Gemcitabine 2g Powder for Solution for Infusion

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Gemcitabine hydrochloride

Tilgængelig fra:

Accord Healthcare Ireland Ltd.

ATC-kode:

L01BC; L01BC05

INN (International Name):

Gemcitabine hydrochloride

Dosering:

2 gram(s)

Lægemiddelform:

Powder for solution for infusion

Terapeutisk område:

Pyrimidine analogues; gemcitabine

Autorisation status:

Not marketed

Autorisation dato:

2011-09-23

Indlægsseddel

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 RECEIVING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have further questions, please ask your doctor, nurse or
pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, nurse or
pharmacist. See section 4
IN THIS LEAFLET
:
1. What Gemcitabine powder for solution for infusion is and what it is
used for
2. Before you are given Gemcitabine powder for solution for infusion
3. How Gemcitabine powder for solution for infusion is given
4. Possible side effects
5. How to store Gemcitabine powder for solution for infusion
6. Further information
1. WHAT GEMCITABINE POWDER FOR SOLUTION FOR INFUSION IS AND WHAT IT IS
USED FOR
Gemcitabine powder for solution for infusion belongs to a group of
medicines called “cytotoxics”. These medicines kill dividing
cells, including cancer cells.
Gemcitabine powder for solution for infusion may be given alone or in
combination with other anti-cancer medicines, depending
on the type of cancer.
Gemcitabine powder 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. BEFORE YOU ARE GIVEN GEMCITABINE POWDER FOR SOLUTION FOR INFUSION
YOU SHOULD NOT BE GIVEN GEMCITABINE POWDER FOR SOLUTION FOR INFUSION:
- if you are allergic (hypersensitive) to gemcitabine or any of the
other ingredients of Gemcitabine powder for solution for infu

Produktets egenskaber

Health Products Regulatory Authority
07 February 2024
CRN00F3S3
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 2g Powder for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains gemcitabine hydrochloride equivalent to 2 g
gemcitabine.
After reconstitution, the solution contains 38 mg/ml of gemcitabine.
Excipients
Each 2 g vial contains 35 mg (1.52 mmol) sodium.
For a 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 the 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 a
performance status of 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 unresectable, locally recurrent or metastatic
breast cancer who have relapsed following adjuvant/neoadjuvant
chemotherapy. The Prior chemotherapy must have included
an anthracycline unless clinically contraindicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gemcitabine can only be prescribed by a physician qualified in the use
of anti-cancer therapy.
Recommended posology
_ _
_Bladder cancer_
_Combination use_
The recommended dose for gemcitabine is 1000 mg/m
2
, as a 30-minute intravenous infusion. The dose must be administered
on D