IOPASEN 408 mg /Ml Инфузионный Раствор

Содержание инструкции

1. IOPASEN 408 mg/ml injectable solution, 612 mg/ml injectable solution, 755 mg/ml injectable solution
   1. What is IOPASEN and what is it used for
   2. What you need to know before IOPASEN is administered
   3. How to administer IOPASEN
   4. Possible side effects
   5. How to store IOPASEN
   6. Contents of the pack and other information

IOPASEN 408 mg/ml injectable solution, 612 mg/ml injectable solution, 755 mg/ml injectable solution

Iopamidol

Read this leaflet carefully before using 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 or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What IOPASEN is and what it is used for
• 2. What you need to know before IOPASEN is administered
• 3. How to administer IOPASEN
• 4. Possible side effects
• 5. How to store IOPASEN
• 6. Contents of the pack and other information

1. What is IOPASEN and what is it used for

IOPASEN contains the active ingredient iopamidol, which belongs to a group of medicines called radiological contrast agents, which, when injected into the body, allow the visualization of the internal structures of the body in an X-ray image (because iodine blocks X-rays).
This medicine is only for diagnostic use and must be used exclusively in hospitals, clinics and nursing homes by competent personnel.
The most common uses of IOPASEN are:

• radiological examinations of the brain and nervous system (neuroradiology);
• radiological examination of blood vessels (angiography);
• radiological examination of the arteries;
• radiological examination of the urinary tract and bladder (urography);
• contrast enhancement in CT (computed axial tomography, CT);
• radiological examination of the joints;
• fistulography (radiological examination that allows analysis of the fistula pathway);
• hysterosalpingography (radiological examination of the uterus and fallopian tubes).

2. What you need to know before IOPASEN is administered

IOPASEN must not be administered

• if you are allergic to iopamidol or any of the other ingredients of this medicine (listed in section 6);
• if you are being treated with medicines such as corticosteroids administered by the intrathecal route, i.e. into the space around the spinal cord;
• if you have a bone marrow disease (multiple myeloma and Waldeström's paraproteinemia);
• if you have problems with your kidneys or liver;
• if you are pregnant or breastfeeding;
• if you suffer from acute gynecological infections, in which case do not undergo investigations of the genital system;
• if you have a history of epileptic seizures, blood in the cerebrospinal fluid or are taking medication that lowers the seizure threshold (neuroleptics,

analgesics, antihistamines, phenothiazine sedatives);

• if you are to undergo a second radiological examination in the intrathecal space shortly after the first (if the first was unsuccessful due to technical problems) as repeated administration of IOPASEN could cause overdose side effects.

Warnings and precautions
Consult your doctor or nurse before using IOPASEN.
The use of contrast agents can only take place in hospitals, clinics and nursing homes where
immediate availability of resuscitation equipment and competent personnel to
use them is ensured.
Certain conditions require particular medical caution, so inform healthcare personnel before undergoing the diagnostic examination if:

• in the past you have suffered from allergic reactions such as nausea, vomiting, shortness of breath, skin flushing, urticaria and low blood pressure (hypotension) following another similar examination;
• you suffer from reduced heart function (congestive heart failure);
• if you suffer from kidney and/or liver problems;
• you suffer from advanced arteriosclerosis and hypertension;
• it is possible that you suffer from hyperthyroidism or have autonomously functioning thyroid nodules;
• you suffer from severe heart and circulatory problems (recent heart attack/stroke or transient ischemic attacks (TIA), altered permeability of the blood-brain barrier, increased intracranial pressure, high blood pressure, advanced atherosclerosis, heart failure, severe systemic disease, cerebral embolism or thrombosis, right heart failure or pulmonary hypertension);
• you have a bone marrow disease (multiple myeloma or other paraproteinemias);
• you suffer from an inherited blood disease (sickle cell anemia);
• you have a muscle disease (myasthenia gravis);
• you have high levels of calcium in your blood (hypercalcemia);
• you have recently had problems with blood flow to the brain (cerebrovascular disease);
• the doctor suspects you have a brain tumor or other problems such as abscesses, hematomas or hemorrhages;
• you have a history of alcoholism;
• you suffer from an inherited disease that affects the heart, nervous system and muscles (homocystinuria);
• if you have ever experienced a severe skin rash or exfoliation of the skin, blisters and/or ulcers in the mouth, after taking IOPASEN or another iodinated contrast agent. Pay particular attention with IOPASEN: 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 association with the use of IOPASEN.

