Pharmorubicin

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

Epirubicin hydrochloride

Disponibbli minn:

Pfizer Australia Pty Ltd

Klassi:

Medicine Registered

Fuljett ta 'informazzjoni

PHARMORUBICIN
®

_Epirubicin hydrochloride_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pharmorubicin.
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 using Pharmorubicin
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PHARMORUBICIN
IS USED FOR
Pharmorubicin 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
PHARMORUBICIN HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Pharmorubicin is only available with
a doctor's prescription. It is not
addictive.
BEFORE YOU ARE GIVEN
PHARMORUBICIN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE PHARMORUBICIN IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
TO EPIRUBICIN (THE ACTIVE INGREDIENT
IN PHARMORUBICIN), OTHER
MEDICINES TO TREAT CANCER OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
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.
DO NOT USE THE MEDICINE FOR
INJECTION INTO A VEIN IF YOU HAVE:
•
a low number of red blood cells,
white blood cells or platelets in
your blood
•
sore, red mouth from previous
treatment or radiation therapy
•
an infection
•
severe liver problems
•
heart problems or have ever had
heart problems
•
already received the highest dose
allowed for medicines such as
mitozantrone, mitomycin C,
doxorubicin or daunorubicin
DO NOT USE THE MEDICINE FOR
INJECTION INTO THE BLADDER IF YOU
HAVE:
•
cancer that has gone into the
bladder wall
•
kidney or urinary tract infection
•
swollen or inflamed bladder
�

Karatteristiċi tal-prodott

Version: pfppharv10312 
Supersedes: pfppharv10212 

Page 1 of 16 
PRODUCT INFORMATION 
PHARMORUBICIN
®
 RD  
(Powder for Injection 50 mg) 
PHARMORUBICIN
®
 INJECTION  
(10 mg/5 mL, 20 mg/10 mL, 50 mg/25 mL and 200 mg/100 mL) 
NAME OF THE DRUG 
Epirubicin hydrochloride 
DESCRIPTION 
PHARMORUBICIN (epirubicin hydrochloride) is supplied in two
presentations: as a 
lyophilised powder with a rapid dissolution
formulation containing methyl hydroxybenzoate 
and lactose
(PHARMORUBICIN RD Powder for Injection) and as a ready-to-use solution 
(PHARMORUBICIN Injection). 
Structurally, PHARMORUBICIN differs from ADRIAMYCIN® (doxorubicin
hydrochloride) 
only in the orientation of the hydroxyl group at the 4
position on the aminoglycoside ring.  
The chemical name of epirubicin hydrochloride is (8S,
10S)-10-(3-amino-2,3,6-trideoxy-
α-L-
_arabino_-hexopyranosyloxy)-8-glycolloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-
methoxynaphthacene-5,12-dione hydrochloride. 
The structural formula is: 
CH
2
OH
CH
3
O
OH
O
O
O
OH
O
OH
O
CH
3
OH
NH
2
.HCl

CAS 56390-09-1 
PHARMORUBICIN is a red-orange,
almost odourless, hygroscopic powder, sparingly soluble 
in water and dilute alcohol. 
Version: pfppharv10312 
Supersedes: pfppharv10212 

Page 2 of 16 
PHARMACOLOGY 
The mechanism of action of PHARMORUBICIN 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. 

PHARMORUBICIN has proved to be active on
the following experimental tumours: L 1210 
ascites and P388 leukaemias, sarcoma SA 180 (solid and
ascitic forms), melanoma B 16, 
mammary carcinoma, Lewis lung carcinoma and colon carcinoma
38. 
The specificity of PHARMORUBICIN toxicity appears to be related primarily to proliferative 
activity of