البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALBUMIN HUMAN
GRIFOLS MALAYSIA SDN. BHD.
ALBUMIN HUMAN
25gm100ml mL; 12.5 gm 50 ml mL
GRIFOLS BIOLOGICALS INC
Albumin (Human) U.S.P. Albutein ® 25% Solution DESCRIPTION: Albumin (Human) U.S.P., Albutein ® 25% Solution is a sterile, aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). Albutein ® 25% 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 albumin. Albutein ® 25% is osmotically equivalent to fi ve times its volume of normal human plasma. Albutein ® 25% contains 130-160 milliequivalents of sodium ion per liter and has a pH of 7.0 ± 0.3. 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 ® 25% is heated at 60 °C for ten hours. No positive assertion can be made that this heat treatment completely destroys the causative agents of viral hepatitis, however, there are no known confi rmed cases of viral hepatitis which have resulted from the administration of Albutein ® 25%. CLINICAL PHARMACOLOGY: Albumin is a highly soluble, globular protein (MW 66,500), accounting for 70-80% of the colloid osmotic pressure of plasma. Therefore, it is important in regulating the osmotic pressure of plasma. 1,2 Albutein ® 25% supplies the oncotic equivalent of approximately 5 times its volume of human plasma. It will increase the circulating plasma volume by an amount approximately 3.5 times the volume infused within 15 minutes, if the recipient is adequately hydrated. 3 This extra fl uid reduces hemoconcentration and decreases blood viscosity. The degree and duration of volume expansion depend upon the initial b اقرأ الوثيقة كاملة