Cytarabine 20mg/ml Solution for Injection or Infusion (5mL vial)

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

CYTARABINE

Saatavilla:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC-koodi:

L01BC01

INN (Kansainvälinen yleisnimi):

CYTARABINE 20 mg/ml

Lääkemuoto:

SOLUTION FOR INJECTION/INFUSION

Koostumus:

CYTARABINE 20 mg/ml

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2007-05-07

Pakkausseloste

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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

Valmisteyhteenveto

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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.
Each 1 ml of solution contains 2.7 mg sodium
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.
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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 observed. Continue to toxicity or
until remission occurs. Results
from one hour infusions have been satisfactory in the majority of
patients.
_Intermittent dosing: _
Cytarabine may be given as intermittent IV doses of 3-5 mg/kg daily,
for
five consecuti