Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
Diagnostic procedures which involve the use of any radiopaque medium should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed.
Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reaction to the contrast medium itself.
During the examination an intravenous route for emergency treatment in the event of a reaction is required.
After the administration of the contrast medium, competent personnel, drugs and equipment for emergency resuscitation must be available for at least 30 minutes.
Caution during injection of contrast media is necessary to avoid extravasation.
Local tissue irritation can occur as an event of perivascular infiltration of the contrast media.
In patients who are known epileptics or have a history of epilepsy, anticonvulsant therapy should be maintained before and following myelographic procedures. In some instances, anticonvulsant therapy may be increased for 48 hours before the examination. If during the procedure a convulsive crisis occurs, it is recommended to administer intravenously diazepam or phenobarbital.
Iopamidol injection should be used with caution in patients with hypercalcaemia and cerebral vascular disease.
The risk associated with a particular investigation may be increased by conditions such as advanced arteriosclerosis and hypertension.
The administration of iodinated contrast media may aggravate the symptoms of myasthenia gravis.
General anaesthesia may be indicated in selected patients. However, a higher incidence of adverse reactions has been reported in these patients, probably due to the hypotensive effect of the anaesthetic.
As with all other contrast media this product may provoke anaphylaxis or other manifestations of allergy with nausea, vomiting, dyspnoea, erythema, urticaria and hypotension. Occasional severe reactions with fatal outcome have been reported.
A positive history of allergy, asthma or untoward reaction during previous similar investigations indicates a need for extra caution; the benefit should clearly outweigh the risk in such patients.
Pre-treatment with antihistamines or corticosteroids to prevent or minimise possible allergic reactions in such patients may be considered.
The risk of bronchospasm-inducing reactions in asthmatic patients is higher after contrast media administration, especially in patients taking beta-blockers.
In patients with suspected or known hypersensitivity to contrast media, sensitivity testing is not recommended, as severe or fatal reactions to contrast media are not predictable from sensitivity tests.
The patient should also be informed that allergic reactions may develop up to several days after the procedure; in such case, a physician should be consulted immediately.
Particular care should be exercised in patients with moderate to severe impairment of renal function (as reflected by a raised blood urea). Substantial deterioration in renal function is minimized if the patient is well hydrated. Renal function parameters, especially urinary output should be monitored after the examination in these patients. Pre-existing renal impairment may predispose to acute renal dysfunction following contrast media administration.
In patients with impairment of renal function, the administration of potentially nephrotoxic drugs should be avoided until the contrast medium is completely excreted. In such patients, renal function parameters should be monitored after the procedure. Further administration of contrast media should be postponed until renal function has returned to its previous level.
Patients on dialysis may receive contrast media such as iopamidol, which can be removed without difficulty by dialysis.
Patients with severe hepatic, renal or combined hepato-renal insufficiency should not be examined unless absolutely indicated. Re-examination should be delayed for 5-7 days.
Care should be taken in renal impairment and diabetes. In these patients it is important to maintain hydration in order to minimize deterioration in renal function.
The presence of renal damage in diabetic patients is one of the factors predisposing to renal impairment following contrast media administration. This may precipitate lactic acidosis in patients who are taking metformin (see section 4.5 - Interaction with medicaments and other forms of interaction).
Patients must be sufficiently hydrated before and after radiographic procedures. Patients with severe functional impairment of the liver or myocardium, myelomatosis, diabetes, polyuria or oliguria, hyperuricemia, infants, elderly patients and patients with severe systemic disease should not be exposed to dehydration.
Fluid intake should not be limited and any abnormalities of fluid or electrolyte balance should be corrected prior to use of this hypertonic solution.
Patients with paraproteinaemia of Waldenström, with multiple myeloma or severely compromised hepatic and renal impairment are also more at risk: in these cases adequate hydration is recommended after contrast medium administration.
Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when injected intravenously and intra-arterially. To prevent crises in patients with sickle cell disease adequate hydration should be assured and a minimal volume of low concentration should be used.
Patients with congestive heart failure should be observed for several hours following the procedure to detect delayed haemodynamic disturbances, which may be associated with a transitory increase in the circulating osmotic load.
In patients undergoing angiocardiographic procedures special attention should be paid to the status of the right heart and pulmonary circulation. Right heart insufficiency and pulmonary hypertension may precipitate bradycardia and systemic hypotension, when the organic iodine solution is injected. Right heart angiography should be carried out only when absolutely indicated.
During intracardiac and/or coronary arteriography, ventricular arrhythmias may infrequently occur.
Caution should be exercised in performing iodinated contrast-enhanced examinations in patients with, or with suspicion of, hyperthyroidism or autonomously functioning thyroid nodule(s), as thyroid storms have been reported following administration of iodinated contrast media.
Iopamiro should be used with caution in patients with hyperthyroidism. It is possible that hyperthyroidism may recur in patients previously treated for Graves' disease.
In patients scheduled for thyroid examination with a radioactive iodine tracer, one must take into consideration that iodine uptake in the thyroid gland will be reduced for several days (up to two weeks) after dosing with an iodinized contrast medium that is eliminated through the kidneys.
Patients with phaeochromocytoma may develop severe hypertensive crisis following intravascular Iopamidol. Pre-medication with -receptor blockers is recommended.
In angiographic procedures, the possibility of dislodging plaque or damaging or perforating the vessel wall should be considered during catheter manipulation and contrast medium injection.
Test injections to ensure proper catheter placements are recommended.
In examinations of the aortic arch the tip of the catheter should be positioned carefully to avoid hypotension, bradycardia and CNS injury due to excess pressure transmitted from the injector pump to the brachiocephalic branches of the aorta.
Angiography should be avoided whenever possible in patients with homocystinuria due to an increased risk of thrombosis and embolism.
In patients undergoing peripheral angiography, there should be pulsation in the artery into which the X-ray contrast medium will be injected. In patients with thromboangiitis obliterans or ascending infections in combination with serious ischemia the angiography should be performed, if at all, with special caution.
In patients undergoing venography, special caution should be exercised in patients with suspected phlebitis, serious ischaemia, local infections, or a complete venous occlusion.
Serious neurological events have been observed following direct injection of contrast media into cerebral arteries or vessels supplying the spinal cord or in angiocardiography due to inadvertent filling of the carotids.
Iopamiro should be administered with caution in elderly patients, in patients with symptomatic cerebrovascular diseases, recent stroke, or frequent TIA, altered permeability of the blood- brain barrier, increased intracranial pressure, suspicion of intracranial tumour, abscess or hematoma/hemorrhage, history of convulsive disorder, chronic alcoholism or multiple sclerosis. Patients with these conditions have an increased risk of neurological complications.
Vasospasm and subsequent cerebral ischemic phenomena may be caused by intra-arterial injections of contrast media.

