Cytarabine 100mg/ml Solution for Injection or Infusion (1ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CYTARABINE

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

L01BC01

INN (International Name):

CYTARABINE 100 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

CYTARABINE 100 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-02-19

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTARABINE 100 MG/ML SOLUTION FOR INJECTION OR INFUSION
Cytarabine
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 under control
and stop it flaring up again.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE INJECTION
DO NOT USE CYTARABINE INJECTION

If you are allergic (hypersensitive) to cytarabine, or any of the
ingredients of Cytarabine Injection.

If

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.
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_1. Remission induction: _
Induction therapy dosage and schedule vary depending on the regimen
used.
a) Continuous treatment:
The
following
dose
regimens
have
been
used
for
continuous
treatment
on
remission
induction.
i) Rapid injection - 2 mg/kg/day is a judicious starting dose.
Administer for 10 days. Obtain
daily blood counts. If no antileukaemic effect is noted and there is
no apparent toxicity,
increase to 4 mg/kg/day and maintain until therapeutic response or
toxicity is evident.
Almost all patients can be carried to toxicity with these doses.
ii) 0.5 - 1.0 mg/kg/day may be given in an infusion of up to 24 hou