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

Concentration	Osmolality (Osm / kg H₂ABOUT) 37 ° C	Viscosity (mPa * C)
Concentration	Osmolality (Osm / kg H₂ABOUT) 37 ° C	20 ° С	37 ° C
300 mg iodine / ml	0,64	11,6	6,1
350 mg iodine / ml	0,78	23,3	10,6

Pharmacotherapeutic group:X-ray contrast medium

ATX: & nbsp

V.08.A Radiocontrast iodine-containing substances

Pharmacodynamics:

Yogexol is a nonionic low-osmolar iodine-containing radiopaque preparation. Contrasting of joint cavities, uterine cavity, fallopian tubes, peritoneal protrusions, pancreatic and biliary ducts, bladder is achieved immediately after administration. Time to achieve maximum radiopaque in normal myelography - up to 30 min. With computed tomography, visualization of contrast - in the thoracic region is possible within 1 hour, in the cervical region - about 2 hours, basal cisterns - 3-4 hours.

Pharmacokinetics:

After 100% of injected intravenously, yogexol is released unchanged through normally functioning kidneys within 24 hours. The maximum concentration of iohexol in urine is determined approximately 1 hour after the injection.

The half-life of the drug in patients with normal renal function is about 2 hours. No metabolites of the drug were found. Binding yogexol to plasma proteins is small (less than 2%), and has no clinical significance.

Indications:

Nioscan is for diagnostic purposes only.

Radiopaque means for use in children and adults, intended for performing cardioangiography, arteriography, urography, phlebography and contrast enhancement in computed tomography (CT); lumbar, cervical myelography, CT-cisternography after subarachnoidal administration; arthrography, hysterosalpingography, sialography and gastrointestinal tract research.

Contraindications:

Hypersensitivity to the active substance or any auxiliary component of the drug; clinically manifested thyrotoxicosis.

Carefully:

- If you have a history of allergies, bronchial asthma or other undesirable reactions to the use of iodine-containing radiocontrast agents. Premedication is recommended glucocorticosteroids or blockers H₁-gistaminovyh receptors.

- in the study of patients with severe cardiovascular diseases and pulmonary hypertension, due to the risk of developing hemodynamic disorders or arrhythmias.

- in the study of patients with acute cerebral pathology, tumors or epilepsy in the anamnesis, in connection with the predisposition of this category of patients to convulsions.The risk of seizures and neurological reactions is also increased in patients with alcoholism or drug dependence.

- in the study of patients with severe combined disorders of the liver and kidneys, as they significantly reduced the clearance of radiopaque means.

- To prevent the development of acute renal failure after the introduction of radiocontrast agents, special attention should be paid to patients at high risk for patients with renal dysfunction and diabetes mellitus, as well as patients with paraloproteinemia (myelomatosis and Waldenstrom macroglobulinemia).

- in the study of patients with pollinosis, food allergy, multiple sclerosis, sickle cell anemia, pheochromocytoma, obliterating thromboangiitis, acute thrombophlebitis, severe atherosclerosis, elderly.

- In the study of patients with hyperthyroidism, patients with multinodular goiter after the introduction of iodine-containing radiocontrast agents have a risk of developing hyperthyroidism. With the introduction of radiopaque means for premature infants, the possibility of developing hyperthyroidism should be considered.

- when examining patients with hypovolemia, adequate rehydration should be provided, at least 100 ml every hour for 4 hours before the study and 24 hours after the test.

- In the study of patients with multiple myeloma, diabetes mellitus, impaired renal function, newborns, children under one year old and elderly patients, adequate rehydration should be carried out before and after the administration of radiopaque.

- patients with diabetes mellitus who receive metformin, before intravascular administration of iodine-containing radiocontrast agents, the drug should be discontinued for at least 48 hours before and within 48 hours after the procedure.

- with the introduction of radiopaque means may worsen the symptoms of myasthenia gravis gravis.

