Gemcitabine 200mg Powder for Solution for Infusion

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:

POWDER FOR SOLUTION FOR INFUSION

Composition:

GEMCITABINE 200 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2011-06-30

Patient Information leaflet

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 200 MG POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE 1 G POWDER FOR SOLUTION FOR INFUSION
Gemcitabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
MEDICINE.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor, nurse or
pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist. See section 4
IN THIS LEAFLET
:
1. What Gemcitabine powder for solution for infusion is and what it is
used for
2. Before you are given Gemcitabine powder for solution for infusion
3. How Gemcitabine powder for solution for infusion is given
4. Possible side effects
5. How to store Gemcitabine powder for solution for infusion
6. Further information
1. WHAT GEMCITABINE POWDER FOR SOLUTION FOR INFUSION IS AND
WHAT IT IS USED FOR
Gemcitabine powder for solution for infusion belongs to a group of
medicines called
“cytotoxics”. These medicines kill dividing cells, including
cancer cells.
Gemcitabine powder for solution for infusion may be given alone or in
combination with
other anti-cancer medicines, depending on the type of cancer.
Gemcitabine powder 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. BEFORE YOU ARE GIVEN GEMCITABINE POWDER FOR SOLUTION FOR
INFUSION
YOU SHOULD NOT BE GIVEN GEMCITABINE POWDER FOR SOLUTION FOR INFUSION:
- if you are allergic (hypersensitive) to gemcitabine or any of the
other ingredients of
Gemcitabine powder for solution for infusion (listed in section 6).
- if you

Summary of Product characteristics

Page 1 of
21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine 200 mg Powder for Solution for Infusion
Gemcitabine 1 g Powder for Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains gemcitabine hydrochloride equivalent to 200 mg
gemcitabine.
One vial contains gemcitabine hydrochloride equivalent to 1 g
gemcitabine.
After reconstitution, the solution contains 38 mg/ml of gemcitabine.
Excipients
Each 200 mg vial contains 3.5 mg (<1 mmol) sodium.
Each 1 g vial contains 17.5 mg (<1 mmol) sodium.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white plug or powder.
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 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.
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21
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine should only be prescribed by a physician qualified in the
use of anti-cancer
chemotherapy.
Recommended posology
_Bladder _
_cancer