Триомбраст

General characteristics. Structure:

Active ingredient: amidotrizoate sodium;

1 ml of 60% of solution contains: diatrizoyevy acid of a dihydrate in terms of 100% anhydrous substance of 471,6 mg, N-metilglyukamina (Megluminum) in terms of 100% dry matter of 125,7 mg;

1 ml of 76% of solution contains: diatrizoyevy acid of a dihydrate in terms of 100% anhydrous substance of 597,3 mg, N-metilglyukamina (Megluminum) in terms of 100% dry matter of 159 mg;

excipients: sodium hydroxide, dinatrium эдетат, water for injections.

Pharmacological properties:

Pharmacodynamics. X-ray contrast means. Increases picture contrast at the expense of X-ray absorption iodine which is a part of an amidotrizoat.

Pharmacokinetics. In case of oral administration absorption of an amidotrizoat is almost equal to zero. After intravascular introduction it is quickly distributed in intercellular substance. Does not get through the unimpaired blood-brain barrier. At intravenous administration of drug its communication with proteins of plasma does not exceed 10%. Amidotrizoat does not get into erythrocytes.

In 5 minutes after intravenous bolyusny administration of Triombrast of 60% in a dose of 1 ml for kg of body weight concentration of drug in plasma, the corresponding 2-3 g of iodine on liter is reached. During

3 hours after introduction are observed rather bystry decrease in concentration in 30 minutes, then - gradual decrease with an elimination half-life 1-2 hours. At introduction in diagnostic doses амидотризоат gives in to glomerular filtering in kidneys. Nearly 15% of the administered drug are removed in not changed state with urine within 30 minutes after introduction, and more than 50% – within 3 hours. Kinetic qualities of distribution and removal from an organism do not depend on a dose within clinically significant range.

At patients with a renal failure амидотризоат it can also eleminirovatsya by a liver, though in small amounts. Drug only in the minimum quantities gets into breast milk. Irrespective of an injection site throughout a short interval of time full elimination even from fabrics is carried out.

Main physical and chemical properties:

transparent colourless or light yellow color slightly viscous liquid.

Indications to use:

Intravenous and retrograde urography. Angiography, artrografiya, intraoperative holangiografiya, endoscopic retrograde holangiopankreatografiya (ERHPG), sialografiya, fistulografiya, gisterosalpingografiya, etc.

Route of administration and doses:

Training of the patient for a research. Within 2 days prior to a research it is necessary to avoid the food causing a meteorism. It concerns first of all bean, salads, fruit, black and fresh bread, and also any vegetables in the raw. The last meal has to be no later than 1800 on the eve of inspection. Besides, it is reasonable to accept in the evening a purgative. Newborns and children of younger age cannot do big intervals between meals and to give them laxative.

Before and after intravascular and intrathecal use of a contrast agent it is necessary to provide the corresponding hydration of an organism. Especially it concerns newborns, babies, children of younger age, elderly people, patients with a diabetes mellitus, a multiple myeloma, a polyuria, an oliguria, a hyperuricemia. It is necessary to eliminate disturbances of water and electrolytic exchange.

Newborns and children up to 2 years.

Children up to 2 years and especially newborns are susceptible to an electrolytic imbalance and hemodynamic changes. It is necessary to pay attention to a dose of a contrast agent that it has to be entered, technical implementation of the radiological procedure and a condition of the patient.

Pain, excitement, uneasiness can provoke emergence of side effects therefore to patients in such state purpose of a calmative is possible.

Test on portability of drug is not recommended to be carried out as it has no predictive value. Moreover, test on portability sometimes led to emergence of reactions of hypersensitivity of heavy degree, even with a lethal outcome.

Carrying out inspection.

It is necessary to gather in the syringe contrast means just before the beginning of inspection.

Solution of a contrast agent is provided only for single application.

The remains of a contrast agent, unused at inspection, do not apply any more.

At intravascular introduction of X-ray contrast means the patient has to lie. After an injection it is necessary to watch within 30 minutes the patient as the majority of heavy complications occurs in the first half an hour after an injection.

The interval between injections has to make 10-15 minutes to give the chance to an organism to compensate increase in osmolality of a blood plasma due to inflow of intersticial liquid in a vascular bed. In case for one research it is necessary to use more than 300 ml of contrast liquid, appoint intravenous administration of water and electrolytic solutions. The dose of drug depends on age, body weight, the minute volume of heart and the general condition of the patient.

Patients with heavy renal and cardiovascular failure and to patients in a serious general condition need to apply a smaller dose of a contrast agent. At these patients it is necessary to control function of kidneys for 3 days after the research.

