Ultravist-370 is an iodine-containing, monomeric, non-ionic X-ray contrast medium.

Iodine absorbs X-rays, which makes it easier to view the areas of the body where Ultravist-370 is present.

The contrast medium will be given to you by trained healthcare professionals.

Ultravist-370 is used for:

-             X-ray imaging of blood vessels (angiography, intra-arterial digital subtraction angiography)

-             enhancing the contrast of computer tomography (CT)

-             imaging of the kidneys and lower urinary tract (urography)

-             imaging of body cavities (exception: myelography, ventriculography, cisternography).

Ultravist-370 is used for diagnostic purposes.

In order to reduce the risk of any possible incompatibilities, your doctor/trained healthcare professional will not mix Ultravist-370 with any other medicines.

Ultravist-370 should not be used

-        if you are allergic to iopromide or iodine, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before using Ultravist-370:

-        If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after use of Ultravist-370.

For all types of uses

Hypersensitivity reactions (allergy-like or anaphylactoid reactions)

Inform your doctor in the following cases:

-        if you have had a reaction to another contrast medium in the past,

-        if you currently have, or have had bronchial asthma or allergies,

because this means you have an increased risk of having an allergy-like reaction to Ultravist-370 (including serious reactions). Your doctor will then decide whether or not the planned examination should be performed.

After using Ultravist-370, dose-dependent allergy-like (allergoid) reactions may occur in varying severity, or even shock or various other symptoms, e.g. in the form of cardiovascular (heart and blood vessels), respiratory (airways) and cutaneous (skin) reactions.

Because such events occur so irregularly, they cannot be predicted in individual cases. Most reactions occur within one half hour of receiving the contrast medium. However, reactions can also occur later (after hours or days).

Inform your doctor if you are taking beta-blockers, i.e. medicines that are used to treat high blood pressures. Patients taking beta-blockers may not respond to standard treatment with beta agonists (also see the subsection "Other medicines and Ultravist-370" in this section).

Your doctor may give you corticosteroids before the examination if you have an increased risk of acute, allergy-like reaction (e.g. if you have already had a moderately severe or severe reaction, if you suffer from asthma or allergies requiring treatment).

Also inform your doctor if you suffer from any diseases of the cardiovascular system. If a severe hypersensitivity reaction occurs, there is an increased risk for serious or even fatal consequences.

Preparing for an emergency

Regardless of the quantity and type of application, minor allergoid symptoms may be the first sign of a serious anaphylactoid reaction requiring treatment. This is why contrast media containing iodine should only given at facilities where emergency treatment is available, i.e. appropriate equipment and medications, suitably trained medical staff and assistants.

Careful precautionary measures to immediately treat serious reactions are therefore should always be readily available for all patients, in addition to the necessary emergency medications and emergency instruments.

After you receive Ultravist-370, your doctor will monitor you closely for at least ½ hour, since experience shows that most serious events occur within this time period.

Serious skin reactions

Take special care with Ultravist-370:

Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in association with Ultravist-370 use. Seek medical attention immediately if you notice any of the signs described in section 4.

Thyroid function disturbances

X-ray contrast media containing iodine influence thyroid function by way of the free iodide contained in the solutions and the iodide that is also subsequently released in the body due to deiodination after receiving the contrast medium.

Please inform your doctor if you suffer from a hyperfunctioning thyroid (hyperthyroidism), if it is suspected that you may have a hyperfunctioning thyroid, or if you suffer from an enlarged nodular thyroid gland. In such cases, iodine-containing contrast media may lead to thyroid hyperfunctioning or even thyrotoxic crisis (severe complications in association with an overly active thyroid gland).

Inform your doctor if you have a medical history of a thyroid disorder, including hypothyroidism (an underactive thyroid). There have been reports of abnormal blood values in thyroid function tests after use of iodine-containing contrast media. This may indicate possible hypothyroidism or a transient (temporary) impairment of thyroid function.

