Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALBUMIN HUMAN
PUSAT DARAH NEGARA
ALBUMIN HUMAN
1Units Units; 1 Units Units
CSL Behring Australia Pty Ltd
Albumex 20 MY PI 5.01r Page 1 of 14 PRODUCT INFORMATION ALBUMEX ® 20 HUMAN ALBUMIN 20% (200 G/L) MALAYSIA NAME OF THE MEDICINE Human albumin, solution for intravenous infusion. DESCRIPTION Albumex ® 20 is manufactured from human plasma donated by Malaysia’s voluntary and non-remunerated donors. Albumex ® 20 is a clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. It is prepared using predominantly by a combination of the Cohn cold-ethanol fractionation process and chromatographic techniques. It is a sterile, preservative-free 20% w/v protein human albumin solution. which It is hyperoncotic and hypo-osmotic with compared to human serum. It has a nominal osmolality of 130 mOsm/kg, is hypotonic and the pH is 6.7 to 7.3. The manufacturing process for Albumex ® 20 contains dedicated steps to reduce the possibility of virus transmission including pasteurisation (Albumex ® 20 is heated at 60°C for 10 hours) and incubationed at low pH to inactivate viruses. The composition of Albumex ® 20 is as follows: Human Albumin 200 g/Litre Sodium 48– to 100 mmol/Litre Octanoate 32 mmol/Litre PHARMACOLOGY Albumin accounts quantitatively for more than half of the total protein in the plasma and represents about 10% of the protein synthesis activity of the liver. The metabolic half-life of albumin _in vivo_ is about 20 19 days and the turnover in an adult is approximately 15 g per day. There is rapid interchange of albumin between the intra- and extravascular spaces. Albumex ® 20 is hyperoncotic with human serum and supplies the oncotic equivalence of approximately four times its volume of human plasma. Albumex ® 20 has two main functions: maintenance of plasma colloid osmotic pressure and carriage of intermediate products in the transport and exchange of tissue metabolites. 10 9 1 3 7 11 12 2 4 5, 6 8 Albumex 20 MY PI 5.01r Page 2 of 14 The beneficial effect of human albumin for fluid resuscitation is thought to result principally from its contribution to colloid osmotic pressure (i.e. oncoti Perskaitykite visą dokumentą