Land: Singapur
Sprache: Englisch
Quelle: HSA (Health Sciences Authority)
FACTOR VIII; VON WILLEBRAND FACTOR
GRIFOLS ASIA PACIFIC PTE. LTD.
B02BD06
500 iu/vial
INJECTION, POWDER, FOR SOLUTION
FACTOR VIII 500 iu/vial; VON WILLEBRAND FACTOR >400 iu / 1000 iu Factor VIII
INTRAVENOUS
Prescription Only
GRIFOLS BIOLOGICALS LLC.
ACTIVE
1996-11-28
Alphanate ® Solvent Detergent / Heat Treated RTA# 70 DESCRIPTION Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate ® sterile, lyophilized concentrate of Factor VIII (AHF) and von Willebrand Factor (VWF), is intended for intravenous administration in the treatment of hemophilia A, acquired Factor VIII deficiency, and von Willebrand Disease (VWD). Alphanate ® is prepared from pooled human plasma by cryoprecipitation of Factor VIII, fractional solubilization, and further purification employing heparin-coupled, cross-linked agarose which has an affinity to the heparin binding domain of VWF/FVIII:C complex. 1 The product is treated with a mixture of tri-n-butyl phosphate (TNBP) and polysorbate 80 to reduce the risks of transmission of viral infection. In order to provide an additional safeguard against potential non-lipid enveloped viral contaminants, the product is also subjected to an 80 °C heat treatment step for 72 hours. However, no procedure has been shown to be totally effective in removing viral infectivity from coagulation factor products. Alphanate ® is labeled with the nominal antihemophilic factor potency (FVIII) in International Units (IU) per vial. Each vial of Alphanate ® also contains specific labeled amount of von Willebrand Factor Ristocetin Cofactor (VWF:RCo) activity expressed in IU. An IU is defined by the current international standard established by the World Health Organization. One IU of Factor VIII or one IU of VWF:RCo is approximately equal to the amount of Factor VIII or VWF:RCo in 1 mL of freshly-pooled human plasma. A Lesen Sie das vollständige Dokument