DBL CYTARABINE 1g/10mL Injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cytarabine, Quantity: 100 mg/mL

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous, Subcutaneous, Intrathecal

Units in package:

1 x10mL (single onco.vial), 1x1g/10mL, 1x1g/10mL(E)E)

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

Cytarabine may be used alone or in combination with other chemotherapeutic agents. It is indicated for induction of remission of leukaemia, particularly for acute myeloid leukaemia, in adults and children. Cytarabine has been used for remission induction in acute lymphocytic leukaemia, chronic myeloid leukaemia and erythroleukaemia; and in the treatment and maintenance therapy of meningeal leukaemia and other meningeal neoplasms.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Life Time: 18 Months; Container Temperature: Store between 15-25 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-01-31

Patient Information leaflet

DBL™ CYTARABINE
INJECTION
_Cytarabine_
CONSUMER MEDICINE INFORMATION
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 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
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DBL CYTARABINE
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 DOCTOR IF YOU HAVE BEEN
GIVEN CYTARABINE PREVIOUSLY.
TELL YOUR DOCTOR IF YOU ARE
PREGNANT OR PLAN TO BECOME
PREGNANT.
Your doctor can discuss with you the
risks and benefits

Summary of Product characteristics

Version: pfpcytri10122
Supersedes: pfpcytri10621
Page 1 of 18
AUSTRALIAN
PRODUCT
INFORMATION
–
DBL™ CYTARABINE INJECTION (CYTARABINE)
1.
NAME OF THE MEDICINE
Cytarabine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DBL Cytarabine Injection (100 mg/mL) is a clear, colourless sterile
solution of cytarabine in
water for injections also contains hydrochloric acid and sodium
hydroxide for pH adjustment.
It is presented in ONCO-TAIN® vials containing 1000 mg/10 mL or 2000
mg/20 mL of
cytarabine solution. The solution does not contain any antimicrobial
preservative.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DBL Cytarabine Injection 100 mg/mL is a clear, colourless sterile
solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cytarabine may be used alone or in combination with other
chemotherapeutic agents. It is
indicated for induction of remission of leukaemia, particularly for
acute myeloid leukaemia, in
adults and children.
Cytarabine has been used for remission induction in acute lymphocytic
leukaemia, chronic
myeloid leukaemia and erythroleukaemia; and in the treatment and
maintenance therapy of
meningeal leukaemia and other meningeal neoplasms.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Dosage of cytarabine must be based on the clinical and haematological
response and tolerance
of the patient so as to obtain optimum therapeutic results with
minimum adverse effects. Even
though higher total doses of cytarabine can be given by IV injection
compared to continuous
IV infusion with similar haematologic toxicity, the most effective
dosage schedule and method
of administration are yet to be established. Moreover, cytarabine is
often used in combination
with other cytotoxic drugs, thereby necessitating dose modification of
cytarabine and other
chemotherapeutic agents, and the method as well as the sequence of
administration.
Following is an outline of dosage schedules for cytarabine therapy as
reported in the literature.
DOSAGE SCHEDULES:
SINGLE-