Immediately consult a doctor if you should notice any of the symptoms related to these severe skin reactions, described in section 4.
Angiography should be avoided as much as possible in this case due to the risk of circulatory problems (thrombotic and embolic phenomena):

• if you have high concentrations of uric acid in your blood (hyperuricemia);
• if you are taking medication used for epilepsy (anticonvulsants), in this case you should continue treatment even in anticipation of the radiological investigation. If seizures occur during the investigation, intravenous diazepam or sodium phenobarbital is recommended;
• if you suffer from heart and circulatory disorders (advanced arteriosclerosis, high blood pressure, heart malfunction, severe systemic disease);
• if you have recently had problems with blood circulation to the brain (cerebral embolism or thrombosis).

Children
Particular caution is required for administration to neonates who may be more susceptible to
adverse effects.

Other medicines and IOPASEN
Tell your doctor or nurse if you are taking, have recently taken or might take any other
medicines.
If you are to undergo a thyroid function test in the weeks following the examination with this
medicine, tell your doctor before performing the test.
In particular, inform your doctor if you are taking medicines for:

• diabetes such as biguanides (metformin). Stop taking it immediately before the examination with IOPASEN, until 48 hours after the examination and consult your doctor on how to proceed with continuing therapy;
• heart disease and/or high blood pressure (diuretics, ACE inhibitors and/or beta blockers);
• the treatment of involuntary visceral contractions (papaverine);
• to increase blood pressure (vasopressors);
• if you have recently undergone an examination called cholecystography to assess the condition of your gallbladder;
• corticosteroids administered by the intrathecal route for the treatment of inflammation (see section 2. IOPASEN will not be administered to you);
• medicines that modify the immune system response such as interleukin 2 and interferon because adverse reactions such as erythema, fever or flu-like symptoms may occur;
• ceftriaxone (an antibiotic) due to the risk of particle formation in the blood (precipitation of ceftriaxone-calcium salt).

If you are to undergo a thyroid examination or perform laboratory tests for bilirubin, proteins and
inorganic substances (e.g. iron, copper, calcium and phosphates) in the two weeks following
administration of the contrast agent, talk to your doctor because the results may be altered.
If you are taking the following drugs, stop taking them 48 hours before the radiological examination. You can
continue therapy 12 hours after the radiological examination:

• medicines used for mental illnesses (neuroleptics);
• medicines that relieve pain (analgesics);
• medicines used for allergies (antihistamines);
• sedative medicines also used against vomiting (phenothiazines).

Pregnancy and breastfeeding
IOPASEN should only be used in pregnancy if absolutely necessary.
Investigations of the female genital system are contraindicated in cases of confirmed or suspected pregnancy.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
nurse for advice before using this medicine.
Iopamidol passes poorly into human milk.

Driving and operating machinery
Before driving or operating machinery, check the effect that IOPASEN has on you, and the
occurrence of any side effects. If IOPASEN has been administered by the intrathecal route, avoid
driving and operating machinery for the 6 hours following administration.

3. How to administer IOPASEN

This medicine will be administered to you by a doctor or another healthcare professional trained in the
administration of contrast agents. If you have any doubts, consult your doctor or nurse.
You may be injected with up to 2 ml/kg of body weight of medicine depending on the type of examination you
need to undergo.

