Universal reference book for medicines
Product name: UNIHEXOL ® (UNIHEXOL ® )

Active substance: iohexol

Type: Radiopaque non-ionic diagnostic preparation for intravascular, intracavitary and oral administration

Manufacturer: UNIQUE PHARMACEUTICAL Laboratories (India) JB Chemicals & Pharmaceuticals (India)
Composition, form of production and packaging
The solution for injections is
clear, from colorless to light yellow color.

1 ml

yogexol 518 mg,

which corresponds to the content of iodine 240 mg

Excipients: trometamol, sodium calcium edetate, hydrochloric acid, water d / u.

20 ml - ampoules glass (5) - thermal containers (1) - packs cardboard.

50 ml - bottles of glass (1) - packs of cardboard.

100 ml - bottles of glass (1) - packs of cardboard.

The solution for injections is clear, from colorless to light yellow color.

1 ml

yogexol 647 mg,

which corresponds to the content of iodine 300 mg

Excipients: trometamol, sodium calcium edetate, hydrochloric acid, water d / u.

20 ml - ampoules glass (5) - thermal containers (1) - packs cardboard.

50 ml - bottles of glass (1) - packs of cardboard.

100 ml - bottles of glass (1) - packs of cardboard.

The solution for injections is clear, from colorless to light yellow color.

1 ml

yogexol 755 mg,

which corresponds to the content of iodine 350 mg

Excipients: trometamol, sodium calcium edetate, hydrochloric acid, water d / u.

20 ml - ampoules glass (5) - thermal containers (1) - packs cardboard.

50 ml - bottles of glass (1) - packs of cardboard.

100 ml - bottles of glass (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

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

PHARMACOKINETICS

About 100% of the iv injected yogexol is released unchanged through normally functioning kidneys within 24 hours. C max yogexol 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. C max in blood plasma - 119 mcg / ml, time to reach C max is 2-6 h. V d - 157 ml / kg, T 1/2 - 3-4 h.
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;

- Sialografii;

- Gastrointestinal tract research.

DOSING MODE

The drug is intended for intra-arterial, intravenous, intracavitary 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, medical supervision of patients should be carried out. It is during this period that most of the adverse reactions occur.
IV introduction:

Urography excretory: for adults - 40-80 ml of Unigexol 300 mg of iodine / ml or Unigexol 350 mg of iodine / ml;
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 the lower extremities: adults - 20-100 ml / finiteness of Unigecsol 240 mg iodine / ml or Unigexol 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;

Strengthening with computed tomography: adults - 100-250 ml of Unigexol 240 mg of iodine / ml or 100-200 ml of Unigexol 300 mg of iodine / ml or 100-150 ml of Unigexol 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 Unihexol 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 Unigexol 300 mg iodine / ml.

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

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

Angiography of the femoral arteries: adults - 30-50 ml per injection of Unigexol 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 Unigecsol 350 mg iodine / ml.

Selective coronarography: adults - 4-8 ml per injection of Unigexol 350 mg iodine / ml;
children - depending on the age, body weight and disease (maximum - 8 ml / kg body weight) of Unigexol 300 mg iodine / ml or Unigexol 350 mg iodine / ml.
Digital subtraction angiography: adults - 1-15 ml per injection of Unihexol 240 mg iodine / ml or Unigexol 300 mg iodine / ml.

Intracavitary injection:

Arthrography: for 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 Unigexol 350 mg of iodine / ml.
Retrograde pancreato 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 Unigexol 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 is 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
Research of the digestive 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 EFFECT

Common Adverse Reactions

Undesirable and adverse reactions to non-ionic radiopaque agents are usually moderate in severity, reversible and less common than with ion contrast media.

There may be a feeling of heat throughout 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 can 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 introduction of iodine-containing contrast agents, expressed in the increase and soreness of the salivary glands after a study 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 administration: gastrointestinal disorders can 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.
Herniography: A mild pain reaction may occur after the study is performed.

