Iomeron 250 mg iodine/ml solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Iomeron 250 mg Iodine/ml injection solution

Iomeprol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Iomeron 250 mg Iodine/ml injection solution is and what it is used for
2. What you need to know before using Iomeron 250 mg Iodine/ml injection solution
3. How to use Iomeron 250 mg Iodine/ml injection solution
4. Possible adverse effects
5. Storage of Iomeron 250 mg Iodine/ml injection solution
6. Contents of the pack and other information

1. What Iomeron 250 mg Iodine/ml injectable solution is and what it is used for

This medicine is for diagnostic use only.

Iomeron belongs to a group of medicines known as low-osmolar, water-soluble, nephrotropic X-ray contrast media.

Iomeron is used to improve the visualization of different areas of the body using certain radiological techniques. In adults, it is used for intravenous urography, computed tomography (CT) of the head and body, peripheral venography, digital subtraction venography, digital subtraction arteriography, and myelography. In children aged 0 to 18 years, it is used for intravenous urography, computed tomography (CT) of the head and body, digital subtraction venography, and peripheral arteriography.

2. What you need to know before using Iomeron 250 mg Iodine/ml injectable solution

Do not use Iomeron 250 mg Iodine/ml injectable solution

• If you are allergic to iomeprol or to any of the other ingredients of this medicine (listed in section 6).
• If you have Waldenström's macroglobulinemia.
• If you have severe liver or kidney disorders.
• If you have multiple myeloma.

Genital investigations in women are contraindicated in case of suspected or confirmed pregnancy and in case of acute inflammation.

Immediate repetition of Iomeron administration following a technical failure is contraindicated in myelography.

Warnings and precautions

• Prior to the examination, you should be adequately hydrated and should refrain from eating for two hours before the procedure.
• In cases of anxiety or pain, as adverse reactions related to the contrast medium may be intensified. In such cases, a sedative may be administered.
• If you are elderly.
• If you have asthma.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after receiving iodinated contrast media.
• If you have hay fever, urticaria, or food allergies, as patients with a history of allergy are more susceptible to adverse reactions to iodinated contrast media.
• If you have hyperthyroidism and/or nodular goiter, as the use of non-ionic contrast media may trigger thyroid crisis.
• If you have renal insufficiency.
• If you have diabetes mellitus; such patients may develop lactic acidosis if they are being treated with biguanides (e.g., Metformin). As a precaution, in patients with moderate renal impairment, biguanides should be discontinued at the time of or 48 hours before the contrast examination and restarted only after renal function has been confirmed to have returned to normal.
• If you have a pheochromocytoma (a type of tumor), as hypertensive crises may occur after intravascular administration of contrast media. Premedication with alpha-adrenergic blockers is recommended.
• If you have sickle cell anemia, as contrast media may worsen your condition.
• If you have myasthenia gravis (a disease causing muscle weakness), as your condition could worsen.
• In case of severe cardiovascular disease, especially if you have heart failure, coronary artery disease, pulmonary hypertension, or valvular heart disease.
• When you have disorders of the Central Nervous System, as convulsive crises may occur.
• In cases of alcoholism and drug addiction.

Fluoroscopy is recommended to minimize extravasation during injection.

You may experience a short-term brain disorder called encephalopathy during or shortly after the imaging procedure. Inform your doctor immediately if you notice any symptoms related to this condition, described in section 4.

Thyroid disorders have been observed after administration of Iomeron in both children and adults. Infants may also be exposed via the mother during pregnancy. Your doctor may need to perform thyroid function tests before and/or after administration of Iomeron.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Iomeron. Seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Consult your doctor before starting to use Iomeron 250 mg Iodine/ml injectable solution.

Children

Infants under one year of age, and especially neonates, are particularly susceptible to electrolyte imbalances and hemodynamic disturbances.

Other medicines and Iomeron 250 mg Iodine/ml injectable solution

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Anticonvulsant treatment should not be interrupted, and optimal dosing should be ensured.

