IOMERON 150 mg /Ml Infusion Solution

Зміст інструкції

1. IOMERON 150 mg/ml injectable solution
   1. What IOMERON is and what it is used for
   2. What you need to know before you are given IOMERON
   3. How IOMERON will be administered to you
   4. Possible side effects
   5. How to store IOMERON
   6. Package contents and other information

IOMERON 150 mg/ml injectable solution

IOMERON 200 mg/ml injectable solution
IOMERON 250 mg/ml injectable solution
IOMERON 300 mg/ml injectable solution
IOMERON 350 mg/ml injectable solution
IOMERON 400 mg/ml injectable solution
Iomeprolo

Read this leaflet carefully before you are given this
medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If any side effects occur, including any not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What IOMERON is and what it is used for
• 2. What you need to know before you are given IOMERON
• 3. How IOMERON will be given to you
• 4. Possible side effects
• 5. How to store IOMERON
• 6. Contents of the pack and other information

1. What IOMERON is and what it is used for

IOMERON contains the active ingredient iomeprol, which belongs to a group of medicines
called contrast agents.
It is used for diagnostic purposes, during a radiological examination, because
absorbing X-rays allows the doctor a greater visualization of blood vessels,
joints, the spinal canal and the organs undergoing radiological examination, and to
recognize with greater clarity both normal structures and any pathological processes

2. What you need to know before you are given IOMERON

You will not be given Iif

• you are allergic to iomeprol or to any of the other ingredients of this medicine (listed in section 6).
• you are pregnant or suspect you may be pregnant, or you have inflammation of the genitals and the radiological examination needs to be performed to visualize the uterus (see section 2. Pregnancy and breastfeeding).
• you have recently undergone a radiological examination with I in the intrathecal space (space around the spinal cord) because repeated administration of I could cause you adverse effects from an overdose.

Warnings and precautions
Talk to your doctor before you are given I.
Considering the possible side effects, even serious ones, the use of iodinated contrast agents
should be limited to cases where an examination using a contrast agent is
clearly indicated. The need to perform an examination with a contrast agent must be
determined by your state of health, with particular attention to cardiovascular, kidney, liver and biliary tract diseases.
Tell the radiologist and/or healthcare professionals if you suffer from a bone marrow disease
(Waldenstrom's paraproteinemia, multiple myeloma), or severe kidney or liver diseases.
Similarly, a radiographic examination of the female genitals is contraindicated if you are
pregnant or think you might be, or if you have acute inflammation of the genital organs
(see section 2. Pregnancy and breastfeeding).
If you are elderly, you may be particularly susceptible to developing side effects. The doctor
will pay particular attention to the dosage to be used.
During or immediately after the imaging procedure, a
brief cerebral disorder called encephalopathy may occur. Immediately inform your doctor if
you notice any of the symptoms related to this condition described in Paragraph 4.
Talk to your doctor before you are given I if you suffer from:

• Allergy (hypersensitivity) to iodinated contrast agents;
• Allergies (e.g. hay fever, urticaria, food allergies), asthma;
• Thyroid disease (gland in the neck);
• Reduced kidney (renal insufficiency) or liver function;
• Diabetes (see section 2. Other medicines and IOMERON);
• Sickle cell anemia (an abnormality of red blood cells, a type of blood cell);
• Myasthenia gravis (a disease characterized by muscle weakness that can lead to paralysis);
• Severe heart and blood vessel diseases, including heart failure (poor heart function), coronary artery disease, heart attack;
• Pheochromocytoma, a disease characterized by excessive production of hormones that cause severe high blood pressure;
• Neurological disorders such as transient ischemic attacks, blockage of blood vessels that prevents blood flow to the brain (acute stroke), sudden leakage of blood from blood vessels in the brain (acute intracranial hemorrhage), accumulation of fluid that causes swelling in the brain (cerebral edema);
• Tumors or brain metastases;
• Disease characterized by uncontrolled movements and possible loss of consciousness (epilepsy), recent stroke (blockage of blood vessels that prevents blood flow to the brain);
• Restlessness, anxiety or pain;
• Alcoholism;
• Drug addiction.

