INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
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.
PHARMACOKINETICS
Almost 100% of injected 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.
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
Yogexol is intended only for diagnostic purposes.
The drug is used in the following diagnostic studies:
- cardioangiography;
- arteriography;
urography;
- phlebography;
- for contrast enhancement in computed tomography (CT);
- arthrography;
- endoscopic retrograde pancreatography (ERGG);
- endoscopic retrograde cholangiopancreatography (ERCP);
- herniography;
- hysterosalpingography;
- Sialografii;
- Gastrointestinal tract research.
DOSING MODE
General information
The drug is intended for intravascular (intra-arterial, intravenous), intracavitary administration, oral administration and rectal administration.
Yogexol must be inspected visually before use for lack of insoluble particles, discoloration, and packaging integrity problems.
Yogexol should be injected into the syringe immediately before use. The drug is intended for single use, unused remnants of the drug must be destroyed.
Do not mix Yogexol with other medicines (you need to use a separate syringe and needle).
It should be noted that the contrast agent is better tolerated if it is heated to body temperature.
When the drug is administered, the patient should be in a horizontal position. Within 30 minutes after the end of the procedure, the patient is monitored physically, since most adverse reactions occur during this period. Preparation of the patient, the procedure for administering the drug, measures for the prevention of adverse reactions are described in the "Special instructions" section of this manual.
Recommended dosing regimen
Intravenous administration
Urography
Adults - 40-80 ml (concentration of iodine 300 mg / ml or 350 mg / ml). In some cases, more than 80 ml can be used.
Children with body weight less than 7 kg - 3 ml / kg body weight (iodine concentration 300 mg / ml) or 4 ml / kg body weight (iodine concentration 240 mg / ml);
Children weighing more than 7 kg - 2 ml / kg body weight (iodine concentration 300 mg / ml) or 3 ml / kg body weight (iodine concentration 240 mg / ml). The volume of the injected drug is not more than 40 ml.
Phlebography of lower extremities
Adults - 20-100 ml per leg (concentration of iodine 240 mg / ml or 300 mg / ml).
Digital subtraction angiography
Adults - 20-60 ml per injection (concentration of iodine 300 mg / ml or 350 mg / ml).
CT scan
Adults -100-250 ml (concentration of iodine 240 mg / ml) or 100-200 ml (concentration of iodine 300 mg / ml) or 100-150 ml (concentration of iodine 350 mg / ml).The total amount of iodine is usually 30-60 g.
Children 2-3 ml / kg body weight (iodine concentration 240 mg / ml) or -1-3 ml / kg body weight (iodine concentration 300 mg / ml). The volume of the injected drug is not more than 40 ml. In rare cases, you can apply up to 100 ml per child, but no more.
Intraarterial administration
Arteriography
Aortic arch. Adults - 30-40 ml per injection (concentration of iodine 300 mg / ml).
Selective cerebral arteriography. Adults - 5-10 ml per injection (concentration of iodine 300 mg / ml).
Aortography. Adults - 40-60 ml per injection (concentration of iodine 350 mg / ml).
Femoral arteriography. Adults - 30-50 ml per injection (concentration of iodine 300 mg / ml or 350 mg / ml).
Other studies. Adults - a drug with an iodine concentration of 300 mg / ml (the amount to be administered depends on the type of study).
Cardioangiography
Adults
Left ventricle and root of the aorta - 30-60 ml per 1 injection (concentration of iodine 350 mg / ml).
Selective coronagraphography - 4-8 ml per injection (concentration of iodine 350 mg / ml).
Children - depending on age, weight and pathology drug with an iodine concentration of 300 mg / ml or 350 mg / ml (maximum 8 ml / kg body weight).
Digital subtraction angiography
Adults - 1-15 ml per injection (concentration of iodine 240 mg / ml or 300 mg / ml).
Depending on the site of injection, it is sometimes possible to use large volumes of up to 30 ml.
Intracavernal administration
Arthrography
To adults - 5-20 ml (concentration of iodine 240 mg / ml); or 5-15 ml (concentration of iodine 300 mg / ml); or 5-10 ml (concentration of iodine 350 mg / ml).
