ETOPOSIDE INJECTION 100 mg5 ml

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

ETOPOSIDE

Dostupné s:

PFIZER PRIVATE LIMITED

ATC kód:

L01CB01

Dávkování:

100 mg/5 ml

Léková forma:

INJECTION

Složení:

ETOPOSIDE 100 mg/5 ml

Podání:

INTRAVENOUS

Druh předpisu:

Prescription Only

Výrobce:

PFIZER (PERTH) PTY LTD

Stav Autorizace:

ACTIVE

Datum autorizace:

1993-02-11

Charakteristika produktu

PRODUCT
INFORMATION
–
ETOPOSIDE
(ETOPOSIDE)
1.
NAME OF THE MEDICINE
Etoposide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Etoposide Injection is a sterile solution containing etoposide 20
mg/mL in an organic
solvent base.
Excipient with known effect: Ethanol
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Concentrate for Solution for Infusion
Etoposide is a white or almost white, crystalline powder, 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 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
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 Special warnings and precautions for use).
_ADULT _
The
dosage
for
Etoposide
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.
In any case, repeat courses should
not be given until the haematological parameters have been checked for
evidence of
myelosuppression and found to be satisfactory.
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
Etoposide
injection.
Etoposide should only be given by slow intravenous infusion (see
section 4.4 Special
warnings and precautions for use, section 4.8 Adverse effects
(undesirable effects)).
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