Clinical and pharmacological group: & nbsp

Radiopaque means

Included in the formulation
  • Introviz
    solution for injections 
    COMPANY VILANA, LLC     Russia
  • Ibriks®
    solution for injections 
       
  • Yogexol
    solution for injections 
    Firm VIPS-MED, LLC     Russia
  • Yogexol
    solution for injections 
    VELFARM, LLC     Republic of San Marino
  • Yogexol TR
    solution for injections 
    MOSFARM, OJSC     Russia
  • Yogexol-Binergia
    solution for injections 
    BINERGIYA, CJSC     Russia
  • Nioscans
    solution for injections 
    ARS, LLC     Russia
  • Omnipack®
    solution for injections 
    JI Halskea Limited     United Kingdom
  • Unigexol
    solution for injections 
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    V.08.A   Radiocontrast iodine-containing substances

    Pharmacodynamics:
    X-ray contrast diagnostic non-ionic monomer. Has low osmolarity. Yogexol highly soluble in water, contains approximately 46.4% iodine.
    Time to achieve maximum radiopaque in normal myelography - up to 30 minutes (after 1 hour is no longer visualized). In carrying out computed tomography visualization of contrast in the thoracic region is possible within 1 hour, in the cervical region - about 2 hours, basal cisterns - 3-4 hours. Contrasting of joint cavities, uterine cavity,fallopian tubes, peritoneal protrusions, pancreatic and bile ducts, the bladder is achieved immediately after administration.
    Pharmacokinetics:

    After intravenous administration of Cmax is noted immediately after the introduction. It is distributed in the extracellular fluid. Quickly accumulates in the kidneys: the contrast of the kidney passage begins 1 minute after intravenous injection and reaches an optimum after 5-15 minutes. It binds to a small extent with plasma proteins and cerebrospinal fluid. It penetrates the placental barrier by simple diffusion. It does not penetrate the intact blood-brain barrier.

    It is excreted by glomerular filtration in unchanged form (about 90% in 24 hours).

    The half-life in the initial phase is about 20 minutes, the intra- and extra-vascular concentrations are equalized within 10 minutes, then the decrease in concentration occurs exponentially with a half-life of about 2 hours. Kidney clearance - 120 minutes, total clearance - 131 ml / min, Vd is 165 ml / kg.

    After intrathecal administration, it is absorbed from the cerebrospinal fluid into the bloodstream and completely excreted by the kidneys (about 88% during the first day) unchanged.Kidney clearance - 99 ml / min, total clearance - 109 ml / min. Cmax in blood plasma is achieved in 2-6 hours and is 119 μg / ml. Vd is 157 ml / kg. The half-life is 3.4 hours.

    When ingestion increases the visualization of the gastrointestinal tract and is practically not absorbed (the kidneys are excreted 0.1-0.5%), absorption increases significantly in the presence of perforation of the intestine or intestinal obstruction.

    Indications:

    Intravascular application: angiography of the lungs, head, neck, brain, abdomen, kidneys; angiocardiography, aortography, phlebography, urography; computed tomography (increase in resolution).

    Subarachnoidal application: lumbar myelography, thoracic myelography, cervical myelography, computed tomography of basal cisterns.

    Intracavitary application: arthrography, retrograde endoscopic pancreatography, retrograde endoscopic cholangiopancreatography, herniography, hysterosalpingography, sialography.

    Oral administration: research of the digestive tract.

    XXI.Z00-Z13.Z03   Medical surveillance and evaluation in case of suspected disease or pathological condition

    Contraindications:

    Pregnancy, hypersensitivity to iodine-containing contrast agents, local and systemic infections.

    Subarachnoidal administration: epilepsy, technical failure in myelography (immediate re-examination is contraindicated), infectious diseases.

    Carefully:Epilepsy, dehydration, severe cardiovascular systemdecompensatedheart failure, pulmonary hypertension, severe renal and hepatic impairment, chronic alcoholism, multiple sclerosis, multiple myeloma and other paraproteinemicshaemoblastosis, pheochromocytoma, thyrotoxicosis, sickle cellanemia, Buerger's disease, acute thrombophlebitis, thrombophilic conditions, allergic diseases (bronchial asthma, pollinosis, food allergy), pronounced atherosclerosis, elderly age.
    Pregnancy and lactation:
    Contraindicated in pregnancy.
    There is no information on the penetration into breast milk. It is recommended to temporarily stop breastfeeding within 24 hours after the administration of yogexol.
    Dosing and Administration:

    Intravenous, intra-arterial, endolumbular, subarachnoid, intracavitary, oral.The dosage regimen is set individually depending on the type of study, the technique used and the technique of the study, the age and body weight of the patient, the general condition of the patient, cardiac output.

    The recommended mean concentrations of iodine for intravenous administration are 240, 300 or 350 mg / ml, with 140, 240, 300 or 350 mg / ml for intra-arterial injection, 180, 240 or 300 mg / ml for intrathecal, 240 or 300 mg / ml, oral - 180, 240, 300 or 350 mg / ml.

    To minimize the risk of adverse reactions, the total dose of iodine should not exceed 3 g.

