Active substanceYogexolYogexol
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  • Unigexol
    solution for injections 
  • Dosage form: & nbspinjection
    Composition:

    1 ml of the solution contains:

    active substance: yogexol 647 mg (concentration of 300 mg iodine / ml) or 755 mg (concentration of 350 mg iodine / ml);

    Excipients: trometamol 1.21 mg, sodium calcium edetate 0.10 mg, 25% hydrochloric acid solution or 1 M hydrochloric acid solution up to pH 6.8-7.6, 1 M sodium hydroxide solution to pH 6.8-7.64, water for injection up to 1 ml.

    Description:Transparent solution from colorless to light yellow color.
    Pharmacotherapeutic group:X-ray contrast medium
    ATX: & nbsp

    V.08.A   Radiocontrast iodine-containing substances

    Pharmacodynamics:

    Yogexol is a nonionic low-molecular iodine-containing radiopaque preparation.Time to achieve maximum radiopaque in normal myelography - up to 30 minutes (after 1 h no longer visualized).

    With computed tomography, visualization contrast in the thoracic region possible within 1 h, cervical region - about 2 h, basal cisterns 3-4 hours Contrasting the joint cavities, uterine cavity, fallopian tubes, peritoneal protrusions, pancreatic and biliary ducts, bladder is achieved immediately after administration.

    Pharmacokinetics:

    Almost 100% of injected yogexol is excreted unchanged through normally functioning kidneys within 24 hours. The maximum concentration of iohexol in the urine is determined approximately 1 hour after the injection.

    The half-life of the drug in patients with normal renal function is about 2 hours. There are no metabolites of the drug. The binding of yogexol to plasma proteins is small (less than 2%) and has no clinical significance.

    When intrathecal administration is absorbed from the cerebrospinal fluid (CSF) into the bloodstream and completely excreted by the kidneys (about 88% during the first day) unchanged. Kidney clearance - 99 ml / min. The total ground clearance is 109 ml / min.The maximum level of concentration in the blood (CmOh) - 2-6 hours. The volume of distribution is 157 ml / kg. The half-life (T1/2) - 3-4 hours.

    Contrasting the joint cavities, uterine cavities, fallopian tubes, peritoneal protrusions, pancreatic and biliary ducts, the bladder is achieved immediately after administration.

    Indications:

    Introviz is only for diagnostic purposes.

    Radiopaque means for use in children and adults, designed for cardioangiography, arteriography, urography, phlebography and contrast enhancement in computed tomography (CT); lumbar, thoracic and cervical myelography, CT-cisternography after subarachnoidal administration; arthrography, hysterosalpingography, sialography and research gastrointestinal tract.

    Contraindications:

    Hypersensitivity to the active component or any auxiliary component.

    Thyrotoxicosis.

    Carefully:

    When using non-ionic radiocontrast agents, care should be taken:

    - if there is a history of allergy, bronchial asthma or other undesirable reactions to iodine-containingradiopaque means. Premedication with glucocorticosteroids or H blockers is recommended.1 and H2-gistaminovyh receptors by medicinal preparations;

    - in the study of patients with severe cardiovascular diseases and pulmonary hypertension, because of the risk of developing hemodynamic disorders or arrhythmias;

    - in the study of patients with acute cerebral pathology, tumors or epilepsy in an anamnesis, in connection with the predisposition of this category of patients to convulsions. The risk of seizures and neurological reactions is also increased in patients with alcoholism or drug dependence;

    - in the study of patients with severe combined disorders of the liver and kidneys, since they significantly reduced the clearance of radiocontrast agents;

    - to prevent the development of acute renal failure after the introduction of radiopaque means should pay special attention to patients at increased risk of kidney failure and diabetes, as well as patients with paraproteinaemia (myelomatosis and macroglobulinemia Waldenstrem);

