Cytarabine 20 mg/ml Solution for Injection or Infusion

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Cytarabine

Tillgänglig från:

Pfizer Healthcare Ireland

ATC-kod:

L01BC; L01BC01

INN (International namn):

Cytarabine

Dos:

20 milligram(s)/millilitre

Läkemedelsform:

Solution for injection/infusion

Receptbelagda typ:

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

Terapiområde:

Pyrimidine analogues; cytarabine

Bemyndigande status:

Marketed

Tillstånd datum:

1989-11-20

Bipacksedel

Page 1 of 9 2021-0073341
PACKAGE LEAFLET INFORMATION FOR THE USER
CYTARABINE 20 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, 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 or Infusion is and what it is
used for
2.
What you need to know before you use Cytarabine Solution for Injection
or Infusion
3.
How to use Cytarabine Solution for Injection or Infusion
4.
Possible side effects
5.
How to store Cytarabine Solution for Injection or Infusion
6.
Contents of the pack and other information
1. WHAT CYTARABINE SOLUTION FOR INJECTION OR INFUSION IS USED FOR
Cytarabine Solution for Injection or Infusion contains the active
substance cytarabine which
is an anti-cancer medicine. Treatment with an anti-cancer medicine is
sometimes called
cancer chemotherapy.
Cytarabine Solution for Injection or Infusion is used to treat some
types of leukaemia in
adults and children (cancer affecting the blood), lymphomas (cancer of
the lymph glands),
leukaemic or lymphoma meningitis (inflammation of part of the spinal
cord) and in some
cancers of the covering of the spinal cord (meningeal cancers). 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 OR INFUSION
DO NOT USE CYTARABINE SOLUTION FOR INJECTION OR INFUSION
•
if you are allergic to cytarabine or any of the other ingredients of
this medicine (listed
in sectio

Produktens egenskaper

Health Products Regulatory Authority
18 August 2021
CRN009ZMP
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cytarabine 20 mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 20 mg of cytarabine.
Presentations
100 mg/5 ml
500 mg/25 ml
1 g/50 ml
Amount cytarabine present
100 mg
500 mg
1 g
Excipient with known effect
Cytarabine 100 mg/5 ml (20 mg/ml) Injection contains 13.25 mg of
sodium in each vial
Cytarabine 500 mg/25 ml (20 mg/ml) Injection contains 66.75 mg of
sodium in each vial.
Cytarabine 1 g/50 ml (20 mg/ml) Injection contains 133.5 mg of sodium
in each vial.
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alone or in combination for the induction of remission in leukaemia,
particularly in acute myeloid leukaemia in adults and
children. Also used in remission induction in acute lymphoblastic
leukaemia, chronic myeloid leukaemia and acute myeloid
leukaemia.
Additionally, in the treatment and prophylaxis of leukaemic or
lymphomatous meningitis. Also the treatment and maintenance
of other meningeal neoplasms.
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