Pfizer (Australia) CYTARABINE 2g/20mL injection vial

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

cytarabine, Quantity: 2 g

Διαθέσιμο από:

Pfizer Australia Pty Ltd

Φαρμακοτεχνική μορφή:

Injection, solution

Σύνθεση:

Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid

Οδός χορήγησης:

Intravenous, Subcutaneous

Μονάδες σε πακέτο:

1 X 20mL

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

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 (blastphase) and erythroleukaemia. May be used alone or in combination with other antineoplastic agents, the best results often being obtained with combination therapy. Children with non-Hodgkin's lymphoma have benefited from a combination drug program (LSA 2L2) that includes cytarabine. INDICATIONS AS AT 24 OCTOBER 2001: 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 combined therapy. Children with non-Hodgkin's lymphoma have benefited from a combination drug program (LSA212) 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.

Περίληψη προϊόντος:

Visual Identification: Clear, colourless to almost pale-yellow aqueous solution, free from visible particles.; Container Type: Vial; Container Material: PP; Container Life Time: 18 Months; Container Temperature: Store between 15-25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

1994-12-20

Φύλλο οδηγιών χρήσης

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 breath
•
wheezing or diffic

Αρχείο Π.Χ.Π.

Version: pfpcytai10320
Supersedes: pfpcytai11117
Page 1 of 16
AUSTRALIAN
PRODUCT
INFORMATION
–
CYTARABINE
(CYTARABINE
20
MG/ML,
100
MG/ML) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Cytarabine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cytarabine
Injection
is
a
sterile,
isotonic,
preservative-free
solution
containing
either
Cytarabine BP 20mg/mL with Sodium Chloride BP 6.8mg/mL in Water for
Injections BP or
Cytarabine BP 100mg/mL in Water for Injections BP.
3.
PHARMACEUTICAL FORM
Cytarabine Injection is a clear, colourless 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.
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.
Version: pfpcytai10320
Supersedes: pfpcytai11117
Page 2 of 16
4.2 DOSE AND METHOD OF ADMINISTRATION
Cytarabine may be administered by intravenous injection or infusion,
or subcutaneously. It
has been administered intrathecally as a special application.
Thrombophlebitis has occurred at the site of drug injection or
infusion in some patients, and
rarely patients have noted pain and inflammation at subcutaneous
injection sites. In most
instances, howeve