CYTARABINE

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

CYTARABINE

Saatavilla:

Accord Healthcare Limited

ATC-koodi:

L01BC01

INN (Kansainvälinen yleisnimi):

CYTARABINE

Annos:

100 Mg/Ml

Lääkemuoto:

Solution for Inj/Inf

Prescription tyyppi:

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

Terapeuttinen alue:

cytarabine

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2013-02-15

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTARABINE 100 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, please ask your doctor or
pharmacist or
nurse
•
This medicine has been prescribed for you. 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 of the side effects talk to your doctor or pharmacist
or nurse. 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 used in adults and children. The active
ingredient is cytarabine.
•
Cytarabine is one of a group of the medicines known as cytotoxics;
these medicines are used in the
treatment of acute leukaemias (cancer of blood where you have too many
white blood cells). Cytarabine
interferes with the growth of cancer cells, which are eventually
destroyed.
•
Remission induction is an intensive treatment to force leukaemia into
retreat. When it works, the balance
of cells in your blood becomes more normal and your health improves.
This relatively healthy spell is
called a remission.
•
Maintenance therapy is a milder treatment to make your remission last
as long as possible. Quite low doses
of Cytarabine are used to keep the leukaemia under control and stop it
flaring up again.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CYTARABINE INJECTION
DO NOT USE CYTARABINE INJECTION
•
If you are allergic (hypersensitive) to cytarabine, or any of the
ingredients of Cytarabine Injection.
•
If the cell cou

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cytarabine 100mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 mg Cytarabine.
Each 1 ml vial contains 100 mg of Cytarabine.
Each 5 ml vial contains 500 mg of Cytarabine.
Each 10 ml vial contains 1g of Cytarabine.
Each 20 ml vial contains 2g of Cytarabine.
Each 40 ml vial contains 4g of Cytarabine.
Each 50 ml vial contains 5g of Cytarabine.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
The product is a clear, colourless solution, which is practically free
from particles.
pH: 7.0 - 9.5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For induction of remission in acute myeloid leukaemia in adults and
for other acute leukaemias of adults and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 accordingly to body weight (mg/kg) or according to BSA
(mg/m
2
).
Dosage
recommendations may be converted from those in terms of bodyweight to
those related to surface area by means of
nomograms.
_1. Remission induction:_
Induction therapy dosage and schedule vary depending on the regimen
used.
a) Continuous treatment:
The following dose regimens have been used for continuous treatment on
remission induction.
i) Rapid injection - 2 mg/kg/day is a judicious starting dose.
Administer for 10 days. Obtain daily blood counts. If no
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