Clinical and pharmacological group: & nbsp

Radiopaque means

Included in the formulation
  • Hexabryx 320
    solution for injections 
    Gerbe     France
  • АТХ:

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

    Pharmacodynamics:
    X-ray contrast medium with low osmolarity. The iodine content is 320 mg / ml, the osmolarity is 600 mOsm / kg, the viscosity at 37 ° C is 7.5 mPa / s.
    Organic iodine compounds absorb X-rays and, selectively accumulating in separate structures of the body, provide a high degree of their opacity, highlighting them against the background of other structures that do not contain iodine. The degree of contrast is directly proportional to the concentration of the iodine-containing contrast agent in the tissue. After intravascular injection, the blood vessels are consistently contrasted, allowing visualization of their internal structure before the onset of significant hemodilution. When instillation in the uterus and fallopian tubes allows you to visualize the internal structure of the latter. It also provides contrasting vessels, urinary tracts, joint cavities, ducts of the salivary glands. Compared with ionic triiodinated contrast agents, it has less osmotic effect and does not lead to a significant increase in diuresis.
    Due to its effect on hemostasis, the drug reduces the risk of thrombus formation in catheters and conductors that are used during angioplasty. The results of several clinical studies conducted in percutaneous transluminal coronary angioplasty suggest that the drug plays a role in reducing the immediate risk of thrombosis associated with this intervention.
    Pharmacokinetics:
    When intravenous and intra-arterial administration is distributed in the vascular system and interstitial space. Not exposed to metabolism. It is excreted by the kidneys (by glomerular filtration) in unchanged form; with chronic renal failure - through the biliary tract, salivary and sweat glands.
    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:Urography, angiography (including cerebral and coronary), arthrography, hysterosalpingographia, sialografiya, research of the intestinal tract.

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

    Contraindications:Hypersensitivityhyperthyroidism, subarachnoidale and epidural administration. Hysterosalpingographs during pregnancy or in the presence of an acute inflammatory process in the abdominal region.
    Carefully:Allergic diseases (eczema, hay fever, food allergy); hepatic insufficiency, cardiac and / or respiratory failure. Brohnhialnaya asthma, diabetes mellitus, myeloma, hyperuricemia, pheochromocytoma, emphysema.
    Pregnancy and lactation:

    FDA recommendation category B for intravascular injection, for hysterosalpingography the category is not defined. Penetrates through the placenta; controlled studies on humans have not been carried out, however other organic iodine-containing substances when injected into the amnion cavity may cause hypothyroidism in some newborns. Also, any x-ray examination of the abdominal cavity is not recommended to avoid fetal irradiation, intrauterine injection during and for 6 months after termination of pregnancy(increased risk of complications and infection).

    In unchanged form is excreted by breast milk. It is recommended to temporarily stop breastfeeding within 24 hours after the administration of yogic acid.

    Dosing and Administration:Intravenous and intra-arterial. Angiography: dose and rate of administration depend on the nature of the study; the total dose for fractional administration is 4-5 ml / kg (not more than 100 ml per each administration). Arthrography: 8-12 ml (depending on the joint being examined). Hysterosalpingographia: 10-20 ml (depending on the volume of the uterine cavity). Sialography: 1-6 ml. Urography: doses are selected individually, taking into account the patient's body weight and kidney function.
    Side effects:

    Heat in the larynx, abdomen and pelvis, skin hyperemia; nausea, vomiting; allergic reactions (including anaphylactic shock). Subarachnoid and epidural administration can lead to the development of seizures and death.

    More serious reactions that often occur quickly but can 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:

    - pelvic pain and fainting during hysterosalpingography;

    - moderate and passing pain with intra-articular injection and / or intraarticular exudation during arthrography.

    Overdose:Overdose may result in cardiorespiratorydeficiency and renal insufficiency. The functions of the basic vital organs should be restored by an emergency prescription of symptomaticabout the treatment. Violation of water-electrolytebalance can be compensated for by rehydration. The function of the kidneys should be observed for a minimum of three days. If necessary, hemodialysis is performed.
    Interaction:

    β-Adrenoblockers - may increase the risk of moderate severity and severe anaphylactoid reactions and increase the hypotensive effect in parallel application; in patients with risk factors, it is recommended that β-blockers be discontinued before radiocontrast agents are introduced.

    Biguanides - treatment with biguanides should be canceled 2 days before the X-ray examination and should not be renewed earlier than 2 days after it.