In emergency cases, when renal function is unknown, the physician should assess the risk / benefit ratio from the use of radiopaque means: stop using metformin, rehydrate, monitor the kidney function, follow signs of lactic acidosis.

Pregnancy and lactation:

Pregnancy

The drug should not be used in pregnant women, unless the intended benefit to the mother from its use outweighs the potential risk to the fetus, and such a study is prescribed by the doctor as necessary.

Hysterosalpingography should not be performed in pregnant women and in the presence of acute pelvic peritonitis.

Breastfeeding period

Radiopaque means are excreted to breast milk to an insignificant degree. If it is necessary to administer the drug, breastfeeding should be discontinued before the introduction of the drug and should not be resumed for at least 24 hours after the test.

Dosing and Administration:

The drug is intended for intravascular (intra-arterial, intravenous), intrathecal, intracavitary, oral and rectal administration. Before use, the preparation should be inspected visually for a period of absence of insoluble particles, discoloration, and damage to the integrity of the package.

Nioscans should be injected into the syringe immediately before use. Unused remnants of the drug for further use are not allowed.

Do not mix the drug with other medicines (you need to use a separate syringe and needle).

When the drug is administered, the patient should be in a horizontal position. Within 30 minutes after the end of the procedure, medical monitoring of the patient, since most adverse reactions occur precisely during this period.

Intrathecal administration

After myelography, the patient should be in horizontal position for 1 hour with head and chest raised to 200. After that, the patient can walk gently, but should not bend over. If the patient stays in bed, then his head and chest should remain elevated for 6 hours, and if the suspicion of a low convulsive threshold is suspected, the patient should remain under medical supervision during this period of time. Outpatients should not be left without medical supervision in the first 24 hours after the study.

The dosage of the drug depends on the type of study, the age and body weight of the patient, as well as the state of hemodynamics, the general state of health, as well as the methods used and the technique for performing the study.Typically, the same concentrations of iodine and the amounts of administration of the drug are used, as with other modern iodine-containing radiopaque agents.

The recommended dosage regimen is given in the table.

Indication	Concentration	Scope	Notes
Intravenous administration
*Urography*
Adults	300 mg iodine / ml or 350 mg iodine / ml	40-80 ml	In some cases, the administration of more than 80 ml
Children under 7 years old	300 mg iodine / ml	40-80 ml 3 ml / kg
Children over 7 years old	300 mg iodine / ml	2 ml / kg (max 40 ml)
*Phlebography (lower limbs)*
	300 mg iodine / ml	20-100 ml per limb
*Digital subtraction angiography*
	300 mg iodine / ml or 350 mg iodine / ml	20-60 ml per injection
*CT scan*
adults	300 mg iodine / ml or 350 mg iodine / ml	100-200 ml 100-150 ml	The total amount of iodine is usually 30-60 g
children	300 mg iodine / ml	1-3 ml / kg body weight not more than 40 ml	In some cases, up to 100 ml can be administered, but not more than
Intraarterial administration
*Arteriography*
Aortic arch	300 mg iodine / ml	30-40 ml per injection	The volume per injection depends on the site of administration.
Selective cerebral angiography	300 mg iodine / ml	5-10 ml per injection
Aortography	350 mg iodine / ml	40-60 ml per injection
Femoral arteriography	300 mg iodine / ml or 350 mg iodine / ml	30-50 ml per injection
Other	300 mg iodine / ml	Depends on the type of study
*Cardioangiography*
Adults: Left ventricle and aorta root	350 mg iodine / ml	30-60 ml per injection
Selective coronary angiography	350 mg iodine / ml	4-8 ml per injection
children	300 mg iodine / ml or 350 mg iodine / ml	Depending on age, body weight and disease (max 8 ml / kg)
Digital subtraction angiography	300 mg iodine / ml	1-15 ml per injection	Depending on the site of administration, large volumes (up to 30 ml)
Intrathecal administration
Cervical myelography (lumbar injection)	300 mg iodine / ml	7-10 ml
Cervical myelography (lateral cervical injection)	300 mg iodine / ml	6-8 ml
To minimize the risk of adverse reactions, the total dosage of iodine should not exceed 3 g.
Introduction to the body cavity
*Arthrography*	300 mg iodine / ml or 350 mg iodine / ml	5-15 ml 5-10 ml
*Hysterosalpingography*	300 mg iodine / ml	15-25 ml
*Sialografiya*	300 mg iodine / ml	0.5-2 ml
Gastrointestinal tract examination
Orally
adults	350 mg iodine / ml	Selected individually
children - esophagus	300 mg iodine / ml or 350 mg iodine / ml	2-4 ml / kg body weight 2-4 ml / kg body weight	The maximum dose of 50 ml The maximum dose of 50 ml
Premature babies	350 mg iodine / ml	2-4 ml / kg body weight
Rectal - children	Dilution with water to 100-150 mg of iodine / ml	5-10 ml / kg body weight	For example: dilute with water Nioscan 300 or 350 water 1: 1 or 1: 2
CT scan
Orally adults	Dilute with water to a concentration of about 6 mg iodine / ml	800-2000 ml of diluted solution for one period of time	For example: dilute with water Nioscan 300 or 350 water 1:50
children	Dilute with water to a concentration of about 6 mg iodine / ml	15-20 ml of solution per kg of body weight
Rectal - children	Dilute with water to a concentration of about 6 mg iodine / ml	Individually

