Ultravist® (Ultravist®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceYopromideYopromide
Similar drugsTo uncover
  • Yopromide
    solution for injections 
    JODAS EKSPOIM, LLC     Russia
  • Yopromide TP
    solution for injections 
    Tiarex, LLC     Russia
  • Yopromide-Biarvist
    solution for injections 
    ALVILS, LTD.     Russia
  • Yopromide-TL
    solution for injections 
    TECHNOLOGY OF DRUGS, LTD.     Russia
  • Ultravist®
    solution for injections 
    Bayer AG     Germany
    • Dosage form: & nbspinjection
    Composition:

    Active substance:

    Solution for injection 240 mg iodine / ml: in 1 ml contains 499 mg of iopromide (equivalent to 240 mg of iodine)

    Solution for injection 300 mg iodine / ml: in 1 ml contains 623 mg of iopromide (equivalent to 300 mg of iodine)

    Solution for injection 370 mg iodine / ml: in 1 ml contains 769 mg of iopromide (equivalent to 370 mg of iodine) in an aqueous solution.

    Excipients:

    sodium calcium edetate 0.1 mg, trometamol 2.42 mg, hydrochloric acid 10% 5.6 mg, water for injection 755.46 / 696.78 / 628.72 mg

    Description:

    Transparent, foreign matter-free solution.

    Pharmacotherapeutic group:radiopaque
    ATX: & nbsp

    V.08.A.B   Water-soluble low-osmolarity radiopaque substances for the study of the kidneys

    Pharmacodynamics:

    Physico-chemical characteristics of Ultravist® depending on the concentration are given below:

    Concentration of iodine (mg / ml)

    240

    300

    370

    Osmolality

    (osm / kg H2О) at a temperature of 37 ° С

    0,48

    0,59

    0,77

    Viscosity (mPa * s)

    at a temperature of 20 ° C

    4,9

    8,9

    22,0

    at a temperature of 37 ° C

    2,8

    4,7

    10,0

    Density (g / ml)

    at a temperature of 20 ° C

    1,263

    1,328

    1,409

    at a temperature of 37 ° C

    1,255

    1,322

    1,399

    The pH values

    6,5-8,0

    6,5-8,0

    6,5-8,0

    Pharmacodynamics

    Yopromide (molecular weight 791.12) is a nonionic, water-soluble triiodinated radiocontrast agent (a derivative of triiodizophthalic acid), which increases the contrast of the image due to the absorption of X-rays by iodine included in its composition.

    Pharmacokinetics:

    Distribution

    After intravenous administration of the drug Ultravist®, the concentration of iopromide in plasma decreases very rapidly due to its distribution in the intercellular space and subsequent elimination. The total volume of distribution in the equilibrium state is about 16 liters, which roughly corresponds to the volume of the extracellular space.

    The connection with plasma proteins is insignificant (about 1%). The drug Ultravist® can not penetrate through the intact blood-brain barrier, but in a small amount passes through the placental barrier (≤ 0.3% of the administered dose in rabbits).

    1-5 minutes after the bolus intravenous injection of the UltraVista® preparation containing 300 mg of iodine, 28 ± 6% of its administered amount is detected in 1 ml of plasma, regardless of the dose.After insertion under the membranes of the brain, maximum plasma iodine concentrations of 4.5% of the administered dose were observed after 3.8 hours. After administration to the bile and / or pancreatic duct during endoscopic retrograde cholangiopancreatography (ERCP), iodine-containing radiopaque agents are absorbed, reaching a peak concentration in the blood plasma at 1 and 4 hours after administration. After the administration of 7.3 g iodine, its maximum serum concentration is about 40 times lower than the maximum levels that occur after intravenous administration of a similar dose.

    Metabolism

    Yopromide is not metabolized.

    Excretion

    Yopromide excretion in patients in the final phase is characterized by a half-life of about 2 hours, regardless of the dose.

