Ultravist 240 mg/ml, solution for injection and infusion in vial: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ultravist 240 mg/ml solution for injection and infusion in vial

Iopromide

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents:

What Ultravist is and what it is used for
What you need to know before using Ultravist
How to use Ultravist
Possible side effects
Storage of Ultravist
Contents of the pack and other information

1. What Ultravist is and what it is used for

This medicine is for diagnostic use only.

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

Ultravist is used to enhance contrast during imaging of various body areas using certain radiological techniques:

Computed tomography (CT, imaging cross-sectional slices of a specific region of the body)
Venography of the limbs (for visualizing veins in the extremities) in adults and venography in children
Digital subtraction angiography (DSA), intra-arterial/intravenous
Intravenous urography (for visualizing the urinary tract)
Lumbar, thoracic, and cervical myelography (visualization of structures within the spinal canal) via 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 using Ultravist

Do not use Ultravist

if you are allergic (hypersensitive) to the active substance or to any of the other components of this medicine (listed in section 6)
if you have clinical hyperthyroidism (your thyroid gland produces too much thyroid hormone)
if you are pregnant or have acute pelvic inflammatory disease and are scheduled to undergo hysterosalpingography (visualization of the uterus and fallopian tubes)

Intrathecal use of Ultravist must not be performed in patients:

with a history of epilepsy
receiving anticonvulsant treatment (taking medications to treat, prevent, or stop seizures or epileptic attacks, e.g., barbiturates, benzodiazepines, bromides, carbamates, and hydantoins)
with convulsive brain disease
with renal dysfunction (serum creatinine > 1.3 mg/dL)

Warnings and precautions

Talk to your doctor or pharmacist before using Ultravist:

If you have ever experienced severe skin rash, skin peeling, and/or oral ulcers after using Ultravist

Use special caution with Ultravist

For all indications

If you have previously had an allergic reaction to another iodinated contrast medium, as there is an increased risk of hypersensitivity (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 experiencing such reactions while on beta-blocker therapy may be resistant to treatment with beta-agonists (see "Use with other medicines").

Patients with cardiovascular diseases (heart conditions) are more susceptible to severe, even fatal, reactions in the event of a serious hypersensitivity reaction.

Due to the possibility of severe hypersensitivity reactions occurring after administration, patients should be observed after completion of the diagnostic procedure.

Severe skin reactions such as Stevens-Johnson syndrome (SJS), 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 immediate medical attention if you notice any of the signs described in section 4.
If you have thyroid dysfunction (abnormal thyroid function). Inform your doctor if you have hyperthyroidism (overactive thyroid) or goiter (enlarged thyroid gland), as iodine-containing contrast media may induce hyperthyroidism or thyrotoxic crisis (a serious complication of overactive thyroid). You may require blood tests and appropriate medication. Your doctor will consider whether thyroid function tests are needed before administering Ultravist.

Inform your doctor if you have a history of thyroid disease, including hypothyroidism (underactive thyroid). Abnormal thyroid function test results have been reported after imaging with iodine-containing contrast agents, which may suggest possible hypothyroidism or a transient (temporary) reduction in thyroid function, potentially requiring treatment.

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

If your child is under 3 years of age:

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

If you have central nervous system (CNS) disorders:

Patients with CNS abnormalities may have an increased risk of neurological complications following Ultravist administration. Neurological complications are more common during or after cerebral angiography (X-ray of brain vessels) and related procedures.

During or shortly after the imaging procedure, you may experience a transient brain disorder called encephalopathy. Inform your doctor immediately if you notice any signs or symptoms related to this condition described in section 4.

Caution is advised in situations where the seizure threshold is reduced, such as a history of seizures or concomitant use of certain medications.

Ultravist must not be administered if you are dehydrated (have not taken enough fluids). To prevent this, your doctor will ensure you are adequately hydrated before the examination (see section "Use special caution with Ultravist"). Adequate hydration status must be ensured in all patients prior to intravascular, intravenous, or intrathecal administration of Ultravist.

This is particularly important if you have multiple myeloma (a type of blood cell cancer), diabetes mellitus, increased urine output (polyuria), reduced urine output (oliguria), hyperuricemia (elevated blood uric acid), or if you are a newborn, infant, young child, or elderly patient.

Inform your doctor if you have kidney problems. Your doctor will ensure you are well hydrated before the examination. However, intravenous fluid administration (fluids into the veins) is not recommended if you have kidney disease.

