ALBUMINEX 25% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. hypovolemia following shock due to trauma or sepsis, in surgical patients and in other similar conditions with volume deficiency when restoration and maintenance of circulating blood volume is required in both adult and pediatric patients. In...
For intravenous administration only. The concentration of ALBUMINEX 25% used, its dosage, and infusion rate should be adjusted to the patient's individual requirements and clinical indication. Indication Dose Hypovolemia Hypovolemia Adults: Initial dose of 25 g. If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given. For acute liver failure: initial dose of 12 to 25 g. An...
How ALBUMINEX 25% is supplied ALBUMINEX 25%, 25 g/dL in clear Type II glass vials. Strength Grams and fill size NDC carton number NDC vial number 25% 12.5 g in 50 mL 64208-2512-3 64208-2512-4 25% 25 g in 100 mL 64208-2512-7 64208-2512-8 Not all pack sizes may be marketed. Storage and handling Do not store above 30°C (86°F). Keep the vial stored in the outer carton in order to protect from light. Do not freeze. Do ...
www.fda.gov/medwatch
www.bapen.org.uk/pdfs/bapen_pubs/giftasup.pdf
www.aasld.org/publications/practice-guidelines-0
ccforum.com/content/18/1/R10ALBUMINEX 25% is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate e.g. hypovolemia following shock due to trauma or sepsis, in surgical patients and in other similar conditions with volume deficiency when restoration and maintenance of circulating blood volume is required in both adult and pediatric patients. In pediatric patients to reverse hypovolemia and achieve normal capillary refill time.1, 2, 3, 4, 5, 6, 7, 8
ALBUMINEX 25% is indicated for prevention of central volume depletion and maintenance of cardiovascular function after large volume parencentesis in patients with liver cirrhosis or other chronic liver disease in adults and children.9, 10, 11, 12
ALBUMINEX 25% infusion plus administration of vasoactive drugs is indicated in the treatment of type I hepatorenal syndrome.6
For patients with spontaneous bacterial peritonitis ALBUMINEX 25% is indicated as adjuvant treatment to antibiotic therapy.9, 10, 13
ALBUMINEX 25% is indicated in patients with severe burn injury (> 20% total body surface area), but not until at least 12 to 24 hours after the burn, in order to correct protein loss, decrease overall fluid requirements, decrease systemic edema and stabilize cardiovascular hemodynamics without fluid overload (initial resuscitation should be with crystalloids).8, 14ALBUMINEX 25% is also indicated in patients with pre- or post-operative hypoproteinemia and for third space protein loss due to infection or burns.
ALBUMINEX 25% is indicated in patients with acute nephrosis in combination with loop diuretics to reinforce the diuretic therapeutic effect, which is reduced by hypoalbuminemia, and for the correction of reduced oncotic pressure.15, 16
ALBUMINEX 25% is indicated in conjunction with diuretics to correct fluid volume overload associated with ARDS.17, 18, 19
ALBUMINEX 25% is indicated in cardiopulmonary bypass procedures as part of the priming fluids to passivate the synthetic surfaces of the extracorporeal circuit and maintain the patient's colloid oncotic pressure.20, 21, 22, 23, 24, 25
For intravenous administration only.
The concentration of ALBUMINEX 25% used, its dosage, and infusion rate should be adjusted to the patient's individual requirements and clinical indication.
| Indication | Dose |
|---|---|
| Hypovolemia | Hypovolemia Adults: Initial dose of 25 g. If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given. 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 25 g and patients should be carefully observed for signs of fluid overload. |
| Prevention of central volume depletion after paracentesis due to cirrhotic ascites | Adults: 8 g for every 1000 mL of ascitic fluid removed. |
| Hypoalbuminemia including from burns | 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 or burns: 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. |
| Acute nephrosis | Adults: 25 g together with diuretic once a day for 7-10 days |
| Adult respiratory distress syndrome (ARDS) | Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. |
| Cardiopulmonary bypass procedures | Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated. |
ALBUMINEX 25% is a sterile, aqueous solution of human albumin (25% w/v i.e. 25 g/dL) for intravenous administration available as:
ALBUMINEX 25% is contraindicated in patients with:
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:
20% - 25% human albumin solutions are relatively low in electrolytes compared to 4% - 5% human albumin solutions so 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).