    In the doses studied, the total clearance of iopromide was 106 ± 12 ml / min, which is similar to the magnitude of renal clearance of 102 ± 15 ml / min. Consequently, iopromide almost completely excreted by the kidneys. Only about 2% of the administered dose is released through the intestine within 3 days. After 3 hours after intravenous injection, about 60% of the administered dose is excreted by the kidneys.After 12 hours, ≥ 93% of the total dose is released. Almost completely iopromide excreted in 24 hours.

    After intrathecal administration with lumbar myelography iopromide Eliminates from plasma to the final phase with a half-life of 14.9 ± 17 hours. After 72 hours approximately 80% of the total amount of iopromide is excreted by the kidneys. After introduction into the bile and / or pancreatic duct during ERCPH concentration of iodine in the serum return to the baseline level after 7 days.

    Additional information for specific patient groups

    Elderly age (over 65 years)

    The total plasma clearance in patients of middle age (from 49 to 64 years) without clinically significant decrease in kidney function is 74 - 114 ml / min (average 102 ml / min), in elderly patients (65 to 70 years) without clinically significant decrease kidney function, this indicator is 72-100 ml / min (an average of 89 ml / min). These values ​​are only slightly lower than in young healthy individuals 88-138 ml / min (average 106 ml / min). Individual values ​​of the half-life were in the interval 1.9-2.9 hours and 1.5-2.7 hours, respectively. When compared with an interval of 1.4-2.1 hours in young healthy volunteers, the terminal half-lives were similar.Small differences correspond to a physiological decrease in the rate of glomerular filtration with age.

    Childhood

    The pharmacokinetics of yopromide has not been studied in this age group (see the section "Dosing and Administration").

    Patients with impaired renal function

    In patients with impaired renal function, the half-life of yopromide from plasma is increased due to a decrease in the rate of glomerular filtration.

    Plasma clearance was reduced to 49.4 ml / min / 1.73 m2 (CI = 53%) in patients with mild to moderate renal dysfunction (80> CLCR > 30 ml / min / 1.73 m2) and up to 18.1 ml / min / 1.73 m2 (CI = 30%) in patients with severe renal dysfunction not on dialysis (CLCR = 30-10 ml / min / 1.73 m2).

    The average terminal half-life is 6.1 hours (CI = 43%) in patients with mild to moderate renal dysfunction (80> CLCR > 30 ml / min / 1.73 m2) and 11.6 hours (CI = 49%) in patients with severe renal dysfunction not on dialysis (CLCR = 30-10 ml / min / 1.73 m2).

    The amount of drug excreted in urine within 6 hours after dosing was 38% in patients with mild to moderate renal impairment and 26% in patients with severe renal impairment compared with more than 83% in healthy volunteers.Within 24 hours after dosing, the detected amount reached 60% in patients with mild to moderate renal impairment and 51% in patients with severe renal dysfunction, compared with more than 95% in healthy volunteers.

    Yopromide can be excreted by hemodialysis. Approximately 60% of the dose of yopromide is removed during 3-hour dialysis.

    Indications:

    The drug Ultravist® is intended exclusively for diagnostic purposes.

    Ultravist® is indicated to enhance image contrast in CT, arteriography and venography, including intravenous / intra-arterial digital subtraction angiography (CSA); intravenous urography, endoscopic retrograde cholangiopancreatography (ERCP); arthrography and examination of other body cavities.
    The drug Ultravist®, containing a solution for injection 370 mg iodine / ml, has special advantages in the conduct of angiocardiography.
    The drug Ultravist®, containing 240/300/370 mg iodine / ml, is intended for intravascular administration and administration to the body cavity, a solution containing 240 mg iodine / ml can also be used for intrathecal administration.
    Injection solutions containing 300 mg iodine / ml and 370 mg iodine / ml, is not recommended for intrathecal administration.
    Contraindications:

    Hypersensitivity to iopromide, iodine preparations or other auxiliary component of the drug.

    Carefully:

    Thyroid gland disorders.

