Gemcitabine Actavis Pdr for Soln for Infusion 1g vial

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

GEMCITABINE HYDROCHLORIDE

Tilgængelig fra:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC-kode:

L01BC05

INN (International Name):

GEMCITABINE HYDROCHLORIDE 228 mg

Lægemiddelform:

POWDER FOR SOLUTION FOR INFUSION

Sammensætning:

GEMCITABINE HYDROCHLORIDE 228 mg

Recept type:

POM

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Autorisation status:

Withdrawn

Autorisation dato:

2009-01-29

Indlægsseddel

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE ACTAVIS 38 MG/ML POWDER 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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
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 Actavis is and what it is used for
2.
What you need to know before you use Gemcitabine Actavis
3.
How to use Gemcitabine Actavis
4.
Possible side effects
5.
How to store Gemcitabine Actavis
6.
Contents of the pack and other information
1.
WHAT GEMCITABINE ACTAVIS IS AND WHAT IT IS USED FOR
Gemcitabine Actavis belongs to a group of medicines called
“cytotoxics”. These medicines kill
dividing cells, including cancer cells.
Gemcitabine Actavis may be given alone or in combination with other
anti-cancer medicines,
depending on the type of cancer.
Gemcitabine Actavis 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 ACTAVIS
DO NOT TAKE GEMCITABINE ACTAVIS:
-
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
evaluate if you have
sufficient kidney and liver function. Before each infusion you will
have samples of your blood
taken to evaluate if

Produktets egenskaber

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 19
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine Actavis 38 mg/ml powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of the reconstituted solution for infusion (see section 6.6)
contains 38 mg gemcitabine (as
hydrochloride).
_200 mg vial: _
Each vial contains 200 mg of gemcitabine (as hydrochloride).
Contains approximately 0.15 mmol (3.56 mg) sodium per 200 mg vial.
_1 g vial: _
Each vial contains 1 g of gemcitabine (as hydrochloride).
Contains approximately 0.77 mmol (17.81 mg) sodium per 1 g vial.
_2 g vial: _
Each vial contains 2 g of gemcitabine (as hydrochloride)
Contains approximately 1.54 mmol (35.62 mg) sodium per 2 g vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White or almost white compact aggregate. After reconstitution in
sodium chloride 0.9% the solution
is clear to pale opalescent and colourless to pale yellow.
The pH of the reconstituted solution in sodium chloride 0.9% solution
is 3.0 ± 0.3.
The osmolarity of the reconstituted solution (38 mg/ml of gemcitabine
(as hydrochloride) in sodium
chloride 0.9% solution) is 775 mOsm/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.
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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-