Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
FLUOROURACIL
Ebewe Pharma Ges.m.b.H Nfg. KG
50 Mg/Ml
Concentrate for Soln for Inf
2002-09-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 5-Fluorouracil “Ebewe” 50 mg/ml, concentrate for solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 50 mg 5-Fluorouracil. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless to slightly yellow, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Palliative treatment, in single as well as in combination therapy, of common carcinomas. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS ONLY: INTRAVENOUS INFUSION: 15 mg/kg or 600mg/m 2 diluted in 300 - 500 ml of glucose injection BP in 0.9% sodium chloride, given over 2-4 hours daily, until side effects occur.Total daily dose should not exceed 1 gram. INITIAL TREATMENT WITH WEEKLY APPLICATION: 15 mg/kg or 600 mg/m 2 once a week slowly i.v. 24 HOURS LONG TERM INFUSION: 5-7 mg/kg/day or 200 mg/m 2 /day An interval of 4-6 weeks should be allowed between courses. MAINTENANCE THERAPY: An initial intensive course may be followed by maintenance therapy providing there are no significant toxic effects. In all instances, toxic side effects must disappear before maintenance therapy is started. Therapy consists of 5-15 mg/kg i.v. once weekly IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/07/2011_ _CRN 2071325_ _page number: 1_ SPECIAL DOSAGE RECOMMENDATIONS: CHILDREN: 5-Fluorouracil is not recommended for use in children. MAXIMUM DAILY DOSE: of 1g may not be exceeded. DURATION OF TREATMENT: will be determined by an experienced oncologist according to nature and clinical course of treatment. 4.3 CONTRAINDICATIONS Hypersensitivity to one of the components of the drug. Use in se Lue koko asiakirja