Section 4.8 completely reformatted
4.8 Undesirable effects
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.
After intra-thecal administration most side effects occur some hours (3 to 6 hours) after the procedure, due to the distribution of the contrast medium in the cerebro-spinal fluid (CSF) circulation from the site of administration to the intravascular space. Most reactions usually occur within 24 hours after injection.
After injection of an iodinated contrast media in body cavities, the majority of the reactions occur some hours after the contrast administration due to the slow absorption from the area of administration.
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 following adverse reactions have been reported with iomeprol. Adverse reactions from clinical trials have been included with an indication of the frequency. Adverse reactions from spontaneous reporting are included with the frequency “not known”.
Administration by intravascular and intrathecal routes
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System Organ Class
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Adverse Reactions
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Common
(>1/100, <1/10)
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Uncommon
(>1/1,000, <1/100)
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Rare (>1/10,000,<1/1,000)
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Not known
( cannot be estimated from the available clinical trial data)
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Blood and lymphatic system disorders
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thrombocytopenia
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Immune system disorders
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Anaphylactic/anaphylactoid reactions
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Psychiatric Disorders
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Agitation
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anxiety
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Nervous System Disorders
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Headache
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Dizziness, paralysis
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Tremor, confusion, loss of consciousness, visual field defect, syncope, aphasia, convulsions, coma
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taste abnormality, dysarthria, parasthesia, cerebral oedema, hypoxic encephalopathy, transient ischaemic attack, meningitis, somnolence.
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Eye disorders
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transient blindness, conjunctivitis, increased lacrimation, visual disturbance, photopsia, photophobia.
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Cardiac Disorders
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Bradycardia, tachycardia
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Cyanosis
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cardiac arrest, myocardial infarction, cardiac failure, angina pectoris, pulmonary oedema, arrhythmias including extrasystoles, ventricular or atrial fibrillation, atrioventricular block
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Vascular Disorders *
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Pallor
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Hypertension, hypotension
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Vasodilatation, circulatory collapse
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shock, flushing, thrombosis
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Respiratory, Thoracic and Mediastinal Disorders
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Dyspnoea, nasal congestion, laryngeal oedema
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respiratory arrest, acute respiratory distress syndrome (ARDS), asthma, bronchospasm, stridor, rhinitis, cough, sneezing, laryngospasm, pharyngeal oedema, hypoxia, dysphonia
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Gastrointestinal Disorders
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Nausea
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Vomiting
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acute pancreatitis, diarrhea, abdominal pain, salivary hypersecretion, dysphagia, ileus
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Skin and Subcutaneous Tissue Disorders
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Rash, erythema, wheals, pruritus, sweating increased
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angioneurotic oedema, urticaria, dermatitis, eczema,
mucocutaneous syndromes **
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Musculoskeletal and Connective Tissue Disorders
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Back pain
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Muscle spasms
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muscle weakness
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Renal and Urinary Disorders
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Renal failure, oliguria, proteinuria
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General Disorders and Administration Site Conditions
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Injection site warmth and pain
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Chest pain, rigors, injection site haemorrhage, pyrexia
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Asthenia
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oedema, malaise, feeling of warmth, chills, pain, injection site reaction ***
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Investigations
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Blood creatinine increased
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abnormal electrocardiogram, abnormal liver function tests
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*
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Cardiac reactions may occur as consequences of the coronary catheterization procedural hazard: these complications include coronary artery thrombosis and coronary artery embolism.
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**
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As with other iodinated contrast media, very rare cases of muco-cutaneous syndromes, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome) and erythema multiforme, have been reported following the administration of Iomeron.
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***
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Injection site pain and swelling may occur. In the majority of cases it is due to extravasation of contrast medium. These reactions are usually transient and result in recovery without sequelae. However, inflammation and even skin necrosis have been seen on very rare occasions. In isolated reports extravasation led to the development of compartment syndrome
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Administration to body cavities.
Hypersensitivity reactions are rare, generally mild and in the form of dermatitis. However, the possibility of severe anaphylactoid reactions cannot be excluded.
After injection into body cavities, local pain may occur.
Section 10
Date of revision 16 August 2011
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