Tomogeksol

General characteristics. Structure:

Active ingredient: iohexol;

1 ml of solution contains a yogeksol in terms of 100% substance that is equivalent to iodine:

mg                          of iodine/ml 240 300 350
mg ®«úѬ߫½á/ml                  518 647 755

excipients: calcium sodium эдетат, трометамин, divorced Acidum hydrochloricum, water for injections.

Pharmacological properties:

Pharmacodynamics. Yogeksol – not ionic, triyodirovanny, water-soluble X-ray contrast means.

At a research of healthy volunteers after an intravenous injection of a yogeksol it was not established significant deviations of the majority of indicators of a hemodynamics, kliniko-biochemical indicators and indicators of coagulation.

Time of achievement of the maximum X-ray contrast at a usual miyelografiya – up to 30 minutes (in 1 hour it is not visualized any more). At a computer tomography visualization of contrast in chest department is possible within 1 hour, cervical department – about 2 hours, basal tanks – 3-4 hours. Contrasting of joint cavities, cavities of the uterus, fallopian pipes, peritoneal protrusions, pancreatic and bilious channels, a bladder is reached directly after introduction.

Pharmacokinetics. About 100% of the yogeksol entered intravenously are allocated in not changed look through normally functioning kidneys for 24 hours. The maximum concentration of a yogeksol in urine is defined in 1 hour after an injection. Time of semi-removal of drug at patients with normal function of kidneys makes 2 hours. Metabolites of drug are not established. Linkng of a yogeksol with proteins of plasma has no clinical value (less than 2%) and therefore can not be taken into account.

Pharmaceutical characteristics

Main physical and chemical properties: transparent colourless or light yellow color liquid (solution).

Indications to use:

Tomogeksol is intended only for the diagnostic purposes.

X-ray contrast agent for use to children and adults for the purpose of carrying out a cardioangiography, arteriography, urography, a flebografiya and contrast strengthening at the computer tomography (CT); at a lumbar, chest and cervical miyelografiya, KT-tsisternografiya after subarachnoidal introduction; artrografiya, endoscopic retrograde pankreatografiya (ERPG), endoscopic retrograde holangiopankreatografiya (ERHPG), gerniografiya, gisterosalpingografiya, sialografiya and researches of digestive tract.

Route of administration and doses:

Apply Tomogeksol at adults and children intravenously, vnutriarterialno, intratekalno, in-band, orally, rektalno. The ampoule is intended for use only at one patient. The unused remains need to be thrown out. At administration of drug the patient has to be in horizontal position. Concentration of solutions and a dose depend on a type of a research, age and body weight of the patient, an indicator of cordial emission, the general state of his health, and also a technique and technology of performance of diagnostic testing (see the table).

Table

 

Indications	Concentration of iodine, mg/ml	Volume of drug, ml	Special instructions
1	2	3	4
Intravenous administration
Urography
adults	300 or 350	40-80	Introduction more than 80 ml is in some cases possible
children (body weight less than 7 kg)	240 300	4 ml/kg 3 ml/kg
children (body weight more than 7 kg)	240 300	3 ml/kg 2 ml/kg (at most 40 ml)
Flebografiya (lower extremities)	240 or 300	20-100 (on one extremity)
Digital subtraction angiography	300 or 350	20-60 (on one injection)
Strengthening at KT
adults	240	100-250	Total quantity  of iodine usually  makes 30-60 g
	300	100-200
	350	100-150
children	240	2-3 ml/kg (to 40 ml)	Introduction to 100 ml is in some cases possible
	300	1-3 ml/kg (to 40 ml)
Intra arterial introduction
Angiography:
1	2	3	4
aortic arch	300	30-40	Volume on one injection depends on an injection site
the selection cerebral angiography	300	5-10 ml (on one injection)
aortografiya	350	40-50 ml (on one injection)
angiography of femoral arteries	300 or 350	30-50 ml (on one injection)
other types	300	depends on a type of a research
Cardioangiography:
adults left ventricle, aorta root	350	30-60 ml (on one injection)
the selection coronary angiography	350	4-8 ml (on one injection)
children	300 or 350	as much as possible 8 ml/kg	The dose depends on age, body weight and a disease
Digital subtraction angiography	240 or 300	1-15 ml (on one injection)	Depending on an injection site can to be used large volumes         to 30 ml
Intrathecal introduction
Lumbar and chest miyelografiya	240	10-15	lumbar introduction
		8-12
Cervical miyelografiya	240	10-12	lumbar introduction
	300	7-10
	240	6-10	cervical introduction
	300	6-8
KT tsisternografiya	240	4-12	lumbar introduction
Intracavitary introduction
Artrografiya	240	5-20
	300	5-15
	350	5-10
ERPG/ERHPG	240	20-50
Gerniografiya	240	50	Introduction volume depends on hernia volume
Gisterosalpingografiya	240	15-50
	300	15-25
Sialografiya	240 or 300	0,5-2
Oral administration
1	2	3	4
Research GIT
Adults	240 or 350	50-100	Is chosen individually
children (gullet)	300 or 350	2-4 ml/kg	Maximum dose 50 ml
premature children	350	2-4
Strengthening at KT
adults	240 or 300, or 350. To part with water to kontsentra- tion about 6 mg of iodine/ml.	800-2000 ml of the received solution during the certain period	For example: to part Tomogeksol-300 or Tomogeksol-350 with water 1:50.
children		15-20 ml of the received solution on kilogram of body weight
Rectal administration
Strengthening at KT children	240 or 300,  or 350. To part with water to concentration about 6 mg of iodine/ml.	Is chosen individually
Research GIT children	240 or 300, or 350	To part with water to concentration  100-150 mg of iodine/ml of 5-10 ml/kg of the received solution	For example: to part Tomogeksol-240, Tomogeksol-300 or Tomogeksol-350 with water 1:1 or 1:2

