Iomeron 400

PATIENT INFORMATION LEAFLET: USER INFORMATION

Iomeron 200, solution for injection, 200 mg iodine/ml
Iomeron 250, solution for injection, 250 mg iodine/ml
Iomeron 300, solution for injection, 300 mg iodine/ml
Iomeron 350, solution for injection, 350 mg iodine/ml
Iomeron 400, solution for injection, 400 mg iodine/ml
Jomeprol (Iomeprolum)

Read the leaflet carefully before using the medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Iomeronand what is it used for
• 2. Important information before using Iomeron
• 3. How to use Iomeron
• 4. Possible side effects
• 5. How to store Iomeron
• 6. Contents of the pack and other information

1. What is Iomeron and what is it used for

Medicinal product intended exclusively for diagnostic purposes.
Iomeronis a sterile aqueous solution of iomeprol in concentrations ranging from 200 to 400 mg iodine/ml.
The active substance of the medicine is iomeprol - a triiodinated, non-ionic, water-soluble contrast agent used in radiological diagnosis of various body regions.
After intravenous administration of Iomeron, most of it is excreted in the urine within the first 24 hours, and small amounts are excreted between 24 and 38 hours after administration.

2. Important information before using Iomeron

When not to use Iomeron:

Do not administer the medicine Iomeronif:

• the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• there is a history of repeated myelography due to the risk of contrast medium overdose.

Warnings and precautions

Before starting treatment with Iomeron, discuss it with your doctor or nurse.

• if the patient is allergic, has asthma, and especially if they are taking blood pressure regulating medications (beta-adrenolytics).

Pregnancy and breastfeeding

Since, if possible, exposure to radiation should be avoided during pregnancy, the benefit of performing an X-ray examination with or without a contrast agent should be carefully considered in the context of possible risk.
Similarly, an X-ray examination with contrast agent should be avoided in breastfeeding women. Contrast agents are excreted in small amounts in the milk of breastfeeding women. Based on existing experience, the occurrence of side effects in the breastfed infant is unlikely. Breastfeeding can be continued after the examination with Iomeron.

Elderly patients

Due to the deterioration of physiological functions in elderly patients, there is a particular risk of side effects, especially when large doses of contrast agents are used.

Hypersensitivity to iodine contrast agents

Diagnosed hypersensitivity or a previous reaction to iodine contrast agents also increases the risk of recurrence of a severe reaction to non-ionic agents. In these patients, it is recommended to administer glucocorticoids and antihistamines to prevent another reaction.

Predisposition to allergic reactions

Side effects of iodine contrast agents occur more frequently in patients with a history of allergy: hay fever, urticaria, and food allergy.

Asthma

The risk of bronchospasm in patients with asthma is higher after the administration of contrast agents, especially in patients receiving beta-adrenolytics.

Hyperthyroidism, nodular goiter

Small amounts of free inorganic iodine that may be present in contrast agents can affect thyroid function. This is more pronounced in patients with hyperthyroidism or goiter. There have been reports of severe thyroid function disorders after the administration of iodine contrast agents.

Renal impairment

Previous renal impairment may predispose to the occurrence of acute renal dysfunction after the administration of contrast agents. Preventive measures include:

• identification of patients at high risk;
• ensuring adequate hydration before the administration of contrast agents, it is recommended to maintain intravenous fluid infusion before and during the procedure until the contrast agent is fully excreted by the kidneys;
• avoiding, if possible, the use of nephrotoxic drugs or performing extensive procedures or procedures such as renal angioplasty until the contrast agent is fully excreted;
• delaying the next examination with a contrast agent until renal function returns to its pre-examination state. In dialyzed patients, contrast agents such as iomeprol can be administered before dialysis.

Diabetes

Diabetic nephropathy is one of the factors that predispose to the development of renal function disorders after the administration of contrast agents. Biguanide derivatives (e.g., metformin) can accelerate the development of lactic acidosis.

