ETOPOSID EBEWE 20 MGML

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

ETOPOSIDE

Disponible depuis:

NOVARTIS ISRAEL LTD

Code ATC:

L01CB01

forme pharmaceutique:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

ETOPOSIDE 20 MG/ML

Mode d'administration:

I.V

Type d'ordonnance:

Required

Fabriqué par:

EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA

Groupe thérapeutique:

ETOPOSIDE

Domaine thérapeutique:

ETOPOSIDE

indications thérapeutiques:

Small cell lung cancer, resistant non-seminomatous testicular carcinoma, Hodgkin's and non-Hodgkin's lymphoma, acute myelocytic leukemia.

Date de l'autorisation:

2014-01-31

Résumé des caractéristiques du produit

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