NIOPAM Solution for injection Ref.[9480] Active ingredients: Iopamidol

Route of administration

Intra-ventricular, Intra-arterial, Intra-venous, Intra-articular, Intra-thecal, Intra-cisternal.

Posology

NIOPAM 300: DOSAGE SCHEDULE:

* repeat as necessary; **according to body size and age;

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.

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

Method of administration

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.

Lumbar myelography

A slow sub-arachnoid injection is made through a fine lumbar puncture needle into one of the lower lumbar interspinous spaces (L3-L4 or L4-L5). Optimum contrast appears immediately after injections and films should be obtained promptly.

Thoraco-cervical myelography

Following a slow sub-arachnoid injection the patient should be turned on his side and tilted 10°-20° head down under fluoroscopic control. In this manner it is possible to control movement of the contrast medium column into the dorsal region.

If the cervical region is to be examined, the contrast medium should be run into the cervical region first, before the examination of the dorsal areas where it is progressively diluted.

Niopam may also be injected sub-occipitally or by lateral cervical puncture technique. Care should be taken to ensure that the contrast medium does not move intracranially.

After completion of direct cervical or lumbo-cervical procedures:

• Raise head of table steeply (45° angle) for about two minutes so that the contrast medium flows towards the caudal end.
• Avoid excessive and particularly active patient movement or straining, maintain the patient under close observation, quiet and in a head up position especially in the first few hours.
• Patients suspected of having a low seizure threshold should be observed during this period.
• The patient should remain supine and at bed rest during this period. - Encourage the patient, if able, to take in fluids orally and eat.

Cerebral angiography

Any of the current techniques is suitable for radiological visualisation of the cerebral vasculature with Niopam 300. Carotid and vertebral angiography, performed by catheterisation or percutaneous injection techniques, require rapid injection, which, if necessary may be repeated.

Peripheral arteriography and phlebography (venography)

Percutaneous injection into the appropriate blood vessel is used for visualisation of peripheral arteries and veins.

Computer tomography enhancement

Contrast enhancement for brain scans can be achieved between one and three minutes after i.v. injection. Niopam 200, 300 and 340 are also used for total body scanning examinations after i.v. administration as a bolus, as a drip infusion or by a combination of the two methods.

Urography

The contrast medium is injected intravenously and rapidly eliminated through the kidneys. In patients with severe renal failure, high dose urography should be used.

Arthrography

Visualisation of joint cavities and articular surfaces can be achieved by either single or double contrast examination.

Dosages exceeding the specific package insert dose are not recommended, as they might lead to life-threatening adverse effects.

If needed, haemodialysis can be used to eliminate Iopamidol from the body. Treatment of overdosage is directed toward the support of all vital functions and prompt institution of symptomatic therapy.

Intravascular

In the event of accidental intravascular overdose in humans, the water and electrolyte losses must be compensated by infusion. Renal function should be monitored for at least three days.

Intrathecal

Signs of intrathecal overdose may be: ascending hyperreflexia or tonic-clonic spasms, up to generalized seizures, and, in severe cases of central involvement, hyperthermia, stupor and respiratory depression.

5 years.

Protect from light.

10ml clear, colourless type I glass ampoules.

20 and 30ml clear, colourless type I or type II glass vials with rubber closures and aluminium caps.

20, 50, 70, 100, 200 and 250ml clear, colourless type I or type II glass bottles with rubber closures and aluminium caps.

Discard if the solution is not clear of particulate matter.

Exceptionally, the event of crystallisation of Niopam could occur. It has been shown that such a phenomenon is caused by a damaged or defective container and therefore the product should not be used in this case.

The bottle, once opened, must be used immediately..

Any unused medicinal product or waste material should be disposed off in accordance with local requirements.

Niopam, as other iodinated contrast media, can react with metallic surfaces containing copper (e.g. brass), therefore the use of equipment, in which the product comes into direct contact with such surfaces, should be avoided.