    Side effects:Feeling of heat, heart rhythm disturbances, chest pain, hypotension, heart failure, bradycardia / tachycardia, asystole, headache, dizziness, back pain, neck, stiffness, neuralgia, paresthesia, seizures, decreased appetite, impaired taste, nausea, vomiting, hypotension / hypertensions, sweating, weakness, photophobia, allergic reactions (fever, chills, profuse diarrhea, pruritus, rash-like rash, nasal congestion, dyspnea, Guillain-Barre syndrome), pain at the injection site.
    Overdose:

    Symptoms: cyanosis, bradycardia, acidosis, pulmonary hemorrhage, cardiac arrest, insomnia or drowsiness, weakness, fatigue, stupor, convulsions, coma, mental disorders: hallucinations, depersonalization, fear, disorientation, echolalia, depression, amnesia, psychosis, amblyopia, diplopia, photophobia, hypoesthesia, visual, auditory or speech disorders, changes electroencephalography, meningism, hyperreflexia or areflexia, hemiplegia, paralysis, quadriplegia, tremor, hemorrhages in the brain.

    Treatment: diazepam 10 mg intravenously slowly, 20-30 minutes after the cessation of convulsive seizure - intramuscularly phenobarbital 200 mg; monitoring and maintenance of vital functions, symptomatic therapy.

    Interaction:Incompatible (with intrathecal administration) with corticosteroidsand. Pharmaceutically incompatible (in one syringe) with antihistamine and many other drugs. Phenothiazine derivatives and other neuroleptics, MAO inhibitors, tricyclic antidepressants, CNS stimulants, analeptics, antipsychotice drugs reduce the convulsive threshold and increase the risk of epileptic seizures.Beta-adrenoblocktori and other antihypertensives increase the likelihood of developing hypotension. It enhances the nephrotoxic properties of other drugs.
    Special instructions:

    The frequency and severity of side effects vary depending on the concentration, amount and technique of the introduction of radiopaque; increase in osmolality, volume, concentration, viscosity and speed of administration increases the frequency and severity of side effects. Most side effects stop automatically in a short time. In general, the frequency of side effects when using nonionic radiocontrast agents, in particular yogexol, is lower than when using ionic agents. It is possible to develop systemic side effects in topical application due to absorption from the bladder, renal pelvis, or into the peritoneal cavity.

    In patients with an increased risk of developing allergic reactions, it is advisable to carry out preliminary therapy with glucocorticosteroids and / or antihistamines.

    Consider the possibility of dehydration in patients with severe thyrotoxicosis, myelomatosis.

    In patients with diabetes mellitus and a serum creatinine concentration greater than 500 μmol / L, the use of yogexol is only possible in cases of extreme necessity.

    After the application of yogexol, the iodo-binding capacity of the thyroid tissue is reduced for a period of several days to 2 weeks.

    Doses and concentrations of yogexol depend on the type of study, the degree of necessary contrast and the equipment used.

    As a solvent, water, carbonated beverages, milk or juice can be used.

    During and for 30-60 minutes after intravascular or intracavitary and 12 hours (in some cases 24 hours), after intra-envelope administration of yogexol, monitoring of possible serious adverse reactions by personnel trained in emergency care is required.

    It is necessary to have anti-shock laying in the compartment containing epinephrine and oxygen, and conditions for emergency intensive care in the development of possible hypersensitivity reactions.

    In patients with a history of convulsive seizures that do not receive anticonvulsant therapy, barbiturates may be premedicated before intraluminal administration.Patients receiving anticonvulsant drugs can continue treatment during the application of yogexol.

    When intramuscular introduction should not be taken 2 hours before the study. Before this, it is possible to follow a normal diet.

    When unintentionally entering the skull cavity or overdose of yogexol, the appointment of anticonvulsants may reduce the risk of convulsive seizures.

    Do not recommend the direct introduction of yogexol into the cisterns and ventricles of the brain during standard radiologic procedures.

    In carrying out myelography, patients should be in a supine position, with an elevated head at least 8 hours after the examination (the vertical position slows the dispersion of the drug and increases its absorption by the arachnoid shell of the lumbar region). It is necessary to observe the usual bed rest for 24 hours. Do not bend the body and active movements for 24 hours after the test to avoid loss of liquor.

    Yogexol for retrograde cystourethrography is not suitable for intravascular injection. The solution is injected into the bladder or ureters and the renal pelvis using special equipment.Any injection should avoid overpressure.

    When preparing for hysterosalpingography, you can prescribe enemas or a vaginal shower. Immediately before the test, it is necessary to empty the bladder.

    When hysterosalpingography yogexol Enter directly into the uterine cavity with a sterile syringe connected to the uterine cannula, or through the tubular insufflator of the kit for hysterosalpingography. It is recommended to fill the uterine cavity under the control of fluoroscopy, to avoid excess pressure and to introduce excess volume of radiopaque.

    The unabsorbed part of the radiopaque means during hysterosalpingography spontaneously poured into the vagina after removal of the cannula.

    The maximum allowable dose for adults is 3.06 g iodine in intraluminal administration and 87.5 g iodine or 250 ml solution with an equivalent iodine concentration of 350 mg / ml for intravascular administration (for repeated or repeated administrations).

    Monitoring (with intravascular application) of blood pressure (during the study, especially with pheochromocytoma and unstable hemodynamics),functions of the thyroid gland (iodine-induced thyrotoxicosis can develop within 4-12 weeks after the administration of radiocontrast agents to elderly patients).

    In severe, life-threatening adverse reactions, careful monitoring of vital functions in the intensive care unit is necessary, artificial lung ventilation (with respiratory depression), indirect cardiac massage (with cardiac arrest).

    Impact on the ability to drive vehicles and manage mechanisms

    Delayed reactions to intravascular injection of iodine-containing contrast agents are rare. However, driving and carrying out works that require an increased speed of psychomotor reactions are undesirable during the first 24 hours after the study.

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