If you receive more IOPASEN than you should
If you are concerned that you may have been given a higher dose of medicine than intended, inform your
doctor or nurse immediately.
The therapy involves maintaining all vital functions and removing the medicine from the body
via urine or through mechanical filtration of the blood (dialysis).
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 that can lead to
death.
Most side effects occur within the first few minutes of administration,
but they can sometimes occur even after 2-3 or, more rarely, 7 days.
In case of intrathecal administration, most side effects occur with a delay of
several hours, usually after 24 hours from the injection.
Immediately report 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 could
require medical intervention.
Consult a doctor immediately if you notice any of the following symptoms:

• red, non-raised, circular or “target-like” 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 swelling under the skin and blisters, associated with fever. The symptoms generally appear at the beginning of treatment (acute generalized exanthematous pustulosis). The frequency of these side effects is not known.

Following intravascular administration, the following side effects have been reported:

Common(may affect up to 1 in 10 patients):

• headache;
• nausea;
• feeling of warmth.

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

• dizziness, taste alterations;
• heart problems (cardiac arrhythmias such as extrasystoles, atrial fibrillation, ventricular tachycardia and ventricular fibrillation);
• severe decrease in blood pressure (hypotension) or increase in blood pressure (hypertension);
• blood vessel dilation (vasodilation with flushing);
• vomiting, diarrhea, abdominal pain, dry mouth;
• skin irritation (rash, urticaria, pruritus, erythema), increased sweating;
• back pain;
• kidney problems (acute renal failure, increased creatinine);
• chest pain and tightness, pain at the injection site, fever, feeling of warmth or cold;
• pain at the injection site.

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

• confusion;
• tingling of the extremities (paresthesia);
• slowed heartbeat (bradycardia);
• fluid accumulation in the lung (pulmonary edema);
• breathing problems (asthma, bronchospasm);
• involuntary muscle contractions (muscle spasms), stiff neck, leg pain of a sciatic type.

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

• decreased number of platelets in the blood (thrombocytopenia);
• allergic reactions (anaphylaxis, anaphylactoid reactions);
• coma, transient ischemic attack, dizziness and loss of consciousness (syncope), decreased level of consciousness or loss of consciousness, convulsions, memory loss (amnesia), muscle disorders (paralysis, paresis), drowsiness, tremors, agitation, involuntary muscle contractions;
• inability to move one side of the body;
• visual disturbances (transient vision loss, conjunctivitis, photophobia);
• alterations in heart rate and rhythm (tachycardia);
• bluish discoloration of the skin and mucous membranes due to lack of oxygen in the blood (cyanosis);
• chest pain (angina pectoris);
• heart attack caused by an allergic reaction;
• heart problems (cardiorespiratory arrest, myocardial ischemia or infarction, heart failure);
• rapid decrease in blood pressure, even very severe (circulatory collapse or shock);
• pallor;
• circulatory problems;
• swelling of the larynx (laryngeal edema), difficulty breathing (dyspnea, rhinitis), respiratory problems (respiratory arrest, apnea, respiratory failure, acute respiratory distress syndrome, respiratory distress);
• enlargement of the salivary glands, increased salivation;
• facial swelling (facial edema);
• muscle problems (musculoskeletal pain, muscle weakness);
• stiffness, pain, discomfort;
• alteration of some diagnostic tests (changes in the electrocardiogram including ST segment depression);
• kidney problems caused by calcium-ceftriaxone deposits. Pain may occur when urinating, or the amount of urine produced may be reduced;
• temporarily inactive thyroid in newborns.

Following intrathecal administration, the following side effects have been reported:

Common(may affect up to 1 in 10 patients):

• headache. Uncommon(may affect up to 1 in 100 patients):
• heart problems (cardiac arrhythmias such as extrasystoles, atrial fibrillation, ventricular tachycardia and ventricular fibrillation);
• blood vessel dilation (vasodilation);
• nausea, vomiting;
• back pain, neck pain, limb pain, feeling of heaviness, muscle cramps.

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

• slowed heartbeat (bradycardia);
• skin rash, increased sweating.

