Cytarabine

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Cytarabine 20 mg/mL

Saadav alates:

Pfizer New Zealand Limited

INN (Rahvusvaheline Nimetus):

Cytarabine 20 mg/mL

Annus:

20 mg/mL

Ravimvorm:

Solution for injection

Koostis:

Active: Cytarabine 20 mg/mL Excipient: Sodium chloride Water for injection

Ühikuid pakis:

Vial, plastic, 25mL, 25 mL

Klass:

Prescription

Retsepti tüüp:

Prescription

Valmistatud:

Euticals SpA

Näidustused:

Cytarabine is indicated primarily for: · Induction and maintenance of remission in acute myelocytic leukaemia of both adults and children. It has also been found to be useful in the treatment of other leukaemias such as · Acute lymphocytic leukaemia · Chronic myelocytic leukaemia (blast phase). Cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy. Children with non-Hodgkin's lymphoma have benefited from a combination drug program (LSA2L2) that includes cytarabine. Remissions induced by cytarabine not followed by maintenance treatment have been brief. Maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity. Cytarabine has been used intrathecally in meningeal leukaemia. Focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.

Toote kokkuvõte:

Package - Contents - Shelf Life: Vial, glass, 5 mLwith bromobutyl rubber stopper sealed with aluminium caps within a clear plastic sleeve - 5 dose units - 18 months from date of manufacture stored at 15°C to 25°C (Controlled room temp) protect from light - Vial, plastic, 5mL - 5 dose units - 18 months from date of manufacture stored at 15°C to 25°C (Controlled room temp) protect from light - Vial, plastic, 25mL - 25 mL - 18 months from date of manufacture stored at 15°C to 25°C (Controlled room temp) protect from light

Loa andmise kuupäev:

1990-12-06

Infovoldik

CYTARABINE INJECTION
1
CYTARABINE INJECTION
_Cytarabine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cytarabine Injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Cytarabine
Injection against the benefits they
expect it will have for you.
This medicine will be used while you
are at the clinic or in hospital. If
possible, please read this leaflet
carefully before this medicine is
given to you. In some cases this
leaflet may be given to you after the
medicine has been used.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CYTARABINE
INJECTION IS USED FOR
Cytarabine belongs to a group of
medicines known as antineoplastics.
It is used to treat cancer.
_HOW CYTARABINE INJECTION _
_WORKS_
Cytarabine works by preventing the
growth of cancer cells and eventually
destroying them. It is used alone or
in combination with other medicines
to treat some cancers, particularly
cancers of the blood (especially
leukaemia).
Cytarabine Injection may be used to
treat other conditions that are not
mentioned above. Your doctor will
be able to tell you about the specific
condition for which you have been
prescribed Cytarabine Injection.
This medicine is available only with
a doctor's prescription.
_USE IN CHILDREN_
Cytarabine Injection is also used in
children to treat blood cancers such
as leukaemia. It is also sometimes
used in combination with other
medicines to treat non-Hodgkins
lymphoma.
BEFORE YOU ARE GIVEN
CYTARABINE INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT_
DO NOT HAVE CYTARABINE INJECTION
IF YOU HAVE AN ALLERGY TO:

any medicine containing
cytarabine

any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:

shortness of brea

Toote omadused

Version: pfdcytai10523
Supersedes: pfdcytai10822
Page 1 of 16
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
CYTARABINE
Cytarabine BP 20mg/ml and 100mg/ml injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cytarabine 20mg/mL is a sterile, isotonic, preservative-free solution
containing Cytarabine BP
20mg/mL with Sodium Chloride BP 6.8mg/mL in Water for Injections BP.
Cytarabine
100mg/mL is
a
sterile,
isotonic,
preservative-free
solution
containing
Cytarabine
BP
100mg/mL in Water for Injections BP.
Each 5 mL vial of Cytarabine 20mg/mL contains 100 mg cytarabine and 34
mg of sodium
chloride BP in Water for Injections BP.
Each 10 mL vial of Cytarabine 100mg/mL contains 1000 mg cytarabine in
Water for Injections
BP
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cytarabine is indicated primarily for:

Induction and maintenance of remission in acute myelocytic leukaemia
of both adults
and children.
It has also been found to be useful in the treatment of other
leukaemias such as

Acute lymphocytic leukaemia

Chronic myelocytic leukaemia (blast phase).
Cytarabine may be used alone or in combination with other
antineoplastic agents, the best
results are often obtained with combination therapy.
Children with non-Hodgkin’s lymphoma have benefited from a
combination drug program
(LSA2L2) that includes cytarabine.
Version: pfdcytai10523
Supersedes: pfdcytai10822
Page 2 of 16
Remissions induced by cytarabine not followed by maintenance treatment
have been brief.
Maintenance therapy has extended these and provided useful and
comfortable remissions with
relatively little toxicity.
Cytarabine has been used intrathecally in meningeal leukaemia. Focal
leukaemic involvement
of the central nervous system may not respond to intrathecal
cytarabine and may better be
treated with radiotherapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
Cytarabine may be administered by intravenous injection or infusion,
or subcutaneously. It has
been adm