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IOMERON is a brand name for Iomeprol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: X-ray contrast medium used for: peripheral arteriography venography angiogardiography and left ventriculography cerebral arteriography visceral arteriography digital subtraction angiography computed tomography enhancement urography ERCP dacryocystography sialography fistulography galactography myelography
Verbatim from this product's MHRA label. Tap a section to expand.
5ml 10 - 15ml by lumbar injection * Repeat as necessary * * According to body size and age In elderly patients the lowest effective dose should be used. Unless otherwise instructed by the doctor, a normal diet may be maintained on the day of the examination.
In myelography, lower doses may be used for lumbar or thoracic studies and higher doses for cervical or total columnar studies. Regardless of the nature of the myelographic study, Iomeron should be injected slowly over 1-2 minutes. The X ray can be taken up to 60 minutes following injection.
Post myelographic CT of the spinal column should be delayed for approximately four hours to allow dilution and clearance of excessive contrast.
General The use of iodinated contrast media may cause untoward side effects. They are usually mild to moderate and transient in nature. However, severe and life-threatening reactions sometimes leading to death have been reported. In most cases, reactions occur within minutes of dosing but at times reactions may occur at later time.
Anaphylaxis (anaphylactoid/hypersensitivity reactions) may manifest with various symptoms, and rarely does any one patient develop all the symptoms. Typically, in 1 to 15 min (but rarely after as long as 2 h), the patient complains of feeling abnormal, agitation, flushing, feeling hot, sweating increased, dizziness, increased lacrimation, rhinitis, palpitations, paresthesia, pruritus, sore throat and throat tightness, dysphagia, cough, sneezing, urticaria, erythema, mild localised oedema, angioneurotic oedema and dyspnoea due to glottic/laryngeal/pharyngeal oedema and/or spasm manifesting with wheezing, and bronchospasm.
Nausea, vomiting, abdominal pain, and diarrhoea are also reported. These reactions, which can occur independently of the dose administered or the route of administration, may represent the first signs of circulatory collapse. Administration of the contrast medium must be discontinued immediately and, if needed, appropriate specific treatment urgently initiated via venous access.
Severe reactions involving the cardiovascular system, such as vasodilatation, with pronounced hypotension, tachycardia, dyspnoea, agitation, cyanosis and loss of consciousness progressing to respiratory and/or cardiac arrest may result in death.
These events can occur rapidly and require full and aggressive cardio-pulmonary resuscitation. Primary circulatory collapse can occur as the only and/or initial presentation without respiratory symptoms or without other signs or symptoms outlined above.
The adverse reactions reported in clinical trials among 4,903 adult patients and from post- marketing surveillance are represented in the tables below by frequency and classified by MedDRA system organ class. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
4 Special warnings and special 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 reactions, including hypersensitivity or anaphylactic reactions, to the contrast medium itself.
In consideration of possible complications, the patient should be kept under observation for at least 30 minutes after the examination. Risk of extravasation Extreme caution during injection of contrast media is necessary to avoid extravasation.
Hypersensitivity In patients with suspected or known hypersensitivity to contrast media, sensitivity test doses are not recommended, as severe or fatal reactions to contrast media are not predictable from sensitivity test. 8 for additional information on anaphylaxis reactions).
Patients using beta-adrenergic blocking agents may have a lower threshold for bronchospasm, especially if asthmatic, and are less responsive to treatment with beta agonists and adrenaline, which may necessitate the use of higher doses of adrenaline.
The benefits should clearly outweigh the risks in such patients and appropriate resuscitative measures should be immediately available. ; Williams and Wilkins; Baltimore 1992; Chapter 2 p 23 Hydration Patients must be well hydrated, and any relevant abnormalities of fluid or electrolyte balance should be corrected prior to and following contrast media injection.
Especially patients with severe functional impairment of the kidneys, liver or myocardium, myelomatosis or other paraproteinaemias, sickle cell disease diabetes mellitus, polyuria, oligouria, hyperuricaemia, neonates, infants, , elderly patients, and patients with severe systemic disease should not be exposed to dehydration.
