Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SYDNA FARMA - Indonesia -
1000 MG
TABLET SALUT ENTERIK PELEPASAN LAMBAT
DEFERIPRONE
DUS, 5 BLISTER @ 10 TABLET SALUT ENTERIK PELEPASAN LAMBAT
Obat
APOTEX INC. - Canada
Berlakus/d 16-03-2028
2023-03-16
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 Baca dokumen lengkapnya