Iomeron 400 mg iodine/ml solution for injection: detailed information

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Iomeron 400 mg Iodine/ml solution for injection

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, consult 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

What Iomeron 400 mg Iodine/ml solution for injection is and what it is used for
What you need to know before using Iomeron 400 mg Iodine/ml solution for injection
How to use Iomeron 400 mg Iodine/ml solution for injection
Possible side effects
How to store Iomeron 400 mg Iodine/ml solution for injection
Contents of the pack and other information

1. What is Iomeron 400 mg Iodine/ml injectable solution and what is it 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 enhance the visualization of different body areas using certain radiological techniques. In adults, it is used for intravenous urography, body computed tomography (CT), conventional angiography, angiocardiography, selective conventional coronary arteriography, digital subtraction venography, fistulography, galactography, dacryocystography, and sialography. In children from 0 to 18 years of age, it is used for intravenous urography, body computed tomography (CT), conventional interventional arteriography, angiocardiography, and digital subtraction venography.

2. What you need to know before using Iomeron 400 mg Iodine/ml injection

Do not use Iomeron 400 mg Iodine/ml injection

If you are allergic to iomeprol or 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.

Examinations of the female genital organs are contraindicated in case of suspected or confirmed pregnancy and in case of acute inflammation.

Warnings and precautions

Before starting the examination, you should be adequately hydrated and should refrain from eating for two hours prior to the examination.
In cases of anxiety and pain, 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 crises.
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 contrast medium examination and restarted only after renal function has been confirmed to have recovered.
If you have pheochromocytoma (a type of tumor), as hypertensive crises may occur after intravascular administration of contrast medium. Premedication with alpha-adrenergic blockers is recommended.
If you have sickle cell anemia (a type of 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 (heart blood vessel disease), pulmonary hypertension, or coronary valvular disease.
In case of central nervous system disorders, as convulsive crises may occur.
In case 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 400 mg Iodine/ml injection.

Children

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

Other medicines and Iomeron 400 mg Iodine/ml injection

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

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

In patients treated with immunomodulating agents such as Interleukin-2, allergic-type reactions to contrast media are more frequent and may manifest 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 400 mg Iodine/ml injection 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 and use machines are known.

3. How to use Iomeron 400 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 400 mg Iodine/ml injectable solution than you should

Overdosage may cause serious adverse reactions, primarily 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 will experience them.

Generally, adverse effects are mild to moderate in intensity 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 occasionally appear later.

Immediately inform your doctor 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:

Intravascular administration

Frequent (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 the 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, skin peeling, mouth ulcers in the mouth, 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 disorder, 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 disturbances, loss of vision, confusion, seizures, loss of coordination, loss of movement on one side of the body, speech problems, and loss of consciousness
temporary blindness, visual impairment, conjunctivitis, increased tearing, photopsia (seeing lights)
myocardial infarction, cardiac arrest, chest tightness, heart rhythm disorders, angina pectoris, heart failure, clot formation 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)
obstruction of the coronary artery (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), inadequate oxygen supply to tissues (hypoxia), sore throat and larynx, 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 accumulation of fluid 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, abnormalities in urine, decreased urine output
general feeling of illness (malaise), chills, localized cold sensation, 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 may be detected during medical examinations (blood tests, cardiac and liver function tests).

Administration into body cavities

allergic reactions
changes in blood test results (after pancreatic examinations)
as with other iodinated contrast media, pelvic pain and general discomfort may occur after examination of the cervix, fallopian tubes and ovaries.

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 type of adverse effect, consult your doctor, even if they are possible adverse effects 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 400 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 packaging 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 have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Iomeron 400 mg Iodine/ml injectable solution

The active substance is iomeprol. 1 ml of injectable solution contains 816.5 mg of iomeprol, equivalent to 400 mg of iodine.
The other components are trometamol, hydrochloric acid for pH adjustment, and water for injections q.s.

Presentation of the product and pack contents

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

Vials of 50 ml, 100 ml, 250 ml, and 500 ml. The 50 ml, 100 ml, and 250 ml vials are single-dose; the 500 ml vial is multi-dose.

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)

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Laboratorios Farmacéuticos ROVI, S.A.

Julián Camarillo, 35

28037 Madrid

Tel: 913756230

Date of latest 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended for healthcare professionals only:

Iomeron 400 mg Iodine/ml is an injectable solution for intravenous, intra-arterial, intramammary, and intraglandular 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	Proposed 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 body	Intravenous	Adults: 100 - 200 ml Children a
Conventional angiography
	Pelvic and lower extremity arteriography	Intraarterial	Adults b
Abdominal arteriography	Intraarterial	Adults b
Pulmonary angiography	Intravenous/Intraarterial	Adults: up to 170 ml
Interventional arteriography	Intraarterial	Adults b Children a
Digital subtraction venography	Intravenous	Adults: 100 - 250 mlb Children a
Angiocardiography	Intravenous/Intraarterial	Adults b Children: 3 - 5 ml/kg
Conventional selective coronary arteriography	Intraarterial	Adults: 4 - 10 ml per artery, repeat if necessary
Fistulography*	Route of administration not applicable*	Adults: up to 100 ml
Galactography	Intramammary	Adults: 0.15 - 1.2 ml per injection
Dacryocystography	Intraglandular	Adults: 2.5 - 8 ml per injection
Sialography	Intraglandular	Adults: 1 - 3 ml per injection
a According to body weight and age, as 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. Fistulography does not have a standardized authorized term for its route of administration, hence it is indicated as route of administration not applicable.