Hypersensitivity to the active substance or any of the excipients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 Intravascular administration Adult patients involved in clinical trials with intravascular administration of Iomeprol were 4,739. Adults Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Common (≥1/100 t o <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Frequency unknown* Blood and lymphatic system disorders Thrombocytopenia, Haemolytic anaemia Immune system disorders Anaphylactoid reaction Endocrine disorders Hyperthyroidism Psychiatric disorders Anxiety Confusional state Nervous system disorders Headache Dizziness Presyncope Coma Transient ischaemic attack Paralysis Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Common (≥1/100 t o <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Frequency unknown* Syncope Convulsion Loss of consciousness Dysarthria Paraesthesia Amnesia Somnolence Taste abnormality Contrast induced encephalopathy*** Eye disorders Blindness transient Visual disturbance Conjunctivitis Lacrimation increased Photopsia Cardiac disorders Bradycardia Tachycardia Extrasystoles Cardiac arrest Myocardial infarction Cardiac failure Angina pectoris Arrhythmia Ventricular or atrial fibrillation Atrioventricular block Vascular disorders Hypertension Hypotension Circulatory collapse or shock Flushing Pallor Cyanosis Coronary artery thrombosis Coronary artery embolism Vasospasm**** Ischemia**** Respiratory, thoracic and mediastinal disorders Dyspnoea Respiratory arrest Acute respiratory distress syndrome (ARDS) Pulmonary oedema Laryngeal oedema Pharyngeal oedema Bronchospasm Asthma Cough Pharynx discomfort Laryngeal discomfort Rhinitis Dysphonia Gastrointestinal disorders Nausea Diarrhoea Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Common (≥1/100 t o <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Frequency unknown* Vomiting Abdominal pain Salivary hypersecretion Dysphagia Salivary gland enlargement Skin and subcutaneous tissue disorders Erythema Urticaria Pruritus Rash Acute generalized exanthematous pustulosis Angioedema Sweating increased Stevens-Johnson’s syndrome Toxic epidermal necrolysis Erythema multiforme Drug Reaction with Eosinophilia and Systemic Symptoms Musculoskeletal and connective tissue disorder Back pain Arthralgia Renal and urinary disorders Acute kidney injury ***** General disorders and administration site conditions Feeling hot Chest pain Injection site warmth and pain Asthenia Rigors Pyrexia Injection site reaction** Coldness local Malaise Thirst Investigations Blood creatinine increased Electrocardiogram ST segment elevation Electrocardiogram abnormal * Since the reactions were not observed during clinical trials with 4,739 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. ** Injection site reactions comprise injection site pain and swelling. In the majority of cases they are due to extravasation of contrast medium.
These reactions are usually transient and result in recovery without sequelae. Cases of extravasation with inflammation, skin necrosis and even development of compartment syndrome have been reported. *** Encephalopathy may manifest with symptoms and signs of neurological dysfunction such as headache, visual disturbance, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, unconsciousness, coma, brain oedema.
**** Vasospasm and consequent ischaemia have been observed during intra-arterial injections of contrast medium, in particular after coronary and cerebral angiography often procedurally related and possibly triggered by the tip of the catheter or excess catheter pressure ***** Transient renal failure […]
Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, including congestive heart failure. Cardiovascular diseases Care should be taken in severe cardiac disease particularly heart failure and coronary artery disease.
The intravascular contrast media injection may precipitate pulmonary oedema in patients with manifest or incipient heart failure, whereas in patients with pulmonary hypertension and valvular heart diseases, contrast media administration may lead to pronounced haemodynamic changes.
Thyroid function and thyroid function tests The small amount of free inorganic iodide that may be present in contrast media might have some effects on thyroid function. These effects appear more evident in patients with latent or overt hyperthyroidism or goitre.
Hyperthyroidism or even thyroid storms have been reported following administration of iodinated contrast media. Myasthenia gravis The administration of iodinated contrast media may aggravate myasthenia signs and symptoms. CNS Disorders and neurological symptoms Particular care is needed in patients with acute cerebral infarction, acute intracranial haemorrhage and any conditions involving damage to the blood brain barrier, brain oedema or acute demyelination.
Convulsive seizures are more likely in patients with intracranial tumours or metastases or with a history of epilepsy. Neurological symptoms related to cerebrovascular diseases, intracranial tumours/metastases or degenerative, ischaemic or inflammatory pathologies may be exacerbated by CM administration.
There is an increased risk of transient neurological complications in these patients, and those with symptomatic cerebrovascular disease (eg stroke, transient ischaemic attacks). Vasospasm and consequent cerebral ischaemic phenomena may be caused by intravascular injection of CM.
Anticonvulsant therapy should not be discontinued. 8). Contrast encephalopathy may manifest with symptoms and signs of neurological dysfunction such as headache, visual disturbance, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, unconsciousness, coma and cerebral oedema within minutes to hours after administration of iomeprol, and generally resolves within days.
The product should be used with caution in patients with conditions that disrupt the integrity of the blood brain barrier, potentially leading to increased permeability of contrast media across the blood brain barrier and increasing the risk of encephalopathy.
If contrast encephalopathy is suspected, administration of iomeprol should be discontinued and appropriate medical management should be initiated. In acute and chronic alcoholism the increase in blood brain barrier permeability facilitates the passage of the contrast medium into cerebral tissue possibly leading to CMS disorders.
There is a possibility of a reduced seizure threshold in alcoholics. In patients with a drug […]