All text inserted unless otherwise commented:
Section 1.
solution for injection.
Section 2.
Each ml contains 755.3 mg Iopamidol.
For excipients, see 6.1.
Section 3.
Clear aqueous solution filled into colourless glass ampoules or bottles.
Section 4.2
Route of administration
Intra-ventricular
Dosage
Elderly: The lowest effective dose should be used.
Method of administration
No other drugs should be mixed with the contrast medium.
Peripheral arteriography and phlebography (venography)
Percutaneous injection into the appropriate blood vessel is used for visualisation of peripheral arteries and veins.
Angiocardiography, left ventriculography, selective coronary arteriography
Niopam may be administered by rapid injection through a catheter into a suitable peripheral artery or vein. 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.
Aortography
The contrast medium may be introduced directly by intra-arterial injection (retro-grade method) for visualisation of the aorta and its main branches.
Selective visceral angiography
Visualisation can be achieved by selective catheterisation and injection into the hepatic, coeliac or mesenteric arteries.
Digital subtraction angiography
For cardiac imaging the contrast medium may be administered intra-arterially by selectivecatheterisation to provide subtracted images. Niopam 340 and 370 injected intravenously either centrally or peripherally is also recommended for use in this modality.
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.
Section 4.4
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. – Removed from this section
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.
Waldenströms macroglobulinemia, multiple myeloma
Niopam should be administered with caution in elderly patients and patients with increased intracranial pressure or suspicion of intracranial tumour, abscess or haematoma, and in those with a history of a previous reaction to contrast media, asthma, allergy, epilepsy, severe cardiovascular disease, renal impairment, chronic alcoholism or multiple sclerosis.
Patients with these conditions have an increased risk of neurological complications.
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.
Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when injected intravenously and intra-arterially.
Patients with phaeochromocytoma may develop severe hypertensive crisis following intravascular iopamidol. Pre-medication with a-receptor blockers is recommended. The administration of iodinated contrast media may aggravate the symptoms of myasthenia gravis.
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. All other patients should be observed for at least one hour after the procedure, as most of the adverse events occur in this period. 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.
In neonates, and particularly in premature neonates, it is recommended that tests of thyroid function (typically TSH and T4), should be checked 7-10 days and 1 month after the administration of iodinated contrast media because of the risk of hypothyroidism due to iodine overload.
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.
Local tissue irritation can occur as an event of perivascular infiltration.
Neuroradiology
Neuroleptics must be absolutely avoided because they lower the seizure threshold. The same applies to analgesics, anti-emetics, antihistamines and sedatives of the phenothiazine group. Whenever possible, treatment with such drugs should be discontinued at least 48 hours before administration of the contrast medium and not be resumed less than 12 hours after completion of the procedure.
Angiography
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.
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.
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.
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.
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.
Urography
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.
Re-examination should be delayed 5-7 days.
Section 4.5
Thyroid Tests will not accurately reflect thyroid function for up to 16 days following administration of iodinated contrast media. Thyroid function tests not depending on iodine estimations, e.g. T3 resin uptake and total or free thyroxine (T4) assays are not affected.
No other specific interference with physiological functions have been noted.
The administration of an X-ray contrast medium in diabetic patients with nephropathy who are taking biguanides may precipitate lactic acidosis.
Arterial thrombosis has been reported when iopamidol was given following papaverine. The administration of vasopressors strongly potentiate the neurological effect of the intra-arterial contrast media.
Contrast media may interfere with laboratory tests for bilirubin, proteins or inorganic substances (eg iron, copper, calcium, phosphate). These substances should not be assayed during the same day following the administration of contrast media
Section 4.6
Niopam is poorly excreted in human milk. From animal experience, Niopam is non toxic in animals after oral administration. Although, no serious adverse reactions have been reported in nursing infants, Niopam should be administered to lactating women only if considered essential by the physician
Section 4.7
There is no known effect on the ability to drive and operate machines. However, because of the risk of early reactions, driving or operating machinery is not advisable for one hour following the last injection.
Section 4.8
The symptoms include diffuse erythema, feeling hot, rhinitis or laryngeal oedema, fever, sweating, asthenia, dizziness, pallor, dyspnoea, moderate hypotension. Skin reactions may occur in the form of various types of diffuse blisters. More severe reactions involving the cardiovascular system such as vasodilatation with pronounced hypotension, tachycardia, agitation, cyanosis, loss of consciousness and cardiac arrest may require emergency treatment.
The occurrence of delayed intolerance reactions, most commonly pruritus and urticaria, has been reported up to several days post administration.
During intracardiac and/or coronary arteriography, ventricular arrhythmias may infrequently occur.
Also cases of myocardial ischemia or infarction and/or cardiac failure/cardiac arrest have been reported rarely.
Other undesirable effects are:
- renal impairment,
- thrombocytopaenia,
- asthma/bronchospasm, and
- pulmonary oedema.
Hyperthyroidism may recur in patients previously treated for Graves' disease.
After cerebral angiography, confusion; stupor; coma; paresis; cortical blindness (usually transient); and convulsions may occur.
Rarely, Steven-Johnson syndrome has been reported.
Local pain and swelling at the injection site may occur.
Section 4.9
Treatment of overdosage is directed toward the support of all vital functions and the elimination of the contrast medium while maintaining the patient well hydrated.
If needed, hemodyalisis can be used to eliminate iopamidol from the body.
Section 5
Pharmacotherapeutic group; ATC code: V08A B04
Section 6.6
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 residue of contrast medium must be discarded.
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.
Section 9.
22nd March 1982 / 9th January 2002
Section 10.
29th July 2005