Features of use:

Before use of X-ray contrast means it is necessary to obtain exact information on the patient, considering important datas of laboratory (creatinine level in blood serum, the electrocardiogram, an allergy in the anamnesis). Before a research at the patient it is necessary to liquidate disturbances of water and electrolytic balance and to provide sufficient intake of liquid and electrolytes.

In 2 hours prior to the procedure the patient has to stop meal.

Before use Tomogeksol it is necessary to check for lack of insoluble particles, discoloration and disturbance of integrity of packaging visually.

Drug cannot be mixed in one syringe with others diagnostic and medicines.

Tomogeksol gather in the syringe just before use. The unused rest of drug for further use is not allowed.

Risk of emergence of heavy side reactions on Tomogeksol very low. However the contrast agents containing iodine can cause anaphylactic reactions or other manifestations of hypersensitivity. It is necessary to determine by this reason the sequence of medical actions in case of side reactions in advance and to have available necessary drugs and equipment. There has to be an intravenous catheter for the period of carrying out a X-ray contrast research for the purpose of simplification of bystry intravenous administration of medicines.

It is necessary to use the separate syringe and a needle for Tomogeksol's introduction and not to mix with other medicines.

Existence in the anamnesis of an allergy, asthma and undesirable reactions to the contrast agents containing iodine requires special attention. In these cases it is necessary to consider the possibility of premedication corticosteroids and antagonists of histamine receptors.

In comparison with ionic drugs, not ionic X-ray contrast means influence in vitro system of blood coagulation less. When carrying out angiographic researches it is necessary to adhere very carefully to their techniques and to often wash out a catheter (for example, chloride sodium solution with heparin addition) for minimization of risk of the thromboses and embolisms connected with intervention.

Before and after administration of contrast agent it is necessary to provide adequate saturation of the organism investigated by liquid. It has special value for patients with a multiple myeloma, Valdenstrem's macroglobulinemia, a diabetes mellitus, a renal failure, and also for children and people of advanced age. At children up to one year, and especially at newborns, disturbance of a hemodynamics and electrolytic balance happens especially easily.

It is necessary to be attentive at a research of patients with a serious cardiovascular illness and pulmonary hypertensia in connection with risk of development of disturbances of a heart rhythm and disturbances of a hemodynamics.

Patients with acute cerebral pathology, tumors of a brain and epilepsy are inclined to development of spasms and require special attention. The risk of development of spasms and neurologic reactions at alcoholics and addicts is increased. Cases of temporary decrease in hearing or deafness after a miyelografiya were seldom observed that it is probably connected with pressure drop of cerebrospinal fluid owing to a lumbar puncture.

Extra care at inspection of the patients who already have renal failures and a diabetes mellitus and belonging to risk group is necessary for prevention of development of the acute renal failure connected with administration of contrast medium. The same concerns also inspection of patients with paraproteinemias (a multiple myeloma, Valdenstrem's macroglobulinemia).

Measures for prevention of side reactions:

– identification of the patients belonging to risk group;

– ensuring adequate hydration if it is necessary, it can be reached by means of continuous intravenous infusion which began even until administration of contrast agent and proceeds until its removal by kidneys;

– prevention of the additional load of kidneys arising at use of nephrotoxic drugs, means for the peroral cholecystography, displacement of renal arteries, angioplasty of renal arteries, surgeries – before removal of a contrast agent from an organism;

– repeated X-ray contrast researches have to be performed after full normalization of function of kidneys after the last administration of drug.

For the prevention of lactoacidosis at the patients with a diabetes mellitus accepting Metforminum before intravascular introduction of the contrast means containing iodine it is necessary to measure creatinine level in blood serum.

