Pfizer (Australia) DAUNORUBICIN (as hydrochloride) 20mg/10mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

daunorubicin, Quantity: 20 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous

Units in package:

10mL x 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 22 NOVEMBER 2004 : Daunorubicin Injection is indicated for the treatment of the following: Acute lymphocytic (lymphoblastic) leukaemia: Daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. However, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease. Acute myeloblastic leukaemia: Daunorubicin has been used in all stages, alone or in combination with other cytotoxic agents (e.g. cytarabine). Disseminated solid tumours: Daunorubicin has been investigated for use in these tumours and found to be effective in some cases of disseminated neuroblastoma and rhabdomyosarcoma.

Product summary:

Visual Identification: Clear red solution; Container Type: Vial; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-13

Patient Information leaflet

PFIZER (PERTH)
DAUNORUBICIN
_Daunorubicin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Daunorubicin.
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 using Daunorubicin
against the benefits it is expected to
have for you.
This medicine is likely to be used
while you are at the clinic or in
hospital.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DAUNORUBICIN IS
USED FOR
Daunorubicin belongs to a group of
anticancer medicines known as
cytotoxic anthracycline antibiotics.
Daunorubicin works by preventing
the growth of cancer cells and
eventually destroying them. It is used
to treat different types of cancers
including the following types of
cancers:
•
leukaemia, a type of cancer that
affects the blood and bone
marrow (the organ that produces
blood cells) or a type of blood
cancer where excess of immature
white blood cells is made by the
bone marrow.
•
cancer in the small glands on top
of the kidneys (adrenal glands)
•
cancer affecting muscle cells.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
DAUNORUBICIN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN
DAUNORUBICIN IF YOU:
•
are allergic to medicines from the
same group (anthracyclines or
anthracenediones)
•
have an allergy to Daunorubicin
or any of the ingredients listed at
the end of this leaflet
•
have heart disease or heart
problems, have recently had a
heart attack or experienced chest
pain or have a severe form of
irregular heartbeats (arrhythmia)
•
have severe infections
•
have severe liver or renal function
impairment
•
have long-term,

Summary of Product characteristics

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Supersedes: pfpdauni10820
Page 1 of 17
AUSTRALIAN
PRODUCT
INFORMATION
–
PFIZER
(AUSTRALIA)
DAUNORUBICIN
(DAUNORUBICIN HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Daunorubicin (as hydrochloride).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Pfizer (Australia) Daunorubicin contains 2.14 mg/mL
daunorubicin hydrochloride
(equivalent to 2 mg/mL daunorubicin).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Pfizer (Australia) Daunorubicin is a clear, red solution. The solution
is isotonic and is
preservative free.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pfizer (Australia) Daunorubicin is indicated for the treatment of the
following:
ACUTE LYMPHOCYTIC (LYMPHOBLASTIC) LEUKAEMIA
Daunorubicin is usually reserved for use in cases shown to be
resistant to other drugs.
However, combined treatment with daunorubicin, vincristine and a
steroid has been used in the
early stages of this disease.
ACUTE MYELOBLASTIC LEUKAEMIA
Daunorubicin has been used in all stages, alone or in combination with
other cytotoxic agents
(e.g., cytarabine).
DISSEMINATED SOLID TUMOURS
Daunorubicin has been investigated for use in these tumours and found
to be effective in some
cases of disseminated neuroblastoma and rhabdomyosarcoma.
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Supersedes: pfpdauni10820
Page 2 of 17
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The dosage of each individual injection may vary from 0.5 to 3 mg/kg,
with the frequency of
repetition according to the dose:
•
0.5 to 1 mg/kg repeated at intervals of one or more days;
•
2 mg/kg repeated at intervals of four or more days;
•
2.5 or 3 mg/kg, if used, should only be given at seven to fourteen day
intervals.
Dosage must be adjusted to meet individual requirements of each
patient, on the basis of
clinical response and appearance or severity of toxicity. One
injection has sometimes sufficed;
commonly three to six injections have been necessary; occasionally up
to 10 injections in one
series