Cytarabine 100mg/ml injection Solution for Injection 100mg/ml (5mL)

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:

Withdrawn

Authorization date:

2014-03-21

Patient Information leaflet

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PACKAGE LEAFLET INFORMATION FOR THE USER
CYTARABINE 100 MG/ML 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. 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 an anti-cancer medicine. Treatment with an
anti-cancer medicine is sometimes
called cancer chemotherapy.
Cytarabine 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 INJECTION
DO NOT USE CYTARABINE INJECTION
•
if you are allergic to cytarabine or any of the other ingredients of
this medicine (listed in section 6)
•
if your blood cell count (number of cells in your blood) is very low
due to some cause other than
cancer (unless your doctor decides the benefits of treatment outweigh
the risks)
•
if you have had severe effects on your brain (encephalopathy) after
radiation treatment or treatment
with another anticancer medicine such as methotrexate
•
if you are pregnant (unless your doctor considers the benefits to the
mother outweigh the risks to the
unborn child)
Tell your

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cytarabine 100 mg/ml Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 100 mg of cytarabine
Presentations
100 mg/1 ml
500 mg/5 ml
1 g/10 ml
2 g/20 ml
Amount
cytarabine Present
100 mg
500 mg
1 g
2 g
For the full list of excipients see 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Cytarabine may be used alone or in combination with other
antineoplastic agents. It is
indicated alone or in combination for induction of remission and/or
maintenance in patients
with acute myeloid leukaemia, acute non-lymphoblastic leukaemias,
acute lymphoblastic
leukaemias, acute lymphocytic leukaemia, erythroleukaemia, blast
crises of chronic myeloid
leukaemia, diffuse histiocytic lymphomas (non-Hodgkin’s lymphomas of
high malignancy),
meningeal leukaemia and meningeal neoplasms. Clinicians should refer
to the current
literature on combination therapy before initiating treatment.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Cytarabine Injection can be diluted with Sterile Water for Injections
BP, Glucose Intravenous
Infusion BP or Sodium Chloride Intravenous Infusion BP. Prepared
infusions, in the
recommended diluents, should be used immediately. Alternatively, the
diluted infusion fluids
may be stored at 2-8°C, protected from light, but portions remaining
unused after 24 hours
must be discarded.
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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 ob