Active substanceYogexolYogexol
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  • Dosage form: & nbspinjection
    Composition:

    Per 1 ml of the preparation:

    Solution for injection 300 mg iodine / ml:

    active substance: yogexol 647.00 mg (in terms of iodine 300.00 mg);

    Excipients: trometamol 1,21 mg, sodium calcium edetate 0.10 mg, hydrochloric acid to a pH of 7.25±0.25, water for injection up to 1 ml.

    Solution for injection 350 mg iodine / ml:

    active substance: yogexol 755.00 mg (in terms of iodine 350.00 mg);

    Excipients: trometamol 1,21 mg, sodium calcium edetate 0.10 mg, hydrochloric acid to a pH of 7.25±0.25, water for injection up to 1 ml.

    Description:Transparent, colorless or light yellow liquid.
    Pharmacotherapeutic group:X-ray contrast medium
    ATX: & nbsp

    V.08.A   Radiocontrast iodine-containing substances

    Pharmacodynamics:

    Physico-chemical characteristics of the preparation:

    Concentration of iodine (mg / ml)

    300

    350

    Osmolality (mOsm / kg H2О) at a temperature of 20 ° С

    605-739

    760-928

    Viscosity (mPa.from) at a temperature of 20 ° C

    11,6

    23,3

    at a temperature of 37 ° C

    6,1

    10,3

    Value pH

    6,8-7,7

    6,8-7,7

    Density (g / cm2)3) at a temperature of 20 ° C

    1,300-1,360

    1,370-1,430

    Pharmacodynamics

    Yogexol is a non-ionic, triiodinated, water-soluble radiocontrast agent.

    In the study of healthy volunteers after intravenous injection of yogexol, no significant deviations were found in the majority of hemodynamic parameters, clinical-biochemical indices and coagulation parameters.

    Time to achieve maximum radiopaque in normal myelography - up to 30 minutes (after 1 h no longer visualized). Computed tomography imaging (CT) visualization of the contrast in the thoracic region is possible within 1 hour, the cervical region - about 2 hours, basal cisterns - 3-4 hours. Contrasting of the joint cavities, uterine cavity, fallopian tubes, peritoneal protrusions, pancreatic and bile ducts, the bladder is reached immediately after administration.

    Pharmacokinetics:

    Approximately 100% of injected yogexol is excreted unchanged through normally functioning kidneys for 24 hours. The maximum concentration of iohexol in the urine is determined 1 h after the injection.

    The half-life of the drug in patients with normal renal function is about 2 hours. Metabolites of the drug are not established. The binding of yogexol to plasma proteins is not clinically important (less than 2%) and therefore may not be taken into account.

    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, total clearance - 109 ml / min.

    The maximum level of concentration in the blood (CmOh) - 119 μg / ml, time to reach the maximum concentration in the blood (TSmOh) - 2-6 hours. The volume of distribution is 157 ml / kg. Half-life (T1/2) - 3-4 hours.

    Indications:

    The drug is intended for diagnostic purposes only!

    Radiopaque preparation for use in children and adults for cardioangiography, arteriography, urography, phlebography and contrast enhancement in CT; with lumbar, thoracic and cervical myelography,CT-cisternography after subarachnoidal administration; arthrography, hysterosalpingography, sialography and gastrointestinal tract (GIT) studies.

    Contraindications:

    Hypersensitivity to iodine or other components of the drug.

    Thyrotoxicosis.

    Epilepsy and cerebral infections (for subarachnoidal administration).

    Carefully:

    - If there is a history of allergy, bronchial asthma or other undesirable reactions to iodine-containing radiopaque agents. Premedication with glucocorticosteroids or H blockers is recommended.1 and H2-gistaminovyh receptors.

    - In the study of patients with severe cardiovascular diseases and pulmonary hypertension due to the risk of developing hemodynamics 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 who suffer from alcoholism or drug dependence.

    - In the study of patients with combined disorders of the liver and kidneys, as they significantly reduced the clearance of radiopaque means.

    - In the study of patients at high risk for patients with impaired renal function, diabetes mellitus, patients with paraproteinaemia (myelomatosis and Waldenstrom macroglobulinemia); after the introduction of radiopaque means, special attention should be paid to them in order to prevent the development of acute renal failure.

    - When examining patients with thyrotoxicosis, especially patients with multinodular goiter (because of the risk of developing hyperthyroidism). With the introduction of radiopaque means for premature infants, the possibility of transient hyperthyroidism should be considered.