    - in the study of patients with hyperthyroidism, patients with multinodular goiter after the introduction of iodine-containing radiopaque means there is a risk of developing hyperthyroidism. With the introduction of radiopaque means for premature infants, consideration should be given to the possibility of developing transient hyperthyroidism;

    - when examining patients with hypovolemia, adequate rehydration should be provided, at least 100 ml every hour for 4 hours before the study and 24 hours after the test;

    - In the study of patients with multiple myeloma, diabetes mellitus, impaired renal function, newborns, children under one year old and elderly patients, adequate rehydration should be performed before and after the introduction of radiopaque;

    - patients with diabetes mellitus metformin Before intravascular injection of iodine-containing radiocontrast agents, the drug should be discontinued for at least 48 h before and in flow 48 h after the procedure;

    - in the study of patients with multiple sclerosis, sickle-cell anemia;

    - with the introduction of radiopaque means may aggravate the symptoms of myasthenia gravis gravis;

    - in patients with pheochromocytoma when performing invasive studies and interventions, prophylactic use of alpha-adrenoblockers is necessary to prevent hypertensive crisis;

    In emergency cases, when the kidney function is unknown, the doctor should evaluate the risk / benefit ratio of the contrast agent: stop using metformin, rehydrate, monitor kidney function, monitor the appearance of the initial signs of lactic acidosis.

    Pregnancy and lactation:

    Pregnancy

    The drug should not be used in pregnant women, unless the intended benefit to the mother from its use outweighs the potential risk to the fetus, and such a study is prescribed by the doctor as necessary.

    Hysterosalpingography should not be performed in pregnant women and in the presence of acute pelvic peritonitis.

    Breastfeeding period

    Radiopaque means is excreted to breast milk to an insignificant degree. Therefore, the likelihood of infecting a child who is breastfed is very unlikely.However, if you need to administer the drug, you should stop breastfeeding before you start the drug and do not resume at least 24 hours after the test.

    Dosing and Administration:

    General information

    The drug is intended for intravascular (intra-arterial, intravenous), intrathecal, intracavitary, oral and rectal administration. Like all preparations for parenteral administration, the Introvision must be visually inspected before use for lack of insoluble particles, discoloration, and packaging integrity problems.

    Introvizone should be injected into the syringe immediately before use. Unused remnants of the drug for further use are not allowed.

    Do not mix Introviz with other medicines (you need to use a separate syringe and needle).

    When the drug is administered, the patient should be in a horizontal position. Within 30 minutes after the end of the procedure, the patient is monitored physically, because It is during this period that most adverse reactions occur.

    Intrathecal administration

    After applying myelography, the patient should be at rest for at least 1 hour, lying with a raised to 20° a headboard. If suspicion of a low threshold of seizures is necessary, follow up for 6 hours. Patients on an outpatient schedule should avoid tilting.

    The dosage of the drug depends on the type of study, the age and body weight of the patient, as well as the state of hemodynamics, the general state of health, as well as the methods used and the technique for performing the study. Typically, the same concentrations of iodine and the amounts of administration of the drug are used, as with other modern iodine-containing radiopaque agents.

    Recommended dosing regimen is given in the table below.

    Indication / Examination

    Concentration

    Scope

    Notes

    Intravenous (iv) administration

    Urography

    Adults

    300 mg iodine / ml

    or 350 mg iodine / ml

    40-80 ml

    40-80 ml

    In some cases, you can use more than 80 ml

    Children (body weight <7 kg)

    300 mg iodine / ml

    3 ml / kg


    Children (body weight> 7 kg)

    300 mg iodine/ml

    2 ml / kg

    (max 40 ml)


    Phlebography (lower limbs)

    300 mg iodine / ml

    20-100 ml per leg


    Digital substraction angiography

    300 mg iodine / ml

    or

    350 mg iodine / ml

    20-60 ml per

    1 injection

    20-60 ml per injection


    CT scan

    Adults

    300 mg iodine / ml

    or

    350 mg iodine / ml

    100-200 ml

    100-150 ml

    The total amount of iodine is usually 30-60 g

    Children

    300 mg iodine / ml

    1-3 ml / kg

    (not more than 40 ml)

