ULTRAVIST 240 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION IN VIAL

Introduction

Package Leaflet: Information for the User

Ultravist 240 mg/ml Solution for Injection and Infusion in Vial

Iopromide

Contents of the pack:

1. What is Ultravist and what is it used for
2. What you need to know before you use Ultravist
3. How to use Ultravist
4. Possible side effects
5. Storage of Ultravist
6. Contents of the pack and other information

1. What is Ultravist and what is it used for

This medicinal product is for diagnostic use only.

Ultravist belongs to a group of medicines called low osmolar, hydrophilic, and nephrotropic X-ray contrast media.

Ultravist is used to enhance contrast during the visualization of different body regions using certain radiological techniques:

• Computed Tomography (CT, obtaining images of sections of a specific region of the body)
• Phlebography of limbs (for visualization of limb veins) in adults and phlebography in children.
• Angiography (visualization of blood vessels) by digital subtraction (ASD) intraarterial/intravenous
• Intravenous urography (for visualization of the urinary tract)
• Lumbar, thoracic, and cervical myelography (visualization of structures within the spinal column) using intrathecal administration (administration into the space surrounding the spinal cord)

Arthrography (visualization of joints) and hysterosalpingography (visualization of the uterus and fallopian tubes)

2. What you need to know before you use Ultravist

Do not use Ultravist

The intrathecaluse of Ultravist should not be performed in patients:

• with a history of epilepsy
• under anticonvulsant treatment (taking medications to combat, prevent, or interrupt seizures or epileptic attacks, such as barbiturates, benzodiazepines, bromides, carbamates, and hydantoins)
• with convulsive brain disease
• with renal dysfunction (serum creatinine > 1.3 mg/dl)

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ultravist:

• If you have ever suffered from a severe skin rash or skin peeling, blistering, and/or oral ulcers after using Ultravist

Be careful with Ultravist

For all indications

• If you have ever had an allergic reactionto another iodine-containing contrast medium, as there is an increased risk of hypersensitivity reactions (allergic reactions).

The risk of allergic reactions is also higher in patients with a history of bronchial asthma or other allergic disorders and in patients with known hypersensitivity to Ultravist or any of its excipients.

Your doctor may consider premedication with corticosteroids to minimize allergic reactions.

Patients who experience these reactions while being treated with beta-blockers may exhibit resistance to treatment with beta-agonists (see taking other medicines).

In the event of a severe hypersensitivity reaction, patients with cardiovascular disease (heart disease) are more susceptible to severe reactions, even with a fatal outcome.

Due to the possibility of severe hypersensitivity reactions after administration, it is recommended to observe patients after the diagnostic procedure.

• Severe skin reactionssuch as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of Ultravist. Seek medical attention immediately if you notice any of the signs described in section 4.

• If you have thyroid dysfunction(thyroid function disorder). Inform your doctor if you have hyperthyroidism (overactive thyroid) or goiter (enlargement of the thyroid gland), as iodine-containing contrast media may induce hyperthyroidism and thyrotoxic crisis (a serious complication of an overactive thyroid). You may undergo a thyroid blood test and receive necessary medication. Your doctor will consider the need for thyroid function tests before administering Ultravist.

Tell your doctor if you have a history of thyroid disease, including hypothyroidism (underactive thyroid). Abnormal thyroid function blood tests have been reported after imaging with iodine-containing contrast media, which may suggest possible hypothyroidism or a transient reduction in thyroid function, which may require treatment.

Newborns may also be exposed to Ultravist through the mother during pregnancy.

If your child is under 3 years old:

Your doctor may monitor and check thyroid function, especially in newborns.

• If you have central nervous system (CNS) disorders:

Patients with central nervous system disorders may have a higher risk of neurological complications related to the administration of Ultravist. Neurological complications are more frequent with cerebral angiography (X-ray of the brain's blood vessels) and related procedures.

During or shortly after the imaging technique, you may experience a short-term brain disorder called encephalopathy. Inform your doctor immediately if you notice any of the signs and symptoms related to this disorder described in section 4.

