Gemcitabine 200 mg powder for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gemcitabine

Available from:

Actavis Group PTC ehf

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:

2008-12-12

Patient Information leaflet

1
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OUTER CARTON
1.
NAME OF THE MEDICINAL PRODUCT
Gemcitabine 200mg powder for solution for infusion
Gemcitabine 1g powder for solution for infusion
Gemcitabine 2g powder for solution for infusion
gemcitabine
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
One ml of the reconstituted solution for infusion contains 38 mg
gemcitabine (as hydrochloride).
Each vial contains 200 mg gemcitabine (as hydrochloride).
Each vial contains 1 g gemcitabine (as hydrochloride).
Each vial contains 2 g gemcitabine (as hydrochloride).
3.
LIST OF EXCIPIENTS
Excipients: mannitol E421, sodium acetate trihydrate, sodium hydroxide
(for pH adjustment).
4.
PHARMACEUTICAL FORM AND CONTENTS
Powder for solution for infusion
1 Vial
200 mg
1 g
2 g
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
_ _
Must be reconstituted before use.
For intravenous use.
For single use only.
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Cytotoxic.
2
8.
EXPIRY DATE
EXP
Read the leaflet for the shelf life of the reconstituted product.
9.
SPECIAL STORAGE CONDITIONS
Do not refrigerate or freeze.
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Discard any unused content according to standard practice for
cytotoxic agents.
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Actavis Group PTC ehf.
Reykjavikurvegi 76-78
220 Hafnarfjordur
Iceland
12.
MARKETING AUTHORISATION NUMBER(S)
PA 1380/15/1
_ _
PA 1380/15/2
_ _
PA 1380/15/4
13.
BATCH NUMBER
LOT
14.
GENERAL CLASSIFICATION FOR SUPPLY
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
[Justification for not including Braille accepted.]
17.
UNIQUE IDENTIFIER – 2D BARCODE_ _
3
2D barcode carrying the unique identifier included.
18.
UNIQUE IDENTIFIER – HUMAN READABLE DATA_ _
PC:
SN:
4
MINIMUM PARTICULARS TO APPEAR ON SMALL

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 the reconstituted solution for infusion (see section 6.6)
contains 38 mg gemcitabine (as hydrochloride).
Each vial contains 200 mg of gemcitabine (as hydrochloride).
Contains approximately 0.15 mmol (3.56 mg) sodium per 200 mg vial.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White or almost white compact
aggregate.
After reconstitution in sodium chloride 0.9% the solution is clear to
pale
opalescent and colourless to pale yellow.
The pH of the reconstituted solution in sodium chloride 0.9% solution
is 3.0 ± 0.3.
The osmolarity of the reconstituted solution (38 mg/ml
of gemcitabine (as hydrochloride) in sodium chloride 0.9%
solution) is 775 mOsm/l.
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.
H
E
A