Gemcitabine 1g powder for solution for infusion vials

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Gemcitabine hydrochloride

Disponível em:

Actavis UK Ltd

Código ATC:

L01BC05

DCI (Denominação Comum Internacional):

Gemcitabine hydrochloride

Dosagem:

1gram

Forma farmacêutica:

Powder for solution for infusion

Via de administração:

Intravenous

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 08010300; GTIN: 5012617018090

Folheto informativo - Bula

Gemcitabine 38mg/ml Powder for Solution for Infusion PIL - UK
item no: AAAG9427
print proof no: 4
origination date: 12.06.14
originated by: S.Anson
revision date: 25.11.14
revised by: S.Anson
dimensions: 124 x 700
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
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date sent: 12.06.14
supplier: Nerviano
technically app. date: 16.06.14
min pt size: 9
TECHNICAL APPROVAL
Black
PHARMACODE
PHARMACODE
10 MM
219 MM
453 MM
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INSTRUCTION FOR USE
Cytotoxic
_HANDLING_
The normal safety precautions for
cytostatic agents must be observed
when preparing and disposing of
the infusion solution. 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 RECONSTITUTION (AND _
_FURTHER DILUTION, IF PERFORMED)_
The only approved diluent for
reconstitution of gemcitabine
sterile powder is sodium chloride
9mg/ml (0.9%) solution for
injection (without preservative).
Due to solubility considerations,
the maximum concentration for
gemcitabine upon reconstitution
is 40mg/ml. Reconstitution at
concentrations greater than 40mg/
ml may result in incomplete
dissolution and should be avoided.
1. Use aseptic technique during
the reconstitution and any
further dilution of gemcitabine
for intravenous infusion
administration.
2. To reconstitute, add the
appropriate volume of sterile
sodium chloride 9mg/ml (0.9%)
solution for injection without
preservative (as stated in the
table below) and shake to
dissolve:
Presentation
Volume of sterile
sodium chloride
9mg/ml (0.9%)
solution for injection
(without preservative)
to

Características técnicas

OBJECT 1
GEMCITABINE 38MG/ML POWDER FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 22-Sep-2015 | Accord-UK Ltd
1. Name of the medicinal product
Gemcitabine 38mg/ml powder for solution for infusion
2. Qualitative and quantitative composition
One ml of the reconstituted solution for infusion (see section 6.6)
contains 38mg gemcitabine (as
hydrochloride).
_200MG VIAL:_
Each vial contains 200mg of gemcitabine (as hydrochloride).
Contains approximately 0.15mmol (3.56mg) sodium per 200mg vial.
_1G VIAL:_
Each vial contains 1g of gemcitabine (as hydrochloride).
Contains approximately 0.77mmol (17.81mg) sodium per 1g vial.
_2G VIAL:_
Each vial contains 2g of gemcitabine (as hydrochloride).
Contains approximately 1.54mmol (35.62mg) sodium per 2g 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 (38mg/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