IOPAMIRO 200 mg /Ml Roztwór Do Infuzji

Treść ulotki

1. IOPAMIRO 150 mgI/ml Injectable Solution, 300 mgI/ml Injectable Solution, 370 mgI/ml Injectable Solution
   1. What is Iopamiro and what is it used for
   2. What you need to know before you are given Iopamiro
   3. How Iopamiro will be administered to you
   4. Possible side effects
   5. How to store Iopamiro
   6. Content of the pack and other information

IOPAMIRO 150 mgI/ml Injectable Solution, 300 mgI/ml Injectable Solution, 370 mgI/ml Injectable Solution

iopamidol

Read this leaflet carefully before you are given this medicine
because 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 those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What is Iopamiro and what is it used for

Iopamiro is a contrast agent containing iodine. The active ingredient of Iopamiro is
iopamidol.
Iopamiro is used for diagnostic purposes, during a radiological examination, as
absorbing X-rays allows the doctor a better visualization of blood vessels, the
urinary tract, joints, the spinal canal and the organs undergoing radiological examination
and to more clearly recognize both normal structures and any
pathological processes present.

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

You will not be given Iopamiro if

• you are allergic to iopamidol, to other similar contrast agents or to any of the other ingredients of this medicine (listed in section 6)
• you have an acute inflammation of the genitals, especially if you are pregnant, confirmed or suspected, as in this case you should not undergo radiological investigations of the genital tract (hysterosalpingography) (see section 2. Pregnancy and breastfeeding)
• you need to repeat the radiological examination with Iopamiro in the intrathecal space (space around the spinal cord) in a short time, as repeated administration of Iopamiro could cause adverse effects from overdose. Warnings and precautions

Considering the possible side effects, even serious ones, the use of iodinated contrast agents
must be limited to cases where an examination using a contrast agent is clearly
indicated.
In all of the following conditions, due to the higher risk of serious adverse events, the
administration of the medicine must be preceded by a particularly careful assessment of the
risk/benefit ratio.
Inform 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.
Inform your doctor if you have experienced allergic reactions, asthma or serious adverse
reactions during similar examinations.
If you suffer from a condition of reduced heart function (congestive heart failure), the doctor
will monitor you for hours after the radiological examination with contrast agent to rule out
the occurrence of circulatory abnormalities (hemodynamic imbalances).
Allergic reactions can occur even several days after the radiological examination with
contrast agent; in these cases you should immediately contact your doctor.
It is important to drink plenty of fluids before and after a radiological examination.
Adequate hydration is particularly important in children, the elderly and patients with severe
systemic diseases or with a severe reduction in liver or heart function, with multiple
spread of tumor lesions (myelomatosis), diabetes, increased or insufficient
urine production, increased uric acid in the blood.
Before the examination with Iopamiro, you must not restrict fluid intake and it is necessary
to intervene to compensate for any imbalances of salts or fluids in the blood. Particular
attention must be paid to infants and children in this regard.
Inform your doctor before you are given Iopamiro if you suffer/have suffered from:

• allergy (hypersensitivity) to iodinated contrast agents
• allergies (pollen allergy, food allergies), asthma
• high levels of calcium in the blood (hypercalcemia)
• thyroid diseases, a gland in the neck (hyperthyroidism, thyroid nodules)
• reduced kidney function (renal insufficiency)
• reduced kidney function and simultaneously of the liver
• diabetes (see section 2. Other medicines and Iopamiro)
• a hardening of the blood vessels (arteriosclerosis), formation of blood clots (thrombosis)
• an abnormality of red blood cells, a type of blood cell (sickle cell anemia)
• a disease characterized by muscle weakness that can lead to paralysis (myasthenia gravis)
• severe heart and blood vessel diseases, including heart failure, high blood pressure (hypertension) and severe inflammation of the blood vessels (thromboangiitis obliterans)
• severe systemic disease, embolism
• too much pressure in the lungs (pulmonary hypertension)
• a disease characterized by the presence of an amino acid in the urine (homocystinuria)
• excessive production of hormones that cause severe high blood pressure (pheochromocytoma)
• cerebrovascular diseases, transient ischemic attacks (TIA), recent episodes of stroke/cerebral infarction (blockage of blood vessels preventing blood flow to the brain), altered permeability of the blood-brain barrier, increased intracranial pressure, suspected intracranial tumors, abscesses or hematoma/hemorrhage
• previous seizures
• alcoholism, drug addiction
• if you have ever experienced a severe skin rash or exfoliation of the skin, blisters and/or ulcers in the mouth, after taking Iopamiro or another iodinated contrast agent .

