ETOPOSID "EBEWE"
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
ETOPOSIDE
Available from:
Ebewe Pharma Ges.m.b.H Nfg. KG
Dosage:
20
Pharmaceutical form:
Concentrate for Soln for Inf
Authorization date:
2005-02-25
Summary of Product characteristics
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
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