Side effects:

General adverse reactions (with all indications for the use of iodine-containing radiocontrast agents).

Hypersensitivity reactions can occur regardless of the dose and mode of administration, mild symptoms may be harbingers of a serious anaphylactoid reaction / shock. In this case, the administration of the radiopaque means should be immediately stopped and, if necessary, the intravascular administration of specific therapeutic agents is started. After the introduction of the iodine-containing radiopaque, there is often an insignificant transient increase in serum creatinine concentration, the development of contrast-induced nephropathy is possible.Yodizm - a rare reaction to the introduction of iodine-containing radiocontrast agents, expressed in the increase and soreness of the salivary glands after a study of up to 10 days. The incidence of adverse events is classified as follows: very often (≥1/10), often from (≥1 / 100 to <1/10), infrequently from (≥1 / 1000 to <1/100), rarely from (≥1 / 10,000 to <1/1000), very rarely from (<1/10000), the frequency is unknown (the frequency can not be determined from the available data).

Impaired immune system. Rarely, hypersensitivity reactions (including dyspnea, rash, erythema, urticaria, pruritus, skin reactions, vasculitis, angioedema, laryngeal edema, laryngospasm, bronchospasm, or non-cardiogenic pulmonary edema). Reactions can occur immediately after the injection or a few days later. Unknown - anaphylactic / anaphylactoid reaction, anaphylactic / anaphylactoid shock.

Violations from the nervous system. Rarely is a headache; very rarely - dysgeusia (transient sensation of a "metallic" taste in the oral cavity); unknown - faint.

Disorders from the cardiovascular system. Rarely, a bradycardia.

Violations from the vessels. Very rarely - increased blood pressure, lower blood pressure.

Disorders from the gastrointestinal tract. Infrequently - nausea; rarely vomiting; very rarely - diarrhea, pain / discomfort in the abdomen; unknown - an increase in the salivary glands.

General disorders and disorders at the site of administration. Often - a feeling of heat; rarely - a fever; very rarely - chills. Injuries, intoxication and complications of manipulation. Unknown - iodism.

Intravascular administration (intraarterially and intravenously).

The nature of adverse reactions that occur with intra-arterial administration depends on the site of injection and the dose administered. Selective angiography and other procedures in which high concentrations of radiopaque means reach a particular organ may be accompanied by the development of complications in this organ.