Normal level of creatinine of serum / normal function of kidneys: reception of Metforminum should be stopped during introduction of contrast means and not to renew for 48 hours or before blood serum kidneys/creatinine function recovery to normal level.

Decrease in level creatinine/renal failure: it is necessary to stop reception of Metforminum and to postpone inspection using contrast means for 48 hours. Therapy by Metforminum is resumed only if function of kidneys or level of creatinine of blood serum remain invariable.

In urgent cases at which the renal failure is noted the doctor has to estimate a ratio risk/advantage for the patient of use of drug and apply preventive measures: to stop Metforminum reception, to hydrate the patient, to control function of kidneys and to watch lactoacidosis symptoms at patients.

Especially careful should be with patients who have heavy combined disturbances of functions of kidneys and a liver as they observe considerable decrease in clearance of contrast agents. Carrying out X-ray contrast researches of patients which are on a hemodialysis is possible provided that dialysis will be carried out right after the research.

Introduction of the X-ray contrast means containing iodine can strengthen myasthenia symptoms.

When using invasive researches and interventions at patients with a pheochromocytoma preventive use of alpha blockers is necessary for prevention of hypertensive crises.

Extra care at inspection of patients with a hyper thyroidism is necessary. At patients with a multinodal craw is after introduction of the contrast means containing iodine there is a risk of development of a hyperthyroidism. It is necessary to remember a possibility of development in connection with administration of contrast mediums of a passing hyperthyroidism in premature children.

Exit of contrast means from vessels in rare instances was followed by local pain and hypostasis that passed without effects. However cases of an inflammation and a necrosis of fabrics are recorded. As general measures it is recommended to lift and cool a drug injection site whenever possible. In case of development of a kompartment-syndrome carrying out a surgical decompression is possible.

Observation of the patient

After administration of contrast agent it is necessary to watch the patient for, at least, 30 minutes as the majority of side reactions arises during this time.

Intrathecal introduction

After performance of a miyelografiya the patient has to be at rest not less than 1 hour, lying with the head and a thorax raised on 20 °. After that the patient can be transferred to the out-patient mode, but has to avoid inclinations. At preservation of a bed rest the lifted position of the head and breast has to remain for the first 6 hours. At suspicion on a low threshold of development of spasms observation for investigated throughout this period is necessary. Ambulatory patients within the first 24 hours after the research should not remain alone.

Ability to influence speed of response at control of motor transport or work with other mechanisms

It is not recommended to manage motor transport and to work with a difficult technique for the first 24 hours after intrathecal introduction of contrast means.

Side effects:

Habit views of side reactions.

Side reactions on not ionic X-ray contrast means usually have moderate or easy extent of clinical implication, reversible character and are registered with a smaller frequency, than when using ionic contrast means.

General reactions: feeling of heat on all body, a headache, short wind, fever, a pyrexia (temperature increase), a tremor, iodic parotitis – reaction to introduction of the contrast means containing iodine (it can be shown in the form of increase in the sizes and pain of a sialaden during up to 10 days after inspection).

Disturbances from a digestive tract: nausea, vomiting, a dysgeusia, passing metal smack in a mouth, discomfort and pain in a stomach.

Integuments and hypodermic cellulose: rashes, erythema, itch, urticaria, toxic skin reactions, Stephens-Johnson's syndrome, toxic epidermal necrolysis.

Disturbances from immune system: Quincke's disease and acute anaphylaxis, anaphylactoid reactions, including anaphylaxis. At the patients accepting β-adrenoblockers of display of an anaphylaxis can be atypical and it is wrong to be accepted to vagal reactions.

Disturbances from cardiovascular system: vazovogalny reactions in the form of arterial hypotension and bradycardia, arterial hypertension, tachycardia.

Disturbances from respiratory system, thoracic and medistinalny disturbances: throat hypostasis, bronchospasm, fluid lungs.

Damages, poisonings or complications of the procedure: iodism.

The side reactions connected with intravascular introduction.

The nature of side reactions which can be observed during intra arterial introduction depends on the place of an injection and a dose. At the selection angiography and other researches when contrast means gets into the studied body, disturbances of functions of this body can be observed.

At introduction to coronary, brain and renal arteries the arterial spasm can develop that leads to tranzitorny ischemia in the studied body.

General reactions: the delayed pain or a caumesthesia meets at a peripheral angiography; contrast means can get through a blood-brain barrier therefore there is an accumulation of drug in a cerebral cortex that allows to visualize brain fabrics at KT; rushes of blood to the person.

Disturbances from cardiovascular system: arrhythmias, decrease in sokratitelny function of a myocardium or ischemia of a myocardium, postflebografichesky thrombophlebitises, fibrinferments.

Disturbances from a musculoskeletal system and connecting fabric: arthralgia.

