Yopromide - instructions for use, dose, side effects, contraindications

	240 mg iodine / ml	300 mg iodine / ml	370 mg iodine / ml
Active substance:
Yopromide	498.72 mg	623.40 mg	768.86 mg
Excipients:
Trometamol	2.42 mg	2.42 mg	2.42 mg
Sodium calcium edetate	0.10 mg	0.10 mg	0.10 mg
Water for injections	up to 1 ml	up to 1 ml	up to 1 ml

Description:A clear, colorless or light yellow solution.

Pharmacotherapeutic group:X-ray contrast medium

ATX: & nbsp

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

Pharmacodynamics:

Physico-chemical characteristics of the preparation:

Concentration of iodine (mg / ml)	240	300	370
Osmolality (osm / kg H₂О) at a temperature of 37 ° С	0,48	0,59	0,77
Viscosity (mPa * s):
at a temperature of 20 ° C	4,9	8,9	22,0
at a temperature of 37 ° C	2,8	4,7	10,0
Density (g / ml):
at a temperature of 20 ° C	1,263	1,328	1,409
at a temperature of 37 ° C	1,255	1,322	1,399
The pH values	6,5-8,0	6,5-8,0	6,5-8,0

Pharmacodynamics

Yopromide (molecular weight 791.12) is a non-ionized, low-osmolarity triiodinated radiocontrast agent (derivative isophthalic acid), which increases the contrast of the image due to X-ray absorption by iodine, included in its composition

Pharmacokinetics:

Distribution

Yopromide after intravascular injection is very quickly distributed in the intercellular space. Its half-life in the distribution phase is 3 minutes.

The connection with plasma proteins at a concentration of 1.2 mg iodine / ml is 0.9 ± 0.2%. Yopromide can not penetrate through the intact blood-brain barrier (BBB), but in a small amount passes through the placental barrier (shown in rabbits).

After 1-5 min after bolus intravenous administration of iopromide containing 300 mg iodine, in 1 ml of plasma, 28 ± 6% of its administered amount is detected irrespective of the dose. After insertion under the membranes of the brain, maximum plasma iodine concentrations of 4.5% of the administered dose were observed after 3.8 hours.

Metabolism

After the administration of iopromide in clinically acceptable doses, its metabolites were not detected.

Excretion

Yopromide excretion in patients with normally functioning kidneys is characterized by a half-life period of approximately 2 hours, regardless of the dose.When yopromide is used in doses recommended for diagnostic purposes, only glomerular filtration takes place. After 30 minutes after the introduction of the kidneys, approximately 18% of the iopromide from the administered dose is excreted, after 3 hours - 60%, and after 24 hours - 92%, respectively. The total clearance with low (150 mg iodine / ml) and high (370 mg iodine / ml) dose is 110 and 103 ml / min, respectively. After lumbar myelography iopromide almost completely excreted by the kidneys in 72 hours.

Dysfunction of the liver and kidneys

In patients with terminal stage of renal failure, incomplete radiopaque agents can be eliminated by hemodialysis. Violation of the function of the liver does not affect the excretion of iopromide, since for 3 days with feces only 1.5% of the administered dose is released.

Indications:

The drug is intended only for diagnostic purposes.

It is used to enhance image contrast in CT, arteriography and venography, including intravenous / intra-arterial digital subtraction angiography (CSA); for intravenous urography, endoscopic retrograde cholangiopancreatography (ERHPG), arthrography and studies of other body cavities.

Solution for injections 240 mg iodine / ml: also in the study of subarachnoid space,

Solution for injections 370 mg iodine / ml: has special advantages in the conduct of angiocardiography.

Injection solutions 300 mg iodine / ml and 370 mg iodine / ml It is not recommended to use for studies of subarachnoid space.

Contraindications:

Hypersensitivity to iopromide, iodine preparations or other auxiliary component of the drug.

Carefully:

The above warnings and precautions refer to all routes of administration of radiopaque means, but the noted risk is higher with its intravascular administration.

