DBL CYTARABINE 100mg/1mL Injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cytarabine

Available from:

Hospira Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

DBL
™
Cytarabine Injection CMI
Page 1
DBL
™
CYTARABINE INJECTION
Cytarabine _(sye-TARE-a-been)_
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_Consumer Name_
_Pharmacist Name_
_Consumer Address_
_Pharmacist Address_
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about DBL
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 or
pharmacist has weighed the risks
of you being given DBL
Cytarabine Injection against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DBLCYTARABINE
INJECTION IS USED FOR
Cytarabine belongs to a group of
medicines known as
antineoplastic or cytotoxic agents.
You may also hear it referred to
as a chemotherapy medicine.
Cytarabine is classified as an
antimetabolite. It interferes with
the growth of cancer cells, which
are eventually destroyed. Since
the growth of normal body cells
may also be affected by
cytarabine, other effects may also
occur (see Side Effects).
Cytarabine is most often used in
combination with other medicines
to treat cancer (especially
leukaemias).
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY DBL
CYTARABINE INJECTION HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
it for another reason.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
DBL CYTARABINE
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT_
DBL CYTARABINE INJECTION
SHOULD NOT BE GIVEN TO YOU 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 to cytarabine
may include:

shortness of breath

wheezing or difficulty
breathing

swelling of the face, lips,
tongue or other parts of the
body

rash, itching or hives on the
skin.
TELL YOUR

Summary of Product characteristics

Product Information – Australia
Version 5.1
Page 1
DBL
®
CYTARABINE INJECTION
NAME OF THE MEDICINE
Cytarabine
The structural formula of cytarabine is shown below:
The CAS registry number of cytarabine is 147-94-4.
DESCRIPTION
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.
DBL Cytarabine Injection 100mg/mL is a clear, colourless sterile
solution of Cytarabine BP in Water
for Injections. It is presented in ONCO-TAIN® vials containing 1 mL,
5 mL, 10 mL or 20 mL of
solution (100 mg, 500 mg, 1 g or 2 g of Cytarabine). DBL Cytarabine
Injection 100mg/mL also
contains hydrochloric acid and sodium hydroxide for pH adjustment. The
solution does not contain
any antimicrobial preservative.
PHARMACOLOGY
PHARMACODYNAMICS
_MECHANISM OF ACTION _
The exact mechanism(s) of action of cytarabine is not fully
understood, but cytarabine triphosphate
appears to inhibit DNA synthesis by the inhibition of DNA polymerase.
Cytarabine is cytotoxic to a
wide variety of proliferating mammalian cells in culture.
Cytarabine’s actions are cell-cycle specific,
primarily killing cells undergoing DNA synthesis (S-phase) and under
certain conditions blocking the
progression of cells from the G1 phase to the S-phase. A limited, but
significant, incorporation of
cytarabine into both DNA and RNA has also been reported. Extensive
chromosomal damage,
including chromatoid breaks, have been produced by cytarabine and
malignant transformation of
rodent cells in culture has been reported. Deoxycytidine prevents or
delays (but does not reverse) the
cytotoxic activity.
N
N
O
NH
2
O
HOCH
2
OH
OH
Product Information – Australia
Version 5.1
Page 2
Cytarabine is also immunosuppressant and has demonstrated antiviral
activity in vitro. However,
efficacy against _herpes zoster_ or smallpox could