    - In the study of patients with hypovolemia. It is necessary to ensure adequate rehydration, at least 100 ml every hour for 4 hours before the test 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. It is necessary to conduct adequate rehydration before and after the introduction of radiopaque.

    - When examining patients with diabetes, receiving metformin. Before intravascular administration of yogexol, the drug should be discontinued for at least 48 hours before and within 48 hours after the procedure.In emergency cases, when renal function is unknown, the physician should assess the risk / benefit ratio of using radiopaque: stop the use of metformin, rehydrate, monitor kidney function, monitor the appearance of signs of lactic acidosis.

    - In the study of patients with pheochromocytoma. It is necessary to evaluate blood pressure during the procedure to prevent the development of hypertensive crisis.

    - In the study of patients with multiple sclerosis, sickle-cell dark, obliterating thromboangiitis (Buerger's disease), acute thrombophlebitis, severe atherosclerosis.

    - When carrying out angiography in patients with homocystinuria (risk of thrombosis and embolism), chronic emphysema of the lungs.

    - When performing urography in patients with severe renal dysfunction and patients with combined impairment of liver and kidney function.

    Pregnancy and lactation:

    The safety of the drug during pregnancy is not established. The drug should not be used in pregnant women, except when 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.

    Radiopaque remedies fall insignificantly into breast milk. Therefore, the risk to the child is unlikely. It is necessary to stop the period of breastfeeding before the introduction of the drug and resume no earlier than 24 hours after the application of the drug Yogexol TR.

    Dosing and Administration:

    For intra-arterial, intravenous, intrathecal, intracavitary, oral administration and rectal administration to adults and children.

    When the drug is administered, the patient should be in a horizontal position. The dose of the drug depends on the method of study, age, body weight, the general condition of the patient and the technique of performing the drug.

    Recommended dosing regimen is given in the table below:

    Indications

    Concentration, mg iodine / ml

    Scope

    preparation, ml

    special instructions

    Intravenous administration

    Urography

    Adults

    300 or 350

    40-80

    In some cases, the administration of more than 80 ml

    Children (body weight <7 kg)

    300

    3 ml / kg

    Children (body weight> 7 kg)

    300

    2 ml / kg

    (max 40 ml)

    Phlebography (lower limbs)

    300

    20-100 (per limb)

    Digital subtraction angiography

    300 or 350

    20-60 ml / per injection

    Gain at CT

    Adults

    300

    100-200

    The total amount of iodine is usually 30-60 g

    350

    100-150

    Children

    300

    1-3 ml / kg (up to 40 ml)

    In some cases, it is possible to administer up to 100 ml, but no more than

    Intraarterial administration

    Arteriography:

    Aortic arch

    300

    30-40

    Volume per one injection depends on the place of administration

    Selective cerebral angiography

    300

    5-10 ml / per injection

    Aortography

    350

    40-60 ml / per injection

    Angiography of the femoral arteries

    300 or 350

    30-50 ml / per injection

    Other types

    300

    depends on the research method

    Cardioangiography

    Adults

    Left ventricle

    Aortic root

    350

    30-60 ml / per injection

    Selective

    coronary angiography

    350

    4-8 ml / per injection

    Dchildren

    300 or 350

    Max. 8 ml / kg

    The dose depends on age, body weight and disease

    Digital subtraction angiography

    300

    1-15 ml / per injection

    Depending on the site of application, volumes up to 30 ml

    Intrathecal administration

    Lumbar and thoracic myelography

    300

    6-10

    Lumbar introduction

    Cervical myelography

    300

    7-10

    Lumbar introduction

    300

    6-8

    Cervical introduction

    CT Cisternography

    300

    3-10

    Lumbar introduction

    Intracavernal administration

    Arthrography

    300

    5-15

    350

    5-10

    Guystereosylpinography

    300

    15-25

    Sialografiya

    300

    0,5-2

    Oral administration

    Gastrointestinal

    Adults

    350

    individually

    Children

    (esophagus)

    300 or 350

    2-4 ml / kg

    The maximum dose of 50 ml

    Premature babies

    350

    2-4 ml / kg

    Gain at CT

    Adults

    Dilute with water

    800-2000 ml of the resulting solution

    For example: dissolve Yogexol TR 300 or Yogexol TP 350 with water 1:50.

    Children

    to a concentration of about 6 mg iodine / ml

    15-20 ml of the resulting solution / kg body weight

    Rectal administration

    Children

    Gain at CT

    Dilute with water to a concentration of about 6 mg iodine / ml

    Selectable

    individually

    For example: dilute Yogexol TR 300 or Yogexol TR 350 with water 1:50.

