FEIBA

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Unit dalam paket:

DUS, 1 VIAL SERBUK 500 U + 1 VIAL WFI 10 ML + 1 DISPOSABLE SYRIN...

Tanggal Otorisasi:

2022-06-10

Karakteristik produk

SmPC FEIBA 50U/mL
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
FEIBA 50 U/ml powder and solvent for solution for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Factor VIII Inhibitor Bypassing Activity
1 ml contains 50 U* factor VIII inhibitor bypassing activity.
FEIBA 50 U/ml is available in three different presentations:
-
The presentation 500 U FEIBA contains 500 U factor VIII inhibitor
bypassing activity in 200
– 600 mg human plasma protein,
-
The presentation 1000 U FEIBA contains 1000 U factor VIII inhibitor
bypassing activity in
400 – 1,200 mg human plasma protein,
-
The presentation 2500 U FEIBA contains 2500 U factor VIII inhibitor
bypassing activity in
1,000 – 3,000 mg human plasma protein.
FEIBA also contains the factors II, IX and X, mainly in non-activated
form, as well as activated
factor VII. Factor VIII coagulation antigen (F VIII C:Ag) is present
at a concentration of up to
0.1 U./1 U. FEIBA. The factors of the kallikrein-kinin system are
present in trace amounts only,
if at all.
* 1 unit of FEIBA shortens the activated partial thromboplastin time
(aPTT) of a factor VIII inhibitor plasma by 50% of the buffer value
(blank
value).
Excipients with known effect:
1.8 mmol sodium (40 mg) per vial with 500 U FEIBA.
3.6 mmol sodium (80 mg) per vial with 1000 U FEIBA.
8.9 mmol sodium (200 mg) per vial with 2500 U FEIBA.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
White, off-white or pale green powder. The pH value of the
ready-to-use solution is between 6.8
and 7.6.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Treatment of bleeding in hemophilia A patients with inhibitors.
DISETUJUI BPOM: 19 JUNI 2023
ID REG: EREG100235VR12200178
SmPC FEIBA 50U/mL
2
-
Treatment of bleeding in hemophilia B patients with inhibitors, if no
other specific
treatment is available (see section 5.1).
-
Treatment of bleeding in non-hemophiliacs with acquired inhibitors to
factor VIII.
-
Prophylax