Ultravist® (Solution) Instructions for Use
ATC Code
V08AB05 (Iopromide)
Active Substance
Iopromide (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Radiocontrast non-ionic diagnostic agent for intravascular, intracavitary and subarachnoid administration
Pharmacotherapeutic Group
Contrast agents; X-ray contrast agents containing iodine; water-soluble nephrotropic low-osmolar X-ray contrast agents
Pharmacological Action
X-ray contrast diagnostic non-ionic monomeric agent. Iopromide contains approximately 48.1% iodine. It has low osmolality. Due to the presence of stably bound iodine, it absorbs X-rays and provides a high degree of opacity of the objects under study.
Pharmacokinetics
After IV administration, the plasma concentration of iopromide decreases very rapidly due to its distribution in the interstitial space and subsequent elimination. The total Vd at steady state is about 16 L, which approximately corresponds to the volume of the extracellular space.
Binding to plasma proteins is insignificant (about 1%). Iopromide cannot penetrate the intact blood-brain barrier but passes through the placental barrier in small amounts.
Within 1-5 minutes after a bolus IV injection of iopromide containing 300 mg iodine, 28±6% of the administered amount is detected in 1 ml of blood plasma, regardless of the dose. After administration into the meninges, maximum plasma iodine concentrations of 4.5% of the administered dose were observed after 3.8 hours. After administration into the biliary and/or pancreatic duct during endoscopic retrograde cholangiopancreatography (ERCP), iodine-containing radiocontrast agents are absorbed, reaching peak plasma concentration 1 and 4 hours after administration. After administration of 7.3 g of iodine, its Cmax in blood serum is approximately 40 times lower compared to the maximum levels that occur after IV administration of a similar dose.
Iopromide is not metabolized.
The elimination of iopromide in patients in the terminal phase is characterized by a T1/2 of approximately 2 hours, regardless of the dose.
In the studied doses, the total clearance of iopromide was 106±12 ml/min, which is similar to the renal clearance value of 102±15 ml/min. Consequently, Iopromide is almost completely eliminated by the kidneys. Only about 2% of the administered dose is excreted through the intestine within 3 days. About 60% of the administered dose is excreted by the kidneys 3 hours after IV administration. After 12 hours, >93% of the total dose is excreted. Iopromide is almost completely excreted within 24 hours.
After administration into the biliary and/or pancreatic duct during ERCP, serum iodine concentrations return to baseline after 7 days.
Indications
For image contrast enhancement during computed tomography (CT), for arteriography and venography, including intravenous/intraarterial digital subtraction angiography (DSA), for intravenous urography, for endoscopic retrograde cholangiopancreatography (ERCP), for arthrography and examinations of other body cavities.
ICD codes
| ICD-10 code | Indication |
| Z03 | Medical observation and evaluation for suspected disease or pathological condition |
| ICD-11 code | Indication |
| QA02 | Medical observation or examination for suspected diseases or conditions that were ruled out |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Determine the dose, concentration, and route of administration based on the specific diagnostic procedure, patient’s age, body weight, and clinical condition.
For computed tomography (CT), administer intravenously. Use 50-150 ml for body CT and 50-100 ml for cranial CT of a solution containing 300 mg iodine/ml. Adjust the volume based on the examination area and diagnostic requirements.
For arteriography, administer intra-arterially. Use 5-40 ml per injection for selective vessels and 40-80 ml for the aortic arch. For venography, administer 30-100 ml intravenously. Utilize solutions with 240-370 mg iodine/ml concentration.
For intravenous urography, administer 50-100 ml of a solution containing 300-370 mg iodine/ml. Inject at a rate of 1 ml/sec.
For digital subtraction angiography (DSA), administer intra-arterially or intravenously. Use 5-40 ml for intra-arterial and 30-80 ml for intravenous routes. Repeat injections as necessary.
For endoscopic retrograde cholangiopancreatography (ERCP), administer 10-40 ml into the biliary/pancreatic duct. Use a solution containing 240-370 mg iodine/ml.
For arthrography and other body cavity examinations, administer the volume required for adequate cavity distention and visualization. Typical doses range from 5-20 ml.
