) In patients with cardiovascular disease (such as early or patent heart failure, coronaropathy, pulmonary hypertension, valvulopathy, cardiac arrhythmias), the risk of cardiovascular reactions is increased after administration of an iodinated contrast agent.
Intravasal injection of the contrast medium may cause pulmonary oedema in patients with manifest or incipient heart failure, whereas administration in pulmonary hypertension and heart valve disorders may result in marked changes in haemodynamics.
The frequency and degree of severity appear related to the severity of the cardiac disorders. In case of severe and chronic hypertension, the risk of renal damage due to administration of the contrast medium and also due to the catheterisation itself may be increased.
Ischaemic ECG changes and severe rhythm disorders are most frequently observed in elderly and heart disease patients. Very rare cases of ventricular fibrillation which occurred immediately after administration of the contrast medium have been reported outside the context of hypersensitivity reactions.
A careful evaluation of the risk-benefit ratio is necessary in these patients. 7 Central nervous system disorders The benefit-to-risk ratio must be evaluated in each case: • due to the risk of aggravation of neurological symptoms in patients with a transient ischaemic attack, acute cerebral infarct, recent intracranial haemorrhage, cerebral oedema, or idiopathic or secondary (tumour, scar) epilepsy.
• if the intra-arterial route is used in an alcoholic patient (acute or chronic alcoholism) and other drug-addicted subject. 8). Contrast-induced 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.
Symptoms usually occur within minutes to hours after administration of iobitridol and generally resolve within days. g. encephalopathy. If contrast encephalopathy is suspected, appropriate medical management should be initiated and iobitridol should not be readministered.
8 Pheochromocytoma Patients with pheochromocytoma can develop a hypertensive crisis after intravascular administration of the contrast agent and must be monitored prior to the examination. 9 Myasthenia gravis Administration of a contrast agent can worsen the symptoms of myasthenia gravis.
10 Intensification of undesirable effects Undesirable effects linked to contrast agent administration may be intensified in patients showing pronounced agitation, anxiety or pain. Appropriate management such as sedation may be necessary.
11 Paediatric population Hypothyroidism or transient thyroid suppression may be observed after exposure to iodinated contrast media. 6). The incidence of hypothyroidism in patients younger than 3 years of age exposed to iodinated contrast media ranges between 1% and 15% depending on the age of the subjects and the dose of the iodinated contrast agent and is more commonly observed in neonates and premature infants.
Younger age, very low birth weight, prematurity, and the presence of other conditions, such as, admission to neonatal or paediatric intensive care units, and cardiac conditions are associated with an increased risk. Paediatric patients with cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures, such as catheterization, and computed tomography (CT).
Special attention should be paid to paediatric patients below 3 years of age because an incident underactive thyroid during early life may be harmful for motor, hearing, and cognitive development and may require transient thyroxin (T4) replacement therapy.
Thyroid function should be evaluated in all paediatric patients after exposure to iodinated contrast media, especially in premature infants and neonates. If hypothyroidism is detected, thyroid function should be monitored as appropriate even when replacement treatment is given.
1 Medicinal products administered via the intrauterine route Contraindication Hysterosalpingography is contraindicated during pregnancy. Special precautions for use Systematic screening for pregnancy should be carried out in women of child- bearing potential.
Exposure of the female genital tract to X-rays should be carefully evaluated when weighing up the benefit/risk ratio. In patients suffering from acute pelvic inflammation or infection, hysterosalpingography should only be performed after careful evaluation of the benefit/risk ratio.
2 Endoscopic retrograde cholangiopancreatography (ERCP) in patients with acute pancreatitis In case of ERP/ERCP there is a potential risk of pancreatitis and/or increase in amylase and lipase blood levels post-examination. e. is essentially “sodium-free”.
1. 4 Precautions for use — renal insufficiency). 4 Special warnings and precaution for use) Iodinated contrast media may affect the uptake of radioactive iodine by the thyroid for several weeks. This may lead to impaired uptake in thyroid scintigraphy, and/or to a decrease in the efficacy of […]