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

Instructions for administration when using single-dose vials:

Multiple doses must not be withdrawn from a single vial of contrast medium. The rubber stopper should never be punctured more than once. It is recommended to use an appropriate extraction cannula to pierce the stopper and withdraw the contrast medium. The solution should not be drawn into the syringe until immediately before use. Any unused portion of the solution remaining after an examination must be discarded.

Instructions for administration when using multidose vials:

Multidose vials should only be used when connected to auto-injectors/pumps.

Auto-injectors/pumps must not be used in young children.

Only a single puncture should be performed.

The tubing connecting the auto-injector/pump to the patient must be changed after each patient.

Any residual contrast medium remaining in the vial, as well as the connecting tubing and all disposable components of the injection system, must be discarded within eight hours.

It is essential to strictly follow any additional instructions provided by the manufacturer of the auto-injector/pump.

Disposal of unused medicinal product and of 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 should be ensured prior to the medical examination, especially in patients with severe renal 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. Adequate fluid intake should be confirmed. However, the patient should refrain from eating for two hours prior to the examination.

Hypersensitivity – In patients with a predisposition to allergies, known hypersensitivity to iodinated contrast media, or 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), some of which may be fatal or potentially fatal, have been reported in patients receiving intravascular iodinated contrast media. 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 stopped immediately. Iomeron must not be re-administered to any patient who has experienced a severe reaction such as SJS, TEN, AGEP, or DRESS.

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

Concomitant treatments – Consider interrupting treatment with drugs that lower the seizure threshold for up to 24 hours after the procedure in 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 less anticoagulant activity than ionic contrast media. Medical and paramedical personnel performing vascular catheterization should be aware of this and pay particular attention to angiographic technique. Non-ionic contrast media should not be allowed to come into contact with blood in the syringe, and intravascular catheters should be flushed frequently to minimize the risk of procedure-related thromboembolic events.

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

Sensitivity testing – Sensitivity testing is virtually 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 with regard to cardiovascular, urinary, and hepatobiliary diseases.

Contrast media used for angiocardiographic examinations should be administered only in hospitals or clinics equipped with trained personnel and the necessary equipment for intensive care in case of emergency. In centers performing more common diagnostic procedures requiring iodinated contrast media, radiology departments must have therapeutic measures and resuscitation equipment proven effective by experience (e.g., 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 alterations. Careful attention must be paid to the dosage, procedural technique, and patient status. Hypothyroidism or transient suppression of thyroid function may occur following exposure to iodinated contrast media. Particular 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 patients under 3 years exposed to iodinated contrast media has been reported to range between 1.3% and 15%, depending on patient age and dose of iodinated contrast medium, 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, treatment should be considered and thyroid function monitored until it normalizes.

Elderly patients – Elderly patients should be considered at increased risk for reactions due to excessive contrast medium dosage. The frequent presence of neurological and vascular disorders 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 reduced response to 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 may affect thyroid function. These effects are more pronounced in patients with latent or overt hyperthyroidism or goiter. Hyperthyroidism or even thyroid crisis has 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 lead to episodes of renal failure. Preventive measures include: identifying high-risk patients; ensuring adequate hydration before contrast administration, preferably by maintaining intravenous infusion before, during, and after the procedure until the contrast medium is 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; and postponing any 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 medium 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 suspended 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 or intra-arterial contrast medium with second-pass renal exposure, or in patients with acute renal injury. Treatment 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 medium administration during radiological procedures.

In patients with pheochromocytoma, premedication with alpha-receptor blockers is recommended 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. Intravenous injection of contrast media may cause pulmonary edema in patients with manifest or incipient cardiac decompensation, while contrast medium administration in cases of pulmonary hypertension and valvular heart disease may promote hemodynamic alterations. The occurrence of ECG signs of ischemia and severe arrhythmias is more common in elderly patients and those with pre-existing heart disease; their frequency and severity appear to correlate with 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 medium administration may exacerbate neurological symptoms due to degenerative, ischemic, inflammatory, or neoplastic cerebrovascular diseases. These patients are at higher risk of transient neurological complications. Intravascular injections of contrast media may cause vasospasm and episodes of cerebral ischemia.

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

Contrast-induced encephalopathy may present with neurological dysfunction 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 resolving within a few days.

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

Alcoholism – Experimental and clinical evidence has shown that acute or chronic alcoholism increases blood-brain barrier permeability. This facilitates the passage of iodinated agents into brain tissue, potentially causing central nervous system disorders. A possible reduction in seizure threshold in alcoholics should be considered.

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

Fluoroscopy is recommended to minimize extravasation during injection.

Overdose

If the responsible physician diagnoses an accidental intravascular overdose of contrast medium, the patient's hydration and electrolyte balance should be monitored and corrected if necessary. In such cases, renal function should be monitored for at least three days.