CYTARABINE 100 Mg/Ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CYTARABINE

Available from:

Hospira UK Limited

ATC code:

L01BC01

INN (International Name):

CYTARABINE

Dosage:

100 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

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

Therapeutic area:

Pyrimidine analogues

Authorization status:

Authorised

Authorization date:

1990-05-21

Patient Information leaflet

17:49
S10821
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08 pt
Ireland
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SVI007-1
118 x 570 mm
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PAR-2017-0012314
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DATE:
11 DEC 2017
TIME:
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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

Summary of Product characteristics

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.
_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 improvement has been reported to occur 7-64
days after the