Thyroid dysfunction
Elderly age
Severe patient condition

Intravascular administration

Renal damage

Nephrotoxicity caused by radiopaque means, which is a transient renal dysfunction, may occur after administration of the drug Yopromide. In rare cases, acute renal disease may develop Mr.Insufficiency.

Risk factors:

- kidney failure;

- dehydration;

- diabetes;

- multiple myeloma / paraproteinaemia;

- repeated and / or large doses of the drug Yopromide.

Cardiovascular diseases

In patients with severe heart disease or severe coronary artery disease, the risk of clinically significant changes in hemodynamics and arrhythmia is increased. In patients with valvular heart disease and pulmonary hypertension, administration of an X-ray contrast agent can lead to severe hemodynamic disturbances. Reactions involving ischemic changes in the electrocardiogram (ECG) and severe arrhythmias are most common in elderly patients and in patients with a history of cardiac pathology. Intravascular injection of radiocontrast can cause pulmonary edema in patients with heart failure.

Diseases of the central nervous system (CNS)

In patients with a history of seizures or other CNS diseases, the risk of seizures or neurological complications may be increased, due to the administration of the drug Yopromide.

Pheochromocytoma

In patients suffering from pheochromocytoma, there is a risk of developing a hypertensive crisis. Premedication with alpha-blockers is recommended.

Patients with autoimmune diseases

The cases of severe vasculitis or Stevens-Johnson syndrome in patients with a history of autoimmune diseases are described.

Myasthenia gravis

The introduction of iodine-containing radiopaque substance may increase the severity of symptoms of myasthenia gravis.

Alcoholism

The acute or chronic form of alcoholism can increase the permeability of the BBB. The facilitated penetration of radiocontrast into the brain tissue can lead to reactions from the CNS.

Introduction to the membranes of the brain

It should be carefully treated in patients with a history of seizures, because they have increased the risk of seizures due to the administration of the drug Yopromide under the shell of the brain. It is necessary to have ready means for arresting seizures.

Introduction to other body cavities

Pregnancy should be excluded before hysterosalpingography.

Inflammation of the bile duct or tubal can increase the risk of reactions after ERCP or hysterosalpingography.

Pregnancy and lactation:

The drug should not be used in pregnant women,when the intended use for the mother from its use exceeds the potential risk to the fetus, and such a study is prescribed by the doctor because of the need.

Excretion of the drug Yopromide with breast milk is negligible, and it is unlikely that it would pose a risk to infants. However, if you need to administer the drug, the mother should stop breastfeeding for at least 24 hours after the test.

Dosing and Administration:

General information

Before use Yopromide should be heated to body temperature.

Before administration, you should carefully inspect the bottle. If the integrity of the vial is violated, a significant change in color, the detection of visible particles (including crystals), the drug should not be used. Because the Yopromide is a highly concentrated solution, it is extremely rare to crystallize (the appearance of milk-like opacities and / or sediment or crystals in the form of a slurry).

For the introduction of a radiopaque solution, it is necessary to use an automatic injector or other special instruments with preservation of sterility. Recruit Yopromide in a syringe or infusomat follows immediately before administration.

Do not make more than one puncture of the rubber stopper in order to prevent a large number of microparticles from entering the prepared solution from the plug. Therefore, to puncture the rubber plug and a set of radiopaque means, it is recommended to use cannulae with long tips with a diameter of no more than 18 G (best suited are marked cannulae with a lateral opening of the type Nocore-Admix). The solution of the drug unused after opening the vial should be destroyed. Vials containing 200 and 500 ml of the drug should be used only for intravascular injection. For the introduction it is necessary to use an automatic injector or other equipment that provides sterility of the drug. Follow the instructions for using an automatic injector or other equipment. Unused after opening the bottle the drug can be applied within 10 hours after the first opening. Then it should be destroyed.

Doses for intravascular injection

The intravascular injection of the radiopaque means, if possible, is best carried out while the patient is lying down.

In patients with severe renal and cardiovascular failure, as well as with a general poor health, the dose of radiopaque should be as low as possible. In such patients, it is recommended that kidney function be monitored for at least 3 days after the examination.

