Gemcitabine 38mg/ml Concentrate for Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-07-2017
Summary of Product characteristics
(SPC)
03-02-2015
Active ingredient:
GEMCITABINE HYDROCHLORIDE
Available from:
Fresenius Kabi Oncology Plc
ATC code:
L01BC; L01BC05
INN (International Name):
GEMCITABINE HYDROCHLORIDE
Dosage:
38 milligram(s)/millilitre
Pharmaceutical form:
Concentrate 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:
2015-01-16
Patient Information leaflet
GEMCITABINE RTU ETHANOL FREE - PACK INSERT - IE+UK+MT (BORDON)
(Travesh
Sharma)
\\fre-kp-fp01\PDD-Artworks\Travesh\Gemita
RTU
(Ethanol
Free)\Ireland+UK+MT\16
Sep
2016\Gemcitabine
RTU
Ethanol
Free
-
Pack
Insert
-
IE+UK+MT
(Bordon).indd
SIZE:
592 X 300 MM
18 JANUARY 2017 3:48 PM
VER.: 01
TIMES NEW ROMAN 10 PTS.
Black
LFT00288
7220132503
V002/BO
THE FOLLOWING INFORMATION
IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY:
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
The approved diluent for
dilution of Gemcitabine
38 mg/ml concentrate for solution for
infusion is sodium chloride 9 mg/ml
(0.9%) solution for injection (without
preservative).
Total quantity of Gemcitabine
concentrate for solution required for
an individual patient must be diluted,
before use, to at least 500 ml of
sodium chloride 9 mg/ml solution for
injection to obtain clinically relevant
concentrations.
Based on the recommended dose
(1000 mg/m
2
and 1250 mg/m
2
) and
body surface area (between 1.0 m
2
to
2.0 m
2
) a concentration range of
2 mg/ml to 5 mg/ml is obtained.
The following instructions for dilution
should be strictly followed in order to
avoid adverse events.
1.
Use aseptic technique during
dilution of gemcitabine
for intravenous infusion
administration.
2.
Parenteral medicinal products
should be inspected visually
for particulate matter
and discolouration prior to
administration. If part
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine 38mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate for solution for infusion contains gemcitabine
hydrochloride, equivalent to 38 mg gemcitabine.
The quantitative composition of each presentation is provided in the
table below:
Excipient with known effect:
3.16 mg/ml to 3.74 mg/ml (0.14 mmol/ml to 0.16 mmol/ml) sodium.
30% v/v (310.8 mg/ml) propylene glycol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless to light straw colored 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
Presentation
Strength
Quantity of gemcitabine
(as hydrochloride)
Volume of Solution
200 mg/5.26 ml
38 mg/ml
200 mg
5.26 ml
1000 mg/26.3 ml
38 mg/ml
1000 mg
26.3 ml
2000 mg/52.6 ml
38 mg/ml
2000 mg
52.6 ml
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_
Read the complete document