Pheochromocytoma

In order to reduce the risk of hypertensive crisis, it is recommended to use alpha-adrenergic blockers in these patients.
Muscle weakness (Myasthenia gravis)
The administration of iodine contrast agents may exacerbate the symptoms of the disease.

Severe cardiovascular diseases

The risk of severe reactions in patients with serious heart diseases, especially in the case of heart failure and coronary artery disease, is increased.
Intravascular injection of a contrast agent can accelerate the onset of pulmonary edema in patients with overt or initial heart failure. The administration of a contrast agent in the case of pulmonary hypertension and valvular defects can lead to significant hemodynamic changes.
Severe and chronic hypertension can increase the risk of kidney damage after the administration of contrast agents and the risk associated with catheterization.

CNS disorders

Particular attention should be paid to the intravascular administration of contrast agents in patients with acute cerebral ischemia, acute intracranial hemorrhage, conditions involving damage to the blood-brain barrier, cerebral edema, and acute demyelination.
The presence of intracranial tumors or metastases, as well as a history of epilepsy, may increase the likelihood of seizures.
Neurological symptoms caused by concomitant degenerative, inflammatory, or neoplastic changes may worsen after the administration of a contrast agent.
Intravascular injection of a contrast agent can cause vascular spasm and resulting ischemic symptoms.
Particular caution should be exercised in the case of phlebography in patients with suspected venous thrombosis, phlebitis, severe ischemic disease, local venous infection, or a completely occluded vascular system.
During or shortly after imaging, the patient may experience a transient cerebral disturbance, known as encephalopathy. If the patient experiences any symptoms related to this disorder, as described in section 4, they should immediately inform their doctor.

Alcoholism

It has been proven that both experimentally and clinically, acute and chronic alcoholism leads to increased permeability of the blood-brain barrier, which facilitates the penetration of iodine contrast agents into brain tissue, potentially leading to CNS disorders. Due to the possible lowering of the seizure threshold, caution should be exercised in individuals dependent on alcohol.

Drug dependence, drug addiction

Caution should be exercised in individuals dependent on drugs or narcotics, due to the possible lowering of the seizure threshold.

States of agitation

States of severe anxiety, excitement, and pain can cause or exacerbate side effects caused by the administration of contrast agents.

Extravasation

Caution should be exercised when injecting a contrast agent to avoid extravasation.

Iomeron and other medicines

The doctor will consider discontinuing treatment with medications that lower the seizure threshold. Treatment will be resumed 24 hours after the procedure.
Antiepileptic therapy should not be discontinued, and medications should be administered in optimal doses.
Biguanide derivatives (e.g., metformin) can accelerate the development of lactic acidosis. As a precaution, it is recommended to discontinue biguanide derivatives 48 hours before the examination with contrast agents and resume them only after checking renal function and ensuring it has returned to its initial state.
Increased risk of side effects, especially delayed ones (rash, erythema, fever, flu-like symptoms), occurs in patients treated with interleukin-2 (IL-2) and interferon.

Thyroid function tests

The uptake of radioactive isotopes in diagnostic tests of thyroid function disorders is reduced for up to 16 days after the administration of iodine contrast agents.
Thyroid test results independent of iodine levels, i.e., T3, T4 levels, are not affected. All tests whose results depend on iodine levels should be performed before the contrast examination. The above observations do not depend on clinical symptoms.

Laboratory tests

High concentrations of contrast agents in serum and urine can affect the results of laboratory tests for bilirubin, protein, or inorganic substances (e.g., iron, copper, calcium, phosphates).

Driving and operating machinery

The effect on the ability to drive and operate machinery is not known.

3. How to use Iomeron

Details on dosing can be found at the end of the leaflet in the section "Information for healthcare professionals or healthcare workers". Diagnostic tests with contrast agents should be performed by appropriately trained medical personnel.

