Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TAKEDA INDONESIA - Indonesia -
250 IU /190 IU
SERBUK DAN PELARUT UNTUK INJEKSI ATAU INFUS
HUMAN COAGULATION FACTOR VIII, HUMAN VON WILLEBRAND FACTOR
DUS, 1 VIAL SERBUK 250 IU FVIII/190 IU VWF + 1 VIAL WFI 5 ML + 1 TRANSFER/FILTER SET + 1 DISPOSABLE SYRINGE 5 ML + 1 DISPOSABLE
Obat
Baxter AG - AUSTRIA
Berlakus/d 31-03-2028
2023-03-31
SUMMARY OF PRODUCT CHARACTERISTICS IMMUNATE S/D HUMAN COAGULATION FACTOR VIII AND VON WILLEBRAND FACTOR DISETUJUI OLEH BPOM: 02/03/2023 EREG10023512100049-50 1. NAME OF THE MEDICINAL PRODUCT Immunate S/D 250 IU FVIII/190 IU VWF powder and solvent for solution for injection Immunate S/D 500 IU FVIII/375 IU VWF powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substances: Human coagulation Factor VIII/ Human von Willebrand Factor - Immunate S/D 250 IU FVIII/190 IU VWF Each vial contains nominally 250 IU human coagulation factor VIII 1 and 190 IU human von Willebrand factor 2 (VWF:RCo). Immunate S/D 250 IU FVIII/190 IU VWF contains approximately 50 IU/ml of human coagulation factor VIII and 38 IU/ml human von Willebrand factor after reconstitution. - Immunate S/D 500 IU FVIII/375 IU VWF Each vial contains nominally 500 IU human coagulation factor VIII 1 and 375 IU human von Willebrand factor 2 (VWF:RCo). Immunate S/D 500 IU FVIII/375 IU VWF contains approximately 100 IU/ml of human coagulation factor VIII and 75 IU/ml human von Willebrand factor after reconstitution. The potency of factor VIII (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Immunate S/D is 70 ± 30 IU FVIII/mg protein 3 . The potency of VWF (IU) is determined using the European Pharmacopoeia ristocetin co- factor assay (VWF:RCo). Produced from the plasma of human donors. Excipients with known effect: 1 vial contains approx. 9.8 mg sodium. FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1. 1 The FVIII potency was determined against the WHO International Standard for FVIII Concentrates. 2 The ristocetin cofactor activity of human von Willebrand factor was determined against the WHO International Standard for von Willebrand Factor, Concentrate. 3 Without stabilizer (albumin); The maximum specific activity at a 1:1 ratio of factor VIII activity to von Willebrand factor-antigen is 100 IU factor VIII per mg protein. DISETUJUI OLEH BPOM: 02/03/2023 EREG10023512100 Baca dokumen lengkapnya