    In rare cases, you can apply up to 100 ml per child, but no more than

    Intraarterial (in / a) administration

    Arteriography

    Aortic arch

    300 mg iodine / ml

    30-40 ml per

    1 injection

    Injection volume depends on the injection site

    Selective cerebral arteriography

    300 mg iodine / ml

    5-10 ml per

    1 injection

    Aortography

    350 mg iodine / ml

    40-60 ml per

    1 injection

    Femoral arteriography

    300 mg iodine / ml

    or

    350 mg iodine / ml

    30-50 ml per

    1 injection

    Other

    300 mg iodine / ml

    depends on the type of study

    Cardioangiography

    Adults:

    Left ventricle and aorta root

    350 mg iodine/ml

    30-60 ml per

    1 injection


    Selective coronary angiography

    350 mg iodine/ml

    4-8 ml per

    1 injection


    Children:

    300 mg iodine / ml

    or 350 mg iodine / ml

    depending on age, weight and pathology (max 8 ml / kg)


    Indication / Examination

    Concentration

    Scope

    Notes

    Digital subtraction angiography

    300 mg iodine / ml

    1-15 ml per

    1 injection

    Depending on the injection site, it is sometimes possible to use large volumes of up to 30 ml

    Intrathecal introduction

    Lumbar and Thoracic Myelography (lumbar injection)

    300 mg iodine / ml

    7-10 ml per

    1 injection


    Cervical myelography (lumbar injection)

    300 mg iodine/ml

    7-10 ml per

    1 injection


    Cervical myelography (lateral cervical injection)

    300 mg iodine/ml

    6-8 ml per

    1 injection


    CT Cisternography (lumbar injection)

    300 m of iodine/ml

    4-8 ml per

    1 injection


    To minimize possible adverse reactions, the total dosage of iodine should not exceed 3 g

    Introduction to the body cavity

    Hysterosalpingography

    300 mg iodine / ml

    15-25 ml


    Sialografiya

    300 mg iodine / ml

    0.5-2 ml


    Gastrointestinal tract examination

    Orally

    Adults:

    350 mg iodine / ml

    individually


    Children:

    -esophagus

    300 mg iodine / ml

    or 350 mg iodine / ml

    2-4 ml / kg body weight

    Maximum dosage 50 ml

    Premature babies:

    350 mg iodine / ml

    2-4 ml / kg body weight


    Rectal

    Children:

    Dilution with water to 100-150 mg iodine / ml

    5-10 ml / kg body weight

    Example: dilute Introviz 300 mg iodine / ml or 350 mg iodine / ml with water 1: 1 or 1: 2

    CT scan

    Orally

    Adults:

    Dilute with water to about 6 mg iodine / ml

    800-2000 ml of diluted solution for one period of time

    Example: dilute Introviz 300 mg iodine / ml or 350 mg iodine with water 1:50

    Children:

    Dilute with water to about 6 mg iodine / ml

    15-20 ml / kg body weight diluted solution


    Rectal

    Children:

    Dilute with water to about 6 mg iodine / ml

    individually


    Side effects:
    Classification of the incidence of side effects: very often> 1/10; often from> 1/100 to <1/10; infrequently from> 1/1000 to <1/100; rarely from> 1/10000 to <1/1000; very rarely from <1/10000.

    1. Common Adverse Reactions (applicable to all iodine-containing radiopaque substrates).

    The following are the main possible side effects associated with the use of non-ionic monomers. Information on the side effects inherent in the methods of use is presented below.

    The undesirable effects associated with the use of iodine-containing radiocontrast substances are usually mild and short-lived and occur less frequently when non-ionic than ionic radiopaque substances are used.