Pay particular attention with Iopamiro
Severe skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (Lyell's syndrome or
TEN) and acute generalized exanthematous pustulosis (AGEP) have been reported in connection with the use of Iopamiro.
Immediately consult a doctor if you notice any of the symptoms related to
these severe skin reactions, described in section 4.
Patients undergoing dialysis can receive contrast agents, such as Iopamiro, which is dialyzable without
difficulty.
Following administration of Iopamiro through a vein, the doctor will monitor you for
at least 30 minutes.
Allergies – If you have had previous allergies or have had allergic reactions during similar examinations or
suffer from asthma, the doctor may consider administering
medicines to prevent or minimize allergies, such as antihistamines and/or corticosteroids.
Epilepsy: if you have suffered from epilepsy in the past, you should continue the specific therapy.
Repeated procedures – If you suffer from a liver or kidney disease, the doctor will subject
you to the examination only if it is absolutely necessary. In general, the examination with the
contrast agent
should not be repeated before 5-7 days.
During or immediately after the diagnostic procedure, a transient disturbance
of the nervous system called encephalopathy may occur. Immediately contact your doctor
if you notice any of the symptoms related to this condition described in paragraph 4.

Children: children under one year of age and especially newborns are susceptible to electrolyte imbalances
in the blood and circulatory alterations. Pay attention to the conditions of the patient and the doses to be used.
Thyroid dysfunction can be observed after exposure to iopamidol. Particular
attention should be paid to newborns, including those whose mother received iopamidol
during pregnancy, and premature infants. Check the child's thyroid function.

Elderly:elderly patients should be considered at risk of adverse reactions due to a
high dose of the contrast agent (see “Dosage, method and time of administration”).

Other medicines and Iopamiro
Inform your doctor if you are taking, have recently taken or may take any other
medicines.
The simultaneous use of Iopamiro and some medicines can lead to the appearance of
side effects.
In particular, inform your doctor if you are taking medicines:

• for diabetes such as biguanides (metformin). Stop taking it immediately before the examination with Iopamiro, up to 48 hours after the examination itself. After subjecting you to blood tests, the doctor will tell you when you can resume therapy
• for treating heart disease and/or high blood pressure (diuretics, ACE inhibitors, and/or beta blockers)
• for the treatment of involuntary contractions of the viscera (papaverine)
• to increase blood pressure (vasopressors)
• if you have recently taken cholecystographic contrasts for diagnostic use to assess the condition of your gallbladder
• medicines to treat mental disorders (psychotropic drugs), pain (analgesics), vomiting, allergies and anxiety. If not specified by the doctor, stop therapy 48 hours before the examination. Resume treatment no earlier than 24 hours after the examination
• medicines that modify the response of the immune system, such as interleukin 2 and interferon, because adverse reactions such as erythema, fever or flu-like symptoms may occur. Alcoholism or drug addiction can facilitate the passage of iodine agents into brain tissue causing possible nervous system disorders. If you are to undergo a thyroid examination or perform laboratory tests for bilirubin, proteins and inorganic substances (for example, iron, copper, calcium and phosphates) in the two weeks following the administration of the contrast agent, talk to your doctor, because they may be altered.

Iopamiro with drinks and alcohol
On the day of the examination, fluid intake should not be limited, especially in infants
and children.
Inform your doctor if you drink alcohol heavily before undergoing the examination with Iopamiro.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor for advice before undergoing the examination with Iopamiro
Pregnancy
Where possible, radiation should be avoided during pregnancy and therefore
the doctor will carefully assess whether a radiological examination, with or without a contrast agent, is necessary.
Radiological examination of the uterus and fallopian tubes with administration of Iopamiro into their cavities is contraindicated
in pregnancy or in the course of acute inflammation of the genitals (hysterosalpingography).
Breastfeeding
Iopamidol passes poorly into human milk, and no reactions have been reported in
the newborn. However, you should consider suspending breastfeeding
for the 24 hours following treatment with iodinated contrast agent.
Fertility
No clinical studies on fertility have been conducted.

Driving and using machines
Before driving or using machines, check if there are any side effects.

Iopamiro contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially
“sodium-free”.

