Yunigexol - instructions for use, doses, side effects, contraindications

With computed tomography, contrast imaging in the thoracic region is achieved within 1 hour, the cervical region - about 2 hours, basal cisterns - 3-4 hours.Contrasting of joint cavities, uterine cavity, fallopian tubes, peritoneal protrusions, pancreatic and biliary ducts, bladder is achieved immediately after administration of the drug.

Pharmacokinetics:

About 100% of intravenously administered yogexol is excreted unchanged through normally functioning kidneys within 24 hours. The maximum concentration of iohexol in urine is determined approximately 1 hour after the injection. Metabolites of the drug were not detected. Binding to plasma proteins is minimal (less than 2%). Kidney clearance - 99 ml / min, total clearance - 109 ml / min. The maximum concentration in the blood plasma is 119 μg / ml, the time to reach the maximum concentration is 2-6 hours. The volume of distribution is 157 ml / kg, the half-life period is 3-4 hours.

Indications:

The drug is used in the following diagnostic X-ray studies: cardioangiography, arteriography, urography, phlebography, contrast enhancement in computed tomography, arthrography, endoscopic retrograde pancreatography, endoscopic retrograde cholangiopancreatography, salpingography, sialography,studies of the gastrointestinal tract.

Contraindications:

Hypersensitivity to the drug or its components.

Expressed thyrotoxicosis.

Local or systemic infections.

Pregnancy.

Carefully:

Care should be taken if there is a history of allergy, bronchospasm, or other undesirable reactions when using iodine-containing contrast media. In these cases, consideration should be given to the advisability of introducing glucocorticosteroids or blockers H₁-gistaminovyh receptors.

Caution should be exercised in the study of patients with uncompensated disorders of the cardiovascular system and pulmonary hypertension due to the risk of cardiac arrhythmias or worsening of hemodynamic instability.

The caution used drug in the study of patients with bronchial asthma, hay fever, multiple myeloma, food allergies, liver failure, dehydration, multiple sclerosis, sickle cell disease, thromboangiitis obliterans (Buerger's disease), acute thrombophlebitis, severe atherosclerosis in the elderly, during lactation.

Patients with acute cerebral pathology, brain tumors or epilepsy are prone to developing seizures and require special attention. In patients with alcoholism and drug addiction, the risk of seizures and neurological reactions increases.

To prevent the development of acute renal failure associated with the administration of a contrast agent, special care is needed in examining patients with impaired renal function, diabetes mellitus, patients with paraproteinaemia (myeloma, Waldenstrom's macroglobulinemia).

The introduction of iodine-containing contrast agents may exacerbate the symptoms of myasthenia gravis.

When performing invasive studies and interventions in patients with pheochromocytoma, preventive administration of alpha-adrenoblockers is necessary to prevent the development of hypertensive crisis.

Special caution is required when examining patients with moderate thyrotoxicosis, especially patients with multinodular goiter.

Pregnancy and lactation:

Unihexol® should not be used in pregnant women, unless the benefit of its use outweighs the risk and such a study is prescribed by the doctor as necessary.

The drug is excreted in small amounts into breast milk and absorbed into the intestines, therefore, one should refrain from breastfeeding for 24 hours after the administration of Unihexol®.

Dosing and Administration:

The drug is intended for intra-arterial, intravenous, intracavitary administration and oral administration. Before use, the preparation should be visually inspected for lack of insoluble particles, discoloration, and packaging integrity problems.

The drug should be dialed into the syringe immediately before use. Vials are for single use only; unused remnants of the drug after opening the vial should be destroyed.

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

Intravenous administration:

Urography excretory: adults - 40-80 ml of Unihexol® 300 mg of iodine / ml or Unihexol® 350 mg of iodine / ml; for children> 7 kg - 3 ml / kg body weight Unihexol® 240 mg iodine / ml, or 2 ml / kg body weight Unihexol® 300 mg iodine / ml; volume of administration - no more than 40 ml.

Phlebography of lower extremities: adults - 20-100 ml / finiteness of Unihexol® 240 mg iodine / ml or Unihexol® 300 mg iodine / ml.

Digital subtraction angiography: adults - 20-60 ml / per injection of Unihexol® 300 mg iodine / ml or Unigexol® 350 mg iodine / ml.

