Epirubicin Hydrochloride Injection

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Download Risalah maklumat (PIL)
16-06-2024
Download Ciri produk (SPC)
16-06-2024

Bahan aktif:

Epirubicin hydrochloride

Boleh didapati daripada:

Actavis Australia Pty Ltd

Kelas:

Medicine Registered

Risalah maklumat

                                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 
 
1/7 
CMI v2 15/6/2010 
•  a very inflamed and sore mouth due to previous chemotherapy
or radiotherapy 
•  you have an infection or high temperature 
•  severe or significant liver proble
                                
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Ciri produk

                                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, 
 1/14 
v2 
15/6/2010 
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 epiru
                                
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