In patients treated with immunomodulatory drugs, such as Interleukin-2, allergic-type reactions to contrast media are more frequent and may present as delayed reactions.

This medicine must not be mixed with other medicinal products.

Interference with laboratory tests:

Iodinated contrast media may interfere with thyroid function tests, as the thyroid's ability to uptake radioisotopes may be reduced for periods of two weeks or more.

High concentrations of contrast media in plasma and urine may alter laboratory test results for bilirubin, proteins, and inorganic substances (e.g., iron, copper, calcium, phosphate).

Use of Iomeron 250 mg Iodine/ml injectable solution with food and drink

Unless otherwise instructed by your doctor, you may follow a normal diet on the day of the examination. Ensure adequate fluid intake. However, you should refrain from eating for two hours before the examination.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

You must inform your doctor if you are pregnant or think you might be.

As with other non-ionic contrast media, there are no controlled studies in pregnant women confirming the safety of this product in humans. Since exposure to radiation should be avoided during pregnancy whenever possible, the risk/benefit ratio of any X-ray examination, with or without contrast media, should be carefully evaluated.

If you are pregnant and have received Iomeron during pregnancy, thyroid function testing of your newborn is recommended.

Breastfeeding

Contrast media are excreted in minimal amounts in breast milk, and the possibility of harm to the infant is remote.

Driving and using machines

No effects on the ability to drive or operate machinery are known.

3. How to use Iomeron 250 mg Iodine/ml injectable solution

This medicine will always be administered by qualified and properly trained personnel in hospitals or clinics equipped with the necessary staff and equipment.

The dose you will receive varies depending on the type of examination, your age, body weight, cardiac output, general condition, and the technique used.

If you use more Iomeron 250 mg Iodine/ml injectable solution than you should

Overdosing may cause serious adverse reactions, mainly due to effects on the cardiovascular and respiratory systems.

Treatment of overdose is aimed at maintaining all vital functions and involves the prompt initiation of symptomatic therapy. Iomeron can be removed from the body by dialysis.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you have any doubts about the use of this product, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

In general, adverse effects are mild to moderate in severity and transient in nature. However, serious and potentially life-threatening reactions have been reported, sometimes resulting in death. In most cases, reactions occur within minutes of administration, although they may sometimes appear later.

Contact your doctor immediately if you experience any of the following symptoms: sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching affecting the whole body.

The following adverse effects have been reported:

Intravenous administration

Common (may affect up to 1 in 10 people):

• sensation of warmth

Uncommon (may affect up to 1 in 100 people):

• headache
• dizziness
• increased blood pressure
• difficulty breathing
• nausea, vomiting
• flushing, urticaria, itching
• chest pain, warmth and pain at injection site

Rare (may affect up to 1 in 1,000 people):

• fainting
• slow or rapid heart rate
• decreased blood pressure
• skin rash
• back pain
• asthenia, rigidity, fever
• increased creatinine in blood

Frequency not known (cannot be estimated from available data):

• Contact a doctor as soon as possible if you experience a severe skin reaction such as:

• blistering, peeling of the skin, mouth ulcers, ulcers in the throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• a red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

• a widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• anxiety, hyperkinetic syndrome (increased motor activity), confusion

• allergic reactions

• hyperthyroidism

• loss of appetite (anorexia)

• taste disturbance, difficulty speaking, brain dysfunction, cerebral edema (fluid in the brain), transient problems with blood supply to the brain with few or no sequelae (transient ischemic attacks), memory loss, drowsiness, altered sensation (tingling, itching), stroke, loss of consciousness, tremors, coma, seizures, alteration of the sense of smell

• brain disorder (encephalopathy) with symptoms including headache, visual difficulties, loss of vision, confusion, seizures, loss of coordination, loss of movement in part of the body, speech problems and loss of consciousness

• temporary blindness, visual impairment, conjunctivitis, increased lacrimation, photopsia (seeing lights)

• myocardial infarction, cardiac arrest, chest tightness, heart rhythm disorders, angina pectoris, heart failure, formation of clots in the coronary arteries (after catheter insertion), irregular heartbeat, cardiac conduction disorders, rapid and weak pulse

• redness, shock (severe drop in blood pressure), pallor, fatigue, cold and clammy skin, reduced consciousness) caused by sudden and severe dilation of blood vessels, bluish discoloration of the skin and mucous membranes, blood clots, vasospasm and, as a consequence, ischemia.

