Composition, form of production and packaging
The solution for intravascular injection is clear, colorless.
1 ml
iomeprol (in terms of iodine 300 mg) 612.4 mg
Excipients: trometamol 1 mg, hydrochloric acid 32% rp to pH 7.0-7.1, water d / and up to 1 ml.
50 ml - vials of colorless glass (1) - packs cardboard.
100 ml - vials of colorless glass (1) - packs cardboard.
The solution for intravascular injection is clear, colorless.
1 ml
iomeprol (in terms of iodine 350 mg) 714.4 mg
Excipients: trometamol 1 mg, hydrochloric acid 32% rp to pH 7.0-7.1, water d / and up to 1 ml.
50 ml - vials of colorless glass (1) - packs cardboard.
100 ml - vials of colorless glass (1) - packs cardboard.
200 ml - vials of colorless glass (1) - packs cardboard.
500 ml - bottles of colorless glass (1) - packs of cardboard.
The solution for intravascular injection is clear, colorless.
1 ml
iomeprol (in terms of iodine 400 mg) 816.5 mg
Excipients: trometamol 1 mg, hydrochloric acid 32% rp to pH 7.0-7.1, water d / and up to 1 ml.
50 ml - vials of colorless glass (1) - packs cardboard.
100 ml - vials of colorless glass (1) - packs cardboard.
200 ml - vials of colorless glass (1) - packs cardboard.
500 ml - bottles of colorless glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Yomeron is a nonionic, water-soluble, nephrotropic, iodine-containing low-molecular-weight rontgencontrast preparation.
PHARMACOKINETICS
The elimination half-life for iomeprol in the distribution and elimination phases is 23 В± 14 min and 109 В± 20 min, respectively. Provided that the kidneys function normally, the total excretion of uterine kidney, expressed as a percentage of the intravenous dose, is approximately 24-34% after 60 minutes, 84% after 8 hours, 87% after 12 hours, and 95% 24-96 hours after administration. Thus, in patients with normal renal function (creatinine clearance> 60 ml / min), the half-life of iomeprol is about 2 hours.
In patients with impaired renal function, the half-life period is prolonged depending on the degree of kidney damage, depending on the creatinine clearance.
Yomeprol does not bind to plasma proteins or blood serum.
In case of intrathecal injection, it is completely absorbed by the cerebrospinal fluid in 3-6 hours. The half-life is 8-11 hours, depending on the dose. Yomeprol is excreted by the kidneys unchanged. Excretion in the urine almost completely occurs within 24 hours after administration, followed by the excretion of small amounts between 24 and 38 hours.
INDICATIONS
For a dose of 300 mg iodine / ml:
Intravenous urography of adults and children, peripheral phlebography, computer tomography of the brain and spinal cord, whole body, cavernosography, intravenous digital subtraction angiography, angiocardiography of adults and children, traditional selective coronary arteriography, interventional coronary arteriography, endoscopic retrograde cholangiopancreatography, arthrography, hysterosalpingography, cholangiography , dacryocystography, sialography, retrograde urethrography, retrograde pyeloretra graphy, myelography.
For a dose of 350 mg iodine / ml:
Intravenous urography of adults and children, computer tomography of the whole body, intravenous digital subtraction angiography, traditional angiography, intra-arterial digital subtraction angiography, angiocardiography of adults and children, traditional selective coronary arteriography, interventional coronary arteriography, arthrography, hysterosalpingography, fistulography, galactography, retrograde cholangiography, dacryocystophage, sialography.
For a dose of 400 mg iodine / ml:
Intravenous urography of adult patients, including patients with chronic renal failure or diabetes mellitus, computerized tomography of the whole body, traditional angiography, intra-arterial digital subtraction angiography, adult and children angiocardiography, traditional selective coronary arteriography, interventional coronary arteriography, fistulography, galactography, dacryocystography, sialography .