Impaired immune system. It is unknown - severe skin reactions in the form of pustules or bullae.

Disorders from the endocrine system. Unknown - thyrotoxicosis, transient hypothyroidism.

Disorders of the psyche. Unknown - confusion.

Violations from the nervous system. Rarely - dizziness; very rarely - convulsions, impaired consciousness, encephalopathy, stupor,disorders in the sensory sphere (including hypoesthesia), paresthesia, tremor; it is unknown - transient motor dysfunction (including speech disturbance, aphasia, dysarthria), transient memory loss, disorientation, coma, and retrograde amnesia.

Disorders from the side of the organ of sight. It is unknown - transient cortical blindness.

Hearing disorders and labyrinthine disturbances. It is unknown - transient hearing loss.

Disorders from the cardiovascular system. Rarely - arrhythmia (including bradycardia, tachycardia); very rarely - myocardial infarction; unknown: severe complications (including cardiac arrest, cardiac arrest and respiration), spasm of the coronary arteries, pain in the chest.

Violations from the vessels. Very rarely - "tides"; unknown - shock, arterial spasm, ischemia, thrombophlebitis and thrombosis.

Disturbances from the respiratory system, chest and mediastinum. Rarely - cough; very rarely - shortness of breath, noncardiogenic pulmonary edema; unknown - severe symptoms and signs of respiratory disorders, bronchospasm, laryngospasm, attack of bronchial asthma.

Disorders from the gastrointestinal tract.Rarely, diarrhea; unknown - exacerbation of pancreatitis, acute pancreatitis.

Disturbances from the skin and subcutaneous tissues. Unknown - bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash, accompanied by eosinophilia and general symptoms, exacerbation of psoriasis.

Disturbances from the musculoskeletal and connective tissue. Unknown - arthralgia.

Disorders from the kidneys and urinary tract. Rarely, renal dysfunction, including acute renal failure.

General disorders and disorders at the site of administration. Often - a feeling of heat; infrequently - pain and discomfort; rarely - asthenic condition (for example, malaise, fatigue); unknown - reactions at the injection site (including extravasation), back pain.

Intrathecal administration.

In case of intrathecal administration, undesired reactions may occur through several hours or even days after the diagnostic procedure. The frequency of adverse reactions is the same as after lumbar puncture. Headache, nausea, vomiting, or dizziness can be largely due to a decrease in pressure in the subarachnoid space due to leakage of the cerebrospinal fluid through the puncture hole.To minimize the pressure drop, you must avoid removing too much cerebrospinal fluid.

Violation of the psyche. Unknown - confusion.

Violations from the nervous system. Very often - headache (can be severe and prolonged); infrequently - aseptic meningitis (including chemical meningitis); rarely - convulsions, dizziness; unknown - abnormalities on the electroencephalogram, meningism, transient encephalopathy, including temporary memory loss, coma, stupor and retrograde amnesia, motor dysfunction (including speech disorders, aphasia, dysarthria), paresthesia, hypesthesia and impaired sensory function.

Disorders from the side of the organ of sight. It is unknown - transient cortical blindness, photophobia.

Hearing disorders and labyrinthine disturbances. It is unknown - transient hearing loss.

Disorders from the gastrointestinal tract. Often - nausea, vomiting.

Disturbances from the musculoskeletal and connective tissue. Rarely, pain in the neck, back pain; unknown - muscle spasms.

General disorders and disorders at the site of administration.Rarely - pain in the limbs; unknown - reactions at the site of administration of the drug.

Intracavitary injection.

Endoscopic retrograde cholangiopancreatography (ERCP).

Disorders from the gastrointestinal tract. Often - pancreatitis, increased activity of amylase in the blood.

Oral administration.

Disorders from the gastrointestinal tract. Very often - diarrhea; often - nausea, vomiting; infrequently - pain in the abdomen.

Hysterosalpingography (GHA).