    With intravascular injection:
    - kidney failure;
    - dehydration;

    - diabetes;

    - multiple myeloma / paraproteinaemia;

    - use of repeated and / or large doses of Ultravist®;

    - severe heart disease or severe coronary artery disease;

    - heart failure;

    - diseases of the CNS, in which the threshold of convulsive activity decreases or in the presence of factors that increase the permeability of the blood-brain barrier;

    - pheochromocytoma;

    - myasthenia gravis gravis.

    When intrathecal administration:

    - cramps in the anamnesis.

    Pregnancy and lactation:

    Appropriate, well-controlled studies in pregnant women have not been conducted. During pregnancy, X-ray studies should be avoided whenever possible. The drug should not be used in pregnant women, except when the intended benefit to the mother from its use exceeds the potential risk to the fetus, and such a study is appointed by the doctor, as necessary.At the same time, the results of the animal study indicate that there is no danger of using iopromide with a diagnostic purpose in people regarding the course of pregnancy, embryo / fetus development, childbirth and postnatal development.

    The safety of Ultravist® in infants who are breastfed has not been studied. Excretion of Ultravist® with breast milk is insignificant, and it is unlikely that it would pose a risk to infants. If it is necessary to administer the drug, the mother should stop breastfeeding for at least 24 hours after the test.

    Dosing and Administration:

    General information

    Before use, the Ultravist® preparation should be heated to body temperature. Before administration, you should carefully inspect the bottle. If the integrity of the vial is violated, a significant change in color, the detection of visible particles (including crystals), the drug should not be used. Because Ultravist® is a highly concentrated solution, it can crystallize (the appearance of milk-like turbidity and / or sediment or crystals in the form of suspended matter), which is very rare.

    For the introduction of a radiopaque solution, it is necessary to use an automatic injector or other special instruments with preservation of sterility. The preparation of Ultravist® in a syringe or infusomat should be taken immediately before administration.

    Do not make more than one puncture of the rubber stopper in order to prevent a large number of microparticles from entering the prepared solution from the plug. To puncture a rubber plug and a set of radiopaque means, it is recommended to use cannulas with long tips with a diameter of no more than 18 G (best suited are marked cannulae with a lateral opening of the type Nocore-Admix).

    The solution of the drug unused after opening the vial should be destroyed. Vials containing 200 and 500 ml of the drug should be used only for intravascular injection. For the introduction it is necessary to use an automatic injector or other equipment that provides sterility of the drug. Follow the instructions for using an automatic injector or other equipment. Unused after opening the bottle the drug can be applied within 10 hours after opening, then it should be destroyed.

    Cartridges should be used in accordance with the instructions supplied with the equipment for using cartridges. Unused solution from the cartridge after use should be destroyed.

    Doses for intravascular injection

    The intravascular injection of the radiopaque means, if possible, is best carried out while the patient is lying down.

    The dose of radiopaque means should correspond to the age, body weight to be solved by the clinical problem and the research method. Doses given below should be considered only as recommended; they are the usual dose for an average adult person with a body weight of 70 kg. The dose is expressed in ml for a single injection or per kg of body weight.

    As a rule, doses up to 1.5 g of iodine per kg of body weight are well tolerated.

    Recommended doses for single injections

    Ordinary angiography

    Type of research

    Dosage of Ultravist®

    (concentration of iodine mg / ml)

    Dose, ml

    Angiography of the arch of the aorta

    300

    50-80

    Selective angiography

    300

    6-15

    Breast aortography

    300/370

    50-80

    Abdominal aortography

    300

    40-60

    Arteriography

    Upper limbs

    300

    8-12

    Lower limbs

    300

    20-30

    Angiocardiography:

    Ventricles of the heart

    370

    40-60

    Coronary angiography

    370

    5-8

    Venography

    Upper limbs

    240

    50-60

    300

    15-30

    Lower limbs

    240

    50-80

    300

    30-60

    Computed Tomography (CT)

    If possible, the Ultravist® drug should be injected into the vein as a bolus using an automatic injector. Only with slow scanning, about half the dose should be administered bolus, and the rest for 2-6 minutes to ensure a relatively constant concentration of the drug in the blood.