DOSING MODE
The dose and method of application depend on the indication, the equipment used, the method of examining the body, body weight, hemodynamic status, the general condition of the patient and are:
Indication Dosage mg iodine / mL Recommended dosage
Intravenous urofafia 300, 350,400 Adults: 50-150 ml Newborns: 3-4.8 ml / kg Children: up to the year: 2.5-4 ml / kg; over 1 year: 1-2.5 ml / kg
Peripheral phlebophasia 300 Adults: 10-100 ml, repeat if necessary (10-50 ml in the upper limbs, 50-100 ml in the lower limbs)
Computer tomography of the brain and spinal cord 300 Adults: 50-100 ml Children **
Computed tomography of the whole body 300, 350, 400 Adults: 100-200 ml Children **
Cavernosography 300 Adults: up to 100 ml
Intravenous digital subtractive angiography 300, 350, 400 Adults: 100-250 ml Children **
Traditional angiography
Arteriography of upper extremities 300, 350 Adults *
Arteriography of the pelvis and lower extremities 300, 350, 400 Adults *
Abdominal arteriography 300, 350, 400 Adults *
Arteriography of the descending part of the aorta 300, 350 Adults *
Pulmonary angiography 300, 350, 400 Adults: up to 170 ml
Cerebral angiography 300, 350 Adults: up to 100 ml
Arteriography of children 300 to 130 ml **
Traditional 300, 350, 400 Adults * Children **
Intraarterial digital subtractive angiography
Cerebral 300, 350 Adults: 30-60 ml for general viewing, 5-10 ml for selective injections Children **
Thoracic 300 Adults *: 20-25 ml (aorta), repeat if necessary, 20 ml (bronchial argeria)
Aortic arch 300, 350 Adult ***
Abdominal cavity 250, 300 Adults ***
Aortography 300, 350 Adults ***
Transylumbyalnaja aortogram 300 Adults *
Peripheral arteriography 300 Adults *: 5-10 ml for selective injections up to 250 ml Children **
Traditional 300 Adults *: 10-30 ml for selective injections up to 250 ml Children **
Angiocardiography 300, 350, 400 Adults * Children: 3-5 ml / kg
Traditional selective coronary arteriography 300, 350, 400 Adults: 4-10 ml in the artery, repeat if necessary
Interventional coronary arteriography 300, 350, 400 Adults: 4-10 ml in the artery, if necessary, repeat
Endoscopic retrograde cholangiopancreatic 300 Adults: up to 100 ml
Arthrography 300, 350 Adults: up to 10 ml per injection
Hysterosalpingography 300, 350 Adults: up to 35 ml
Fistulography 300, 350, 400 Adults: up to 100 ml
Discography 300 Adults: up to 4 ml
Galactography 300, 350, 400 Adults: 0.15-1.2 ml per injection
Dacryocystography 300, 350, 400 Adults: 2.5-8 ml per injection
Sialografiya 300, 350, 400 Adults: 1-3 ml per injection
Cholangiography 300, 350 Adults: up to 60 ml
Retrograde urethrography 300 Adults: 20-100 ml
Retrograde pyelography 300 Adults: 10-20 ml per injection
Myelography 300 Adults: 8-15 ml
* Not more than 250 ml. Individual dosing or volume is determined by the size of the part being examined. ** Depending on body weight and age. *** No more than 350 ml.
It is desirable to preheat the drug solutions to body temperature with intravascular or intrathecal administration. Before use, make sure that the product package is not damaged. When performing angiographic studies, one should carefully observe their technique, aseptic rules, and often wash the catheter (for example, 0.9% sodium chloride solution with heparin addition) to minimize the risk of thrombosis and embolism.
SIDE EFFECT
Undesirable adverse reactions are usually mild or moderate, reversible and not common.
Most adverse reactions develop within the first minutes after the administration of the drug.
General types of reactions.
The most common headache, pain at the injection site, generalized feeling of heat, increased sweating, a sense of metallic taste in the mouth.
Much less likely to be a feeling of discomfort or pain in the abdomen, nausea, vomiting.
Hypersensitivity reactions.
Usually it can be such skin or respiratory reactions as various types of rash, erythema, urticaria, itching, pale skin; acute rhinitis, laryngeal edema, shortness of breath and a moderate decrease in blood pressure. These effects are usually short-lived.
