| 1742217 | 50 ML albumin human, USP 200 MG/ML Injection [Albutein] | SBD | 15 |
| 1741295 | 100 ML albumin human, USP 200 MG/ML Injection | SCD | 15 |
| 1741290 | 50 ML albumin human, USP 200 MG/ML Injection | SCD | 15 |
| 1741290 | albumin human 10 GM per 50 ML Injection | SY | 15 |
| 1741295 | albumin human 20 % per 100 ML Injection | SY | 15 |
| 1741290 | albumin human 20 % per 50 ML Injection | SY | 15 |
| 1741295 | albumin human 20 GM per 100 ML Injection | SY | 15 |
| 1742217 | Albutein 10 GM per 50 ML Injection | SY | 15 |
| 1742220 | Albutein 20 % per 100 ML Injection | SY | 15 |
| 1742217 | Albutein 20 % per 50 ML Injection | SY | 15 |
| 1742220 | Albutein 20 GM per 100 ML Injection | SY | 15 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ALBUMIN (HUMAN) Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20120517 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68516-5215-1 | ALBUTEIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 15 | |
| 68516-5215-2 | ALBUTEIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 15 | |
| 68516-5215-3 | ALBUTEIN | 50 mL in 1 VIAL | INJECTION, SOLUTION | 50 | 15 | |
| 68516-5215-4 | ALBUTEIN | 100 mL in 1 VIAL | INJECTION, SOLUTION | 100 | 15 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Albumin (Human) | ACTIVE INGREDIENT | ZIF514RVZR | 3 | |
| Albumin (Human) | ACTIVE MOIETY | ZIF514RVZR | 3 | |
| Sodium Acetyltryptophanate | INACTIVE INGREDIENT | 3EN9H0M2FX | 3 | |
| Sodium Caprylate | INACTIVE INGREDIENT | 9XTM81VK2B | 3 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68516-5215 | 68516-5215-3, 68516-5215-1, 68516-5215-4, 68516-5215-2 |
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 102478 | Albutein | Albumin (Human) | 351(a) | Rx | 2026-09-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Albumin Human | ZIF514RVZR | ACTIB |
| Sodium Chloride | 451W47IQ8X | IACT |
| Sodium Caprylate | 9XTM81VK2B | IACT |
| Sodium Acetyltryptophanate | 3EN9H0M2FX | IACT |
| Water | 059QF0KO0R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVENOUS | 2916 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVENOUS | 2916 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVENOUS | 2916 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVENOUS | 2916 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVENOUS | 2916 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7a5bc0ff-1dd9-4c8f-918f-97dd52bf2a86 | d18a7e13-1ef0-495c-aa57-ace2e446a823 | 2008-07-01 | Warnings, Adverse reactions | d18a7e13-1ef0-495c-aa57-ace2e446a823 |
Adverse event summaries are temporarily unavailable. Other product information remains available.