Active substanceSodium amidotrisoateSodium amidotrisoate
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  • Dosage form: & nbspSolution for injections 60 %, 76 %
    Composition:

    1 ampoule of 60% solution contains: amidotrisoic acid dihydrate - 9.432 g in terms of amidotrisoic acid (diatrizoic acid dihydrate), meglumine in terms of 100% dry matter - 2.514 g;

    1 ampoule 76 % solution contains: amidotrizoic acid dihydrate - 11.946 g in terms of amidotrizoic acid (diatrizoic acid dihydrate), meglumine in terms of 100% dry matter - 3.180 g;

    Excipients: sodium hydroxide 0.099 g or 0.157 g, disodium edetate 0.0024 g, water for injection up to 20 ml.

    Description:

    Transparent colorless or light yellow slightly viscous liquid.

    Pharmacotherapeutic group:X-ray contrast medium.
    ATX: & nbsp

    V.08   Contrast substances

    Pharmacodynamics:

    Iodine containing radiopaque. Included in the preparation iodine due to the absorption of X-rays increases the contrast of the image.

    Pharmacokinetics:

    When introduced into the vascular bed the drug is distributed in the hemocirculation system, practically not penetrating beyond the vascular bed,does not accumulate in tissues and organs. It does not penetrate the intact blood-brain barrier. The drug does not penetrate into the red blood cells. At intravenous introduction of a preparation its communication with fibers of a plasma of blood makes 10%. Within 3 hours after administration, a relatively rapid decrease in concentration after 30 minutes is observed, then a gradual decrease with a half-life of 1-2 hours. It is filtered in the kidneys and is

    urine in unchanged form. During the first 30 minutes after the introduction of urine, about 15% of the injected drug is withdrawn, and during the first 3 hours - more than 50%. In patients with impaired renal function, the drug can be eliminated in small amounts by the liver. Breastmilk is excreted in minimal amounts.
    Indications:

    Triombrast® 76% - angiography, digital subtraction angiography, computed tomography, angiocardiography, ascending pyelography, lymphography, urethrocystography, splenoportografiya, fistulography, arthrography, hysterosalpingography, preoperative cholangiography.

    Triombrast® 60% - angiography, digital subtraction angiography, computed tomography (incl.computed tomography of the abdominal cavity in combination with barium sulfate), excretory urography, hysterosalpingography.

    Contraindications:

    Decompensated chronic heart failure; severe arterial hypertension; for ascending pyelography - acute uroinfection; for phlebography - acute phlebitis; plasmacytoma; severe arterial hypertension; acute coronary insufficiency; active tuberculosis; shock; collapse; hypercoagulation; chronic renal failure; thyrotoxicosis; nodular, goiter; pronounced atherosclerosis of cerebral vessels; liver failure; general severe condition; pregnancy; lactation; childhood.

    Hysterosalpingography is not performed in the presence of acute inflammatory processes in the pelvic region. Endoscopic retrograde cholangiopancreatography is not performed with acute pancreatitis.

    Contraindicated to use Triombrast ® for myelography, ventriculography and cisternography (neurotoxic effect is possible). Hypersensitivity (including iodine-containing radiopaque drugs).

    Carefully:

    Be wary appoint studies using Triombrast® to patients with decompensated diabetes mellitus, pulmonary emphysema, pheochromocytoma, subclinical hyperthyroidism, generalized myeloma; patients with severe cardiovascular diseases and pulmonary hypertension; patients with a history of allergies (bronchial asthma, allergic dermatosis, hay fever, drug and food allergy).

    Pregnancy and lactation:

    Contraindicated use of the drug during pregnancy or the period of breastfeeding.

    Dosing and Administration:

    Apply the drug only under the supervision of a doctor.

    To draw into the syringe a contrast substance is necessary immediately before the beginning of the examination.

    The solution of contrast medium is intended for single use only. For the prevention of thrombosis, angiography, it is often necessary to flush the intravenous catheter with saline solution of sodium chloride. Before use, the preparation should be heated to body temperature. The solution is administered in the patient's "lying" position.

    For intracavitary administration (in the bladder, renal pelvis), Triombrast® should be diluted with an isotonic solution of sodium chloride or 5% glucose solution until a 30% solution is obtained.

    Angiography.

    Preparation of the patient for angiography: at night appoint tranquilizers, in the evening and in the morning - cleansing enema; on the day of the study, the patient should not take food.
    Triombrast® is administered intraarterially for angiocardiography, aortography, arteriography, selective angiography. Phlebography, as well as splenoportografiya carried out by intravenous injection.

    Phlebography: for the lower limbs, 20-40 ml is injected, for the upper ones - 10-20 ml of 60% Triombrast® solution at a rate of 3-5 ml / sec. When examining the vena cava, the drug is administered in an amount of 25-30 ml at a rate of 10-13 ml / s. Pictures are taken already during the administration of the drug. After the examination it is necessary to ensure the removal of the contrast agent from the extremities: the limb is lifted and the vein is washed with 50-70 ml of 0.9% sodium chloride solution.
    Peripheral arteriography: 20 ml are used for the lower limbs, and 60% solution for the upper extremities.For better tolerability, it is recommended that the drug be administered in a direction opposite to the blood flow.

    Cerebral angiography: on average, 7 ml of a 60% solution is injected into the carotid artery or 4 ml is injected into the vertebral artery. With simultaneous seriography in 2 planes, 1 injection is enough, otherwise for the second projection, you need to repeat the injection. The solution is injected rapidly (10 ml in about 1.5 s).

    Aortography: 30-50 ml 76% solution intra-abortally at a rate of 8 ml / sec.

    Digital (digital) arteriography: inject 60% solution in an amount, corresponding to the blood flow of the examined artery.