Intravenous urography.

Speed of intravenous administration makes 20 ml/min. For patients with heart failure which appointed a dose of 100 ml or more, is recommended to increase introduction time up to 20-30 minutes.

Dosing. For adults: Triombrast's dose of 76% – 20 ml, Triombrast of 60% – 50 ml. Increase in a dose of Triombrast of 76% up to 50 ml significantly increases probability of more exact diagnosis. Further increase in a dose is possible if it is necessary because of special indications.

For children: because of reduced physiological concentration ability still of unripe nephron of kidneys rather high doses of Triombrast of 76% are necessary for children:

to children age till 1 year: 7-10 ml; from 1 to 2 years: 10-12 ml; from 2 to 6 years: 12-15 ml; from 6 to 12 years: 15-20 ml; 12 years are more senior: as for adults.

Time of performance of pictures. For the best display of a renal parenchyma pictures should be done right after the end of introduction of contrast means. For the image of a renal pelvis and urinary tract the first picture is done in 3-5 minutes, and the second – in 10-12 minutes after administration of contrast medium, for young patients it is necessary to be guided on lower, and for elderly patients – by the upper bound of the specified time range. For children of chest and younger age the first picture is recommended to be done in 2 minutes after introduction of contrast means.

Angiography.

Триомбраст it is possible to apply to angiographic researches. 76% prefer as solution when especially high concentration of iodine, for example, is important for an aortografiya, angiocardiography or coronary angiography.

The dose is established depending on age, weight, minute volume of heart, the general state, a technique of a research, a look and volume of the explored vascular site.

Retrograde urography.

It is possible to apply Triombrast of 60%. Despite its high concentration, symptoms of irritation are observed very seldom. For the purpose of prevention of irritation cold that causes spasms of ureters, recommends to warm up contrast means to body temperature.

Features of use:

Cardiovascular diseases. Patients with pathology of valves have hearts and pulmonary hypertensia administration of contrast mediums can lead to the expressed hemodynamic changes. The reactions including ischemic changes on an ECG and heavy arrhythmia are more widespread among elderly people and patients with a heart disease in the anamnesis. Intravenous administration of a contrast agent can lead to a fluid lungs at patients with heart failure.

Frustration of TsNS. Special attention at intravenous administration of a contrast agent should be paid to patients with the acute ischemic stroke, acute intracranial bleeding and other states including disturbance of a blood-brain barrier, wet brain or acute demyelination. Intracranial tumors or metastasises and epilepsy in the anamnesis increase probability of developing of spasms after administration of iodinated contrast medium.

At administration of contrast medium neurologic symptoms because of a cerebrovascular disease, intracranial tumors or metastasises, degenerative or inflammatory pathologies can become aggravated. Intra arterial administration of contrast medium can cause a vasospasm and, as a result, brain ischemia. Patients with symptomatic cerebrovascular diseases, recently had stroke or the frequent tranzitorny ischemic attacks treat group of the increased risk of emergence of neurologic complications.

 Abnormal liver function of heavy degree. In case of a renal failure of heavy degree along with existence of abnormal liver functions of heavy degree can detain substantially excretion of a contrast agent that, perhaps, will demand a hemodialysis.

The myeloma or paraproteinemia can create conditions for development of a renal failure after administration of contrast medium. The corresponding hydration is obligatory.

At patients with a pheochromocytoma hypertensive crisis of heavy degree (sometimes uncontrollable) after intravenous use of a contrast agent can develop. Premedication is recommended by blockers of alpha adrenoceptors.

To patients with autoimmune frustration. It was reported about cases of emergence of heavy vasculites or syndromes of similar to Stephens-Johnson's syndrome, at patients with autoimmune frustration in the anamnesis.

Bulbospinalny paralysis (myasthenia gravis). Administration of iodinated contrast mediums can strengthen symptoms of bulbospinalny paralysis.

Acute or the alcoholism can increase permeability of a blood-brain barrier. It facilitates passing of a contrast agent to brain tissues that can lead to reactions from TsNS. It is necessary to pay special attention to patients with alcohol and drug addiction because of a reduced threshold of convulsive activity.