    Serious reactions, as well as cases with a fatal outcome, are very rare.

    Feelings of "heat in the whole body" or transient metalespresso "in the oral cavity.

    Seldom can there be a feeling of discomfort or pain in the abdomen (<1: 1000); infrequently - gastrointestinal reactions in the form of nausea, vomiting and diarrhea (> 1: 1000 to <1: 100).

    There are hypersensitivity reactions that usually manifest as mild breathing disorders (dyspnea, bronchospasm) or skin reactions such as rash, erythema,urticaria, itching; in some cases angioedema develops.

    Allergic manifestations can occur either immediately after the administration of the drug, or several days later.

    Often, severe skin reactions may occur in the form of Stevens-Johnson syndrome or toxic epidermal necrosis.

    Severe manifestations of hypersensitivity reactions, such as laryngeal edema, pulmonary edema and anaphylactic shock are rare.

    Anaphylactic reactions can occur regardless of the dose and mode of administration; a serious adverse reaction can begin with minor manifestations of hypersensitivity reactions. In this case, it is necessary to immediately stop the introduction of radiopaque and start, if necessary, appropriate therapy.

    Vazovagal reactions may occur in the form of arterial hypotension and bradycardia.

    Very rarely there may be an increase in temperature with the development of convulsive syndrome.

    There have been cases of temporary loss of hearing or deafness after myelography, which, apparently, is associated with a decrease in the pressure of cerebrospinal fluid due to lumbar puncture.

    Iodism, or "iodine pig" - a rare reaction to the introduction of iodine-containing radiocontrast agents, expressed in the increase and soreness of salivary glands lasting up to 10 days after the study.

    There may be "tides" of blood to the face.

    2. Adverse reactions associated with intravascular (intra-arterial and intravenous administration).

    The nature of adverse reactions observed during intra-arterial administration of radiocontrast agents depends on the site of injection and dose. With selective angiography and other studies, when the radiopaque preparation enters the body under examination at a high concentration, there may be abnormalities in the functions of this organ.

    Pain along the vessel or sensation of heat in peripheral angiography is very common (> 1:10).

    Very often, there may be a transient increase in serum creatinine, but it usually has no clinical significance. However, patients from the high-risk group described severe manifestations, up to a lethal outcome.

    Renal insufficiency develops very rarely.

    When injected into the coronary, cerebral or renal arteries, an arterial spasm can develop that leads to transient ischemia in the organ being examined.

    Neurological reactions are very rare and can manifest as seizures, transient disorders of sensitivity or motor function.

    In some reports, the contrast agent can penetrate the blood-brain barrier, resulting in accumulation of the drug in the cerebral cortex, which allows visualization of brain tissue with CT. This phenomenon can persist throughout the day the next for research, sometimes accompanied by a transient disruption of orientation in space or cortical blindness.

    Severe reactions from the cardiovascular system in the form of rhythm disturbances, reduction of myocardial contractility or ischemia myocardium are very rare.

    There may be acute respiratory symptoms and signs (including dyspnea, bronchospasm, laryngospasm, noncardiogenic pulmonary edema), cough.

    Thyrotoxicosis may develop. Patients at risk for thyrotoxicosis should be carefully examined before using iodinated radiocontrast.

    At the injection site, local soreness and radicular pain can be felt.

    Postphlebographic thrombophlebitis or thrombosis develop very rarely.

    Single cases of arthralgia are described.

    3. Adverse reactions associated with intrathecal administration.

    Adverse reactions associated with the intrathecal administration of radiocontrast agents can be delayed, and occur within a few hours or even after the study. Their frequency approximately corresponds to the frequency of complications after lumbar punctures without the introduction of radiopaque substance.

    Headache, nausea, vomiting or dizziness occur very often, and the cause of their development can be associated with a decrease in pressure in the subarachnoid space due to leakage of the cerebrospinal fluid through the puncture site. Some patients may experience a severe headache within a few days.

