Gemcitabine 38mg/ml concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GEMCITABINE

Available from:

Fresenius Kabi Oncology PLC

ATC code:

L01BC05

INN (International Name):

GEMCITABINE

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

GEMCITABINE 38 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2015-02-12

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 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
Page 2 of 9
condition and if your blood cell counts are too lo

Summary of Product characteristics

Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine 38 mg/ml concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of 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
200 mg/5.26 ml
38 mg/ml
200 mg
5.26 ml
1000 mg/26.3 ml
38 mg/ml
1000 mg
26.3 ml
2000 mg/52.6 ml
38 mg/ml
2000 mg
52.6 ml
Excipient with known effect:
3.16 mg/ml to 3.74 mg/ ml (0.14 mmol/ml to 0.16 mmol/ml) sodium.
30% v/v (310.8 mg/ml) propylene glycol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to light straw colored 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.
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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 ant