Trazograf

General characteristics. Structure:

Active agents:         Trazograf of 60%   Trazograf of 76% 

Diatrizoatum меглумин           600 mg 660 mg           

Sodium Diatrizoatum              -                           100 mg 

Content of iodine               is 282 mg 370 mg           

Excipients: эдетат calcium dinatrium, monobasic sodium phosphate, a sodium hydroxide, water for injections. 

Pharmacological properties:

Pharmacodynamics. Trazograf – ionic, triyodirovanny, X-ray contrast means. 

Pharmacokinetics. Trazograf is not metabolized, does not collect in a liver and eliminirut in chemically invariable look by glomerular filtering. 

At intravascular introduction Trazograf is quickly distributed in intercellular space; no more than 10% of drug contact proteins of plasma. Drug does not get through the unimpaired blood-brain barrier. 

Intravenous jet administration of Trazograf in a dose of 1 ml/kg of body weight allows to reach in 5 minutes high concentration of drug in a blood plasma, the corresponding 2-3 g of iodine on liter. The elimination half-life makes 1-2 hours. 

Indications to use:

- intravenous and retrograde urography; 

- angiography (arteriography, venografiya); 

- amniografiya; 

- artrografiya; 

- intraoperative holangiografiya; 

- fistulografiya; 

- splenoportografiya; 

- flebografiya; 

- vezikulografiya, etc. 

Trazograf should not be used for a miyelografiya, a ventrikulografiya and a tsisternografiya in connection with possible neurotoxic reactions. 

Route of administration and doses:

Training of the patient for the procedure. Introduction of contrast means is carried out on an empty stomach, however, reception of water is not limited. Previously disturbances of water and electrolytic exchange have to be eliminated if those are available. It is especially important for patients with a dekompensirovanny diabetes mellitus, a polyuria, an oliguria or gout, a generalized myeloma, and also at children of early age and elderly patients who cannot limit reception of liquid before use of hypertensive X-ray contrast means. 

At an angiography of vessels of an abdominal cavity and urography for improvement of diagnosis it is recommended to clear the patient's intestines carefully. Therefore in two days prior to inspection by the patient it is necessary to avoid meal, causing a meteorism (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 18 hours prior to inspection. Besides, it is reasonable to accept the night before laxative. Write big intervals in reception to chest and small children, and also purpose of laxative medicines are contraindicated. 

The patients feeling fear of the procedure need to appoint calmatives. 

For patients with a pheochromocytoma preliminary preparation by blockers of alpha receptors in order to avoid risk of development of hypertensive crisis is recommended. 

General rules of holding procedure. It is necessary to gather in the syringe contrast means just before the beginning of a research. 

The remains of contrast means, unused at research, are not applied any more. When performing an angiography frequent washing of the used catheters is required by normal saline solution to minimize possible risk of developing of a thrombembolia. It is necessary to consider that contrast means is transferred better if it is heated to body temperature. 

It is not recommended to hold preliminary testing of individual sensitivity with use of small doses of drug, in view of risk of development of heavy reactions of hypersensitivity. 

At intravascular introduction of X-ray contrast means it is desirable that the patient lay. After an injection careful observation of the patient within not less than 30 minutes as the majority of complications comes in the first half an hour after administration of drug is necessary. 

If specification of diagnosis requires several high single doses, then the interval between injections has to make 10-15 minutes (for compensation of the increased serumal osmolarity due to inflow of intersticial liquid). If more than 300 ml of a contrast agent are once entered, intravenous infusion of solutions of electrolytes is appointed. 

I. Research of kidneys and urinary tract. 

Solution of a trazograf is used for excretory urography, a retrograde piyelografiya and a tsistografiya by intravenous or intracavitary (in a bladder, a renal pelvis) by introductions. 

1.1. Excretory urography 

The adult enter intravenously struyno 20-50 ml of 60% of solution or 20 ml of 76% of solution of Trazograf with a speed of 0,3 ml/sec. At corpulent patients it is more reasonable to use 76% Trazograf's solution. At children use 76% Trazograf's solution in age doses: 

- till 1 year              of 6 ml 

- from 1 year to 2 years        of 8 ml 

- from 2 to 6 years           of 10 ml 

- from 6 to 12 years        of 12-14 ml 

- from 12 to 15 years          of 16 ml 

1.2. Infusional urography. Intravenously kapelno the adult enter mix of 80 ml of 60% or 76% of solution of Trazograf and 80 ml of 5% of solution of glucose with a speed of 20-30 thaws a minute.   

1.3. Retrograde piyelografiya. For intracavitary introduction Trazograf it is reasonable to dilute with isotonic solution of sodium of chloride or 5% glucose solution before receiving 30% of solution. 30% enter Trazograf's solution retrogradno through a catheter into uric ways under small pressure under direct radiological vision (without allowing pain in lumbar area) usually in a dose of 3-8 ml; in case of an ectasia of cavities of system - to 20 ml and more depending on extent of expansion of cavities of kidneys. 

1.4. Tsistografiya. 30% enter Trazograf's solution into a bladder retrogradno or through an epicystostoma under direct radiological vision in volume a little smaller, than the bladder capacity (100-200 ml). 

2. Angiography. Trazograf use for angiocardiography, aortografiya, arteriography, the selection angiography, a flebografiya by intravascular introduction, and also at a splenoportografiya. 