3. How Iopamiro will be administered to you

Iopamiro will be administered by the radiologist and/or healthcare professionals. Iopamiro may be
injected into a vein, an artery, the intrathecal space, i.e. the space around the spinal
cord, or into a body cavity.
The injected dose may vary depending on the route of administration, the type of examination, the
technique used, but also based on your age, weight and 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 based on weight and age.

If you are given too much Iopamiro
It is highly unlikely that you will be given more Iopamiro than you should, as your
doctor will carefully monitor the procedure during the examination.
In case of excessive administration, the doctor will promptly
administer an appropriate treatment to avoid any damage and to ensure
adequate fluid intake to facilitate elimination, which occurs almost
entirely via the urinary tract.
Iopamidol can be eliminated through blood filtration and purification (hemodialysis).
To compensate for the loss of water and electrolytes, you will be given fluids in a
vein.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The use of solutions containing iodine can cause side effects that are generally mild or moderate
and of a transient nature. Rarely, more serious allergic-type reactions may occur which
can lead to death.
Report immediately to your doctor if you suddenly experience wheezing, difficulty breathing, swelling of eyelids, face or lips, skin rash or
a feeling of itching (especially if widespread over the whole body). These are signs of an
allergic reaction, which may also be severe and may require medical intervention.
Consult a doctor immediately if you notice any of the following symptoms:

• red, non-raised, circular or “target-shaped” spots, located on the trunk, often associated with central blisters, skin exfoliation, ulcers affecting the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread scaly rash, red in color, with bumps under the skin and blisters, associated with fever. Symptoms generally appear at the beginning of treatment (acute generalized exanthematous pustulosis). The frequency of these side effects is not known. Most side effects occur within minutes of administration, but sometimes they can also occur after 2-3 or more rarely 7 days. In case of intrathecal administration, most side effects occur with a delay of a few hours, usually after 24 hours from the injection. Symptoms of allergic (anaphylactoid or hypersensitivity) reactions may manifest as:
• swelling of the face or mucous membranes localized or widespread (localized or widespread angioedema), swelling of the tongue, laryngospasm or laryngeal edema, difficulty swallowing (dysphagia)
• pharyngitis and a feeling of constriction in the throat, pharyngolaryngeal pain, cough
• Conjunctivitis, rhinitis, sneezing
• feeling of heat, increased sweating, weakness (asthenia), dizziness
• pallor, dyspnea, wheezing, bronchospasm and moderate lowering of blood pressure (moderate hypotension). More serious reactions may involve:
• the heart and circulation, whose symptoms are:
• redness and blood pressure too low (hypotension) and heartbeat too fast (tachycardia)
• shortness of breath (dyspnea) and agitation, loss of consciousness (syncope)
• bluish/purple discoloration of the skin and mucous membranes (cyanosis)
• the skin, whose symptoms are:
• skin rash, redness, widespread blisters
• urticaria and itching
• as with other contrast agents, very rarely, severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and erythema multiforme, may occur following the administration of iopamidol. If you experience any of the symptoms listed above, your doctor will immediately STOP theadministrationof Iopamiro and will subject you to appropriate and specific treatment. The following side effects have also been reported with iopamidol, listed below according to their frequency, depending on the route of administration.

Administration into a blood vessel (into a vein or an artery)
The possible side effects are listed below according to their frequency:

common (may affect up to 1 in 10 people)