If the use of iodine-containing contrast media is planned for a patient with such risks, the patient's thyroid function must be examined prior to receiving Ultravist-370, and thyrostatic treatment should be initiated if necessary.

Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age

Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast media. Among patients 0 to 3 years of age exposed to iodinated contrast media, thyroid dysfunction has been reported in 1% to 15% depending on the age of the patient and the dose of the iodinated contrast agent.

Younger age, very low birth weight, prematurity, and the presence of other conditions, such as, admission to neonatal or pediatric intensive care units, and cardiac conditions are associated with an increased risk. Pediatric patients with cardiac conditions may be at the greatest risk given that they often require high doses of contrast during invasive cardiac procedures, such as catheterization and computed tomography (CT).

Pediatric patients 0 to 3 years of age warrant closer monitoring because an underactive thyroid during early life may be harmful for motor, hearing, and cognitive development and may require transient T4 replacement therapy. Evaluate thyroid function in all pediatric patients 0 to 3 years of age within 3 weeks following exposure to iodinated contrast media, especially in term and preterm neonates. If thyroid dysfunction is detected, treat and monitor thyroid function as clinically needed.

Nervous system disturbances

During or shortly after the imaging procedure you may experience a short-term brain disorder called encephalopathy. Tell your doctor straight away if you notice any of the signs and symptoms related to this condition described in section 4.

Inform your doctor if you suffer from any CNS disorders (disorders of the central nervous system), e.g. seizures. In connection with using Ultravist-370 you may be at a higher risk for developing neurological complications. These occur more frequently during cerebral angiographies (X-ray examinations of the blood vessels in the brain) and other similar examinations.

Particular caution is indicated for patients with lower seizure thresholds, e.g. due to previous seizures and simultaneous use of certain medications.

Factors that increase the permeability of the blood-brain barrier make it easier for contrast medium to pass into brain tissue, which may result in neurological complications.

Fluid balance of the body (hydration)

Ultravist-370 should not be given to you if you are dehydrated (there is not enough fluid in your body). To avoid this, your doctor will make sure that you have consumed enough fluid before your examination (see also section 2 "Intravascular applications (administration into a blood vessel)").

This applies particularly to patients who are at an increased risk of contrast medium-associated acute kidney injury (PC-AKI) (see section 2 “Intravascular applications - Acute kidney injury”) as well as to patients with increased urine discharge (polyuria), reduced urine discharge (oliguria), newborns, infants, small children and older patients.

Tell your doctor if your kidney function is impaired. Your doctor will ensure that you are well hydrated before your examination. Adequate hydration by administration of a solution for injection into a vein will be considered, especially for patients with contrast medium-associated acute kidney injury (PC-AKI). The decision will be made by your doctor based on recommendations of current clinical guidelines and the individual benefit-risk ratio. The presence of any accompanying conditions will be taken into account. Tell your doctor if you have severe renal impairment associated with heart disease. Intravenous hydration (administration of an injection solution into a vein) can lead to serious complications in patients suffering from heart disease.

Anxiety

If you suffer from anxiety, inform your doctor prior to using Ultravist-370. Over-excitement, anxiety and pain may increase the risk for side effects or intensify contrast media-related reactions (also see section 4 "Possible side effects").

Pretesting

Pretesting for hypersensitivity using a low test dose of Ultravist-370 is not recommended, inasmuch as this approach has no predictive value, and on occasion, has even led to serious and sometimes even lethal hypersensitivity reactions.

Intravascular applications (administration into a blood vessel)

Cardiovascular diseases

If you are injected with Ultravist-370 for the purpose of examining your blood vessels and you have a serious circulatory disease or severe disease of the coronary vessels (oxygen undersupply of the myocardial muscle, chest pain), you have an increased risk for clinically relevant changes in blood circulation (haemodynamic changes) and for irregular heartbeat (arrhythmia). (Also see section 3 “How Ultravist-370 is administered - Patients with impaired renal function”).

