IOMERON 300 MG IODO/ML INJECTABLE SOLUTION

Introduction

PATIENT INFORMATION LEAFLET

Iomeron300 mg Iodo/ml injectable solution

Iomeprol

Read the entire leaflet carefully before starting to use this medication, as 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 medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Iomeron 300 mg Iodo/ml injectable solution is and what it is used for
2. What you need to know before using Iomeron 300 mg Iodo/ml injectable solution
3. How to use Iomeron 300 mg Iodo/ml injectable solution
4. Possible side effects
5. Storage of Iomeron 300 mg Iodo/ml injectable solution
6. Package contents and additional information

1. What Iomeron 300 mg Iodo/ml injectable solution is and what it is used for

This medication is for diagnostic use only.

Iomeron belongs to the group of medications known as low-osmolar, water-soluble, and nephrotropic X-ray contrast media.

Iomeron is used to improve the visualization of different body areas using certain radiological techniques. In adults, it is used for intravenous urography, computed tomography (CT) of the head and body, cavernosography, conventional angiography, angiocardiography, selective conventional coronary arteriography, peripheral phlebography, digital subtraction phlebography, digital subtraction arteriography, CPER, arthrography, hysterosalpingography, fistulography, discography, galactography, dacryocystography, sialography, retrograde cholangiography, retrograde ureterography, retrograde pyelography, and myelography. In children from 0 to 18 years old, it is used for intravenous urography, computed tomography (CT) of the head and body, conventional angiography, angiocardiography, digital subtraction phlebography, and digital subtraction arteriography.

2. What you need to know before using Iomeron 300 mg Iodo/ml injectable solution

Do not use Iomeron 300 mg Iodo/ml injectable solution

• If you are allergic to iomeprol or any of the other components of this medication (listed in section 6).
• If you have Waldenström's paraproteinemia.
• If you have severe hepatic or renal disorders.
• If you have multiple myeloma.

Investigations of female genitals are contraindicated in cases of suspected or confirmed pregnancy and in cases of acute inflammation.

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

Warnings and precautions

• Before starting the examination, you should be adequately hydrated and should avoid eating food for two hours before the examination.
• In cases of anxiety and pain, as they may intensify adverse reactions related to the contrast medium. In these cases, a sedative may be administered.
• If you are elderly.
• If you have asthma.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after receiving iodinated contrast media.
• If you have hay fever, urticaria, or food allergies, as patients with a history of allergies 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; these patients may develop lactic acidosis if they are being treated with biguanides (e.g., metformin). As a precaution, in patients with moderate renal insufficiency, biguanides should be discontinued at the time of or 48 hours before the examination with a contrast medium and reinstated only after it has been verified that renal function has recovered.
• If you have acute pancreatitis and need to undergo a CPER procedure to explore your pancreas.
• If you have pheochromocytoma (a type of tumor), as hypertensive crises may occur after using the contrast medium intravascularly. Premedication with alpha-adrenergic blockers is recommended.
• If you have sickle cell anemia (a type of anemia), as the contrast medium may worsen your condition.
• If you have myasthenia gravis (a disease that causes muscle weakness), as your condition may worsen.
• In cases of severe cardiovascular disease, especially if you have heart failure, coronary arteriopathy (disease of the heart's blood vessels), pulmonary hypertension, and coronary valvulopathy.
• When you have central nervous system disorders, 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 cerebral 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 Iomeron administration in both children and adults. Infants may also be exposed through the mother during pregnancy. Your doctor may need to perform thyroid function tests before and/or after Iomeron administration.

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

Consult your doctor before starting to use Iomeron 300 mg Iodo/ml injectable solution.

Children

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

Other medications and Iomeron 300 mg Iodo/ml injectable solution

Inform your doctor if you are using, have recently used, or may need to use any other medication.

Do not interrupt treatment with anticonvulsant medications, and ensure their administration in optimal doses.

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

This medication should not be mixed with others.

Interference with laboratory tests:

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

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

Using Iomeron 300 mg Iodo/ml injectable solution with food and drinks

If there are no specific instructions from your doctor, you can follow a normal diet on the day of the examination. Confirm adequate fluid intake. However, you should avoid eating food 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 medication.

Pregnancy

You should inform your doctor if you are pregnant or think you may be pregnant.

As with other non-ionic contrast media, there are no controlled studies in pregnant women that confirm the safety of the product in humans. Since, whenever possible, exposure to radiation should be avoided during pregnancy, 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, it is recommended to analyze the thyroid function of your newborn.

Breastfeeding

Contrast media are barely excreted in breast milk, and the possibility of the infant suffering harm is remote.

Driving and using machines

No effects on the ability to drive and use machines are known.

