Visipaque

/ Eldan

The dosage may vary depending on the type of examination, the age, weight, cardiac output and general condition of the patient and the technique used. Usually approximately the same iodine concentration and volume is used as with other iodinated X-ray contrast media in current use, but adequate diagnostic information has also been obtained in some studies with iodixanol injection with somewhat lower iodine concentration. Adequate hydration should be assured before and after administration as for other contrast media. The product is for intravenous, intraarterial and intrathecal use.
For full details see prescribing information.

X-ray contrast medium for use in adults for cardioangiography, peripheral arteriography (conventional and i.a.DSA), abdominal angiography (i.a.DSA), urography, venography and CT enhancement and for use in children for cardioangiography, urography and CT enhancement. Lumbar, thoracic and cervical myelography.

Manifest thyrotoxicosis (hyperthyroidism), decompensated cardiac insufficiency, previous hypersensitivity to iodine or iodixand.

Special precautions for use of non-ionic contrast media in general: A positive history of allergy, asthma, or untoward reactions to iodinated contrast media indicates a need for special caution. Premedication with corticosteroids or histamine H1 and H2 antagonists might be considered in these cases. The risk of serious reactions in connection with use of this product is regarded as minor. However, iodinated contrast media may provoke, anaphylactoid reactions or other manifestations of hypersensitivity. A course of action should therefore be planned in advance, with necessary drugs and equipment available for immediate treatment, should a serious reaction occur. It is advisable always to use an indwelling cannula or catheter for quick intravenous access throughout the entire X-ray procedure. Non-ionic contrast media have less effect on the coagulation system in vitro, compared to ionic contrast media. When performing vascular catheterization procedures one should pay meticulous attention to the angiographic technique and flush the catheter frequently (e.g.: with heparinised saline) so as to minimize the risk of procedure-related thrombosis and embolism. Adequate hydration should be assured before and after contrast media administration. This applies especially to patients with multiple myeloma, diabetes mellitus, renal dysfunction, as well as to infants, small children and elderly patients. Young infants (age < 1 year) and especially neonates are susceptible to electrolyte disturbance and haemodynamic alterations. Care should also be taken in patients with serious cardiac disease and pulmonary hypertension as they may develop haemodynamic changes or arrhythmias. Patients with acute cerebral pathology, tumours or a history of epilepsy are predisposed for seizures and merit particular care. Also alcoholics and drug addicts have an increased risk for seizures and neurological reactions.
To prevent acute renal failure following contrast media administration, special care should be exercised in patients with preexisting renal impairment and diabetes mellitus as they are at risk. Patients with paraproteinemias (myelomatosis and Waldenström=s macroglobulinemia) are also at risk.
For full details see prescribing information.

