Gemcitabine 1g/25ml concentrate for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gemcitabine hydrochloride

Available from:

Actavis UK Ltd

ATC code:

L01BC05

INN (International Name):

Gemcitabine hydrochloride

Dosage:

40mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010300; GTIN: 5012617026132

Patient Information leaflet

Gemcitabine 40mg/ml Concentrate for Solution for Infusion PIL - UK
item no: AAAI6631
print proof no: 3
origination date: 13.01.16
originated by: S.Anson
revision date: 14.01.16
revised by: S.Anson
dimensions: 124 x 640
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
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5.
6.
1.
2.
3.
date sent: 13.01.16
supplier: Actavis Nerviano
technically app. date: 13.01.16
min pt size: 9
TECHNICAL APPROVAL
10 MM
10 MM
5 MM
10 MM
306 MM
14 MM
14 MM
20 MM
-1 MM
20 MM
+1 MM
ITF 6 MM
306 MM
N. 000000000.0
11
10
9
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2
1
✁
GEMCITABINE 40MG/ML
CONCENTRATE FOR SOLUTION FOR
INFUSION
PACKAGE LEAFLET: INFORMATION FOR THE USER
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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 only approved diluent for
dilution of Gemcitabine Concentrate
for Solution for Infusion is sodium
chloride 9mg/ml (0.9%) solution for
injection (without preservative).
• Use aseptic technique during
dilution of gemcitabine for
intravenous infusion administration.
• Diluted solution is a clear colourless
or light straw-coloured solution.
• Parenteral medicinal products
should be inspected visually
for particulate matter and
discolouration prior to
administration. If particulate matter
is observed, do not administer.
The following information is intended for healthcare professionals
only:
INSTRUCTION

Summary of Product characteristics

OBJECT 1
GEMCITABINE 40MG/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
Summary of Product Characteristics Updated 12-May-2017 | Accord-UK Ltd
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 gemcitabine
hydrochloride)
Each 25 ml vial contains 1 g gemcitabine (as gemcitabine
hydrochloride)
Each 50 ml vial contains 2 g gemcitabine (as gemcitabine
hydrochloride)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
The pH of the concentrate is 2.4 ± 0.4 and the osmolarity is 270-280
mOsmol/kg.
Clear, colourless or pale yellow solution.
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 shoul