Cisplatin 1 mg/ml concentrate for solution for infusion

Pays: Royaume-Uni

Langue: anglais

Source: myHealthbox

Ingrédients actifs:

cisplatin.

Disponible depuis:

Cipla (EU) Limited

Code ATC:

L01XA01

DCI (Dénomination commune internationale):

cisplatin.

Dosage:

1mg/ml

forme pharmaceutique:

Concentrate for solution for infusion

Mode d'administration:

intravenously by infusion

Unités en paquet:

10, 50, 100 ml type I amber glass vial

Type d'ordonnance:

POM - Prescription Only Medicine

Fabriqué par:

S&D Pharma CZ

Groupe thérapeutique:

Other antineoplastic agents, Pla

indications thérapeutiques:

for the treatment of: • advanced or metastatic testicular cancer • advanced or metastatic ovarian cancer • advanced or metastatic bladder carcinoma • advanced or metastatic squamous cell carcinoma of the head and neck • advanced or metastatic non-small cell lung carcinoma • advanced or metastatic small cell lung carcinoma

Statut de autorisation:

Authorised

Date de l'autorisation:

2015-03-06

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CISPLATIN 1MG/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 further questions, please ask your doctor or your 
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, pharmacist
or 
nurse. This includes any possible side effects not listed in 
this leaflet. See section 4.
The name of your medicine is ‘Cisplatin 1 mg/ml concentrate 
for solution for infusion’ but in the rest of the leaflet it will
be 
called “Cisplatin Injection”.
  WHAT IS IN THIS LEAFLET
  1.What Cisplatin Injection is and what it is used for
  2.What you need to know before you are given Cisplatin   
   Injection
  3.How you are given Cisplatin Injection
  4.Possible side effects
  5.How to store Cisplatin Injection
  6.Contents of the pack and other information

1. WHAT CISPLATIN INJECTION 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.
Cisplatin is used to treat cancers of the testis, ovary, urinary 
bladder, head and neck, and lung. 
Cisplatin is used to treat cervical cancer in combination with 
radiotherapy.
Your doctor will be able to provide you with more information

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN    
       CISPLATIN INJECTION

DO NOT TAKE CISPLATIN INJECTION:
•  If you are allergic (hypersensitive) to cisplatin or other 
platinum compounds or to any of the other ingredients of this 
medicine (listed in section 6),
•  If you have kidn

Résumé des caractéristiques du produit

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. 

One vial of 10 ml of concentrate for solution for infusion
contains 10 mg of cisplatin 

One vial of 50 ml of concentrate for solution for infusion
contains 50 mg of cisplatin 

One vial of 100 ml of concentrate for solution for
infusion contains 100 mg of 
cisplatin 

Excipient with known effect: 

Each ml of solution contains 3.5 mg of sodium.  

For a full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Concentrate for solution for infusion 

Clear, colourless to pale yellow solution in an amber glass vial,
which is practically 
free from particles. 

The pH is between 3.5 to 6.5 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Cisplatin is intended for the treatment of:  

•

advanced or metastatic testicular cancer  
•

advanced or metastatic ovarian cancer  
•

advanced or metastatic bladder carcinoma  
•

advanced or metastatic squamous cell carcinoma of the head and
neck  
•

advanced or metastatic non-small cell lung carcinoma  
•

advanced or metastatic 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 

_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 regimen