    Spiral CT and especially multilayer CT allows a large amount of data to be obtained with one breathing delay. To optimize the diagnostic effect of the intravenously administered bolus (80-150 ml of the Ultravist® injection for 300 mg iodine / ml) in the study area (peak, time and duration of contrast), it is recommended to use an automatic injector and monitor the time interval from the beginning of the introduction of radiopaque before scanning.

    Whole body CT

    The necessary doses of radiopaque means and the speed of their administration depend on the organ under examination, the diagnostic problem being solved and, in particular, on the differences in scanning and the duration of image reconstruction.

    CT of head

    Adults:

    Ultravist®, injection, 240 mg iodine / ml: 1.5-2.5 ml / kg.

    Ultravist®, injection, 300 mg iodine / ml: 1.0-2.0 ml / kg.

    Ultravist®, injection, 370 mg iodine / ml: 1.0-1.5 ml / kg.

    Intravenous urography

    In connection with the physiologically weak concentrating ability of immature kidney nephrons, children need relatively high doses of radiopaque.

    The following doses of Ultravist® are recommended

    Age

    Amount of iodine, g / kg body weight

    Dosage of Ultravist®, ml / kg body weight

    240 mg iodine / ml

    300 mg iodine / ml

    370 mg iodine / ml

    Newborns (up to 1 month)

    1,2

    5,0

    4,0

    3,2

    Young children from 1 month to 2 years

    1,0

    4,2

    3,0

    2,7

    Children from 2 to 12 years old

    0,5

    2,1

    1,5

    1,4

    Children over 12 years and adults

    0,3

    1,3

    1,0

    0,8

    If necessary, in some cases, adults may increase these doses.

    Snapshot Time

    The timing of the images after the administration of the drug Ultravist® 300 mg iodine / ml or 370 mg iodine / ml with a duration of 1-2 minutes (3-5 min in the case of the administration of the drug Ultravist® 240 mg iodine / ml) are for the kidney parenchyma 3-5 min (5-10 minutes in the case of the administration of the drug Ultravist® 240 mg iodine / ml), and for visualization of the renal pelvis and ureter system - 8-15 min (12-20 minutes in the case of administration of the Ultravist® preparation240 mg iodine / ml) after initiation of the administration of the radiopaque.

    The younger the patient, the earlier the picture is taken. Usually, you should take the first picture 2-3 minutes after the introduction of radiopaque. In newborns, children under 2 years and patients with impaired renal function, imaging at a later date may improve the visualization of the urinary tract.

    Doses for intrathecal injection

    Adults:

    Dosages can depend to a large extent on the clinical problem being solved, the method and the field of examination.

    If there is equipment that allows recording the image in all projections without changing the position of the patient's body, and with the introduction of radiopaque means under fluoroscopic control, smaller volumes of the diagnostic drug may be sufficient.

    Recommended dose for individual studies

    Myelography

    The amount of the drug Ultravist® 240 mg iodine / ml is up to 12.5 ml.

    Usually the dose of Ultravist® 240 mg iodine / ml is 3 g iodine (12.5 ml), and it should not be exceeded for one study.

    Important: the more the patient moves or strains after the administration of the drug, the faster the radiocontrast is mixed with the liquid from other areas of no interest.Because of this, the contrast density decreases faster than usual.

    After the examination, the radiopaque should be directed to the lumbar region, which is achieved by giving the patient a sitting position or raising his head on the bed by 15 ° for at least 6 hours.

    The patient should be at rest about 18 hours to minimize the discomfort caused by the leakage of the cerebrospinal fluid. During this period it is recommended to monitor the patient's condition for the development of possible unwanted reactions. Patients with suspected lowered epileptic threshold should be subjected to particularly careful monitoring for several hours.

    Children:

    The safety and efficacy of Ultravist® in myelography have not been studied.

    Doses when administered to the body cavity

    In the conduct of arthrography, ERCP and hysterosalpingography, the introduction of radiopaque means should be carried out under the control of fluoroscopy.