The dose of radiopaque means should correspond to the age, body weight to be solved by the clinical problem and the research method. Doses given below should be considered only as recommended; they are the usual dose for an average adult person with a body weight of 70 kg. The dose is expressed in ml for a single injection or per kg of body weight.

As a rule, doses up to 1.5 g of iodine per kg of body weight are usually well tolerated. Between individual injections, the body should be given sufficient time to remove fluid from the interstitial space to normalize the increased serum osmolality. If necessary, in some cases, exceed the total dose of 300-350 ml in adults, the introduction of water and, possibly, electrolytes is indicated.

Recommended doses for single injections

Ordinary angiography

Type of research	Dosage of the drug (concentration of iodine mg / ml)	Dose, ml
Angiography of the arch of the aorta	300	50-80
Selective angiography	300	6-15
Breast aortography	300/370	50-80
Abdominal aortography	300	40-60
*Arteriography*
Upper limbs	300	8-12
Lower limbs	300	20-30
Angiocardiography
Ventricles of the heart	370	40-60
Coronary angiography	370	5-8
*Venography*
Upper limbs	240 300	50-60 15-30
Lower limbs	240 300	50-80 30-60

Intravenous CSA

In order to carry out large vessels in the CAA, Yopromide solutions for injection 300 mg iodine / ml and 370 mg iodine / ml in a volume of 30-60 ml. The drug is administered bolus at a rate of 8-12 ml / s to the ulnar vein or at a rate of 10-20 ml / s through the catheter into the vena cava. The contact time of the radiopaque substance with the vein wall can be shortened by the condition of rapid bolus administration immediately after the preparation Yopromide 0.9% solution of sodium chloride.

Adults

30-60 ml of injection for 300 mg of iodine / ml and solution for injection 370 mg of iodine / ml of the drug Yopromide.

Intraarterial CSA

When performing intra-arterial CSA, in contrast to conventional angiography, smaller amounts of the drug can be administered Yopromide and its lower concentrations.

If it is possible, Yopromide It should be injected into a vein in the form of a bolus using an automatic injector.Only with slow scanning, about half the dose should be administered bolus, and the rest for 2-6 minutes to ensure a relatively constant concentration of the drug in the blood.

Spiral CT and especially multi-layer CT allows a large amount of data to be obtained with a single breath delay. To obtain the optimal diagnostic effect from the intravenously administered bolus (80-150 ml of injection for 300 mg of iodine / ml of the drug Yopromide) in the area under examination (peak, time and duration of contrast), it is recommended to use an automatic injector and to control the time interval from the beginning of the introduction of radiopaque before starting the scan.

Whole body CT

Required doses radiopaque means and the speed of their administration depend on the organ being examined, the diagnostic problem being solved and, in particular, on the differences in scanning and the duration of image reconstruction.

CT of the skull

Adults:

Iopromide, injection, 240 mg iodine / ml: 1.0-2.5 ml / kg.

Iopromide, injection, 300 mg iodine / ml: 1.0-2.0 ml / kg.

Iopromide, injection, 370 mg iodine / ml: 1.0-1.5 ml / kg.

Intravenous urography

In connection with the physiologically weak concentration capacity of immature kidney nephrons in children, relatively high doses of radiopaque agents are required.

The following doses of Yopromide are recommended

Age	Amount of iodine, g / kg body weight	Yopromide ml / kg body weight
Age	Amount of iodine, g / kg body weight	240 mg iodine / ml	300 mg iodine / ml	370 mg iodine / ml
Newborns (<1 month)	1,2	5,0	4,0	3,2
Young children (1 month-2 years)	1,0	4,2	3,0	2,7
Children (2-11 years old)	0,5	2,1	1,5	1,4
Adolescents and adults	0,3	1,3	1,0	0,8

If necessary, in some cases, adults may increase these doses.

