Active substanceYogic AcidYogic Acid
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  • Hexabryx 320
    solution for injections 
    Gerbe     France
  • Dosage form: & nbspinjection
    Composition:

    1 ml of the solution contains:

    Active substances:

    Yogsaglate meglumine

    393 mg

    Sodium Yogsaglate

    196.5 mg

    Excipients:

    Calcium disodium edetate

    0.1 mg

    Water for injections

    up to 1 ml

    Description:A clear, colorless or pale yellow solution.
    Pharmacotherapeutic group:X-ray contrast medium
    ATX: & nbsp

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

    Pharmacodynamics:

    Hexabrix 320 is an X-ray contrast agent for blood vessels, urinary tracts, articular cavities, uterine cavity and appendages.

    The active substances of the drug are the product of the interaction of the active ingredient of ioxagolic acid and the auxiliary components of meglumine and sodium hydroxide. Yogsaglate is the only ionic low osmolar radiopaque agent.

    Due to its influence on hemostasis, Hexabryx 320 reduces the risk of thrombus formation in catheters and conductors that are used during angioplasty. The results of several clinical studies performed in the conditions of percutaneous transluminal coronary angioplasty,suggest that Hexabryx 320 plays a role in reducing the immediate risk of thrombosis associated with this intervention.

    Pharmacokinetics:

    After intravascular injection, the drug is distributed in the circulatory system and interstitial space without marked increase in blood volume or hemodynamic equilibrium.

    It is quickly excreted through the kidneys in an unchanged form (not metabolized) by glomerular filtration. Due to low osmolality of solution, osmotic diuresis is very low.

    In patients with renal insufficiency, the drug can be excreted through alternative routes - bile ducts, salivary glands, sweat and large intestine.

    The components that make up the drug can be removed by dialysis.

    Indications:

    - Intravenous urography.

    - Angiography of any location, including cerebral and coronary angiography.

    - Arthrography.

    - Hysterosalpingography.

    - Sialografiya.

    Contraindications:

    - Subarachnoid or epidural administration, as it can cause seizures and lead to death.

    - Expressed thyrotoxicosis.

    - Hypersensitivity to yoxagolic acid or to any of the components of the drug.

    - Hysterosalpingography during pregnancy or in the presence of an acute inflammatory process in the abdominal region.

    Carefully:

    It is recommended to be careful in patients with severe hepatic insufficiency, chronic heart failure, severe respiratory failure, having anamnestic reactions (hay fever, food allergy), bronchial asthma, diabetes mellitus, myeloma, hyperuricemia, pheochromocytoma, emphysema.

    Pregnancy and lactation:

    In animal experiments, the teratogenic effect was not detected was.

    Isolated overloading of the body with iodine after the administration of the contrast preparation can theoretically lead to a disruption of thyroid function in the fetus, if the examination is performed 14 weeks after the termination of menstruation. However, given the reversibility of this effect and the expected benefit for the mother associated with a thorough examination of any pathology, conducting an examination during pregnancy seems justified.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 because of its need.

    Since there are no data on the passage of the drug into breast milk, breast-feeding should be temporarily stopped for at least 24 hours.

    Dosing and Administration:


    Adults

    Dchildren


    Indications

    Average dose

    Total dose

    Average dose

    General information

    dose

    Comments

    Intravenous urography

    1 ml / kg

    50 to 150 ml

    More than 1 year:

    2 ml / kg;

    Up to 12 kg:

    2 ml / kg


    The dose of the drug should be chosen depending on the body weight of the patient and kidney function. The patient should be able to fasting, but the fluid intake should not be limited.

    Up to 1 yeara:

    2-4 ml / kg;

    More than 12 kg:

    1,5 ml / kg, min. 24 ml.


    Older than 10 years: lowest dosage level for adults

    Angiography

    <4-5ml / kg, divided into repeated injections

    Do not exceed 100 ml in each injection

    > 1 year: 4 ml / kg


    The rate of injection depends on type of survey.

    <1 year: 4-8 ml / kg

    Arthrography

    - knee

    10 ± 2 ml

    8 to 10 ml, double contrast: 3 to 5 ml

    2 to 4 ml / kg

    1 to 2 ml


    - Shoulder

    Up to 10 ml, double contrast: up to 5 ml

    - thigh

    Up to 5 ml; up to 20 ml after replacement by the endoprosthesis of the femoral neck

    - ankle joint

    Up to 5 ml

    - elbow

    Up to 5 ml; double contrast: up to 1 ml

    - Brush and finger

    0.5 to 2 ml

    Hysterosalpingography


    From 10 to 20 ml, depending on the volume of the uterine cavity



    Slow introduction through the cervix with a syringe or cannula

    Sialografiya

    3 ml

    1 to 6 ml



    Intra-flow introduction to the excretory ducts of the glands.

