Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ifosfamide
Baxter Healthcare Ltd
L01AA06
Ifosfamide
1gram
Powder for solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010100; GTIN: 05413760208787
OBJECT 1 IFOSFAMIDE INJECTION 1G Summary of Product Characteristics Updated 24-Oct-2016 | Baxter Healthcare Ltd 1. Name of the medicinal product Ifosfamide Injection 1g 2. Qualitative and quantitative composition Each vial contains 1g of ifosfamide. When reconstituted as directed, each milliliter of concentrate contains 80 mg Ifosfamide 3. Pharmaceutical form Powder for concentrate for solution for infusion. White powder. 4. Clinical particulars 4.1 Therapeutic indications Ifosfamide is a cytotoxic drug for the treatment of malignant disease. As a single agent it has successfully produced objective remissions in a wide range of malignant conditions. Ifosfamide is also frequently used in combination with other cytotoxic drugs, radiotherapy and surgery. Children and adolescents - see section 5.1-Paediatric population 4.2 Posology and method of administration Ifosfamide should only be administered when there are facilities for regular monitoring of clinical, biochemical and haematological parameters before, during and after administration and under the direction of a specialist oncology service by physicians experienced with this drug. Dosage must be individualised. Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient's general state of health and organ function, and the results of laboratory monitoring. In combination with other agents of similar toxicity, a dose reduction or extension of the therapy-free intervals may be necessary. Method of administration A guide to the dosage regimens used for most indications is given below: a) 8 - 12 g/m² equally fractionated as single daily doses over 3 - 5 days every 2 - 4 weeks. b) 5 - 6 g/m² (maximum 10 g) given as a 24 hour infusion every 3 – 4 weeks. The frequency of dosage is determined by the degree of myelosuppression and the time taken to recover adequate bone marrow function. The usual number of courses given is 4, but up to 7 (6 by 24 hour infusion) courses have been gi Leggi il documento completo