This applies particularly after injection of contrast media into the cardiac arteries or chambers (see section “Possible side effects”).

Patients particularly at risk for cardiac reactions are those with cardiac muscle weakness (heart failure), severe coronary heart disease, unstable angina pectoris, heart valve disease, recent myocardial infarction, coronary bypass, and high lung pressure (pulmonary hypertension). If you have suffered heart failure, the application of Ultravist-370 may lead to fluid accumulation in the lungs (pulmonary oedema).

Acute kidney injury

There is a risk of kidney injury (contrast medium-associated acute kidney injury / PC-AKI) following the intravascular administration (administration into a blood vessel) of Ultravist-370. This can lead to temporarily disturbed kidney function. Kidney failure may occur in some patients.

Predisposing factors include:

-        existing impairment of kidney function (renal insufficiency),

-        You can also find more information in section 3 “How Ultravist-370 is administered - Patients with impaired renal function”,

-        dehydration,

-        diabetes mellitus,

-        cancer of bone marrow plasma cells (multiple myeloma) /

increased number of paraproteins in the blood (paraproteinaemia),

-        high doses of contrast media and/or multiple injections of Ultravist-370.

Patients whose kidneys no longer function properly and who require dialysis can be given Ultravist-370 for radiological examinations, inasmuch as iodine-containing contrast media can be eliminated by means of dialysis. Haemodialysis should be carried out immediately after the radiological examination.

In case of severe kidney failure, any additional severe functional disorder can seriously delay excretion of the contrast medium from the liver, which may require haemodialysis.

Diabetes mellitus

In order to avoid the increased formation of acid in the blood (lactic acidosis), diabetes mellitus patients receiving metformin treatment should have their serum creatinine levels measured before receiving an intravascular administration of an iodinated contrast medium. (see section "Other medicines and Ultravist-370").

Depending on the results of kidney function tests, a pause in taking Metformin should be considered.

For emergency patients and in case of restricted or unknown renal function, physicians must carefully determine the risks versus the benefits of a contrast-enhanced examination and must also take the necessary precautions: discontinue metformin therapy, hydrate the patient, monitor renal function values, serum lactate and pH, and observe the patient closely for clinical signs of lactic acidosis.

Disturbances of the coagulation system

Contrast media examinations of the blood vessels using a catheter are associated with the risk of causing vascular occlusions in the form of blood clots (thromboembolism). In addition to the contrast medium itself, numerous other factors can contribute to the development of vein blockage due to blood clots (thromboembolic events). These include: length of the examination procedure, number of injections, type of catheter and syringe materials, existing underlying diseases and concomitant medication. To minimise the examination-related risk of blocked veins due to blood clots (risk of thrombosis and embolism), examination techniques need to be conducted as carefully as possible when visualising blood vessels, the catheter needs to be flushed frequently with physiological saline solution (with the addition of heparin if possible), and the examination should be kept as short as possible.

Disturbances of the central nervous system

Caution should be exercised as regards intravascular administration (into the blood vessels) in patients with acute cerebral infarction or acute intracranial haemorrhage, in patients with diseases causing damage to the blood-brain barrier, as well as in patients with cerebral oedema or acute demyelinisation. For patients with brain tumours, brain metastases or epilepsy, the frequency of cerebral seizures may increase after administration of contrast media. Neurological symptoms caused by diseases of the blood vessels in the brain (cerebrovascular diseases), brain tumours or brain metastases, degenerative or inflammatory processes can be intensified by the administration of contrast media. Administration of contrast media into an artery may cause spasms of the blood vessels and the accompanying symptoms of inadequate blood supply to the brain. Patients with symptomatic cerebrovascular diseases, recent stroke or frequent transient ischaemic attacks have an increased risk of contrast media-induced neurological complications.

Further risk factors

Patients with a certain disease of the adrenal gland (phaeochromocytoma) may be at increased risk of developing blood pressure crisis (hypertensive crisis) after intravascular administration (administration into a blood vessel) of the contrast medium.