    Vasopressors - it is possible to increase the frequency and severity of neurological side effects, including irreversible paralysis, when combined with arteriography of the brain, spine, blood vessels supplying the spinal cord, using yoksagolic acid; when administered after the use of hypertensive drugs, spasm of the vessels of the internal organs leads to an increase in the intake of radiopaque means in the bloodstream of the brain and spinal cord with an increase in the frequency of neurological side effects.

    Diuretics - increase the risk of acute renal failure.

    Interleukin-2 - may increase the frequency of delayed (after 1 hour after administration) reactions to radiopaque agents (hypersensitivity, fever, skin rashes, flu-like syndrome, pain in the joints, itching, vomiting, hypotension, dizziness) with parallel application; In severe cases, supportive therapy may be required; administration of radiopaque agents 6 weeks after the administration of interleukin-2 reduces the frequency of these reactions.

    Metformin - with the simultaneous use of metformin may develop laktatatsidoza (in patients with diabetes mellitus).

    Nephrotoxic agents (aldesleukin, aminoglycosides (for parenteral administration or topically for damaged mucous membranes), amphotericin B (for parenteral use), amphotericin B liposomal, paracetamol (in high doses), paracetamol in combination with acetylsalicylic acid or other salicylates (with prolonged high-dosage therapy), acyclovir (for parenteral administration), bacitracin (for parenteral administration), vancomycin (for parenteral administration), deferoxamine (with prolonged use), ifosfamide, capreomycin, carmustine, methotrexate (in high doses), methoxyflurane, sodium calcium edetate (in high doses), neomycin (with oral administration), non-steroidal anti-inflammatory drugs, oxaliplatinum, gold preparations, lithium preparations, pamidronic acid, penicillamine, pentamidine, polymyxins (for parenteral use), radiocontrast iodine-containing water-soluble drugs (for intravascular administration), rifampicin, means for oral cholecystography, streptozocin, a combination of sulfamethoxazole and trimethoprim, sulfonamides (for systemic use), tacrolimus, tetracyclines (with the exception of doxycycline and minocycline), tretinoin, phenacetin, sodium foscarnet, ciprofloxacin, cisplatin, cyclosporin] - it is possible to enhance the nephrotoxicity of yogsaglic acid with intraluminal or intravascular administration with parallel application.

    Drugs for oral cholecystography - may increase the risk of nephrotoxicity, especially if the liver function is impaired.

    Blood pressure lowering agents [β-adrenoblockers, aldesleukin, alprostadil, amantadine, amifostine, general anesthetics, antidepressants, MAO inhibitors, tricyclic antidepressants, antihypertensives, benzodiazepines used for premedication, calcium channel blockers, brethil tosylate, bromocriptine, haloperidol, hydralazine, deferoxamine (at a dose of more than 15 mg / kg per day, administered intravenously), diuretics, droperidol, ACE inhibitors, cabergoline, calcium-containing infusion solutions, carbidopa, quetiapine, acid gadopentetovaya, clozapine, contrast agents paramagnetic, contrast agents superparamagnetic, levodopa, lidocaine (for systemic use), loxapine, magnesium sulfate (for parenteral administration), mirtazapine, molindone, narcotic analgesics, sodium calcium edetate, nitrates, nitrites, olanzapine, paclitaxel, pentamidine, pentoxifylline, pimozide, pramipexole, procainamide, propofol, protamine (with very rapid administration), ranitidine, bismuth citrate, radiocontrast water-soluble agents, organic iodides (for intravascular application), risperidone, rituximab, ropinirole, thioxanthenes, tizanidine, tokainid, tolcapone, thrombolytic agents, phenothiazines, quinidine, ethanol] - may increase the risk of severe hypotension with parallel application.

    Pharmaceutically incompatible with other drugs when mixed in a single syringe or infusion system.

    Special instructions:

    During the study, constant monitoring of the heart rate and blood pressure, constant access to the venous bed for emergency treatment of possible adverse reactions is necessary.Before the study, it is recommended to avoid dehydration and maintain copious diuresis in patients with renal insufficiency, diabetes, myeloma, hyperuricemia, in children and elderly patients. Individual dosage adjustment of yogsaglic acid is necessary for intravascular administration depending on the size of the study area, the vascular system and the expected hemodilution.

    A few hours before the study should be refused food intake (to prevent aspiration of the contents of the stomach during vomiting). Let's take moderate amounts of fluid to prevent dehydration.

    During and during 30-60 minutes after the administration of yogic acid it is necessary to monitor possible serious adverse reactions by personnel trained in the rules of emergency care.

    The department requires the presence of anti-shock laying, containing epinephrine and oxygen, and conditions for emergency intensive care in the development of possible hypersensitivity reactions.

    Impact on the ability to drive vehicles and manage mechanisms

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

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