Inform your doctor if you have severe kidney disease accompanied by heart disease. Intravenous fluid administration may be dangerous for the heart.

If you suffer from anxiety

States of excitement, anxiety, and severe pain may increase the risk or severity of adverse reactions associated with contrast media. In such cases, inform your doctor, who will attempt to minimize your anxiety.

If you are elderly, as vascular and neurological conditions commonly seen in these patients increase the risk of adverse reactions.
If you have a significantly impaired general health status, your doctor will assess whether the examination is necessary.

Additionally, with intra-arterial or intravenous injection of Ultravist, special caution is also required in the following situations:

When Ultravist is administered, there is a risk of developing contrast-induced acute kidney injury (Post-Contrast Acute Kidney Injury (PC-AKI)). As a result, your kidneys may not function properly for a short period. Some patients may develop renal failure. This is especially relevant if you have any of the following conditions:
pre-existing renal impairment (kidneys not functioning properly). For further information, see section 3: "How to use Ultravist", subsection "Patients with renal impairment",
diabetes mellitus,
dehydration,
multiple myeloma (cancer of bone marrow blood cells),
paraproteinemia (a condition involving excessive production of certain proteins),
patients receiving high or repeated doses of Ultravist.
If you have severe kidney or liver dysfunction, combined disorders of kidney and liver, or are scheduled for liver transplantation. Ultravist will only be administered if absolutely necessary. In such cases, adequate hydration before contrast administration is essential.
If you have diabetes mellitus, as administration of iodinated contrast media in diabetic patients with pre-existing kidney damage predisposes to renal dysfunction.
If you have cardiovascular disease.

There is an increased risk of clinically relevant cardiovascular changes and arrhythmias (abnormal heart rhythms) in patients with significant cardiac disease or severe coronary artery disease.

Intra-arterial or intravenous injection of contrast medium may precipitate pulmonary edema in patients with heart failure. (See section 3: "How to use Ultravist", subsection "Patients with renal impairment").

If you have been diagnosed with pheochromocytoma (a type of tumor), as you may be at increased risk of hypertensive crisis.
If you have an autoimmune disease (immune system disorders that attack the body's own tissues), as severe vasculitis (inflammation of blood vessels) and Stevens-Johnson-like syndrome (a condition characterized by polymorphic erythema and cutaneous, mucosal, and ocular manifestations) have been reported.
If you have myasthenia gravis (a condition causing muscle weakness and fatigue), as symptoms may worsen.
Caution is required if you have homocystinuria (a protein metabolism disorder) due to the risk of thrombosis and embolism.
If you have multiple myeloma (a type of blood cell cancer) or Waldenström's paraproteinemia (a condition involving excessive production of certain proteins), as you may be predisposed to transient renal dysfunction after contrast administration.

Additionally, with intrathecal use, special caution with Ultravist is required in the following situations:

Intrathecal use of Ultravist is not indicated for cerebral ventriculography (X-ray of brain ventricles) or cisternography (X-ray of cranial cisterns).
There are no data on the use of Ultravist via intrathecal route in pediatric populations or in patients with renal dysfunction (serum creatinine > 1.3 mg/dL).
If you have any type of brain disease associated with seizures, Ultravist must not be administered without careful evaluation. Additionally, equipment and medications necessary to manage potential seizures must be available beforehand.
Most adverse reactions following myelography occur several hours after contrast administration. Patients must be observed during this period.

Additionally, when using Ultravist for hysterosalpingography, the following considerations must be taken into account:

Pregnancy must be ruled out.
Inflammation of the fallopian tubes may increase the risk of reactions after hysterosalpingography.

Consult your doctor, even if any of the above conditions occurred in the past.

