CYTARABINE ACCORD cytarabine 1000 mg/10 mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cytarabine, Quantity: 1000 mg

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; macrogol 400; trometamol

Administration route:

Intravenous, Subcutaneous

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: A clear, colourless solution in a glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-04-16

Patient Information leaflet

Version 1.0
Page 1 of 4
CYTARABINE ACC AND CYTARABINE ACCORD
_Cytarabine Injection 20 mg/mL and 100 mg/mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cytarabine
Accord/Cytarabine ACC.
It does not contain all the available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have benefits and risks.
Your doctor has weighed the risks of
you taking Cytarabine
Accord/Cytarabine ACC against the
benefits this medicine is expected to
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
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT CYTARABINE IS
USED FOR
Cytarabine belongs to a group of
medicines known as antineoplastics. It
is used to treat cancer.
_HOW CYTARABINE _
_ACCORD/CYTARABINE ACC _
_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 Accord/Cytarabine ACC
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
Accord/Cytarabine ACC.
This medicine is available only with a
doctor's prescription.
_USE IN CHILDREN _
Cytarabine Accord/Cytarabine ACC 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
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT HAVE CYTARABINE
ACCORD/CYTARABINE ACC IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing cytarabine
•
any of the ingredients listed

Summary of Product characteristics

Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
CYTARABINE ACC (20 MG/ML) AND CYTARABINE ACCORD (100 MG/ML)
(CYTARABINE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Cytarabine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CYTARABINE ACC, 1 ML CONTAINS 20 MG CYTARABINE
1 vial of 2 mL solution for injection contains 40 mg cytarabine.
1 vial of 5 mL solution for injection contains 100 mg cytarabine.
CYTARABINE ACCORD, 1 ML CONTAINS 100 MG CYTARABINE
1 vial of 1 mL solution for injection contains 100 mg cytarabine.
1 vial of 5 mL solution for injection contains 500 mg cytarabine.
1 vial of 10 mL solution for injection contains 1000 mg cytarabine.
1 vial of 20 mL solution for injection contains 2000 mg cytarabine.
1 vial of 40 mL solution for injection contains 4000 mg cytarabine.
1 vial of 50 mL solution for injection contains 5000 mg cytarabine.
Cytarabine
is
a
synthetic
nucleoside
which
differs
from
the
normal
nucleosides
cytidine
and
deoxycytidine in that the sugar moiety is arabinose rather than ribose
or deoxyribose. It is a white or
almost white, crystalline powder, freely soluble in water, very
slightly soluble in alcohol and in
methylene chloride.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Cytarabine Accord and Cytarabine ACC are clear, colourless solutions
for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.