Gemcitabine 100 mg/ml Concentrate for Solution for Infusion

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Gemcitabine

Disponible depuis:

Accord Healthcare Ireland Ltd.

Code ATC:

L01BC; L01BC05

DCI (Dénomination commune internationale):

Gemcitabine

Dosage:

100 milligram(s)/millilitre

forme pharmaceutique:

Concentrate for solution for infusion

Domaine thérapeutique:

Pyrimidine analogues; gemcitabine

Statut de autorisation:

Not marketed

Date de l'autorisation:

2012-03-09

Notice patient

1
NL/H/2136/001/IA/034, ver01, Nov 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEMCITABINE 100 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 100 mg/ml Concentrate for Solution for Infusion is
and what it is used for
2.
What you need to know before you take Gemcitabine 100 mg/ml
Concentrate for Solution for Infusion
3.
How to take Gemcitabine 100 mg/ml Concentrate for Solution for
Infusion
4.
Possible side effects
5.
How to store Gemcitabine 100 mg/ml Concentrate for Solution for
Infusion
6.
Contents of the pack and other information
1.
WHAT GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION IS
AND WHAT IT IS USED FOR
Gemcitabine 100 mg/ml Concentrate for Solution for Infusion belongs to
a group of medicines called
“cytotoxics”. These medicines kill dividing cells, including
cancer cells.
Gemcitabine 100 mg/ml Concentrate for Solution for Infusion may be
given alone or in combination with
other anti-cancer medicines, depending on the type of cancer.
Gemcitabine 100 mg/ml Concentrate 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GEMCITABINE 100 MG/ML
CONCENTRATE FOR SOLUTION FOR
INFUSION
DO NOT TAKE GEMCITABINE 100 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
-
if you are allergic to Gemcitabine or any of the other ingredients of
this medicine (listed

Résumé des caractéristiques du produit

Health Products Regulatory Authority
15 January 2024
CRN00F19D
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 100 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains Gemcitabine hydrochloride equivalent to 100 mg
gemcitabine.
Each vial of 2 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to 200 mg gemcitabine.
Each vial of 10 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to 1000 mg gemcitabine
Each vial of 15 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to 1500 mg gemcitabine
Each vial of 20 ml concentrate for solution for infusion contains
Gemcitabine hydrochloride equivalent to 2000 mg gemcitabine
Excipients with known effect:
9.192 mg/ml (0.4 mmol/ml) sodium.
440 mg/ml (44 % w/v) ethanol anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to slightly yellow solution. pH in the range of
approximately 6.0 to 7.5 and osmolarity in the range of
approximately 270 to 330 mOsmol/Litre after dilution with 0.9 % sodium
chloride solution at 0.1 mg/ml concentration.
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-fre