XYNTHA

Country: Indónesía

Tungumál: indónesíska

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

Virkt innihaldsefni:

MOROCTOCOG ALFA

Fáanlegur frá:

PFIZER INDONESIA - Indonesia

INN (Alþjóðlegt nafn):

MOROCTOCOG ALFA

Skammtar:

250 IU

Lyfjaform:

SERBUK INJEKSI LIOFILISASI

Einingar í pakka:

DUS, 1 VIAL @ 250 IU + 1 PRE-FILLED SYRINGE @ 4 ML + 1 VIAL ADAPT...

Framleitt af:

WYETH FARMA, S.A. - Spain

Leyfisdagur:

2021-05-16

Vara einkenni

Generic Name: Moroctocog alfa
Trade Name: XYNTHA
CDS Effective Date: January 18, 2019
Supersedes: NA
Approved by BPOM:
2020-0058307
Page 1 of 25
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Moroctocog alfa
Trade Name: XYNTHA
CDS Effective Date: January 18, 2019
Supersedes: NA
1.
NAME OF THE MEDICINAL PRODUCT
XYNTHA
*Note: XYNTHA information applies to the product manufactured using
the albumin-free process.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Moroctocog alfa (INN)
Physical characteristics
XYNTHA is a white to off-white cake. Upon reconstitution, XYNTHA
appears as a clear to
slightly opalescent, colorless solution.
Single-use vial containing nominally 250, 500 or 1000 International
Units (IUs) of moroctocog
alfa (recombinant coagulation factor VIII).
3.
PHARMACEUTICAL FORM
Single use vial:
Powder and solvent for solution for intravenous (IV) injection.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
DISETUJUI BPOM 7/4/2021
ID REG : EREG10024112000148
EREG10024112000149
EREG10024112000150
Generic Name: Moroctocog alfa
Trade Name: XYNTHA
CDS Effective Date: January 18, 2019
Supersedes: NA
Approved by BPOM:
2020-0058307
Page 2 of 25
XYNTHA is used for the control and prevention of hemorrhagic episodes
and for routine and
surgical prophylaxis in patients with haemophilia A (congenital factor
VIII deficiency or classic
haemophilia). (XYNTHA is appropriate for use in children of all ages.)
XYNTHA does not contain von Willebrand factor, and therefore is not
indicated in Von
Willebrand’s disease.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with XYNTHA should be initiated under the supervision of a
physician experienced
in the treatment of haemophilia A.
Dosage and duration of treatment depend on the severity of the factor
VIII deficiency, the
location and extent of bleeding, and the patient’s clinical
condition. Individual patients may vary
in their response to factor VIII, achieving different levels of
recovery and demonstrating
different half-lives. Doses adminis