In pediatric patients, calculate the dose based on body weight. Do not exceed the recommended adult dose. For neonates and infants, pay special attention to hemodynamic stability and hydration status.
In patients with renal impairment, use the lowest effective dose. Ensure adequate hydration before and after administration to minimize nephrotoxicity risk.
For all procedures, inject at body temperature. Monitor the patient closely during and after administration for signs of hypersensitivity or adverse reactions.
Adverse Reactions
From the immune system uncommon – hypersensitivity reactions/anaphylactoid reactions (anaphylactic shock, respiratory arrest, bronchospasm, laryngeal/pharyngeal edema, facial edema, tongue edema, laryngeal/pharyngeal spasm, bronchial asthma, conjunctivitis, lacrimation, sneezing, cough, mucosal edema, rhinitis, hoarseness, sore throat, urticaria, itching, angioedema).
From the endocrine system frequency unknown – thyrotoxic crisis, thyroid dysfunction.
From the nervous system very common – dizziness, headache, dysgeusia; uncommon – vasovagal reactions, confusion, restlessness, paresthesia, hypoesthesia, drowsiness; rare – anxiety; frequency unknown – coma, cerebral ischemia/infarction, stroke, cerebral edema (only with intravascular administration), seizures, transient cortical blindness (only with intravascular administration), loss of consciousness, agitation, amnesia, tremor, speech disorders, paresis/paralysis.
From the organ of vision very common – blurred vision, visual impairment.
From the organ of hearing frequency unknown – hearing impairment.
From the cardiovascular system: very common – chest pain/discomfort, increased BP, vasodilation; uncommon – decreased BP, arrhythmia; rare – cardiac arrest, myocardial ischemia, palpitations; frequency unknown – myocardial infarction, heart failure, bradycardia, tachycardia, cyanosis, shock, thromboembolism, vasospasm.
From the respiratory system uncommon – dyspnea; frequency unknown – pulmonary edema, respiratory failure, aspiration.
From the digestive system very common – nausea, vomiting; uncommon – abdominal pain; frequency unknown – dysphagia, salivary gland enlargement, diarrhea.
From the skin and subcutaneous tissues: frequency unknown – bullous skin diseases (including Stevens-Johnson syndrome or Lyell’s syndrome), rash, erythema, hyperhidrosis.
From the musculoskeletal system frequency unknown – compartment syndrome (in case of extravasation – only with intravascular administration).
From the urinary system frequency unknown – renal function disorders (only with intravascular administration), acute renal failure (only with intravascular administration).
Allergic reactions itching, urticaria, sneezing, lacrimation, difficulty breathing, skin redness.
General reactions frequency unknown – malaise, chills, pallor.
Local reactions rare – pain, warmth sensation, swelling, inflammation and soft tissue damage at the injection site; uncommon – edema.
Contraindications
Hypersensitivity to iopromide and iodine preparations; intrathecal route of administration.
With caution in case of thyroid dysfunction, history of allergy, bronchospasm or other adverse reactions when using iodine-containing radiocontrast agents, history of bronchial asthma or other allergic diseases, in patients in a state of severe agitation, restlessness or anxiety; in case of intravascular administration in the presence of renal failure, dehydration, diabetes mellitus, multiple myeloma/paraproteinemia; when using repeated and/or large doses of iopromide; in severe heart disease or significant coronary artery lesions, heart failure; CNS diseases in which the seizure threshold is lowered, or in the presence of factors that increase the permeability of the BBB; pheochromocytoma, myasthenia gravis.
Use in Pregnancy and Lactation
During pregnancy, should be used only in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.
If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.
Use in Hepatic Impairment
Use with caution in severe liver dysfunction.
Use in Renal Impairment
Should be used with caution in patients with renal failure.
Pediatric Use
Can be used in children according to indications in doses recommended according to age and body weight.
Children under 1 year of age, especially newborns, are sensitive to disturbances in water-electrolyte balance and hemodynamic disorders. Special attention should be paid to the dose of the radiocontrast agent, the technical support of the radiological examination, and the patient’s condition.