Very rarely there is dizziness, stiff neck, low back pain, temporary confusion. In some cases, fever occurs. Individual hypersensitivity is possible, especially in people with a predisposition to allergies, and also taking beta-blockers. In cases of hypersensitivity reactions, the administration of the contrast medium should be immediately stopped and, if necessary, an appropriate emergency intravenous therapy is performed.
Severe cases of anaphylaxis involving the cardiovascular system are extremely rare and include the development of peripheral vasodilation with significant lowering of arterial pressure, reflex tachycardia, shortness of breath, agitation, cyanosis, loss of consciousness following a respiratory and / or heart attack, which can lead to death. Since these phenomena can develop very quickly, they require urgent cardiopulmonary resuscitation. Initially, cardio-circulatory collapse may occur, isolated or as an initial manifestation without respiratory or other symptoms listed above.
From the side of the cardiovascular system: peripheral vasodilation, marked decrease in arterial pressure, tachycardia, shortness of breath, agitation, cyanosis and loss of consciousness (may require urgent treatment), transient bradycardia.
From the side of the nervous system: tonic / clonic convulsions, aphasia, syncope, temporary narrowing of the visual fields, hemiparesis, coma (developed in patients suffering from diseases of the central nervous system). In some cases, patients with increased convulsive readiness or using psychotropic drugs, with the introduction of the drug may cause spasms of skeletal muscles or generalized convulsions.
General measures to prevent adverse reactions.
- identify patients at risk (patients with dehydration, impaired renal function, diabetes mellitus, severe cardiovascular failure, patients with adverse reactions to the introduction of iodinated radiocontrast in the past, children under one year, patients older than 70 years, patients who use nephrotoxic drugs (NSAIDs, loop diuretics, ACE inhibitors (enalapril, captopril, etc.), aminoglycosides, platinum compounds, methotrexate in high dosages, pentamidine, foscarnet at dence, some antiviral agents (acyclovir, ganciclovir, valaciclovir, adefovir, cidofovir, tenofovir), vancomycin, amphotericin B; immunosuppressants such as cyclosporine or tacrolimus; and phosphamide, etc.).;
- Provide sufficient hydration orally, or if necessary, by intravenous infusion (every hour by? 100 ml or intravenously (0.9% sodium chloride solution, sodium hydrogen carbonate) for 4 hours before and 24 after the administration of the radiocontrast drug, depending on the condition patient);
- avoid simultaneous use of nephrotoxic drugs; if such a combination is necessary, monitoring of renal function should be strengthened;
- to observe the interval not less than 48 hours between two radiological examinations with the introduction of radiopaque preparation or postpone a new examination until the restoration of the initial renal function;
- Prevent an acidosis with an increase in the concentration of lactates in diabetic patients taking metformin, based on the data of creatinineemia. Normal renal function: Metformin administration ceases at least 48 hours before the introduction of the radiopaque drug or until normal renal function is restored. Abnormal renal function: metformin is contraindicated. For urgent indications: if the examination is urgently needed, the following precautions should be taken: discontinuation of metformin intake, hydration, monitoring of renal function and the search for signs of acidosis with increasing lactate concentration. Patients on hemodialysis can take iodinated radiopaque substances, as they are amenable to dialysis. It is necessary to take a preliminary conclusion from the hemodialysis department;
- after the introduction of the radiocontrast drug, it is necessary to observe the patient for at least 30 minutes, since the majority of severe side effects occur during this period;
- the patient should be warned about the possibility of delayed-type reactions (up to 7 days).
Adverse reactions and warnings in neuroradiogenological studies
In the case of cerebrospinal blockade when the drug is administered, as much as possible of the injected contrast solution should be removed. In cases of the presence of blood in the cerebrospinal fluid, the physician should carefully evaluate the necessary need for a diagnostic procedure taking into account the risk to the patient.
The appointment of myelography to patients with a risk of epilepsy, history of epilepsy or severe renal-hepatic insufficiency should be carefully weighed. Patients taking anticonvulsant drugs should not interrupt their treatment. Manipulation with the patient during and after the examination should be minimal. After examination, the patient should remain in a supine position, with a raised head, for at least 8 hours. Observation of the patient should be especially attentive within 24 hours, at this time the patient is advised not to bend over.
