CISPLATIN TEVA 1 Mg/Ml Concentrate for Soln for Inf

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

CISPLATIN

Disponible des:

Teva Pharma B.V.

Codi ATC:

L01XA01

Designació comuna internacional (DCI):

CISPLATIN

Dosis:

1 Mg/Ml

formulario farmacéutico:

Concentrate for Soln for Inf

tipo de receta:

Product subject to prescription which may not be renewed (A)

Área terapéutica:

Platinum compounds

Estat d'Autorització:

Authorised

Data d'autorització:

2010-02-26

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE USER
CISPLATIN TEVA 1 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION
_ _
Cisplatin
READ ALL OF THIS_ _ LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cisplatin Teva is and what it is used for
2.
Before you are given Cisplatin Teva
3.
How you are given Cisplatin Teva
4.
Possible side effects
5.
How to store Cisplatin Teva
6.
Contents of the pack and other information
1.
WHAT CISPLATIN TEVA IS AND WHAT IT IS USED FOR
Cisplatin forms part of a group of medicines called cytostatics, which
are used in the treatment of
cancer. Cisplatin can be used alone but more commonly Cisplatin is
used in combination with other
cytostatics.
WHAT IS IT USED FOR?
Cisplatin can destroy cells in your body that may cause certain types
of cancer (tumor of testis, tumor
of ovary, tumor of the bladder, head and neck epithelial tumor, lung
cancer and for cervical cancer in
combination with radiotherapy).
Your doctor will be able to provide you with more information.
_ _
2.
BEFORE YOU ARE GIVEN CISPLATIN TEVA
DO NOT USE CISPLATIN IF:

you are allergic to cisplatin or any of the other ingredients of this
medicine (listed in section 6)

you are allergic to any other medicine that contains platinum
compounds

you have kidney problems (renal dysfunction)

you suffer from dehydration

you suffer from severe suppression of bone marrow functionality,
symptoms may be: extreme
tiredness, easy bruising or bleeding, occurrence of infections

your hearing is impaired

you suffer from nervous disorders caused by cisplatin

you are breastfeeding

combined with yellow fever vaccine and phenytoin (see “Other
medicines and Cispl

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cisplatin Teva 1 mg/ml, concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cisplatin Teva 1 mg/ml concentrate for
solution for infusion contains 1 mg/ml of cisplatin.
Each ml of solution contains 3.5 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, light yellow solution free from visible particles
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cisplatin Teva is intended for the treatment of :
advanced or metastasised testicular cancer
advanced or metastasised ovarian cancer
advanced or metastasised bladder carcinoma
advanced or metastasised squamous cell carcinoma of the head and neck
advanced or metastasised non-small cell lung carcinoma
advanced or metastasised small cell lung carcinoma.
Cisplatin is indicated in combination with radiotherapy in the
treatment of cervical carcinoma.
Cisplatin can be used as monotherapy and in combination therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Cisplatin Teva 1 mg/ml concentrate for solution for infusion is to be
diluted before administration. For instructions on
dilution of the medicinal product before administration, see section
6.6.
_Adults and children_
The cisplatin dosage depends on the primary disease, the expected
reaction, and on whether cisplatin is used for
monotherapy or as a component of combination chemotherapy. The dosage
directions are applicable for both adults and
children.
For monotherapy, the following two dosage regimens are recommended:
Single dose of 50 to 120 mg/m² body surface every 3 to 4 weeks;
15 to 20 mg/m²/day for five days, every 3 to 4 weeks.
If cisplatin is used in combination chemotherapy, the dose of
cisplatin must be reduced. A typical dose is 20 mg/m² or
more once every 3 to 4 weeks.
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