During or shortly after the imaging procedure, a brief
cerebral disorder called encephalopathy may occur. Immediately inform your doctor if you notice any of the symptoms
related to this condition described in Paragraph 4.
Following administration of IOMERON through a vein, the doctor will monitor you for
at least 30 minutes.
Allergies – If you are prone to allergies, you know you are allergic to iodine-containing contrasts and/or suffer from asthma, it may be helpful to administer medications to prevent
allergies, such as antihistamines and/or corticosteroids.
Anxiety – If you suffer from anxiety, it may be helpful to administer a sedative, a
medicine to reduce your discomfort and/or excitement.
Repeated procedures – If you suffer from a kidney disease, the doctor will ask you to undergo
specific blood tests to analyze your kidneys before the examination.
In general, the examination with the contrast agent should not be repeated before 5-7 days.

Children
Children under one year of age and especially newborns are particularly sensitive to
the development of side effects. The doctor will pay particular attention to the dosage to
be used, the technique of the procedure and the patient's condition.
Thyroid disorders can be observed in newborns and premature babies following a
diagnostic procedure, both of the mother during pregnancy and of the newborn. It is
recommended to monitor thyroid function.

Other medicines and IOMERON
Tell your doctor if you are taking, have recently taken or might take
any other medicines.
Taking IOMERON and some other medicines at the same time can lead to the appearance
of side effects.
Tell your doctor if you are taking:

• Medicines for psychiatric disorders (neuroleptics or antidepressants), stimulant medicines, medicines against nausea or phenothiazine derivatives; anticonvulsant drugs should not be stopped;
• medicines for diabetes such as metformin. If you suffer from moderate renal insufficiency, the intake must be stopped 48 hours before treatment with I. After subjecting you to blood tests, the doctor may have you resume therapy only after 48 hours;
• medicines to treat heart disease and/or high blood pressure (beta-blockers);
• medicines to modify the response of the immune system, such as interleukin-2; If you are to undergo a thyroid or gallbladder examination (by cholecystography) or perform laboratory tests within two weeks of administration of the contrast agent, talk to your doctor, as they may be altered.

IOMERON with food, drinks and alcohol
Unless otherwise specified by your doctor, you can follow a normal diet on the day of the examination,
with adequate fluid intake. However, you should not eat food in the two hours
before the examination.
Tell your doctor if you drink heavily before undergoing the examination with I.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a
pregnancy, or if you are breastfeeding, inform your doctor or nurse before you are
given this medicine.
Pregnancy
Where possible, radiation should be avoided during pregnancy and therefore the
doctor will carefully assess whether a radiological examination is necessary, with or without a
contrast agent.
If you are pregnant or suspect you may be, you should not undergo radiological examinations to
visualize the uterus (see section 2. You will not be given IOMERON).
If you are pregnant and have received Iomeron during pregnancy, it is recommended to monitor the
thyroid function of the child after birth.
Breastfeeding
Iomeprol passes into human milk, but no harmful effects on the newborn should occur.
However, unless otherwise specified by your doctor, discontinue breastfeeding for the 24 hours following
treatment with a contrast agent.
Fertility
The doctor will take particular measures when performing the examination if you are a woman of childbearing age.

Driving and operating machinery
Before driving or operating machinery, check if there are side effects such as
hypotension (blood pressure too low), dizziness, confusion, dyspnea
(difficulty breathing).

3. How IOMERON will be administered to you

It will be administered by the radiologist and/or healthcare professionals. It may be
injected into a vein, an artery, a body cavity or the intrathecal space, that is the
space around the spinal cord.
The injected dose may vary depending on the type of examination, the technique used, but also
based on your age, your weight and your general condition. The dose to be injected is
strictly determined by the doctor and/or radiology technician.

Use in children
In children, the dosage is also based on age.

If you are given more IOMERON than you should
It is highly unlikely that you will be given more IOMERON than necessary, as your
doctor will carefully monitor the procedure during the examination.
Excessive administration can lead to serious adverse effects on the heart, on
blood circulation and on the lungs. The doctor will promptly administer
suitable therapy to avoid any damage. Iomeprol can be eliminated through blood filtration and purification (hemodialysis).

