Ebeposide 20mgml Injection

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

Etoposide

Disponibil de la:

NOVARTIS (SINGAPORE) PTE LTD

Codul ATC:

L01CB01

Dozare:

20.00 mg

Forma farmaceutică:

INJECTION, SOLUTION, CONCENTRATE

Compoziție:

Etoposide 20.00 mg

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

Prescription Only

Produs de:

Fareva Unterach GmbH

Statutul autorizaţiei:

ACTIVE

Data de autorizare:

2009-08-11

Caracteristicilor produsului

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1.
NAME OF THE MEDICINAL PRODUCT
Ebeposide 20 mg/ml Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml concentrate for solution for infusion contains 20 mg
etoposide.
Excipient with known effect: Ethanol
Excipient: Benzyl alcohol 20 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Description
Etoposide is a semisynthetic derivative of podophyllotoxin. It appears
as a white or almost white,
crystalline powder. It is practically insoluble in water, sparingly
soluble in methanol, slightly soluble in
alcohol and in methylene chloride.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Small cell carcinoma of the lung
•
Acute monocytic and myelomonocytic leukaemia
•
Hodgkin's disease
•
Non-Hodgkin's lymphoma
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The usual dose of etoposide must be based on the clinical and
haematological response and tolerance of the
patient. A repeat course of etoposide should not be administered until
the patient’s haematological function is
within acceptable limits (see section 4.4).
_ADULT _
The dosage for Ebeposide Injection is 50-60 mg/m
2
/day intravenously for 5 consecutive days followed by a
treatment free interval of 2-3 weeks. Total dose should not usually
exceed 400 mg/m
2
per course.
METHOD OF ADMINISTRATION
Plastic devices made of acrylic or ABS (a polymer of acrylonitrile,
butadiene and styrene) have been
reported to crack or leak when used with undiluted Ebeposide
injection.
Etoposide should only be given by slow intravenous infusion (see
sections 4.4 and 4.8).
Etoposide should not be administered by intrapleural or
intraperitoneal injection.
Etoposide must be diluted before administration. Resultant
concentrations should not be greater than 0.4
mg/mL since precipitation can occur. Usually etoposide is added to 250
mL of 0.9% sodium chloride or
5% glucose. The infusion should be administered over a period of 30-60
minutes.
Concentrations of etoposide of 0.4 mg/mL in 5%