Etopophos

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Etoposide phosphate 119.3mg equivalent to 100 mg etoposide (includes 5% overage);  

Disponibbli minn:

Link Pharmaceuticals Ltd

INN (Isem Internazzjonali):

Etoposide phosphate 119.3 mg (equivalent to 100 mg etoposide; includes 5% overage)

Dożaġġ:

100 mg

Għamla farmaċewtika:

Powder for injection

Kompożizzjoni:

Active: Etoposide phosphate 119.3mg equivalent to 100 mg etoposide (includes 5% overage)   Excipient: Dextran 40 Nitrogen Sodium citrate dihydrate

Unitajiet fil-pakkett:

Vial, glass, single dose, 100 mg

Klassi:

Prescription

Tip ta 'preskrizzjoni:

Prescription

Manifatturat minn:

Nippon Kayaku Co Ltd

Indikazzjonijiet terapewtiċi:

In combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Vial, glass, single dose, - 100 mg - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Data ta 'l-awtorizzazzjoni:

1995-07-21

Karatteristiċi tal-prodott

ETOPOPHOS V12
1
DATA SHEET
1
PRODUCT NAME
ETOPOPHOS

100 mg powder for injection.
ETOPOPHOS

500 mg powder for Injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ETOPOPHOS 100 MG
Each single use vial contains 113.6 mg of etoposide phosphate
(equivalent to 100 mg etoposide) as a
lyophilised powder for injection.
Excipients with known effect:
Each 100 mg vial of ETOPOPHOS contains 7.7 mg of sodium.
ETOPOPHOS 500 MG
Each pharmacy bulk vial contains 568 mg of etoposide phosphate
(equivalent to 500mg etoposide) as
a lyophilised powder for injection
Excipients with known effect:
Each 500 mg vial of ETOPOPHOS contains 38.3 mg of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Lyophilised powder for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ETOPOPHOS is indicated in the treatment of:
SMALL CELL LUNG CANCER
- ETOPOPHOS Injection in combination with other approved
chemotherapeutic agents as first-line treatment in patients with small
cell lung cancer.
HODGKIN'S DISEASE
MALIGNANT (NON-HODGKIN'S) LYMPHOMAS,
especially of the histiocytic variety.
ACUTE NON-LYMPHOCYTIC LEUKAEMIA
TESTICULAR TUMOURS
both as first-line combination regimens and for the treatment of
refractory
testicular tumours.
ETOPOPHOS V12
2
4.2
DOSE AND METHOD OF ADMINISTRATION
ETOPOPHOS is administered by slow intravenous infusion.
ETOPOPHOS SHOULD NOT BE
GIVEN BY RAPID INTRAVENOUS INJECTION.
The usual dose for etoposide is 50 to
100 mg/m
2
/day, days 1 to 5 or 100 mg/m
2
/day, days 1, 3 and 5 every 3 to 4 weeks in combination with
other agents approved for use in the disease to be treated. Dosage
should be modified to take into
account the myelosuppressive effects of other medications in the
combination or the effects of prior
X-ray therapy or chemotherapy which may have compromised bone marrow
reserve.
ETOPOPHOS may be infused over 5-210 minutes.
Prior to use, the contents of each vial must be reconstituted with
Sterile Water for Injection, 5%
Dextrose Injection, 0.9% Sodium Chloride Injection, Ba