Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
MESNA
Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands
V03AF01
MESNA 100 mg/ml
SOLUTION FOR INFUSION OR INJECTION
MESNA 100 mg/ml
POM
ALL OTHER THERAPEUTIC PRODUCTS
Authorised
2007-03-02
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT UROMITEXAN 100 MG/ML SOLUTION FOR INJECTION OR INFUSION (MESNA) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, nurse or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Throughout this leaflet, UROMITEXAN 100 mg/ml Solution for Injection or infusion will be called UROMITEXAN. WHAT IS IN THIS LEAFLET: 1. What UROMITEXAN is and what it is used for 2. What you need to know before you are given UROMITEXAN 3. How UROMITEXAN is given 4. Possible side effects 5. How UROMITEXAN is stored 6. Contents of the pack and other information 1 WHAT UROMITEXAN IS AND WHAT IT IS USED FOR The name of your medicine is UROMITEXAN. UROMITEXAN is used to help reduce and prevent bleeding in the bladder (haemorrhagic cystitis) caused by cyclophosphamide and ifosfamide. UROMITEXAN helps to protect the lining of the bladder from damage caused by these two drugs. The body breaks down these two drugs to form products that can harm the bladder. UROMITEXAN works by helping to make these breakdown products less harmful. UROMITEXAN should only be given when you are also given cyclophosphamide or ifosfamide. The damage to your bladder may show up as blood in your urine. Very small amounts of blood may not be seen, so your doctor or nurse will test your urine with a ‘dipstick’ or microscope to check for blood. If a larger amount of blood is in your urine, you will notice that it is red and very occasionally you may be able to see blood clots in it. 2 WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN UROMITEXAN YOU WILL NOT BE GIVEN UROMITEXAN IF: • yo Baca dokumen lengkap
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Uromitexan 100 mg/ml Solution for Injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mesna 100 mg/ml. Each 4ml ampoule contains 400 mg mesna. Each 10ml 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 are used. Page 2 of 13 Example dosage schedule: 0 hrs Baca dokumen lengkap