Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
ETOPOSIDE PHOSPHATE
Bristol-Myers Squibb Pharmaceuticals Ltd
100 Milligram
Pdr for Soln for Injection
1996-10-10
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etopophos 100mg Powder for Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains etoposide phosphate equivalent to 100mg etoposiode. Each vial also contains 7.64 mg (0.33mmol) sodium. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for solution for injection. White to off-white lyophilised powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Etopophos is an anti-neoplastic drug for intravenous use, which can be used alone or in combination with other cytotoxic drugs. Present data indicate that Etopophos is applicable in the therapy of: small cell lung cancer, resistant non-seminomatous testicular carcinoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Etopophos should be administered intravenously. The usual dose for etoposide is 50 to 100 mg/m2/day, days 1 to 5 or 100 mg/m2, days 1, 3, and 5 every 3 to 4 weeks in combination with other drugs indicated in the disease to be treated. Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiation therapy or chemotherapy, which may have compromised bone marrow reserve. Etopophos may be infused over 5 minutes to 3.5 hours. In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance: Subsequent dosing should be based on patient tolerance and clinical effect. Data are not available in patients with creatinine clearance <15 ml/min and further dose reductions should be considered in these patients. As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of Etopophos. Skin reactions as Прочетете целия документ