Snapshot Time

The timing of the pictures after the administration of the drug Yopromide 300 mg iodine / ml / 370 mg iodine / ml with the duration of administration of 1-2 minutes (3-5 min in the case of drug administration Yopromide 240 mg iodine / ml) are 3-5 minutes for the renal parenchyma (5-10 minutes in the case of drug administration Yopromide 240 mg iodine / ml), and for visualization of the renal pelvis and ureter system - 8-15 min (12-20 minutes in the case of drug administration Yopromide 240 mg iodine / ml) after initiation of the administration of the radiopaque substance. The younger the patient, the earlier the picture is taken. Usually, you should take the first picture 2-3 minutes after the introduction of radiopaque.In newborns, infants and patients with impaired renal function, taking pictures at a later date can improve the visualization of the urinary tract.

Doses when administered under the membranes of the brain

Adults

Dosages can depend to a large extent on the clinical problem being solved, the method and the field of examination.

If there is equipment to record images in all projections without changing the position of the patient's body and with the introduction of radiopaque means under fluoroscopic control, smaller volumes of the diagnostic drug may be sufficient.

Recommended dose for individual studies

Myelography

Amount of preparation Yopromide 240 mg of iodine / ml is up to 12.5 ml.

The maximum dose of the drug Yopromide 240 mg iodine / ml (12.5 ml) corresponds to a total dose of iodine of 3 g and should not be exceeded for one study.

After the examination, the radiopaque should be directed to the lumbar region, which is achieved by giving the patient a direct sitting position or by raising the patient's bed head at an angle of 15 ° for at least 6 hours.

Children

Safety and efficacy of the drug Yopromide during myelography are not studied.

Doses when administered to the body cavity

When carrying out arthrography, ERCP and hysterosalpingography, the introduction of radiopaque means should be carried out under the control of fluoroscopy

Recommended doses for individual studies:

The dose can be highly dependent on age, body weight, general condition of the patient, as well as on the clinical problem being solved, the technical equipment used and the field of examination. Below are the average doses recommended to adults in the norm.

Arthrography:

5-15 ml Yopromide 240 mg iodine / ml / 300 mg iodine / ml / 370 mg iodine / ml.

Hysterosalpingography:

10-25 ml Yopromide 240 mg iodine / ml.

ERCPR:

The dose depends on the clinical problem being solved and the size of the visualized structure.

Other cavities:

The dose depends on the clinical problem being solved and the size of the visualized structure.

Side effects:

Side effects in the case of intravascular application of iodine-containing radiopaque substances are usually of a transient nature. However, serious and life-threatening reactions, not excluding reactions with a fatal outcome, did take place.

Most often, with intravascular application, there are reactions such as nausea, vomiting, pain and a feeling of heat.

For all indications:

System of organs	Often (>1/100)	Infrequently (>1/1000, <1/100)	Rarely (<1/1000)
Immune system disorders		Anaphylactoid reactions / hypersensitivity	Anaphylactic shock (including fatal cases)
Disorders from the endocrine system			Changes in thyroid function, thyrotoxic crisis
Disturbances from the nervous system		Dizziness, restlessness	Paresthesia / hypostasia, confused consciousness, fear, agitation, amnesia, speech disturbance, drowsiness, loss of consciousness, coma, tremor, convulsions, paresis / stroke, cerebral anemia / infarction, stroke, transient cortical blindness
Disturbances on the part of the organ of sight		Blurred vision perception / violation view	Conjunctivitis, lacrimation
Hearing disorders			Hearing impairment
Heart Disease		Arrhythmia	Heart palpitations, chest pain / chest tightness, bradycardia, tachycardia, cardiac arrest, cardiac Mr.insufficiency, myocardial ischemia / infarction, cyanosis
Vascular disorders		Vascular expansion	Increased blood pressure, lowering blood pressure, shock, vasospasm, thromboembolism
Disturbances from the respiratory system		Sneezing, coughing	Rhinitis, shortness of breath, swelling of the mucous membranes, bronchial asthma, dysphonia, larynx / pharyngeal / tongue / face swelling, bronchospasm, larynx / pharyngeal spasm, pulmonary edema, respiratory failure, respiratory arrest
Disorders from the gastrointestinal tract	Nausea	Vomiting, taste disorder	Throat irritation, dysphagia, salivary gland swelling, stomach pain, diarrhea
Disturbances from the skin and subcutaneous tissues		Urticaria, itching, rash, erythema	Vascular Edema, Stevens-Johnson Syndrome, Lyell's Syndrome)
Disorders from the kidneys and urinary tract		Impaired renal function	Acute renal Mr.sufficiency
General disorders and disorders at the site of administration	Feeling of heat or pain, headache	Malaise, chills, increased sweating, fainting	Pallor, changes in body temperature, swelling, local pain, slight fever and swelling, inflammation and tissue damage in the case of extravasal administration