Use of Ultravist with other medicines

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

Certain medicines may interact, and in such cases, dose adjustments or discontinuation of one of the medicines may be necessary. It is especially important to inform your doctor if you are taking any of the following medicines:

Metformin (biguanide: a drug used in the treatment of certain forms of diabetes mellitus): In patients with renal impairment, elimination of biguanides may be reduced, leading to accumulation and development of lactic acidosis (accumulation of lactic acid in the body). Since the use of Ultravist may cause renal impairment or worsen existing renal function, patients on metformin may have an increased risk of developing lactic acidosis, particularly those with pre-existing renal impairment. Based on renal function measurements, discontinuation of metformin should be considered.
Neuroleptics (medications commonly used to treat psychosis), analgesics (pain-relieving medications), antiemetics (drugs that prevent nausea or vomiting), antihistamines (medications for allergic rhinitis or dermatitis), and sedatives (tranquilizers). Use of these medications may reduce your seizure threshold and thus increase the risk of contrast medium-related reactions. Therapy with these drugs should be discontinued 48 hours before contrast administration and not resumed until at least 12 hours after the procedure.
Beta-blockers, as hypersensitivity reactions may be exacerbated, especially in patients with allergic predisposition, bronchial asthma, or a history of allergy to other contrast media. Additionally, standard treatment with beta-agonists may not be effective.
Interleukin-2, as previous treatment (up to several weeks) with interleukin-2 has been associated with an increased risk of delayed reactions to Ultravist.
Oral cholecystographic contrast agents: There is no evidence of interaction with renal-excreted contrast agents.
Diuretics: Due to the risk of diuretic-induced dehydration, your doctor should administer rehydration salts before administering iodinated contrast medium to minimize the risk of acute renal failure.
Interference with laboratory tests: Iodinated contrast media may interfere with thyroid function tests, as the thyroid's ability to bind iodine may be reduced for several weeks.
Radiopharmaceuticals: If you are scheduled for diagnostic or therapeutic procedures involving radioisotopes for thyroid disease, these should be delayed for several weeks after Ultravist administration due to reduced radioisotope uptake.

Use of Ultravist with food and drink

You may maintain a normal diet up to two hours before the examination. During the 2 hours prior to the study, you must refrain from eating.

Pregnancy and Lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Well-controlled studies in pregnant women have not been conducted.

Following diagnostic administration of Ultravist in humans, animal studies have not indicated harmful effects on pregnancy, embryonal/fetal development, delivery, or postnatal development.

The risk-benefit ratio should be carefully evaluated before administering an iodinated contrast agent, considering the fetal thyroid sensitivity to iodine, since acute iodine overload following administration of an iodinated contrast agent to the mother may cause fetal thyroid dysfunction.

The safety of Ultravist in women who are breastfeeding has not been investigated. Contrast media are excreted in breast milk in minimal amounts. Harm to the breastfed infant is not expected.

Driving and Use of Machines

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

Ultravist contains Sodium

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

3. How to use Ultravist

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Ultravist is a contrast medium used to perform a diagnostic test, which should be carried out in the presence of qualified personnel, preferably under the supervision of a physician, who will guide you through each step.

Before administering the contrast medium via intra-arterial, intravenous, or intrathecal route, your doctor must rule out possible renal dysfunction through clinical history and/or laboratory tests.

Dosage in adults

The recommended doses in adults are as follows:

Indication	Recommended Dose (single injection)	Total Maximum Dose
Peripheral Venography	Intra-arterial or intravenous administration
upper limbs	50 – 60 ml	1.5 g I per kg body weight
lower limbs	50 – 80 ml	1.5 g I per kg body weight
Digital Subtraction Angiography (DSA)
intravenous	40 – 70 ml	1.5 g I per kg body weight
Flow rate: 8–12 ml/sec in the cubital vein; 10–20 ml/sec in the vena cava only for visualization of large trunk vessels. The amount of contrast medium in the veins can be reduced and still provide diagnostic images by immediately administering an isotonic saline bolus thereafter.
intra-arterial	3 – 30 ml	1.5 g I per kg body weight
In intra-arterial DSA, smaller volumes and lower iodine concentrations are sufficient compared to the intravenous technique. The more selective the angiography, the lower the required contrast dose. Therefore, this method is recommended for patients with impaired renal function.
Computed Tomography (CT)
cranial	1.5 – 2.5 ml/kg body weight	1.5 g I per kg body weight
whole body	1.5 – 2.5 ml/kg body weight	1.5 g I per kg body weight
The required doses of contrast medium and their administration rates depend on the organ being studied, the diagnostic question, and especially on the various scanning and image reconstruction times of the scanners used.
Intravenous Urography	0.3 g I/kg body weight = 1.3 ml/kg body weight	1.5 g I per kg body weight
The recommended dose may be increased in obese patients or in patients with impaired renal function, if considered necessary.
Lumbar, thoracic, and cervical myelography	Up to 12.5 ml	3 g I (12.5 ml) per procedure	Administration via intrathecal route. Repeated use is not authorized for this indication.
Smaller doses are often sufficient when equipment is available that allows imaging in all necessary projections without moving the patient and when contrast administration can be performed under fluoroscopic control. The dose of 3 g of iodine per procedure must not be exceeded.
Arthrography	3 – 15 ml	15 ml	Administration via intra-articular route. Repeated use is not authorized for this indication.
Hysterosalpingography	10 – 25 ml	25 ml	Administration via intrauterine route. Repeated use is not authorized for this indication.