Enhancement in computed tomography: adults - 100-250 ml of Unihexol® 240 mg of iodine / ml or 100-200 ml of Unihexol® 300 mg of iodine / ml or 100-150 ml of Unihexol® 350 mg of iodine / ml; the total amount of iodine is usually 30-60 g; children - 2-3 ml / kg body weight Unihexol® 240 mg iodine / ml or 1-3 ml / kg body weight, Unigexol® 300 mg iodine / ml (the amount of administration should not exceed 40 ml).

Intraarterial administration:

1. Angiography

Thoracic aorta: adults - 30-40 ml per injection of Unihexol® 300 mg of iodine / ml.

Selective cerebral angiography: adults - 5-10 ml per injection of Unihexol® 300 mg of iodine / ml.

Aortography: adults - 40-60 ml per injection of Unihexol® 350 mg of iodine / ml.

Angiography of the femoral arteries: adults - 30-50 ml per injection of Unihexol® 300 mg iodine / ml or Unigexol® 350 mg iodine / ml.

2. Cardioangiography: adults - Introduction to the left ventricle and root of the aorta: 30-60 ml per injection of Unigexol® 350 mg of iodine / ml.

Selective coronary angiography: adults - 4-8 ml per injection of Unihexol® 350 mg of iodine / ml; children - depending on age, body weight and disease (maximal - 8 ml / kg body weight) of Unihexol® 300 mg of iodine / ml or Unigexol® 350 mg of iodine / ml

Digital subtraction angiography: adults - 1-15 ml per injection of Unihexol® 240 mg iodine / ml or Unigexol® 300 mg iodine / ml.

Intracavernal administration:

Arthrography: adults - 5-20 ml of Unihexol® 240 mg of iodine / ml; or 5-15 ml of Unihexol® 300 mg of iodine / ml; or 5-10 ml of Unihexol® 350 mg of iodine / ml.

Retrograde pancreatic and cholangiography: adults - 20-50 ml of Unihexol® 240 mg of iodine / ml.

Gerniography: adults - 50 ml of Unihexol® 240 mg of iodine / ml. The volume of administration depends on the volume of the hernia.

Hysterosalpingography: adults - 15-50 ml of Unihexol® 240 mg of iodine / ml; or 15-25 ml of Unihexol® 300 mg of iodine / ml;

Sialografiya: adults - 0.5-2 ml of Unihexol® 240 mg of iodine / ml; or 0.5-2 ml of Unihexol® 300 mg of iodine / ml.

Enhancement in computed tomography:

Oral contrast: adults - Unigexol 300 mg iodine / ml or 350 mg iodine / ml diluted with water at a ratio of 1:50 to a concentration of about 6 mg iodine / ml.The total volume of the solution is 800-2000 ml; children - 15-20 ml of solution per 1 kg of body weight.

Studies of the gastrointestinal tract:

Oral contrast: adults - the volume of the administered dose is selected individually (Unigexol® 350 mg iodine / ml); children (esophagus) - 2-4 ml / kg body weight Unihexol® 300 mg iodine / ml or 2-4 ml / kg body weight Unihexol® 350 mg iodine / ml, the total amount of administration should not exceed 50 ml.

Side effects:

Common Adverse Reactions

Undesirable and adverse reactions to non-ionic radiocontrast agents are usually of a moderate degree of severity, reversible and less common than when ion contrast media are used.

There may be a feeling of "heat all over the body" or a temporary "metallic" taste in the mouth, a feeling of discomfort or pain in the abdomen, nausea, vomiting.

The appearance of a hypersensitivity reaction in the form of moderate respiratory disorders (dyspnea, bronchospasm) or skin reactions (rash, erythema, urticaria, pruritus), in some cases angioedema may develop. Allergic manifestations can occur either immediately after the administration of the drug, or after a few days.Sometimes severe skin reactions may occur in the form of Stevens-Johnson syndrome or toxic epidermal necrosis. Severe manifestations of hypersensitivity reactions, such as laryngeal edema, pulmonary edema and anaphylactic shock are rare.

Anaphylactoid reactions can occur regardless of the dose and mode of administration; serious side effects may begin with minor manifestations of hypersensitivity reactions. In this case, it is necessary to stop the contrast preparation immediately and begin the appropriate therapy.