4. Possible side effects

Like all medicines, I may cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience a severe skin reaction: red and scaly rash with the formation of pustules and blisters (pustular exanthematous reaction).
Most allergic reactions occur within minutes of administration of
iodinated contrast agents, but they can sometimes occur even after 24 hours.
The symptoms of allergic reactions mainly present as:

• A generalized feeling of heat, sweating, dizziness, tearing, rhinitis, palpitations, paresthesia, itching, throbbing in the ears, pain and tightness in the throat, dysphagia, cough, sneezing;
• Skin reactions such as erythema, itching, urticaria;
• Fluid accumulation throughout the body or in the lungs (pulmonary edema), difficulty breathing (bronchospasm);
• Swelling of the face or mucous membranes (angioedema), low blood pressure (hypotension);

Severe anaphylactic reactions affecting the cardiovascular system are represented by
peripheral vasodilation with pronounced hypotension, reflex tachycardia, dyspnea,
agitation, cyanosis and loss of consciousness and, following respiratory and/or cardiac arrest,
can lead to death.
These events can occur rapidly and require cardiopulmonary resuscitation maneuvers.
The administration of the contrast agent must be stopped immediately and, if
necessary, appropriate and specific treatment must be urgently initiated intravenously.
Primitive cardiovascular collapse can manifest as sole and/or initial manifestation
without respiratory symptoms or without the other signs or symptoms indicated above.
The following side effects have been reported with iomeprol, listed below according to
their frequency:

Common (may affect up to 1 in 10 people)

• Pallor and feeling of warmth Uncommon (may affect up to 1 in 100 people)
• Dizziness, headache
• High blood pressure (hypertension)
• Difficulty breathing (dyspnea), nasal congestion
• Vomiting, nausea
• Erythema, urticaria, blisters and itching
• Involuntary muscle contractions (muscle spasms)
• Chest pain, pain and warmth at the injection site Rare (may affect up to 1 in 1000 people)
• Feeling of fainting (presyncope)
• Heart rate too slow and/or too fast (bradycardia and tachycardia), abnormal heart contraction (extrasystoles)
• Low blood pressure (hypotension)
• Skin rash
• Back pain
• Kidney damage (renal dysfunction), decreased amount of urine passed daily (oliguria), abnormal amount of protein in the urine (proteinuria)
• Weakness (asthenia), muscle stiffness, fever
• Increased levels of an indicator of kidney function (creatinine) in the blood

Not known (frequency cannot be estimated based on available data)

• red and scaly rash with the formation of pustules and blisters (pustular exanthematous reaction)
• Reduced production of platelets (thrombocytopenia)
• Hemolytic anemia (damage to red blood cells that can cause fatigue, increased heart rate and shortness of breath)
• Anaphylactoid reactions (characterized by cardiovascular, respiratory and skin symptoms) / anaphylactic reactions
• Anaphylactoid/anaphylactic reactions causing a widespread pustular rash with fever or swelling of the face or throat, cold sweats
• Loss of appetite (anorexia)
• Anxiety, confused state, coma
• Loss/weakening of the ability to move a muscle area (paralysis/paresis)
• Memory disorder (amnesia)
• Temporary interruption of blood flow to an area of the brain (transient ischemic attack), disorders of the blood vessels of the head
• Brain disorders (encephalopathy) with symptoms including headache, visual disturbances, loss of vision, confusion, convulsions, loss of coordination, loss of movement on one side of the body, speech problems, and loss of consciousness
• Accumulation of fluid in the brain causing swelling (cerebral edema), transient loss of consciousness (syncope)
• Convulsions, loss of consciousness, difficulty speaking (dysarthria), numbness of the limbs (paresthesia), drowsiness, altered taste
• Impaired perception of smells (parosmia), tremor, impairment of language ability (aphasia)
• Transient loss of vision, visual disturbances, conjunctivitis, increased tearing, sensation of seeing lights and flashes (photopsia)
• Cardiac arrest, heart attack, reduced heart function (heart failure), chest pain caused by temporary decrease in blood flow to the heart (angina pectoris)
• Irregular heart rhythm (arrhythmias, atrial fibrillation, ventricular, atrioventricular block)
• Bluish/violet discoloration of the skin and mucous membranes (cyanosis), reduced blood flow to the body (circulatory collapse or shock)
• Vasodilation, redness
• Respiratory arrest, acute respiratory failure caused by various diseases (acute respiratory distress syndrome), fluid retention in the lungs (pulmonary edema), swelling at the level of the pharynx or larynx (pharyngeal or laryngeal edema), bronchospasm, asthma
• Oxygen deficiency (hypoxia), noisy breathing (stridor), cough
• Disorders of the pharynx or larynx, rhinitis, voice disorder (dysphonia)
• Diarrhea, abdominal pain, increased saliva secretion, difficulty swallowing (dysphagia) enlargement of the glands that produce saliva
• Acute swelling of the skin or mucous membranes (angioedema), increased sweating, various skin eruptions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)
• Reduced kidney function (renal insufficiency and acute renal failure);
• Reaction at the injection site, malaise, localized feeling of cold, swelling (edema)
• Irregular electrocardiogram, altered liver function tests, increased urea in the blood.
• Brain disorders (encephalopathy) with symptoms including headache, visual disturbances, loss of vision, confusion, convulsions, loss of coordination, loss of movement on one side of the body, difficulty speaking and loss of consciousness.

