PATIENT INFORMATION LEAFLET

Iomeron 400 mg Iodo/ml injectable solution

Iomeprol

Read this leaflet carefully before you start using this medicine, as 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. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

1. What is Iomeron 400 mg Iodo/ml injectable solution and what it is used for

2. What you need to know before using Iomeron 400 mg Iodo/ml injectable solution

3. How to use Iomeron 400 mg Iodo/ml injectable solution

4. Possible side effects

5. Storage of Iomeron 400 mg Iodo/ml injectable solution

6. Contents of the pack and additional information

This medication is solely for diagnostic use.

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

Iomeron is used to improve visualization of different body areas through certain radiological techniques. It is used in adults for intravenous urography, computed tomography (CT) of the body, conventional angiography, angiocardiography, selective conventional coronary arteriography, digital subtraction phlebography, fistulography, galactography, dacryocystography, and sialography. In children from 0 to 18 years for intravenous urography, computed tomography (CT) of the body, conventional interventional arteriography, angiocardiography, and digital subtraction phlebography.

Do not use Iomeron 400 mg Iodo/ml injectable solution

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

Warnings and precautions

It is recommended to perform fluoroscopy 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 administration of Iomeron in both children and adults. Newborns may also be exposed through 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 (SSJ), toxic epidermal necrolysis (TEN), acute generalized pustular psoriasis (PGAP), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with the use of Iomeron. Seek medical attention immediately if you observe any symptoms related to these severe skin reactions described in section 4.

Consult your doctor before starting to use Iomeron 400 mg Iodo/ml injectable solution.

Children

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

Other medications and Iomeron 400 mg Iodo/ml injectable solution

Inform your doctor if you are using, have used recently, 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 medicationshould 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).

Use ofIomeron 400 mg Iodo/ml injectable solution with food and beverages

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 abstain from eatingfor two hours before the examination.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Pregnancy

Inform your doctor if you are pregnant or think you may be.

Like 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 during pregnancy should be avoided, the risk-benefit ratio of any X-ray examination, with or without contrast medium, 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.

Lactation

Contrast media are rarely excreted in breast milk, and it is remote that the infant may be harmed.

Driving and operating machinery

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

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

The dose you will receive will vary depending on the type of examination, age, body weight, cardiac output, and overall condition you present, as well as the technique used.

If you use more Iomeron 400 mg Iodo/ml injectable solution than you should

Overdosing may cause severe adverse reactions, mainly through effects on the cardiovascular and pulmonary systems.

The treatment of an overdose is aimed at maintaining all vital functions and preventing the rapid onset of symptomatic therapy. Iomeron may be eliminated from the body through dialysis.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological 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 with your doctor or pharmacist.

Like all medicines, this medicine 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 fatal outcome. In most cases, reactions occur within minutes of administration, although they can sometimes appear later.

Inform your doctor immediately if you experience any of the following symptoms: sudden hissing breathing, difficulty breathing, eyelid, face, or lip inflammation, skin rash or itching affecting the entire body.

The following side effects have been reported:

Intravascular administration

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

• feeling of heat

Infrequent(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 1000 people):

• syncope
• abnormal heart rhythm or rate
• decreased blood pressure
• skin rash
• back pain
• asthenia, rigidity, fever
• increased creatinine in the blood

Unknown frequency(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, 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, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).
• a generalized rash, elevated body temperature, and increased lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)