• circulatory failure (circulatory collapse)

• coronary artery obstruction (after catheter insertion)

• respiratory arrest, cough, acute respiratory distress syndrome (ARDS), wheezing, asthma attacks, fluid accumulation in the throat, fluid in the lungs, inflammation of the nasal mucosa characterized by nasal congestion, sneezing and discharge (rhinitis), hoarseness (dysphonia), insufficient oxygen supply to tissues (hypoxia), sore throat and larynx pain, sudden constriction of the airways (bronchospasm)

• intestinal incontinence, diarrhea, abdominal pain, excessive salivation, difficulty swallowing, inflammation of the pancreas accompanied by severe upper abdominal pain radiating to the back with nausea and vomiting (pancreatitis), enlargement of the salivary glands, intestinal obstruction

• severe hypersensitivity reactions, characterized by symptoms such as increased sweating, dizziness, itching, pulsating headache, throat tightness, swelling of the mucous membranes of the mouth and throat, making breathing difficult

• eczema, skin rash, increased sweating, sudden fluid accumulation in the skin and mucous membranes (e.g. throat or tongue), possibly with difficulty breathing and/or itching and skin rash (angioedema), appearance of circular blisters on the skin (usually with a paler center) (erythema multiforme)

• joint pain, muscle stiffness

• acute kidney failure, urinary incontinence, urinary abnormalities, decreased urine output

• general feeling of illness (general malaise), chills, localized feeling of cold, thirst, reaction at injection site, bruising at injection site

• blood disorders (decreased platelet count) accompanied by bruising and tendency to bleed (thrombocytopenia)

• hemolytic anemia (abnormal decrease in red blood cells which may cause fatigue, rapid heartbeat and shortness of breath)

Transient hypothyroidism may occur in children under 3 years of age.

In some cases, abnormalities are detected during medical examinations (blood values, cardiac and liver function tests).

Administration into cerebrospinal fluid

Very common (more than 1 in 10 people):

• headache

Common (more than 1 in 100 people and less than 1 in 10 people):

• dizziness
• increased blood pressure
• nausea, vomiting
• back pain, limb pain
• reaction at injection site

Uncommon (more than 1 in 1,000 people and less than 1 in 100 people):

• loss of consciousness
• altered sensation
• drowsiness
• decreased blood pressure
• redness
• muscle rigidity
• neck pain
• sensation of warmth
• chest pain
• fever

Frequency not known (cannot be estimated from available data):

• allergic reactions
• epilepsy
• skin rash
• general malaise
• brain disorder (encephalopathy) with symptoms including headache, visual difficulties, loss of vision, confusion, seizures, loss of coordination, loss of movement in part of the body, speech problems and loss of consciousness

Consult your doctor if you experience severe symptoms or allergic (hypersensitivity) reactions, or if symptoms persist for long periods.

The safety profile of iomeprol is similar in adults and children for all routes of administration.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Iomeron 250 mg Iodine/ml injection solution

Keep this medicine out of the sight and reach of children.

Store the vial in the outer packaging to protect it from light.

Although iomeprol has low sensitivity to X-rays, it is advisable to store the product away from ionizing radiation.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. If you are unsure how to dispose of medicines and containers you no longer need, consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Iomeron 250 mg Iodine/ml injectable solution

• The active substance is iomeprol. 1 ml of injectable solution contains 510.3 mg of iomeprol, equivalent to 250 mg of iodine.
• The other components are trometamol, hydrochloric acid for pH adjustment, and water for injectable preparations q.s.