3. How to use Iomeron 300 mg Iodo/ml injectable solution

This medication will always be administered by qualified and trained personnel, in hospitals or clinics that have the necessary personnel and equipment.

The dose that will be administered to you will vary depending on the type of examination, age, body weight, cardiac output, and general condition you present, as well as the technique used.

If you use more Iomeron 300 mg Iodo/ml injectable solution than you should

Overdose can cause severe adverse reactions, mainly through effects on the cardiovascular and pulmonary systems.

Treatment of an overdose is aimed at maintaining all vital functions and involves the rapid initiation of symptomatic therapy. Iomeron can be eliminated from the body through dialysis.

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Generally, side effects range from mild to moderate and are of a transient nature. However, severe and potentially fatal reactions have been reported, sometimes with a fatal outcome. In most cases, reactions occur within minutes of administration, although they may sometimes appear later.

Inform 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 that affects the whole body.

The following side effects have been reported:

Intravascular administration

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

• feeling of heat

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

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

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

• fainting
• slow or fast heart rate
• decreased blood pressure
• skin rash
• back pain
• asthenia, stiffness, 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:

• blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• a red and scaly rash with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
• a widespread rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome)

• anxiety, hyperkinetic syndrome (increased motor activity), confusion
• allergic reactions
• hyperthyroidism
• loss of appetite (anorexia)
• altered taste, difficulty speaking, brain disorder, cerebral edema (fluid in the brain), transient ischemic attacks (temporary lack of blood supply to the brain with few or no sequelae), memory loss, somnolence, altered sensitivity (tingling, itching), stroke, loss of consciousness, tremors, coma, convulsions, altered sense of smell
• cerebral disorder (encephalopathy) with symptoms that include headache, vision difficulties, loss of vision, confusion, convulsions, loss of coordination, loss of movement in a part of the body, speech problems, and loss of consciousness.
• temporary blindness, vision loss, conjunctivitis, increased tearing, photopsia (seeing lights)
• myocardial infarction, cardiac arrest, chest pressure, arrhythmias, angina pectoris, heart failure, coronary artery thrombosis (after catheter insertion), irregular heartbeat, conduction disorders, rapid and weak pulse
• flushing, shock (severe drop in blood pressure), pallor, fatigue, cool and moist skin, reduced consciousness) caused by sudden and severe dilation of blood vessels, blue discoloration of the skin and mucous membranes, blood clots, vasospasm, and consequent 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 a blocked nose, sneezing, and discharge (rhinitis), hoarseness (dysphonia), insufficient oxygen supply to tissues (hypoxia), throat and larynx pain, sudden constriction of the airways (bronchospasm)
• intestinal incontinence, diarrhea, abdominal pain, excessive salivation, difficulty swallowing, pancreatitis, salivary gland enlargement, intestinal obstruction
• severe hypersensitivity reactions, characterized by symptoms such as increased sweat production, dizziness, itching, pulsating headache, throat pressure, inflammation of the mouth and throat mucosa, which can make breathing difficult
• eczema, skin rash, increased sweat production, 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 (whose center is usually paler) (erythema multiforme)
• joint pain, muscle stiffness
• acute renal failure, urinary incontinence, urine abnormalities, decreased urine production
• general feeling of illness (malaise), chills, localized cold sensation, thirst, reaction at the injection site, hematoma at the injection site
• blood disorders (decreased platelet count) accompanied by bruising and a tendency to bleed (thrombocytopenia)
• hemolytic anemia (abnormal decrease in red blood cells that can cause fatigue, rapid heart rate, and difficulty breathing)

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

In some cases, alterations are detected during medical examinations (blood tests, cardiac and hepatic function tests).

Administration in 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, pain in the limbs
• reaction at the injection site

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

• loss of consciousness
• altered sensitivity
• somnolence
• decreased blood pressure
• flushing
• muscle stiffness
• neck pain
• feeling of heat
• chest pain
• fever

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

• allergic reactions
• epilepsy
• skin rash
• general feeling of illness
• cerebral disorder (encephalopathy) with symptoms that include headache, vision difficulties, loss of vision, confusion, convulsions, loss of coordination, loss of movement in a part of the body, speech problems, and loss of consciousness

Administration in body cavities

• allergic reactions
• alteration of blood tests (after pancreatic examinations)
• as with other iodinated contrast media, pelvic pain and general discomfort may occur after an examination of the cervix, fallopian tubes, and ovaries.

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use http://www.notificaRam.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Iomeron 300 mg Iodo/ml injectable solution

Keep this medication out of 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 out of reach of ionizing radiation.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. In case of doubt, ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

6. Container Content and Additional Information

Composition of Iomeron 300 mg Iodo/ml injectable solution

• The active ingredient is iomeprol. 1 ml of injectable solution contains 612.4 mg of iomeprol, equivalent to 300 mg of iodine.
• The other components are trometamol, hydrochloric acid for pH adjustment, and water for injectable preparations c.s.p.

