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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CYTARABINE

Available from:

Hospira UK Limited

ATC code:

L01BC01

INN (International Name):

CYTARABINE

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

Page 1 of 7
2017-0027232
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTARABINE 100 MG/ML INJECTION
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.
•
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE INJECTION
DO NOT USE CYTARABINE INJECTION
•
if you have shown signs of hypersensitivity (severe allergy) to
cytarabine in the past, 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 doctor if you think any of the above applies to you before
this medicine is used.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH CYTARABINE INJECTION
•
if your blood cell count is

Summary of Product characteristics

Cytarabine 100mg/mL Sept 2017
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 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
Cytarabine 100 mg/ml Injection is a ready to use injection and can be
administered
by the intravenous and subcutaneous routes. CYTARABINE 100 MG/ML
INJECTION
SHOULD
NOT
BE
ADMINISTERED
BY
THE
INTRATHECAL
ROUTE
DUE
TO
THE
SLIGHT
HYPERTONICITY OF THIS FORMULATION. (SEE SECTION 4.8 UNDESIRABLE
EFFECTS).
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.
Cytarabine 100mg/mL Sept 2017
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