Gemcitabine 1 g Powder for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gemcitabine

Available from:

Accord Healthcare Limited

ATC code:

L01BC; L01BC05

INN (International Name):

Gemcitabine

Dosage:

1 gram(s)

Pharmaceutical form:

Powder for solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Pyrimidine analogues; gemcitabine

Authorization status:

Not marketed

Authorization date:

2009-07-24

Patient Information leaflet

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
infus

Summary of Product characteristics

Health Products Regulatory Authority
28 September 2018
CRN008L3X
Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 1 g Powder for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains gemcitabine hydrochloride equivalent to 1 g
gemcitabine.
After reconstitution, the solution contains 38 mg/ml of gemcitabine.
Excipients
Each 1 g vial contains 17.5 mg (<1 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 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.
Health Products Regulatory Authority
28 September 2018
CRN008L3X
Page 2 of 23
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