Active substanceYomeprolYomeprol
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  • Yomeron
    solution in / vessel. 
  • Dosage form: & nbspintravascular solution
    Composition:

    Per 1 ml:

    Active ingredient: yomeprol 612.4 mg (in terms of iodine 300 mg), 714.4 mg (calculated as iodine 350 mg) or 816.5 mg (iodine equivalent to 400 mg);

    auxiliary components: trometamol 1 mg, hydrochloric acid 32% solution to pH 7.0-7.1, water for injection up to 1 ml.

    Description:

    A clear, colorless solution.

    Pharmacotherapeutic group:radiopaque
    ATX: & nbsp

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

    Pharmacodynamics:

    Yomeron is a non-ionic water-soluble nephrotropic iodine-containing low-molecular radiopaque preparation.

    Pharmacokinetics:

    The elimination half-life for iomeprol in the distribution and elimination phases is 23 ± 14 min and 109 ± 20 min, respectively. Provided that the kidneys function normally, the total excretion of uterine kidney, expressed as a percentage of the intravenous dose, is approximately 24-34% after 60 minutes, 84% after 8 hours, 87% after 12 hours, and 95% 24-96 hours after administration. Thus, in patients with normal renal function (creatinine clearance> 60 ml / min), the half-life of iomeprol is about 2 hours.

    In patients with impaired renal function, the half-life period is prolonged depending on the degree of kidney damage, depending on the creatinine clearance Yomeprol does not bind to plasma proteins or serum.

    With intrathecal administration yomeprol Absorbed completely by cerebrospinal fluid for 3-6 hours. The half-life is 8-11 hours, depending on the dose. Yomeprol is excreted by the kidneys unchanged. Excretion in the urine almost completely occurs within 24 hours after administration, followed by the excretion of small amounts between 24 and 38 hours.

    Indications:

    For a dose of 300 mg iodine / ml:

    Intravenous urography of adults and children, peripheral phlebography, computer tomography of the brain and spinal cord, whole body, cavernography, intravenous digital subtraction angiography, angiocardiography of adults and children, traditional selective coronary arteriography, interventional coronary arteriography, endoscopic retrograde cholangiopancreatography, arthrography, hysterosalpingography, cholangiography , dacryocystography, sialography, retrograde urethrography, retrograde pyeloretra graphy, myelography.

    For a dose of 350 mg iodine / ml:

    Intravenous urography of adults and children, computer tomography of the whole body, intravenous digital subtraction angiography, traditional angiography, intra-arterial digital subtraction angiography, angiocardiography of adults and children, traditional selective coronary arteriography, interventional coronary arteriography, arthrography, hysterosalpingography, fistulography, galactography, retrograde cholangiography, dacryocystography, sialography.

    For a dose of 400 mg iodine / ml:

    Intravenous urography of adult patients, including patients with chronic renal failure or diabetes mellitus, computerized tomography of the whole body, traditional angiography, intraarterial digital subtraction angiography, adult and child angiocardiography, traditional selective coronary arteriography, interventional coronary arteriography, fistulography, galactography, dacryocystography, sialography .

    Contraindications:

    Hypersensitivity to the components of the drug.

    Pregnancy, the period of breastfeeding.

    Waldenstrom's macroglobulinemia.

    Severe hepatic, renal and cardiovascular failure.

    Multiple myeloma.

    Expressed thyrotoxicosis (see information in the section "With caution").

    In acute inflammatory diseases of the pelvic organs, hysterosalpingography is contraindicated.

    In acute pancreatitis, endoscopic retrograde cholangiopancreatography is contraindicated.

    Carefully:

    Care should be taken when prescribing the drug to patients with impaired renal, hepatic and cardiovascular function, emphysema, severe general condition, severe atherosclerosis, requiring correction of diabetes mellitus, latent hyperthyroidism, nodular goiter of mild and moderate severity.

    With all modes of administration, in view of the possible development of serious side effects, the use of the drug should be limited in cases where there are no clear clinical indications for carrying out radiopaque studies. The need for the study should be determined taking into account the clinical state of the patient and the features of the course of possible diseases of the cardiovascular system, kidney and / or hepatobiliary system.

    Cardioangiography using radiopaque substances should be performed in hospitals and in hospitals.

    Special measures should be taken in patients with suspected thrombosis, phlebitis, severe ischemia, local infection, or arteriovenous obstruction.

