Etoposide (Rex)

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Etoposide 20 mg/mL

Tilgængelig fra:

REX Medical Ltd

INN (International Name):

Etoposide 20 mg/mL

Dosering:

20 mg/mL

Lægemiddelform:

Solution for injection

Sammensætning:

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

Enheder i pakken:

Vial, glass, Type I with bromobutyl rubber stopper., 5 mL

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Cipla Ltd

Terapeutiske indikationer:

Small-cell lung cancer: Etoposide Solution for Injection is indicated for the first-line treatment of small cell lung cancer with additional chemotherapeutic agents.

Produkt oversigt:

Package - Contents - Shelf Life: Vial, glass, Type I with bromobutyl rubber stopper. - 5 mL - 36 months from date of manufacture stored at or below 25°C protect from light

Autorisation dato:

2006-06-28

Produktets egenskaber

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
Etoposide Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Etoposide 100 mg/5 ml Solution for Injection
3 PHARMACEUTICAL FORM
Etoposide Injection is a sterile solution that is clear and colourless
to pale yellow with a pH of
3–4.
Etoposide Injection is available in a 5 ml single-use clear glass vial
containing 100 mg
etoposide.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
SMALL-CELL LUNG CANCER: Etoposide Solution for Injection is indicated
for the first-line
treatment of small-cell lung cancer with additional chemotherapeutic
agents.
HODGKIN’S DISEASE
MALIGNANT (NON-HODGKIN’S) LYMPHOMAS, PARTICULARLY OF THE HISTIOCYTIC
VARIETY
ACUTE NON-LYMPHOCYTIC LEUKAEMIA
TESTICULAR TUMOURS: Etoposide Solution for Injection is indicated both
as the first-line
combination regimens and for the treatment of refractory testicular
tumours.
4.2 Dose and method of administration
Etoposide Solution for Injection must be diluted immediately prior to
administration with
either
5%
Dextrose
Injection
or
0.9%
Sodium
Chloride
Injection
to
give
a
solution
concentration of 0.2 to 0.4 mg/ml of Etoposide (see Preparation for
Administration).
_ _
_DOSAGE IN ADULTS _
Etoposide Solution for Injection is to be administered slowly at a
dosage of 50–100 mg/m
2
on days 1 to 5 every 3 or 4 weeks or 100 mg/m
2
on days 1, 3 and 5 every 3 or 4 weeks.
Total dosage must be adapted based upon the myelosuppressive effects
of combinations
with other medicines and or the effects of previous chemotherapy or
X-ray therapy which
possibly could have compromised the reserves of the bone marrow.
Most patients undergo three or four treatment cycles with Etoposide
Solution for Injection.
Treatment
cycles
may
be
repeated
and
dosage
adjusted
(increased
or
decreased)
depending on the individual patient’s bone marrow reserve and tumour
reserve. The
optimum
use
of
Etoposide
Solution
for
Injection
is
in
combination
with
other
chemotherapeutic agents.
_ _
_DOSAGE IN ADULTS WITH RENAL IMPAIRMENT _
The dosage of Etopos