After intravascular administration (administration into a blood vessel) of the contrast medium, Ultravist-370 may intensify the symptoms of a muscle weakness disease (myasthenia gravis).

Use in body cavities

Patients with acutely inflamed pancreas (pancreatitis) and acutely inflamed bile ducts (cholangitis) should undergo a careful risk-benefit assessment before using Ultravist-370 for endoscopic examination of the bile and pancreatic duct (ERCP endoscopic retrograde cholangiopancreaticography). The examination must be postponed until any acute symptoms have subsided (3‑4 weeks), unless immediate therapeutic measures such as the removal of an obstructing stone (blockage due to stone in the bile duct) or stenosis bypass are required.

Other medicines and Ultravist-370

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This also includes medicines that you do not take regularly, but that you may have used during the days leading up to the radiological examination.

It is particularly important that you inform your doctor if you are taking any of the following medications:

-             Biguanides (Metformin, a medication used to treat diabetes mellitus): If you suffer from acute kidney failure or severe, chronic kidney disease, there may be a delay in eliminating biguanides, which then accumulates in the blood and may result in lactic acidosis (too much acid in the blood).

Because the use of Ultravist-370 may cause kidney problems or make existing kidney problems worse, you may be exposed to an increased risk of developing lactic acidosis.

This is particularly true if you already suffer from impaired kidney function (see section 2, sub-section "Intravascular applications"; "Kidney function disorders"). Depending on the results of a kidney function test, the advisability of stopping Metformin treatment should be carefully considered.

-             Interleukin-2: Previous treatment (up to several weeks) with interleukin-2 (a cancer drug) has been linked to an increased risk for delayed onset of contrast media reactions in association with Ultravist-370 use.

-             Radioisotopes: Following intravascular administration (application in blood vessels) iodine-containing contrast media can reduce the ability of thyroid tissue to absorb isotopes. As a consequence, the diagnosing and treatment of disturbed thyroid gland function with thyrostatic radioisotopes may be impaired for several weeks after using Ultravist-370, and even longer in isolated cases.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

No well controlled studies have been conducted in pregnant women. Therefore, the safety of using Ultravist-370 during human pregnancy has not been sufficiently proven. Animal studies with iopromide did not show any evidence of a damaging effect during pregnancy as regards the development of the embryo/foetus, birth, or development of newborns after the use of iopromide for diagnostic purposes in humans.

An X-ray examination exposes both the mother and the unborn baby to radiation. Because exposure to radiation should generally be avoided during pregnancy as far as possible, your physician needs to carefully assess the possible risks associated with radiological examinations, whether with or without contrast medium. In addition to the necessity of protecting the unborn baby from radiation, whenever iodine-containing contrast media are used the sensitivity of the foetal thyroid gland to iodine must also be considered.

Breast-feeding

The safety of Ultravist-370 in breast-fed infants has not been studied. It is not expected that small quantities of the active ingredient in Ultravist-370 might damage a breast-feeding infant, since only small quantities of the active ingredient in Ultravist-370 pass into breast milk (also see sections "Warnings and precautions"; "Thyroid function disturbances". To avoid any possible overexposure to iodide by the breastfeeding baby (risk of blocking thyroid hormone synthesis), for safety reasons it is thus recommended that breastfeeding be suspended for 2 days for babies of less than 4 months of age, and that any siphoned milk be discarded.

Driving and using machines

No studies on the effects on the ability to drive and use machines after use of Ultravist have been performed.

Ultravist-370 contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose (based on the average amount for a person weighing 70 kg), that is to say essentially ‘sodium-free’.

Ultravist-370 is injected or infused into a blood vessel (intravascular injection or infusion) or introduced into body cavities (intracavitary use).

Ultravist-370 will be given to you by a doctor or a trained healthcare professional.

