Ülke: Singapur
Dil: İngilizce
Kaynak: HSA (Health Sciences Authority)
Deferiprone
PHARMAFORTE SINGAPORE PTE LTD
V03AC02
100.00g/l
SOLUTION
Deferiprone 100.00g/l
ORAL
Prescription Only
Apotex Inc.- Richmond Hill Site
ACTIVE
2009-06-26
PRODUCT INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Ferriprox® 100 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 100 mg deferiprone. Excipient: Each ml of oral solution contains 0.4 mg Sunset Yellow (E110). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. Clear, reddish orange coloured liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate. 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 usually given as 25 mg/kg body weight, orally, three times a day for a total daily dose of 75 mg/kg body weight. Dose per kilogram body weight should be calculated to the nearest 2.5 ml. See table below for recommended doses for body weights at 10 kg increments. Doses above 100 mg/kg/day are not recommended because of the potentially increased risk of adverse reactions; chronic administration of more than 2.5 times the maximum recommended dose has been associated with neurological disorders (see sections 4.4, 4.8, and 4.9). There are limited data available on the use of deferiprone in children between 6 and 10 years of age, and no data on deferiprone use in children under 6 years of age. 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 patients’ absolute neutrophil count (ANC) is low, as we Belgenin tamamını okuyun
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