    Children

    Gastrointestinal

    Dilute with water to a concentration of 100-150 mg iodine / ml

    5-10 ml / kg of the obtained solution

    For example: dilute Yogexol TR 300 or Yogexol TR 350 with water 1: 1 or 1: 2

    Side effects:

    1. General adverse reactions

    The undesirable consequences associated with the use of nonionic radiocontrast agents usually have a moderate or mild degree of clinical manifestation, are short-lived and are recorded at a lower frequency than with ionic radiopaque agents.

    General reactions: sensation of "heat in the whole body" or a transient "metallic" taste in the mouth, fever with the development of convulsive syndrome, "tides" of blood to the face, iodine parotitis (iodism) - reaction to the introduction of radiopaque agents containing iodine (it can manifest as an increase in the size and pain of the salivary gland for up to 10 days after the examination).

    Disturbances from the digestive tract: nausea, vomiting, diarrhea, discomfort and pain in the abdomen.

    Skin and subcutaneous tissue: eruptions, erythema, pruritus, urticaria, toxic skin reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis.

    Immune system disorders: angioedema and rarely - anaphylactic shock, anaphylactoid reactions, including anaphylaxis.

    Disorders from the cardiovascular system: vasovagal reactions in the form of arterial hypotension and bradycardia.

    Disturbances from the respiratory system, thoracic and mediastinal disorders: shortness of breath, bronchospasm, laryngeal edema, pulmonary edema.

    2. Adverse reactions associated with intravascular injection

    The nature of adverse reactions that may occur during intra-arterial administration of radiopaque means depends on the site of injection and dose. With selective angiography and other studies, when the radiocontrast means penetrates the organ under investigation, abnormalities of the functions of this organ can be observed.

    When introduced into the coronary, cerebral and renal arteries, arterial spasm can develop, leading to transient ischemia in the organ under investigation.

    Common reactions: delayed pain or sensation of heat occurs in peripheral angiography: the radiocontrast can penetrate the blood-brain barrier, resulting in accumulation of the drug in the cerebral cortex and its visualization with CT.

    Disorders from the cardiovascular system: arrhythmias, decreased myocardial contractile function or myocardial ischemia, post-venereal thrombophlebitis, thrombosis.

    Disorders from the musculoskeletal system and connective tissue: arthralgia.

    Disturbances from the nervous system: convulsions, transient disorders of sensitivity, transient impairment of motor functions, impaired orientation in space, cortical blindness.

    Disorders from the urinary system: renal insufficiency.

    Disturbances from the respiratory system, thoracic and mediastinal disorders: laryngospasm, bronchospasm, dyspnea, noncardiogenic pulmonary edema, cough.

    Disorders from the endocrine system: patients with a risk of developing thyrotoxicosis should be carefully examined before using an X-ray contrast agent containing iodine. Perhaps the development of thyrotoxicosis.

    Violations from laboratory indicators: increase serum creatinine concentration.

    Reactions at the site of administration: pain along the vessels and sensation of heat in peripheral angiography.

    3. Adverse reactions associated with from intrathecal administration

    Adverse reactions may occur several hours or days after intrathecal administration. Their frequency approximately corresponds to the frequency of complications after lumbar punctures without the introduction of radiopaque means. Possible reactions at the injection site.

    Disturbances from the nervous system: headache (even for several days), dizziness, local pain, paresthesia and radicular pain at the puncture site, convulsions, photophobia, meningitis, meningitis, including infectious, disorientation, sensitivity disorders, impaired motor functions.

    Disturbances from the digestive tract: nausea, vomiting.

    Disorders from the cardiovascular system: change electrocardiograms.

    Vision disorders: short-term loss of vision.

    Disorders from the musculoskeletal system: pain in the neck, pain in the legs.

    4. Adverse reactions, laced with intracavitary injection

    Immune system disorders: general hypersensitivity reactions.

    Endoscopic retrograde pancreatocholangiography

    Violations from laboratory indicators: an increase in the activity of amylase in the blood serum.

    Disturbances from the digestive tract: pancreatic necrosis.

    Oral administration

    Disturbances from the digestive tract: diarrhea, nausea, vomiting, discomfort and pain in the abdomen.

    Hysterosalpingography

    Disturbances from the digestive tract: moderate and rapidly passing pain in the lower abdomen.

    Arthrography

    Disorders from the musculoskeletal system and connective tissue: arthralgia, arthritis, including infectious arthritis.

    Gerniography

    Common violations: pain after the study.

