Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Albumin (human), USP
Takeda Malaysia Sdn Bhd
Albumin (human), USP
50ml mL; 100ml mL
Baxalta US Inc
Not Applicable Preberite celoten dokument
SHIRETAKEDA FLEXBUMIN 20%, Albumin (Human), USP, 20% Solution in GALAXY Single Dose Container FULL PRESCRIBING INFORMATION DESCRIPTION FLEXBUMIN 20% in 50 and 100 mL GALAXY plastic container is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 ml contains 20 g of albumin and was prepared from human venous plasma using the Cohn cold ethanol fractionation process. Source material for fractionation may be obtained from another U.S. licensed manufacturer. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with N-acetyltryptophan (0.016 M) and sodium caprylate (0.016 M). The sodium content is 145 ± 15 mEq/L. This solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. FLEXBUMIN 20% is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color. The likelihood of the presence of viable hepatitis viruses has been minimized by testing the plasma at three stages for the presence of hepatitis viruses, by fractionation steps with demonstrated virus removal capacity and by heating the product for 10 hours at 60°C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective. The GALAXY plastic container is fabricated from a specially designed multilayered plastic (PL 2501). Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies. CLINICAL PHARMACOLOGY Albumin is responsible for 70-80% of the colloid osmotic pressure of normal plasma, thus making it useful in regula Preberite celoten dokument