Cytarabine 100mg/ml Solution for Injection or Infusion (50ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CYTARABINE

Available from:

Accord Healthcare Limited

ATC code:

L01BC01

INN (International Name):

CYTARABINE

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

CYTARABINE 100 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2014-01-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTARABINE 100 MG/ML SOLUTION 
FOR INJECTION OR INFUSION
Cytarabine
The name of your medicine is ‘Cytarabine 100 mg/ml 
solution for injection or infusion’ but in the rest of the
leaflet 
it will be called “Cytarabine Injection”.
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, please ask your doctor 
or pharmacist or nurse
• This medicine has been prescribed for you. 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 of the side effects talk to your doctor or 
pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet, See section 4
WHAT IS IN THIS LEAFLET
1. What Cytarabine injection is and what it is used for
2. What you need to know before you use Cytarabine injection
3. How to use Cytarabine injection 
4. Possible side effects
5. How to store Cytarabine injection 
6. Contents of the pack and other information
  1.  WHAT CYTARABINE INJECTION IS AND 
     WHAT IT IS USED FOR
• Cytarabine injection is used in adults and children. The 
active ingredient is cytarabine. 
• Cytarabine is one of a group of the medicines known as 
cytotoxics; these medicines are used in the treatment of 
acute leukaemias (cancer of blood where you have too 
many white blood cells). Cytarabine interferes with the 
growth of cancer cells, which are eventually destroyed. 
• Remission induction is an intensive treatment to force 
leukaemia into retreat. When it works, the balance of cells 
in your blood becomes more normal and your health 
improves. This relatively healthy spell is called a 
remission. 
• Maintenance therapy is a milder treatment to make your 
remission last as long as possible. Quite low doses of 
Cytarabine are used to keep the leukaemia

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Cytarabine 100 mg/ml Solution for Injection or Infusion 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 ml contains 100 mg Cytarabine. 

Each 1 ml vial contains 100 mg of Cytarabine. 
Each 5 ml vial contains 500 mg of Cytarabine. 
Each 10 ml vial contains 1 g of Cytarabine. 
Each 20 ml vial contains 2 g of cytarabine. 
Each 40 ml vial contains 4g of cytarabine. 
Each 50 ml vial contains 5g of cytarabine. 

For full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Solution for injection or infusion.  

The product is a clear, colourless solution, which is practically free from particles. 

pH:  7.0 – 9.5 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

For induction of remission in acute myeloid leukaemia in adults and for other acute leukaemias of 
adults and children.  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION  

Posology 

Treatment with cytarabine should be initiated by, or be in consultation with, a doctor with extensive 
experience  in  treatment  with  cytostatics.  Only  general  recommendations  can  be  given,  as  acute 
leukaemia is almost exclusively treated with combinations of cytostatics. 

Dosage recommendations, may be  made accordingly to body weight (mg/kg) or according to BSA 
(mg/m
2
).  Dosage  recommendations  may  be  converted  from  those  in  terms  of  bodyweight  to  those 
related to surface area by means of nomograms.  

_1. Remission induction:  _

Induction therapy dosage and schedule vary