Cytarabine Mylan Solution for Inj/Inf 20mg/ml (50ml)

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

CYTARABINE

Saatavilla:

Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France

ATC-koodi:

L01BC01

INN (Kansainvälinen yleisnimi):

CYTARABINE 20 mg/ml

Lääkemuoto:

SOLUTION FOR INFUSION OR INJECTION

Koostumus:

CYTARABINE 20 mg/ml

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2014-01-13

Pakkausseloste

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYTARABINE MYLAN
CYTARABINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or
pharmacist.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Cytarabine Mylan is and what it is used for
2.
Before you are given Cytarabine Mylan
3.
How to use Cytarabine Mylan
4.
Possible side effects
5.
How to store Cytarabine Mylan
6.
Further information
1.
WHAT CYTARABINE MYLAN IS AND WHAT IT IS USED FOR

Cytarabine Mylan 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 the
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.

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 period 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.
BEFORE YOU ARE GIVEN CYTARABINE
DO NOT USE CYTARABINE MYLAN IF YOU:

are allergic (hypersensitive) to cytarabine, or any of the other
ingredients of cytarabine.

If the cell count in your blood report is very low due to some cause
other than cancer, or as
decided by your doctor.

If you are feeling increasing difficulties in body coordination after
radiation treatment or
treatment with another anticancer drug such as methotrexate.

if you are pregnant.

Valmisteyhteenveto

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cytarabine Mylan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cytarabine Mylan 20 mg/ml: 1 ml solution contains 20 mg cytarabine.
Each 5 ml vial contains 100 mg of cytarabine.
Each 25 ml vial contains 500 mg of cytarabine
Each 50 ml vial contains 1000 mg of cytarabine.
Cytarabine Mylan 100 mg/ml: 1 ml solution contains 100 mg cytarabine.
Each 20 ml vial contains 2000 mg of cytarabine.
Excipients:
Cytarabine Mylan 20 mg/ml: 1 ml solution contains 6,8 mg sodium
chloride equivalent to
2,67 mg/ml sodium.
To be taken into consideration by patients on a CONTROLLED SODIUM
DIET.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for Injection or Infusion.
Clear, colourless solution.
pH- 7.0 - 9.5
Osmolarity: 250 to 400 mOsm/L
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 including prophylaxis and treatment
of CNS involvement
(meningeal leukaemia).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cytarabine Mylan 20 mg/ml, solution for injection/infusion is intended
for intravenous,
intramuscular, subcutaneous or intrathecal use.
Page 2 of 16
Cytarabine Mylan 100 mg/ml, solution for injection/infusion is
intended for intravenous
use.
Subcutaneous injection is generally well tolerated, and may be
recommended when used in
maintenance therapy.
CYTARABINE 100 MG/ML SHOULD NOT BE ADMINISTERED BY THE INTRATHECAL
ROUTE.
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.
1)
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