ETOPOSIDE EBEWE etoposide 50 mg/2.5 mL injection vial

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

etoposide, Quantity: 20 mg/mL

Disponible desde:

Sandoz Pty Ltd

formulario farmacéutico:

Injection, concentrated

Composición:

Excipient Ingredients: polysorbate 80; ethanol; benzyl alcohol; macrogol 300; citric acid

Vía de administración:

Intravenous Infusion

Unidades en paquete:

1 vial

clase:

Medicine Registered

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Small cell carcinoma of the lung. Acute monocytic and myelomonocytic leukaemia; Hodgkin's disease Non-Hodgkin's lymphoma.

Resumen del producto:

Visual Identification: clear light-yellow concentrate for solution for infusion; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2005-08-23

Ficha técnica

200403-Etoposide Ebewe-pi
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
ETOPOSIDE EBEWE
®
(ETOPOSIDE) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Etoposide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Etoposide is a semi-synthetic derivative of podophyllotoxin. It
appears as a white or almost
white, crystalline powder, soluble in methanol and chloroform,
slightly soluble in ethanol and
sparingly soluble in water and ether. It is more miscible with water
by means of organic
solvents.
Active: Etoposide (20 mg/mL)
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Etoposide Ebewe is concentrated injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Etoposide Ebewe concentrated injection (etoposide) is indicated for
use in the treatment of:
1.
Small cell carcinoma of the lung
2.
Acute monocytic and myelomonocytic leukaemia
3.
Hodgkin's disease
4.
Non-Hodgkin's lymphoma
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_Adults _
Administer intravenously, 50 to 60 mg/m
2
/day for five days followed by a treatment free
interval of two to four weeks.
Total dose should not exceed 400 mg/m
2
per course.
METHOD OF ADMINISTRATION
_Note._
Hard plastic devices made of acrylic or ABS (a polymer composed of
acrylonitrile,
butadiene and styrene) have been reported to crack and leak when used
with UNDILUTED
Etoposide Ebewe concentrated injection.
Etoposide Ebewe is non-aqueous.
Etoposide Ebewe must be diluted prior to use with either sodium
chloride intravenous infusion
(0.9%) or 5% glucose injection to give a final concentration of 0.2 to
0.4 mg/mL. More
concentrated solutions show crystal formation upon stirring or seeding
within five minutes and
should not be given intravenously. Hypotension following rapid
intravenous administration has
200403-Etoposide Ebewe-pi
Page 2 of 16
been reported, hence, the diluted etoposide solution should be
administered over a period of 30
to 60 minutes. More prolonged infusion lessens the risk of a
hypotensive reaction.
Etoposide Ebewe should not be adm