IOPAMIRO 370

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

IOPAMIDOL

Disponibil de la:

DEXCEL LTD, ISRAEL

Codul ATC:

V08AB04

Forma farmaceutică:

SOLUTION FOR INJECTION

Compoziție:

IOPAMIDOL 755.3 MG/ML

Calea de administrare:

I.V

Tip de prescriptie medicala:

Required

Produs de:

BRACCO IMAGING S.P.A., ITALY

Grupul Terapeutică:

IOPAMIDOL

Zonă Terapeutică:

IOPAMIDOL

Indicații terapeutice:

X-ray contrast medium in neuroradiology, angiography, urography, ct scanning, arthrography and fistulography

Data de autorizare:

2021-09-30

Caracteristicilor produsului

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Iopamiro 300 mg/ml solution for injection
Iopamiro 370 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Iopamiro
300 mg/mL
Solution for
Injection
Iopamiro
370 mg/mL
Solution for
Injection
Active ingredient
IOPAMIDOL
equal to IODINE
612.4 mg/mL
300.0 mg/mL
755.3 mg/mL
370.0 mg/mL
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear aqueous solution filled into colourless glass ampoules or
bottles.
Iodine
concentratio
n
Iopamidol
concentration
PH
Viscosity
cP
Density
Osmometric values
at 37° C
mg l/mL
mg l/mL
20° C
37° C
20° C
37° C
Osmolality
(osmol.kg
-1
)
Π
(atm)
300
_ _
612.4
_ _
7±0.5
_ _
8.8
_ _
4.7
_ _
1.335
_ _
1.328
_ _
0.616
15.7
370
_ _
755.3
_ _
7±0.5
_ _
20.9
_ _
9.4
_ _
1.415
_ _
1.405
_ _
0.796
20.3
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
This medicinal product is for diagnostic use only.
X-ray contrast medium in neuroradiology, angiography, urography, CT
scanning, arthrography
and fistulography.
4.2
Posology and method of administration
Neuroradiology
Concentration(mg I/ml)
Recommended Dose
(ml)
mieloradiculography
300
5 - 15
cisternography and
ventriculography
300
5 - 15
2
Angiography
Concentration
(mg I/ml)
Recommended Dosage
(ml)
Cerebral arteriography
300
5 - 10 per bolus
Coronary arteriography
370
8 - 15 per bolus
Thoracic aortography
370
1.0 – 1.2/kg
Abdominal aortography
370
1.0 – 1.2/kg
Angiocardiography
370
1.0 - 1.2/kg
Selective visceral
arteriography
300-370
depends on the vascular
area to be examined
Peripheral arteriography
300-370
40 – 50
Digital Subtraction
Angiography
150-370
depends on the vascular
area to be examined
Venography (phlebography)
300
30 - 50
Urography
The recommended dosage for this type of investigation is 30-50 ml for
adults. The less
marked osmotic diuresis induced by the non ionic agent makes Iopamiro
®
370 especially
suitable for patients with mild or moderately severe renal
insufficiency and for neo