    Often (with a frequency of <1:10, but> 1: 100), moderate local pain, paresthesia and radicular pain at the puncture site, convulsions and pain in the legs are noted.

    In some cases, signs of irritation of the dura mater can be detected in the form of photophobia and meningism.

    The development of meningitis to administer the drug is very rare.However, the possibility of infectious meningitis should also be considered.

    Rarely there are manifestations of transient dysfunction of the central nervous system. They can be expressed at disorders of orientation, disorders of sensitivity, motor functions, convulsions. Some of these patients may experience changes in the electroencephalogram (EEG).

    Short-term loss of vision.

    There may be pain in the neck.

    4. Adverse reactions with intracavitary injection.

    General hypersensitivity reactions develop very rarely.

    Endoscopic retrograde pancreatocholangiography:

    There is often a slight increase in serum amylase activity. Rare cases of pancreatonecrosis are described.

    Oral reception: there may be gastrointestinal disorders (diarrhea, nausea, vomiting, abdominal pain).

    Hysterosalpingography (GHA): infrequent moderate and transient pain in the lower abdomen.

    Arthrography: after the study, a feeling of pressure and pain at the injection site may occur. Arthritis to administer the drug is rare.There is a risk of developing infectious arthritis.

    Gerniography: a mild pain reaction may occur after the study is completed.

    The extravascular introduction of radiopaque preparations (extravasation) in rare cases can lead to the development of local pain and swelling, which usually pass without any consequences. Cases of inflammation and even tissue necrosis are described. As a routine therapeutic measures recommended cold and elevated position of the limb. In the case of development of compression symptoms, surgical decompression is recommended.

    Overdose:

    Overdose is unlikely in patients with normal renal function. In the case of using high doses of the drug, the duration of the study (the half-life of the drug is approximately 2 hours) has a large effect on the kidneys. There is no specific antidote, treatment is symptomatic, hemodialysis is possible.

    Interaction:

    When used concomitantly with antipsychotic agents (njeroleptics), monoamine oxidase inhibitors, tetracyclic antidepressants, CNS stimulants, phenothiazine derivatives, analeptics can reduce the convulsive threshold and increase the risk of adverse reactions.

    Use of Introviz 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. Patients who took less than 2 weeks before the study of interleukin-2 are prone to an increased incidence of delayed adverse reactions (flu-like conditions or skin reactions).

    In patients taking beta-adrenoblockers, the manifestations of anaphylaxis with the use of yogexol can be atypical and mistaken for vagal reactions. Beta-adrenoblockers and other antihypertensives increase the likelihood of developing arterial hypertension.

    Introvision enhances the nephrotoxic properties of other drugs.

    Special instructions:

    Preparation of the patient and protsedupa introduction of the drug

    Before applying radiopaque, you need to obtain accurate information about the patient, including laboratory data (including serum creatinine, electrocardiogram, history of allergy and pregnancy).

    Prior to the study, the patient should eliminate disturbances in the water-electrolyte balance and ensure sufficient supply of fluid and electrolytes.

    This is especially true for patients with multiple myeloma, sugar diabetes, polyuria or gout, as well as newborns, children under one year old, and elderly patients.

    2 hours before the procedure, the patient should stop eating.

    It is not recommended to perform preliminary testing of individual sensitivity with the use of small doses of the drug, due to the risk of severe hypersensitivity reactions.

    Patients who are afraid of waiting before the procedure need premedication with sedatives.

    The risk of developing severe adverse reactions to Introviz is small.

    However, all iodine-containing radiopaque agents can cause anaphylactic reactions or other manifestations of hypersensitivity.

    For this reason, it is necessary to foresee the sequence of medical measures in case of their occurrence and to have the necessary drugs and equipment for immediate medical care.

    It is recommended to always install a cannula or catheter to ensure rapid intravenous access throughout the radiographic procedure.