Geriatric Use
Should be used with caution in elderly patients.
Special Precautions
Due to the possibility of developing severe hypersensitivity reactions after the administration of iopromide, it is necessary to monitor the patient’s condition after the end of the procedure; if necessary, emergency care should be provided to the patient. Consider premedication with corticosteroids for patients with bronchial asthma or other allergic diseases.
The risk/benefit ratio should be weighed especially carefully in patients with established or suspected hyperthyroidism, since iodine-containing radiocontrast agents can cause hyperthyroidism or thyrotoxic crisis in them. Thyroid function should be assessed before iopromide administration and/or prophylactic thyrostatic therapy should be prescribed in patients with established or suspected hyperthyroidism.
In newborns, especially premature infants, whose mothers received Iopromide during pregnancy or after childbirth, it is recommended to monitor thyroid function, since exposure to excess iodine can cause hypothyroidism, which may require treatment.
Patients with CNS diseases have an increased risk of neurological complications associated with the administration of iopromide. Caution should be exercised in situations where a lowered seizure threshold may occur, such as a history of seizures and concomitant use of certain medications. Factors that increase the permeability of the BBB facilitate the penetration of the radiocontrast agent into the brain tissue, which can cause CNS reactions.
Before and after intravascular administration of iopromide, adequate hydration should be ensured to minimize the risk of contrast-induced nephrotoxicity. This is especially important for patients with multiple myeloma, diabetes mellitus, polyuria, oliguria, hyperuricemia, as well as for newborns, infants, young children and elderly patients.
If the patient has feelings of anxiety, anxiety and pain, the risk of developing the intensity of side undesirable reactions caused by the radiocontrast agent may increase. If necessary, drug therapy is used to reduce anxiety.
To reduce nephrotoxicity, adequate hydration should be ensured in all patients when administering iopromide. Risk factors include, for example, renal failure; dehydration; diabetes mellitus; multiple myeloma/paraproteinemia; repeated and/or large doses of iopromide.
In patients with severe heart disease or significant coronary artery lesions, there is an increased risk of developing clinically significant hemodynamic changes and arrhythmia.
Administration of an iodine-containing radiocontrast agent may increase the severity of myasthenia gravis symptoms.
Effect on ability to drive vehicles and mechanisms
Within 24 hours after the examination with iopromide, patients should avoid driving vehicles and other activities requiring high concentration and speed of psychomotor reactions.
Drug Interactions
Biguanides (metformin): in patients with renal failure or severe chronic kidney disease, the elimination of biguanides may be reduced, leading to their accumulation and the development of lactic acidosis. Since the use of iopromide may increase the risk of developing or worsening acute renal failure, patients taking metformin may have an increased risk of developing lactic acidosis, especially if there is a history of acute renal failure.
Beta-blockers: it should be taken into account that patients taking beta-blockers may be resistant to the treatment of hypersensitivity reactions to drugs with beta-adrenomimetic action.
Drugs that lower the seizure threshold: simultaneous use with iopromide may lead to an increased risk of neurological complications.
Interleukin-2: with prior treatment with interleukin-2 (for several weeks), the risk of developing delayed reactions upon administration of iopromide increases.
Effect on diagnostic tests. Radioisotopes: for several weeks after the administration of iopromide, the absorption of thyrotropic isotopes by the thyroid gland decreases, which reduces their effectiveness for the diagnosis and treatment of thyroid diseases.
Storage Conditions
Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for injection 623 mg/1 ml (300 mg iodine/1 ml): fl. 10 ml, 20 ml, 50 ml, 100 ml or 200 ml 10 pcs., fl. 500 ml 8 pcs., cartridges 100 ml or 150 ml 10 pcs.