Caution should be exercised in situations where the convulsive threshold is decreased, such as a history of previous seizures or use of certain concomitant medications.

• Ultravist should not be administered to you if you are dehydrated (have not taken enough fluids). To avoid this, your doctor will ensure that you have taken enough fluids before your examination (see section "Be careful with Ultravist"). Adequate hydration statusshould be ensured in all patients before administration of Ultravist via the intraarterial, intravenous, or intrathecal route.

This is especially important if you have multiple myeloma (a type of blood cell cancer), diabetes mellitus, polyuria (excessive urine production), or oliguria (reduced urine production), hyperuricemia (elevated uric acid in the blood), as well as in newborns, infants, young children, and elderly patients.

Tell your doctor if you have kidney problems. Your doctor will ensure that you are well-hydrated before your examination. However, it is not recommended to administer fluids intravenously (into the veins) if you have kidney problems.

Tell your doctor if you have severe kidney problems accompanied by heart disease. Administering fluids intravenously (into the veins) can be dangerous for the heart.

• If you have anxiety

States of excitement, anxiety, and intense pain can increase the risk of adverse reactions or the intensity of reactions associated with contrast media. In these cases, inform your doctor, who will try to minimize your anxiety.

• If you are elderly, as vascular pathology and neurological disorders commonly seen in these patients increase the risk of adverse reactions.

• If you have a significant deterioration in your health status, your doctor will assess the need to perform the examination.

Additionally, in the case of intraarterial or intravenous injectionof Ultravist, you should also be careful in the following situations:

• If you receive Ultravist, there is a risk that you may develop acute kidney injury after injection(Contrast-Induced Acute Kidney Injury(CI-AKI)). As a result, your kidneys may not function properly for a short period. Some patients experience renal failure. This is especially relevant if you have any of the following conditions:

• pre-existing renal insufficiency (your kidneys do not function properly). For more information, see section 3: "How to use Ultravist", subsection "Patients with renal insufficiency",
• diabetes mellitus,
• dehydration,
• multiple myeloma (cancer of blood cells in the bone marrow),
• paraproteinemia (disease in which an excessive amount of certain proteins is produced),
• patients receiving high or repeated doses of Ultravist.

• If you have severe kidney or liver dysfunction, combined kidney and liver disorders, or are going to undergo a liver transplant. Ultravist will only be administered to you if it is absolutely necessary. In these cases, adequate hydration before administration of the contrast medium is essential.

• If you have diabetes mellitus, as the administration of iodine-containing contrast media in diabetic patients with pre-existing kidney damage predisposes to renal dysfunction.

• If you have any cardiovascular disease.

There is a higher risk that clinically relevant changes in the cardiovascular system and arrhythmias (abnormal heart rhythms) may occur in patients with significant heart disease or severe coronary artery disease.

Intraarterial or intravenous injection of the contrast medium can precipitate the onset of pulmonary edema in patients with heart failure. (See section 3: "How to use Ultravist", subsection "Patients with renal insufficiency").

• If you have been diagnosed with a pheochromocytoma(a type of tumor), as you may have a higher risk of developing a hypertensive crisis.

• If you have any autoimmune disease(diseases of the immune system that recognize the body's own tissues as foreign and attack them), as severe cases of vasculitis (inflammation of blood vessels) and Stevens-Johnson syndrome (a disease characterized by polymorphic erythema and mucocutaneous, ocular, and other systemic manifestations) have been described.

• If you have myasthenia gravis(a disease in which muscles weaken and fatigue easily), as symptoms may worsen.

• Caution should be exercised if you have homocystinuria(a disease of protein metabolism) due to the risk of inducing thrombosis and embolism.

• If you have multiple myeloma(a type of blood cell cancer) or Waldenström's paraproteinemia(a disease in which an excessive amount of certain proteins is produced), as you are more likely to experience a transient decrease in renal function after administration of the contrast medium.