    Recommended doses for individual studies:

    The dose can be highly dependent on age, body weight, general condition of the patient, as well as on the clinical problem being solved, the technical equipment used and the field of examination.Below are the average doses recommended for adults in normal with a single study.

    Arthrography:

    5-15 ml of the drug Ultravist® 240 mg iodine / ml / 300 mg iodine / ml / 370 mg iodine / ml.

    Hysterosalpingography:

    10-25 ml of the drug Ultravist® 240 mg iodine / ml.

    ERCPR:

    The dose depends on the clinical problem being solved and the size of the visualized structure.

    Other cavities:

    The dose depends on the clinical problem being solved and the size of the visualized structure.

    Additional information for specific patient groups

    Newborns (<1 month) and small children (1 month - 2 years)

    Children under the age of 1 year and especially newborns are characterized by sensitivity to disturbance of the water-electrolyte balance and hemodynamic disorders. Attention should be paid to the dose of radiopaque, technical support of radiological examination and the condition of the patient.

    Elderly age (over 65 years)

    In the clinical study, there was no difference in the pharmacokinetics of yopromide between the elderly (age 65 years and older) and younger patients. Therefore, there are no specific recommendations for dosage adjustment for elderly patients, other than those listed in the "Method of administration and dose".

    Dysfunction of the liver

    The excretion of iopromide does not have an effect of impaired liver function, since only about 2% of the dose is excreted through the intestine, and iopromide not metabolized. No dosage adjustment is required for patients with hepatic insufficiency.

    Renal impairment

    Because the iopromide is excreted by the kidneys in practically unchanged form, in patients with renal insufficiency, its excretion takes longer than usual.

    To reduce the risk of additional renal dysfunction caused by radiopaque, patients with a history of renal insufficiency should use the lowest possible dose (see the section "Pharmacokinetics").
    Side effects:

    The overall safety profile of Ultravist® is based on data from more than 3,900 patients observed in clinical trials and more than 74,000 patients in post-registration surveillance studies, as well as on data obtained from spontaneous reports and literature.

    The most frequent adverse adverse reactions (NAD) (≥ 4%) in patients treated with Ultravist® were headache, nausea, and vasodilatation.

    The most serious NDP in patients treated with Ultravist® was anaphylactoid shock, respiratory arrest, bronchospasm, laryngeal edema, pharyngeal edema, bronchial asthma, coma, cerebral infarction, stroke, cerebral edema, convulsions, arrhythmia, cardiac arrest, myocardial ischemia, myocardial infarction myocardium, heart failure, bradycardia, cyanosis, lowering of blood pressure, shock, dyspnea, pulmonary edema, respiratory failure and aspiration.

    The adverse reactions reported in connection with the use of Ultravist® are given in the table. The frequency is defined as very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1,000 to <1/100), rarely (from ≥1 / 10,000 to <1/1 000), very rarely (<1/10 000).

    For additional NDPs detected only during post-marketing observations, and for which it was not possible to estimate the occurrence frequency, "frequency is unknown" is indicated.

    Table: Unfavorable adverse reactions (CPD) observed in clinical trials or in the postemergence follow-up period in patients who received Ultravist®

    System of organs

    Often

    Infrequently

    Rarely

    Frequency

    Unknown

    Immune system disorders

    Hypersensitivity reactions / anaphylactoid reactions (Anaphylactoid shock, respiratory failure, bronchospasm, laryngeal / pharyngeal edema, face, tongue edema, spasm of the larynx / pharynx, bronchial asthma, conjunctivitis, watery eyes, sneezing, coughing, mucosal edema, rhinitis, hoarseness, sore throat, rash, itching, angioedema)

    Disorders from the endocrine system

    Thyrotoxic crisis, thyroid dysfunction

    Disorders of the psyche

    Anxiety

    Disturbances from the nervous system

    Dizziness, headache, dysgeusia

    Vasovagal reactions, confusion, anxiety, paresthesia / hypersensitivity, drowsiness