Intravascular use: Undesirable effects associated with the use of iodinated contrast media are usually mild to moderate and transient in nature, and less frequent with non-ionic than with ionic contrast media. Serious reactions as well as fatalities are only seen on very rare occasions. The most frequent adverse event is a mild, general feeling of warmth or cold. Heat sensation in peripheral angiography is common (Incidence: >1:10), while distal pain occurs occasionally (Incidence < 1:10, but >1:100). Abdominal discomfort/pain is very rare (Incidence < 1:1000) and gastrointestinal reactions like nausea or vomiting are rare (Incidence < 1:100, but > 1:1000).
Hypersensitivity reactions: occur occasionally and usually present as mild respiratory or cutaneous symptoms like dyspnoea, rash, erythema, urticaria, pruritus and angioedema. They may appear either immediately after the injection or up to a few days later. Hypotension or fever may occur. Severe till toxic skin reactions have been reported. Severe manifestations such as laryngeal oedema, bronchospasm, pulmonary oedema and anaphylactic shock are very rare.
Anaphylactoid reactions may occur irrespectively of the dose and mode of administration and mild symptoms of hypersensitivity may represent the first signs of a serious reaction. Administration of the contrast medium must be discontinued immediately and, if necessary, specific therapy instituted via the vascular access. Patients using beta blockers may present with atypical symptoms of anaphylaxis which may be misinterpreted as a vagal reaction.
Vagal reactions: giving hypotension and bradycardia are seen on very rare occasions.
Iodism or “iodide mumps”: is a very rare complication of iodinated contrast media resulting in swelling and tenderness of the salivary glands for up to approximately 10 days after the examination.
A minor transient increase in S-creatinine is common after iodinated contrast media, but usually of no clinical relevance. Renal failure is very rare. However, fatalities have been reported in high risk patient groups.
Arterial spasm: may follow injection into coronary, cerebral or renal arteries and result in transient ischaemia.
Neurological reactions: are very rare. They may include headache, dizziness, seizures or transient motor or sensory disturbances. On very rare occasions the contrast medium may cross the blood-brain barrier resulting in uptake of contrast medium in the cerebral cortex being visible on CT-scanning until the day following examination, sometimes associated with transient confusion or cortical blindness.
Cardiac complications: are very rare, including arrhythmias, depression or signs of ischaemia. Hypertension may occur.
Post phlebographic thrombophlebitis or thrombosis is very rare. A very few cases of arthralgia have been reported.
Severe respiratory symptoms and signs (including dyspnoea and non-cardiogenic pulmonary oedema), and cough may occur.
Intrathecal use: Undesirable effects following intrathecal use may be delayed and present some hours or even days after the procedure. The frequency is similar to lumbar puncture alone.
Headache, nausea, vomiting or dizziness: are common and may largely be attributed to pressure loss in the subarachnoid space resulting from leakage at the puncture site. Some of these patients may experience a severe headache lasting for several days. Excessive removal of cerebrospinal fluid should be avoided in order to minimize pressure loss.
Mild local pain and radicular pain at the site of injection may occur.
Meningeal irritation: giving photophobia and meningism and frank chemical meningitis have been observed with other nonionic iodinated contrast media. The possibility of an infective meningitis should also be considered.
Similarly, manifestations of transient cerebral dysfunction have been seen on very rare occasions with other nonionic iodinated contrast media. These include seizures, transient confusion or transient motor or sensory dysfunction. Changes in the EEG was noted in a few of these patients.
For full details see prescribing information.

All iodinated contrast media may interfere with tests on thyroid function, thus the iodine binding capacity of the thyroid may be reduced for up to several weeks. High concentrations of contrast media in serum and urine can interfere with laboratory tests for bilirubin, proteins or inorganic substances (e.g. iron, copper, calcium and phosphate). These substances should therefore not be assayed on the day of examination. Use of iodinated contrast media may result in a transient impairment of renal function and this may precipitate lactic acidosis in diabetics who are taking metformin.
Patients treated with interleukin-2 less than two weeks previous to an iodinated contrast medium injection have been associated with an increased risk for delayed reactions (flu-like symptoms or skin reactions).

Pregnancy: The safety of this product  for use in human pregnancy has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to reproduction, development of the embryo or fetus, the course of gestation and peri- and postnatal development.
Since, wherever possible, radiation exposure should be avoided during pregnancy, the benefits of any X-ray examination, with or without contrast media, should be carefully weighed against the possible risk. The product should not be used in pregnancy unless benefit outweighs risk and it is considered essential by the physician.
Lactation: The degree of excretion into human milk is not known, although expected to be low. Breast feeding should be discontinued prior to administration of VISIPAQUE and should not be recommenced until at least 24 hours after.

Overdose is unlikely in patients with a normal renal function. The duration of the procedure is important for the renal tolerability of high doses of contrast media  (t½ ~ 2 hours). In the event of accidental overdosing, the water and electrolyte losses must be compensated by infusion. Renal function should be monitored for at least the next 3 days. If needed, haemodialysis may be used to remove iodixanol from the patient=s system. There is no specific antidote.