• headache, nausea
• feeling of warmth uncommon (may affect up to 1 in 100 people)
• dizziness, altered taste
• heart rhythm disturbances (cardiac arrhythmias such as extrasystoles, atrial fibrillation, ventricular tachycardia, and ventricular fibrillation)
• blood pressure too high or too low (hypertension/hypotension), flushing
• vomiting, diarrhea, abdominal pain, dry mouth
• skin rash, urticaria, itching, erythema, increased sweating
• back pain
• pain and tightness in the chest, pain at the injection site, fever, feeling of cold
• reduced kidney function (acute renal failure), increased creatinine in the blood (an indicator of kidney function) rare (may affect up to 1 in 1,000 people)
• confusional state
• numbness (paresthesia), muscle spasms
• heartbeat too slow (bradycardia)
• fluid retention in the lungs (pulmonary edema), asthma, bronchospasm (
• swelling at the injection site frequency not known (the frequency cannot be estimated based on the available data)
• reduced production of platelets (thrombocytopenia)
• increased acids in the blood (acidosis), loss of appetite (anorexia)
• allergic reactions (anaphylactoid or hypersensitivity)
• coma, transient ischemic attack (TIA), transient loss of consciousness (syncope)
• decreased level of consciousness or loss of consciousness, seizures, memory loss, paralysis
• drowsiness, tremors
• temporary vision loss, visual disturbances, conjunctivitis, increased sensitivity to light (photophobia), itchy eyes, increased tear production
• hearing loss
• cardiorespiratory arrest, ischemia or myocardial infarction, poor heart function (heart failure), chest pain caused by temporary reduction of blood flow to the heart (angina pectoris), bluish/purple discoloration of the skin and mucous membranes (cyanosis)
• heartbeat too fast (tachycardia)
• circulatory collapse or shock
• blood clot inside a blood vessel obstructing blood flow (thromboembolism), blood clot in an artery or vein (arterial thrombosis, venous thrombosis)
• inflammation of a vein caused by a blood clot (thrombophlebitis)
• pallor
• respiratory arrest, cessation of breathing (apnea)
• respiratory failure, acute respiratory distress syndrome, respiratory distress, swelling of the larynx (laryngeal edema), difficulty breathing (dyspnea), cough, nasal inflammation, sneezing
• swelling of the salivary glands, increased saliva production
• fluid retention in the face and/or around the eyes
• musculoskeletal pain, muscle weakness
• muscle pain with abnormal sensations (compartment syndrome)
• failure to produce urine (anuria), urinary retention, kidney damage (including acute renal failure and renal impairment), decreased daily urine output (oliguria), blood in the urine (hematuria), urinary incontinence
• Stiffness, pain, discomfort
• Irregular electrocardiogram (ST segment depression, increased T wave amplitude, prolonged QT interval);
• decreased systolic pressure, imbalances in blood salts
• Side effects that can occur during the diagnostic procedure (dissection of the coronary artery, peripheral emboli, brachial plexus injury, pseudoaneurysm, hematoma at the injection site).
• Heart attack caused by an allergic reaction.
• Brain pathology (encephalopathy) with symptoms including headache, visual impairment, vision loss, confusion, seizures, loss of coordination, inability to move one side of the body, speech problems and loss of consciousness.

Children
Thyroid disorders have been reported in premature infants.

Administration into the space around the spinal cord (intrathecal)
The possible side effects are listed below according to their frequency:

very common (may affect more than 1 in 10 people)

• headache common (may affect up to 1 in 10 people)
• flushing
• nausea, vomiting
• back pain, neck pain, limb pain, feeling of heaviness uncommon (may affect up to 1 in 100 people)
• skin rash, increased sweating frequency not known (the frequency cannot be estimated based on the available data)
• inflammation of the system of membranes surrounding the brain and spinal cord (aseptic and bacterial meningitis, as a consequence of procedural risk)
• increased acids in the blood (acidosis)
• allergic reactions (anaphylactoid or hypersensitivity)
• hallucinations, confusional state, disorientation
• depression, anxiety, irritability
• coma, transient loss of consciousness (syncope), decreased level of consciousness or loss of consciousness, seizures
• memory disorder (amnesia)
• paralysis
• inflammation of the spinal cord (myelitis), irritation of the meninges (meningism), dizziness, altered sensation of the limbs (paresthesia), decreased sensation (hypoesthesia)
• dizziness, pain in the nerve roots, drowsiness
• tremors, involuntary muscle contractions (muscle spasms)
• temporary blindness, conjunctivitis, increased sensitivity to light (photophobia), increased tear production, itchy eyes
• hearing problems, ringing in the ears (tinnitus)
• heart rhythm disturbances (arrhythmia), heartbeat too fast (tachycardia), bluish/purple discoloration of the skin and mucous membranes (cyanosis)
• hypertension
• cessation of breathing, apnea, respiratory failure, shortness of breath (dyspnea)
• muscle weakness
• kidney disease (acute renal failure), urinary retention, blood in the urine (hematuria), inability to retain urine
• fever, malaise, stiffness
• Brain pathology (encephalopathy) with symptoms including headache, visual impairment, vision loss, confusion, seizures, loss of coordination, inability to move one side of the body, speech problems and loss of consciousness.

Children
Thyroid disorders have been reported in premature infants.

Use in a body cavity (intracavitary)
After the injection of iodinated contrast medium, most reactions occur after
a few hours due to the slow absorption from the area of administration and the slow
distribution throughout the body.

