optison
albumin human · by ge healthcare
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Overview
11 DESCRIPTION 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. Table 1: Virus Reduction for Albumin (Human) 25% Mean Reduction Factors (log 10 ) Enveloped Virus Enveloped Virus Enveloped Virus Enveloped Virus Non-Enveloped Virus Non-Enveloped Virus nd:…
How to use
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 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…
Side effects
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%.
Warnings
Important safety information
Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the injection and implementation of appropriate medical treatment. ( 5.1 ) Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the patient's volume status. Use with caution in conditions where hypervolemia and its consequences or hemodilution could represent a special risk to the patient. ( 5.2 ) When concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. ( 5.3 ) Assessment of electrolytes, coagulation and hematology parameters, and hemodynamic status when albumin is administered. ( 5.4 ) Do not dilute with sterile water for injection. ( 5.5 ) This product is made from human plasma and may contain infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease agent. ( 5.6 ) 5.1 Hypersensitivity Reactions Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the infusion and implementation of appropriate medical treatment. 5.2 Hypervolemia 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…
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.
Drug class
Dosage forms
INJECTABLE
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Frequently asked questions
- What is Optison?
- 11 DESCRIPTION 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. Table 1: Virus Reduction for Albumin (Human) 25% Mean Reduction Factors (log 10 ) Enveloped Virus Enveloped Virus Enveloped Virus Enveloped Virus Non-Enveloped Virus Non-Enveloped Virus nd:…
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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