Intrathecal administration
An accurate evaluation of the risk/benefit ratio is needed if from clinical history there is a previous history of epilepsy or in the presence of blood in the cerebrospinal fluid or presence of local or systemic infection where bacteremia is likely.
The contrast medium should be removed as much as possible in case of spinal fluid blockage.

Use in Special Populations
Newborns, children
Infants (age<1 year), and especially newborns are particularly susceptible to electrolyte imbalances and haemodynamic alterations. Care should be taken regarding the dosage to be used, the details of the procedure, and the patient’s status.
When examining small children or babies, do not limit fluid intake before administering a hypertonic contrast solution. Also, correct any existing water and electrolyte imbalance.

In paediatric roentgenology, one should proceed with great caution when injecting the contrast medium into the right heart chambers of cyanotic neonates with pulmonary hypertension and impaired cardiac function.

Transient hypothyroidism may occur in neonates when the mother or the neonate has received an iodinated contrast agent. Thyroid function tests (usually TSH and T4) are recommended in neonates 7-10 days and 1 month after exposure to Iopamiro especially in preterm neonates.

Elderly
The elderly are at special risk of reactions due to reduced physiological functions, especially when high dosage of contrast medium is used. Myocardial ischemia, major arrhythmias and premature ventricular complexes are more likely to occur in these patients. The probability of acute renal insufficiency is higher in these patients.

Women of child-bearing potential
X-ray examination of women should if possible be conducted during the pre-ovulation phase of the menstrual cycle and should be avoided during pregnancy. Appropriate investigations and measures should be taken when exposing women of child-bearing potential to any X-ray examination, whether with or without contrast medium.

Effects on Driving

4.7 Effects on ability to drive and use machines
There is no available data on Iopamiro effects on the ability to drive and operate machines.
Before driving or operating machinery, side effects such as hypotension, dizziness, confusion, shortness of breath, which may occur with the use of this medicinal product, should be taken into account.