• anxiety, hyperkinetic syndrome (increased motor activity), confusion
• allergic reactions
• hyperthyroidism
• loss of appetite (anorexia)
• alteration of taste, difficulty speaking, brain function disorder, cerebral edema (fluid in the brain), transient cerebral blood supply problems with few or no sequelae (transient ischemic attacks), memory loss, drowsiness, altered sensitivity (tingling, itching) apoplexy, loss of consciousness, tremors, coma, convulsions, alteration of the sense of smell
• cerebral disorder (encephalopathy) with symptoms including headache, vision difficulties, vision loss, confusion, convulsions, loss of coordination, loss of movement in a part of the body, speech difficulties, and loss of consciousness.
• temporary blindness, vision deterioration, conjunctivitis, increased tear production, photopsia (light flashes)
• myocardial infarction, cardiac arrest, chest tightness, cardiac rhythm disorders, angina pectoris, heart failure, coronary artery thrombosis (after catheter insertion), irregular heartbeat, cardiac conduction disorders, rapid and weak pulse
• flushing, shock (severe drop in blood pressure, pallor, fatigue, cold and moist skin, reduced consciousness) caused by sudden and severe dilation of blood vessels, blue discoloration of the skin and mucous membranes, clots, vasospasm, and as a result, ischemia.,
• circulatory failure (circulatory collapse)
• coronary artery obstruction (after catheter insertion)
• respiratory arrest, cough, acute respiratory distress syndrome (ARDS), wheezing, asthma attacks, accumulation of fluid in the throat, fluid in the lungs, nasal mucosa inflammation characterized by nasal obstruction, sneezing, and discharge (rhinitis), hoarseness (dysphonia), inadequate oxygen supply to tissues (hypoxia), throat and laryngeal pain, sudden constriction of airways (bronchospasm)
• intestinal incontinence, diarrhea, abdominal pain, excessive salivation, difficulty swallowing, pancreatitis inflammation along with severe abdominal pain radiating to the back with nausea and vomiting, salivary gland enlargement, intestinal obstruction
• severe allergic reactions, characterized by symptoms such as increased sweat production, dizziness, itching, pulsating headache, throat constriction, inflammation of the mucous membranes of the mouth and throat, which make breathing difficult
• eczema, skin rash, increased sweat production, sudden accumulation of fluid in the skin and mucous membranes (e.g., throat or tongue), possibly with difficulty breathing and/or 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 feeling of cold, thirst, reaction at the injection site, hematoma at the injection site
• blood disorders (thrombocytopenia) accompanied by hematomas and a tendency to bleed
• hemolytic anemia (abnormal decrease in red blood cells, which can cause fatigue, rapid heart rate, and difficulty breathing)

This may cause transient hypothyroidism in children under 3 years old.

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

Administration in body cavities

• allergic reactions
• alteration of blood tests (after pancreas examination)
• like other iodinated contrast media, it may cause pelvic pain and general discomfort after a uterine, fallopian tube, and ovary examination.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use http://www.notificaRam.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

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

Although the X-ray sensitivity of iomeprol is low, it is advisable to store the product out of the reach of ionizing radiation.

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

Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Iomeron 400 mg Iodo/ml injectable solution

• The active ingredient 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 to adjust the pH, and water for injection.

Aspect of the product and content of the packaging

Iomeron is packaged in glass bottles closed with halobutilo stoppers and an aluminum capsule.

Bottles of 50 ml, 100 ml, 250 ml, and 500 ml. The 50 ml, 100 ml, and 250 ml bottles are single-dose; the 500 ml bottle is multi-dose.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bracco Imaging s.p.a.

Via E. Folli 50

20134(Milán – Italia)

Responsible for manufacturing

Patheon Italia s.p.a.

2nd Trav. SX Vía Morolense, 5

03013 Ferentino (Italia)

BIPSO GmbH

Robert-Gerwig-Strasse 4

78224 Singen (Alemania)

Bracco Imaging S.p.A.

Bioindustry Park - Via Ribes, 5

10010 Colleretto Giacosa (TO) (Italia)

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 review of this leaflet:September 2023

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Iomeron 400 mg Iodo/ml is an injectable solution for intravenous, intraarterial, intramammary, and intraglandular administration.

Whenever possible, intravascular administration of contrast media should be performed with the patient lying down. Maintain 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 will be used.

Instructions for administration if single-dose bottles are used:

Do not remove multiple doses from a bottle of contrast medium. The rubber stopper should never be perforated more than once. It is recommended to use an appropriate extraction cannula to pierce the stopper and extract the contrast medium. This should not be extracted in the syringe until immediately before use. The residual amount of solution not used for an examination should be discarded.

Instructions for administration if multi-dose bottles are used:

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

Autoinjectors/pumps should not be used in small children.

