Gemcitabine 40 mg/ml concentrate for solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gemcitabine

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

L01BC; L01BC05

INN (International Name):

Gemcitabine

Dosage:

40 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Pyrimidine analogues; gemcitabine

Authorization status:

Not marketed

Authorization date:

2012-11-23

Patient Information leaflet

GEMCITABINE RTU - PACK INSERT - IRE+GBR+MT
xxxxxx
V005/BO
(Travesh Sharma) \\fre-kp-fp01\PDD-Artworks\EU\Gemita
RTU\Ireland+UK+MT\2018 DEC\Gemcitabine RTU - Pack Insert -
IRE+GBR+MT.indd
Black
FONT SIZE: 12 PT TIMES NEW ROMAN
DATE: 8 DECEMBER 2018 10:04 AM VERSION: 02
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 colourles

Summary of Product characteristics

Health Products Regulatory Authority
30 September 2019
CRN008TM0
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 40 mg/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 AN