When administered under the membranes of the brain

In addition to the side effects listed earlier, when non-ionic radiopaque agents are administered to the brain membranes, the following additional undesirable effects are possible:

System of organs

Often

(>1/100)

Infrequently

(>1/1000, <1/100)

Rarely

(<1/1000)

Disorders from the nervous system

Neuralgia, meningism

Paraplegia, psychosis, aseptic meningitis, changes in the EEG

Are common disorders and disorders at the site of administration

Difficulty urination

Back pain, pain in the limbs, pain at the injection site

Headache, including cases of severe severe form, nausea and vomiting are common. Most adverse reactions after myelography or contrasting body cavities occur within a few hours after the administration of the radiopaque.

ERCPR

In addition to the listed undesirable affects in carrying out ERCPH, it is possible to increase the activity of pancreatic enzymes (often), the development of pancreatitis (rarely).

Overdose:

When studying acute toxicity in animals, there is no risk of acute intoxication after drug administration Yopromide.

Intravascular administration

Symptoms can include a violation of the balance of fluid and electrolytes, kidney failure, complications of the cardiovascular system and lungs, it is necessary to monitor the volume of fluid, the content of electrolytes, the function of the kidneys. Treatment of overdose should be aimed at maintaining vital body functions. Yopromide can be removed from the body by hemodialysis. In the case of an erroneous dose exceeding with intravascular injection of the drug into the human body, it is necessary to compensate for the loss of water and electrolytes by infusion. It is necessary to observe the kidney function for at least 3 days.

If necessary, hemodialysis can be used to remove the main part of the radiopaque substance from the human body.

Introduction to the membranes of the brain

Possible development of serious neurological complications. It is recommended to carefully monitor the patient's condition.

To prevent the ingestion of large amounts of the drug Yopromide in the ventricles of the brain, it is necessary to produce as far as possible a complete aspiration of the radiopaque substance.In the case of an erroneous dose increase when the drug is injected under the membranes of the brain, it is necessary to carefully monitor the manifestations of severe CNS disorders for at least the first 12 hours. Such signs may be an increasing increase in reflexes or tonic-clonic muscular spasms, in severe cases involving CNS - generalized convulsions, hyperthermia, stupor and respiratory depression.

Interaction:

Biguanides (metformin): in patients taking biguanides, with intravascular injection of yopromide, it is possible to accumulate biguanides and develop lactic acidosis. To prevent this complication, you should stop taking biguanides 48 hours before radiopaque testing and do not renew it for at least 48 hours after the radiocontrast injection. Renewal should only be after the restoration of kidney function.

Simultaneous use of neuroleptics and antidepressants can reduce the convulsive threshold, increasing the risk of reactions associated with the use of radiopaque.

Patients receiving beta-blockers, can be resistant to drugs that have a beta-agonist effect, used to treat hypersensitivity reactions (see "Special instructions").

Interleukin-2: the risk of developing delayed reactions in response to the administration of yopromide increases with the preliminary treatment (within a few weeks) of patients with interleukin-2.

Effect on diagnostic tests

Radioisotopes: within a few weeks after the administration of yopromide there is a decrease in the absorption of thyrotropic isotopes by the thyroid gland, which reduces their effectiveness for diagnosis and treatment of thyroid diseases.

Special instructions:

Diet suggestions

You can adhere to the usual diet, but in the last 2 hours before the study should refrain from eating.

Fluid consumption

Before and after intravascular injection of Yopromide or its administration under the membranes of the brain, an adequate amount of fluid should be consumed. Of particular importance this has for patients with multiple myeloma, diabetes mellitus, polyuria, hyperuricemia, as well as to infants, small children, patients in advanced age.