Disorders from the gastrointestinal tract. Very often pain in the lower abdomen.

Arthrography.

Disturbances from the musculoskeletal and connective tissue. Unknown - arthritis.

General disorders and disorders at the site of administration.

Very often - pain.

Hernography.

General disorders and disorders at the site of administration. Unknown - pain after the procedure.

Description of some unwanted reactions.

There have been reports of thromboembolic complications in contrasting cardioangiography and angiography of the cerebral, renal and peripheral arteries. The introduction of radiopaque means could contribute to the development of these complications. Cases of cardiac complications, including acute myocardial infarction, during or after coronary angiography with radiopaque enhancement are described.In elderly patients or in the presence of severe coronary artery disease, unstable angina and left ventricular dysfunction, the risk of cardiac complications is increased.

In very rare cases, the radiopaque can pass through the blood-brain barrier into the cerebral cortex, which can lead to transient neurologic reactions, particular, convulsions, transient motor or sensory disorders, confusion, loss of memory and encephalopathy.

Anaphylactoid reaction and shock can develop severe arterial hypotension and associated hypoxic encephalopathy, renal and hepatic insufficiency. In some cases, extravasation of radiopaque means there are local pain and swelling, but these symptoms are resolved without consequences. Cases of inflammation, tissue necrosis and the appearance of compartmental syndrome are described.

Application in pediatrics.

There have been reports of cases of transient hypothyroidism in children, including preterm and newborns, after the introduction of iodine-containing radiopaque agents.Premature babies are particularly sensitive to iodine effects. The case of transient hypothyroidism in a preterm child was reported. An adequate rehydration is necessary before and after the introduction of radiopaque means, this is especially important for young children.

Nephrotoxic drugs should be discontinued. Reduced glomerular filtration, characteristic of young children, can also lead to a delayed removal of radiopaque substances.

Overdose:

Overdose is unlikely in patients with normal renal function. In the case of using high doses of the drug, the duration of the study (the half-life of the drug is approximately 2 hours) has a large effect on the kidneys. There is no specific antidote, treatment is symptomatic, hemodialysis is possible.

Interaction:

When used concomitantly with antipsychotic agents (neuroleptics), monoamine oxidase inhibitors, tetracyclic antidepressants, analgesics, phenothiazine derivatives can reduce the convulsive threshold and increase the risk of adverse reactions.

Use of the drug 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, it is necessary to stop taking biguanides 48 hours before the test and resume after complete stabilization of kidney function. Patients taking less than 2 weeks before interleukin-2 study are prone to an increased incidence of delayed adverse reactions (flu-like conditions or skin reactions).

In patients taking beta-adrenoblockers, the manifestations of anaphylaxis with the use of yogexol can be atypical and mistaken for vagal reactions.

Special instructions:

Preparation of the patient and the procedure for administering the drug

Before applying radiopaque, you need to obtain accurate information about the patient, including important laboratory data (including serum creatinine, ECG, history of allergy, exclude pregnancy).

Before the study, the patient should eliminate violations of water electrolyte balance and ensure sufficient supply of fluid and electrolytes.This is especially true for patients with multiple myeloma, diabetes, polyuria or gout, as well as newborns, children under one year, and elderly patients.

Two hours before the procedure, the patient should not eat.

It is not recommended to perform preliminary testing of individual sensitivity with the use of small doses of the drug, due to the risk of severe hypersensitivity reactions.

Patients who are afraid of waiting before procedure is necessary premedication with sedatives.

The risk of developing serious adverse reactions is small.

However, all iodine-containing radiopaque agents can cause anaphylactoid reactions or other manifestations of hypersensitivity. For this reason, it is necessary to foresee the sequence of medical measures in case of their occurrence and to have the necessary drugs and equipment for immediate medical care.

It is recommended to always install a cannula or catheter to ensure rapid intravenous access throughout the radiographic procedure.

You should use a separate syringe and needle to inject the drug and do not mix it with other drugs.