In case of intravascular administration (administration into a blood vessel) of Ultravist-370, your doctor will examine you for any underlying diseases, will ask you about any medicines you are taking/using, as these may possibly cause thromboembolic events to occur (blocking of a vessel by a blood clot).

Adequate fluid intake should be ensured before and after using Ultravist-370.

Your doctor will

-             be particularly careful in carrying out the procedure to examine your blood vessels (angiography),

-             frequently rinse the catheter with saline solution (and using heparin if possible – a blood thinning drug),

-             keep the examination as short as possible to minimise the risk of developing an examination-related blood clot in blood vessels (thrombosis) or congestion (narrowing or blockage) of the vascular lumen by an embolus, e.g. a blood clot (embolism).

Your doctor will determine the correct dose of contrast medium for the radiological examination. If you're interested, ask him/her to explain the examination to you.

How Ultravist-370 is dosed

General information

The dose is determined on the basis of age, weight, heart and kidney functions, general health status, the specific clinical question, examination method and examined body region.

The treating physician will determine the suitable iodine concentration and required volume for each individual patient. An overview of the recommended volumes for the various concentrations of iopromide solutions for each body region to be visualised is provided in the form of a table at the end of this leaflet.

The total dose of 1.5 g iodine per kg of body weight (equivalent to about 4 mL Ultravist-370 per kg body weight) should not be exceeded on any given examination day.

Ultravist-370 should be warmed to body temperature before being applied, which improves tolerability and makes it easier to inject because of the lower viscosity.

The following instructions pertain to the different types of use

Unless prescribed otherwise, the following dosage guidelines apply for the specific areas of use:

Imaging of the kidneys and urinary tract (intravenous urography)

It is important to note that when conducting intravenous urography, relatively high doses of contrast medium are required for infants, because of the poor physiological concentrating ability of the immature nephron of the infantile kidney.

Computerised tomography (CT)

Ultravist-370 should be administered as a rapid intravenous injection, and if possible, with the aid of a high pressure injector. When slow scanners are used, in order to achieve relatively constant blood levels we recommend that half of the dose be administered as a bolus and the remainder of the dose within 2 - 6 minutes, even if a steady peak cannot be maintained. The scan process is started upon completion of the initial administration phase.

When performing spiral CT, and in particular multi-slice techniques, a variety of data are compiled with the patient holding his/her breath. In order to optimise the effect of the intravenous bolus injection in the region of interest (optimal enhancement is achieved at different times in the pathologically changed tissues), the use of an automatic high-pressure injector and bolus is recommended.

When performing CT, the required quantity of contrast media and administration rate are determined relative to the organs to be examined, the diagnostic question at hand, but also in consideration of the apparatus actually available for the specific examination (e.g. scan and image forming times). Infusion is recommended when using slow-working devices, and bolus injection for fast scanners.

Digital subtraction angiography (DSA)

In many cases, intra-arterial DSA can yield strongly enhanced images of the great vessels and arteries of the neck, kidney and limbs, even in cases where the applied concentration of Ultravist-370 is insufficient for conventional angiography. This method is thus recommended for patients with impaired renal function.

Visualization of body cavities

When performing arthrography, hysterosalpingography or ERCP, the contrast medium should be injected under fluoroscopic monitoring.

Additional information for certain patient populations

Newborns and infants

Infants under 1 year of age, in particular newborns, are vulnerable to electrolyte balance disturbances and changes in blood circulation (haemodynamic changes). The doctor will carefully select the dose of contrast medium and conduct the radiological examination in such a way so as to take the patient's actual status into account.

Patients with impaired kidney function

Because iopromide, the active ingredient in Ultravist-370, is almost always excreted via the kidneys in unchanged form, the time required to eliminate iopromide is longer in patients with kidney failure. The dose of contrast medium for patients with pre-existing impaired kidney function should be kept as low as possible in order to reduce the risk of any contrast-medium-induced kidney injury (also see section "Warnings and precautions").