The extravascular administration of contrast agents (extravasation) in rare cases can lead to the development of local pain and swelling, which usually pass 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.
CONTRAINDICATIONS

- expressed thyrotoxicosis;

- local or systemic infections;

- Pregnancy;

- Hypersensitivity to the drug or its components.

Care should be taken if there is a history of allergy, bronchospasm, or other adverse reactions when using iodine-containing contrast media.
In these cases, the expediency of introducing glucocorticosteroids or blockers of histamine H 1 -receptors should be considered.
Caution should be exercised in the study of patients with decompensated cardiovascular diseases and pulmonary hypertension due to the risk of heart rhythm disturbances or aggravation of hemodynamic disorders.

With caution use the drug in the study of patients with bronchial asthma, pollinosis, myeloma, food allergy, liver failure, dehydration, multiple sclerosis, sickle cell anemia, obliterating thromboangiitis (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, except when the benefits of its use outweigh the risk and such a study is prescribed by the doctor as necessary.

The drug in a small amount is excreted into breast milk and absorbed into the intestine, so you should refrain from breastfeeding for 24 hours after the administration of Unigexol.

APPLICATION FOR FUNCTIONS OF THE LIVER

To prevent the development of acute renal failure associated with the introduction of contrast media, special care is needed when examining patients with impaired renal function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution use the drug in the study of patients with hepatic insufficiency.

APPLICATION FOR CHILDREN

Requires dose adjustment.

APPLICATION IN ELDERLY PATIENTS

With caution use the drug in a study in the elderly.

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 medicines 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, impaired renal function, and elderly patients.
For the introduction of Unigexol, you should use a separate syringe and needle and do not mix it with other medicines.

Compared with ion 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 the catheters (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 tests for determining thyroid function, tk.
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 (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 study and resume their reception after complete stabilization of kidney function.

Measures for the prevention of adverse reactions:

- identification of patients belonging to the high-risk group;

- Ensure adequate hydration.
Hydration can be achieved with the help of a constant IV 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 care should be taken in patients with severe combined disorders of liver and kidney function,
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.
Impact on the ability to drive vehicles and manage mechanisms

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

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.
Symptoms: cyanosis, bradycardia, acidosis, pulmonary hemorrhage, heart failure, insomnia or drowsiness, weakness, fatigue, stupor, epileptic syndrome, coma, disturbances of mental activity: hallucinations, depersonalization, fear, disorientation, echolalia, depression, amnesia, psychosis, amblyopia, diplopia, photophobia, hypersensitivity, visual, hearing or speech disorders, changes in elektroentsefologramme, meningismus, hyperreflexia or areflexia, hemiplegia, paralysis, quadriplegia, tremor, cerebral haemorrhage.
Treatment:In case of overdose should take action to correct any violations of water-electrolyte balance. During the 3 consecutive days should monitor renal function.If necessary, to remove excess product, you can resort to dialysis.
There is no specific antidote. Assign diazepam 10 mg / slow; 20-30 min after termination of convulsive seizure - a / m phenobarbital 200 mg. Monitoring and maintenance of vital functions, symptomatic therapy.
DRUG INTERACTION

The use of contrast media in patients with diabetes mellitus, host biguanides (metformin) may lead to a transient disturbance of kidney function and the development of lactic acidosis.
Patients who took at least 2 weeks prior to study IL-2, are prone to increased rates of delayed side reactions (flu-like condition or skin reactions).
Patients taking beta-blockers, the manifestations of anaphylaxis may be atypical and mistaken for vagal reaction.
Pharmaceutically preparation incompatible with drugs other groups.
Phenothiazine derivatives and other antipsychotic drugs (neuroleptics), MAO inhibitors, tetracyclic antidepressants, CNS stimulants, analeptic, antipsychotic drugs - reduced epileptic threshold and increases the risk of epileptic seizures.
Beta-blockers and other antihypertensive drugs increases the risk of hypotension.
Enhances nephrotoxic properties of other drugs.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

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 expiry date stated on the package.
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