Effects concerning the pancreas
Rare cases of pancreatitis have been described.

Allergic reactions (anaphylactoid or hypersensitivity)
Systemic hypersensitivity reactions are rare, generally mild and predominantly of a
cutaneous type. However, the possibility of severe anaphylactoid reactions should be considered.
In the case of hysterosalpingography (examination that allows a morphological analysis of the uterus and
tubes), vaso-vagal type manifestations may occur during the procedure.

Additional side effects in children
The same side effects observed in adults have occurred in children.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Iopamiro

Keep this medicine out of the sight and reach of children.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the packaging after
Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Iopamiro contains

• The active ingredient is iopamidol
• The other ingredients are Trometamol, Sodiumcalcium-edetate (see section 2. Iopamiro contains sodium), hydrochloric acid, water for injections.

Description of the appearance of Iopamiro and content of the pack
Iopamiro presents as a clear, aqueous, injectable solution.
It is available in vials of 10 ml and bottles of 30, 50 ml, 100 ml, 200 ml, 250 ml, 500 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bracco Imaging s.p.a. -Via E. Folli, 50 – 20134 Milano

Manufacturer

• Patheon Italia s.p.a. 2° trav. sx, Via Morolense 5 - 03013 Ferentino (FR)
• Bracco Imaging s.p.a., Bioindustry Park Via Ribes 5 - 10010 Colleretto Giacosa (TO)

---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:

Therapeutic Indications
Water-soluble, non-ionic contrast medium for diagnostic use.

Neuroradiology

• Myeloradiculography
• Cisternography and Ventriculography Angiography
• Cerebral arteriography
• Coronary arteriography
• Thoracic aortography
• Abdominal aortography
• Angiocardiography
• Selective visceral arteriography
• Peripheral arteriography
• Phlebography Digital Subtraction Angiography (D.S.A.)
• D.S.A. of the cerebral arteries, peripheral arteries and abdominal D.S.A. Urography
• Intravenous urography Other indications
• Contrast enhancement in C.T. (Computed Tomography)
• Arthrography
• Fistulography
• Hysterosalpingography Iopamiro 150mgI/ml Injection solution is indicated in paediatric radiology and digital angiography.

Contraindications
Hypersensitivity to the active ingredient and water-soluble contrast media and/or to iodine or to any
of the excipients.

Intrathecal Administration
Concomitant intrathecal administration of corticosteroids with Iopamidol is
contraindicated (see Interactions).
Due to the possibility of overdose, immediate repetition of a failed myelographic examination due to technical problems is contraindicated.

Hysterosalpingography
Investigations of the female genital tract are contraindicated in cases of confirmed or suspected pregnancy
and in cases of acute inflammation (see section Special warnings –
Pregnancy and breastfeeding).

Precautions for use
Exceptionally, a pack of Iopamiro may be found to have
crystal formation. It has been shown that such an event is indicative of a damaged or otherwise imperfect container and therefore the use of the pack in
question is not recommended.
The use of contrast agents should be limited to cases where there is a clear
clinical indication for the examination.
Diagnostic procedures relating to the use of any radiopaque agent must be
carried out under the direction of personnel with specific training and with complete
knowledge of the particular procedure to be performed.
To cope with any complications following the administration procedure and for the
emergency treatment of severe contrast media reactions, adequate equipment must be
available.
An intravenous access route is required during the examination for emergency treatment in
case of severe reactions.
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 it is ensured.
For other contrastographic examinations of more common diagnostic practice, it is necessary that in
radiology departments, whether public or private, those supplies and medications which experience has shown to be suitable (Ambu bag, oxygen,
antihistamines, vasoconstrictors, corticosteroids, etc.) are present and immediately available.
Extreme care is required during the injection of the contrast medium to avoid
extravasation.
In case of perivascular infiltration by the contrast medium, local inflammation of the tissues may occur.
Adequate hydration of patients should be provided before and after radiographic procedures. Patients with severe hepatic or myocardial insufficiency, myeloma, diabetes,
polyuria or oliguria, hyperuricemia, as well as children and the elderly and patients with severe systemic diseases
should not be exposed to dehydration.
Iopamidol should be administered with caution in patients with symptomatic cerebrovascular disease, recent myocardial infarction/stroke or transient ischaemic attacks (TIA), altered permeability
of the blood-brain barrier, increased intracranial pressure, suspected intracranial tumors,
abscesses or hematoma/hemorrhage, previous convulsive episodes, alcoholism.
As with other contrast media, Iopamidol can cause anaphylaxis or other allergic reactions such as nausea, vomiting, dyspnea, erythema, urticaria and hypotension. Severe, life-threatening reactions have been
reported occasionally.
Particular attention should be paid to patients with a positive history of allergies, asthma
or adverse reactions during similar examinations; the benefits in these patients must clearly
outweigh the risk. Premedication with antihistamines or corticosteroids may be
considered to prevent or minimize potential allergic reactions in these patients.
After the administration of contrast medium, the risk of reactions that can induce
bronchospasm is greater in asthmatic patients, especially in patients who are
taking beta-blockers.
After the administration of the contrast medium, personnel with specific training, drugs and emergency equipment for resuscitation must be available. All patients
must be kept under observation for at least 30 minutes.