Appearance of the product and contents of the container

Iomeron is packaged in glass vials closed with halobutyl rubber stoppers and aluminum caps.

Single-dose vials of 50 ml, 100 ml and 200 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bracco Imaging s.p.a.

Via E. Folli 50

20134 (Milan – Italy)

Manufacturer

Patheon Italia s.p.a.

2° Trav. SX Via Morolense, 5

03013 Ferentino (Italy)

BIPSO GmbH

Robert-Gerwig-Strasse 4

78224 Singen (Germany)

Bracco Imaging S.p.A.

Bioindustry Park - Via Ribes, 5

10010 Colleretto Giacosa (TO) (Italy)

You may request further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Tel: 913756230

Date of the most recent revision of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Iomeron 250 mg Iodine/ml is an injectable solution for intravenous, intraarterial, and intrathecal administration.

Whenever possible, intravascular administration of contrast media should be performed with the patient lying down. Keep the patient under observation for at least 30 minutes after administration.

Indication	Route of administration	Recommended dosages
Intravenous urography	Intravenous	Adults: 50 – 150 ml Neonates: 3 – 4.8 ml Children: < 1 year: 2.5 – 4 ml/kg > 1 year: 1 – 2.5 ml/kg
Computed tomography of head	Intravenous	Adults: 50 – 200 ml Children a
Computed tomography of body	Intravenous	Adults: 100 – 200 ml Children a
Conventional angiography
	Peripheral venography	Intravenous	Adults: 10 – 100 ml, repeat if necessaryb (10 – 50 ml for upper extremities; 50 – 100 ml for lower extremities)
Digital subtraction arteriography
	Abdomen	Intraarterial	Adults c
Peripheral arteriography	Intraarterial	Adults: 5 – 10 ml for selective injections, up to 250 ml Children a
Digital subtraction venography	Intravenous	Adults: 100 – 250 mlb Children a
Myelography	Intrathecal	Adults: 10 – 18 ml
a According to body weight and age, and determined by the physician responsible for the procedure. b Do not exceed 250 ml. The volume of each single injection depends on the vascular area to be examined. c Do not exceed 350 ml.

Before use, the solution should be visually inspected. Only solutions without visible signs of deterioration or particles should be used.

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations.

Precautions

• Regarding the patient:

Hydration – Any severe disturbance in fluid and electrolyte balance should be corrected. Adequate hydration must be ensured prior to the medical examination, especially in patients with severe renal functional impairment, multiple myeloma or other paraproteinemias, sickle cell anemia, diabetes mellitus, polyuria, oliguria, hyperuricemia, as well as in neonates, children, and elderly patients.

Dietary recommendations – Unless specific instructions are given by the physician, a normal diet may be followed. Ensure adequate fluid intake. However, the patient should refrain from eating for two hours prior to the examination.

Hypersensitivity – In patients predisposed to allergies, with known hypersensitivity to iodinated contrast media, or with a history of asthma, premedication with antihistamines and/or corticosteroids may be considered to prevent possible anaphylactoid reactions.

Severe cutaneous adverse reactions (SCARs) – Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients receiving intravascular iodinated contrast media. These reactions may be fatal or potentially fatal. At the time of administration, patients should be informed of the signs and symptoms, and closely monitored for the development of cutaneous reactions. If signs or symptoms suggestive of such reactions occur, administration of Iomeron must be immediately discontinued. Iomeron must not be re-administered to any patient who has previously developed a severe reaction such as SJS, TEN, AGEP, or DRESS.

Anxiety – States of excitement, anxiety, and pain may cause or exacerbate adverse effects or contrast-related reactions. In such cases, a sedative may be administered.

Concomitant treatments – Consider interruption of medications that lower the seizure threshold for up to 24 hours after the procedure in the case of intrathecal use, and in patients with blood-brain barrier disorders (see “Neurological symptoms”).