In the case of intrathecal administration, i.e. into the space around the spinal cord, the
following side effects may occur, with varying frequency:

• Very common: headache
• Common:dizziness, hypertension, nausea, vomiting, back and limb pain and reaction at the injection site
• Rare:loss of consciousness, inability to move the arms and/or legs (paraparesis), numbness (paresthesia), decreased sensitivity to a stimulus (hypoesthesia), drowsiness, hypotension, flushing, increased sweating, itching, muscle stiffness, neck pain, feeling of warmth and fever.
• Not known:Allergic reactions, epilepsy, skin rashes, brain disorders (encephalopathy) with symptoms including headache, visual disturbances, loss of vision, confusion, convulsions, loss of coordination, loss of movement on one side of the body, difficulty speaking and loss of consciousness

In addition, after administration into a body cavity (intracavitary), you may
experience the following side effects, the frequency of which cannot be estimated:

• A slight increase in the levels of enzymes that metabolize sugars (amylase) is common following examination to visualize the bile ducts and pancreas. Rare cases of pancreatitis have been described.
• Allergic reactions, predominantly affecting the skin.
• Lower abdominal pain and malaise

Additional side effects in children
The same side effects observed in adults have occurred in children.
A transient thyroid disorder may occur in newborns, especially premature or low birth weight infants.
No side effects have been reported after administration into the space where fluid flows around the
spinal cord (intrathecal).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor.
You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store IOMERON

This medicine does not require any particular storage temperature.
Keep the bottle in the outer packaging to protect the medicine from light.
Store the product away from ionizing radiation.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the package after Scad.
The expiry date refers to the last day of that month.
Do not use this medicine if the solution has changed color or if there are particles
suspended.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What IOMERON contains
IOMERON 150 mg/ml injectable solution

• The active ingredient is iomeprol. 100 ml of solution contains 30.62 g of iomeprol
• The other components are trometamol, hydrochloric acid, water for injections

IOMERON 200 mg/ml injectable solution

• The active ingredient is iomeprol. 100 ml of solution contains 40.82 g of iomeprol
• The other components are trometamol, hydrochloric acid, water for injections

IOMERON 250 mg/ml injectable solution

• The active ingredient is iomeprol. 100 ml of solution contains 51.03 g of iomeprol
• The other components are trometamol, hydrochloric acid, water for injections

IOMERON 300 mg/ml injectable solution

• The active ingredient is iomeprol. 100 ml of solution contains 61.24 g of iomeprol
• The other components are trometamol, hydrochloric acid, water for injections

IOMERON 350 mg/ml injectable solution

• The active ingredient is iomeprol. 100 ml of solution contains 71.44 g of iomeprol
• The other components are trometamol, hydrochloric acid, water for injections

IOMERON 400 mg/ml injectable solution

• The active ingredient is iomeprol. 100 ml of solution contains 81.65 g of iomeprol
• The other components are trometamol, hydrochloric acid, water for injections

Description of the appearance of IOMERON and contents of the pack
IOMERON is presented as an injectable solution.
IOMERON 150 mg/ml injectable solution
It is available in vials of 50 and 100 ml.
IOMERON 200 mg/ml injectable solution
It is available in vials of 50, 75, 100, 150, 200 ml.
IOMERON 250 mg/ml injectable solution
It is available in vials of 50, 100, 150, 200, 250 ml.
IOMERON 300 mg/ml injectable solution
It is available in pre-filled syringes of 90 and 125 ml and in vials of 50, 75, 100, 150, 200, 500
ml.
IOMERON 350 mg/ml injectable solution
It is available in pre-filled syringes of 125 ml and in vials of 50, 100, 150, 200, 250, 500 ml.
IOMERON 400 mg/ml injectable solution
It is available in pre-filled syringes of 90 and 125 ml and in vials of 50, 75, 100, 150, 200,
250, 500 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Bracco Imaging S.p.A.
Via E. Folli, 50
20134 Milan

