IMAGOPAQUE Solution for Injection 300 Mg/Ml

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

IOPENTOL

Inapatikana kutoka:

GE Healthcare AS

Kipimo:

300 Mg/Ml

Dawa fomu:

Solution for Injection

Idhini ya tarehe:

2001-09-07

Tabia za bidhaa

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imagopaque 300 mg I/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iopentol is a non-ionic, monomeric, triiodinated,
water-soluble X-ray contrast medium.
The osmolality and
viscosity values of Imagopaque are as follows: 
* Method: Vapour – pressure osmometry.
3 PHARMACEUTICAL FORM
Solution for injection. Imagopaque injection
is a clear colourless sterile solution.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
X-ray contrast medium for arteriography, urography, phlebography
and CT-enhancement, arthrography, endoscopic 
retrograde cholangiopancreatography (ERCP), hysterosalpingography,
gastrointestinal studies using oral water-soluble 
contrast medium.
Active ingredient
Strength
Content per. ml.
Iopentol (INN)
300 mg I/ml 
658 mg equiv. 300 mg I
Concentration
Osmolality*
Osm/kg H
2
O
Viscosity (mPa s)
37ºC
20ºC 
37ºC
300 mg I/ml
0.64
13.2
6.5
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/12/2005_
_CRN 2017605_
_page number: 1_
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
The dosage depends on the type of examination, the condition
of the patient and the technique used. Usually the same 
iodine concentration and volume is used as for other iodinated
X-ray contrast media in current use. Adequate 
hydration should be assured before and after administration
as for other contrast media.
For intravenous and intra-arterial use, and use in body cavities.
The following dosages may serve as a guide:
GUIDELINES FOR INTRAVENOUS USE 
GUIDELINES FOR INTRA-ARTERIAL USE
Indication
Concentration
Volume
Comments
UROGRAPHY
Adults
children < 1 year
children > 1 year
300 mg I/ml
or 350 mg I/ml
300 mg I/ml
300 mg I/ml
or 350 mg I/ml
40-80 ml
3 ml/kg
1.5-2 ml/kg
1-2 ml/kg
(max. 60 ml)
In high-dose urography 
higher doses ca