There may be vasovagal reactions in the form of arterial hypotension and bradycardia. Occasionally, there may be an increase in temperature with the development of convulsive syndrome.

Iodism or "iodine guinea pig" is a rare reaction to the administration of iodine-containing contrast agents, expressed in the increase and soreness of the salivary glands after a test of up to 10 days.

Adverse reactions associated with intraarterial administration

The nature of adverse reactions observed during intra-arterial administration of radiocontrast agents depends on the site of injection and the dose administered.In selective angiography and other studies, when the contrast preparation enters the target organ in high concentration, abnormalities in the functions of this organ can be observed. Pain along the vessels or sensation of heat in peripheral angiography occurs quite often.

Quite often, there may be a transient increase in serum creatinine, but it usually has no clinical significance; kidney failure develops rarely.

When injected into the coronary, cerebral or renal arteries, an arterial spasm can develop that leads to transient ischemia in the organ being examined.

Occasionally neurological reactions are observed in the form of convulsions, transient disorders of sensitivity or motor functions. In rare cases, the radiopaque can penetrate the blood-brain barrier, resulting in the accumulation of the drug in the cerebral cortex, which allows visualization of brain tissue in computed tomography. This phenomenon can persist for 1-2 days and is accompanied by a transient disruption of orientation in space or cortical blindness.

Severe reactions from the cardiovascular system may occur in the form of rhythm disturbances, a decrease in the contractile function of the myocardium, or myocardial ischemia.

Adverse reactions associated with intravenous administration

Postphlebographic thrombophlebitis or thrombosis develop very rarely.

Single cases of arthralgia are described.

Adverse reactions with intracavitary injection

General hypersensitivity reactions develop extremely rarely.

Endoscopic retrograde pancreatocholangiography: there is often a slight increase in serum amylase activity, and rare cases of pancreatic necrosis are described.

Oral reception: gastrointestinal disorders may occur. Hysterosalpingography: often there is a moderate and transient pain in the lower abdomen.

Arthrography: after the study is often marked pain. Arthritis to administer the drug is rare. There is a risk of developing infectious arthritis.

Gerniography: a mild pain reaction may occur after the study is completed.

Extravascular administration of contrast agents (extravasation) in rare cases, can lead to the development of local pain and swelling, which usually occur without any consequences. Cases of inflammation and tissue necrosis are described. As a therapeutic measure, the cold and the elevated position of the limb are recommended. In the case of development of compression symptoms, surgical decompression is recommended.

Overdose:

The development of symptoms of an overdose is unlikely, unless more than 2000 mg of iodine / kg is administered to the patient within a short period of time. The duration of the procedure with the introduction of high doses of the drug may affect the function of the kidneys. Accidental overdose of the drug is possible with complex angiographic procedures in children, especially with multiple doses.

Symptomscyanosis, bradycardia, acidosis, pulmonary hemorrhage, cardiac arrest, insomnia or drowsiness, weakness, fatigue, stupor, epileptic syndrome, coma, mental disorders: hallucinations, depersonalization, fear, disorientation, echolalia, depression, amnesia, psychosis, amblyopia , diplopia, photophobia, hyperesthesia, visual, auditory or speech disorders,changes on the electroencephalogram, meningism, hyperreflexia or areflexia, hemiplegia, paralysis, tetraplegia, tremor, hemorrhages in the brain.

In cases of overdose, measures should be taken to correct the water-electrolyte balance violations that have arisen. During the next 3 days, kidney function should be monitored. If necessary, to remove excess drug, you can resort to hemodialysis.

There is no specific antidote.

Treatment: diazepam 10 mg, intravenously slowly, 20-30 minutes after the cessation of convulsive seizure - intramuscularly phenobarbital 200 mg. Control and maintenance of vital functions, the conduct of symptomatic therapy.

Interaction:

Use of radiocontrast agents in diabetic patients taking biguanides (metformin) can lead to a transient disruption of kidney function and the development of lactic acidosis.

Patients who took less than 2 weeks before the study of interleukin-2 are prone to an increased incidence of delayed adverse reactions (flu-like conditions or skin reactions).