• Regarding the procedure:

Coagulation, catheterization – A property of non-ionic contrast media is their minimal interference with physiological functions. As a consequence, non-ionic contrast media have in vitro a lower anticoagulant activity than ionic contrast media. Medical and paramedical personnel performing vascular catheterization must be aware of this and should pay particular attention to angiographic technique. Non-ionic contrast media should not come into contact with blood in the syringe, and intravascular catheters should be flushed frequently to minimize the risk of thromboembolic events related to the procedure.

Patient monitoring – Whenever possible, intravascular administration of contrast media should be performed with the patient lying down. The patient should remain under observation for at least 30 minutes after administration.

Sensitivity testing – A sensitivity test is practically useless, as severe or fatal reactions to contrast media cannot be predicted by such testing.

Risk of inflammation and extravasation – Caution is recommended during injection of contrast media to avoid extravasation.

Warnings

• Common to all routes of administration

Due to the potential for serious adverse effects, the use of organic iodine-containing contrast media should be restricted to situations where there is a clear need for contrast imaging.

This need should be evaluated based on the patient's clinical condition, particularly in relation to cardiovascular, urinary, and hepatobiliary diseases.

Contrast media for angiocardiographic examinations should be used only in hospitals or clinics equipped with competent personnel and necessary equipment for appropriate intensive care in case of emergency. In centers performing more common diagnostic examinations requiring iodinated contrast media, radiology departments must have therapeutic measures and resuscitation equipment proven effective by experience (Ambu bag, oxygen, antihistamines, vasoconstrictors, etc.).

Use in:

Pediatric population – Infants under one year of age, and especially neonates, are particularly susceptible to electrolyte imbalances and hemodynamic disturbances. Careful attention must be paid to the dosage used, the procedural technique, and the patient's condition. Hypothyroidism or transient suppression of thyroid function may occur following exposure to iodinated contrast media. Special attention should be given to pediatric patients under 3 years of age, as episodes of low thyroid activity during the first years of life may impair motor, auditory, and cognitive development and may require temporary T4 replacement therapy. The incidence of hypothyroidism in pediatric patients under 3 years exposed to iodinated contrast media has been reported to range between 1.3% and 15%, depending on patient age and contrast dose, and is more frequently observed in neonates and preterm infants. Thyroid function should be evaluated in all pediatric patients under 3 years of age after exposure to iodinated contrast media. If hypothyroidism is detected, the need for treatment should be considered and thyroid function should be monitored until it normalizes.

Elderly – Elderly patients should be considered at special risk for reactions due to excessive contrast medium dosage. The frequent association of neurological disorders and vascular pathologies constitutes an aggravating factor.

Patients with specific pathological conditions

• Hypersensitivity to iodinated contrast media – Hypersensitivity or previous reactions to iodinated contrast media increase the risk of recurrence of a severe reaction, even with non-ionic contrast media.

• Allergic predisposition – Adverse reactions to iodinated contrast media are known to be more common in patients with a history of allergies such as hay fever, urticaria, or food allergies.

• Asthmatic patients – Patients taking beta-adrenergic blockers, particularly asthmatic patients, may have a lower threshold for bronchospasm and a reduced response to treatment with beta-agonists and epinephrine, which may require higher doses.

• Thyroid function and thyroid function tests – Small amounts of free inorganic iodide may be present in contrast media, which could affect thyroid function. These effects are more evident in patients with latent or overt hyperthyroidism or goiter. Hyperthyroidism, and even thyroid crisis, have been reported after administration of iodinated contrast media.