Additionally, in the case of intrathecal use, you should also be careful with Ultravist in the following situations:

• The intrathecal use of Ultravist is not indicated for cerebral ventriculography (X-ray of the brain's ventricles) and cisternography (X-ray of the cisterns at the base of the skull).

• There are no data on the use of Ultravist via the intrathecal route in the pediatric population or in patients with renal dysfunction (serum creatinine > 1.3 mg/dl).

• If you have any type of brain disease with seizures, you should not be administered Ultravist without prior careful evaluation. Additionally, the necessary equipment and medications should be available to counteract any seizures that may occur.

• Most adverse reactions after myelography appear several hours after administration of the contrast medium. During this period, the patient should be observed.

Additionally, in the case of useof Ultravist for , the following considerations should be taken into account:

• It is necessary to rule out any possibility of pregnancy.

• Inflammation of the fallopian tubes may increase the risk of reactions after hysterosalpingography.

Consult your doctor, even if any of the above circumstances have occurred to you at some point.

Using Ultravist with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Certain medicines may interact, and in these cases, it may be necessary to change the dose or interrupt treatment with one of the medicines. It is especially important to inform your doctor if you are using any of the following medicines:

• Metformin (biguanide: a medication used to treat some forms of diabetes mellitus): in patients with renal insufficiency, the elimination of biguanides may be decreased, leading to accumulation and development of lactic acidosis (accumulation of lactic acid in the body). As the use of Ultravist may lead to renal insufficiency or worsening of existing renal insufficiency, patients treated with metformin may have a higher risk of developing lactic acidosis, especially those with pre-existing renal insufficiency. Based on measurements of renal function, the need to interrupt metformin administration should be considered.

• Neuroleptics (medications commonly used to treat psychosis), analgesics (medications that relieve or eliminate pain), antiemetics (medications that prevent vomiting or nausea), antihistamines (medications for the treatment of allergic rhinitis or dermatitis), and sedatives (tranquilizers). With the use of these medications, your susceptibility to seizures may be reduced, and you may have a higher risk of reactions related to the contrast medium. Therapy with these medications should be suspended 48 hours before administration of the contrast medium and not resumed before 12 hours after the procedure.

• Beta-blockers, as hypersensitivity reactions may be worsened, especially in cases of allergic predisposition, bronchial asthma, or history of allergy to other contrast media. Additionally, you may not respond to standard treatment with beta-agonists.

• Interleukin-2, as previous treatments (up to several weeks) with interleukin-2 have been associated with an increased risk of delayed reactions to Ultravist.

• Oral cholecystographic contrast media: There is no evidence of interaction with contrast media eliminated by the renal route.

• Diuretics: Due to the risk of dehydration caused by diuretics, before administering the iodine-containing contrast medium, your doctor should administer rehydration salts to minimize the risk of acute renal failure.

• Interference with laboratory tests: Iodine-containing contrast media may interfere with thyroid function tests, as the thyroid's ability to uptake iodine may be reduced for several weeks.

• Radioactive drugs: If you are going to undergo tests for the diagnosis and treatment of thyroid diseases with radioisotopes, they should be delayed until several weeks after administration of Ultravist, due to a decrease in the uptake of the radioisotope.

Using Ultravist with food and drinks

You can maintain a normal diet until two hours before the examination. During the 2 hours prior to the study, you should abstain from eating.

Pregnancy and Breastfeeding

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

No well-controlled studies have been conducted in pregnant women.

After diagnostic application of Ultravist in humans, animal studies do not indicate harmful effects on pregnancy, embryonic/fetal development, childbirth, or postnatal development.

The risk-benefit ratio should be assessed before administering an iodine-containing contrast medium, considering the sensitivity of the fetal thyroid to iodine, as acute iodine overload after administration of an iodine-containing contrast medium to the mother may cause fetal thyroid dysfunction.

The safety of Ultravist has not been investigated in breastfeeding women. Contrast media are excreted in breast milk in minimal amounts. No harm to the breastfed child is expected.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

Ultravist contains Sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose (based on the average amount administered to a person weighing 70 kg); it is essentially "sodium-free".