ERCHG / ERPG
Adults - 20-50 ml (concentration of iodine 240 mg / ml).
Gerniography
Adults - 50 ml (concentration of iodine 240 mg / ml). The volume to be administered depends on the size of the hernia.
Hysterosalpingography
Adults - 15-50 ml (concentration of iodine 240 mg / ml) or 15-25 ml (concentration of iodine 300 mg / ml).
Sialografiya
Adults - 0.5-2 ml (concentration of iodine 240 mg / ml or 300 mg / ml).
Gastrointestinal
Orally
Adults - the volume of the administered dose is selected individually (iodine concentration 350 mg / ml).
Children (esophagus) - 2-4 ml / kg body weight (concentration of iodine 300 mg / ml or 350 mg / ml). The total amount of administration should not exceed 50 ml.
Preterm infants - 2-4 ml / kg body weight (iodine concentration 350 mg / ml).
Rectal
Children - 5-10 ml / kg of body weight (concentration of iodine 350 mg / ml). Before administration, the preparation should be diluted with water to an iodine concentration of 100-150 mg / ml.
CT scan
Yogexol (concentration of iodine 300 mg / ml or 350 mg / ml) is diluted with water to an iodine concentration of about 6 mg / ml.
Adults (oral) - the volume of the injected solution is 800-2000 ml.
Children (oral) - the volume of the administered solution is 15-20 ml / kg body weight.
Children (rectally) - the volume of the solution administered is selected individually.
SIDE EFFECT
Common Adverse Reactions
Undesirable and adverse reactions to non-ionic X-ray contrast media are usually of a moderate degree of severity, reversible and less common than when ion contrast media are used. Serious reactions, as well as cases with a fatal outcome, are extremely rare.
Adverse reactions to contrast agents in patients with allergies occur twice as often. Anaphylactoid reactions can occur regardless of the dose and mode of administration; A serious side effect can begin with minor manifestations of hypersensitivity reactions. In this case, it is necessary to immediately stop the introduction of the contrast drug and begin, if necessary, appropriate therapy.
When assessing the frequency of occurrence of various adverse reactions, the following grades are used: very often - 10% and more often; often - 1-10%; infrequently - 0.1-1%; rarely -0.01-0.1%; very rarely - less than 0.01% encountered.
Often:
Feeling of heat all over the body; "metallic taste" in the oral cavity; from the digestive system - nausea, vomiting, diarrhea.
Infrequently:
from the side of the cardiovascular system - vasovagal reactions in the form of arterial hypotension and tachycardia; reactions of hypersensitivity on the part of the respiratory system - dyspnea, bronchospasm or skin - urticaria, rash, erythema, pruritus (allergic manifestations can occur immediately after administration of the drug, or several days later); severe skin reactions in the form of Stephen-Johnson syndrome or toxic epidermal necrosis.
Rarely:
from the digestive system - a feeling of discomfort or pain in the abdomen; severe hypersensitivity reactions - laryngeal edema, pulmonary edema and anaphylactic shock; other reactions - iodine ("iodine guinea pig", expressed in the increase and soreness of the salivary glands and can manifest up to 10 days after the study), hypothermia, flushes of blood to the face.
Rarely:
cases with a fatal outcome (the main cause of cardiac arrest in patients with cardiovascular diseases).
Intravascular administration (intra-arterial and intravenous)
The nature of adverse reactions observed during intra-arterial administration of radiocontrast agents depends on the site of injection and dose. 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. The frequency of serious adverse reactions is higher in cardioangiography.
Often:
pain along the vessel or sensation of heat in peripheral angiography; cardiovascular system - arrhythmia with digital subtraction angiography; pain in the legs with phlebography (usually small and short); a transient increase in serum creatinine (has no clinical significance, however, in patients from the high-risk group, severe manifestations are described, up to a lethal outcome).
Often:
from the cardiovascular system - arrhythmias, angina / chest pain; from the side of the nervous system - impaired vision, headache. At the injection site, local soreness and radicular pain can be felt.
Infrequently:
from the cardiovascular system - heart failure, asystole, bradycardia; from the nervous system - dizziness, anxiety, drowsiness; from the side of the urinary system - transient proteinuria. Thyrotoxicosis may develop.
