OMNIPAQUE 240

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IOHEXOL

Available from:

ELDAN ELECTRONIC INSTRUMENTS CO LTD

ATC code:

V08AB02

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

IOHEXOL 518 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

GE HEALTHCARE AS, NORWAY

Therapeutic group:

IOHEXOL

Therapeutic area:

IOHEXOL

Therapeutic indications:

X-ray contrast medium for use in adults and children for cardioangiography, arteriography, urography, phlebography and CT- enhancement. Lumbar, thoracic, cervical myelography and computed tomography of the basal cisterns, following subarachnoid injection. Arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography, sialography and studies of the gastrointestinal tract.

Authorization date:

2021-04-30

Summary of Product characteristics

OMNIPAQUE
 INJECTION X-RAY CONTRAST MEDIUM
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
OMNIPAQUE 240 MG I/ML, 300 MG I/ML, 350 MG I/ML
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Iohexol 518mg/ml equivalent to 240mg/ml iodine.
Iohexol 647 mg/ml equivalent to 300mg/ml Iodine
Iohexol 755 mg/ml equivalent to 350 mg/ml iodine.
Iohexol is a non-ionic, monomeric, triiodinated, water-soluble X-ray
contrast medium.
The osmolality and viscosity values of Omnipaque 240, 300, 350 mg I\ml
are as follows:
Concentration
Osmolality *
Osm/kg H
2
O
Viscosity (mPa
⋅
s)*
37°C
20°C
37°C
240 mg I/ml
300 mg I/ml
350 mg I/ml
0.51
0.64
0.78
5.6
11.6
23.3
3.3
6.1
10.6
* Method: Vapour - pressure osmometry.
This medicinal product contains 0.012mg sodium per ml, i.e.
essentially sodium free.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless to pale yellow, sterile aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
X-ray contrast medium for use in adults and children for
cardioangiography, arteriography,
urography, phlebography and CT-enhancement. Lumbar, thoracic, cervical
myelography
and computed tomography of the basal cisterns, following subarachnoid
injection.
Arthrography, endoscopic retrograde pancreatography (ERP), endoscopic
retrograde
cholangiopancreatography (ERCP), herniography, hysterosalpingography,
sialography and
studies of the gastrointestinal tract.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The dosage vary depending on the type of examination age, weight,
cardiac output and
general condition of the patient
and the technique used. Usually, the same iodine
OMNIPAQUE
 INJECTION X-RAY CONTRAST MEDIUM
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concentration and volume is used as with 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, intra-arterial and intrathecal