3. How to use Ultravist

Follow your doctor's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

Ultravist is a contrast medium used for a diagnostic test, which should be carried out in the presence of qualified personnel, preferably under the supervision of a doctor, who will indicate the instructions to follow at all times.

• Before administering the contrast medium by intra-arterial, intravenous, or intrathecal route, your doctor should rule out possible renal dysfunction through medical history and/or laboratory tests.

Dosage in adults

The recommended doses in adults are as follows:

Dosage in special populations

Elderly patients (population over 65 years of age):

No dose adjustment is necessary.

Pediatric population (under 18 years of age):

The recommended doses in children are shown in the table below.

Infant kidneys, still immature, require relatively high doses of the contrast medium for intravenous urography in relation to the rest of the indications, as indicated in the table below:

Children under 1 year, especially newborns, are susceptible to suffering from alterations in blood dynamics and electrolyte content in the body. Caution should be exercised with the dose of the contrast medium to be administered, the technical performance of the radiological procedure, and their general condition.

The recommended doses in neonates, infants, young children, and pediatric population from 11 to 18 years should not be exceeded.

Patient with hepatic impairment:

No dose adjustment is necessary (see section 2).

Patient with renal impairment:

Since Ultravist is excreted almost exclusively unchanged by the kidneys, the elimination of Ultravist is prolonged in patients with renal impairment. In order to reduce the risk of additional contrast-induced renal injury, the lowest diagnostic dose should be used in patients with pre-existing renal impairment. Do not administer by intrathecal route in patients with renal dysfunction (serum creatinine > 1.3 mg/dl); see section 2.

If you think the effect of Ultravist is too strong or too weak, tell your doctor or pharmacist.

Your doctor will inform you about all the characteristics related to the administration of Ultravist.

If you use more Ultravist than you should

Intra-arterial or intravenous use(in an artery or vein)

Symptoms may include hydroelectrolytic imbalance (increase or decrease in total water and electrolyte volume in the body), renal failure, and cardiovascular and pulmonary complications.

In case of accidental intra-arterial or intravenous overdose, it is recommended to monitor hydroelectrolytic balance and renal function. Treatment of overdose should be aimed at ensuring support for vital functions. Water and electrolyte loss should be compensated by perfusion. Renal function should be monitored for at least 3 days after the test. If necessary, hemodialysis can be used to eliminate most of the contrast medium from the body.

Ultravist is dialyzable.

Intrathecal use(in the space surrounding the spinal cord)

Severe neurological complications may occur. In case of accidental intrathecal overdose, close monitoring is recommended.

You should be closely monitored during the first 12 hours to detect signs indicative of a severe CNS alteration. These signs may be hyperreflexia (exaggerated reflexes) ascending or tonic-clonic spasms and, in severe cases, encephalic involvement with generalized seizures, hyperthermia (elevated body temperature), stupor (state of partial unconsciousness), and respiratory depression. In order to prevent large amounts of Ultravist from reaching the cerebral cisterns, aspiration of the contrast medium should be performed as completely as possible.

In case of overdose or accidental ingestion, consult the Toxicology Information Service; Telephone 91 562 04 20.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

The overall safety profile of Ultravist is based on data obtained from pre-marketing studies in over 3,900 patients and post-marketing studies in over 74,000 patients, as well as spontaneous reporting data and literature.

The most frequently observed adverse reactions in patients receiving Ultravist are headache, nausea, and vasodilation.

The most serious adverse reactions observed in patients receiving Ultravist are anaphylactic shock, respiratory arrest, bronchospasm, laryngeal or pharyngeal edema, asthma, coma, cerebral infarction, stroke, cerebral edema, convulsion, arrhythmias, cardiac arrest, myocardial ischemia, myocardial infarction, heart failure, decreased heart rate, cyanosis, hypotension, shock, respiratory distress, pulmonary edema, and respiratory failure.