Manufacturer
Patheon Italia S.p.A.
2° Trav. SX, Via Morolense 5
03013 Ferentino (FR)
BIPSO GmbH
Robert-Gerwig-Strasse 4
78224 Singen
Germany
Bracco Imaging S.p.A.- Bioindustry Park
Via Ribes, 5
10010 Colleretto Giacosa (TO) (Italy)
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The following information is intended exclusively for doctors or healthcare professionals:

Therapeutic indications
I150 mg/ml injectable solution
Infusional urography, digital subtraction angiography, Computed Tomography (CT) of the head
and body, cavernosography, endovenous and intra-arterial Digital Subtraction Angiography (DSA),
Endoscopic Retrograde Cholangio-Pancreatography (ERCP), Voiding Cystourethrography (MCU)
in adults and children.

I200 mg/ml injectable solution
Peripheral and digital subtraction angiography, CT (head and body), cavernosography, endovenous and
intra-arterial DSA, ERCP, arthrography, hysterosalpingography, cholangiography, urethrography and
retrograde pyelo-ureterography, myelography.

I250 mg/ml injectable solution
Intravenous urography, peripheral phlebography, CT (head and body), endovenous and
intra-arterial DSA, myelography.

I300 mg/ml injectable solution
Intravenous urography (in adults and children), peripheral phlebography, CT (head and body),
cavernosography, endovenous DSA, conventional angiography, intra-arterial DSA,
cardioangiography (in adults and children), selective conventional coronary angiography, interventional
coronary angiography, ERCP, arthrography, hysterosalpingography, fistulography, discography,
galactography, cholangiography, dacryocystography, sialography, urethrography and retrograde
pyelo-ureterography, myelography

I350 mg/ml injectable solution
Intravenous urography (in adults and children), CT (body), endovenous DSA, conventional angiography,
intra-arterial DSA, cardioangiography (in adults and children), selective conventional coronary
angiography, interventional coronary angiography, arthrography, hysterosalpingography,
fistulography, galactography, retrograde cholangiography, dacryocystography and sialography

I400 mg/ml injectable solution
Intravenous urography (adults even with renal insufficiency or diabetes), CT (body), angiography
conventional, endovenous DSA, cardioangiography (in adults and children), selective conventional
coronary angiography, interventional coronary angiography, fistulography, galactography,
dacryocystography and sialography.

WARNINGS AND PRECAUTIONS
Common to all routes of administration
Diagnostic procedures relating to the use of any radiopaque agent must be
carried out under the direction of personnel with specific training and with knowledge
of the particular procedure to be performed.
To treat any complications following the administration procedure and
to treat emergency severe reactions to the contrast agent itself, adequate facilities must be
available. These include resuscitation equipment and personnel trained in resuscitation and in the treatment of anaphylaxis. After
parenteral administration of the radiopaque agent, such personnel should remain
available for at least 30 minutes after the end of the examination to be able to cope with any
complications of the procedure and the emergency treatment of acute or
delayed severe reactions to the contrast agent.
Given the possible serious side effects, the use of organoiodinated contrast agents
should be limited to those cases where there is a precise clinical indication for the
contrast examination, an indication that must be assessed in relation to the clinical condition of
the subject, particularly in relation to known diseases of the cardiovascular, urinary and
hepatobiliary systems.
The risk associated with particular diagnostic investigations may increase in conditions such as
severe arteriosclerosis, hypertension, myocardial infarction, severe systemic diseases, and
cerebrovascular pathologies.
The use of products for cardioangiographic investigations may only take place in
Clinics, Hospitals or Nursing Homes where the immediate availability of the necessary
resuscitation equipment and competent personnel to use them is ensured.
Vital signs and the electrocardiogram of the patient should be routinely monitored during the procedure.