Patients with a risk of developing thyrotoxicosis should be carefully examined before using iodinated contrast medium.
Rarely:
from the digestive system - diarrhea, indigestion, convulsions, dry mouth; from the side of the urinary system - transient oliguria or anuria.
Rarely:
from the urinary system - kidney failure. When injected into the coronary, cerebral or renal arteries, an arterial spasm can develop that leads to transient ischemia in the organ being examined.
From the cardiovascular system - severe reactions in the form of rhythm disturbances, reducing myocardial contractility or myocardial ischemia.
From the side of the nervous system - cramps, transient disorders of sensitivity or motor function. In isolated cases, the contrast agent can penetrate the blood-brain barrier, resulting in the accumulation of the drug in the cerebral cortex, which allows visualization of brain tissue with CT. This phenomenon can persist during the day following the research, sometimes accompanied by a transient disruption of orientation in space or cortical blindness.
Development of post-venereal thrombophlebitis or thrombosis.
Single cases of arthralgia are described.
Adverse reactions with intracavitary injection
General hypersensitivity reactions develop extremely rarely.
Endoscopic retrograde pancreatocholangiography:
Often: there is a slight increase in the activity of amylase in the blood serum.
Rarely: cases of pancreatic necrosis.
Oral reception:
there may be gastrointestinal disorders (diarrhea, nausea, vomiting, abdominal pain).
Hysterosalpingography (GHA):
Often: moderate and transient pain in the lower abdomen.
Arthrography:
After performing the study, a feeling of pressure and pain at the injection site may occur. Arthritis to administer the drug is rare. There is a risk of developing infectious arthritis.
Gerniography:
Often: moderate pain reaction after the study.
The extravascular administration of contrast agents (extravasation) can rarely lead to the development of local pain and edema, which usually pass without any consequences. Cases of inflammation and even tissue necrosis are described. As a routine therapeutic, activities are recommended cold and elevated limb position. In the case of development of compression symptoms, surgical decompression is recommended.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
- expressed thyrotoxicosis.
With caution
- if there is a history of allergy, asthma or other undesirable reactions to iodine-containing radiopaque agents. Premedication with corticosteroids or antihistamines is recommended;
- in the study of patients with severe cardiovascular diseases and pulmonary hypertension due to the risk of developing hemodynamics 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, since they significantly reduced the clearance of radiocontrast agents;
- in the study of patients at high risk for patients with impaired renal function, diabetes mellitus, patients with paraproteinaemia (myelamatosis and Waldenstrom macroglobulinemia). To prevent the development of acute renal failure after the introduction of radiopaque means, such patients require special attention;
- when examining patients with thyrotoxicosis, especially patients with multinodular goiter (due to the risk of hyperthyroidism). With the introduction of radiopaque means for premature infants, the possibility of transient hyperthyroidism should be considered;
- in the study of patients with hypovolemia. It is necessary to ensure adequate hydration of at least 100 ml every hour for 4 hours before the test 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. It is necessary to conduct adequate hydration before and after the introduction of radiopaque.
- when examining patients with diabetes mellitus taking metromorphine. Before intravascular administration of yogexol, the drug should be discontinued for at least 48 hours before and within 48 hours after the procedure. In emergency cases, when the kidney function is unknown, the doctor should evaluate the risk / benefit ratio of using the contrast agent: stop using metromorphine, hydrate, monitor kidney function, monitor the appearance of signs of lactic acidosis;
- in the study of patients with pheochromocytoma. It is necessary to evaluate the blood pressure during the procedure to prevent the development of hypertensive crisis;
- in the study of patients with multiple sclerosis, sickle-cell anemia, obliterating thromboangiitis (Buerger's disease), acute thrombophlebitis, severe atherosclerosis;
- for angiography in patients with homocystinuria (risk of thrombosis and embolism), chronic emphysema of the lungs;
- when performing urography in patients with severe renal dysfunction and patients with combined liver and kidney disease.
PREGNANCY AND LACTATION
Studies on the safety and efficacy of Yogexol in pregnant and lactating mothers have not been conducted. 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.
