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SCANLUX is a brand name for Iopamidol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: This medicinal product is for diagnostic use only. X-ray contrast media for peripheral arteriography and venography, angiocardiography, digital subtraction angiography, left ventriculography and coronary arteriography, computer tomography enhancement and urography
Verbatim from this product's MHRA label. Tap a section to expand.
For intravenous or intra arterial use. 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 as for other iodinated X-ray contrast media in current use.
4 must be considered before administering this product. All patients should be observed for 20 to 30 minutes after the procedure, as most of the adverse events occur in this period. 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.
Caution during injection of contrast media is necessary to avoid extravasation. As with all contrast media, the lowest dose necessary to obtain adequate visualisation should be used. The total volume that must not be exceeded is 250 ml.
There are no special dosage requirements for elderly patients. Non-ionic contrast media should not be allowed to remain in contact with blood in the syringe or intravascular catheters which should be flushed frequently to minimize the risk of clotting and thromboembolic events during angiographic techniques.
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.
The following doses are recommended as a guide. 5 ml/kg** * Repeat as necessary. ** Proportional to the adult dose according to body size and age. *** Procedure not normally applicable to children. Method of administration No other drugs or contrast media should be mixed with iopamidol solution for injection.
Peripheral arteriography and phlebography (venography) Percutaneous injection into the appropriate blood vessel is used for visualisation of peripheral arteries and veins. v. injection. v. administration as a bolus, as a drip infusion or by a combination of the two methods.
Iopamidol may cause adverse reactions, which are generally mild or moderate and transient although rare severe and life-threatening reactions sometimes leading to death have been reported. Following intravascular administration, in most cases reactions occur within minutes of dosage.
However, delayed reactions, usually involving skin, may occur, mostly within 2-3 days, more rarely within 7 days, after the administration of the contrast medium. Anaphylaxis (anaphylactoid reactions/hypersensitivity) may manifest with: mild localized or more diffuse angioneurotic oedema, tongue oedema, laryngospasm or laryngeal oedema, dysphagia, pharyngitis and throat tightness, pharyngolaryngeal pain, cough, conjunctivitis, rhinitis, sneezing, feeling hot, sweating increased, asthenia, dizziness, pallor, dyspnoea, wheezing, bronchospasm, and moderate hypotension.
Skin reactions may occur in the form of various types of rash, diffuse erythema, diffuse blisters, urticaria, and pruritus. These reactions, which occur irrespective of the dose administered and the route of administration, may represent the first signs of incipient state of shock.
Administration of the contrast medium must be discontinued immediately and – if necessary – specific treatment initiated via a venous access. More severe reactions involving the cardiovascular system such as vasodilatation with pronounced hypotension, tachycardia, dyspnoea, agitation, cyanosis and loss of consciousness (syncope) may require emergency treatment.
Hypersensitivity reactions are more frequent in patients with an allergic disposition or who have shown hypersensitivity reactions during a previous examination with an iodinated contrast agent. Injection site pain and swelling may occur.
On very rare occasions extravasation of contrast medium led to inflammation (manifested with local erythema, oedema and blisters), skin necrosis and compartment syndrome. As with other iodinated contrast media, very rare cases of mucocutaneous syndromes, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome) and erythema multiforme, have been reported following the administration of Iopamidol.
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.
Appropriate resuscitative measures should be immediately available. 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 andany abnormalities of fluid or electrolyte balance should be corrected prior to use of this hypertonic solution. As experience shows that warmed contrast media are better tolerated, the contrast medium should be warmed up to body temperature before administration.
Care should be exercised in patients with moderate to severe impairment of renal function. 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 with severe hepatic, renal or combined hepato-renal insufficiency should not be examined unless absolutely indicated.
Iopamidol is strictly contraindicated in patients with manifest hyperthyroidism. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
4). 5%) after intravascular administration. The adverse reactions reported in clinical trials among 2,680 adult subjects and 35 paediatric patients, and from post marketing surveillance are presented in the tables below by frequency and classified by MedDRA system organ classes.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Adult patients involved in clinical trials with intravascular administration of Iopamidol were 2,548, of whom 1,597 with intra-arterial and 951 with intravenous administration.