For more information on the use and handling of Ultravist-370, see the instructions provided at the end of this leaflet (see section "The following information is intended for doctors and qualified medical staff only").

Notes on practical use

Ultravist-370 is supplied as a ready-to-use, clear, colourless to pale yellow solution. The contrast medium must be inspected visually prior to use. Because Ultravist-370 is a highly concentrated solution, crystallization may occur in rare cases (milky-turbid appearance and/or bottom sediment or swimming crystals). It is prohibited to use a contrast medium if it is severely discoloured, if particles (incl. crystals) are visible, or if the container is damaged.

The contrast medium solution must be drawn up into the syringe or the container attached to the infusion device just prior to conducting the examination.

To prevent significant quantities of micro-particles from entering the solution via the stopper the rubber stopper may only be pierced once. A long-tip cannula with a maximum diameter of 18 G is recommended for piercing the stopper and for drawing up the contrast medium (special withdrawal cannulas with a side hole are particularly suitable).

Contrast media solutions as solutions for injection are packaged for one-time use only. Any contrast media remaining after the examination procedure must discarded and disposed of appropriately.

Whenever an automatic application system is used to administer a medicinal product, the medicinal product manufacturer must provide evidence of the suitability of any such planned use, as well as the sterility of the contrast medium. The instructions for use of the medicinal product in question must be strictly followed. It is prohibited to use automatic application systems in babies and small children.

The following supplemental rules apply when using prefilled plastic cartridges: only qualified medical staff are allowed to administer contrast media and the procedure must always be conducted using the appropriate methods and apparatus. Sterile handling techniques must be strictly followed for all injections involving contrast media. The contrast media must be administered with a suitable injector. The type of injector required is clearly marked on the container itself. Any pertinent manufacturer instructions must be strictly followed.

If you are given more Ultravist-370 than planned

Inform your doctor immediately if you are given more Ultravist-370 than is required and you do not feel well.

An overdose can affect the pulmonary and cardiovascular system, which can cause undesired effects and even life-threatening reactions. Symptoms of an overdose include an imbalance of bodily fluids and electrolytes, kidney failure, cardiovascular (heart and blood vessels) and respiratory (pertaining to breathing functions) complications.

For this reason, treatment for an overdose consists of maintaining all life-preserving functions and carefully initiating therapy for the specific symptoms. In the event of an accidental overdose your water/electrolyte imbalance and kidney function must be monitored. Your doctor may decide to perform dialysis to remove Ultravist-370 from your body.

If you have any further questions about this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Please tell your doctor or pharmacist if you notice any side effects or suspect that any complaints you may have are connected with the administration of this X-ray contrast medium. This also applies if the complaints are not listed as a side effect in this leaflet. Note that side effects can also occur after some delay – possibly much later after the X-ray examination.

The most frequently occurring side effects observed in patients after using Ultravist-370 (≥4%) are headache, nausea and dilated blood vessels (vasodilation).

The most serious side effects observed in patients after using Ultravist-370 are shock, anaphylactoid shock, respiratory arrest, difficulty in breathing (bronchospasm), swelling of the larynx (laryngeal oedema), swelling in the pharynx (pharyngeal oedema), asthma, coma, reduced blood supply to the brain (cerebral ischaemia/cerebral infarction), stroke, swelling of the brain (cerebral oedema), cerebral seizures/convulsion, irregular heartbeat (arrhythmia), cardiac arrest, chest pain resulting from reduced oxygen supply to the heart (myocardial ischaemia), heart attack (myocardial infarction), heart failure, slower heart rate (bradycardia), bluish colour of skin and mucosa due to lack of oxygen (cyanosis), low blood pressure, breathlessness (dyspnoea), accumulation of fluid in the lungs (pulmonary oedema) and shortness of breath (respiratory insufficiency).

