Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
ETOPOSIDE
NOVARTIS ISRAEL LTD
L01CB01
CONCENTRATE FOR SOLUTION FOR INFUSION
ETOPOSIDE 20 MG/ML
I.V
Required
EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA
ETOPOSIDE
ETOPOSIDE
Small cell lung cancer, resistant non-seminomatous testicular carcinoma, Hodgkin's and non-Hodgkin's lymphoma, acute myelocytic leukemia.
2014-01-31
PRESCRIBING INFORMATION ETOPOSID “EBEWE” 20 mg/ml concentrate for solution for infusion COMPOSITION 1 vial of 2.5 ml contains: 50 mg etoposide 1 vial of 5 ml contains: 100 mg etoposide 1 vial of 10 ml contains: 200 mg etoposide 1 vial of 20 ml contains: 400 mg etoposide 1 vial of 50 ml contains: 1,000 mg etoposide CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Etoposide may be administered alone or in combination with other cytostatic drugs in the treatment of small cell lung cancer or resistant non-seminomatous testicular carcinoma. Etoposide, when given in combination with other chemotherapeutic agents, has been shown to be of benefit in treating the following malignancies: Hodgkin's and non-Hodgkin's lymphoma, acute myelocytic leukemia. PHARMACOTHERAPEUTIC GROUP Podophyllotoxin derivative ATC Code: LO1CB DOSAGE AND METHOD OF ADMINISTRATION Etoposid “EBEWE” is only administered by slow infusion over 30 minutes to 2 hours. Etoposide concentrate for solution for infusion must be diluted before use (see_ Instructions_ _for Use and Handling_). _ADULTS:_ The recommended dose of Etoposid “EBEWE” is 60-120 mg/m 2 i.v. per day for 5 subsequent days. As Etoposid “EBEWE” causes myelosuppression, the course of treatment must not be repeated more often than with intervals of 21 days. Repeated courses of treatment with Etoposid “EBEWE” infusion must not be given before the blood picture has been controlled for signs of myelosuppression and found satisfactory. _PAEDIATRIC PATIENTS:_ Safety and efficacy in children have not been established. _ELDERLY:_ Dose adjustment is not necessary. _RENAL IMPAIRMENT:_ In patients with renal impairment but with normal hepatic function, the dose of etoposide must be reduced and haematological minimum values and renal function must be monitored. Recommended dose regimen on the basis of creatinine clearance is as follows: Creatinine Recommended clearance daily dose (ml/min) (% of standard dose) >50 100 15-50 75 <15 Contraindicated (_Contraindications_) The diluted solution f Læs hele dokumentet