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

Pharmaceutically, the drug is incompatible with the drugs of other groups.

Phenothiazine derivatives and other antipsychotic drugs (antipsychotics), monoamine oxidase inhibitors, tetracyclic antidepressants, CNS stimulants, analeptics, antipsychotic drugs - the epileptic threshold decreases and the risk of epileptic seizures increases.

Beta-adrenoblockers and other antihypertensive drugs increase the likelihood of developing arterial hypotension.

It enhances the nephrotoxic properties of other drugs.

Special instructions:

Preparation of the patient and the procedure for administering the drug

Before the introduction of a contrast agent, it is necessary to obtain accurate information about the patient, including laboratory data (for example, serum creatinine level, electrocardiogram, history of allergy, pregnancy).

Before the study, it is necessary to eliminate the disturbances in the electrolyte electrolyte balance in the patient and ensure sufficient supply of fluid and electrolytes to the patient's body.This is especially true for patients with multiple myeloma, diabetes mellitus, polyuria or gout, as well as infants and elderly patients.

2 hours before the procedure, the patient should stop eating.

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

Patients who are afraid of waiting before the procedure, need premedication calming means.

The risk of developing severe adverse reactions to the drug is small, but iodine-containing contrast media can cause anaphylactoid reactions or other manifestations of hypersensitivity. In this connection, it is necessary to provide in advance a sequence of medical measures in case of their occurrence and to have the necessary medications and equipment available.

Before and after the introduction of the contrast drug, care should be taken to saturate the body of the subject with the fluid (hydration). This is of particular importance in patients with myeloma, diabetes mellitus, impaired renal function, and elderly patients.

To administer Unihexol®, you should use a separate syringe and needle and do not mix it with other medicines.

Compared with ionic preparations, non-ionic radiopaque agents less influence in vitro on the blood coagulation system. When carrying out angiographic studies, the procedure should be carefully followed and catheters (eg heparinized saline) often washed to minimize the risk of developing thrombosis and embolism associated with the intervention.

All iodine-containing radiopaque agents affect the results of thyroid function tests, since the iodine binding capacity of the gland may decrease within a few weeks after the study.

High concentrations of the drug in blood plasma or urine can affect the results of bilirubin, protein or inorganic substances (eg, iron, copper, calcium and phosphate), so these tests should not be performed on the day of the study. It is necessary to stop taking biguanides 48 hours before the test and resume their reception after complete stabilization of kidney function.

Measures for the prevention of adverse reactions:

- identification of patients at high risk;

- ensuring adequate hydration. Hydration can be achieved with the help of a continuous intravenous infusion, started before the introduction of the contrast preparation and continuing until the end of excretion of the radiopaque agent by the kidneys.

- repeated radiopaque studies should not be performed until the kidney function is restored to its original level.

Particular caution should be observed in patients with severe combined disorders of the liver and kidneys, as these patients significantly reduced the clearance of contrast media. Performing radiopaque studies in patients on hemodialysis is possible provided that dialysis will be performed immediately after the study.

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

Avoid the management of vehicles and mechanisms within 24 hours after the administration of the drug.

Form release / dosage:

Solution for injection, 240 mg iodine / ml, 300 mg iodine / ml, 350 mg iodine / ml.

Packaging:

1. 20 ml into glass ampoules with a notch (type 1, F. USA).5 ampoules in a thermo container ("thermocouple") complete with a knife ampoule and instructions for use. 1 thermo-container in a cardboard box.

2. 50 ml or 100 ml in a glass bottle (type 1, USP). 1 bottle complete with a bottle holder and instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 30 ° C. Do not freeze. Protect from light and secondary X-rays.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-004745/08

Date of registration:23.06.2008

The owner of the registration certificate:Unik Chemicals (Department of JB Chemicals and Pharmaceuticals Ltd.)Unik Chemicals (Department of JB Chemicals and Pharmaceuticals Ltd.) India

Manufacturer: & nbsp

UNIQUE CHEMICALS (A DIVISION OF JB CHEMICALS & PHARMACEUTICALS LTD.) India

Representation: & nbsp"UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")""UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")"India

Information update date: & nbsp09.11.2015

Illustrated instructions

Instructions

Unigexol (Unigexol)