DBL® Etoposide

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Etoposide 20 mg/mL;  ;  

Disponível em:

Pfizer New Zealand Limited

DCI (Denominação Comum Internacional):

Etoposide 20 mg/mL

Dosagem:

100 mg/5mL

Forma farmacêutica:

Solution for injection

Composição:

Active: Etoposide 20 mg/mL     Excipient: Citric acid Ethanol Macrogol 300 Polysorbate 80

Unidades em pacote:

Ampoule, glass, 1 x 5 mL, 5 mL

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Sicor (Societa Italiana Corticosteroidi) Srl

Resumo do produto:

Package - Contents - Shelf Life: Ampoule, glass, - 5 mL - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, - 5 mL - 24 months from date of manufacture stored at or below 25°C

Data de autorização:

1989-11-20

Características técnicas

Version 4.0
Page 1 of 11
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL
®
Etoposide Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Etoposide is a semi-synthetic derivative of podophyllotoxin.
DBL
®
Etoposide Injection contains Etoposide, citric acid, polysorbate 80,
Macrogol 300, and
ethanol.
EXCIPIENT(S) WITH KNOWN EFFECT

Macrogol 300

Ethanol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL® Etoposide Injection is available as a clear, colourless to pale
yellow viscous liquid, in
clear glass vials.
Solution for injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL
®
Etoposide Injection 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 DOSE AND METHOD OF ADMINISTRATION
DOSE
Biological activity appears to be schedule dependent with multiple
dosage over 3 or 5 days
showing superiority over single dose administration.
Version 4.0
Page 2 of 11
ADULT :
_Intravenous_: Intravenously, 50-60 mg/m
2
/day for 5 days followed by a treatment-free interval
of 2-4 weeks.
Total dose should not exceed 400 mg/m
2
per course.
DBL
®
Etoposide
Injection
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 5 minutes and should not be given intravenously.
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 Injection.
Hypotension following rapid intravenous administration has been
reported, hence, the diluted
DBL
®
Etoposide Injection solution should be administered over a period of
30 to 60 minutes.
More prolonged infusion lessens the risk of a hypotensive reaction.
DBL
®
ETOPOSIDE
INJECTION
SHOULD
NOT
BE
GIVEN
BY
A
RAPID
INTRAVEN