CYTARABINE 20 Mg/Ml Solution for Inj/Inf

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

CYTARABINE

Saadav alates:

Hospira UK Limited

ATC kood:

L01BC01

INN (Rahvusvaheline Nimetus):

CYTARABINE

Annus:

20 Mg/Ml

Ravimvorm:

Solution for Inj/Inf

Retsepti tüüp:

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

Terapeutiline ala:

Pyrimidine analogues

Volitamisolek:

Authorised

Loa andmise kuupäev:

1989-11-20

Infovoldik

15:05
S10820
S10328
Svus
N/A
8 pt
Ireland
02
Leaflet
N/A
SVI007-1
118 x 570 mm (20 panels)
N/A
PAR-2017-0012315
BLACK
BARCODE Nº
PHARMA CODE
NEW COMPONENT Nº
DATE:
26 DEC 2017
TIME:
OLD COMPONENT Nº
PACKAGING SITE
SMALLEST
BODY TEXT
SIZE
MARKET
PROOF Nº
COMPONENT
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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.
Y

Toote omadused

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.
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 consecutive days.
This course of treatment can be repeated after an