ACCORD DOXORUBICIN

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Doxorubicin hydrochloride

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Doxorubicin hydrochloride

Patient Information leaflet

ACCORD DOXORUBICIN
Doxorubicin Hydrochloride Concentrated Injection 10 mg/5 mL and 200
mg/100 mL
CONSUMER MEDICINE INFORMATION
Version 2.0
Page 1 of 6
WHAT IS IN THIS LEAFLET
_ _
PLEASE READ THIS LEAFLET
CAREFULLY BEFORE TREATMENT
WITH ACCORD
DOXORUBICIN
This leaflet answers some
common questions about this
medicine.
It does not contain all the
available information.
It does not take the place of
talking to your doctor.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you
taking ACCORD
DOXORUBICIN against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
PLEASE KEEP THIS LEAFLET.
You may need to read it again.
WHAT ACCORD
DOXORUBICIN IS
USED FOR
ACCORD DOXORUBICIN is
used to treat certain cancers.
This medicine belongs to a
group of medicines called
antineoplastic or cytotoxic
medicines. You may also hear
of these being called
chemotherapy medicines.
ACCORD DOXORUBICIN is
thought to work by killing
cancer cells, and stopping
cancer cells from growing and
multiplying. It contains the
active ingredient doxorubicin
hydrochloride.
Your doctor may have
prescribed ACCORD
DOXORUBICIN for another
reason. Ask your doctor if you
have any questions about why
ACCORD DOXORUBICIN
has been prescribed for you.
ACCORD DOXORUBICIN is
not addictive. This medicine is
available only with a doctor’s
prescription.
ACCORD DOXORUBICIN is
to be given only under the
strict supervision of your
doctor.
BEFORE YOU ARE GIVEN
ACCORD
DOXORUBICIN
_ _
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
ACCORD DOXORUBICIN
IF YOU HAVE AN ALLERGY TO
ACCORD DOXORUBICIN
OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET
Symptoms of an allergic
reaction to ACCORD
DOXORUBICIN 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.
YOU MUST NOT BE GIVEN
ACCORD DOXORUBICIN
IF YOU HAVE ANY OF THE
FOLLOWING:
•
VERY LOW WHITE BLOOD

Summary of Product characteristics

ACCORD DOXORUBICIN
Doxorubicin Hydrochloride Concentrated Injection 10 mg/5 mL and 200
mg/100 mL Version 2.0
Page 1 of 19
PRODUCT INFORMATION
ACCORD DOXORUBICIN CONCENTRATED INJECTION
(Doxorubicin Hydrochloride Concentrated Injection 10 mg/5 mL and 200
mg/100 mL)
NAME OF THE MEDICINE
Doxorubicin hydrochloride
Chemical
Name:
(8S,10S)-10-[(3-Amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)-oxy]-8-
glycoloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-
naphthacenedione hydrochloride.
Molecular Formula: C
27
H
29
NO
11
HCl
Molecular Weight: 579.99
CAS Number: 25316-40-9
Doxorubicin hydrochloride is a cytotoxic anthracycline antibiotic
isolated from cultures of
_Streptomyces _
_peucetius _
_var. _
_caesius._
The
chemical
structure
of
doxorubicin
consists
of
a
tetracyclic ring, with the sugar daunosamine attached by a glycosidic
linkage.
Structurally, doxorubicin is related to daunomycin (daunorubicin) and
differs only in hydroxyl
group substitution (instead of hydrogen) at the alkyl side chain, at
position ‘9’ of the ‘A’ ring.
ITS STRUCTURAL FORMULA IS AS FOLLOWS:
ACCORD DOXORUBICIN
Doxorubicin Hydrochloride Concentrated Injection 10 mg/5 mL and 200
mg/100 mL Version 2.0
Page 2 of 19
DESCRIPTION:
Doxorubicin hydrochloride
is soluble in water; slightly soluble in methanol
; practically insoluble
in acetone and in ethanol.
Doxorubicin hydrochloride concentrated injection is a sterile, red
colored, clear solution of
doxorubicin hydrochloride and sodium chloride in water for injections.
Hydrochloric acid is
added as necessary to adjust the pH.
PHARMACOLOGY
Though not completely elucidated, the mechanism of action of
doxorubicin is related to its
ability to bind to DNA and inhibit nucleic acid synthesis. Cell
culture studies have demonstrated
rapid cell penetration and perinucleolar chromatin binding, rapid
inhibition of mitotic activity
and nucleic acid synthesis, mutagenesis and chromosomal aberrations.
Doxorubicin
has
immunosuppressive
effects.
It
inhibits
the
titre
of
haemolytic
and
haemagglutinating a