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

• inflammation of the meninges (aseptic meningitis, bacterial meningitis as a consequence of procedural risk);
• disorders of metabolism and nutrition (acidosis);
• allergic reactions (anaphylaxis, anaphylactoid reactions);
• confusion, agitation, disorientation, depression, hallucinations, depersonalization, psychosis, anxiety, irritability, fatigue, restlessness;
• speech disorder (echolalia);
• coma, dizziness and fainting (syncope), convulsions, decreased level of consciousness or loss of consciousness, amnesia, muscle disorders (paralysis), altered sensitivity in the hands and feet (paresthesias), reduced sensitivity (hypoesthesia);
• irritation of the meninges without inflammation with symptoms such as stiff neck, headache, photophobia, sluggish sensorium and amnesia (meningism);
• alterations to the nervous system that affect movement (Guillain-Barré syndrome, ataxia, sensorimotor disorders, radiculopathies or cauda equina syndrome);
• increased muscle tone (hypertonia);
• dizziness, cervical pain, drowsiness;
• loss of appetite (dysphagia);
• burning sensation, tremors;
• involuntary muscle contractions and spasms;
• temporary vision loss and other eye disorders such as conjunctivitis, increased tear production, itchy eyes, light sensitivity;
• heart problems (cardiorespiratory arrest, myocardial ischemia or infarction, heart failure, angina pectoris);
• heart attack caused by an allergic reaction
• hearing loss and ringing in the ears (tinnitus);
• alterations in the rhythm of the heartbeat (arrhythmias), alterations in heart rate and rhythm (tachycardia);
• bluish discoloration of the skin and mucous membranes due to lack of oxygen in the blood (cyanosis);
• increased pressure (hypertension), hot flashes, cold hands and feet;
• difficulty breathing (dyspnea, apnea), respiratory arrest;
• diarrhea;
• kidney problems (acute renal failure) with problems urinating (oliguria, incontinence), blood in the urine (hematuria) or poor urine output (urinary retention, renal block);
• discomfort, fever, muscle stiffness (rigor), chest pain, fatigue, irritability;
• alteration of the results of kidney function tests and alteration of mineral salts in the blood;
• temporarily inactive thyroid in newborns.

As with other contrast agents, very
rarely serious skin reactions such as mucocutaneous syndrome, including Stevens-Johnson syndrome,
toxic epidermal necrolysis (Lyell's syndrome) and erythema multiforme can occur following the administration of iopamidol.

Use in a body cavity (intracavitary)
After 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.

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

5. How to store IOPASEN

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the packaging after the words
“Expiry”.
The expiry date refers to the last day of that month.
IOPASEN must be stored in its original packaging at a temperature not exceeding 25°C and protected from
light.
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. Contents of the pack and other information

What contains IOPASEN
IOPASEN 408 mg/ml

• The active ingredient is iopamidol. Each ml of solution contains 408 mg of iopamidol.
• The other components are: trometamol, sodium calcium edetate, concentrated hydrochloric acid, water for injections.

IOPASEN 612 mg/ml

• The active ingredient is iopamidol. Each ml of solution contains 612 mg of iopamidol.
• The other components are :trometamol, sodium calcium edetate, concentrated hydrochloric acid, water for injections.

IOPASEN 755 mg/ml

• The active ingredient is iopamidol. Each ml of solution contains 755 mg of iopamidol.
• The other components are :trometamol, sodium calcium edetate, concentrated hydrochloric acid, water for injections.

Description of the appearance of IOPASEN and contents of the pack
IOPASEN 408 mg/ml Injectable solution
Packs of 1 Vial and 10 Glass Vials, 10 ml
IOPASEN 612 mg/ml Injectable solution
Packs of 1 Vial and 10 Glass Vials, 10 ml
Packs of 1 Type I glass bottle, 30 ml, 50 ml, 100 ml, 200 ml
IOPASEN 755 mg/ml Injectable solution
Packs of 1 Vial and 10 Glass Vials, 10 ml
Packs of 1 Type I glass bottle, 30 ml, 50 ml, 100 ml, 200 ml

Marketing Authorisation Holder and manufacturer
INDUSTRIA FARMACEUTICA GALENICA SENESE S.r.l.
Via Cassia Nord, 351 - 53014
Monteroni d’Arbia (SI)

The following information is intended exclusively for doctors or healthcare professionals
CLINICAL INFORMATION
Therapeutic indications
Water-soluble non-ionic contrast agent for radiological investigations: neuroradiology, angiography,
digital subtraction angiography (D.S.A.), urography, contrast enhancement in CT scans, arthrography,
fistulography and hysterosalpingography.