Different kinds of side effects may occur in association with the use of contrast media containing iodine. We differentiate between unpredictable pseudo-allergic reactions (also see section “Warnings and precautions”, hypersensitivity reactions in the form of allergoid and anaphylactoid or pseudo-allergic reactions, as well as pharmacologically explainable and predictable organotoxic reactions. Pseudo-allergic and organotoxic reactions can also occur simultaneously, and it is not always possible to definitively categorise the specific event.

Common: Can affect up to 1 in 10 patients treated

-        Dizziness

-        Headache

-        Taste disorders (dysgeusia)

-        Blurred vision/visual impairment

-        Chest pain/feeling of tightness in chest

-        High blood pressure (hypertension)

-        Dilated blood vessels (vasodilation)

-        Vomiting

-        Nausea

-        Pains

-        Reaction at injection site of various types: e.g. pain, sensation of heat^§), swelling^§) (oedema), inflammation^§) and injury to surrounding soft tissues^§) if Ultravist-370 is discharged from the injection site)

-        Flushing

Uncommon: Can affect up to 1 in 100 patients treated

-        Hypersensitivity/allergy-like (anaphylactoid) reactions:

anaphylactoid shock^§)*), respiratory arrest^§)*), cramping of bronchial musculature^*) (bronchospasm), swelling of the larynx region^*) (laryngeal oedema)/swelling of the pharynx^*) (pharyngeal oedema)/swelling in the face (facial oedema), (swelling of the tongue^§) (tongue oedema), laryngospasm (cramping in the area of the larynx/cramping in the area of the pharynx^§) (laryngospasm/pharyngeal spasm), asthma^§)*), inflammation of the conjunctiva^§) (conjunctivitis), lacrimation^§), sneezing, coughing, swelling of the mucosa (mucosal oedema), inflammation of the nasal lining^§) (rhinitis), hoarseness^§), throat irritation^§), hives (urticaria), itchiness (pruritus), swelling of the skin and mucosa (angioedema)

-        Unconsciousness/fainting, drop in blood pressure with related drop in heart rate (vasovagal reactions)

-        Disorientation

-        Restlessness

-        Unusual skin sensitivity such as burning, tingling, itching or prickling (paraesthesia)/limited sense of touch or skin sensation (hypaesthesia)

-        Reduced alertness/drowsiness (somnolence)

-        Disturbed heart rhythm^*) (arrhythmia)

-        Low blood pressure^*) (hypotension)

-        Shortness of breath^*) (dyspnoea)

-        Stomach ache (abdominal pain)

-        Swollen tissues (oedema)

Rare: Can affect up to 1 in 1,000 patients treated

-        Anxiety attacks

-        Cardiac arrest^*)

-        Chest pain due to reduced oxygen supply to the heart^*) (myocardial ischaemia)

-        Palpitations

Not known: cannot be estimated from the available data

-        Episodes of life-threatening hyperfunctioning of the thyroid gland (thyrotoxic crisis)

-        Thyroid function disturbances

-        Coma^*)

-        Reduced blood supply in the brain^*) (cerebral ischaemia/cerebral infarction)

-        Stroke^*)

-        Swelling of the brain^a)*) (cerebral oedema)

-        Cerebral seizures/convulsions^a)*)

-        Temporary impaired vision^a) (cortical blindness)

-        Unconsciousness

-        Excitation and restlessness (agitation)

-        Memory loss (amnesia)

-        Trembling (tremor)

-        Speech disorders

-        Partial/complete body paralysis (paresis/paralysis)

-        Hearing disturbances

-        Heart attack^*) (myocardial infarction)

-        Heart failure^*)

-        Slower heartbeat^*) (bradycardia)

-        Faster heartbeat (tachycardia)

-        Bluish colour of skin and mucosa due to lack of oxygen^*) (cyanosis)

-        Shock^*)

-        Blocking of a vessel by blood clots^a) (thromboembolic events)

-        Sudden cramp-like constriction of a blood-carrying vessel^a) (vasospasm)

