国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Mesna
Baxter Holding B.V.
V03AF; V03AF01
Mesna
100 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Detoxifying agents for antineoplastic treatment; mesna
Marketed
1996-09-25
Health Products Regulatory Authority 22 October 2019 CRN009233 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Uromitexan 100mg/ml Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mesna 100 mg/ml Each 4 ml ampoule contains 400 mg mesna Each 10 ml ampoule contains 1 g mesna For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection or infusion.(Oral solution) Clear, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention of urothelial toxicity including haemorrhagic cystitis, microhaematuria and macrohaematuria in patients treated with ifosfamide and cyclophosphamide, in doses considered to be urotoxic. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sufficient mesna must be given to adequately protect the patient from the urotoxic effects of the oxazaphosphorine. The duration of mesna treatment should equal that of the oxazaphosphorine treatment plus the time taken for the urinary concentration of oxazaphosphorine metabolites to fall to non-toxic levels. This usually occurs within 8-12 hours after the end of oxazaphosphorine treatment but may vary depending on the scheduling of oxazaphosphorine. Urinary output should be maintained at 100 ml/hr (as required for oxazaphosphorine treatment) and the urine monitored for haematuria and proteinuria throughout the treatment period. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. Any solutions which are discoloured, hazy, or contain visible particulate matter should not be used. Where ifosfamide or cyclophosphamide is used as an iv bolus: Mesna is given by intravenous injection over 15-30 minutes at 20% of the simultaneously administered oxazaphosphorine on a weight for weight basis (w/w). The same dose of mesna is repeated after 4 and 8 hours. The total dose of mesna is 60% (w/w) of the oxazaphosphorine dose. This is repeated on each occasion that the cytotoxic agents a 阅读完整的文件