Posology and Method of Administration

NEURORADIOLOGY

Concentration (mg I/ml)Recommended doses (ml)
Myeloradiculography 200-300 5-15
Cisternography 200-300 3-15
Ventriculography 200-300 3-15

ANGIOGRAPHY

Concentration (mg I/ml)Recommended dose (ml)
Cerebral arteriography 300 5-10 per bolus
Coronary arteriography 370 8-15 per bolus
Angiocardiography 370 1.0-1.2/Kg
Thoracic aortography 370 1.0-1.2/Kg
Abdominal aortography 370 1.0-1.2/Kg
Selective visceral arteriography 300-370 According to the investigation
Peripheral arteriography 300-370 40-50
Digital subtraction angiography 150-370 According to the investigation
Phlebography 300 30-50

UROGRAPHY
The recommended dose for this type of investigation is 30 – 50 ml in adults. The reduced osmotic diuresis makes
IOPASEN 755 mg/ml particularly suitable for use in patients with moderate or severe
renal insufficiency and in newborns. Even in patients with severe renal insufficiency, a
valid nephrographic effect can be obtained for diagnostic purposes.

OTHER TYPES OF INVESTIGATION

Concentration (mg I/ml)Recommended dose (ml)
Contrast enhancement in
CT scan
300-370 0.5-2/Kg
Arthrography 300
Fistulography 300
Hysterosalpingography 200-300-370 5-20
Regarding contrast enhancement in computed axial tomography, the administration
of the contrast agent can be carried out either as a bolus or by infusion, or with both methods.
In hysterosalpingography, the total dose to be injected depends on the anatomical, biological and pathological
situation of the patient.

