Cytarabine 20 mg/ml Solution for Injection/Infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Cytarabine

Disponível em:

Accord Healthcare Ireland Ltd.

Código ATC:

L01BC; L01BC01

DCI (Denominação Comum Internacional):

Cytarabine

Dosagem:

20 milligram(s)/millilitre

Forma farmacêutica:

Solution for injection/infusion

Tipo de prescrição:

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

Área terapêutica:

Pyrimidine analogues; cytarabine

Status de autorização:

Not marketed

Data de autorização:

2018-06-22

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTARABINE 20 MG/ML SOLUTION FOR INJECTION/INFUSION
cytarabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAIN IMPORT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this section. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Cytarabine solution for injection/infusion is and what it is used
for
2.
What you need to know before you use Cytarabine solution for
injection/infusion
3.
How to use Cytarabine solution for injection/infusion
4.
Possible side effects
5.
How to store Cytarabine solution for injection/infusion
6.
Contents of the pack and other information
1. WHAT CYTARABINE SOLUTION FOR INJECTION/INFUSION IS AND WHAT IT IS
USED FOR
Cytarabine solution for injection/infusion is used in adults and
children. The active ingredient is
cytarabine.
Cytarabine is one of a group of medicines known as cytotoxics, these
medicines are used in treatment of
acute leukaemias (cancer of blood where you have too many white blood
cells) including prophylaxis
and treatment of CNS involvement (meningeal leukaemia). Cytarabine
interferes with the growth of
cancer cells, which are eventually destroyed.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE SOLUTION FOR
INJECTION/INFUSION
DO NOT USE CYTARABINE SOLUTION FOR INJECTION/INFUSION
•
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 that it is safe to take cytarabine
•
if you are feeling increasing difficulties in body coordination after
radiation treatment or treatment
with another anticancer medicine such as methotrexate
•
if you are pregnant
WARNING AND PRECAUTIONS
Talk to your doctor, pharmaci

Características técnicas

Health Products Regulatory Authority
16 June 2023
CRN00D022
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cytarabine 20 mg/ml Solution for Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution contains 20 mg of Cytarabine.
Each vial of 2 ml of solution contains 40 mg of Cytarabine.
Each vial of 5 ml of solution contains 100 mg of Cytarabine.
Excipient with known effect:
Each vial contains <1 mmol sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution, free from visible particles.
pH: 7.0 to 9.5
Osmolarity: Approx. 300 mOsmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the induction of remission in acute myeloid leukaemia in adults
and for other acute leukaemias of adults and children
including prophylaxis and treatment of CNS involvement (meningeal
leukaemia).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cytarabine 20 mg/ml solution for injection/infusion is intended for
intravenous, intramuscular, subcutaneous or intrathecal use.
Subcutaneous injection is generally well tolerated, and may be
recommended when used in maintenance therapy.
Cytarabine 20 mg/ml solution for injection/infusion can be diluted
with Sterilised Water for Injections, Glucose Intravenous
Infusion or Sodium Chloride Intravenous Infusion.
Treatment with cytarabine should be initiated by, or be in
consultation with, a doctor with extensive experience in treatment
with cytostatics. Only general recommendations can be given, as acute
leukaemia is almost exclusively treated with
combinations of cytostatics.
Dosage recommendations, may be made according to body weight (mg/kg)
or according to BSA(mg/m
2
). Dose
recommendation may be converted from those in terms of bodyweight to
those related to surface area by means of
nomograms.
REMISSION INDUCTION:
CONTINUOUS TREATMENT: The usual dose in leukaemia is 2 mg/kg/day by
rapid intravenous injection daily for ten days. If after
ten days neither thera