CYTARABINE EBEWE 100 Mg/Ml Solution for Inj/Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CYTARABINE

Available from:

Fannin Limited

ATC code:

L01BC01

INN (International Name):

CYTARABINE

Dosage:

100 Mg/Ml

Pharmaceutical form:

Solution for Inj/Inf

Prescription type:

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

Therapeutic area:

Pyrimidine analogues

Authorization status:

Authorised

Authorization date:

2012-12-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

CYTARABINE “EBEWE” 20MG/ML SOLUTION FOR INJECTION OR INFUSION 
CYTARABINE “EBEWE” 50MG/ML SOLUTION FOR INJECTION OR INFUSION 
CYTARABINE “EBEWE” 100MG/ML SOLUTION FOR INJECTION OR INFUSION 

READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have further questions, please
ask your doctor or your nurse. 
- 
If you get any side effects, talk to your doctor or nurse,
this includes any possible side effects 
not listed in this leaflet. 

WHAT IS IN THIS LEAFLET:  
1. 
What Cytarabine “Ebewe” is and what it is used for 
2. 
What you need to know before you take Cytarabine Ebewe”   
3. 
How to take Cytarabine Ebewe”   
4. 
Possible side effects 
5 
How to store Cytarabine Ebewe”   
6. 
Contents of the pack and other information 

1. 
WHAT CYTARABINE IS AND WHAT IT IS USED FOR 

Cytarabine “Ebewe” solution for injection or infusion, contains
the active substance Cytarabine  
The drug Cytarabine is used to treat cancer. It can be used alone
but more commonly it is used in 
combination with other anti-cancer agents. 

Cytarabine can be used as monotherapy or in combination with other
chemotherapeutics in adults and 
children with some types of leukaemia (cancer affecting the
blood): 

  Acute myeloid leukaemia  
  Acute non-lymphoblastic leukaemia  
  Acute lymphocytic leukaemia  
  Erythroleukaemia 
  Blast crises of chronic myeloid leukaemia 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYTARABINE “EBEWE” 

DO NOT TAKE CYTARABINE ”EBEWE”: 
  If you are hypersensitive (severe allergy) to cytarabine or
any of the other ingredients of 
Cytarabine “Ebewe”. 
  If your bone marrow is still recovering from damage
caused by other medicines (your doctor 
will check for this using blood test and will

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cytarabine Ebewe 100mg/ml solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml solution for injection or infusion contains 100mg Cytarabine
Each 50ml solution for injection or infusion contains 5000 mg Cytarabine
Each 100ml solution for injection or infusion contains 10000 mg Cytarabine
Excipients:
This medicinal product contains 4.27mg of sodium in 1ml of solution
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection or infusion
Clear, colourless sterile solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cytarabine can be used alone or in combination for induction of remission and/or maintenance therapy in patients with
acute myeloid leukaemia, acute non-lymphoplastic leukaemias, acute lymphocytic leukaemia, erythroleukaemia, blast
crises of chronic myeloid leukaemia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Cytarabine “Ebewe” can be diluted with water for injection BP, Glucose intravenous infusion BP or sodium chloride
intravenous infusion BP.
METHOD OF ADMINISTRATION
The product is hypertonic and must not be administered by the intrathecal route.
May be administered intravenously (IV) or subcutaneously (SC) only.
The following doses are given as a guide, but the clinician should consult relevant protocols for the appropriate dosage
of cytarabine and other antineoplastic agents given in combination. Most doses are given in mg/kg but may be
converted to doses related to surface area by the use of standard nomograms.
Remission Induction (Adults):
Continuous Dosing: The usual dose in leukaemia is 2 mg/kg by rapid intravenous injection daily for ten days. If after
ten days neither therapeutic response nor toxicity has been obser