All indications

Common side effects(may affect 1 to 10 in 100 patients):

• dizziness, headache, taste alteration
  • blurred vision, vision disturbances
  • chest pain or discomfort
  • high blood pressure, vasodilation
  • vomiting, nausea
  • pain, injection site reactions (e.g., pain, and with unknown frequency, sensation of heat, swelling, inflammation, and injury) and sensation of heat.

Uncommon side effects(may affect 1 to 10 in 1,000 patients):

• allergic reactions (hypersensitivity/anaphylactoid reactions, e.g., facial edema, sneezing, coughing, mucosal edema, rhinitis, pruritus, rapid swelling of the skin and mucous membranes; with unknown frequency and *: anaphylactic shock, respiratory arrest, and asthma; *: bronchospasm, laryngeal or pharyngeal edema; with unknown frequency: tongue edema, pharyngeal or laryngeal spasm, conjunctivitis, lacrimation, rhinitis, hoarseness, and throat irritation)
• fainting, confusion, nervousness, sensitivity disturbances, decreased sensitivity, somnolence
• arrhythmias (*)
• low blood pressure (*)
• respiratory distress (*)
• abdominal pain
• edema

Rare side effects(may affect 1 to 10 in 10,000 patients):

• anxiety
• cardiac arrest (*), myocardial ischemia (*), palpitations

Side effects of unknown frequency(frequency cannot be estimated from available data)

• thyrotoxic crisis (acute worsening of thyroid function), thyroid disorder
• coma (*), cerebral hypoperfusion or infarction (*), stroke (*), cerebral edema (*, only with intra-arterial or intravenous administration), convulsion (*), total or partial loss of vision in one eye (only with intra-arterial or intravenous administration), loss of consciousness, agitation, memory loss, tremor, speech disorders, paresis/paralysis, contrast encephalopathy
• hearing disorders
• myocardial infarction (*), heart failure (*), decreased heart rate (*), increased heart rate, cyanosis (*)
• shock (*), decreased perfusion due to arterial obstruction (only with intra-arterial or intravenous administration), arterial constriction (only with intra-arterial or intravenous administration)
• pulmonary edema (*), respiratory failure (*), aspiration (*)
• respiratory distress, salivary gland enlargement, diarrhea
• bullous skin reactions (e.g., Stevens-Johnson syndrome or Lyell's syndrome), skin color and appearance changes, skin rash, excessive sweating, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms
• compartment syndrome in case of extravasation (only with intra-arterial or intravenous administration)
• renal failure (only with intra-arterial or intravenous administration), acute renal failure (only with intra-arterial or intravenous administration)
• general malaise, chills, pallor
• body temperature fluctuations

*There have been life-threatening cases.

Seek immediate medical attention if you notice any of the following signs and symptoms (whose frequency is unknown):

• Reddish plaques on the trunk, which are target-shaped or circular, often with central blisters, skin peeling, and ulcers in 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 rash, elevated body temperature, and lymph node enlargement (DRESS or drug hypersensitivity syndrome).
• Generalized exanthematous pustulosis with subcutaneous nodules and blisters accompanied by fever after imaging (acute generalized exanthematous pustulosis).

Short-term cerebral disorder (encephalopathy) that can cause memory loss, confusion, hallucinations, vision problems, loss of vision, convulsions, loss of coordination, loss of mobility on one side of the body, speech problems, and fainting.

Intrathecal administration

In addition to the adverse reactions listed above, the following adverse reactions have been reported with intrathecal administration: chemical meningitis and meningism with unknown frequency.

Most reactions after myelography or use of the contrast medium in body cavities appear a few hours after administration.

Based on experience with other non-ionic contrast media, the following side effects may occur with intrathecal administration, in addition to the side effects listed above: psychosis, neuralgias, paraplegia, aseptic meningitis, back pain, limb pain, urinary difficulties, abnormal electroencephalogram.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Class effects

Exploration with the contrast medium is performed under general anesthesia in some selected patients. However, a high incidence of adverse reactions has been described in these patients, which is attributed to the patient's lack of criteria to distinguish between adverse reactions themselves and the effects of low tension anesthesia, which prolongs the circulation time and increases the duration of exposure to the contrast medium.

