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יופמירו 370 IOPAMIRO 370 (IOPAMIDOL)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-ורידי : I.V

צורת מינון:

תמיסה להזרקה : SOLUTION FOR INJECTION

Posology : מינונים

4.2    Posology and method of administration

Neuroradiology
Concentration(mg I/ml)            Recommended Dose
(ml) mieloradiculography                 300                               5 - 15 cisternography and                  300                               5 - 15 ventriculography



Angiography

Concentration             Recommended Dosage
(mg I/ml)                         (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                          300-370                 depends on the vascular arteriography                                                         area to be examined Peripheral arteriography                    300-370                          40 – 50 Digital Subtraction                         150-370                 depends on the vascular Angiography                                                           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 neonates.
The new contrast medium affords diagnostically useful nephrography even in patients with major renal insufficiency.

OTHER DIAGNOSTIC PROCEDURES

Concentration (mg I/ml)         Recommended Dosage (ml)
Contrast enhancement in CT       300 - 370                       0.5 – 2.0/kg scanning
Artrography                      300                             depending on examination Fistulography                    300                             depending on examination 
For the enhancement of contrast in CT scans IOPAMIRO® may be injected intravenously as a bolus, as a drip infusion or by a combination of the two methods.
The administration as an infusion is limited to old generation CT equipment. With spiral CT and the new multislice CT, it is recommended to administer a bolus specially for investigations aiming at increasing contrast enhancement in the arterial phase.
With slow equipment infusion is recommended whilst with fast equipment bolus injection is preferable.

Method of administration
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.


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.
Iopamiro 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 intra-cranially.
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 Iopamiro 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)
Iopamiro may be administered by rapid injection through a catheter into a suitable peripheral artery or vein. 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. Iopamiro 300 is 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.

Angiocardiography, left ventriculography, selective coronary arteriography It can also be introduced under pressure through a cardiac catheter into any of the heart chambers, or injected into large vessels for immediate visualisation. The contrast medium may also be administered during selective catheterisation of the coronary arteries.

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

Digital subtraction angiography
For cardiac imaging the contrast medium may be administered intra-arterially by selective catheterisation to provide subtracted images. Iopamiro 370 injected intravenously either centrally or peripherally is also recommended for use in this modality.

שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
תאריך הכללה מקורי בסל 01/01/1995
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יופמירו 370

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