Only one perforation should be made.

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

The remaining contrast medium solution in the bottle, as well as the connection tubes and all replaceable parts of the injection system, should be discarded within 8 hours.

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

The elimination 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 hydro-electrolyte 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 for two hours before 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), generalized acute pustular psoriasis (GAPP), 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 by intravascular route. At the time of administration, patients should be warned of the signs and symptoms, and closely monitored for the appearance of cutaneous reactions. If signs and symptoms suggest the onset of these reactions, administration of Iomeron should be suspended immediately. If a patient has developed a severe reaction such as SJS, TEN, GAPP, or DRESS with the use of Iomeron, Iomeron should not be administered to that patient at any time.

Anxiety- States of excitement, anxiety, and pain can be a cause of secondary effects or can intensify reactions related to the contrast medium. In these cases, a sedative may 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, catheterism- A property of non-ionic contrast media is their slight 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 catheterism should be informed 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 catheters should be cleaned frequently to minimize the risk of thromboembolism related to the procedure.

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

Test for sensitivity- A test for sensitivity is practically useless, as severe or fatal reactions due to contrast media cannot be predicted with this test.

Risk of inflammation and extravasation- It is recommended to exercise caution during the injection of contrast media to avoid extravasation.

Warnings

• Common to all administration routes

Considering the possible severe secondary effects, the use of organic iodine contrast media should be limited to specific needs for contrastographic explorations.

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 explorations should be used in hospitals or clinics with competent personnel and necessary equipment for intensive care in case of emergency. In centers where common diagnostic examinations requiring the use of iodinated contrast media are performed, the radiology services where these examinations are performed should have therapeutic measures and resuscitation equipment confirmed by experience to be suitable (Ambu balloon, oxygen, antihistamines, vasoconstrictors, etc.).

Use in:

Pediatric population- Children under one year of age, 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.Observation of hypothyroidism or transient thyroid suppression may occur 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 may be detrimental to motor, auditory, and cognitive development and may require temporary replacement treatment with T4. The incidence of hypothyroidism in pediatric 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 patients- Elderly patients should be considered to be at special risk of 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

• Administration via intraarterial and intravenous routes

Use in patients with special pathological conditions

Renal impairment- In patients with compromised renal function, administration of contrast media may cause episodes of renal insufficiency. Preventive measures include: identifying patients at high risk; ensuring adequate hydration before 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, administration of nephrotoxic drugs and subjecting the patient to major 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, which are dialyzable without difficulty.

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

The renal impairment may cause lactic acidosis in diabetic patients with renal damage treated with biguanides (metformin). To prevent it, treatment with biguanides should be suspended in the following cases:before intraarterial administration of a contrast medium with first-pass renal exposure, in patients with an eGFR of less than 30 ml/min/1.73 m2who receive a contrast medium by intravenous route or a contrast medium by intraarterial route with second-pass renal exposure, or in patients with acute renal injury, and should only be resumed after 48 hours, provided that renal function has not changed significantly.

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

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

Myasthenia gravis-The administration of iodinated contrast media may exacerbate the 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 heart failure, while administration of the contrast medium in cases of pulmonary hypertension and valvular disease may favor hemodynamic alterations. The appearance of ECG signs of ischemia and severe arrhythmias is more common in older patients and those with pre-existing cardiovascular disease: their frequency and severity appear to be related to the severity of the cardiovascular disease.

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

Contrast-induced encephalopathy– Contrast-induced 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 administration of iomeprol, and usually resolves within days.

The product should be used with caution in patients with diseases affecting the integrity of the blood-brain barrier (BBB), which may cause increased permeability of the contrast medium through the BBB and increase the risk of encephalopathy. If encephalopathy induced by contrast is suspected, administration of iomeprol should be suspended and appropriate medical control should be 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 iodated agents into the cerebral tissue that can produce CNS disorders. It should be taken into account that there may be a reduction in the epileptic threshold in alcoholics.

Toxicomania- Toxicomanic patients require particular attention due to the possible reduction of the convulsive threshold.

It is recommended to perform fluoroscopy 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.