GENEPHARM DOXORUBICIN HYDROCHLORIDE INJECTION 100mg/50mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

doxorubicin hydrochloride

Available from:

Novotech Australia Pty Ltd

INN (International Name):

Doxorubicin hydrochloride

Authorization status:

Registered

Patient Information leaflet

CONSUMER MEDICINE INFORMATON
DOXORUBICIN HYDROCHLORIDE INJECTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about DOXORUBICIN
HYDROCHLORIDE 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 risk
of you taking DOXORUBICIN HYDROCHLORIDE INJECTION against the
benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET.
You may want to read it again.
WHAT DOXORUBICIN HYDROCHLORIDE INJECTION IS USED FOR
DOXORUBICIN HYDROCHLORIDE INJECTION is used to treat many types of
cancer. DOXORUBICIN HYDROCHLORIDE INJECTION works by stopping
cancer cells from growing and multiplying. It contains the active
ingredient
doxorubicin hydrochloride.
Ask your doctor if you have any questions about why DOXORUBICIN
HYDROCHLORIDE INJECTION has been
prescribed for you.
DOXORUBICIN HYDROCHLORIDE INJECTION is to be given only under the
strict supervision of your doctor.
DOXORUBICIN HYDROCHLORIDE INJECTION is not addictive.
BEFORE YOU ARE GIVEN DOXORUBICIN HYDROCHLORIDE INJECTION
_WHEN YOU MUST NOT BE GIVEN DOXORUBICIN HYDROCHLORIDE INJECTION _
_ _
DOXORUBICIN HYDROCHLORIDE INJECTION is usually given as an injection
or infusion into a vein. It might also be infused into the bladder.
DO NOT HAVE DOXORUBICIN HYDROCHLORIDE INJECTION IF YOU ARE
ALLERGIC TO DOXORUBICIN HYDROCHLORIDE INJECTION OR HAVE HAD AN
1/7
CMI SRN 1/9/2010
ALLERGIC REACTION TO ANY OTHER CANCER MEDICATION E.G. DAUNORUBICIN,
DOXORUBICIN,
MITOZANTRONE.
Symptoms of an allergic reaction to DOXORUBICIN HYDROCHLORIDE
INJECTION 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
•
light-headedness or back pain.
DO NOT HAVE DOXORUBICIN HYDROCHLORIDE INJECTION IF:
•
you have bone marrow suppression

Summary of Product characteristics

1/17
PI SRN 24/11/11
PRODUCT INFORMATION
NAME OF THE MEDICINE
Doxorubicin Hydrochloride Injection
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.
Chemical Structure: (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
DESCRIPTION
Doxorubicin Hydrochloride Injection is a clear red solution of
doxorubicin hydrochloride
and sodium choride in Water for Injections. It is freely soluble in
water, and slightly
soluble in methanol. 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.
2/17
PI SRN 24/11/11
Doxorubicin has immunosuppressive effects. It inhibits the titre of
haemolytic and
haemagglutinating antibodies in mice immunised with sheep red blood
cells. Similar
evidence in humans indicates that doxorubicin is a powerful but
temporary
immunosuppressant agent. It is a cell cycle phase nonspecific
cytotoxic drug.
The toxic effects of doxorubicin on the bone marrow appear to be
related to its action on
proliferating myeloid cells. The cardiotoxicity of doxorubicin is
probably mediated by
different mechanisms.
Although in animal systems doxorubicin i