Scanlux® 370 mg I/ml Solution for injection

 

Product Description

Therapeutic indications:

X-ray contrast media for:

– peripheral arteriography

– angiocardiography & left ventriculography

– coronary arteriography

– digital subtraction angiography:

– intravenous injection

– left ventriculography

– selective coronary arteriography by intra-arterial DSA

– intravenous urography

 

Qualitative and quantitative composition

Active substance: Iopamidol

ScanluxR 300 mg I/ml: 1 ml of solution for injection contains 612 mg Iopamidol

corresponding to 300 mg Iodine

ScanluxR 370 mg I/ml: 1 ml of solution for injection contains 755 mg Iopamidol

corresponding to 370 mg Iodine

Excipients: Trometamol, Hydrochloric acid, Sodium calcium edetate, Water for injections.

 

This medicinal product is for diagnostic use only.

X-ray contrast medium for injection, particularly in digital subtraction angiography.

 

Posology

Scanlux 370 mg/ml 150: DOSAGE SCHEDULE

Procedure Dosage
Intra arterial procedures Adults: 1-40 ml

Children: 0.5 – 0.75 ml/kg

Ventricular angiography Children: 1-1.5 ml/kg

The dosage must be adapted to the examination, the age, body weight, cardiac output, renal function, general condition of the patient and the technique used. Usually the same iodine concentration and volume are used with other iodinated x-ray contrast in current use.

Method of administration

As with all contrast media, the lowest dose necessary to obtain adequate visualisation should be used.

Non-ionic contrast media have less anti-coagulant activity in-vitro than ionic media. Meticulous attention should therefore be paid to angiographic technique. Non-ionic media should not be allowed to remain in contact with blood in the syringe and intravascular catheters should be flushed frequently, to minimise the risk of clotting, which rarely has led to serious thromboembolic complications after procedures. Factors such as length of procedure, catheter and syringe material, underlying disease state, and concomitant medications may contribute to the development of thromboembolic events. Therefore, meticulous angiographic techniques are recommended including close attention to guide wire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions, and minimizing the length of the procedure.

As experience shows that warmed contrast media are better tolerated, the contrast medium should be warmed up to body temperature before administration.

No other drugs or contrast media should be mixed with the iopamidol solution for injection.

Digital subtraction angiography

For cardiac imaging the contrast medium may be administered intra-arterially by selective catheterisation to provide subtracted images. Scanlux 370 mg/ml 340 and 370 injected intravenously either centrally or peripherally is also recommended for use in this modality.

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