    Dosing and Administration:

    The dose and method of application depend on the indication, the equipment used, the method of examining the body, body weight, hemodynamic status, the general condition of the patient and are:

    Indication

    Dosage mg of iodine / ml

    Recommended dosage

    Intravenous urography

    300, 350,400

    Adults: 50-150 ml


    Newborn: 3-4.8 ml / kg


    Children: up to 1 year: 2.5-4 ml / kg;


    over 1 year: 1-2.5 ml / kg

    Peripheral phlebography

    300

    Adults: 10-100 ml, repeat if necessary *

    (10-50 ml in the upper limbs;

    50-100 ml in the lower limbs)

    Computer tomography of the brain and spinal cord

    300

    Adults: 50-200 ml **

    Children **

    Computed tomography of the whole body

    300, 350, 400

    Adults: 100-200 ml

    Children **

    Cavernography

    300

    Adults: up to 100 ml

    Intravenous digital subtractive angiography

    300, 350, 400

    Adults: 100-250 ml

    Children **

    Traditional angiography

    Arteriography upper limbs

    300, 350

    Adults *

    Arteriography of the pelvis and lower limbs

    300,350,400

    Adults *

    Abdominal arteriography

    300,350, 400

    Adults *

    Arteriography of the descending part of the aorta

    300, 350

    Adults *

    Pulmonary angiography

    300,350,400

    Adults: up to 170 ml

    Cerebral angiography

    300, 350

    Adults: up to 100 ml

    Arteriography children

    300

    Up to 130 ml **

    Traditional

    300,350,400

    Adults *

    Children **

    Intraarterial digital subtractive angiography

    Cerebral

    300, 350

    Adults: 30-60 ml for general viewing, 5-10 ml for selective injections

    Children **

    Thoracic

    300

    Adults: 20-25 ml (aorta), if necessary, repeat, 20 ml (bronchial arteries)

    Aortic arch

    300,350

    Adults ***

    Abdomen

    250,300

    Adults ***

    Aortography

    300, 350

    Adults ***

    Transluminal aortography

    300

    Adults *

    Peripheral arteriography

    300

    Adults: 5-10 ml for selective injections up to 250 ml

    Children **

    Traditional

    300

    Adults: 10-30 ml for selective injections up to 250 ml

    Children **

    Angiocardiography

    300, 350,400

    Adults *

    Children: 3-5 ml / kg

    Traditional selective coronary arteriography

    300, 350,400

    Adults: 4-10 ml in the artery, repeat if necessary

    Interventional coronary arteriography

    300,350,400

    Adults: 4-10 ml in the artery, repeat if necessary

    Endoscopic retrograde cholangiopancreatography

    300

    Adults: up to 100 ml

    Arthrography

    300,350

    Adults: up to 10 ml per injection

    Hysterosalpingography

    300,350

    Adults: up to 35 ml

    Fistulography

    300, 350,400

    Adults: up to 100 ml

    Discography

    300

    Adults: up to 4 ml

    Galactography

    300, 350,400

    Adults: 0.15-1.2 ml per injection

    Dacryocystography

    300, 350,400

    Adults: 2.5-8 ml per injection

    Sialografiya

    300, 350,400

    Adults: 1-3 ml per injection

    Cholangiography

    300, 350

    Adults: up to 60 ml

    Retrograde urethrography

    300

    Adults: 20-100 ml

    Retrograde pyelography

    300

    Adults: 10-20 ml per injection

    Myelography

    300

    Adults: 8-15 ml

    * Not more than 250 ml. Individual dosing or volume is determined by the size of the part being examined.

    ** Depending on body weight and age.

    *** No more than 350 ml.

    It is desirable to preheat the drug solutions to body temperature with intravascular or intrathecal administration. Before use, make sure that the product package is not damaged. When performing angiographic studies, one should carefully observe their technique, aseptic rules, and often wash the catheter (for example, 0.9% sodium chloride solution with heparin addition) to minimize the risk of thrombosis and embolism.

    Side effects:

    Undesirable adverse reactions are usually mild or moderate, reversible and infrequent.

    Most adverse reactions develop within the first minutes after the administration of the drug.

    General types of reactions

    The most common headache, pain at the injection site, generalized feeling of heat, increased sweating, a sense of metallic taste in the mouth.

    Much less likely to be a feeling of discomfort or pain in the abdomen, nausea, vomiting.