• Intra-arterial and intravenous administration

Use in patients with specific pathological conditions

Renal impairment – In patients with compromised renal function, administration of contrast media may cause episodes of renal failure. Preventive measures include: identification of high-risk patients; ensuring adequate hydration before contrast administration, preferably by maintaining intravenous infusion before, during, and after the procedure until the contrast medium has been eliminated by the kidneys; avoiding, if possible, administration of nephrotoxic drugs and major surgical interventions or procedures such as renal angioplasty until the contrast medium has been completely eliminated; postponing a new contrast examination until renal function returns to pre-examination levels. Patients on dialysis may receive contrast media such as iomeprol, which are readily dialyzable.

Diabetes mellitus – The presence of renal damage in diabetic patients is one of the factors predisposing to renal dysfunction following contrast administration.

Renal impairment may lead to lactic acidosis in diabetic patients with renal damage treated with biguanides (metformin). To prevent this, treatment with biguanides should be discontinued in the following cases: prior to intra-arterial administration of a contrast medium with first-pass renal exposure, in patients with eGFR < 30 ml/min/1.73 m² receiving intravenous contrast medium or intra-arterial contrast medium with second-pass renal exposure, or in patients with acute kidney injury, and should only be resumed 48 hours after contrast administration, provided renal function has not significantly changed.

Pheochromocytoma – These patients may develop severe hypertensive crises (rarely uncontrollable) after intravascular contrast administration during radiological procedures.

In patients with pheochromocytoma, premedication with alpha-receptor blockers is advised due to the risk of hypertensive crises.

Myasthenia gravis – Administration of iodinated contrast media may worsen signs and symptoms of myasthenia.

Cardiac disease and pulmonary hypertension – There is a high risk of severe reactions in patients with severe cardiovascular disease, particularly those with heart failure and coronary artery disease. Intravascular injection of contrast media may cause pulmonary edema in patients with manifest or incipient cardiac decompensation, while contrast administration in cases of pulmonary hypertension and valvular heart disease may promote hemodynamic disturbances. ECG signs of ischemia and severe arrhythmias are more common in elderly patients and those with pre-existing heart disease; their frequency and severity appear related to the severity of cardiac pathology.

Neurological symptoms – Particular caution is required when administering contrast media to patients with acute cerebral infarction, intracranial hemorrhage, blood-brain barrier disruption, cerebral edema, or acute demyelination. The presence of intracranial tumors or metastases and a history of epilepsy may increase the likelihood of seizure occurrence. Contrast administration may exacerbate neurological symptoms due to degenerative, ischemic, inflammatory, or neoplastic cerebrovascular diseases. These patients have an increased risk of transient neurological complications. Intravascular injections of contrast media may cause angiospasm and episodes of cerebral ischemia.

Alcoholism – Acute or chronic alcoholism has been shown experimentally and clinically to increase blood-brain barrier permeability, facilitating the passage of iodinated agents into brain tissue and potentially causing central nervous system (CNS) disturbances. A possible reduction in seizure threshold in alcoholics should be considered.

Contrast-induced encephalopathy – Encephalopathy has been reported with the use of iomeprol.

Contrast-induced encephalopathy may present with neurological symptoms and signs such as headache, visual disturbances, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, unconsciousness, coma, and cerebral edema, occurring minutes to hours after iomeprol administration, and usually resolves within a few days.

The product should be used with caution in patients with conditions affecting the integrity of the blood-brain barrier (BBB), which may increase contrast permeability through the BBB and elevate the risk of encephalopathy. If contrast-induced encephalopathy is suspected, administration of iomeprol should be discontinued and appropriate medical management initiated.

Drug addiction – Drug-addicted patients require special attention due to a possible reduced seizure threshold.

Fluoroscopy is recommended to minimize extravasation during injection.

Overdose

In case the responsible physician diagnoses an accidental intravascular overdose of contrast medium, hydration and electrolyte balance should be monitored and corrected if necessary. In this situation, renal function should be monitored for at least three days.

In case of accidental intrathecal overdose, the patient should be carefully monitored for at least 24 hours for signs and symptoms of central nervous system disorders. Such signs may include increased hyperreflexia or tonic-clonic spasms, generalized seizures, hyperthermia, stupor, and respiratory depression.