Gemcitabine 38mg/ml Concentrate for Soln for Inf (2000mg/52.6ml Vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GEMCITABINE

Available from:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

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:

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 38 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
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:
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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 c

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
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
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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
i