Gemcitabine 40mg/ml concentrate for solution for infusion - (50ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GEMCITABINE HYDROCHLORIDE

Available from:

Fresenius Kabi Oncology PLC Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom

ATC code:

L01BC05

INN (International Name):

GEMCITABINE HYDROCHLORIDE 40 mg

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

GEMCITABINE HYDROCHLORIDE 40 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-05-08

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 40 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, nurse or
pharmacist.
-
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 is and what it is used for
2.
What you need to know before you use Gemcitabine
3.
How to use Gemcitabine
4.
Possible side effects
5.
How to store Gemcitabine
6.
Contents of the pack and other information
1.
WHAT GEMCITABINE IS AND WHAT IT IS USED FOR
Gemcitabine belongs to a group of medicines called “cytotoxics”.
These medicines kill dividing
cells, including cancer cells.
This medicine may be given alone or in combination with other
anti-cancer medicines, depending
on the type of cancer.
This medicine 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 USE GEMCITABINE
DO NOT USE
GEMCITABINE:
-
if you are allergic to gemcitabine or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are breast-feeding.
WARNINGS AND PRECAUTIONS:
Before the first infusion you will have samples of your blood taken to
check if your liver and
kidneys are working well enough for you to receive this medicine.
Before each infusion you will
have samples of your blood taken to check if you have enough blood
cells to receive Gemcitabine.
Your doctor may decide to change the dose or delay treating you
depending on your general
condition and if your blood cell counts are too low. Periodica

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Gemcitabine 40 mg/ml concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 40 mg
gemcitabine (as gemcitabine
hydrochloride).
Each 5 ml vial contains 200 mg gemcitabine (as hydrochloride).
Each 25 ml vial contains 1,000 mg gemcitabine (as hydrochloride).
Each 50 ml vial contains 2,000 mg gemcitabine (as hydrochloride).
Excipient(s) with known effect:
3.40 mg/ml to 3.70 mg/ml (0.15 mmol/ml to 0.16 mmol/ml) sodium.
421.0 mg/ml (42.1% w/v) ethanol (96%)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to slightly yellow solution, free from visible
particles.
pH: 7.0 to 9.0
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 should