    Side effects:

    Like all iodine-containing contrast agents, Hexabryx 320 can cause mild, severe or even lethal reactions. These reactions are always unpredictable, but are more frequent in patients with an allergy or anxiety history, or in patients who had a hypersensitivity reaction during an earlier survey using iodine-containing contrast. The test for sensitivity to iodine does not allow to predict the development of these reactions.

    There can develop non-hazardous reactions: a feeling of heat, tidal flow, less often - nausea and vomiting. These reactions are transitory and go without consequences.

    More serious reactions, which often occur quickly, but can also be delayed,include skin symptoms, respiratory tract disorders, neurosensory and gastrointestinal disorders, which can be observed either singly or in combination.

    In some cases, fever and chills may be associated with these symptoms or occur independently.

    Adverse effects associated with specific uses:

    - pain in the pelvic region and fainting during hysterosalpingography;

    - moderate and passing pain with intraarticular administration and / or intraarticular exudation in arthrography.

    Overdose:

    As a result of an overdose, cardiorespiratory insufficiency and renal failure may occur.

    The functions of the basic vital organs should be restored by an emergency appointment of symptomatic treatment. Violation of the water-electrolyte balance can be compensated by conducting rehydration. The function of the kidneys should be observed for a minimum of three days. If necessary, hemodialysis is performed.

    Interaction:

    Significant interactions of Hexabrix 320 with other drugs have not been identified, however,this medication should not be confused with others when administered.

    Combinations of drugs that require precaution:

    Beta-blockers:

    In the case of development of shock or lowering of arterial pressure with the administration of yoxagolic acid, beta-adrenoblockers suppress compensatory reactions from the side of the cardiovascular system.

    Before the X-ray examination, the use of beta-blockers should be stopped, if possible. If continuity of therapy is extremely important for the patient, you should have appropriate resuscitation equipment at hand.

    Diuretics:

    If diuretics caused dehydration, this increases the risk of developing acute renal failure, especially when using large doses of yogic acid. Before administering yoxagolic acid, the patient should be rehydrated.

    Metformin:

    In patients with diabetes mellitus, a decrease in renal function caused by an X-ray examination may be a trigger factor in the development of lactic acidosis. Metformin should be temporarily discontinued 48 hours before and resumed only 2 days after the X-ray examination.

    Combinations of drugs that should be taken into account:

    Interleukin II:

    The risk of developing a reaction to the administration of contrast agents is increased if the patient previously received intravenous therapy with interleukin II: skin rash or, less often, lower blood pressure, oliguria and even kidney failure.

    Special instructions:

    Due to the risk associated with the use of the drug, the physician must provide constant medical supervision and maintain a venous access throughout the procedure of the examination. At the ready there should always be equipment for emergency resuscitation.

    In patients with renal insufficiency, diabetes mellitus, myeloma, hyperuricemia, children under 7 years of age, and in patients with atherosclerosis, it is important to avoid dehydration before the examination and to maintain sufficient diuresis.

    Effect on the ability to drive transp. cf. and fur:

    Perhaps the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed psychomotor reactions taking into account the profile of side effects, therefore use with caution.

    Form release / dosage:Injection.
    Packaging:

    For 10, 20, 50, 100 or 200 ml in glass bottles (type II), sealed with butyl rubber stoppers, crimped with aluminum caps with plastic lids.

    Vials of 100 and 200 ml are graduated in ml and are either covered with a transparent film with a holder at the bottom of the vial (the label of the vial is pasted over the film) or the label has a detachable part used as a holder.

    One bottle of 10, 20, 50, 100 or 200 ml is placed in a cardboard box together with instructions for use.

    Packing for hospitals:

    25 bottles of 10, 20, 50 ml or 10 bottles of 100 or 200 ml are placed in a cardboard box together with instructions for use.

    Storage conditions:

    Store in a place protected from light and out of the reach of children, at a temperature not exceeding 30 ° C.

    Shelf life:

    3 years.

    Do not use after the date shown on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N008678
    Date of registration:31.01.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:GerbeGerbe France
    Manufacturer: & nbsp
    GUERBET France
    Representation: & nbspNGO ASTA, CJSCNGO ASTA, CJSCRussia
    Information update date: & nbsp17.03.2017
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