Omnipaque

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Iohexol 302 mg/mL equivalent to 140 mg I/mL

Available from:

GE Healthcare Limited t/a GE Healthcare - Medical Diagnostics

INN (International Name):

Iohexol 302 mg/mL (=140 mg I/mL)

Dosage:

140 mg I/ mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Iohexol 302 mg/mL equivalent to 140 mg I/mL Excipient: Sodium calcium edetate Trometamol Water for injection

Units in package:

Bottle, glass, 6 x 200 mL, 1200 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

GE Healthcare AS

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 6 x 200 mL - 1200 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, 10 x 50mL - 500 mL - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1985-08-08

Summary of Product characteristics

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
OMNIPAQUE™
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iohexol240, 300 and 350 mg iodine per ml.
3 PHARMACEUTICAL FORM
240 mg, bottles containing 518 mg iohexol per ml, equivalent to 240 mg
Iodine per ml.
300 mg, bottles containing 647 mg iohexol per ml, equivalent to 300 mg
iodine per ml.
350 mg, bottles containing 755 mg iohexol per ml, equivalent to 350 mg
iodine per ml.
OMNIPAQUE solutions are colourless.
The osmolality and viscosity values are as follows:
Concentration
(mg I/ml)
Osmolality* (mol/kg)
Viscosity
(mPa s) 20ºC
Viscosity
(mPa s) 37ºC
240
300
350
0.51
0.64
0.78
5.6
11.6
23.3
3.3
6.1
10.6
*
at 37ºC, in aqueous solutions of iohexol.
OMNIPAQUE is isotonic to blood (300 mOsm/kg) and cerebrospinal fluid
(CSF) at a
concentration of 140 mg I/ml. The density of OMNIPAQUE at the
available concentrations is
hyperbaric to CSF.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
This medicinal product is for diagnostic use only.
INTRAVSCULAR
OMNIPAQUE is indicated in adults for angiography, excretory
urographyand CT-enhancement.
In children, OMNIPAQUE is indicated for angiography and urography.
INTRATHECAL
OMNIPAQUE is indicated for lumbar, thoracic, cervical and total
columnar myelography and
computed tomography of the CNS in adults and children.
ORAL/BODY CAVITIES
OMNIPAQUE is indicated in adults in arthrography, endoscopic
retrograde pancreatography
(ERP),
endoscopic
retrograde
cholangiopancreatography
(ERCP),
herniography,
hysterosalpingography,
and
in
adults,
children
and
prematurte
babies
for
studies
of
the
gastrointestinal tract.
2
4.2 Dose and method of administration
Administration of contrast media should be performed by qualified
personnel familiar with the
procedure, and an appropriate technique should be utilised.
The dosage varies depending on the type of examination, age, weight,
cardiac output and
general condition of the patient and the technique used. Adequate
hydration should be assured
before and after administration as for other contrast media.
As