    You should use a separate syringe and needle to inject the Introviz and not mix it with other drugs.

    Compared with ionic preparations, non-ionic radiopaque agents less influence in vitro on the blood coagulation system. When performing angiographic studies, one should carefully follow their methodology and often flush the catheters (for example, 0.9% solution of sodium chloride with the addition of heparin) to minimize the risk of thrombosis and embolism associated with the intervention.

    The introduction of iodine-containing radiocontrast agents may aggravate the symptoms of myasthenia gravis.

    All iodine-containing radiopaque agents distort the results of thyroid radioisotope studies (iodine-binding capacity of the thyroid tissue remains reduced within 2 weeks after administration).

    High concentrations of radiocontrast in blood plasma or urine can affect the results of biochemical tests to determine the concentration of bilirubin,proteins or inorganic substances (for example, iron, copper, calcium and phosphates). Therefore, such tests should not be performed on the day of the study.

    Patients with diabetes who take metformin, before intravascular administration of iodine-containing radiocontrast agents, drug cancellation is necessary for at least 48 hours before and within 48 hours after PProcedures.

    In emergency cases, when the kidney function is unknown, the doctor should evaluate the risk / benefit ratio of using radiopaque: stop the use of metformin, rehydrate, monitor kidney function, monitor the appearance of initial signs of lactic acidosis.

    Measures for the prevention of adverse reactions

    - Identification of patients at high risk.

    - Ensure adequate rehydration of the patient, if necessary by continuous intravenous infusion, started before the introduction of the drug and continuing until it is excreted by the kidneys.

    - Prevention of an additional burden on the kidneys arising from the use of nephrotoxic drugs, drugs for oral administration during cholecystography,clamping of the renal artery, angioplasty, or extensive surgical operations, before removal of radiopaque material from the body.

    - Repeated radiopaque studies should be performed not earlier than the moment when the kidney function is restored to its original values.

    - In patients with impaired renal and hepatic function, the clearance of the drug can be significantly reduced.

    - Patients on hemodialysis can be given radiopaque agents provided hemodialysis is performed immediately after the examination.

    Intrathecal administration

    After myelography, the patient should be in a horizontal position for 1 hour with a raised head and chest raised to 20 °. After that, the patient can walk gently, but should not bend over. If the patient remains in bed, then within 6 hours his head and chest should remain elevated. If you suspect a low convulsive threshold, the patient should remain under medical supervision during this period of time. Outpatient patients can not be left unattended in the first 24 hours after the administration of radiopaque.

    It is not recommended to use the drug in patients with local infection, septicemia.

    Contraindicated simultaneous intrathecal administration of the drug with glucocorticosteroids.

    In connection with the possibility of an overdose, an immediate reoccurrence, in the event of a technical malfunction, is contraindicated.
    Effect on the ability to drive transp. cf. and fur:It is not recommended to drive vehicles or work with any other mechanisms within the first 24 hours after the intrathecal administration of radiopaque means.
    Form release / dosage:

    Solution for injection, 300 mg iodine / ml and 350 mg iodine / ml.

    Packaging:

    To 50 or 100 ml of the preparation in a colorless glass bottle (type I), closed with a stopper of chlorobutyl rubber and crimped with an aluminum cap, top covered with a flip-open plastic lid.

    1, 6, 10 glass vials of the preparation together with the instruction for use are placed in a cardboard box.

    On 25 glass vials of the preparation together with an equal number of instructions for use are placed in a cardboard box (for hospitals).

    Storage conditions:

    In a place protected from light and secondary X-rays, at a temperature not exceeding 30 ° С.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003208
    Date of registration:22.09.2015 / 15.12.2016
    Expiration Date:22.09.2020
    Date of cancellation:2020-09-22
    The owner of the registration certificate:COMPANY VILANA, LLC COMPANY VILANA, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp26.10.2017
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