País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
ETOPOSIDE
Ebewe Pharma Ges.m.b.H Nfg. KG
20
Concentrate for Soln for Inf
2005-02-25
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etoposide ”Ebewe” 20 mg/ml – Concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 20 mg of etoposide. 1, 5, or 10 vials of 2.5 ml concentrate for solution for infusion contains 50 mg etoposide. 1, 5, or 10 vials of 5 ml concentrate for solution for infusion contains 100 mg etoposide. 1, 5, or 10 vials of 10 ml concentrate for solution for infusion contains 200 mg etoposide. 1, 5, or 10 vials of 20 ml concentrate for solution for infusion contains 400 mg etoposide. 1, 5, or 10 vials of 50 ml concentrate for solution for infusion contains 1000 mg etoposide. Excipients: Benzyl alcohol, ethanol. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, light yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Etoposide is a antineoplastic agent for intravenous use. It can be used alone or in combination with other oncolytic agents. Available data show that etoposide may be used in treatment of small-celled lung cancer, resistant non-seminomatous testicular carcinoma, acute myelomonocytic and myelocytic leukaemia (AML, FAB subtype M4 or M5) as part of combination therapy after failure of induction chemotherapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Etoposide should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents. Pregnant personnel should not handle chemotherapeutic agents. Etoposide should be administered by slow intravenous infusion only (see below). Etoposide concentrate for solution for infusion must be diluted before use (see section Leia o documento completo