Renal failure. In isolated cases the temporary renal failure can be observed. The precautionary measures directed to prevention of an acute renal failure after administration of contrast medium include:
identification of patients with high risk, for example, of patients with existence in the anamnesis of diseases of kidneys, a renal failure after administration of contrast medium, a diabetes mellitus with a nephropathy, reduction of volume of the circulating blood, multiple myelomas, persons 60 years are more senior, than patients with the started stage of a disease of vessels, a paraproteinemia, arterial hypertension of heavy degree and chronic hypertensia, gout, the patients receiving high or repeated doses of drug;
ensuring the corresponding hydration at the patients belonging to risk group before administration of contrast medium, is desirable by maintenance of intravenous infusion before and after the procedure and before removal of a contrast agent kidneys;
to avoid additional load of kidneys in the form of nephrotoxic drugs, peroral holetsistografichesky means, perezhimany arteries, renal arterial angioplasty, radical surgical intervention, etc. before removal of a contrast agent kidneys;
transferrings of term of carrying out a new research with a contrast agent before return of indicators of function of kidneys to initial levels.
patients on dialysis can receive contrast agents for radiological procedures as iodinated substances are removed in the course of dialysis.

Dysfunction of a thyroid gland. A small amount of free inorganic iodide from an iodinated contrast agent can influence function of a thyroid gland. Therefore it is necessary to approach especially carefully carrying out a research at patients with a latent hyperthyroidism or a craw, considering possible risk.

Hypersensitivity. From time to time after use of X-ray contrast means allergic reactions are observed (see the section "Side reactions"). They are usually shown by frivolous respiratory or skin symptoms, such as frustration of external respiration of easy degree, erubescences (erythema), a small tortoiseshell, itch or swelled persons. Emergence of serious side reactions, such as angioneurotic, subchordal swelled, a bronchospasm and allergic shock is possible. Usually such reactions are observed within one hour after administration of contrast medium. However in isolated cases the remote reactions are possible (in several hours or days after introduction).

Patients with hypersensitivity or reaction to the X-ray contrast means containing iodine have the increased risk of emergence of serious complications.

Giperergichesky reaction arises at the patients inclined to an allergy more often (for example, an allergy to seafood, hay fever, a small tortoiseshell, hypersensitivity to iodine or radio graphic contrast means and bronchial asthma in the anamnesis). For the purpose of prevention administration of antihistamines and/or glucocorticoids is possible. Patients with bronchial asthma treat group of extra risk of emergence of a bronchospasm or reaction of hypersensitivity.

Reactions of hypersensitivity can escalate at the patients accepting beta-blockers, especially in the presence of bronchial asthma. Besides it is necessary to consider that the patients accepting beta-blockers can be insensitive to standard therapy of reaction of hypersensitivity by beta-agonists.

In case of hypersensitivity reaction introduction of contrast means needs to be stopped immediately and if it is necessary, to carry out intravenously specific therapy. Therefore for intravenous administration of a contrast agent it is recommended to use flexible constant cannulas (catheters). It is very important to expect and provide all actions on a case of emergence of complications at introduction of contrast means, namely – to have all necessary medicines and tools for rendering acute management, and also to own practical skills for implementation of urgent measures of this kind.

Patients of advanced age. The pathology of vessels and neurologic frustration which are observed at people of advanced age make the increased risk of emergence of serious reactions to iodinated contrast means.

Ionic iodinated contrast means have big anticoagulating activity of in vitro, than not ionic contrast means. Therefore when holding a procedure it is necessary to watch carefully technology of performance of an angiography, to often wash out a catheter normal saline solution (if it is possible, with heparin addition) and to reduce procedure duration for the purpose of minimizing of risk of developing of the thromboses and embolisms connected with the procedure.

It was reported that use of plastic syringes instead of glass reduces probability of turning of in vitro blood.

It is recommended to be the patient with a homocystinuria, especially attentive to patients, because of the increased risk of developing of thrombosis and an embolism.

It is recommended to patients who accept guanyl guanidines for treatment of a diabetes mellitus for

48 hours prior to inspection to cancel them because of risk of emergence of a lactacidemia. After inspection it is necessary to begin administration of drug only after recovery of renal function.

Способностьвлиять on speed of response at control of motor transport to an ilirabota with other mechanisms.

Otstrochenny reactions to administration of iodinated contrast mediums meet seldom, nevertheless it is undesirable to drive the car or to work with moving mechanisms within the first 24 hours after carrying out a research.

Side effects:

By-effects which arise in connection with use of intravascular iodinated contrast means, as a rule, pass and belong to the category easy and moderately severe though heavy and life-threatening reactions, including even lethal outcomes were observed.

Allergic reactions: often - an itch, urticaria, a Quincke's disease, conjunctivitis, rhinitis, sneezing, cough. These reactions arising it is not dependent on amount of drug which is administered, and a way of its introduction, can be the first signs of an initial stage of shock. Administration of contrast medium needs to be stopped at once and, if necessary, it is necessary to carry out purposeful therapy through venous access. Sometimes – the bronchospasm, a spasm or swelled throats, or arterial hypotension. The remote reactions connected with administration of contrast mediums meet in isolated cases.