Colloid-osmotic effect of human albumin 25% is approximately five 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.
The following parameters should be assessed during administration of ALBUMINEX 25%:
ALBUMINEX 25% 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. 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 ever been identified for ALBUMINEX 25%.
In general, human albumin solutions are well-tolerated and no specific, clinically relevant alterations in organ function or coagulopathy have been substantiated.26
The most common adverse reactions associated with infusion of human albumin solutions are rigors, hypotension/decreased BP, tachycardia/increased heart rate, pyrexia, feeling cold (chills), nausea, vomiting, dyspnea/bronchospasm, rash/pruritus. Reactions usually resolve when the infusion is slowed or stopped.
Anaphylaxis, with or without shock, may occur and in this situation, stop the infusion.
No clinical studies were done using ALBUMINEX 25%.
Do not mix ALBUMINEX 25% with blood, blood components, protein hydrolysates, alcoholic solutions or other medicinal products except 0.9% saline or 5% dextrose. However, it can be administered, via a separate IV line, concomitantly with other parenterals.
Risk Summary
There are no data with ALBUMINEX 25% use in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted using ALBUMINEX 25%. It is not known whether ALBUMINEX 25% can cause fetal harm when administered to a pregnant woman or can affect fertility. ALBUMINEX 25% should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Risk Summary
There is no information regarding the presence of ALBUMINEX 25% in human milk, the effects on the breast-fed infant, or the effects on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for ALBUMINEX 25% and any potential adverse effects on the breast-fed infant from ALBUMINEX 25% or from the underlying maternal condition.
No human or animal data. Use only if clearly needed.
No human or animal data. Use only if clearly needed.
ALBUMINEX 25% is a sterile, ready-for-use, clear, slightly viscous, almost colorless, yellow, amber or slightly green aqueous solution of human albumin for single dose intravenous infusion. It is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US. The product also contains 130-160 mmol/L of sodium, less than 200 micrograms/L of aluminum and is stabilized with caprylate (0.08 mmol/g albumin) and acetyltryptophanate (0.08 mmol/g albumin) but does not contain any preservative.
12.5 g (50 mL) of ALBUMINEX 25% is oncotically equivalent to 250 mL plasma.
25 g (100 mL) of ALBUMINEX 25% is oncotically equivalent to 500 mL plasma.
The vials are closed with a synthetic rubber stopper. The stopper is not made with natural rubber latex.
The viral risk from human plasma is minimized by the fractionation process and pasteurization of the albumin solution for 10 hours at 60°C (140°F) in its final container. These processes are effective for both enveloped and non-enveloped viruses. There have been no reports of virus transmission with products manufactured using this combination of processes. Typical reductions of experimental viral loads are shown in Table 1.
| Mean Reduction Factors (log10) | ||||||
|---|---|---|---|---|---|---|
| Enveloped Virus | Enveloped Virus | Enveloped Virus | Enveloped Virus | Non-Enveloped Virus | Non-Enveloped Virus | |
| nd: not determined HIV-1: Human Immunodeficiency Virus Type 1 BVDV: Bovine Viral Diarrhoea Virus IBR: Infectious Bovine Rhinotracheitis HAV: Hepatitis A Virus CPV: Canine Parvovirus | ||||||
| Manufacturing Step | HIV-1 | Sindbis | BVDV | IBR | HAV | CPV |
| A+1 Precipitation | nd | 4.1 | >3.4 | 3.4 | 3.4 | 3.7 |
| Fraction IV Precipitation | >4.6 | >7.1 | >4.2 | >5.7 | 4.2 | 6.0 |
| Pasteurization | >6.6 | >6.2 | >4.0 | >5.0 | 4.7 | 4.2 |
| Overall | >11.2 | >13.3 | >8.2 | >10.7 | 8.9 | 10.2 |
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 25% 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.
