Cisplatin 1 mg/ml Concentrate for Solution for Infusion

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Cisplatin

Commercializzato da:

Pfizer Healthcare Ireland

Codice ATC:

L01XA; L01XA01

INN (Nome Internazionale):

Cisplatin

Dosaggio:

1 milligram(s)/millilitre

Forma farmaceutica:

Concentrate for solution for infusion

Tipo di ricetta:

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

Area terapeutica:

Platinum compounds; cisplatin

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1986-11-19

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
CISPLATIN 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 or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cisplatin 1mg/ml Concentrate for Solution for Infusion is and
what it is used
for
2.
What you need to know before you use Cisplatin 1mg/ml Concentrate for
Solution for
Infusion
3.
How to use Cisplatin 1mg/ml Concentrate for Solution for Infusion
4.
Possible side effects
5.
How to store Cisplatin 1mg/ml Concentrate for Solution for Infusion
6.
Contents of the pack and other information
1. WHAT CISPLATIN 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION IS AND
WHAT IT IS USED
FOR
Cisplatin 1mg/ml Concentrate for Solution for Infusion contains the
active substance cisplatin
which 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 cyostatics.
WHAT IS IT USED FOR?
Cisplatin can destroy cells in your body that may cause certain types
of cancer (tumour of
testis, tumour of ovary, tumour of the bladder, head and neck
epithelial tumour, lung cancer
and for cervical cancer in combination with radiotherapy).
Your doctor will be able to provide you with more information.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CISPLATIN 1MG/ML CONCENTRATE
FOR SOLUTION FOR
INFUSION
DO NOT USE CISPLATIN

if you are allergic to cisplatin or similar anti-cancer

Scheda tecnica

Health Products Regulatory Authority
14 March 2023
CRN009KDG
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cisplatin 1 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of concentrate for solution for infusion contains 1 mg of
cisplatin.
1 vial of 10 ml concentrate for solution for infusion contains 10 mg
of cisplatin. 1 vial of 50 ml concentrate for solution for
infusion contains 50 mg of cisplatin. 1 vial of 100 ml concentrate for
solution for infusion contains 100 mg of cisplatin.
Excipients with known effect:
Cisplatin 10 mg/10 ml (1 mg/ ml) concentrate forsolution for infusion
contains 35.4 mg of sodium in each 10 ml vial.
Cisplatin 50 mg/50 ml (1 mg/ ml) concentrate for solution for infusion
contains 177 mg of sodium in each 50 ml vial.
Cisplatin 100 mg/100 ml (1 mg/ ml) concentrate for solution for
infusion contains 354 mg of sodium in each 100 ml vial.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for Solution for Infusion.
Clear, colourless to pale yellow solution free fromvisible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cisplatin 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 the treatment of cervical carcinoma in
combination with other chemotherapeutics or with radiotherapy.
Cisplatin can be used as monotherapy and in combination therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS AND PAEDIATRIC POPULATION
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.
To obtain optimum therapeutic results with minimum adverse ef