BILISCOPIN

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Meglumine iotroxate

Patient Information leaflet

1209 BILISCOPIN
® 
CMI 

1 

BILISCOPIN® 
(BILL•EE•SCO•PIN)

_meglumine iotroxate _

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS 
LEAFLET 
This leaflet answers some 
common questions about 
Biliscopin. It does not 
contain all the available 
information. It does not take 
the place of talking to your 
doctor.  

All diagnostic agents have 
risks and benefits. Your 
doctor has weighed the risks 
of you using Biliscopin 
against the benefits they 
expect it will have for you. 

The doctors conducting your 
X-ray examination are able 
to weigh up all the relevant 
facts and you should consult 
them about all aspects of 
this medicine as it relates to 
you. 

IF YOU HAVE ANY CONCERNS 
ABOUT USING THIS DIAGNOSTIC 
AGENT, ASK YOUR DOCTOR OR 
RADIOLOGIST. 

KEEP THIS LEAFLET. 
You may need to read it 
again. 

WHAT BILISCOPIN 
IS USED FOR  
Biliscopin is an X-ray 
contrast medium or X-ray 
dye that is injected directly 
into the bloodstream before  

X-rays are taken.  All 
injectable X-ray dyes, 
including Biliscopin, 
contain iodine.  X-rays are 
able to pass through bones 
in your body and thus 
produce a `picture' but X-
rays are unable to pass 
through the iodine in 
contrast agents.   

When Biliscopin is injected 
into your body it is excreted 
by your liver into the bile.  
It is used by X-ray specialist 
doctors (radiologists) who 
are able to see the X-ray dye 
in your gall bladder and 
other areas where bile flows. 

Biliscopin is only available 
in X-ray departments and X-
ray practices for use in 
conjunction with the taking 
of X-rays. 

The radiologist will advise 
the use of Biliscopin if 
he/she feels that it is likely 
to assist the X-ray 
examination in finding out 
more about your medical 
condition. 

ASK YOUR DOCTOR IF YOU 
HAVE A

Summary of Product characteristics

PRODUCT INFORMATION 

BILISCOPIN
®
 FOR INFUSION 

NAME OF THE MEDICINE 

Each 1 mL Biliscopin for infusion contains 0.105
g meglumine iotroxate (3,3'-(3,6,9-
trioxaundecanedioyl-diimino) -bis-(2,4,6-triiodobenzoic acid),
N-methylglucamine salt) along with 
small amounts of sodium calciumedetate, sodium bicarbonate and
sodium chloride in aqueous 
solution.  The solution is clear, colourless to faintly yellowish
and odourless.  It should be protected 
from light. 

STRUCTURE 

Molecular formula C
22
H
18
I
6
N
2
O
9

Molecular weight  1215.83 
Iodine content per bottle of 100 mL: 5g 
Iodine concentration: 5% w/v 
Meglumine iotroxate content per bottle of 100 mL: 10.5g 
Meglumine iotroxate concentration: 10.5% w/v 
Osmotic pressure at 37 
o
C: 0.69-0.77 mPa 
CAS Registry number: 72704-51-9 

DESCRIPTION 

Biliscopin for infusion is a radiocontrast medium
for cholangiography and cholecystography.   

PHARMACOLOGY 
Following intravenous administration Biliscopin is rapidly excreted,
mainly by the liver into the bile.  
Visualisation of the hepatic and common bile ducts and the
gallbladder can, therefore, be achieved.  
Visualisation of the biliary ducts is usually possible 30-60 minutes
after completion of administration. 
_In vitro_ meglumine iotroxate binds to plasma proteins to
the extent of 60-90% depending on 
concentration.  In animals it crosses the placental barrier. 

INDICATIONS 
Biliscopin for infusion is indicated for radiological examination
of the hepatic and biliary ducts and 
gallbladder when examination by oral technique is unsuccessful
or inappropriate. 

CONTRAINDICATIONS 
Severe cardiovascular insufficiency, particularly right ventricular
failure or cardiac decompensation, 
hypersensitivity to iodine-containing contrast media, thyrotoxicosis,
severe functional disturbance of 
the liver or of the kidneys, monoclonal IgM gammopathy, e.g.
macroglobulinaemia (Waldenstrom's 
d