Neuroradiology
In case of obstructed liquor flow (blockage), the contrast medium should be removed as much as possible.
If convulsions occur during the investigation, intravenous administration of diazepam or sodium phenobarbital is recommended.

Intrathecal Administration
A particularly careful risk/benefit assessment is required if
the medical history reveals an epileptic condition or if blood is present in the cerebrospinal fluid or local or systemic infections with the possibility of bacteremia.
The operator must in these cases assess the diagnostic needs in relation to
possible and potential risks to the patient.
After completion of examinations in the cervical or cervicothoracic regions:

• raise the end of the table at an angle of approximately 45° for approximately 2 minutes to allow the contrast medium to drain caudally
• raise the head end of the stretcher 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 raised especially in the very first hours after the examination
• the patient must remain supine and bedridden during this period
• encourage the intake of fluids by mouth and a diet, if tolerated.

Angiography
Advanced arteriosclerosis, hypertension, heart failure, severe systemic disease,
recent cerebral embolism or thrombosis can increase the incidence of risks associated with the type of
investigation.
During angiocardiography, particular attention should be paid to the
conditions of the right heart and the pulmonary circulation. When organoiodine contrast media are administered, the presence of right heart failure and pulmonary
hypertension can cause bradycardia and systemic hypotension.
Right heart angiography should only be performed when absolutely necessary.
During intracardiac and/or coronary arteriography, ventricular arrhythmias may occur,
not infrequently.
In paediatrics, injection into the right heart requires particular caution in cyanotic neonates with pulmonary hypertension and compromised cardiac function.
Intravascular injection of a contrast medium can evolve into pulmonary edema in
patients with congestive heart failure.
In angiographic procedures, the possibility that plaque detachment or damage or
perforation of the vessel wall may occur during catheter placement and
contrast medium injection must be taken into consideration.
It is recommended to perform test injections to verify the correct positioning of the
catheter.
During examinations of the aortic arch, particular attention should be paid to
the positioning of the catheter tip.
Excessive pressures transmitted by the injector in the brachiocephalic vessels can cause
hypotension, bradycardia and damage to the central nervous system.
Vasospasm and subsequent cerebral ischemic events can be caused by intra-arterial injections
of the contrast medium.
Even in abdominal angiography, excessive pressures transmitted by the automatic pump
can cause renal infarction, spinal cord injury, retroperitoneal hemorrhage,
infarction and intestinal necrosis.
In peripheral arteriographies, the use of Iopamiro 370 mgI/ml Injection solution can
cause the onset of painful effects that do not occur with Iopamiro 300 mgI/ml
Injection solution.
In patients undergoing peripheral angiography, the pulsation of the artery into which the contrast medium is to be injected must be appreciable. In patients with thromboangiitis
obliterans or ascending infections in association with severe ischemia, caution is required
in performing angiography, if necessary.
In patients undergoing phlebography, particular caution is required in patients with suspected phlebitis,
severe ischemia, local infections, or total venous occlusion.
It has been demonstrated in vitro that the inhibitory effects of non-ionic contrast media on
hemostasis mechanisms are lower than those of ionic contrast media at equal
concentration.

Dosage, route and time of administration
Normally the same iodine concentration and the same volume are used for other iodine-based contrast agents commonly used in radiology.
As with other contrast media, the minimum dose necessary to obtain
adequate visualization should be used.
Doses can be expressed as total volume (ml), per single injection or per
kilogram (kg) of body weight, especially in paediatric use.

