Gemcitabin "Ebewe" 500 mg/50ml

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Gemcitabine Hcl 500 mg/50ml

Available from:

مستودع ادوية الصباغ - Sabbagh Drug Store

ATC code:

L01BC05

INN (International Name):

Gemcitabine Hcl 500 mg/50ml

Dosage:

500 mg/50ml

Units in package:

1 vial X 50ml

Manufactured by:

EBEWE Pharma (النمسا)

Patient Information leaflet

1.
NAME OF THE MEDICINAL PRODUCT
GEMCITABIN EBEWE 10 MG/ML
CONCENTRATE FOR SOLUTION FOR INFUSION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 11.4 mg gemcitabine hydrochloride which corresponds to
10 mg of the active ingredient
gemcitabine. Excipients included in the drug product that contain
sodium are sodium acetate trihydrate
and sodium hydroxide.
Gemcitabin Ebewe 200 mg contains 21.49 mg (0.93 mmol), 500 mg contains
53.74 mg (2.34 mmol)
and 1000 mg contains 107.47 mg (4.67 mmol) sodium per vial.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Concentrate for solution for infusion.
Product description: clear, colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gemcitabine is indicated for the treatment of locally advanced or
metastatic bladder cancer in
combination with cisplatin.
Gemcitabine is indicated for treatment of patients with locally
advanced or metastatic adenocarcinoma
of the pancreas.
Gemcitabine, in combination with cisplatin is indicated as first line
treatment of patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC). Gemcitabine
monotherapy can be
considered in elderly patients or those with performance status 2.
Gemcitabine is indicated for the treatment of patients with locally
advanced or metastatic epithelial
ovarian carcinoma, in combination with carboplatin, in patients with
relapsed disease following a
recurrence-free interval of at least 6 months after platinum-based,
first-line therapy.
Gemcitabine,
in
combination
with
paclitaxel,
is
indicated
for
the
treatment
of
patients
with
unresectable, locally recurrent or metastatic breast cancer who have
relapsed following adjuvant/
neoadjuvant chemotherapy. Prior chemotherapy should have included an
anthracycline unless clinically
contraindicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine
should
only
be
prescribed
by
a
physician
qualified
in
the
use
of
anti-cancer
chemotherapy.
Recommended posology
Bladder cancer
Combination use
The reco