Contrast agent-induced encephalopathy
The onset of encephalopathy has been reported with the use of iomeprol (see section 4.8).
Contrast agent-induced encephalopathy can 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, which occur
within minutes or hours after the administration of iomeprol, and generally resolve within
a few days.
The medicine should be used with caution in patients with conditions that alter the integrity
of the blood-brain barrier (BBB), which could lead to an increase in the
permeability of the contrast agent across the BBB and increase the risk of encephalopathy.
If contrast agent-induced encephalopathy is suspected, the administration of iomeprol
should be discontinued and appropriate medical treatment should be initiated.

Special populations
Paediatric population- Children under one year of age and especially newborns are
particularly susceptible to electrolyte imbalances and haemodynamic alterations. Care should
be taken with the dosage to be used, the technique of the procedure and the patient's condition.
Transient suppression of the thyroid or hypothyroidism has been observed in children after
exposure to iodinated contrast media. Following a diagnostic procedure, this has been observed more frequently in newborns and premature babies and also after
procedures associated with higher doses. Newborns may also be exposed through
maternal exposure. In newborns, especially premature babies, who have been exposed to
Iomeprol, either through the mother during pregnancy or in the neonatal period, thyroid function is recommended.
If hypothyroidism is detected, the need for treatment should be considered and thyroid function should be monitored until
normalization.

Elderly- Elderly patients should be considered at risk of reactions due to an excessive dosage
of the contrast agent. The frequent coexistence of neurological diseases and
severe vasculopathies constitutes a particular aggravating factor.

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

Allergic predisposition- It is known that adverse reactions to iodinated contrast media are
more common in patients who have a history of allergies: hay fever, urticaria and food allergies.

Asthmatic subjects– Patients using beta-adrenergic blocking agents, especially
asthmatic patients, may have a lower threshold for bronchospasm and are less
reactive to treatment with beta agonists and adrenaline, which may necessitate the use
of higher doses.
Therefore, particular attention is required in these patients.

Thyroid function and thyroid function tests- Traces of inorganic iodide may be present in contrast agents
able to interfere with thyroid function
especially in patients with latent or manifest hyperthyroidism or goiter associated with
thyrotoxicosis. Thyrotoxic crises have been described with ionic contrast media. It is therefore
necessary to pay particular attention in these patients.
Intra-arterial and intravenous administrations

Renal insufficiency- In subjects with impaired renal function, the administration
of contrast agents can cause episodes of renal failure. Preventive measures
include: identifying high-risk patients; ensuring adequate hydration before
administration of the contrast agent, preferably maintaining intravenous infusion
before and during the procedure, until the contrast agent has been eliminated by the kidneys; avoiding, if possible, the administration of nephrotoxic drugs or subjecting the patient to
major surgery or procedures such as renal angioplasty, until the contrast agent has been completely eliminated from the kidneys; postponing a new examination with contrast
agent until renal function returns to pre-examination levels.
Patients undergoing dialysis can receive contrast agents, such as Iomeprol, which
are dialyzable without difficulty.

Diabetes mellitus- Diabetic nephropathy can predispose to renal failure following
the administration of contrast agents by intravascular route. Intravascular administration of contrast agents can cause lactic acidosis in patients treated with
biguanides (metformin) and with moderate renal insufficiency.
(See section 4.5. Interaction with other medicinal products and other forms of interaction).

Pheochromocytoma- These patients may develop severe hypertensive crises (rarely
uncontrollable) during procedures with contrast agents.
Therefore, premedication with alpha and beta-blockers is recommended in these patients.

Myasthenia Gravis -The administration of organo-iodinated contrast agents may
worsen the signs and symptoms of myasthenia.

Cardiovascular and pulmonary hypertension diseases- There is a high risk of severe reactions
in individuals with serious cardiovascular disease, especially those with
heart failure and coronary artery disease.
Intravascular injection of contrast agents can cause pulmonary edema in patients
with overt or incipient heart failure while the presence of pulmonary hypertension and
valvular heart disease can favor marked hemodynamic alterations.

Neurological symptoms- Particular attention should be paid in patients with acute stroke or
hemorrhage, and when there is damage to the blood-brain barrier, cerebral edema
and acute demyelination. The presence of primary or secondary intracranial tumors and
previous episodes of epilepsy increase the probability of seizures.
Do not interrupt therapies with anticonvulsant drugs and ensure that they are
administered at an optimal dosage.
Neurological symptoms due to degenerative, ischemic, inflammatory or neoplastic cerebrovascular pathologies may be exacerbated by the administration of contrast agents. These patients have an increased risk of transient neurological complications.
Phenomena of vasospasm and subsequent episodes of cerebral ischemia can be
caused by intravascular injections of contrast agent.

