DepoCyte

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

cytarabine

Saatavilla:

Pacira Limited

ATC-koodi:

L01BC01

INN (Kansainvälinen yleisnimi):

cytarabine

Terapeuttinen ryhmä:

Antineoplastic agents,

Terapeuttinen alue:

Meningeal Neoplasms

Käyttöaiheet:

Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.

Tuoteyhteenveto:

Revision: 15

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2001-07-10

Pakkausseloste

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEPOCYTE 50 MG SUSPENSION FOR INJECTION
Cytarabine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have further questions, ask your doctor.
−
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4..
WHAT IS IN THIS LEAFLET:
1.
What DepoCyte is and what it is given
for
2.
Wh
at you need to know before you are given DepoCyte
3.
How DepoCyte is given
4.
Possible side effects
5.
How to store DepoCyte
6.
Contents of the pack and other information
1.
WHAT DEPOCYTE IS AND WHAT IT IS GIVEN FOR
DepoCyte is used to treat lymphomatous meningitis.
Lymphomatous meningitis is a condition in which tumour cells have
invaded the fluid or membranes
that surround the brain and spinal cord.
DepoCyte is used in adults to kill lymphoma tumour cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DEPOCYTE
DEPOCYTE S
HOULD NO
T BE GIVEN
−
if you are allergic to cytarabine or any of the other ingredients of
this medicine (listed in
section 6).
−
if you have a meningeal infection.
WARNINGS AND PRECAUTIONS
Severe neurological side effects have been reported with the use of
DepoCyte. Symptoms have
included effects on the nervous system (e.g. convulsions, pain,
numbness or tingling, blindness or
visual disturbances). Your doctor will check for these symptoms
regularly.
Make sure you take as directed any dexamethasone tablets that you may
have been prescribed, as they
reduce the risk of unwanted effects caused by DepoCyte.
If your side effects get worse or you notice any new side effects,
tell your doctor.
OTHER MEDICINES AND DEPOCYTE
Please tell your doctor if you are taking or have recently taken any
other medicines, including
medicines obtained without a prescription.
22
PREGNANCY, BREAST-FEEDING AND FERTILITY
DepoCyte should not be given to pregnant women as

Valmisteyhteenveto

1
ANNEX 1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
DepoCyte 50 mg suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of suspension contains 10 mg cytarabine.
Each 5 ml vial contains 50 mg cytarabine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
White to off-white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intrathecal treatment of lymphomatous meningitis. In the majority of
patients such treatment will be
part of symptomatic palliation of the disease.
4.2
P
OSOLOGY AND METHO
D OF ADMINISTRATION
DepoCyte should be administered only under the supervision of a
physician experienced in the use of
cancer chemotherapeutic agents.
Posology
_Paediatric population_
Safety and efficacy in children aged under 18 years have not been
established. Currently available data
are described in section 5.1 but no recommendation on a posology can
be made. DepoCyte is not
recommended for use in children and adolescents until further data
become available.
_Adults and the elderly_
For the treatment of lymphomatous meningitis, the dose for adults is
50 mg (one vial) administered
intrathecally (lumbar puncture or intraventricularly via an Ommaya
reservoir). The following r
egimen
of
induction, consolidation and maintenance therapy is recommended:
Induction therapy: 50 mg administered every 14 days for 2 doses (weeks
1 and 3).
Consolidation therapy: 50 mg administered every 14 days for 3 doses
(weeks 5, 7 and 9) followed by
an additional dose of 50 mg at week 13.
Maintenance therapy: 50 mg administered every 28 days for 4 doses
(weeks 17, 21, 25 and 29).
Method of administration
DepoCyte is to be administered by slow injection over a period of 1-5
minutes directly into the
cerebrospinal fluid (CSF) via either an intraventricular reservoir or
by direct injection into the lumbar
3
sac. Following administration by lumbar puncture, it is recommended
that the patient should be
instructed to lie flat for one hour. All