    Hypersensitivity reactions

    Usually it can be such skin or respiratory reactions as various types of rash, erythema, urticaria, itching, pale skin; acute rhinitis, edema of the larynx, dyspnea and a moderate decrease in blood pressure. These effects are usually short-lived.

    Very rarely there is dizziness, stiff neck, low back pain, temporary confusion. In some cases, fever occurs.

    Possible individual hypersensitivity, especially pronounced the persons with a predisposition to allergies, and also taking beta-blockers. In cases of hypersensitivity reactions, the administration of contrast medium should be immediatelydiscontinued and, if necessary, an appropriate emergency intravenous therapy.

    Severe cases of anaphylaxis involving the cardiovascular system are extremely rare and include the development of peripheral vasodilation with significant lowering of arterial pressure, reflex tachycardia, shortness of breath, agitation, cyanosis, loss of consciousness following a respiratory and / or heart attack, which can lead to death. Since these phenomena can develop very quickly, they require urgent cardiopulmonary resuscitation. Initially, cardiovascular collapse may occur, isolated or as an initial manifestation without respiratory or other symptoms listed above.

    From the side of the cardiovascular system: peripheral vasodilation, marked decrease in blood pressure, tachycardia, shortness of breath, agitation, cyanosis and loss of consciousness (may require urgent treatment), transient bradycardia.

    From the nervous system: tonic / clonic convulsions, aphasia, syncope, temporary narrowing of the visual fields, hemiparesis, coma (developed in patients suffering from diseases of the central nervous system).In some cases, patients with increased convulsive readiness or using psychotropic drugs, with the introduction of the drug may cause spasms of skeletal muscles or generalized convulsions.

    General measures to prevent adverse reactions

    - to identify patients at risk (patients with dehydration, impaired renal function, diabetes mellitus, severe cardiovascular failure, patients with adverse reactions to the introduction of iodinated radiopaque substance in history, children under one year old, patients older than 70 years, patients, using nephrotoxic drugs (NSAIDs, loop diuretics, ACE inhibitors (enalapril, captopril and others), aminoglycosides, platinum compounds, methotrexate in high dosages, pentamidine, sodium foscarnet, some antiviral agents (acyclovir, ganciclovir, valaciclovir, adefovir, cidofovir, tenofovir); vancomycin, amphotericin B; immunosuppressants, such as ciclosporin or tacrolimus; and phosphamide, etc.);

    - provide sufficient hydration orally or, if necessary, by intravenous infusion (every hour for ≥ 100 ml orally or intravenously (0.9% solution of sodium chloride, sodium hydrogen carbonate) within 4 hours before and 24 after the administration of the radiopaque preparation, depending on the patient's condition);

    - avoid simultaneous use of nephrotoxic drugs; if such a combination is necessary, monitoring of renal function should be strengthened;

    - to observe the interval not less than 48 hours between two radiological examinations with the introduction of radiopaque preparation or postpone a new examination until the restoration of the initial renal function;

    - PReducing acidosis with increasing lactate concentration in patients with diabetes mellitus taking metformin, based on the data of creatininemia. Normal renal function: the administration of metformin is stopped at least 48 hours before the introduction of the radiopaque preparation or until the normal renal function is restored. Abnormal renal function: metformin is contraindicated. For urgent indications: if the examination is urgently needed, the following precautions should be taken: discontinuation of metformin intake, hydration, monitoring of renal function and the search for signs of acidosis with increasing lactate concentration.Patients on hemodialysis can take iodinated radiopaque substances, since they are amenable to dialysis. It is necessary to take a preliminary conclusion from the hemodialysis department;

    - after the introduction of the radiopaque preparation, it is necessary to observe the patient for at least 30 minutes, since the majority of serious side effects occur during this period;

    - the patient should be warned about the possibility of delayed-type reactions (up to 7 days).

    Adverse reactions and warnings in neuroradiogenological studies

    In the case of cerebrospinal blockade when the drug is administered, as much as possible of the injected contrast solution should be removed.

    In cases of the presence of blood in the cerebrospinal fluid, the physician should carefully evaluate the necessary need for a diagnostic procedure taking into account the risk to the patient.

    The appointment of myelography to patients with a risk of epilepsy, history of epilepsy or severe renal and hepatic impairment should be carefully weighed. Patients taking anticonvulsant drugs should not interrupt their treatment.Manipulation with the patient during and after the examination should be minimal. After examination, the patient should remain in a supine position, with a raised head, for at least 8 hours. Observation of the patient should be especially attentive within 24 hours, at this time the patient is advised not to bend over.