Alcoholism- It has been demonstrated, both experimentally and clinically, that acute or chronic alcoholism increases the permeability of the blood-brain barrier. This facilitates the passage of iodinated agents into brain tissue with possible CNS disorders. It is important to consider a possible lowering of the epileptic threshold.

Drug Addiction- In patients with drug addiction, the permeability of the blood-brain barrier is also increased. This facilitates the passage of iodinated agents into brain tissue with possible CNS disorders. It is important to consider a possible lowering of the epileptic threshold.

Precautions for use
In relation to the patient

Hydration- Adequate hydration of the patient is necessary and any alteration of the hydro-electrolytic balance must be corrected before and after administration of the contrast agent. In particular, patients with severe hepatic or renal insufficiency, myeloma or other paraproteinemia, sickle cell anemia, diabetes mellitus, polyuria, oliguria, hyperuricemia, as well as newborns, children and the elderly, must not be exposed to dehydration.
Particular attention should be paid to the hydration of patients who present with conditions that may worsen following a fluid overload, such as congestive heart failure.

Dietary recommendations- Unless otherwise specified by the attending physician, a normal diet may be followed on the day of the examination.
However, the patient should refrain from eating for the two hours preceding the examination.
Adequate fluid intake should be ensured before and after the vascular administration of iodine-containing contrast agents.

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

Anxiety- Evident states of excitement, anxiety and discomfort can be the cause of side effects or can intensify reactions related to the contrast agent. In these cases, a sedative may be administered.
Repeated procedures
In patients with moderate or severe renal insufficiency, attention should be paid to renal function values before examination with the contrast agent.
In general, the examination with the contrast agent should not be repeated before 5-7 days.

Patient monitoring
Intravascular administration of contrast agents should occur, if possible, with the patient in a supine position. Keep the patient under observation for at least 30 minutes after administration.
Intrathecal administration
After completion of examinations in the cervical or cervico-lumbar regions:

• raise the end of the table at an angle of approximately 45° for about 2 minutes to allow the contrast agent to drain to the caudal level
• raise the end of the stretcher at the patient's head to at least 30° before placing the patient on it
• avoid excessive and particularly active movements or stretching of the patient
• keep the patient under close observation, calm and with the head elevated, especially in the very first hours after the examination
• the patient must remain supine and bedridden during this period
• encourage oral fluid intake and a diet, if tolerated.

In relation to the procedure

Coagulation, catheterization techniques- A property of non-ionic contrast agents is the poor interference with normal physiological functions.
Non-ionic contrast agents therefore have in vitroa lower anticoagulant activity than ionic contrast agents.
Medical and paramedical personnel performing vascular catheterization procedures must be informed of this and pay particular attention to the angiographic technique and washing the catheter with saline solution (if necessary with the addition of heparin), so as to reduce the risk of thromboembolism related to the procedure.

Sensitivity test- There are no sensitivity tests with predictive value for adverse reactions to contrast agents.

Risk of inflammation and extravasation -During injection of the contrast agent, extreme care is necessary to avoid extravasation of the contrast agent. This is particularly important in patients with severe artero-venous pathologies.

Intrathecal administration -Iomeprol should be administered with caution in patients with increased intracranial pressure or with suspected intracranial tumors, abscesses or hematomas.
Anticonvulsant therapy should be maintained before and after myelography procedures for patients suffering from seizures.

INTERACTIONS
Consider interrupting treatment with drugs that lower the seizure threshold up to 24 hours after the procedure for intrathecal use and for patients with blood-brain barrier disorders (see CNS Disorders in section 4.4 of the SmPC).
Similarly, allergic-like reactions are more frequent and can manifest as delayed reactions in patients treated with immunomodulators, such as Interleukin 2 (IL-2).