    Angiocardiography: Introduce up to 60 ml of 76% solution at a rate of 8 ml / sec.

    Splenoportography: Introduce 20-30 ml of a 76% solution of Triombrast® at a rate of 8 ml / s.

    Examination of the urinary tract.

    Preparation of the patient for research: the day before the study, the diet of the patient should not contain products that cause fermentation and swelling of the intestine. It is recommended to exclude from the diet dairy products, fruits, vegetables, salads, smoked products, rough black or freshly baked bread. The night before and in the morning before the study - cleansing enemas.Immediately before the test, it is necessary to empty the bladder. The study is performed on an empty stomach. Excretory urography: 20-40 ml of a 60% solution warmed to body temperature, slowly injected into the ulnar vein. For unprepared (without cleansing enema) or obese patients, it is better to use 76% solution in the same amount. With a decreased function of the kidneys, I / drip in, diluting in 250-300 ml of 5% glucose, for 5-10 minutes.

    Ascending pyelography: 5-10 ml of a 30% solution is slowly injected with a catheter; When there is any pain or pressure in the kidneys, the injection stops. Cystography: average 60-80 ml of a 30% solution (after a preliminary dilution of Triombrast® 60% in a 1: 2 ratio with isotonic sodium chloride solution or 5% glucose solution to 30%) into the external opening of the urethra or 20 ml when the catheter is inserted bladder with air (lacunar cystography).

    Cholangiography: 5-20 ml of a 30% solution of Triombrast® (after a preliminary dilution of Triombrast 60% in a 1: 2 ratio with isotonic sodium chloride solution or 5% glucose solution to obtain 30%) is introduced;

    Аоттюграфия: 30% solution (after preliminary dilution of Triombrast® 60% in a ratio of 1: 2 with isotonic sodium chloride solution or 5% glucose solution to 30%), warmed to body temperature, slowly enter in the required amount after the usual disinfection of the joint. Triombrast® is administered after removal of the exudate under aseptic conditions. The solution is administered in the patient's "lying" position. To dilute the solution, use only water for injection. Special instructions.

    Since Triombrast® is an iodine-containing drug, in a small amount it can be absorbed by the thyroid gland. Therefore, after the application of Triombrast®, a radioisotope study of the thyroid gland will be uninformative.

    If you have allergies in your anamnesis (hay fever, bronchial asthma, drug and food allergies, allergic dermatoses), you should consider the possibility of increased sensitivity to contrast medium and premedication antihistamines.

    In the case of itching, urticaria, runny nose, edema, a sharp decrease in blood pressure, tachycardia,bronchospasm and other manifestations of hypersensitivity, the use of the drug is contraindicated.

    When stored in the cold, part of the active substance in the ampoules can crystallize. The crystals dissolve, dropping the ampoule for several minutes in hot water or heating in a boiling water bath. If the crystals disappear and the solution becomes transparent, and upon cooling to 33-36 ° C the crystals do not fall again, then the solution is usable.

    Side effects:

    Common reactions: fever, dizziness, headache, nausea, vomiting, cyanosis, lacrimation, itching, erythematous rashes, urticaria, bronchospasm, Quincke edema, anaphylactoid reactions, pulmonary edema, anaphylactic shock, arterial hypotension, neurological disorders, diarrhea, exacerbation of enteritis or colitis, acute renal failure. Rarely, convulsions.

    Local reactions: pain in the injection site, phlebitis, thrombosis.

    Adverse reactions in certain types of studies.

    Ventricular ventricular fibrillation can occur with coronary and angiocardiography. An attack of angina pectoris may occur in coronary angiography, left ventriculography.Violation of the rhythm of the heart - ekstrasistoliya, arrhythmia, tachycardia can be caused by contrasting the heart and coronary arteries.

    Overdose:

    In case of an overdose, Triombrast® can be removed from the body by extracorporeal dialysis.

    Interaction:

    In patients taking beta-adrenoblockers, the manifestations of anaphylaxis in the use of the drug can be atypical and mistaken for vagal reactions. Use of Triombrast® 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, you should stop taking biguanides 48 hours before the test and resume after complete stabilization of kidney function.

    Triombrast® should not be mixed in the same syringe with other drugs, as it is possible to change the pharmacological and physico-chemical properties of the preparations.
    Special instructions:

    not described

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

    It is undesirable to drive or work with moving machinery during the first 24 hours after the study.

    Form release / dosage:

    Solution for injection 60%, 76%.To 20 ml in ampoules of colorless glass with or without ring fracture.

    For 5 or 10 ampoules, together with the instructions for medical use and a knife with an ampoule ceramic or a cutting ceramic disc are placed in a pack of cardboard.

    5 ampoules (with a break ring) are placed in the blister. For 1 or 2 blisters together with instructions for medical use are put in a pack of cardboard.

    Packaging:ampoules (10) / complete with a ceramic or knife disc ampoule, if necessary for ampoules of this type / -tacks cardboard
    ampoules (5) / complete with a ceramic or knife disc ampoule, if necessary for ampoules of this type / -tackage cardboard
    ampoules (5) - packers-packs, cardboard
    Storage conditions:

    Store in a dark place at a temperature of 15 ° C to 25 ° C. When storing the drug, crystals may fall out. In such cases, the ampoule should be heated in a boiling water bath. If the crystals disappear and the solution becomes transparent, and upon cooling to (33-36) ° C the crystals do not fall again, the solution is usable. Keep out of the reach of children.

    Shelf life:

    Shelf life: 3 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015855 / 01
    Date of registration:10.06.2009
    The owner of the registration certificate:FARMAK, PAO FARMAK, PAO Ukraine
    Manufacturer: & nbsp
    Information update date: & nbsp21.07.2014
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