www.bapen.org.uk/pdfs/bapen_pubs/giftasup.pdf
(Guideline Ref ID GIFTASUP2011)
www.aasld.org/publications/practice-guidelines-0 [accessed 15 April 2016]ccforum.com/content/18/1/R10 [accessed 02 November 2016]
www.bundesaerztekammer.de/aerzte/medizin-ethik/wissenschaftlicher-beirat/veroeffentlichungen/haemotherapie-transfusionsmedizin/english [accessed 15 April 2016]How ALBUMINEX 25% is supplied
ALBUMINEX 25%, 25 g/dL in clear Type II glass vials.
| Strength | Grams and fill size | NDC carton number | NDC vial number |
|---|---|---|---|
| 25% | 12.5 g in 50 mL | 64208-2512-3 | 64208-2512-4 |
| 25% | 25 g in 100 mL | 64208-2512-7 | 64208-2512-8 |
Not all pack sizes may be marketed.
Do not store above 30°C (86°F).
Keep the vial stored in the outer carton in order to protect from light.
Do not freeze.
Do not use ALBUMINEX 25% after the expiration date which is stated on the carton and label after "EXP." The expiration date refers to the last day of that month.
ALBUMINEX 25% should be inspected visually for particulate matter and discoloration prior to administration.
U.S. federal law prohibits dispensing without prescription.
Ensure that patients to be treated with ALBUMINEX 25% are informed of the potential risks and benefits of its use for their clinical condition [see Warnings and Precautions (5)].
Check that they are not known to be allergic to the product or its excipients [see Contraindications (4) and Description (11)].
Make them aware of the symptoms of anaphylaxis [see Hypersensitivity (5.1)].
Make them aware of the symptoms of potential circulatory overload [see Hypervolemia (5.2)
Inform patients that because ALBUMINEX 25% is derived from human blood plasma it may contain infectious agents that cause disease (e.g. viruses and, theoretically CJD agent) although the risk of infection from ALBUMINEX 25% has been reduced by the procedures used in donor selection and during manufacture [see Infectious Diseases (5.6) and Description (11)].
Manufactured by:
Bio Products Laboratory Ltd.,
Elstree,
Borehamwood,
WD6 3BX.
United Kingdom
Marketed by:
Kedrion Biopharma, Inc.
Parker Plaza,
400 Kelby Street,
Fort Lee, NJ 07024
United States
U.S. Licence No: 1811
ALBUMINEX® is a registered trademark of Bio Products Laboratory Ltd.
Version 2
NDC 64208-2512-8
Albumin (Human) - kjda
solution for infusion
For intravenous use only
Marketed by: Kedrion Biopharma, Inc,
400 Kelby St., Fort Lee, NJ 07024, United States
NDC 64208-2512-7
Albumin (Human) - kjda
ALBUMINEX® 25%
25 g
solution for infusion
For intravenous use only
Rx only
1 vial
100 mL
Bio Products Laboratory
NDC 64208-2512-4
Albumin (Human) - kjda
solution for infusion
For intravenous use only
Marketed by: Kedrion Biopharma, Inc,
400 Kelby St., Fort Lee, NJ 07024, United States
NDC 64208-2512-3
Albumin (Human) - kjda
ALBUMINEX® 25%
12.5 g
solution for infusion
For intravenous use only
Rx only
1 vial
50 mL
Bio Products Laboratory
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2054173 | albumin human-kjda 25 % in 100 ML Injection | PSN | 8 |
| 2054168 | albumin human-kjda 25 % in 50 ML Injection | PSN | 8 |