Overdose

Overdose can lead to life-threatening side effects, mainly due to the effect on the respiratory and cardiovascular systems. Treatment of overdose focuses on maintaining vital functions and symptomatic therapy. Dialysis or hemodialysis can also be used.
In the event of overdose after intravascular administration, careful observation is necessary to detect any CNS disorders. Symptoms include: ascending enhancement of deep reflexes, tonic-clonic convulsions, generalized seizures, increased body temperature, stupor, respiratory depression.

4. Possible side effects

Like any contrast agent, Iomeroncan cause side effects, although not everyone will experience them.
Side effects are usually mild to moderate and transient. However, severe and life-threatening reactions leading to death have also been reported. Reactions usually occur within a few minutes of administration, but may occur much later.
Anaphylaxis (anaphylactoid/anaphylactic reactions) can manifest in various ways, and it is rare for one patient to exhibit all possible symptoms. Usually, within 1 to 15 minutes (rarely longer than 2 hours), the patient complains of malaise, agitation, heat waves, feeling of heat, increased sweating, dizziness, increased lacrimation, nasal congestion, palpitations, paresthesia, itching, feeling of pulsation in the head, sore throat, and feeling of constriction in the throat, difficulty swallowing, coughing, sneezing, urticaria, erythema, mild local edema, angioedema, dyspnea caused by tongue and laryngeal edema and (or) its spasm, which manifests as wheezing and bronchospasm.
There have also been reports of nausea, vomiting, abdominal pain, and diarrhea.
These reactions, which occur regardless of the dose and route of administration, may be the first symptoms of circulatory failure.
The administration of the contrast agent should be stopped immediately, and appropriate treatment should be initiated intravenously if necessary.
Severe reactions from the cardiovascular system, such as vasodilation with a drop in blood pressure, tachycardia, dyspnea, agitation, cyanosis, loss of consciousness progressing to cardiac arrest and respiratory failure, can lead to death. These reactions may occur rapidly and require full and intensive cardiopulmonary resuscitation (restoration of cardiovascular and respiratory function).
Primary circulatory collapse may occur as the only and (or) initial reaction without additional respiratory symptoms or other symptoms mentioned earlier.

Side effects after intravascular administration

Adults

Frequent (occurring in 1 to 10 out of 100 patients):

feeling of heat

Uncommon (occurring in 1 to 10 out of 1,000 patients):

dizziness, headache, hypertension, dyspnea, vomiting, nausea, erythema, urticaria, itching, chest pain, pain and feeling of heat at the injection site

Rare (occurring in 1 to 10 out of 10,000 patients):

premonitory symptoms, bradycardia (slow heart rate), tachycardia (significant acceleration of heart rate), extrasystoles, hypotension, rash, back pain, asthenia (decreased or absent natural physical and nervous resistance), chills, fever, increased serum creatinine levels.

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

If the patient experiences a severe skin reaction: red, scaly rash with nodules under the skin and blisters (pustular psoriasis), they should immediately contact their doctor.
Thrombocytopenia, hemolytic anemia (abnormal breakdown of red blood cells, which can cause fatigue, accelerated heart rate, and shortness of breath), anaphylactic reaction, anxiety, confusion, coma, transient ischemic attacks, paralysis, syncope, seizures, loss of consciousness, dysarthria (articulation disorders), paresthesia, amnesia, somnolence, taste disorders, transient blindness, vision disorders, conjunctivitis, increased lacrimation, photopsia (perception of flashes or colors), cardiac arrest, myocardial infarction, heart failure, angina pectoris, arrhythmia, atrial fibrillation or atrial flutter, atrioventricular block, cyanosis, circulatory collapse or shock, heat waves, pallor, respiratory arrest, acute respiratory distress syndrome (ARDS), pulmonary edema, laryngeal edema, pharyngeal edema, bronchospasm, asthma, coughing, discomfort in the throat, discomfort in the larynx, rhinitis, dysphonia (voice disorders), diarrhea, abdominal pain, excessive salivation, swallowing difficulties, salivary gland enlargement, angioedema, increased sweating, renal failure, reaction at the injection site*, fatigue, malaise, ST segment elevation, ECG abnormalities. Cerebral disturbance (encephalopathy) with symptoms including headache, vision disorders, loss of vision, confusion, seizures, loss of coordination, loss of motor function on one side of the body, speech difficulties, and loss of consciousness.
* Reactions at the injection site include pain at the injection site and edema. In most cases, they are caused by extravasation of the contrast agent. These reactions are usually transient and do not result in permanent consequences. There have been reports of extravasation associated with inflammation, skin necrosis, and even the development of compartment syndrome.
There have been reports of coronary artery thrombosis and embolism as a complication of coronary angiography.
After intravascular administration of a contrast agent, vascular spasm and subsequent ischemia have been observed, especially after angiography of blood vessels and the brain, often related to the technique of the examination and presumably caused by the action of the catheter tip or excessive pressure in the catheter.
After the administration of iomeprol, as with other iodine contrast agents, rare cases of undesirable mucocutaneous reactions have been reported, such as Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and erythema multiforme.