    Extravasation (extra-vascular reduction of radiocontrast preparations)

    In rare cases, it can lead to the development of local pain and swelling, which usually occur 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:

    The risk of developing symptoms of an overdose is minimal, unless more than 2000 mg of iodine / kg is injected into the patient for a short time. A prolonged procedure with high doses of the drug may affect the function of the kidneys (half-life - 2 h). Accidental overdose of the drug is most likely when performing complex angiographic procedures in children, especially in cases of multiple injection of the drug in high concentrations.

    In case of an overdose it is necessary to correct the disturbances of the water-electrolyte balance and monitor the function of the kidneys during the next three days. If necessary, hemodialysis should be used. There is no specific antidote.

    Interaction:

    Phenothiazine derivatives and other antipsychotic drugs (neuroleptics), monoamine oxidase inhibitors, tricyclic antidepressants,stimulants of the central nervous system, analeptics reduce the epileptic threshold and increase the risk of epileptic seizures.

    In patients taking beta-adrenoblockers, manifestations of anaphylaxis can be atypical and can be mistaken for vagal reactions. Beta-adrenoblockers and other antihypertensive drugs increase the likelihood of developing hypertension.

    The use of radiopaque substances in patients with diabetic nephropathy can lead to reversible renal dysfunction and lactic acidosis. To prevent this, it is necessary to stop taking biguanides 48 hours before the test and begin it after complete stabilization of kidney function.

    Patients who received less than 2 weeks prior to interleukin-2 study tend to have delayed adverse reactions (flu-like condition or skin reactions).

    Yogexol TP can enhance the nephrotoxic properties of other drugs and (with intrathecal administration) is incompatible with glucocorticosteroids.

    Special instructions:

    Before applying radiopaque means, you need to obtain accurate information about the patient,taking into account important laboratory data (serum creatinine concentration, electrocardiogram, allergy and pregnancy).

    Before the study, the patient must eliminate violations of the water-electrolyte balance and ensure sufficient supply of fluid and electrolytes.

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

    A high concentration of radiocontrast agents in blood serum and urine can influence laboratory results of bilirubin, proteins and inorganic compounds (for example, iron, copper, calcium, phosphates), so laboratory tests should not be carried out on the same day.

    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 and funds.

    Before use, the iohexol TP should be visually inspected for insoluble particles, discoloration, and packaging integrity.

    It is necessary to use a separate syringe and needle for the administration of the drug Yogexol TP and not to mix with other diagnostic and medicinal products.

    Yogexol TP is injected into the syringe immediately before use. Unused residue for further use is not allowed.

    The risk of serious adverse reactions to Yogexol TP is very low. However, radiopaque substances containing iodine, can cause anaphylactic reactions or other manifestations of hypersensitivity. For this reason, it is necessary to determine in advance the sequence of treatment measures in case of adverse reactions and to have the necessary drugs and equipment for immediate medical care. It is recommended to always install a cannula or an intravenous catheter for the time of the radiopaque study to facilitate rapid intravenous administration of medications.

    Presence in the anamnesis of an allergy, a bronchial asthma and undesirable reactions to radiopaque preparations containing iodine, requires increased attention.In these cases, it is necessary to consider the possibility of premedication of glucocorticosteroids and H blockers1 and H2-gistaminovyh receptors.

    In comparison with ionic preparations, non-ionic radiocontrast agents are less influential in vitro on the blood coagulation system. When carrying out angiographic studies, one should very carefully adhere to their methods and often flush the catheter (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.

    Before and after the introduction of the radiopaque preparation it is necessary to ensure adequate saturation of the organism of the liquid being examined. This is of particular importance for patients with myeloma, Waldenstrom macroglobulinemia, diabetes mellitus, impaired renal function, and also for children and the elderly. In children up to one year, and especially in newborns, the violation of hemodynamics and water-electrolyte balance is particularly easy.

    One should be careful when examining patients with severe cardiovasculardiseases and pulmonary hypertension due to the risk of heart rhythm disturbances and hemodynamic disorders.

    Patients with acute cerebral pathology, brain tumors and epilepsy are prone to developing seizures and require special attention.

    The risk of seizures and neurological reactions in patients with alcoholism and drug dependence is increased.

    There were rare cases of temporary loss of hearing or deafness after myelography, which is probably due to a decrease in pressure of cerebrospinal fluid due to lumbar puncture.

    To prevent the development of acute renal failure associated with the introduction of radiocontrast agents, special care is needed in the examination of patients already having impaired renal function and diabetes mellitus and belonging to the risk group. The same applies to the examination of patients with paraproteinaemia (myeloma, Waldenstrom's macroglobulinemia).