Special warnings and precautions for use
The container, once opened, must be used immediately; any residual contrast agent is no longer usable. Protect the solution from intense light.
Exceptionally, a pack of IOPASEN may be found to have crystal formation. It has been shown that this event is an indication of a damaged or otherwise imperfect container and
therefore the use of the pack in question is not recommended.
IOPASEN, 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.
The use of these substances should be limited to cases where there is a precise clinical indication
for the contrast examination, an indication that must be evaluated in relation to the clinical condition of
the subject, in particular in relation to diseases affecting the cardiovascular, uropoietic and
hepatobiliary systems, if known.
The use of products for cardio-angiographic investigations can only take place in clinics, hospitals
or nursing homes where the immediate availability of the necessary resuscitation equipment and the
personnel competent to use them is ensured. For other diagnostic contrast examinations of more common practice, it is
necessary that in radiological departments, whether public or private, those supplies and medications are present and immediately available
that experience has shown to be suitable (Ambu balloon,
oxygen, antihistamines, vasoconstrictors, corticosteroids, etc.).
Administration should be stopped at the first sign of alarm: it is advisable to place the patient in
a horizontal position and ensure the patency of the airways by administering oxygen in case of
severe dyspnea or performing artificial ventilation.
In infants and children, fluid intake should not be limited and, in addition, before the use of hypertonic contrast agents, any disturbances of water and electrolyte balance must be compensated.
The performance of a radiological examination during pregnancy and in subjects with hyperthyroidism should be considered only if the doctor deems it essential.
Patients with severe hepatic, renal or hepato-renal insufficiency should not be subjected
to the examination unless absolutely necessary.
Any repetition of the examination should not occur before 5-7 days.
If a possible diagnostic examination of the thyroid with the use of radioactive iodine is planned, it should be kept in
mind that the uptake of iodine by the thyroid tissue is reduced for a few days, sometimes up to
two weeks, after the use of iodinated contrast agents with renal elimination.
In neuroradiology, keep in mind that, in case of obstructed liquor flow (blockage), it will be necessary to
remove, as much as possible, the contrast agent.
If an epileptic-type pathology is detected in the medical history, this may be a relative contraindication
to the use of organoiodinated contrast agents.
The presence of blood in the cerebrospinal fluid may also be considered a contraindication to the use of
IOPASEN. The operator will in this case have to evaluate the diagnostic needs in comparison with
possible and potential risks for the patient. Patients undergoing anticonvulsant therapy should continue the
treatment even in view of the radiological investigation.
If convulsive seizures occur during the investigation, intravenous administration of
diazepam or sodium phenobarbital is recommended. Neuroleptics, analgesics, antihistamines and sedatives of the phenothiazine group should be avoided as they lower the epileptogenic threshold. If possible, therapy with the
aforementioned drugs should be suspended for at least 48 hours before the radiological examination and may be
resumed no earlier than 12 hours after the examination.
In cerebral angiography, the use of IOPASEN can cause the onset of secondary phenomena generally
transient or of mild entity. A feeling of warmth in the face and neck is often perceived, and headache is rarely found.
Cardiovascular reactions that can manifest with a certain frequency, but are
transient and do not require any treatment, are bradycardia and decrease in systemic arterial pressure.
Any severe neurological reactions such as tonic-clonic convulsions, aphasia, syncope, transient reduction
of the visual field, hemiparesis and coma may be directly related to the pre-existing
objective conditions of the patient.
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 the angiographic examination, particular attention should be paid to the conditions of the right heart and
the pulmonary circulation; in case of insufficiency, supplementary volumes of organoiodinated contrast agents can
produce circulatory overload with bradycardia and decrease in systemic arterial pressure.
In pediatrics, injection into the right heart requires particular caution in cyanotic newborns with
pulmonary hypertension and compromised cardiac function.
During examination of the aortic arch, care should be taken to pay attention to the positioning of the end of the
catheter. Excessive pressures transmitted by the injector in the brachiocephalic vessels can cause hypotension,
bradycardia and damage to the central nervous system.
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 IOPASEN 755 mg/ml can cause the onset of painful effects
that do not occur with the concentration of 612 mg/ml.
It has been shown in vitrothat the inhibitory effects of non-ionic contrast agents on the mechanisms of
hemostasis are lower than those of ionic contrast agents at equal concentration. For this reason, it is
recommended to follow the correct angiographic procedures: catheters must be flushed frequently and
prolonged contact between blood and contrast agent in catheters and syringes should be avoided.

Interactions with other medicines and other forms of interaction
It is advisable not to mix other drugs with the contrast agent.
Neuroleptics should be absolutely avoided as they lower the epileptogenic threshold. This also applies to
analgesics, antiemetics, antihistamines and sedatives of the phenothiazine group. If possible, therapy with the
aforementioned drugs should be suspended at least 48 hours before the radiological examination and may be resumed
no earlier than 12 hours after the examination.

Overdosage
Do not exceed the dosages indicated in the “Posology and method of administration” section, as
they can cause adverse reactions potentially life-threatening.
Most side effects are not dose-dependent and therefore require therapeutic interventions
(see section 4 “Possible undesirable effects”). 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 the introduction of the contrast agent, this
can be easily eliminated by dialysis.
Administration should be stopped at the first sign of alarm: it is advisable to place the patient in
a horizontal position and ensure the patency of the airways by administering oxygen in case of
severe dyspnea or performing artificial ventilation.
Treatment of overdosage should include support of vital functions and rapid initiation of
symptomatic therapy.

Intravascular administration
In case of overdosage, water and electrolyte loss should be compensated by infusion. Renal function should be monitored for at least three days.

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

For further information, see the Summary of Product Characteristics.