OMNIPAQUE INJECTION 350 mg Iml

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

IOHEXOL 755 mg/ml EQV IODINE

Tillgänglig från:

GE HEALTHCARE PTE. LTD.

ATC-kod:

V08AB02

Dos:

350 mg/ml

Läkemedelsform:

INJECTION

Sammansättning:

IOHEXOL 755 mg/ml EQV IODINE 350 mg/ml

Administreringssätt:

INTRAVENOUS, INTRAVASCULAR, INTRACAVITARY, INTRA-ARTERIAL

Receptbelagda typ:

Prescription Only

Tillverkad av:

GE HEALTHCARE IRELAND LIMITED (by Parametric Release)

Bemyndigande status:

ACTIVE

Tillstånd datum:

1991-05-17

Bipacksedel

1155404 GE 7
NAME OF THE MEDICINAL PRODUCT
OMNIPAQUE injection 140 mg I/ml, 180 mg I/ml, 200 mg I/ml,
240 mg I/ml, 300 mg I/ml, 350 mg I/ml
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Active ingredient
Strength
Content per. ml.
Iohexol (INN)
140 mg I/ml
302 mg  equiv. 140 mg I
Iohexol (INN)
180 mg I/ml
388 mg  equiv. 180 mg I
Iohexol (INN)
200 mg I/ml
431 mg  equiv. 200 mg I
Iohexol (INN)
240 mg I/ml
518 mg  equiv. 240 mg I
Iohexol (INN)
300 mg I/ml
647 mg  equiv. 300 mg I
Iohexol (INN)
350 mg I/ml
755 mg  equiv. 350 mg I
Iohexol is a non-ionic, monomeric, triiodinated, water-soluble
X-ray contrast medium. Omnipaque in the concentration of
140 mg I/ml is isotonic with blood and tissue fluid.
The osmolality and viscosity values of Omnipaque are as
follows:
Osmolality **
Viscosity (mPa·s)
Concentration
Osm/kg H
2
O
37°C
20°C
37°C
140 mg I/ml
0.29
2.3
1.5
180 mg I/ml
0.36
3.2
2.0
200 mg I/ml
0.41
3.8
2.4
240 mg I/ml
0.51
5.6
3.3
300 mg I/ml
0.64
11.6
6.1
350 mg I/ml
0.78
23.3
10.6
** 
Method: Vapour - pressure osmometry.
PHARMACEUTICAL FORM
Solution for injection.
Omnipaque injection is supplied ready to use as clear, colour-
less to pale yellow, sterile aqueous solutions.
CLINICAL PARTICULARS
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 cholangio-
pancreatography (ERCP), herniography, hysterosalpingography,
sialography and studies of the gastrointestinal tract.
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 concen-
tration and volume is used as with other iodinated X-ray
contrast media in current use. Adequate hydration should be
assured before and

Produktens egenskaper

Page 1 of 22
1197014 SGP
1197014
IOHEXOL
1
NAME OF THE MEDICINAL PRODUCT
OMNIPAQUE injection 140 mg I/ml, 180 mg I/ml, 200 mg I/ml, 240 mg
I/ml, 300 mg
I/ml, 350 mg I/ml
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Strength
Content per. ml.
Iohexol (INN)
140 mg I/ml
302 mg equiv. 140 mg I
Iohexol (INN)
180 mg I/ml
388 mg equiv. 180 mg I
Iohexol (INN)
200 mg I/ml
431 mg equiv. 200 mg I
Iohexol (INN)
240 mg I/ml
518 mg equiv. 240 mg I
Iohexol (INN)
300 mg I/ml
647 mg equiv. 300 mg I
Iohexol (INN)
350 mg I/ml
755 mg equiv. 350 mg I
______________________________________________________
Iohexol is a non-ionic, monomeric, tri-iodinated, water-soluble X-ray
contrast medium.
Omnipaque in the concentration of 140- mg-I/ml is isotonic with blood
and tissue fluid.
The osmolality and viscosity values of Omnipaque are as follows:
Concentration
Osmolality **
Osm/kg H
2
O
37°C
Viscosity (mPa

s)
20°C
37°C
140 mg I/ml
0.29
2.3
1.5
180 mg I/ml
0.36
3.2
2.0
200 mg I/ml
0.41
3.8
2.4
240 mg I/ml
0.51
5.6
3.3
300 mg I/ml
0.64
11.6
6.1
350 mg I/ml
0.78
23.3
10.6
** Method: Vapour - pressure osmometry.
This medicinal product contains 0.012 mg sodium per ml, i.e.
essentially sodium free.
Page 2 of 22
For a full list of Excipients, see Section
6.1
LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Solution for injection.
Omnipaque injection is supplied ready to use as clear, colourless to
pale yellow, sterile
aqueous solutions.
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