Disturbances from a nervous system: spasms, passing disturbances of sensitivity, passing disturbances of motive functions, disturbances of orientation in space, a cortical blindness.

Disturbances from an urinary system: renal failure.

Disturbances from respiratory system, thoracic and mediastinal disturbances: laryngospasm, bronchospasm, диспноэ, not cardiogenic fluid lungs, cough.

Disturbances from endocrine system: patients with risk of developing of a thyrotoxicosis have to be carefully inspected before use of the contrast means containing iodine. Development of a thyrotoxicosis is possible.

Disturbances from laboratory indicators: increase in level of creatinine of blood serum.

Reactions in an injection site: pain on the course of vessels and a caumesthesia at a peripheral angiography.

The side reactions connected with intrathecal introduction.

Side reactions can arise in several hours or days after intrathecal introduction. Their frequency approximately answers the frequency of complications after lumbar punctures without introduction of contrast means. Reactions in a drug injection site are possible.

Disturbances from a nervous system: a headache (even for several days) dizziness, local pain, paresthesias and radicular pains in the place of a puncture, a spasm, photophobia, a meningism, meningitis, including infectious, disturbances of orientation, disorder of sensitivity, disturbance of motive functions.

Disturbances from a digestive tract: nausea, vomiting.

Disturbances from cardiovascular system: changes of the electrocardiogram.

Disturbances from organs of sight: short-term loss of sight.

Disturbances from a musculoskeletal system: neck pain, onychalgia.

The side reactions connected with intracavitary introduction.

Disturbances from immune system: general reactions of hypersensitivity.

Endoscopic retrograde pankreatokholangiografiya.

Disturbances from laboratory indicators: increase in activity of amylase in blood serum.

Disturbances from a digestive tract: pancreatonecrosis.

Oral administration. Disturbances from a digestive tract.

Gisterosalpingografiya.

Disturbances from a digestive tract: the moderated and quickly passing pain in lower parts of a stomach.

Artrografiya.

Disturbances from a musculoskeletal system and connecting fabric: arthralgia, arthritises, including infectious arthritises.

Gerniografiya.

General disturbances: pain after carrying out a research.

Interaction with other medicines:

Derivatives of a fenotiazin and other antipsychotic medicines (neuroleptics), monoamine oxidase inhibitors, tricyclic antidepressants, stimulators of the central nervous system, analeptics reduce an epileptic threshold and increase risk of epileptic attacks.

The patients accepting beta adrenoblockers, can have atypical displays of an anaphylaxis and can be mistakenly taken for vagal reactions.

Use of contrast agents to the diabetics accepting guanyl guanidines (Metforminum) can lead to a reversible renal failure and lactic acidosis. For prevention of it it is necessary to stop reception of guanyl guanidines in 48 hours prior to a research and to begin it after full stabilization of function of kidneys.

Patients who accepted less than in 2 weeks prior to a research interleykin-2 have tendency to the remote side reactions (a grippopodobny state or skin reactions).

Tomogeksol (at intrathecal introduction) is not compatible to glucocorticosteroids.

High concentration of contrast means in blood serum and urine can influence results of laboratory indicators of bilirubin, proteins and inorganic compounds (for example, gland, copper, calcium, phosphates) therefore laboratory analyses should not be carried out on the same day.

Contraindications:

Hypersensitivity to iodine or to other components of drug. The expressed thyrotoxicosis. Epilepsy and cerebral infections (for subarachnoidal introduction).

Overdose:

Risk of development of symptoms of overdose minimum if only to the patient more than 2000 mg/kg of iodine are not entered within a short period of time. The long procedure at high doses of drug can affect function of kidneys (an elimination half-life – 2 hours). The accidental overdose of drug can occur at difficult angiographic procedures at children, especially in cases of reusable introduction of high doses.

In case of overdose it is necessary to carry out correction of disturbances of water and electrolytic balance. The next 3 days it is necessary to carry out monitoring of function of kidneys. In case of need it is necessary to apply a hemodialysis to removal of excesses of drug. The specific antidote does not exist.

Use during pregnancy or feeding by a breast

 

Safety of use of drug during pregnancy is not established. Tomogeksol during pregnancy can be applied only in urgent cases and after careful assessment of a ratio advantage/risk.

Contrast means in insignificant degree get to breast milk. Therefore the risk for the child is improbable. It is necessary to stop feeding by a breast before administration of drug and to renew not earlier than in 24 hours after Tomogeksol's use.

Children

Drug is used in pediatric practice.

Storage conditions:

Term godnosti.3 years. Not to apply after the termination of the period of validity specified on packaging. To store in original packaging in the place protected from secondary x-ray emission at a temperature not over 25 ºС. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

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

On 20 ml or 50 ml, or 100 ml in a bottle. On 1 bottle in a pack.