Gemcitabine 1 g powder for solution for infusion

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Gemcitabine

Disponibil de la:

Actavis Group PTC ehf

Codul ATC:

L01BC; L01BC05

INN (nume internaţional):

Gemcitabine

Dozare:

1 gram(s)

Forma farmaceutică:

Powder for solution for infusion

Tip de prescriptie medicala:

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

Zonă Terapeutică:

Pyrimidine analogues; gemcitabine

Statutul autorizaţiei:

Marketed

Data de autorizare:

2008-12-12

Prospect

1
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 any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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 TAKE 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
evaluate if you have sufficient
kidney and liver function. Before each infusion you will have samples
of your blood taken to evaluate
if y

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 1 g powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of the reconstituted solution for infusion (see section 6.6)
contains 38 mg gemcitabine (as hydrochloride).
Each vial contains 1 g of gemcitabine (as hydrochloride).
Contains approximately 0.77 mmol (17.81 mg) sodium per 1 g vial.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White or almost white compact
aggregate.
After reconstitution in sodium chloride 0.9% the solution is clear to
pale
opalescent and colourless to pale yellow.
The pH of the reconstituted solution in sodium chloride 0.9% solution
is 3.0 ± 0.3.
The osmolarity of the reconstituted solution (38 mg/ml
of gemcitabine (as hydrochloride) in sodium chloride 0.9%
solution) is 775 mOsm/l.
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