FERRIPROX

País: Indonésia

Língua: indonésio

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

Disponível em:

SYDNA FARMA - Indonesia -

Dosagem:

1000 MG

Forma farmacêutica:

TABLET SALUT ENTERIK PELEPASAN LAMBAT

Composição:

DEFERIPRONE

Unidades em pacote:

DUS, 5 BLISTER @ 10 TABLET SALUT ENTERIK PELEPASAN LAMBAT

Classe:

Obat

Fabricado por:

APOTEX INC. - Canada

Status de autorização:

Berlakus/d 16-03-2028

Data de autorização:

2023-03-16

Características técnicas

1
1. NAME OF THE MEDICINAL PRODUCT
Ferriprox 1,000 mg delayed release enteric coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1,000 mg deferiprone as active substance.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Delayed release enteric coated tablet
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ferriprox is indicated for the treatment of iron overload in patients
1 year of age and older with
thalassaemia major.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Deferiprone therapy should be initiated and maintained by a physician
experienced in the
treatment of patients with thalassaemia.
Deferiprone is most commonly given at a total daily dose of 75 mg/kg
body weight, divided into
two doses taken approximately 12 hours apart with food. Dosage per
kilogram body weight
should be calculated to the nearest half tablet. See Table below.
Doses above 100 mg/kg/day are not recommended because of the
potentially increased risk of
adverse reactions (see sections 4.4, 4.8, and 4.9).
Due to the serious nature of agranulocytosis that can occur with the
use of deferiprone, special
monitoring is required for all patients. Caution must be used when the
patient’s absolute
neutrophil count (ANC) is low.
Engraved “FPX” score “DR” on one side,
“APO”
score “1000” on the other side.
The tablets are scored and breakable in half.
White to off‐white, capsule‐shaped, bevelled edge, biconvex coated
tablets
.
FERRIPROX™
D
ELAYED RELEASE ENTERIC COATED TABLETS
DEFERIPRONE
1000 MG
2
_Dose table_
To obtain a dose of about 75 mg/kg/day, use the number of tablets
suggested in the following
table for the body weight of the patient. Sample body weights at 10 kg
increments are listed.
BODY WEIGHT
(KG)
TOTAL DAILY DOSE
(MG)
NUMBER OF 1,000 MG DELAYED
RELEASE ENTERIC COATED
TABLETS*
MORNING
EVENING
20
1500
0.5
1.0
30
2250
1.0
1.5
40
3000
1.5
1.5
50
3750
2.0
2.0
60
4500
2.0
2.5
70
5250
2.5
3.0
80
6000
3.0
3.0
90
6750
3.5
3.5
*number of tablets rounded to nearest half tablet
The ef