System Organ Class Adverse Reactions Clinical Trials Post-marketing surveillance Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Frequency unknown* Blood and lymphatic system disorders Thrombocytopenia immune system disorders Anaphylaxis, Anaphylactoid reaction Psychiatric disorders Confusional state Nervous system disorders Headache Dizziness, Taste alteration Paraesthesia Coma, Transient ischaemic attack, Syncope, Depressed level of consciousness or loss of consciousness, Convulsion, Hemiplegia Eye disorders Blindness transient, Visual disturbance, Conjunctivitis, Photophobia Cardiac disorders Cardiac dysrhythmias such as extrasystoles, atrial fibrillation, ventricular tachycardia and ventricular fibrillation** Bradycardia Myocardial ischaemia or infarction, Cardiac failure, Cardio- respiratory arrest, Tachycardia, Kounis syndrome Vascular disorders Hypotension, Hypertension, Flushing Circulatory collapse or shock Respiratory, thoracic and mediastinal disorders Pulmonary oedema, Asthma, Bronchospasm Respiratory arrest, Respiratory failure, Acute respiratory distress syndrome, Respiratory distress, Apnoea, Laryngeal oedema, Dyspnoea Gastrointestinal disorders Nausea Vomiting, Diarrhea, Abdominal pain, Dry mouth Salivary hypersecretion, Salivary gland enlargement Skin and subcutaneous tissue disorders Rash, Urticaria, Pruritus, Erythema, Sweating increased Face oedema, Acute generalised exanthematous pustulosis (AGEP) Musculoskeletal and connective tissue disorders Back pain Muscle spasms Musculoskeletal pain, Muscular weakness Renal and urinary disorders Acute renal failure General disorders and administration site conditions Feeling hot Chest pain, Injection site pain, Pyrexia, Feeling cold Rigors, Pain, Malaise Investigations Blood creatinine increased Electrocardiogram change including ST segment depression * Since the reactions were not observed during clinical trials with 2,548 patients, best estimate is that their relative occurrence is rare (≥1/10,000 to <1/1000).
The most appropriate MedDRA term is used to describe a certain reaction and its symptoms and related conditions. ** Cardiac dysrhythmias may occur mostly after cardiac angiographic and coronary catheterization procedures In addition, the following adverse events can occur with unknown frequency: Metabolism and nutrition disorders: Acidosis, abnormalities in blood electrolyte values.
Nervous system disorders: amnesia, paresis and paralysis, tremors, somnolence. Eye disorders: watery/itchy eyes, lacrimation.
Ear and labyrinth disorders:
Impaired hearing, echoacousia, progressive transitory hearing loss or other auditory symptoms.
Gastrointestinal disorders:
Anorexia, severe retching and choking.
Renal and urinary disorders:
Transient changes in renal chemistry tests indicating renal impairment, anuria, oliguria, urinary retention or incontinence, pain, […]
Re-examination should be delayed for 5-7 days. Patients on dialysis may receive contrast media such as iopamidol, which can be removed without difficulty by dialysis. The presence of renal damage in diabetic patients is one of the factors predisposing to acute renal impairment following intravascular contrast media administration.
5). The risk associated with a particular investigation may be increased by conditions such as advanced arteriosclerosis and hypertension. 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. Great caution should be paid when injecting the contrast medium into the heart chambers, especially in cyanotic neonates with pulmonary hypertension and impaired cardiac function.
During intracardiac and/or coronary arteriography, ventricular arrhythmias may infrequently occur. 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 placement 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 ischaemia 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.
Patients who are known epileptic or have a history of epilepsy should have their medicine maintained. In some instances, anticonvulsant therapy may be increased for 48 hours before the examination. Iopamidol should be administered with caution in patients with symptomatic cerebrovascular diseases, recent stroke, or frequent TIA, altered permeability of the blood-brain barrier, increased intracranial pressure, suspicion of intracranial tumor, abscess or hematoma/hemorrhage, history of convulsive disorder, alcoholism.
Use of this product may interfere with tests for thyroid function. In patients scheduled for thyroid examination and/or treatment with a radioactive iodine tracer, iodine update in the thyroid gland will be reduced for several days, sometimes up to 2 weeks after dosing with an iodinated contrast medium that is eliminated through the kidneys.
It is possible that hyperthyroidism may recur in patients previously treated for Graves’ disease. In patients with hyperthyroidism, the radiological examination should be performed only if thought necessary by the physician. Patients with phaeochromocytoma can develop severe hypertensive crises following intravascular iopamidol administration.
Premedication with α-receptor blockers is recommended. Patients with paraproteinaemia of Waldenström, with multiple myeloma or severely compromised hepatic and renal impairment are also more at […]