Albumin (Human) 200 g/1000mL
Albumin Human · SOLUTION · Octapharma USA Inc
Albumin (Human) is a prescription solution containing albumin human at 200 g/1000mL, taken intravenous. Manufactured by Octapharma USA Inc.
Key Facts
- Brand Name
- Albumin (Human)
- Generic Name
- Albumin Human
- NDC Code (Product)
68982-633- Manufacturer
- Octapharma USA Inc
- Strength
- 200 g/1000mL
- Dosage Form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- PLASMA DERIVATIVE
- Application #
- BLA125154
- Drug Class
- Human Serum Albumin [EPC]; Increased Intravascular Volume [PE]
- Marketing Start
- 10/17/2006
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ALBUMINEX 25% is a 25% albumin solution indicated for adults and children : Hypovolemia ( 1.1 ) Ascites ( 1.2 ) Hypoalbuminemia including from burns ( 1.3 ) Acute Nephrosis ( 1.4 ) Acute Respiratory Distress Syndrome (ARDS) ( 1.5 ) Cardiopulmonary Bypass ( 1.6 ) 1.1 Hypovolemia 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 pediatric patients to reverse hypovolemia and achieve normal capillary refill time. 1, 2, 3, 4, 5, 6, 7, 8 1.2 Ascites 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 hepatoren…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravenous administration only. For intravenous use only. ALBUMINEX 25% may be diluted with 0.9% saline or 5% dextrose (glucose). Dosage and infusion rate should be adjusted to the patient's individual requirements. Indication Dose Hypovolemia Adults: Initial dose of 25 g (including renal dialysis). For acute liver failure: initial dose of 12 to 25 g. ( 2.1 ) Prevention of central volume depletion after paracentesis due to cirrhotic ascites Adults: 8 g for every 1000 mL of ascitic fluid removed. ( 2.1 ) Hypoalbuminemia including from burns 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 100 mL. Third space protein loss due to infection: initial dose of 50 to 100 g. ( 2.1 ) Acute nephrosis Adults: 25 g together with diuretic once a day for 7-10 days. ( 2.1 ) Adult respiratory distress syndrome (ARDS) Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. ( 2.1 ) Cardiopulmonary bypass procedures Adults: Initial dose of 25 g. ( 2.1 ) 2.1 Dose The concentration of ALBUM…
Contraindications
4 CONTRAINDICATIONS ALBUMINEX 25% is contraindicated in patients with: Hypersensitivity to human albumin or any of the excipients Severe anemia or cardiac failure with normal or increased intravascular volume Hypersensitivity to human albumin or the excipients Severe anemia or cardiac failure with normal or increased intravascular volume
Drug Interactions
7 DRUG INTERACTIONS 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.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions are rigors, hypotension/decreased BP, tachycardia/increased heart rate, pyrexia, feeling cold (chills), nausea, vomiting, dyspnea/bronchospasm, rash/pruritus. Stop the infusion if anaphylaxis, with or without shock, is observed. To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma, Inc. at 1-855-3KDRION (1-855-353-7466) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 General 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. 6.2 Clinical Trials Experience No clinical studies were done using ALBUMINEX 25%.
Frequently Asked Questions
What is Albumin (Human) used for?
Albumin (Human) contains Albumin Human. It is a solution taken intravenous. Consult your doctor for specific uses.
Is Albumin (Human) a controlled substance?
Albumin (Human) is not classified as a controlled substance by the DEA.
What is the generic name for Albumin (Human)?
The generic name for Albumin (Human) is Albumin Human. There are 4 other brand versions of Albumin Human.
What is the NDC code for Albumin (Human) 200 g/1000mL?
The NDC (National Drug Code) for Albumin (Human) 200 g/1000mL is 68982-633, listed by Octapharma USA Inc.