Marketing Authorization Holder
Bayer, AG (Germany)
Dosage Form
 |
Ultravist® | Solution for injection 623 mg/1 ml (300 mg iodine/1 ml): fl. 10 ml, 20 ml, 50 ml, 100 ml or 200 ml 10 pcs., fl. 500 ml 8 pcs., cartridges 100 ml or 150 ml 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, free of foreign particles.
| 1 ml | |
| Iopromide | 623 mg, |
| Equivalent to iodine content | 300 mg |
| Osmolality at 37°C (98.6°F) – 0.59 osmol/kg H2O Viscosity at 20°C (68°F) – 8.9 mPa×s, at 37°C (98.6°F) – 4.7 mPa×s Density at 20°C (68°F) – 1.328 g/ml, at 37°C (98.6°F) – 1.322 g/ml PH value 6.5-8.0 |
|
Excipients : sodium calcium edetate 100 mcg, trometamol 2.42 mg, hydrochloric acid 10% 5.6 mg, water for injections 696.78 mg.
10 ml – glass bottles (10) – cardboard boxes.
20 ml – glass bottles (10) – cardboard boxes.
50 ml – glass bottles (10) – cardboard boxes.
100 ml – glass bottles (10) – cardboard boxes.
200 ml – glass bottles (10) – cardboard boxes.
500 ml – glass bottles (8) – cardboard boxes.
100 ml – plastic cartridges (5) – cardboard packages (2) – cardboard boxes.
150 ml – plastic cartridges (5) – cardboard packages (2) – cardboard boxes.
Solution for injection 769 mg/1 ml (370 mg iodine/1 ml): fl. 30 ml, 50 ml, 100 ml or 200 ml 10 pcs., fl. 500 ml 8 pcs., cartridges 100 ml or 150 ml 10 pcs.
Marketing Authorization Holder
Bayer, AG (Germany)
Dosage Form
|
Ultravist® | Solution for injection 769 mg/1 ml (370 mg iodine/1 ml): fl. 30 ml, 50 ml, 100 ml or 200 ml 10 pcs., fl. 500 ml 8 pcs., cartridges 100 ml or 150 ml 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, free of foreign particles.
| 1 ml | |
| Iopromide | 769 mg, |
| Equivalent to iodine content | 370 mg |
| Osmolality at 37°C (98.6°F) – 0.77 osmol/kg H2O Viscosity at 20°C (68°F) – 22 mPa×s, at 37°C (98.6°F) – 10 mPa×s Density at 20°C (68°F) – 1.409 g/ml, at 37°C (98.6°F) – 1.399 g/ml PH value 6.5-8.0 |
|
Excipients : sodium calcium edetate 100 mcg, trometamol 2.42 mg, hydrochloric acid 10% 5.6 mg, water for injections 628.72 mg.
30 ml – glass bottles (10) – cardboard boxes.
50 ml – glass bottles (10) – cardboard boxes.
100 ml – glass bottles (10) – cardboard boxes.
200 ml – glass bottles (10) – cardboard boxes.
500 ml – glass bottles (8) – cardboard boxes.
100 ml – plastic cartridges (5) – cardboard packages (2) – cardboard boxes.
150 ml – plastic cartridges (5) – cardboard packages (2) – cardboard boxes.
Solution for injection 499 mg/1 ml (240 mg iodine/1 ml): fl. 10 ml or 50 ml 10 pcs.
Marketing Authorization Holder
Bayer, AG (Germany)
Dosage Form
|
Ultravist® | Solution for injection 499 mg/1 ml (240 mg iodine/1 ml): fl. 10 ml or 50 ml 10 pcs. |
Dosage Form, Packaging, and Composition
Solution for injection transparent, free of foreign particles.
| 1 ml | |
| Iopromide | 499 mg, |
| Equivalent to iodine content | 240 mg |
| Osmolality at 37°C (98.6°F) – 0.48 osmol/kg H2O Viscosity at 20°C (68°F) – 4.9 mPa×s, at 37°C (98.6°F) – 2.8 mPa×s Density at 20°C (68°F) – 1.263 g/ml, at 37°C (98.6°F) – 1.255 g/ml PH value 6.5-8.0 |
|
Excipients : sodium calcium edetate – 100 mcg, trometamol – 2.42 mg, hydrochloric acid 10% – 5.6 mg, water for injections – 755.46 mg.
10 ml – glass bottles (10) – cardboard boxes.
50 ml – glass bottles (10) – cardboard boxes.
![Ultravist® [Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Ultravist® [Solution] 2")