Neuroradiology
Angiography
Urography
The recommended dose for this type of investigation is 30-50 ml in adults.
The reduced osmotic diuresis makes the use of Iopamiro 370 mgI/ml
Injection solution particularly suitable in patients with moderate renal insufficiency and in neonates.
Even in patients with severe renal insufficiency, a valid nephrographic effect is possible
for diagnostic purposes.

Regarding contrast enhancement in computed tomography (CT), the
administration of the contrast medium is via the intravenous route and can be carried out
either as a bolus or by infusion or using both modalities during the same
examination.
Infusion is limited to older CT equipment. With
spiral CT equipment and new multi-slice CT equipment, bolus injection is preferred, especially for examinations aimed at
arterial phase contrast enhancement.
With slow equipment, infusion is preferred, with faster equipment, rapid bolus injection.
In hysterosalpingography, as well as in arthrography and fistulography, the total dose to be injected
depends on the local and general anatomical and pathological conditions of the patient.

Use in the elderly:it is necessary to evaluate a possible dosage reduction (see “Special precautions with Iopamiro”)

Use in paediatrics (see “Special precautions with Iopamiro”):Iopamiro 150 mgI/ml
Injectable solution is particularly indicated in paediatric radiology.
Iopamiro 370 mgI/ml Injectable solution is recommended in paediatric urography, especially
in neonates, and in patients with renal insufficiency.

Method of administration
The non-ionic contrast agent should not remain in contact with the blood in the syringe
or in intravascular catheters, which should be flushed frequently to minimize the
risk of coagulation and thromboembolic events during angiographic procedures.
Factors such as the length of the procedure, the material of catheters and syringes, the state of
underlying pathology, and concomitant therapies can contribute to the development of thromboembolic
events.
In patients with known or suspected hypersensitivity to contrast agents, the sensitization test is not
recommended, as severe or fatal reactions to contrast agents cannot be predicted by sensitivity tests.
Caution should be exercised during the injection of contrast agents to avoid extravasation.
The contrast agent solution for intravascular and intrathecal use must be warmed
to body temperature, as it is thus better tolerated.
Before use, examine the product to ensure that the container and closure are not
damaged.
Withdrawal of the contrast agent solution from the vial must be carried out under
aseptic conditions and using sterile syringes.
Intravascular, intrathecal and/or catheter and guide administration must observe
maximum asepsis.
The vial, once opened, must be used immediately; any residual contrast agent is no longer usable.
If disposable equipment is not used, particular attention must be paid
to avoid residual contamination with traces of detergents.
Iopamiro, like other iodinated contrast agents, can interact with metal surfaces
containing copper (e.g. brass); therefore, the use of accessories in which the product comes
into direct contact with such surfaces should be avoided.
No medicinal product or contrast agent should be mixed with Iopamidol injectable solution.

Pharmaceutical form and content
Injectable solution.
Aqueous solution, clear, in transparent glass vials

Iopamiro is available in different dosages and packs to allow the healthcare professional
to choose the most suitable ones for the examination to be performed.

• 150 mgI/ml injectable solution: 100 ml of solution contains 30.62 mg of iomeprol equivalent to iodine 15000 mg
• 300 mgI/ml injectable solution: 100 ml of solution contains 61.24 mg of iomeprol equivalent to iodine 30000 mg
• 370 mgI/ml injectable solution: 100 ml of solution contains 75.53 mg of iomeprol equivalent to iodine 37000 mg

Shelf life and storage
Do not use Iopamiro after the expiry date which is stated on the packaging.
The expiry date refers to the last day of the month.
Store protected from light.

Overdose
Most side effects (see section Adverse effects) are not dose-dependent and therefore require therapeutic interventions as specified in the section
Precautions for use.
In case of voluntary or accidental administration of doses higher than normal, facilitate
elimination, which occurs almost entirely via the urinary tract, ensuring good
hydration of the patient. In case of pre-existing renal insufficiency or onset after
introduction of the contrast agent, this can be easily eliminated by dialysis.
Do not exceed the dosages indicated in the section Dosage, method and time of administration of
endangering life.
Iopamidol can be removed by hemodialysis, if necessary.
Treatment of overdose should include support of vital functions and rapid
establishment of symptomatic therapy.

Intrathecal administration
Signs of overdose may be: ascending hyperreflexia, tonic-clonic spasms, up to
sudden attacks, and, in cases of severe central involvement, hyperthermia, stupor and
respiratory depression.