Compared with ionic preparations, non-ionic radiopaque agents less influence in vitro on the blood coagulation system. When performing angiographic studies, one should carefully follow their technique and often flush the catheters (for example, 0.9% sodium chloride solution with heparin addition) to minimize the risk of thrombosis and embolism associated with the intervention.

The introduction of iodine-containing radiocontrast agents may aggravate the symptoms of myasthenia gravis.

All iodine-containing radiopaque agents affect the results of thyroid radioisotope studies, since the iodine binding capacity of the thyroid tissue remains reduced within 2 weeks after the administration of the drug.

High concentrations of radiocontrast in blood and urine can affect the results of biochemical tests to determine the concentration of bilirubin, proteins and inorganic substances (for example, iron, copper, calcium and phosphates). therefore similar analyzes should not be perform on the day of the study.

Patients with diabetes who take metformin, before intravascular administration of iodine-containing radiocontrast agents, the drug should be discontinued for at least 48 hours before and within 48 hours after the procedure.

In emergency cases, when renal function is unknown, the physician should assess the risk / benefit ratio of using radiopaque: stop the use of metformin, rehydrate, monitor kidney function, monitor the appearance of the initial signs of lactic acidosis.

When conducting a diagnostic study in patients with pheochromocytoma, it is necessary to introduce alpha-adrenoblockers to prevent the development of hypertensive crisis and to apply low doses of the drug with constant monitoring of blood pressure. In patients who have a history of allergy, bronchial asthma, as well as in the case of a patient's earlier allergic reactions to the introduction of iodine-containing radiocontrast agents, premedication with glucocorticosteroids and blockers H₁-gistaminovyh receptors. In patients with an acute cerebral pathology or epilepsy in an anamnesis, predisposed to convulsions,Premedication with barbiturates and phenytoin is recommended.

Measures for the prevention of adverse reactions

- Identification of patients at high risk.

- Ensuring adequate rehydration of the patient, if necessary, by continuous intravenous infusion, started before the administration of the drug and continuing until it is excreted by the kidneys.

- Prevention of an additional burden on the kidneys arising from the use of nephrotoxic drugs, oral medicines for cholecystography, renal artery clamping, angioplasty, or extensive surgical operations, prior to removal of the radiocontrast from the body.

- Repeated radiopaque studies should be performed no earlier than the moment when the kidney function is restored.

- In patients with impaired renal and hepatic function, the clearance of the drug can be significantly reduced.

Patients on hemodialysis can be given radiopaque agents provided hemodialysis is performed immediately after the examination.

After myelography, the patient should be in horizontal position for 1 hour with head and chest raised to 200.After that, the patient can walk gently, but should not bend over. If the patient stays in bed, then his head and chest should remain elevated for 6 hours, and if the suspicion of a low convulsive threshold is suspected, the patient should remain under medical supervision during this period of time. Outpatients should not be left without medical supervision in the first 24 hours after the study.

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

Studies on the effect on the ability to drive vehicles, mechanisms have not been carried out. It is not recommended to drive vehicles or engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions within 24 hours after the study.

Form release / dosage:

Solution for injection, 300 mg iodine / ml, 350 mg iodine / ml.

Packaging:

To 50 ml of the drug in a bottle of colorless glass (type I, F. USA), Corked with a cork made of chlorobutyl rubber, crimped aluminum cap with a protective plastic cap. Each bottle together with instructions for use is placed in a cardboard pack.

Storage conditions:

Protected from light and secondary X-ray radiation at a temperature of no higher than 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:2 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004432

Date of registration:28.08.2017

Expiration Date:28.08.2022

The owner of the registration certificate:ARS, LLC ARS, LLC Russia

Manufacturer: & nbsp

UNIJULES LIFE SCIENCES LIMITED India

Information update date: & nbsp12.10.2017

Illustrated instructions

Instructions

Nioscans (Nioskan)