Thyroid function tests- After the administration of iodinated contrast agents, the ability of thyroid tissue to capture radioisotopes for the diagnosis of thyroid diseases is reduced for periods of up to two weeks, or even longer.
Thyroid function tests performed with "iodine binding to protein" and with "radioactive iodine uptake" may not reflect the real thyroid function in the 2 weeks following the administration of iodinated contrast agents. In such cases, it is advisable to use thyroid function tests such as "T3 on resin" and "total or free thyroxine (T4)".
Any test that could be affected by the contrast agent should be performed before its administration.

Oral cholecystographic agents- Recent studies have not shown interactions of contrast agents excreted by the kidneys with oral cholecystographic agents.

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

Metformin.Intravascular administration of contrast agents can cause lactic acidosis in patients undergoing metformin therapy (see also paragraph 4.4).
The presence of renal impairment in diabetic patients represents one of the risk factors predisposing to renal insufficiency following the administration of Contrast Agent. Renal insufficiency can cause lactic acidosis in diabetic patients treated with biguanide class drugs (metformin).
To prevent the onset of lactic acidosis in these patients, it is recommended to discontinue metformin therapy 48 hours before the examination with contrast agent until 48 hours after the examination and to resume it only after checking that renal function (creatinine values) has returned to the values ​​prior to the investigation.
In case of emergency or if renal function is impaired or unknown, a careful assessment of the benefit/risk ratio is required. If the administration of the contrast agent is considered essential, precautions must be taken. Metformin must be discontinued during the administration of the contrast agent. After the diagnostic procedure, the patient must be monitored for the onset of lactic acidosis. Metformin administration can be resumed 48 hours after the contrast agent if the serum creatinine/eGFR level has returned to the values ​​prior to the examination.
Patients with normal renal function can continue to take metformin regularly.

DOSE, METHOD AND TIME OF ADMINISTRATION
The dosage and rate of administration may vary depending on the clinical question, the technique, the area to be visualized, the type of equipment as well as the age, weight, cardiac output and general condition of the patient.
IOMERON is available in various dosages and packages to allow healthcare personnel to choose the most suitable for the investigation to be performed.

Instructions for Use
The intravascular contrast medium solution must be warmed to
body temperature.
Before use, examine the product to ensure that the container and closure are not
damaged. Withdrawal of the contrast medium solution from the vial must be carried out under
aseptic conditions and using sterile syringes.
Intravascular administration and/or with catheters and guides must observe maximum
asepsis.
If single-use equipment is not used, particular attention must be paid to
avoid residual contamination with traces of detergents.
Follow the general recommendations for intravascular administration as indicated above.
More than one dose should not be drawn from a package of contrast medium. The rubber stopper should never be punctured more than once. It is recommended to use a
specific needle-cannula to puncture the stopper and aspirate the contrast medium. The contrast
medium must be aspirated into the syringe immediately before use and must not
be diluted. The residual amount not used in an examination must be discarded together with the
connection tubes.
For use of 500 ml vials, it is recommended to observe the following rules. The solution
of contrast medium must be administered by means of an automatic injector. The
tube connecting the injector to the patient (patient tube) must be replaced after each
examination because it may be contaminated with blood. The contrast medium
not used and present in the vial, in the connection tubes and in any part of the injector
must be discarded at the end of the examination day.
Also, follow any further instructions provided by the manufacturer of the injection system or equipment.

OVERDOSAGE
Overdosage can lead to serious adverse reactions, primarily with effects on the
cardiovascular and pulmonary systems. Treatment of an overdose is directed towards
maintaining all vital functions and involves the prompt initiation of symptomatic
therapy. Iomeprolo does not bind to plasma or serum proteins and is therefore dialyzable.
If necessary, Iomeprolo can be removed by hemodialysis.
In case of overdose of the contrast medium administered intravenously,
hydration and the patient's electrolyte status must be monitored in order to intervene if
necessary. In this situation, renal function must be monitored for at least three
days.
In case of overdose of the contrast medium administered by the intrathecal route, the patient
must be carefully monitored for at least 24 hours for the onset of CNS disorders.
These signs may include hyperreflexia or tonic-clonic spasms, hyperthermia, stupor and
respiratory depression.
In case of passage of contrast medium to the intracranial level, it is advisable to initiate
prophylactic anticonvulsant treatment with diazepam or barbiturates orally for 24-48
hours.

STORAGE
Do not use this medicine if you notice that it has changed color or if suspended particles
are present.
Although Iomeprolo's sensitivity to X-rays is low, it is advisable to store protected
from ionizing radiation.