Children

Experience with the use of iomeprol in children is limited. The safety profile of iomeprol is similar in children and adults.

Side effects after intravascular administration

Adults

The most commonly reported side effects after intravascular administration of iomeprol are: headache, dizziness, nausea, vomiting, and back pain. These side effects are mild to moderate and transient. In rare cases, headache may last for several days. Most side effects occur within 3-6 hours after administration, depending on the rate of distribution of the contrast agent from the injection site to the blood vessels. Most reactions occur within 24 hours of administration.

Very common (occurring in more than 1 in 10 patients):

headache.

Common (occurring in 1 to 10 out of 100 patients):

dizziness, hypertension, nausea, vomiting, back pain, pain in the limbs, reaction at the injection site*.

Uncommon (occurring in 1 to 10 out of 1,000 patients):

loss of consciousness, paralysis, paresthesia, numbness, somnolence, hypotension, sudden flushing, increased sweating, itching, stiffness of muscles and joints, neck pain, feeling of heat, fever.

Frequency not known:

anaphylactic reaction, epilepsy, rash.
* Reactions at the injection site include pain at the injection site and edema.

Children

No side effects have been reported after intravascular administration of iomeprol in children.

Side effects after administration into body cavities

After the administration of iodine contrast agents into body cavities, the contrast agents are slowly absorbed from the injection site into the circulatory system and then excreted by the kidneys.
An increase in amylase levels is common after endoscopic retrograde cholangiopancreatography (ERCP). Rare cases of pancreatitis have been reported.
Reactions reported during arthrography and fistulography are related to symptoms of irritation, which occur in previously inflamed tissues.
Hypersensitivity reactions are rare, mild, or in the form of skin inflammation. However, severe anaphylactic reactions cannot be ruled out.
As with other iodine contrast agents, after hysterosalpingography (a radiological examination aimed at visualizing the uterine cavity and fallopian tubes), pelvic pain and malaise may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: (22) 49 21 301, fax: (22) 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Iomeron

Store at a temperature below 30°C.
Store in the outer packaging to protect from light.
Although iomeprol is not very sensitive to X-rays, it is recommended to store the medicine outside the range of ionizing radiation.
Vials containing the contrast agent solution are not intended for multiple use.
The contrast agent should not be drawn into a syringe until immediately before use. Unused solutions and their residues in syringes should be discarded.
Do not use Iomeronif signs of spoilage are visible.
Do not use after the expiration date stated on the packaging.
Before administration, check for any visible mechanical contamination and changes in the color of the medicine, if the packaging allows.