Adverse reactions and warnings in angiographic studies
In patients undergoing angiocardiographic procedures, special attention should be given to the state of the right heart and pulmonary circulation. The introduction of an organic iodine-containing solution with a deficiency of the right heart and pulmonary hypertension can cause bradycardia and a decrease in blood pressure.Increased caution should be observed when introducing a contrast agent in the right heart cavity of newborns with pulmonary hypertension and impaired cardiac function.
When contrasting the arch of the aorta in a number of cases, it is possible to develop a decrease in blood pressure, bradycardia.
With abdominal aortography, kidney infarction, damage to the spinal cord, retroperitoneal bleeding, and bowel necrosis may occur. With peripheral arteriography with a drug at a dosage of 350 mg / ml, pain in the examined extremity may sometimes occur. Usually this is not observed when using a less concentrated solution - 300 mg / ml.
At the catheterization of vessels it is necessary to pay special attention to angiographic technique, since nonionic contrast preparations, in comparison with ionic ones, have a lower anti-coagulant activity in vitro. In this regard, to minimize the risk of thromboembolism associated with the procedure, it is necessary to properly install the catheter, wash it with saline, if possible with the addition of heparin, and also minimize the duration of the procedure.
CONTRAINDICATIONS
- hypersensitivity to the components of the drug;
- Pregnancy;
- the period of breastfeeding;
- Valdenstrom's macroglobulinemia;
- severe hepatic, renal and cardiovascular insufficiency;
- multiple myeloma;
- expressed thyrotoxicosis;
- with acute inflammatory diseases of the pelvic organs, hysterosalpingography is contraindicated;
- with acute pancreatitis, endoscopic retrograde cholangiopancreatophathy is contraindicated.
Carefully
Care should be taken when prescribing the drug to patients with impaired renal, hepatic and cardiovascular function, pulmonary emphysema, severe general condition, severe atherosclerosis, requiring correction of diabetes mellitus, latent hyperthyroidism, nodular goiter of mild to moderate severity. With all modes of administration due to the possible development of serious side effects, the use of the drug should be limited in cases where there are no clear clinical indications for carrying out radiopaque studies. The need for the study should be determined taking into account the clinical state of the patient and the features of the course of possible diseases of the cardiovascular system, kidney and / or hepatobiliary system. Cardioangiographic research using radiogenic contrast substances should be carried out in hospitals and in hospitals. Special measures should be taken in patients with suspected thrombosis, phlebitis, severe ischemia, local infection, or arterio-venous obstruction.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in liver failure.
APPLICATION FOR CHILDREN
The application is possible according to the dosing regimen.
SPECIAL INSTRUCTIONS
Do not mix radiopaque preparation with other drugs in the same syringe.
In applying the drug in patients who are to study the thyroid gland, it should be borne in mind that the thyroid uptake of iodine reduced tissue for up to 2 weeks, which could affect the study results.
Rooms in which the procedures are carried out using renttenokontrastnyh preparations should be provided with equipment and medicines, which are needed in emergencies (oxygen tanks, antihistamines and decongestants, glucocorticosteroid agents).
OVERDOSE
Overdose is unlikely in patients with normal renal function. In the case of using high doses of important influence of the drug on the kidney has a duration procedure. There is no specific antidote, symptomatic treatment; possibly hemodialysis.
DRUG INTERACTION
Simultaneous administration yomeprola and glucocorticosteroid in the spinal canal can lead to arachnoiditis. When used with psychotropic drugs, analgesics and antidepressants yomeprol can reduce the seizure threshold. Application yomeprola diabetic nephropathy in patients taking biguanides (metformin), may lead to a transient disturbance of kidney function and the development of lactic acidosis. As a precaution, you must stop taking biguanides for 48 hours prior to the study and resume after complete stabilization of kidney function. Patients taking beta-blockers, symptoms of anaphylaxis when using yomeprola may be atypical and mistaken for vagal reaction.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
At temperatures above 25 В° C, do not freeze. Keep out of the reach of children. Shelf life - 5 years for the dosage of 400 mg of iodine / ml in vials of 500 mL - 3 years.