    Coma*, cerebral ischemia / infarction *, stroke *, cerebral edemaa*, convulsions *, short-term cortical blindnessa, loss of consciousness, agitation, amnesia, tremor, speech disorders, paresis / paralysis

    Disturbances on the part of the organ of sight

    blurred vision / visual impairment

    Hearing disorders and labyrinthine disorders

    Hearing Impairment

    Heart Disease

    Pain / discomfort in the chest

    Arrhythmia*

    Stop heart *, myocardial ischemia *, palpitations

    Heart Attack myocardium *, heart failure *, bradycardia *, tachycardia, cyanosis *

    Vascular disorders

    Increase arterial pressure, vasodilation

    Lowering blood pressure

    Shock*, thromboembolisma, vasospasm

    Disturbances from the respiratory system, chest and mediastinal organs

    Dyspnea*

    Pulmonary edema *, respiratory failure *, aspiration *

    Disturbances from the liver and bile ducts

    Vomiting, nausea

    Abdominal pain

    Dysphagia, an increase in the salivary glands, diarrhea

    Disturbances from the skin and subcutaneous tissues

    Bullous skin diseases (including Stevens-Johnson syndrome or syndrome Lyell), rash, erythema, hyperhidrosis

    Disturbances from musculoskeletal and connective tissue

    Compartment syndrome in the case of extravasationa

    Disorders from the kidneys and urinary tract

    Renal impairmenta, acute renal failurea

    General disorders and disorders at the site of administration

    Pain, reactions at the injection site (various types, for example, pain, sensation of heat, swelling, inflammation and soft tissue damage in the case of extravasation, a feeling of heat)

    Edema

    Malaise, chills, pallor

    Laboratory and instrumental data indicators

    Changes in body temperature

    * Cases of a life threat and / or with a lethal outcome are marked.

    a only with intravascular application.

    In addition to the NDPs listed above, the following NDPs were noted when used internallyand: chemical meningitis and meningism - with an unknown frequency.

    In addition to the NDPs listed above, the following NDPs were noted when ERCPR: increased activity of pancreatic enzymes and pancreatitis - with unknown frequency.

    Most of the reactions after myelography or when injected into the body cavity arose several hours after the administration.

    Based on experience with other non-ionic radiopaque agents, the following NDPs can also be observed when administered intrathecally: psychosis, neuralgia, paraplegia, aseptic meningitis, back pain, pain in the extremities, painful urination, changes in the EEG.

    Overdose:

    In the study of acute toxicity in animals, there was no risk of acute intoxication after the use of Ultravist®.

    Intravascular administration

    Symptoms may include a violation of the water-electrolyte balance, the development of renal failure, complications of the cardiovascular system and lungs.

    In case of an unintentional overdose with intravascular injection, it is necessary to monitor the volume of fluid, the content of electrolytes and the function of the kidneys. Treatment of overdose should be aimed at maintaining vital body functions. The drug Ultravist® can be removed from the body by hemodialysis.

    Intrathecal administration

    Possible development of serious neurological complications. It is recommended that the patient's condition be carefully monitored when there is an unintentional excess of the dose during intrathecal administration.

    Interaction:

    Biguanides (metformin): in patients with renal insufficiency or severe chronic kidney disease, elimination of biguanides can be reduced, which leads to their accumulation and development of lactic acidosis. Since the use of yopromide can lead to acute renal failure or its amplification, patients receiving metformin, may have an increased risk of developing lactic acidosis, especially with a history of acute renal insufficiency (cf.section "Special instructions").

    Interleukin-2: with the previous treatment with interleukin-2 (within a few weeks), the risk of developing delayed reactions with the administration of yopromide increases.