Reporting of side effects

If you experience any type of side effect, consult your doctor or radiologist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ultravist

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

Store in the original packaging to protect it from light and X-rays.

Do not store above 30°C.

Do not use this medicine after the expiration date shown on the packaging after EXP.

Ultravist is supplied as a clear, colorless to pale yellow solution, ready for use. Do not use Ultravist if you observe significant changes in color, appearance of particles in suspension, or if the packaging is defective.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Ultravist 240

• The active ingredient is iopromide. 1 ml of injectable solution contains 499 mg of iopromide, equivalent to

240 mg of iodine.

1 vial with 10 ml of injectable solution contains 4.99 g of iopromide, equivalent to 2.4 g of iodine.

1 bottle with 50 ml of injectable solution contains 24.95 g of iopromide, equivalent to 12 g of iodine.

1 bottle with 500 ml of injectable solution contains 249.5 g of iopromide, equivalent to 120 g of iodine.

• The other components are: calcium and sodium edetate, trometamol, hydrochloric acid (diluted to 10%) (to adjust the pH), sodium hydroxide (to adjust the pH) and

water for injectable preparations.

Appearance of the Product and Container Content

Ultravist 240 is supplied as a clear, colorless to pale yellow injectable solution and for perfusion, ready to use. Each container contains: 10 ml vials (single dose) or 50 ml bottles (single dose) or 500 ml bottles (multi-dose).

Container sizes: 1 vial or 1 bottle.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bayer Hispania, S.L.

Avda. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

The manufacturer can be identified by the batch number printed on the box and on the label of each vial/bottle:

• If the first and second characters are MA, the manufacturer is:

Berlimed S.A.

Polígono Industrial Santa Rosa

C/ Francisco Alonso, s/n

28806 Alcalá de Henares (Madrid) – Spain

• If the first and second characters are KT, the manufacturer is:

Bayer AG

Müllerstrasse 178

13353 Berlin, Germany

Date of the Last Revision of this Prospectus: September 2023

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for doctors or healthcare professionals (see also section 3: How to use Ultravist)

Before Injection

Ultravist must be warmed to body temperature before administration.

The contrast medium should be visually inspected before use and should not be administered if its color has changed, particles are present in suspension (including crystals), or if the container is defective.

Handling

• Vials/Bottles (≤ 50 ml)

The contrast medium solution should not be drawn into a syringe, nor should the bottle be connected to the perfusion equipment, until immediately before the examination.

The rubber stopper should not be punctured more than once to avoid transferring large amounts of microparticles from the stopper to the solution. The use of long-tip cannulas with a maximum diameter of 18 G is recommended to puncture the stopper and extract the contrast medium (special extraction cannulas with a lateral opening are particularly suitable).

The contrast medium solution administered to a patient and not used in an examination should be discarded. The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.

• Large Volume Containers (500 ml, for intra-arterial or intravenous administration only)

Multiple extraction of the contrast medium should be performed with authorized equipment for multiple administration. Auto-injectors/pumps should not be used in small children.

The rubber stopper of the bottle should not be punctured more than once to avoid transferring large amounts of microparticles from the stopper to the solution.

The contrast medium should be administered through an automatic injector or other approved means that ensures the sterility of the contrast medium.

The patient injector tube (patient tube) should be replaced with each patient to avoid any possible contamination.

The connection tubes and all disposable parts of the injection system should be discarded when the perfusion bottle is empty.

Any remaining contrast medium solution in the bottle, connection tubes, or any other part of the disposable material of the injection system should be discarded 10 hours after the first opening of the container.

It is essential to follow the additional instructions provided by the manufacturers of the respective materials used.

The contrast medium remaining in the opened Ultravist container must be discarded ten hours after the container has been opened. The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.