Appearance of the Product and Container Content

Iomeron is packaged in glass vials closed with halobutyl stoppers and an aluminum cap.

Vials of 50 ml, 75 ml, 100 ml, and 500 ml. The 50 ml, 75 ml, and 100 ml vials are single-dose; the 500 ml vial is multi-dose.

Only some package 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.

2nd 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 can request more information about this medication 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 Last Revision of this Prospectus:September 2023

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

<-------------------------------------------------------------------------------------------------------------->

This information is intended only for healthcare professionals:

Iomeron 300 mg Iodo/ml is an injectable solution for intravenous, intraarterial, intracavernous, intracholangiopancreatic, intraarticular, intrauterine, intradiscal, intramammary, intraglandular, intravesical, and intrathecal administration.

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

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

Instructions for administration if single-dose vials are used:

A single dose should not be drawn from a vial of contrast medium. The rubber stopper should never be punctured more than once. It is recommended to use an appropriate extraction cannula to puncture the stopper and extract the contrast medium. This should not be extracted into the syringe until immediately before use. The residual amount of unused solution for an examination should be discarded.

Instructions for administration if multi-dose vials are used:

Multi-dose vials should only be used connected to autoinjectors/pumps.

Autoinjectors/pumps should not be used in small children.

A single puncture should be performed.

The connection route from the autoinjector/pump to the patient should be changed after each patient.

The remaining contrast medium solution in the vial, as well as the connection tubes and all disposable elements of the injection system, should be discarded within eight hours.

It is essential to strictly follow the additional instructions provided by the manufacturer of the autoinjector/pump.

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

Precautions

• Regarding the Patient:

Hydration- Any severe alteration of the hydroelectrolytic balance should be corrected. Before the medical examination, ensure adequate hydration, especially in patients with severe functional impairment of the kidneys, multiple myeloma or other paraproteinemias, sickle cell anemia, diabetes mellitus, polyuria, oliguria, hyperuricemia, as well as in neonates, children, and elderly patients.

Dietary Suggestions- If there are no specific instructions from the doctor, a normal diet can be followed. Confirm adequate fluid intake. However, the patient should abstain from eating food in the two hours prior to the examination.

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

Severe Cutaneous Adverse Reactions- 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), which can be fatal or potentially fatal, have been reported in patients who received iodinated contrast media intravascularly. At the time of administration, patients should be warned of the signs and symptoms, and closely monitored for the appearance of skin reactions. If signs and symptoms suggesting the appearance of these reactions occur, administration of Iomeron should be suspended immediately. If the patient has developed a severe reaction such as SJS, TEN, AGEP, or DRESS with the use of Iomeron, Iomeron should not be administered to that patient again at any time.

Anxiety- States of excitement, anxiety, and pain can cause side effects or intensify reactions related to the contrast medium. In these cases, a sedative can be administered.

Concomitant Treatments- Consider interrupting treatment with drugs that reduce the convulsive threshold up to 24 hours after the intervention, in the case of intrathecal use, and in patients with disorders of the blood-brain barrier (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. The medical and paramedical personnel performing vascular catheterization should be informed of this and should pay particular attention to the angiographic technique. Non-ionic contrast media should not come into contact with blood in the syringe, and intravascular catheters should be frequently flushed to minimize the risk of thromboembolism related to the procedure.

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

Sensitivity Test- A sensitivity test is practically useless, as the occurrence of severe or fatal reactions due to contrast media cannot be predicted with such a test.

Risk of Inflammation and Extravasation- Caution is recommended during the injection of contrast media to avoid extravasation.

Warnings

• Common to All Forms of Administration

Considering the possible serious side effects, the use of iodinated contrast media should be limited to specific needs for contrastographic examinations.

This need should be considered according to the patient's clinical conditions, especially in relation to cardiovascular, urinary, and hepatobiliary pathologies.

Contrast media for angiocardiographic examinations should be used in hospitals or clinics with competent personnel and necessary equipment for intensive care in case of emergencies. In centers where more common diagnostic tests are performed that require the use of iodinated contrast media, it is necessary for the radiology services where these tests are performed to have therapeutic measures and resuscitation equipment that experience has confirmed to be suitable (Ambu bag, oxygen, antihistamines, vasoconstrictors, etc.).