    Adverse reactions and warnings in angiographic studies

    In patients undergoing angiocardiographic procedures, special attention should be given to the state of the right heart and pulmonary circulation. The introduction of an organic iodine-containing solution in the absence of right heart and pulmonary hypertension can cause bradycardia and lowering blood pressure. Increased caution should be observed when introducing a contrast agent in the right heart cavity of newborns with pulmonary hypertension and impaired cardiac function.

    When contrasting the arch of the aorta in a number of cases, it is possible to develop a decrease in blood pressure, bradycardia.

    With abdominal aortography, kidney infarction, damage to the spinal cord, retroperitoneal bleeding, and bowel necrosis may occur.

    With peripheral arteriography with a drug at a dosage of 350 mg / ml, pain in the examined extremity may sometimes occur. Usually this is not observed when using a less concentrated solution - 300 mg / ml.

    When vessels are catheterized, special attention should be given to angiographic techniques, since non-ionic contrast agents, in comparison with ionic contrast agents, have a lower anticoagulant activity in vitro. In this regard, to minimize the risk of thromboembolism associated with the procedure, it is necessary to properly install the catheter, wash it with saline, if possible with the addition of heparin, and also minimize the duration of the procedure.

    Overdose:

    Overdose is unlikely in patients with normal renal function. In the case of high doses, the long-term effect of the drug on the kidneys is of great importance. There is no specific antidote, the treatment is symptomatic; it is possible to conduct hemodialysis.

    Interaction:

    Simultaneous administration of io-meprola and glucocorticosteroids into the spinal canal can lead to the development of arachnoiditis.

    When used with psychotropic drugs, analgesics and antidepressants yomeprol can reduce the convulsive threshold.

    The use of yomeprol in patients with diabetic nephropathy who take biguanides (metformin), can lead to a transient disruption of kidney function and the development of lactic acidosis. As a precaution, it is necessary to stop taking biguanides 48 hours before the test and resume after complete stabilization of kidney function.

    In patients taking beta-adrenoblockers, the manifestations of anaphylaxis in the use of io-meprol can be atypical and mistaken for vagal reactions.

    Special instructions:

    It is forbidden to mix radiopaque drug with other drugs in one syringe.

    When using the drug in patients who are to study the thyroid gland, it should be borne in mind that the absorption of iodine by thyroid tissues decreases for up to 2 weeks, which may affect the results of the study.

    Premises in which procedures are performed using radiocontrast preparations should be provided with equipment and medicines,which are necessary in emergency situations (oxygen cylinders, antihistamines and vasoconstrictors, glucocorticosteroid agents).

    Form release / dosage:

    Solution for intravascular injection, 300 mg iodine / ml, 350 mg iodine / ml, 400 mg iodine / ml.

    Packaging:

    For the dosage of 300 mg iodine / ml:

    To 50 ml or 100 ml in bottles of colorless glass type I, sealed with an elastomer stopper (chlorobutyl rubber), crimped aluminum roll and lid type flip-off, consisting of an aluminum ring and a central disk of polypropylene in various colors. Aluminum run-in and aluminum lid type ring flip-off represent one element of packaging. A label is attached to the vial.

    1 bottle is placed in a cardboard box together with instructions for medical use.

    For dosages of 350 mg iodine / ml and 400 mg iodine / ml:

    50 ml, 100 ml, 200 ml, or 500 ml in flasks of colorless glass type I, sealed with an elastomer stopper (chlorobutyl rubber), crimped aluminum roll and lid type flip-off, consisting of an aluminum ring and a central disk of polypropylene in various colors. Aluminum run-in and aluminum lid type ring flip-off represent one element of packaging.A label is attached to the vial. 1 bottle is placed in a cardboard box together with instructions for medical use.

    Storage conditions:

    At a temperature of no higher than 25 ° C, do not freeze.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    3 years - for a dosage of 400 mg of iodine / ml in 500 ml bottles.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001939
    Date of registration:18.12.2012
    Date of cancellation:2017-12-18
    The owner of the registration certificate:Brakko Imajing SpABrakko Imajing SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspIMEX, CJSCIMEX, CJSCRussia
    Information update date: & nbsp12.11.2015
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