Cisplatin Teva Concentrate for Soln for Inf 1mg/ml (100mg vial)

Pajjiż: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

CISPLATIN

Disponibbli minn:

Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

Kodiċi ATC:

L01XA01

INN (Isem Internazzjonali):

CISPLATIN 1 mg/ml

Għamla farmaċewtika:

CONCENTRATE FOR SOLUTION FOR INFUSION

Kompożizzjoni:

CISPLATIN 1 mg/ml

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ANTINEOPLASTIC AGENTS

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2013-06-26

Fuljett ta 'informazzjoni

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 TAKING 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 Cisp

Karatteristiċi tal-prodott

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.
For treatment of cervical cancer cisplatin is used in combination with
radiotherapy. A typical dose is
40 mg/m
2
weekly for 6 we