Gemcitabine Teva 40mg/ml Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gemcitabine

Available from:

Teva B.V.

ATC code:

L01BC; L01BC05

INN (International Name):

Gemcitabine

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Pyrimidine analogues; gemcitabine

Authorization status:

Marketed

Authorization date:

2016-03-04

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2023
CRN00DZ0T
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine Teva 40mg/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)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The pH of the concentrate is 2.4 ± 0.4 and the osmolarity is 270-280
mOsmol/kg.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine should only be prescribed by a