6. Contents of the pack and other information

What Iomeron contains

The active substance is iomeprol.
Iomeronsolution contains (per 100 ml) the following excipients:
trometamol
100 mg
hydrochloric acid (d = 1.18)
24 mg
water for injections q.s.
100 ml

What Iomeron looks like and contents of the pack

Iomeronis packaged in vials/bottles made of colorless glass, closed with a rubber stopper, metal cap, and plug, placed in cardboard boxes.
Available packages:

Iomeron 200

Bottles of 50 ml, 100 ml, 150 ml, or 200 ml

Iomeron 250

Bottles of 50 ml, 100 ml, 150 ml, or 200 ml

Iomeron 300

Vials of 20 ml
Bottles of 50 ml, 100 ml, 150 ml, 200 ml, or 500 ml

Iomeron 350

Vials of 20 ml
Bottles of 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, or 500 ml

Iomeron 400

Bottles of 50 ml, 100 ml, 150 ml, 200 ml, 250 ml, or 500 ml

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bracco Imaging Deutschland GmbH
Max-Stromeyer-Strasse 116
D-78467 Konstanz
Germany

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

Representative of the marketing authorization holder:

Bracco Imaging Polska Sp. z o.o.
ul. Domaniewska 39 A
02-672 Warsaw

Date of last revision of the leaflet: 09/2021

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INFORMATION FOR HEALTHCARE PROFESSIONALS OR HEALTHCARE WORKERS

1 ml of Iomeroncontains:

Indications

Iomeron 200Peripheral phlebography, digital subtraction phlebography, computed tomography (CT) (brain and body), cavernography, intravenous and intra-arterial digital subtraction angiography (DSA), endoscopic retrograde cholangiopancreatography (ERCP), arthrography, hysterosalpingography, cholangiography, retrograde urethrography, retrograde pyeloureterography, myelography.
Iomeron 250Intravenous urography, peripheral phlebography, computed tomography (CT) (brain and body), intravenous and intra-arterial digital subtraction angiography (DSA), myelography.
Iomeron 300Intravenous urography (in adults and children), peripheral phlebography, computed tomography (CT) (brain and body), cavernography, intravenous digital subtraction angiography (DSA), conventional angiography, intra-arterial digital subtraction angiography (DSA), angiocardiology (in adults and children), conventional selective coronary arteriography, interventional coronary arteriography, endoscopic retrograde cholangiopancreatography (ERCP), arthrography, hysterosalpingography, fistulography, discography, galactography, cholangiography, dacryocystography, sialography, retrograde urethrography, retrograde pyeloureterography, myelography.
Iomeron 350Intravenous urography (in adults and children), computed tomography (CT) (body), intravenous digital subtraction angiography (DSA), conventional angiography, intra-arterial digital subtraction angiography (DSA), angiocardiology (in adults and children), conventional selective coronary arteriography, interventional coronary arteriography, arthrography, hysterosalpingography, fistulography, galactography, cholangiography, dacryocystography, sialography.
Iomeron 400Intravenous urography (in adults, including those with impaired renal function or diabetes), computed tomography (CT) (body), conventional angiography, intra-arterial digital subtraction angiography (DSA), angiocardiology (in adults and children), conventional selective coronary arteriography, interventional coronary arteriography, fistulography, galactography, dacryocystography, sialography.

Dosage

The recommended doses for adults were calculated for an average body weight of 70 kg. Each time before administering the medicinal product, the dose should be adjusted to the patient's current body weight and other relevant factors (e.g., clinical condition).
The recommended doses for newborns, infants, and children are given for a single injection/kg body weight and should not exceed 250 ml. The volume of a single injection depends on the vascularized area to be examined
and should not exceed 350 ml
and should not exceed 4500 mg of iodine and a concentration above 300 mg I/ml when administered intrathecally
= newborns 0-27 days old
= infants from 28 days to 12 months old
= includes children and adolescents (1-17 years old)