    Radioisotopes: within a few weeks after the administration of yopromide, there is a decrease in the absorption of thyroid-stimulating isotopes by the thyroid gland, which reduces their effectiveness for the diagnosis and treatment of thyroid diseases.
    Special instructions:

    Hypersensitivity

    With the use of the drug Ultravist®, anaphylactoid reactions / hypersensitivity reactions (see section "Side effect") or other manifestations of idiosyncrasy from the side of the cardiovascular, respiratory system and skin can be observed. The severity of allergic reactions can be from mild to severe, including the development of shock. Most reactions occur within 30 minutes after the introduction of radiopaque (see section "Side effect"). However, deferred reactions (from hours to days) may develop.

    The risk of developing hypersensitivity reactions increases in the following cases:

    - in the presence of previously existing reactions to iodine-containing radiopaque agents;

    - if there is an anamnesis of bronchial asthma or other allergic diseases.

    Patients with a known hypersensitivity to Ultravist® or any of its components or with a previous hypersensitivity reaction to some other iodine-containing radiopaque agent have an increased risk of developing hypersensitivity reactions (including severe).

    Nevertheless, such reactions are rare and unpredictable.

    It should be borne in mind that patients taking beta-blockers may be resistant to the treatment of hypersensitivity reactions with drugs that have a beta-adrenergic effect.

    In cases of development of severe hypersensitivity reactions, the consequences can be more serious and even lead to a fatal outcome.

    In connection with the possibility of developing severe hypersensitivity reactions after the administration of the radiopaque means after the end of the procedure, it is necessary to observe the patient's condition.

    In all cases, it is necessary to be prepared, if necessary, to provide emergency care to the patient.

    It is recommended to consider premedication of glucocorticosteroids in patients with bronchialasthma or other allergic diseases.

    Thyroid dysfunction

    Particular care should be taken to weigh the risk / benefit ratio in patients with established or suspected hyperthyroidism, since iodine-containing radiopaque agents may cause them to have hyperthyroidism or a thyrotoxic crisis. Consideration should be given to the need to evaluate the function of the thyroid gland prior to the administration of Ultravist® and / or to prescribe thyreostatic therapy for prophylactic purposes in patients with established or suspected hyperthyroidism.

    In newborns, especially premature infants who received the Ultravist® drug either through the mother during pregnancy or after childbirth, it is recommended to monitor the thyroid function, since exposure to excessive amounts of iodine can cause hypothyroidism, which may require treatment.

    Diseases of the central nervous system

    Patients with CNS diseases have an increased risk of neurological complications due to the administration of Ultravist®. Neurological complications develop more often when carrying out cerebral angiography and related procedures.

    Caution should be exercised in situations where there may be a lowered convulsive threshold, such as having a history of seizures and the concomitant use of certain medications.

    Factors that increase the permeability of the blood-brain barrier, facilitate the penetration of radiopaque in the brain tissue, which can cause reactions from the CNS.

    Hydration

    Before and after intravascular or intrathecal administration of Ultravist®, adequate hydration should be provided to minimize the risk of contrast-induced nephrotoxicity. This is of particular importance for patients with multiple myeloma, diabetes, polyuria, oliguria, hyperuricemia, as well as for newborns, infants, young children, and elderly patients.

    Fear

    If there is a feeling of excitement, anxiety and pain, the risk of developing CPD or the intensity of these reactions caused by the radiopaque means may increase. Such patients require more careful observation. In some cases, they may need medication to reduce anxiety.

    Conducting a preliminary test

    The use of a small amount of radiopaque for carrying out the sensitivity test is not recommended, since it has no prognostic significance. Moreover, carrying out such testing alone can lead to serious and even fatal hypersensitivity reactions.

    Renal damage

    Nephrotoxicity caused by radiopaque means, which is a transient renal dysfunction, may occur after intravascular injection of the Ultravist® preparation. In rare cases, acute renal failure may develop.

    Risk factors include, for example:

    - previous renal failure;

    - dehydration;

    - diabetes;

    - multiple myeloma / paraproteinaemia;

    - repeated and / or large doses of Ultravist®.

    It is necessary to provide adequate hydration in all patients with the administration of Ultravist®. Patients on dialysis may be given the Ultravist® drug for diagnostic purposes, since the iodine-containing radiopaque can be removed from the body by dialysis.

