Gemcitabine 38 mg/ml Concentrate for Solution for Infusion (10ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GEMCITABINE

Available from:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC code:

L01BC05

INN (International Name):

GEMCITABINE 38 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

GEMCITABINE 38 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2011-03-28

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 38 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
GEMCITABINE
READ ALL OF THIS LEAFLET CAREFULLY, BEFORE YOU START RECEIVING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please 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 Concentrate for Solution for Infusion is and what it
is used for
2.
What you need to know before you are given Gemcitabine Concentrate for
Solution for
Infusion
3.
How Gemcitabine Concentrate for Solution for Infusion is given
4.
Possible side effects
5.
How to store Gemcitabine Concentrate for Solution for Infusion
6.
Contents of the pack and other information
1.
WHAT GEMCITABINE CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT
IS USED FOR
Gemcitabine Concentrate for Solution for Infusion (Gemcitabine)
belongs to a group of medicines
called ‘cytotoxics’. These medicines kill dividing cells,
including cancer cells.
Gemcitabine may be given on its own or in combination with other
anti-cancer medicines (e.g.
cisplatin, paclitaxel, carboplatin), depending on the type of cancer
you have.
Gemcitabine is used in the treatment of the following types of cancer:
•
NON-SMALL CELL LUNG CANCER (NSCLC),
when given alone or together with cisplatin
•
PANCREATIC CANCER
•
BREAST CANCER
, when given together with paclitaxel
•
OVARIAN CANCER,
when given together with carboplatin
•
BLADDER CANCER
, when given together with cisplatin
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GEMCITABINE CONCENTRATE FOR
SOLUTION FOR
INFUSION
YOU SHOULD NOT BE GIVEN GEMCITABINE IF:
•
you are allergic to gemcitabine or any of the other ingredients of
this medicine (listed in
section 6).
•
you are breast-feeding
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WARNINGS AND PRECAUTIONS
Be

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of Gemcitabine Concentrate for Solution for Infusion contains
gemcitabine hydrochloride,
equivalent to 38 mg gemcitabine.
The quantitative composition of each presentation is provided in the
table below:
Presentation
Strength
Quantity of
gemcitabine
(as hydrochloride)
Volume of
Solution
200mg/5.3 ml
38 mg/ml
200 mg
5.3 ml
1g/26.3 ml
38 mg/ml
1 g
26.3 ml
2g/52.6 ml
38 mg/ml
2 g
52.6 ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
A clear, colourless or light straw-coloured solution, practically free
from visible particles.
pH:
2.0-3.0
Osmolarity:
266 mOsmol/L
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.
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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 sho