Gemcitabine 2 g powder for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gemcitabine

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

L01BC; L01BC05

INN (International Name):

Gemcitabine

Dosage:

2 gram(s)

Pharmaceutical form:

Powder for solution for infusion

Therapeutic area:

Pyrimidine analogues; gemcitabine

Authorization status:

Not marketed

Authorization date:

2010-04-23

Patient Information leaflet

Ver 004, Nov 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 200 MG POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE 1 G POWDER FOR SOLUTION FOR INFUSION
GEMCITABINE 2 G 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 further questions, please 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 belongs to a group of medicines called “cytotoxics”.
These medicines kill
dividing cells, including cancer cells.
Gemcitabine may be given alone or in combination with other
anti-cancer medicines,
depending on the type of cancer.
Gemcitabine 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
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

Summary of Product characteristics

Health Products Regulatory Authority
15 March 2024
CRN00F0YX
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 2 g powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of reconstituted solution contains 38 mg gemcitabine
Each vial contains gemcitabine hydrochloride equivalent to 2000 mg
gemcitabine for reconstitution in 50 ml of solvent.
Excipients(s) with known effect:
Each 2000 mg vial contains 35 mg (1.5 mmol) sodium.
For the 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 older 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 physician qualified in the
use of anti-cancer chemotherapy.
Recommended posology
_Bladder cancer_
_Combination use_
The recommended dose for gemcitabine is 1,000 mg/m², given b