Newborns (<1 month) and small children (1 month - 2 years)

Infants (up to a year) and especially newborns are characterized by sensitivity to disturbance of water-electrolyte balance and hemodynamic disorders. Attention should be paid to the dose of radiopaque, technical support of radiological examination and the condition of the patient. Yopromide, as a low osmolar water-soluble radiocontrast agent, is used in routine gastrointestinal tract studies in newborns, infants and older children due to the fact that this category has an increased risk of aspiration, intestinal obstruction and penetration of radiocontrast from the lumen of the intestine to the abdominal cavity .

Fear

In the presence of a state of excitement, fear and pain, the risk of side effects or the intensity of reactions caused by radiopaque means may increase. Such patients can be prescribed sedatives.

Preheating the radiopaque preparation before use

An X-ray contrast agent heated to the body temperature prior to administration is better tolerated and easier to administer due to a decrease in the viscosity of the solution.Heated in a thermostat to 37 ° C follows only the amount of the drug that is supposed to be used.

Conducting a preliminary test

The use of a small amount of radiopaque for carrying out the sensitivity test is not recommended, since it has no prognostic significance. Moreover, carrying out such testing alone can lead to serious adverse reactions.

Hypersensitivity

Sometimes after the application of non-ionic radiopaque agents of the type Yopromide allergic reactions of hypersensitivity are observed (see "Side effect") or other manifestations of idiosyncrasy from the side of the cardiovascular, respiratory system and skin. Usually, these reactions, the severity of which can be moderate to severe, including shock, occur within one hour after the introduction of radiopaque. However, in rare cases, deferred reactions (from hours to days) may develop.

Patients with hypersensitivity or with previous reactions to iodine-containing radiopaque agents have an increased risk of developing severe reactions.However, such reactions are rare and unpredictable.

The risk of developing allergic reactions is increased in the following cases:

- in the presence of previously existing reactions to iodine-containing radiopaque agents;

- if there is an anamnesis of bronchial asthma or other allergic diseases.

Patients with severe cardiovascular diseases have an increased risk of developing severe or even fatal side effects.

In connection with the possibility of developing severe hypersensitivity reactions after the administration of radiopaque, after the end of the procedure, it is necessary to observe the patient's condition.

In all cases, it is necessary to be prepared, if necessary, to provide emergency care to the patient.

If hypersensitivity reactions occur (see "Side effect"), the administration of the radiopaque should be stopped immediately and, if necessary, started adequate therapy, preferably intravenously. Therefore, it is advisable to use a flexible catheter for intravenous radiocontrast. In order to be able to take urgent measures in emergency cases, it is necessary to have appropriate medicines at the ready,endotracheal intubation tube and apparatus for artificial ventilation. It should be noted that patients taking beta-blockers may be resistant to the treatment of hypersensitivity reactions with drugs that have a beta-agonist effect. Caution is needed when using iodine-containing radiopaque agents in patients receiving beta-blockers.

When conducting premedication, it is recommended to use glucocorticosteroids.

Thyroid dysfunction

Particularly careful weighing of the risk / benefit ratio follows in patients with established or suspected hyperthyroidism or goiter, since iodine-containing radiopaque agents can cause them to have hyperthyroidism or a thyrotoxic crisis. Consideration should be given to the need to evaluate the function of the thyroid gland prior to the administration of the drug Yopromide and / or prescribe for prophylactic purposes thyreostatic therapy in patients with established or suspected hyperthyroidism.

Age

Vascular pathology and neurological disorders, usually found in older people, increase the risk of adverse reactions to iodine-containing radiopaque agents.

Severe patient condition

The need for the study should be especially carefully evaluated in patients with a severe general condition.

Renal damage

In all patients who are administered Yopromide, adequate rehydration should be provided prior to the administration of the radiopaque, preferably by intravascular infusion before and after the procedure until the radiopaque means is excreted by the kidneys.

Before excretion of the radiopaque agent by the kidneys, it is necessary to exclude the additional burden on the kidneys in the form of nephrotoxic drugs, oral cholecystography, restriction of arterial blood flow in the kidney, angioplasty of the renal arteries, extensive surgical interventions, etc. It should be postponed a new study with the introduction of radiopaque means before the restoration of kidney function to the baseline.

