IMMUNATE S/D

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Tersedia dari:

TAKEDA INDONESIA - Indonesia -

Dosis:

500 IU /375 IU

Bentuk farmasi:

SERBUK DAN PELARUT UNTUK INJEKSI ATAU INFUS

Komposisi:

HUMAN COAGULATION FACTOR VIII, HUMAN VON WILLEBRAND FACTOR

Unit dalam paket:

DUS, 1 VIAL SERBUK 500 IU FVIII/375 IU VWF + 1 VIAL WFI 5 ML + 1 TRANSFER/FILTER SET + 1 DISPOSABLE SYRINGE 5 ML + 1 DISPOSABLE

Kelas:

Obat

Diproduksi oleh:

Baxter AG - AUSTRIA

Status otorisasi:

Berlakus/d 31-03-2028

Tanggal Otorisasi:

2023-03-31

Karakteristik produk

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