Dosage in special populations

Elderly patients (population over 65 years of age):

Dose adjustment is not required.

Pediatric population (under 18 years of age):

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

Immature pediatric kidneys require relatively higher doses of the contrast medium for intravenous urography compared to other indications, as indicated in the table below:

Indication	Pediatric population	Recommended dose (single injection)	Route of administration
Intravenous Urography	Neonates (less than 1 month)	1.2 g I/kg.b.w. = 5.0 ml/kg.b.w.	Intravenous administration
Infants (between 1 month and 2 years)	1.0 g I/kg.b.w. = 4.2 ml/kg.b.w.
Young children (between 2 and 11 years)	0.5 g I/kg.b.w. = 2.1 ml/kg.b.w.
Pediatric population from 11 to 18 years	0.3 g I/kg.b.w. = 1.3 ml/kg.b.w.
Computed Tomography (CT)	from 0–18 years	Depending on age, weight, and pathology. Recommended dose: 2–3 ml/kg.b.w. In extreme cases, a maximum volume of 125 ml may be administered.	Intravenous administration
Digital Subtraction Angiography (DSA)	from 0–18 years	Depending on age, weight, and pathology. Children 28 days and younger: maximum volume: 4 ml/kg.b.w. Children 29 days and older: maximum volume: 6 ml/kg.b.w.	Intravenous and intraarterial administration
Phlebography	from 0–18 years	Depending on age, weight, and pathology. Maximum volume: 3 ml/kg.b.w.	Intravenous administration

Infants under 1 year of age, and especially newborns, are susceptible to disturbances in both blood dynamics and electrolyte balance. Caution must be exercised regarding the dose of contrast medium to be administered, the technical performance of the radiological procedure, and the patient's general condition.

Recommended doses in neonates, infants, young children, and pediatric patients aged 11 to 18 years must not be exceeded.

Patients with hepatic impairment:

Dosage adjustment is not required (see section 2).

Patients with renal impairment:

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

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

Your doctor will provide you with information on all characteristics related to the administration of Ultravist.

If you use more Ultravist than you should

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

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

In case of accidental intra-arterial or intravenous overdose, monitoring of hydroelectrolytic balance and renal function is recommended. Treatment of overdose should focus on maintaining vital functions. Loss of water and electrolytes should be compensated by infusion. Renal function should be monitored for at least 3 days following the procedure. If necessary, hemodialysis may be used to remove most of the contrast medium from the body.

Ultravist is dialyzable.

Intrathecal use (into the space surrounding the spinal cord)

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

You must be closely monitored for the first 12 hours to detect signs of serious CNS impairment. These signs may include ascending hyperreflexia (exaggerated reflexes) or tonic-clonic spasms, and in severe cases, cerebral involvement with generalized seizures, hyperthermia (elevated body temperature above normal), stupor (partial unconsciousness), and respiratory depression. To prevent large amounts of Ultravist from reaching the cerebral cisterns, contrast medium should be aspirated as completely as possible.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

The most frequently observed adverse reactions in patients receiving Ultravist are headache, nausea, and dilation of blood vessels.

The most serious adverse reactions observed in patients receiving Ultravist are anaphylactic shock, respiratory arrest, bronchial constriction or obstruction, fluid accumulation in the larynx and pharynx, asthma, coma, cerebral infarction, stroke, fluid accumulation in the brain, convulsions, abnormal heart rhythms, cardiac arrest, myocardial ischemia, myocardial infarction, heart failure, decreased heart rate, bluish discoloration of the skin and mucous membranes, low blood pressure, shock, difficulty breathing, pulmonary edema, respiratory failure, and aspiration.

All indications

Frequent adverse effects (may affect between 1 and 10 out of 100 patients):

dizziness, headache, taste disturbances
- blurred vision, visual disturbances
- chest pain or discomfort
- high blood pressure, dilation of blood vessels
- vomiting, nausea
- pain, reactions at injection site (e.g., pain, and unknown frequency sensation of warmth, fluid accumulation, swelling, and injury), and sensation of warmth.