Reactions from skin: often - the erythematic rashes itching a dieback. In isolated cases – toxic skin reactions (for example, Stephens-Johnson or Layell's syndrome).

From a nervous system: at hit of a contrast agent in a brain with an arterial blood in high concentration such tranzitorny neurologic complications as dizziness, a headache, excitement, confusion of consciousness, amnesia, disturbance of the speech, sight and hearing, a photophobia, temporary loss of sight, a tremor, spasms, paresis/paralysis, a coma, drowsiness can be observed. In isolated cases - heavy, and in some cases - the fatal thromboembolic phenomena leading to a stroke.

From cardiovascular system: infrequently - increase or a lowering of arterial pressure, an asystolia, arrhythmias. Vazovagalny reactions after carrying out a gisterosalpingografiya. The heavy reactions demanding emergency treatment can have an appearance of disturbances of blood circulation that is shown by peripheral vasodilatation with the subsequent falling of arterial pressure and reflex tachycardia, an asthma excited by a state, confusion of consciousness and cyanosis up to a loss of consciousness. In isolated cases – the heavy thromboembolic phenomena leading to a myocardial infarction.

From respiratory system: often – tranzitorny disturbance of a respiration rate, an asthma, frustration of external respiration and cough; in isolated cases – an apnoea a fluid lungs.

From digestive tract: often – nausea, vomiting, slight increase of level of amylase (after ERHPG); infrequently – an abdominal pain; in isolated cases – pancreatitis and necrotizing pancreatitis (after ERHPG).

From an urinary system: in isolated cases - a renal failure or a renal failure which passes after a while.

Local reactions: pain in the place of an injection arises at a peripheral angiography. Drug flowing paravazalno causes strengthening of pain and swelled in the place of an injection which usually pass completely, the inflammation and even a necrosis of fabrics were very seldom observed. In isolated cases – thrombophlebitis and a vein thrombosis.

Other reactions: often – a headache, feeling of heat; infrequently – weakness, fever, perspiration, vazovagalny reactions; in isolated cases – fervescence, swelling of sialadens.

Interaction with other medicines:

It is recommended to patients who accept guanyl guanidines for treatment of a diabetes mellitus for

48 hours prior to inspection to cancel them because of risk of developing of lactoacidosis. After inspection it is necessary to begin administration of drug only after recovery of renal function.

At patients who accept beta-blockers reactions of hypersensitivity are more expressed.

At inclusion of Interlaken the possibility of the remote reactions (temperature increase, rash, a grippopodobny syndrome, a joint pain and an itch) increases.

Interaction with diagnostic tests. After intravascular administration of iodinated contrast mediums ability of tissues of thyroid gland to absorb radioisotopes for diagnosis of diseases of a thyroid gland decreases for the period up to two weeks, and in some cases even for longer period.

Contraindications:

Триомбраст it is impossible to apply to a miyelografiya, a ventrikulografiya and a tsisternografiya because of the possible neurotoxic phenomena. The expressed hyperthyroidism. Dekompensirovanny heart failure. During pregnancy and at acute inflammatory processes it is impossible to carry out a gisterosalpingografiya to pelvic cavities. At acute pancreatitis ERHPG is contraindicated. Hypersensitivity to components of drug and to iodinated means.

Overdose:

At accidental overdose loss of water and electrolytes needs to be compensated by intravenous infusion of solutions. It is necessary to watch function of kidneys for the next 3 days. Триомбраст it is possible to remove from an organism by a hemodialysis.

Use during pregnancy or feeding by a breast.

It is not recommended to use drug during pregnancy. Penetration of drug into breast milk insignificant therefore probability of harming the child low, but before purpose of drug during feeding by a breast it is necessary to consider possible danger to the child.
Children.

Because of physiologically reduced concentration ability still of unripe nephron at children rather high doses of drug are necessary. Therefore to children apply Triombrast of 76%.

Storage conditions:

Period of validity. 3 years. Not to use drug after the termination of the period of validity specified on packaging. To store in protected from light and the place, unavailable to children, at a temperature from 15 ºС to 25 ºС.

At storage of drug loss of crystals is possible. In such cases the ampoule needs to be heated on the boiling water bath. If crystals disappear and solution will become transparent, and when cooling to 33-36 0C crystals will not drop out again, solution is suitable for use.

Issue conditions:

According to the recipe

Packaging:

On 20 ml in an ampoule. On 5 ampoules enclosed in a pack.