Gemcitabine 200 mg powder for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gemcitabine

Available from:

Fresenius Kabi Oncology Plc

ATC code:

L01BC; L01BC05

INN (International Name):

Gemcitabine

Dosage:

200 milligram(s)

Pharmaceutical form:

Powder for solution for infusion

Prescription type:

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

Therapeutic area:

Pyrimidine analogues; gemcitabine

Authorization status:

Marketed

Authorization date:

2010-04-23

Patient Information leaflet

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GEMCITABINE - PACK INSERT - IRELAND (BORDON)
(Travesh Sharma) \\fre-kp-fp01\PDD-Artworks\EU\Gemita\2013\Ireland\20
Jan 2017\Gemcitabine - Pack Insert - Ireland (Bordon).indd
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V003/IE
FONT SIZE: 10 PT TIMES NEW ROMAN
DATE: 24 APRIL 2017 11:55 AM VERSION: 02
FINAL PACKAGING SITE: BORDON
MFG. SITE: BADDI-2
DIMENSION: 592 X 300 MM
FOLDING SIZE: 60 X 33 MM
(OUTLINE OF FOLDING SIZE FOR INDICATION PURPOSE ONLY, IT
SHOULD BE REMOVED BEFORE FINAL PRINTING.)
Form No.: SOP/PDD/014-02 Rev. 00
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 200 mg 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 200 mg
gemcitabine for reconstitution in 5 ml of solvent.
Excipients(s) with known effect:
Each 200 mg vial contains 3.5 mg (<1 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 by
30-minute infusion. The dose should be given on
Days 1, 8 and 15 of each