Uncommon adverse effects (may affect between 1 and 10 out of 1,000 patients):

allergic reactions (hypersensitivity/anaphylactoid reactions, e.g., fluid accumulation in the face, sneezing, cough, fluid accumulation in mucous membranes, hives, itching, rapid swelling of the skin and mucous membranes; unknown frequency and *: anaphylactic shock, respiratory arrest, and asthma; *: bronchial constriction or obstruction, fluid accumulation in larynx or pharynx; unknown frequency: fluid accumulation in the tongue, pharyngeal or laryngeal spasm, conjunctivitis, lacrimation, rhinitis, hoarseness, and throat irritation)
fainting, confusion, restlessness, sensory disturbances, decreased sensitivity, drowsiness
abnormal heart rhythms (arrhythmias, *)
low blood pressure (*)
difficulty breathing (*)
abdominal pain
fluid accumulation (edema)

Rare adverse effects (may affect between 1 and 10 out of 10,000 patients):

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

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

thyrotoxic crisis (acute worsening of thyroid gland function), thyroid disorder
coma (*), cerebral ischemia or cerebral infarction (*), stroke (*), fluid accumulation in the brain (*, 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-induced encephalopathy
hearing disorders
myocardial infarction (*), heart failure (*), decreased heart rate (*), increased heart rate, bluish discoloration of the skin and mucous membranes (*)
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 (*)
difficulty breathing, enlargement of salivary glands, 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 (DRESS)
compartment syndrome in case of extravasation (only with intra-arterial or intravenous administration)
renal failure (only with intra-arterial or intravenous administration), acute kidney injury (only with intra-arterial or intravenous administration)
general malaise, chills, pallor
fluctuations in body temperature

* Cases reported that were life-threatening.

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

Reddish patches on the trunk, often target-shaped or circular macules, frequently with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may 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).
Generalized, scaly red rash with bumps under the skin and blisters accompanied by fever after imaging procedure (acute generalized exanthematous pustulosis).

Transient brain disorder (encephalopathy) that may cause memory loss, confusion, hallucinations, vision problems, vision loss, seizures, loss of coordination, hemiplegia (loss of movement on one side of the body), speech difficulties, 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 following myelography or use of contrast medium in body cavities occur several 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 previously listed side effects: psychosis, neuralgias, paraplegia, aseptic meningitis, back pain, limb pain, urinary difficulties, abnormal electroencephalogram.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Class effects

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or radiologist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 from light and X-rays.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP.

Ultravist is supplied as a clear, colourless to pale yellow solution for immediate use. Do not use Ultravist if you notice significant changes in colour, the appearance of particles in suspension, or if the container is damaged.

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

6. Contents of the container and other information

Composition of Ultravist 240

The active substance 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 sodium edetate, tromethamine, hydrochloric acid (10% diluted) (to adjust pH), sodium hydroxide (to adjust pH), and
water for injections.

Presentation of the product and contents of the container

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

Pack sizes: 1 vial or 1 bottle.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 carton 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 most recent review of this summary: September 2023

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

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

Before injection

Ultravist must be warmed to body temperature prior to administration.

The contrast medium should be inspected visually before use and must not be administered if there is any change in colour, presence of particles in suspension (including crystals), or if the container is damaged.

Handling

Vials/Bottles (≤ 50 ml)

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

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

Any unused contrast medium remaining after administration to a patient must be discarded. Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.

Large-volume containers (500 ml, for intra-arterial or intravenous administration only)

Multiple withdrawals of the contrast medium must be performed using equipment authorized for multiple administration. Auto-injectors/pumps must not be used in young children.

The rubber stopper of the bottle must not be punctured more than once to avoid introducing large quantities of microparticles from the stopper into the solution.

The contrast medium must be administered using an automated injector or another approved method that ensures sterility of the contrast medium.

The patient tubing from the injector to the patient (patient tubing) must be replaced for each patient to prevent possible contamination.

Connecting tubes and all disposable parts of the injection system must be discarded when the infusion bottle is empty.

Any remaining contrast medium solution in the bottle, connecting tubes, or any other part of the disposable injection system components must 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.

Contrast medium remaining in the opened Ultravist container must be discarded 10 hours after the container has been opened. Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.