Cytarabine 100mg/ml injection 100mg/ml (10mL)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CYTARABINE

Available from:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC code:

L01BC01

INN (International Name):

CYTARABINE 100 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

CYTARABINE 100 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2014-03-21

Patient Information leaflet

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PACKAGE LEAFLET INFORMATION FOR THE USER
CYTARABINE 100 MG/ML SOLUTION FOR INJECTION
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, 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 Cytarabine Solution for Injection is and what it is used for
2. What you need to know before you use Cytarabine Solution for
Injection
3. How to use Cytarabine Solution for Injection
4. Possible side effects
5. How to store Cytarabine Solution for Injection
6. Contents of the pack and information
1.
WHAT CYTARABINE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR
Cytarabine Solution for Injection is an anti-cancer medicine.
Treatment with an anti-cancer
medicine is sometimes called cancer chemotherapy.
Cytarabine Solution for Injection is used to treat some types of
leukaemia (cancer affecting
the blood) and lymphomas (cancer of the lymph glands). It may be used
in combination with
other anti-cancer medicines.
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 CYTARABINE SOLUTION FOR
INJECTION
DO NOT USE CYTARABINE SOLUTION FOR INJECTION

if you are allergic to cytarabine or any of the other ingredients of
this medicine (listed
in section 6)

if the cell count in your blood report is very low due to some cause
other than cancer,
unless your doctor decides otherwise

if you have had severe effects on your brain (encephalopathy) are
feeling increasing
difficulties in body coordination after radiation treatment or
treatment with another
anticancer medicine

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
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 100 mg of cytarabine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, sterile solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alone or in combination for the induction of clinical remission and/or
maintenance therapy in
patients with acute myeloid leukaemia, acute non-lymphoblastic
leukaemias, lymphoblastic
leukaemia,
erythroleukaemia,
blast
crises
of
chronic
myeloid
leukaemia
and
non-Hodgkin
lymphoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 observed,
the dose may be increased to 4 mg/kg until a therapeutic response or
toxicity is evident. Daily
blood counts should be taken. Almost all patients can be carried to
toxicity with these doses.
Alternatively, 0.5 to 1 mg/kg may be infused daily in 1-24 hours for
ten days, and then at a rate
of 2 mg/kg/day until toxicity is observed. Continue to toxicity or
until remission occurs. Results
from one hour infusions have been satisfactory in the majority of
patients.
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_Intermittent dosing:_
Cytarabine may be given as intermittent IV doses of 3-5 mg/kg daily,
for
five consecutive days This course of treatment can be repeated after
an interval of 2 to 9 days,
and repeated until the therapeutic response or toxicity is exhibited.
Evidence of bone marrow im