    Measures to prevent adverse reactions:

    - identification of patients at risk;

    - ensuring adequate rehydration, if necessary, this can be achieved with the help of a continuous intravenous infusion,which began before the introduction of radiopaque preparation and continues until the moment of its excretion by the kidneys;

    - prevention of an additional burden on the kidneys arising from the use of nephrotoxic drugs, oral medicines for cholecystography, clamping of the renal arteries, angioplasty of the renal arteries, surgical operations - to removing the radiopaque substance from the body;

    - repeated radiopaque studies should be performed after complete normalization of kidney function after the last administration of the drug.

    To prevent lactic acidosis in patients with diabetes mellitus, metformin, before intravascular administration of an X-ray contrast agent containing iodine, it is necessary to determine the concentration of creatinine in the blood serum.

    Normal serum creatinine concentration / normal renal function: taking metformin should be discontinued during the introduction of radiopaque and do not resume for 48 hours or until the restoration of renal function / serum creatinine to normal levels.

    Reduction of creatinine concentration / impaired renal function: should stop taking metformin and delay the examination with radiopaque for 48 hours. Metformin therapy is resumed only if the kidney function or serum creatinine concentration remains unchanged.

    In urgent cases, at which there is a violation of kidney function, the doctor should evaluate the risk / benefit ratio for the patient from the use of the drug and apply preventive measures: stop taking metformin, restore the water-salt balance, monitor kidney function and observe the symptoms of lactic acidosis in patients.

    Particular care should be taken with patients who have severe combined renal and hepatic impairment, as they have a significant reduction in the clearance of radiocontrast substances. It is possible to conduct radiopaque studies of patients who are on hemodialysis, provided that dialysis will be performed immediately after the study.

    When using invasive studies and interventions in patients with pheochromocytoma, prophylactic use of alpha-adrenoblockers is necessary to prevent hypertensive crises.

    Need special care when examining patients with hyperthyroidism. In patients with multinodular goitre after the administration of radiopaque agents containing iodine, there is a risk of developing hyperthyroidism. It should be remembered about the possibility of development in connection with the introduction of radiopaque substances of transient hyperthyroidism in premature infants.

    The output of radiopaque means from the vessels in rare cases was accompanied by local pain and swelling, which took place without consequences. However, cases of inflammation and tissue necrosis are documented. As a general measure, it is recommended that the injection site be raised and cooled as much as possible. In case of development of compartmental syndrome, surgical decompression is possible.

    Patient monitoring

    After the introduction of the radiopaque drug, the patient should be observed for at least 30 minutes, since most adverse reactions occur during this time.

    Intrathecal administration

    After performing myelography, the patient should be at rest for at least 1 hour, lying with his head raised up by 20 ° and chest. After this, the patient can be transferred to an outpatient regime, but should avoid slopes.When maintaining bed rest, the raised position of the head and chest should be maintained during the first 6 hours. If suspicion of a low threshold of seizures is necessary to monitor the patient during this period of time. Ambulatory patients should remain under observation for the first 24 hours after the study.

    He recommended use of 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, in the event of a technical malfunction, an immediate re-run of myelography 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 during the first 24 hours after the administration of the drug.

    Form release / dosage:

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

    Packaging:

    Solution for injection 300 mg iodine / ml.

    For 20, 50, 100 or 200 ml of the drug in vials of colorless glass, sealed with rubber stoppers and crimped with aluminum caps.

    For 1 bottle of 20, 50, 100 or 200 ml, along with the instructions for medical use, put in a pack of cardboard.

    For hospitals, 10 bottles with a volume of 20, 50 or 100 ml, along with instructions for medical use, are placed in a carton box.

    For hospitals with 28 bottles of 200 ml, along with instructions for medical use, are placed in a cardboard box.

    Solution for injection 350 mg iodine / ml.

    To 20, 50. 100 or 200 ml of the drug in vials of colorless glass, sealed with rubber stoppers and crimped with aluminum caps.

    For 1 bottle of 20, 50, 100 or 200 ml, along with the instructions for medical use, put in a pack of cardboard.

    For hospitals, 10 bottles with a volume of 20, 50 or 100 ml, along with instructions for medical use, are placed in a carton box.

    Storage conditions:

    In a place protected from light and secondary X-rays, at a temperature of no higher than 25 ° C.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003107
    Date of registration:21.07.2015 / 31.01.2017
    Expiration Date:21.07.2020
    Date of cancellation:2020-07-21
    The owner of the registration certificate:MOSFARM, OJSC MOSFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.11.2017
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