In patients on hemodialysis, the injected radiocontrast agents are removed from the body during hemodialysis.

Diseases of the central nervous system

The presence of intracranial tumors or metastases, as well as epilepsy, can increase the incidence of convulsive episodes after the introduction of radiopaque preparation.Neurological complications occur more often when performing cerebral angiography or similar studies.

Alcoholism

Care must be taken when conducting a study in patients with alcoholism and drug addiction due to the possibility of reducing the convulsive threshold.

Angiography

One of the properties of nonionic radiopaque substances is their extremely small impact on the normal physiological functions of the body. That is why non-ionic radiopaque substances have less anticoagulant activity in vitro, than ionic ones. A number of factors, in addition to the properties of the radiopaque agent itself, such as the duration of the study, the number of injections, the properties of the catheter and the syringe, the state of the disease and the treatment being administered, can influence the development of thromboembolic complications. Therefore, during the catheterization of the vessel it is necessary to take into account these factors and pay special attention to the performance of the angiography technique, and also to wash the catheter with 0.9% sodium chloride solution (if necessary with the addition of heparin) and minimize the time of this procedure in order to minimize the risk of thrombosis and embolism.

The use of plastic syringes instead of glass can reduce, but not eliminate the possibility of blood clotting in vitro.

Caution is needed in the study of patients with homocystinuria due to the risk of thrombosis and embolism.

Introduction to the membranes of the brain

Most adverse reactions after myelography are developed within a few hours after the administration of radiopaque. During this period, you should monitor the patient's condition. Patients with a history of epilepsy or who are receiving anticonvulsant therapy should continue treatment with appropriate drugs during the study with the introduction of an X-ray contrast medium under the membranes of the brain.

Care is needed in the study of patients with alcoholism and drug addiction in connection with the possibility of reducing the convulsive threshold.

Myelography

The more the patient moves or strains his muscles after the introduction of the radiopaque, the sooner it is mixed with the biological fluids of other areas that do not belong to the area under examination. As a result, the contrast density decreases faster than usual.

To avoid discomfort caused by loss of cerebrospinal fluid, the patient needs to rest for about 18 hours. During this period, it is necessary to monitor the possibility of developing adverse reactions. Patients with a reduced threshold of convulsive activity should be under particularly careful supervision for several hours.

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

It is not recommended to drive vehicles or work with any other mechanisms during the first 24 hours after the introduction of radiopaque means.

Form release / dosage:

Solution for injection, 240 mg iodine / ml, 300 mg iodine / ml, 370 mg iodine / ml.

Packaging:

Dosage of 240 mg iodine / ml:

For 10 or 50 ml in neutral glass bottles, corked with rubber stoppers, rolled up with aluminum caps and covered with plastic caps.

Dosage 300 mg iodine / ml:

10, 20, 50, 100, 200 or 500 ml in neutral glass bottles, sealed with rubber stoppers, rolled with aluminum caps and closed with plastic caps.

Dosage 370 mg iodine / ml:

At 30, 50, 100, 200 or 500 ml in neutral glass bottles, sealed with rubber stoppers, rolled up with aluminum caps and covered with plastic caps.

1 bottle with instructions for use in a pack of cardboard.

For hospitals:

10 vials of 10, 20, 30, 50, 100 or 200 ml together with the instructions for use are placed in a cardboard box.

8 bottles of 500 ml together with the instruction for use are placed in a cardboard box.

Storage conditions:

In a place protected from light and X-rays, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002892

Date of registration:03.03.2015 / 21.04.2016

Expiration Date:03.03.2020

Date of cancellation:2020-03-03

The owner of the registration certificate:JODAS EKSPOIM, LLC JODAS EKSPOIM, LLC Russia

Manufacturer: & nbsp

NOVALEK PHARMACEITICAL, Pvt. Ltd. India

Representation: & nbspJodas Expoim, Open CompanyJodas Expoim, Open Company

Information update date: & nbsp29.11.2017

Illustrated instructions

Instructions

Yopromide (Iopromide)