Yoghexol is excreted in breast milk to a small extent, so you should refrain from breastfeeding for 24 hours after drug administration.
SPECIAL INSTRUCTIONS
Preparation of the patient and the procedure for administering the drug
Before applying the contrast agent, you need to obtain accurate information about the patient, including laboratory data (including serum creatinine, electrocardiogram, history and pregnancy). Prior to the study, the patient should eliminate disturbances in the 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. 2 hours before the procedure, the patient should stop eating.
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 the procedure need premedication with sedatives.
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.
For this reason it is necessary to foresee a sequence of remedial measures in the event of their occurrence, and to have available the necessary drugs and equipment to provide immediate medical care.
It is always recommended to install the cannula or catheter for quick intravenous access throughout the entire X-ray procedure. In comparison with ionic agents, nonionic X-ray contrast agent is less influence on in vitro blood coagulation system. When performing angiographic studies should be carefully observe their methodology and often washed catheters (e.g., 0.9% sodium chloride solution supplemented with heparin), to minimize the duration of the procedure to minimize the risk of thrombosis and embolism associated with interference.
The introduction of iodine-containing contrast media may aggravate the symptoms of myasthenia gravis.
All iodinated contrast agents distorts the results of radioisotope thyroid studies (yodosvyazyvayuschaya ability thyroid tissue is reduced to within 2 weeks after introduction).
High concentrations of contrast agent in the blood plasma or urine can affect the results of the biochemical tests but bilirubin concentration determination, proteins or inorganic substances (such as iron, copper, calcium and phosphate). Therefore, these tests should not be performed in the study day.
You must stop taking biguanides for 48 hours prior to the study and to renew their reception after complete stabilization of kidney function.
In emergency cases where renal function is unknown, the physician should evaluate the risk / benefit ratio of using contrast media: stop the use of metformin, to conduct hydration, monitoring of renal function, watch for the appearance of initial symptoms of lactic acidosis.
Measures to prevent adverse reactions:
identification of patients at increased risk.
To ensure adequate hydration of the patient, if necessary, by a constant intravenous infusion, which started before the drug administration and continuing up to its excretion by the kidneys.
Preventing additional load on the kidneys arising from the application of nephrotoxic drugs, drugs for receiving peroralyyugo during cholecystography, cross-clamping of the renal artery, renal artery angioplasty or extensive surgery, to elimination of contrast medium from the organism.
Repeated radiopaque studies should be carried out not earlier than the moment when the renal function is restored to the original level.
Patients with impaired renal function and liver may be significantly reduced clearance of the drug.
Patients who are on hemodialysis, radiopaque agents may be administered under the condition of dialysis immediately after the test.
Impact on the management of vehicles and machinery
Delayed reactions to intravascular administration of iodine-containing contrast media are rare. However, driving a car or working with any other mechanisms are undesirable for the first 24 hours after the study.
Overdose
Overdose is unlikely in patients with normal renal function. In the case of using high doses great influence on the kidney has study duration (half-life of the drug is approximately 2 hours).
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), hyperesthesia, visual, hearing or speech disturbances, changes in the electroencephalogram (EEG), meningismus, hyperreflexia or areflexia, hemiplegia, paralysis, quadriplegia, tremors, cerebral hemorrhage.
In cases of overdose should take action to correct any violations of water-electrolyte balance. Over the next three days should monitor renal function.
There is no specific antidote, treatment is symptomatic, hemodialysis possible.
Treatment: diazepam 10 mg IV slowly over 20-30 minutes after the cessation of convulsive seizure - vnutimyshechno phenobarbital 200 mg. Monitoring and maintenance of vital functions, symptomatic therapy.
Drug Interactions
Using radiopaque agents 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. Incompatible (intrathecal) with glucocorticosteroids.
Phenothiazine derivatives and other antipsychotic drugs (neuroleptics), monoamine oxidase inhibitors, tricyclic antidepressants, CNS stimulants, analeptic, antipsychotic drugs reduce epileptic threshold and increases the risk of epileptic seizures.
Beta-blockers and other antihypertensive drugs increases the risk of arterial gipoteizii. Enhances nephrotoxic properties of other drugs.
