Epirubicin hydrochloride 20mg/ 10mL injection vial

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

epirubicin hydrochloride

Verfügbar ab:

Novotech Australia Pty Ltd

INN (Internationale Bezeichnung):

epirubicin hydrochloride

Klasse:

Medicine Registered

Berechtigungsstatus:

Registered

Gebrauchsinformation

CONSUMER MEDICINE INFORMATON
EPIRUBICIN HYDROCHLORIDE INJECTION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Epirubicin
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 has weighed the
risks of you being
given epirubicin 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 EPIRUBICIN HYDROCHLORIDE INJECTION IS USED FOR
Epirubicin Hydrochloride Injection is used in the treatment of various
types of cancer. It
may be used alone or with other medicines.
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 reason.
This medicine is available only with a doctor's prescription. It is
not addictive.
BEFORE YOU ARE GIVEN EPIRUBICIN HYDROCHLORIDE INJECTION
_WHEN YOU MUST NOT BE GIVEN IT _
_ _
YOU MUST NOT BE GIVEN EPIRUBICIN HYDROCHLORIDE INJECTION IF YOU HAVE
AN ALLERGY TO
ANY MEDICINE CONTAINING EPIRUBICIN, ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS
LEAFLET OR ANY OTHER SIMILAR MEDICINES, INCLUDING ANTHRACYCLINES.
Symptoms of an allergic reaction 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 THIS MEDICINE IF YOU HAVE, OR HAVE HAD, ANY OF
THE FOLLOWING
MEDICAL CONDITIONS:
•
a low number of blood cells or platelets in your blood
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•
a very inflamed and sore mouth due to previous chemotherapy or
radiotherapy
•
you have an infection or high temperature
•
severe or significant liver problems
•
heart problems, including a heart attack
•
already received the highest dose allowed for medicines such as
mitozantrone,
mitomycin C, doxorubicin or daun

Fachinformation

PRODUCT INFORMATION
NAME OF THE MEDICINE
EPIRUBICIN HYDROCHLORIDE INJECTION
Epirubicin hydrochloride
DESCRIPTION
The chemical name of epirubicin hydrochloride is (8S,
10S)-10-(3-amino-2,3,6-trideoxy-
alpha-L-arabino-hexopyranosyloxy)-8-glycolloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-
1-methoxynaphthacene-5,12-dione hydrochloride.
Molecular formula: C
27
H
30
CINO
11
Relative Molecular Mass: 579.99
CAS Number: 56390-09-1
Epirubicin hydrochloride is a red-orange, almost odourless,
hygroscopic powder,
sparingly soluble in water and dilute alcohol.
Structurally, epirubicin hydrochloride differs from doxorubicin
hydrochloride only in the
orientation of the hydroxyl group at the 4 position on the
aminoglycoside ring.
PHARMACOLOGY
The mechanism of action of epirubicin hydrochloride has not been fully
elucidated but is
probably related to its ability to bind DNA. Cell culture studies have
shown cell
penetration, localisation in the nucleus and inhibition of nucleic
acid synthesis and
mitosis. Epirubicin hydrochloride has proved to be active on the
following experimental
tumours: L 1210 ascites and P388 leukemias, sarcoma SA 180 (solid and
ascitic forms),
melanoma B 16, mammary carcinoma, Lewis lung carcinoma and colon
carcinoma 38.
The specificity of epirubicin hydrochloride toxicity appears to be
related primarily to
proliferative activity of normal tissue. Thus, bone marrow,
gastrointestinal tract,
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lymphoid organs and the gonads are the main normal tissues damaged.
Degenerative or
functional alterations in liver and kidneys were also seen in animals
dosed with epirubicin
hydrochloride.
Like most other antitumour and immunosuppressant agents, epirubicin
hydrochloride,
under experimental conditions, has mutagenic properties and is
carcinogenic in laboratory
animals (see Precautions, Use in Pregnancy).
Toxicity studies in animals have indicated that on a weight (mg per
mg) basis epirubicin
hydrochloride has a better therapeutic index and less systemic and
cardiac toxicity than
doxorubicin.
PHARMACOKINET