2.1. At an aortografiya enter 30-60 ml of 76% of solution of drug into an aorta with a speed of 25-35 ml/sec.; 

2.2. At angiocardiography apply to 60 ml 76% of solution of Trazograf with a speed of 10-30 ml/sec.; 

2.3. At peripheral arteriography - vnutriarterialno on the lower extremity enter 20-40 ml, on an upper extremity - 10-20 ml of 60% of solution of Trazograf with a speed of 8-12 ml/sec.; 

2.4. At the selection angiography apply 60% and 76% Trazograf's solution in quantity, corresponding to the volume of a bed of the studied vessel with a speed of 3-12 ml/sec.; 

2.5. At a flebografiya intravenously on the lower extremity enter 20-40 ml, on an upper extremity - 10-20 ml of 60% of solution of drug with a speed of 3-5 ml/sec.; 

2.6. At a vena cava research the drug is administered in number of 25-30 ml with a speed of 10-13 ml/sec.; 

2.7. At a splenoportografiya enter 30-50 ml of 76% of solution of Trazograf into a spleen with a speed of 8 ml/sec. 

Features of use:

With care it is necessary to use drug at a renal failure, a liver, cardiovascular insufficiency, the expressed atherosclerosis of vessels of a brain, a dekompensirovanny diabetes mellitus, a hyperthyroidism, a nodal craw, a plasmacytoma.
 
Pregnancy and period of a lactation. At pregnancy drug is appointed only in cases if the attending physician considers it absolutely necessary taking into account possible risk for a fruit. During pregnancy it is forbidden to carry out a gisterosalpingografiya.
 
Drug excretion with breast milk is insignificant and, according to the available experience, the probability of harming the child is small, however, before purpose of drug in the period of a lactation it is necessary to consider possible danger to the child.
 
Influence on control of motor transport and mechanisms. After use of drug reaction delay is in rare instances possible. It is necessary to avoid control of motor transport and mechanisms within 24 hours after administration of drug.

Side effects:

The by-effects connected with intravascular use of iodinated contrast means, as a rule, it is passing and treat the category easy or moderately severe though also the heavy, life-threatening reactions including leading to a lethal outcome were observed. 

At intravascular introduction of contrast means were most often observed: nausea, vomiting, erubescence, feeling of heat. Reduction of feeling of heat and nausea can achieve if a contrast agent is entered slowly or to do short breaks (each 3-5 minutes) during administration of drug. 

Perhaps also development of the following symptoms: a fever, temperature increase, perspiration, a headache, dizziness, pallor, weakness, desires on vomiting and feeling of suffocation, the complicated breath, sneezing, dacryagogue, increase or lowering of arterial pressure, an itch, urticaria, hypostases, spasms, a muscular tremor. It is not excluded that emergence of such side reactions can be a harbinger of the beginning acute anaphylaxis. In case of shock introduction of contrast means needs to be stopped immediately and if necessary to appoint the corresponding intravenous therapy. Allergic and anaphylactic reactions can come irrespective of quantity and a way of introduction of contrast means. Giperergichesky reactions arise at the patients predisposed to an allergy more often. 

The heavy side reactions demanding rendering acute management can be shown in the form of blood circulation disturbances which are expressed in expansion of peripheral vessels and the subsequent falling of arterial pressure, reflex tachycardia, asthma, cyanosis, the excited state, confusion of consciousness, up to a loss of consciousness. In this regard when carrying out a research for the purpose of rendering acute management there have to be on call corresponding medicines, an endotracheal tube and the medical ventilator. 

In isolated cases, mainly, at the patients having epilepsy or diseases of a brain development of neurologic complications, such as is possible: coma, disorientation, drowsiness, temporary paresis, vision disorder, and also epilepsy attacks. 

In some cases at use of drug development of phlebitis, thromboses is possible. In rare instances there can be a reversible renal failure. 

Interaction with other medicines:

It must be kept in mind that iodinated X-ray contrast means reduce ability of tissue of thyroid gland to accumulate radio isotope drugs at diagnostic testings for the term of more than two weeks. 

At the patients suffering from a diabetic nephropathy and accepting guanyl guanidines at introduction of contrast means development of a lactacidemia is possible. For the prevention of this complication it is necessary to stop reception of guanyl guanidines in 48 hours prior to the procedure. For resuming of reception of guanyl guanidines it is necessary to be convinced of lack of a renal failure. 

Reactions of hypersensitivity can be stronger expressed at the patients accepting beta adrenoblockers. 

The patients accepting Interlaken have delayed reactions more often (for example, fever, rash, an itch, joint pains) and the symptoms reminding flu. 

Contraindications:

- hypersensitivity to iodinated drugs; 

- severe forms of a hyperthyroidism;

- a circulatory unefficiency with the decompensation phenomena; 

- the expressed renal and liver failure; 

- active pulmonary tuberculosis and emphysema of lungs;

- damages of a myocardium; 

- heavy arterial hypertension; 

- pregnancy;

- state of shock and collapse; 

- epilepsy.

Overdose:

At accidental overdose or considerably reduced function of kidneys the trazograf can be brought out of an organism by method of extracorporal dialysis. 

Storage conditions:

To store at a temperature not above 30 °C in the place, unavailable to children. Not to freeze. To protect from light and secondary X-ray.   

Issue conditions:

According to the recipe

Packaging:

Ampoules from light-protective glass on 20 ml. In packaging of 5 ampoules.