البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
Albumin Human (UNII: ZIF514RVZR) (Albumin Human - UNII:ZIF514RVZR)
KEDRION BIOPHARMA, INC.
Albumin Human
Albumin Human 2.5 g in 50 mL
INTRAVENOUS
Emergency Treatment of Hypovolemic Shock Albuked 5 is iso-oncotic with normal plasma and on intravenous infusion will expand the circulating blood volume by an amount approximately equal to the volume infused. In conditions associated mainly with a volume deficit, albumin is best administered as a 5% solution (Albuked 5); but where there is an oncotic deficit, Albumin (Human) 25%, USP (Albuked™ 25) may be preferred. This is also an important consideration where the treatment of the shock state has been delayed. If Albuked 25 is used, appropriate additional crystalloid should be administered.(1) Crystalloid solutions in volumes several times greater than that of Albuked 5 may be effective in treating shock in younger individuals who have no preexisting illness at the time of the incident. Older patients, especially those with preexisting debilitating conditions, or those in whom the shock is caused by a medical disorder, or where the state of shock has existed for some time before active therapy could be insti
Albuked 5 is available in 50 mL and 250 mL rubber-stoppered vials. Each single dose vial contains albumin in the following approximate amounts: 76125-790-05 76125-790-25
Biologic Licensing Application
ALBUKED - ALBUMIN (HUMAN) SOLUTION KEDRION BIOPHARMA, INC. ---------- ALBUMIN (HUMAN) 5%, USP ALBUKED™ 5 DESCRIPTION Albumin (Human) 5%, USP (Albuked™ 5) is made from large pools of human venous plasma by the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration. Albuked 5 is a 5% sterile solution of albumin in an aqueous diluent. The preparation is stabilized with 0.004 M sodium caprylate and 0.004 M acetyltryptophan. The aluminum content of the product is not more than 200 µg/L. The approximate sodium content of the product is 145 mEq/L. Albuked 5 is clear, slightly viscous, almost colorless to yellow, amber or green. Each vial of Albuked 5 is heat-treated at 60°C for 10 hours against the possibility of transmitting the hepatitis viruses. Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents.(8-11) The production steps from Pooled Plasma to Effluent IV-1 in the Albuked 5 manufacturing process have been shown to decrease TSE infectivity of that experimental model agent (a total of ≥7.0 logs). These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed. CLINICAL PHARMACOLOGY Albuked 5 is oncotically equivalent volume for volume to normal human plasma. When administered intravenously to an adequately hydrated subject, the oncotic (colloid osmotic) effect of Albuked 5 is to expand the circulating blood volume by an amount approximately equal to the volume infused. It is primarily used in the treatment of shock associated with hemorrhage, surgery, trauma, burns, bacteremia, renal failure, and cardiovascular collapse.( اقرأ الوثيقة كاملة