| 2054174 | ALBUMINEX 25 % in 100 ML Injection | PSN | 8 |
| 2054170 | ALBUMINEX 25 % in 50 ML Injection | PSN | 8 |
| 2054174 | 100 ML albumin human-kjda 250 MG/ML Injection [Albuminex] | SBD | 8 |
| 2054170 | 50 ML albumin human-kjda 250 MG/ML Injection [Albuminex] | SBD | 8 |
| 2054173 | 100 ML albumin human-kjda 250 MG/ML Injection | SCD | 8 |
| 2054168 | 50 ML albumin human-kjda 250 MG/ML Injection | SCD | 8 |
| 2054173 | albumin human-kjda 25 % per 100 ML Injection | SY | 8 |
| 2054168 | albumin human-kjda 25 % per 50 ML Injection | SY | 8 |
| 2054173 | albumin human-kjda 250 MG/ML per 100 ML Injection | SY | 8 |
| 2054168 | albumin human-kjda 250 MG/ML per 50 ML Injection | SY | 8 |
| 2054174 | Albuminex 25 % per 100 ML Injection | SY | 8 |
| 2054170 | Albuminex 25 % per 50 ML Injection | SY | 8 |
| 2054174 | Albuminex 250 MG/ML per 100 ML Injection | SY | 8 |
| 2054170 | Albuminex 250 MG/ML per 50 ML Injection | SY | 8 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ALBUMIN (HUMAN) Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20120517 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64208-2512-3 | ALBUMINEX | 1 in 1 CARTON | SOLUTION | 1 | 8 | |
| 64208-2512-4 | ALBUMINEX | 50 mL in 1 VIAL, GLASS | SOLUTION | 50 | 8 | |
| 64208-2512-7 | ALBUMINEX | 1 in 1 CARTON | SOLUTION | 1 | 8 | |
| 64208-2512-8 | ALBUMINEX | 100 mL in 1 VIAL, GLASS | SOLUTION | 100 | 8 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64208-2512 | ALBUMINEX (ALBUMIN HUMAN) SOLUTION [BPL] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250109_167f48d0-8ae5-4f7e-b050-9673dad78acc.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64208-2512-3 | ML - Milliliter | 64208-2512 | c86cf615-9a91-4a57-83dc-936eceb78fb2 | 1 | 2018-12-13 |
| 64208-2512-4 | ML - Milliliter | 64208-2512 | 8e6b36bd-bfff-4d22-8d21-be42c8612925 | 1 | 2019-06-19 |
| 64208-2512-7 | ML - Milliliter | 64208-2512 | f9006057-f212-4168-98a9-17e10e725ec3 | 1 | 2018-12-13 |
| 64208-2512-8 | ML - Milliliter | 64208-2512 | 02da426e-e1a7-46a2-88b9-622b29bfd20e | 1 | 2019-06-19 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 64208-2512 | 64208-2512-8, 64208-2512-7, 64208-2512-4, 64208-2512-3 |
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125644 | Albuminex | Albumin (Human)-kjda | 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 Hydroxide | 55X04QC32I | IACT |
| Caprylic Acid | OBL58JN025 | IACT |
| N-ACETYL-DL-TRYPTOPHAN SODIUM | 3EN9H0M2FX | IACT |
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 |
|---|---|---|---|---|---|---|
| BEIZRAY | DOCETAXEL | Zydus Pharmaceuticals USA Inc. | 8fb7d980-d6c7-468b-a9f0-adff16101a4b | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 64208-2512-4 64208251204 |
| ALBUMINEX | ALBUMIN HUMAN | BPL | 167f48d0-8ae5-4f7e-b050-9673dad78acc | 2024-12-31 | Warnings, Adverse reactions | 64208-2512-4 64208-2512-8 64208-2512-3 64208-2512-7 64208-2512 64208251203 64208251208 64208251207 64208251204 85f1cecd-a23d-498f-adfb-0a09feed1994 167f48d0-8ae5-4f7e-b050-9673dad78acc |
Adverse event summaries are temporarily unavailable. Other product information remains available.