Instructions for use

Contrast agents administered intravascularly and intrathecally should have body temperature during injection.
Before administration, check for any visible mechanical contamination and changes in the color of the medicinal product, if the packaging allows.
Never mix other medicinal products with contrast agents.
The contrast agent is drawn from the packaging under sterile conditions and with a sterile syringe.
Sterile conditions and technique should be maintained when performing intrathecal puncture, intravascular administration, and when using catheters and guidewires.
Once opened, packaging must be used immediately. The rubber stopper should never be punctured more than once.
It is recommended to use appropriate cannulas for piercing the stopper and drawing the contrast agent from the packaging.
Contrast agents in packaging intended for multiple use and with a capacity of 500 ml should be used with appropriate injection devices. After the examination, all parts intended for single use should be discarded. The instructions provided by the manufacturer of the injection device should be followed.
Iomeprol, like other contrast agents, may react with metal surfaces containing copper, e.g., brass, so it is recommended to avoid using equipment made of this type of material.
Contraindications to intrathecal administration:
Repeated myelography is contraindicated due to the risk of contrast medium overdose.

Special warnings and precautions for use

Diagnostic tests with contrast agents should be performed by appropriately trained medical personnel (especially in the treatment of anaphylactic shock and maintenance of vital functions).

General precautions for use in relation to the patient

Hydration

Patients must be well-hydrated, and any significant water-electrolyte imbalance should be corrected before and after the administration of the contrast agent. Patients with severe functional liver or heart failure, multiple myeloma, sickle cell anemia, diabetes, polyuria, oliguria, hyperuricemia, infants, elderly patients, and patients with severe systemic disease should not be exposed to dehydration. Caution should be exercised in patients who are hydrated and whose condition may worsen with the administration of excessive fluid, including those with congestive heart failure.

Dietary recommendations

Unless otherwise instructed by the doctor, a normal diet can be followed on the day of the examination. Adequate fluid intake should be ensured before and after intravascular administration.

Allergy test

In patients with suspected or known hypersensitivity to contrast agents, an allergy test is not recommended, as severe or fatal reactions to contrast agents are unpredictable based on the results of allergy tests.

Hypersensitivity

In patients with a tendency to allergies, hypersensitivity reactions to iodine contrast agents, and (or) asthma, it is recommended to administer antihistamines and (or) glucocorticoids to reduce the risk of pseudo-anaphylactic reactions.

Anxiety

Severe anxiety, agitation, and pain can cause or exacerbate side effects associated with the administration of contrast agents.

Newborns, infants, children

Infants (<1 year old), especially newborns, are particularly susceptible to water-electrolyte imbalance and hemodynamic changes. attention should be paid the planned dosage, details of procedure, patient's health status.< p>

General precautions for use in relation to the procedure

Intrathecal administration

As with other contrast agents, Iomeronshould be administered with particular caution to patients with increased intracranial pressure or suspected tumor, abscess, or intracranial hemorrhage. In patients with a history of seizures, antiepileptic medications should be administered before and after myelography.

Catheterization

Non-ionic contrast agents exhibit weaker anticoagulant activity than ionic agents in vitro. Medical personnel performing catheterization should be informed of this. The angiographic procedure and catheter flushing should be performed very carefully to minimize the risk of thrombosis and embolism associated with the procedure. To maintain catheter patency, it can be flushed with a physiological saline solution (if necessary, with the addition of heparin).

Patient monitoring

Intravascular administration - contrast agents should, if possible, be administered to a patient in a supine position. The patient should be monitored for at least 30 minutes after the administration of the contrast agent.
Intrathecal administration - after completing the direct administration to the cervical or lumbar region, the head of the bed should be elevated (approximately 45°) for about 2 minutes to allow the contrast agent to fill the lower parts of the spinal canal. During the first hours after the examination, the patient should avoid excessive, sudden movements and remain under close observation. They should lie on their back with their head elevated.
Administration into the basal cisterns or ventricles - direct administration is not recommended when using conventional radiography without computer enhancement.
The label torn off from the vial or bottle should be attached to the patient's chart to allow for proper registration of the administered medicinal product. The dose should also be recorded.