-        Fluid accumulation in the lungs^*) (pulmonary oedema)

-        Shortness of breath^*) (respiratory insufficiency)

-        Swallowing disorders (dysphagia)

-        Swelling of the salivary gland

-        Loose bowels (diarrhoea)

-        Diseases of the skin with blister formation (e.g. Stevens-Johnson or Lyell's syndrome)

-        Rash (exanthema)

-        Reddening of the skin (erythema)

-        Excessive sweating (hyperhidrosis)

-        Pressure in muscle tissue leading to damaged muscle and nerve tissues, in addition to blood flow disorders^a) (Compartment syndrome following extravasation)

-        Kidney function disorders^a)

-        Acute kidney failure^a)

-        Malaise

-        Chills

-        Paleness

-        Changes in body temperature

^*) life-threatening and/or cases involving death have been reported

^a) applies only for intravascular application

^§) observed only after market launch (unknown frequency of occurrence)

Seek medical attention immediately if you notice any of the following signs and symptoms (whose frequency is not known):

-        Reddish patches on the trunk, the patches are target-like macules or circular, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

-        Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

-        A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever after the imaging procedure (acute generalised exanthematous pustulosis).

-        Short term brain disorder (encephalopathy) which can cause memory loss, confusion, hallucinations, difficulties with vision, loss of vision, seizures, loss of coordination, loss of movement in one side of the body, problems with speech, and loss of consciousness.

Intravascular use (administration into a blood vessel)

Side effects associated with the intravascular administration of iodinated contrast media are usually mild to moderate and temporary in nature. Nevertheless, serious and rare life-threatening reactions can occur that require rapid and effective emergency treatment.

Reactions to contrast media occur much more frequently and are more severe after intravascular administration, than when they are introduced into body cavities (intra-ductal and intracavitary administration).

Use in body cavities

Since small quantities of contrast media can also pass into the blood vessel after placing the contrast medium into body cavities (intra-ductal, intracavitary administration), when this administration method is used, allergy-like reactions can occur such those also described for contrast medium administration into blood vessels.

When visualising body cavities, symptoms tend occur as a function of the examined region, and in most cases, are caused by the chosen examination techniques. Most adverse events occurring after use in body cavities occur within one hour after the examination.

Pain due to expansion may be experienced when filling body cavities with contrast media.

In addition to the side effects mentioned above, after ERCP examinations, a temporary (reversible) increase in pancreas enzymes (amylase and lipase) and onset of pancreatitis (inflammation of the pancreas) have also been reported, including necrotising (dying tissues) pancreatitis. The frequency of occurrence of these side effects is unknown. The reason for this may be increased pressure in the small pancreatic ducts, due to an excess quantity of contrast medium being injected.

Uncommon cases of gastrointestinal problems have been reported after swallowing contrast media.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

To report any side effect(s):

The National Pharmacovigilance Centre (NPC).

Fax: + 966 - 11 - 205 - 7662.

SFDA call center: 19999.

E - mail: npc.drug@sfda.gov.sa.

Website: https://ade.sfda.gov.sa

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

Do not use this medicine after the expiry date which is stated on the container/carton after “EXP”. The expiry date refers to the last day of that month.

Storage conditions

Protect from light and X-rays.

Do not store above 30°C.

It is prohibited to use contrast media that are severely discoloured, that contain particles, or if the container is damaged.

This medicinal product is meant for one-time use only.

Note about shelf-life after opening

The chemical and physical stability of the ready-to-use preparation (solution for injection or infusion) has been demonstrated at 36-38º Celsius for a period of 10 hours. From a microbiological point of view, the ready-to-use preparation should be used immediately, unless the method used to open the container ensures that there is no risk of contamination.

If the ready-to-use preparation is not administered immediately, the operator must ensure that the remaining solution is used within the allotted time period and under the appropriate conditions.

Never throw away any medicines via wastewater (e.g. down the toilet or sink). Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.