    Cardiovascular diseases

    In patients with severe heart disease or severe coronary artery disease, the risk of clinically significant changes in hemodynamics and arrhythmia is increased.

    Intravascular injection of radiocontrast can cause pulmonary edema in patients with heart failure.

    Pheochromocytoma

    In patients with pheochromocytoma, there is a risk of developing a hypertensive crisis.

    Myasthenia gravis

    The introduction of iodine-containing radiopaque means may increase the severity of symptoms of myasthenia gravis gravis.

    Thrombogenicity

    One of the properties of nonionic radiopaque means is their low ability to influence the normal physiological functions of the body. That is why non-ion radiopaque agents have less anticoagulant activity in vitro, than ionic ones. A number of factors, in addition to the properties of the radiopaque agent itself, such as the duration of the study, the number of injections, the properties of the catheter and the syringe, the state of the disease and the treatment being administered, can influence the development of thromboembolism. Therefore, during the catheterization of the vessel it is necessary to take into account these factors and pay special attention to the performance of the technique of angiography,and also wash the catheter with 0.9% sodium chloride solution (if necessary with the addition of heparin) and minimize the timing of this procedure in order to minimize the risk of thrombosis and embolism.

    Intrathecal administration

    Care should be taken for patients with a history of seizures, since they have a higher risk of seizures due to the administration of the Ultravist® preparation to the brain membranes. It is necessary to have ready means for the treatment of convulsions.

    Most adverse reactions after myelography are developed within a few hours after the administration of radiopaque. During this period it is recommended to monitor the patient's condition.

    Myelography

    The more the patient moves or strains his muscles after the injection of the radiopaque, the sooner it is mixed with the biological fluids of other areas that are not relevant to the area under examination. As a result, the contrast density decreases faster than usual.

    To avoid discomfort caused by loss of cerebrospinal fluid, the patient needs to rest for about 18 hours. During this period, it is necessary to monitor the possibility of developing adverse reactions.Patients with a reduced threshold of convulsive activity should be under particularly careful supervision for several hours.

    Preheating the radiopaque preparation before use

    An X-ray contrast agent heated to the body temperature prior to administration is better tolerated and easier to administer due to a decrease in the viscosity of the solution.

    Form release / dosage:Solution for injection, 240 mg iodine / ml, 300 mg iodine / ml and 370 mg iodine / ml.
    Packaging:

    Ultravist®, injection, 240 mg iodine / ml: 10 or 50 ml in neutral glass bottles (EF), sealed with rubber stoppers (EF), rolled up with aluminum caps and covered with plastic caps. 10 bottles together with the instruction for use are placed in a cardboard box.

    Ultravist®, injection, 300 mg iodine / ml: 10, 20, 50, 100, 200 or 500 ml in neutral glass (EF) bottles, sealed with rubber stoppers (EF), rolled with aluminum caps and covered with plastic caps. 10 vials of 10, 20, 50, 100 or 200 ml together with the instructions for use are placed in a cardboard box. 8 bottles of 500 ml together with the instruction for use are placed in a cardboard box. For 100 or 150 ml in plastic cartridges.5 cartridges per carton. For 2 cartons, along with instructions for use, are placed in a cardboard box.

    Ultravist®, injection, 370 mg iodine / ml: 30, 50, 100, 200 or 500 ml in neutral glass (EF) bottles, sealed with rubber stoppers (EF), rolled with aluminum caps and covered with plastic caps. 10 vials of 30, 50, 100 or 200 ml together with the instructions for use are placed in a cardboard box. 8 bottles of 500 ml together with the instruction for use are placed in a cardboard box. For 100 or 150 ml in plastic cartridges. 5 cartridges per carton. By 2 The carton packs, together with the instructions for use, are placed in a cardboard box.

    Storage conditions:

    In a place protected from light and X-rays, at a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 of the year.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N002600
    Date of registration:09.07.2010
    The owner of the registration certificate:Bayer AGBayer AG Germany
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp13.11.2015
    Illustrated instructions
      Instructions
      Up