Use in:

Pediatric Population- Children under one year of age, and especially neonates, are particularly susceptible to electrolyte imbalances and hemodynamic alterations. Attention should be paid to the doses to be used, the procedure technique, and the patient's condition. Hypothyroidism or transient thyroid suppression may be observed after exposure to iodinated contrast media. Special attention should be paid to pediatric patients under 3 years of age, as an episode of low thyroid activity during the first years of life can be harmful to motor, auditory, and cognitive development and may require temporary replacement treatment with T4. The incidence of hypothyroidism in patients under 3 years of age exposed to iodinated contrast media has been reported to be between 1.3% and 15%, depending on the age of the subjects and the dose of the iodinated contrast medium, and is more frequently observed in neonates and premature 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 dosing of the contrast medium. The frequent association of neurological disorders and vascular pathologies constitutes an aggravating factor.

Patients with Particular Pathological Conditions

• Hypersensitivity to Iodinated Contrast Media- Hypersensitivity or previous reactions to iodinated contrast media also increase the risk of recurrence of a severe reaction, even with non-ionic contrast media.
• Allergic Predisposition- It is known that adverse reactions to iodinated contrast media are more common in patients with a history of allergy: hay fever, urticaria, and food allergies.
• Asthmatic Patients- Patients taking beta-adrenergic blockers, in particular asthmatic patients, may have a lower threshold for bronchospasm and a lower response to treatment with beta-agonists and adrenaline, which may require the use of higher doses.
• Thyroid Function and Thyroid Function Tests- Iodinated contrast media may contain small amounts of free inorganic iodide that could have effects on thyroid function. These effects are more evident in patients with latent or overt hyperthyroidism, or goiter. Hyperthyroidism or even thyroid crises have been reported after the administration of iodinated contrast media.

• Intraarterial and Intravenous Administration

Use in Patients with Special Pathological Conditions

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

Diabetes Mellitus- The presence of renal damage in diabetic patients is one of the factors that predisposes to renal dysfunction as a consequence of the administration of contrast media.

Renal impairment can cause 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: before the intraarterial administration of a contrast medium with first-pass renal exposure, in patients with eGFR below 60 ml/min/1.73 m², or when there are other risk factors for lactic acidosis.

In patients with severe renal impairment (creatinine clearance less than 30 ml/min/1.73 m2) who receive intravenous or intra-arterial contrast media with secondary renal exposure, or in patients with acute renal injury, and it should only be resumed after 48 hours, provided that renal function has not changed significantly.

CPER- The risk associated with CPER procedures in patients with acute, obstructive, or non-obstructive pancreatitis should be carefully assessed with respect to the expected benefits.

Pheochromocytoma- These patients may develop severe hypertensive crises (rarely uncontrollable) after using intravascular contrast media during radiological procedures.

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

Myasthenia Gravis- The administration of iodinated contrast media may exacerbate the 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 arteriopathy. The intravascular injection of contrast media can cause pulmonary edema in patients with overt or incipient cardiac decompensation, while the administration of contrast media in cases of pulmonary hypertension and valvulopathy can favor hemodynamic alterations. The appearance of signs of ischemia on the ECG and severe arrhythmias is more common in older patients and those with pre-existing heart disease: their frequency and severity seem to be related to the severity of cardiac disease.

Neurological symptoms- Particular attention should be paid when administering contrast media to patients with acute cerebral infarction, intracranial hemorrhage, and those with alterations of the blood-brain barrier, cerebral edema, or acute demyelination. The presence of intracranial tumors or metastases and a history of epilepsy can increase the likelihood of seizures. The administration of contrast media can exacerbate neurological symptoms due to degenerative, ischemic, inflammatory, or neoplastic cerebrovascular diseases. These patients have a higher risk of transient neurological complications. Intravascular injections of contrast media can cause angiospasm phenomena and episodes of cerebral ischemia.

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

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

The product should be used with caution in patients with diseases that affect the integrity of the blood-brain barrier (BBB), which could cause increased permeability of the contrast medium through the BBB and increase the risk of encephalopathy. If contrast-induced encephalopathy is suspected, the administration of iomeprol should be discontinued and adequate medical monitoring initiated.

Alcoholism- It has been demonstrated, experimentally and clinically, that acute or chronic alcoholism increases the permeability of the blood-brain barrier. It facilitates the passage of iodinated agents to the brain tissue, which can produce CNS disorders. A possible reduction of the epileptic threshold in alcoholics should be taken into account.

Drug addiction- Drug-addicted patients require particular attention due to the possible reduction of the convulsive threshold.

Fluoroscopy is recommended to minimize extravasation during injection.

Overdose

In the event that the responsible physician diagnoses an accidental intravascular overdose of the contrast medium, the patient's 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 the event of an accidental intrathecal overdose, the patient should be carefully monitored for at least 24 hours to detect signs and symptoms of CNS disorders. These signs may include: increased hyperreflexia or tonic-clonic spasms, and even generalized seizures, hyperthermia, stupor, and respiratory depression.