Gemcitabin Actavis 40mg/ml (50ml vial) Concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GEMCITABINE

Available from:

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

ATC code:

L01BC05

INN (International Name):

GEMCITABINE 2 g

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

GEMCITABINE 2 g

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2011-03-16

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABIN ACTAVIS 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, pharmacist or
nurse.
-
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 Gemcitabin Actavis is and what it is used for
2.
What you need to know before you use Gemcitabin Actavis
3.
How to use Gemcitabin Actavis
4.
Possible side effects
5.
How to store Gemcitabin Actavis
6.
Contents of the pack and other information
1.
WHAT GEMCITABIN ACTAVIS IS AND WHAT IT IS USED FOR
Gemcitabin Actavis belongs to a group of medicines called
“cytotoxics”. These medicines kill
dividing cells, including cancer cells.
Gemcitabin Actavis may be given alone or in combination with other
anti-cancer medicines,
depending on the type of cancer.
Gemcitabin 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 GEMCITABIN ACTAVIS
DO NOT TAKE GEMCITABIN 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
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 Gemcitabin
Actavis. Your doctor may decide to change the dose or delay treating
you dependi

Summary of Product characteristics

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabin Actavis 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 gemcitabine
hydrochloride).
Each 25 ml vial contains 1 g gemcitabine (as gemcitabine
hydrochloride).
Each 50 ml vial contains 2 g gemcitabine (as gemcitabine
hydrochloride).
Excipients with known effect:
Sodium 3.95 mg/ml and ethanol anhydrous 395 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless or pale yellow solution.
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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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine should only be prescribed by a physician qualified in the
use of anti