Gemcitabine 40mg/ml concentrate for solution for Infusion

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

GEMCITABINE HYDROCHLORIDE

Disponibil de la:

Fresenius Kabi Oncology Plc

Codul ATC:

L01BC; L01BC05

INN (nume internaţional):

GEMCITABINE HYDROCHLORIDE

Dozare:

40 milligram(s)/millilitre

Forma farmaceutică:

Concentrate 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:

Not marketed

Data de autorizare:

2012-11-23

Prospect

GEMCITABINE RTU - PACK INSERT - IRE+GBR+MT
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V003/BO
(Travesh Sharma) \\fre-kp-fp01\PDD-Artworks\EU\Gemita
RTU\Ireland+UK+MT\08 Jan 2015\Gemcitabine RTU - Pack Insert -
IRE+GBR+MT.indd
Black
FONT SIZE: 10 PT TIMES NEW ROMAN
DATE: 4 SEPTEMBER 2017 3:31 PM VERSION: 13
FINAL PACKAGING SITE: BORDON
MFG. SITE: BADDI
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
THE FOLLOWING INFORMATION
IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY:
INSTRUCTION FOR USE
Cytotoxic
_HANDLING_
The
normal
safety
precautions
for
cytostatic
agents
must
be
observed
when preparing and disposing of the
infusion solution. Pregnant personnel
should
not
handle
the
product.
Handling of the solution for infusion
should be done in a safety box and
protective coats and gloves should be
used. If no safety box is available, the
equipment
should
be
supplemented
with a mask and protective glasses.
If the preparation comes into contact
with the eyes, this may cause serious
irritation. The eyes should be rinsed
immediately
and
thoroughly
with
water.
If
there
is
lasting
irritation,
a doctor should be consulted. If the
solution is spilled on the skin, rinse
thoroughly with water.
_INSTRUCTIONS FOR DILUTION_
Instructions
for
dilution
should
be
strictly
followed
in
order
to
avoid
adverse events.
The only approved diluent for dilution
of Gemcitabine 40 mg/ml concentrate
for
solution
for
infusion
is
sodium
chloride 9 mg/ml (0.9%) solution for
injection (without preservative).
1.
Use
aseptic
technique
during
dilution
of
gemcitabine
for
intravenous infusion administration.
2.
THE
TOTAL
QUANTITY
of
the
gemcitabine 40 mg/ml concentrate
for solution for infusion required
for
an
individual
patient
SHOULD
BE DILUTED INTO AT LEAST 500 ML
OF STERILE SODIUM CHLORIDE 9 MG/
ML (0.9%) SOLUTION FOR INJECTION
(WITHOUT
PRESERVATIVE)
AND
INFUSED
OVER
30
MIN.
Further
dilution with the same diluent can
be done. Diluted solution is a clear
colou

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 40mg/ml concentrate for solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains 40 mg
gemcitabine (as gemcitabine hydrochloride).
Each 5 ml vial contains 200 mg gemcitabine (as hydrochloride).Each 25
ml vial contains 1000 mg gemcitabine (as
hydrochloride).
Each 50 ml vial contains 2000 mg gemcitabine (as hydrochloride).
Excipient(s) with known effect:
3.40 mg/ml to 3.70 mg/ml (0.15 mmol/ml to 0.16 mmol/ml) sodium.
421.0 mg/ml (42.1% w/v) ethanol (96%)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to slightly yellow solution, free from visible
particles.
pH: 7.0 to 9.0
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 AND METHOD OF ADMINISTRATION
Gemcitabine should only be prescribed by a physician