Gemcitabine 100mg/ml Concentrate for Solution for Infusion - 2ml vial

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GEMCITABINE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

L01BC05

INN (International Name):

GEMCITABINE 200 mg

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

GEMCITABINE 200 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2012-03-29

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Gemcitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet See section 4.
WHAT IS IN THIS LEAFLET
1.
What Gemcitabine 100 mg/ml Concentrate for Solution for Infusion is
and what it is used for
2.
What you need to know before you take Gemcitabine 100 mg/ml
Concentrate for Solution for
Infusion
3.
How to take Gemcitabine 100 mg/ml Concentrate for Solution for
Infusion
4.
Possible side effects
5.
How to store Gemcitabine 100 mg/ml Concentrate for Solution for
Infusion
6.
Contents of the pack and other information
1.
WHAT GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION IS
AND WHAT IT IS
USED FOR
Gemcitabine 100 mg/ml Concentrate for Solution for Infusion belongs to
a group of medicines
called “cytotoxics”. These medicines kill dividing cells,
including cancer cells.
Gemcitabine 100 mg/ml Concentrate for Solution for Infusion may be
given alone or in
combination with other anti-cancer medicines, depending on the type of
cancer.
Gemcitabine 100 mg/ml Concentrate for Solution for Infusion is used in
the treatment of the
following types of cancer:
-
non-small cell lung cancer (NSCLC), alone or together with cisplatin.
-
pancreatic cancer.
-
breast cancer, together with paclitaxel.
-
ovarian cancer, together with carboplatin.
-
bladder cancer, together with cisplatin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GEMCITABINE 100 MG/ML
CONCENTRATE FOR
SOLUTION FOR INFUSION
DO NOT TAKE GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
-
if you are allergic to Gemcitabine or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are

Summary of Product characteristics

Page 1 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine
100 MG/ML
Concentrate for Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains Gemcitabine hydrochloride equivalent to 100 mg
gemcitabine.
Each vial of 2 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride
equivalent to 200 mg gemcitabine.
Each vial of 10 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride
equivalent to 1000 mg gemcitabine
Each vial of 15 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride
equivalent to 1500 mg gemcitabine
Each vial of 20 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride
equivalent to 2000 mg gemcitabine
Excipients with known effect:
9.192 mg/ml (0.4 mmol/ml) sodium.
440 mg/ml (44 % w/v) ethanol anhydrous
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to slightly yellow solution. pH in the range of
approximately 6.0 to 7.5 and
osmolarity in the range of approximately 270 to 330 mOsmol/Litre after
dilution with 0.9 % sodium
chloride solution at 0.1 mg/ml concentration.
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 comb