Joversol (Ioversolum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Radiopaque means

Included in the formulation
  • Optiray
    solution in / in 
    Mallinkrodt Inc.     USA
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    V.08.A   Radiocontrast iodine-containing substances

    Pharmacodynamics:Nonionic radiopaque substance. Organic iodine compounds absorb X-rays and, selectively accumulating in separate structures of the body, provide a high degree of their opacity, highlighting them against the background of other structures that do not contain iodine. The degree of contrast is directly proportional to the concentration of the iodine-containing contrast agent in the tissue. With intravascular injection, a blood stream containing a contrast agent becomes opaque to X-rays, which ensures visualization of the circulatory system of organs until the concentration of contrast medium is reduced to a certain value.
    Pharmacokinetics:The connection with proteins is less than 2%. With intravenous administration, it is quickly distributed in the extracellular fluid and is rapidly excreted from the body by the kidneys through glomerular filtration. TCmax - 1 hour after the infusion. Does not penetrate the blood-brain barrier; in small amounts penetrates through the placental barrier and into breast milk. Virtually not metabolized and not subjected to deiodination. The half-life after administration of 50 and 150 ml was 113 ± 8.4 and 104 ± 15 min, respectively.More than 95% of the administered dose of the drug is excreted within the first 24 hours. Withdrawal of the drug with mildew masses is negligible.
    Indications:In adults, angiography of the brain, angiography of peripheral vessels and vessels of the abdominal cavity, including digital subtractive intraarterial and intravenous angiography, venography, intravenous urography and computed tomography of the patient's head and body. Children - angiography of the brain, peripheral vessels and vessels of the abdominal cavity, intravenous urography (safety and effectiveness of the drug for other examinations in children is not established).
    ICD-10

    XXI.Z00-Z13.Z03   Medical surveillance and evaluation in case of suspected disease or pathological condition

    Contraindications:Hypersensitivity(including other iodine-containing contrast agents). Severe thyrotoxicosis, decompensatedrenal and / or liver failure, severe cardiovascular disease, epilepsy, multiple myeloma, intrathecal injection, lactation.Acute inflammatory diseases of the pelvic organs, pregnancy - for hysterosalpingography. Acute pancreatitis - for endoscopic retrograde cholangiopancreatitisography.
    Carefully:Use with caution in renal and / or hepatic insufficiency, cardiovascular diseasesthat system, emphysema, severe general condition, severe cerebral arteriosclerosis, decompensateddiabetes mellitus, latent hyperthyroidism, nodular goiter of mild and moderate severity, sickle cellanemia, pheochromocytoma, for administration to the right heart cavity in neonates with pulmonary hypertension and heart failure.
    Pregnancy and lactation:

    Recommendations of Category B. Controlled studies on humans have not been carried out, however other organic iodine-containing substances, when introduced into the amnion cavity, can cause hypothyroidism in some newborns.

    Do not recommend any radiographic examination of the abdominal cavity in order to avoid irradiation of the fetus. In studies on animals, no signs of toxic effects on the fetus have been identified.

    Due to the possibility of penetration into breast milk, it is recommended to temporarily stop breastfeeding for 24 hours after the administration of the yoersol.

    Dosing and Administration:

    Intravenous or intra-arterial, jet or drip. The dose depends on the age, weight, condition of hemodynamics and the general condition of the patient, as well as the area of ​​the vessels that are examined. The administered dose is also affected by the examination technology and the selected concentration of iodine in the preparation (160, 240, 300, 320, 350 mg / ml).

    Joversol (160 mg / ml): digital subtractive intra-arterial angiography - 5-80 ml.

    Joversol (240, 300, 320 mg / ml)

    Angiography of the carotid or vertebral artery - 2-12 ml; angiography of four vessels - 20-50 ml. If necessary, repeated administration of a single dose is possible.

    Angiography of peripheral vessels: aortic branching - 20-90 ml, common iliac or femoral artery - 10-50 ml, subclavian / brachial artery - 15-30 ml. If necessary, repeated administration of a single dose is possible.

    Angiography of the vessels of the abdominal cavity: the celiac artery - 12-60 ml, the superior mesenteric artery - 15-60 ml, the inferior mesenteric artery - 6-15 ml, the angiography of the kidneys - 6-15 ml. If necessary, repeated administration of a single dose is possible.

    Digital subtractive intra-arterial angiography - 5-40 ml, digital subtracting intravenous angiography - 30-50 ml. If necessary, repeated administration of a single dose is possible.

    Venography - 30-80 ml. Intravenous urography is 65-80 ml. In case of doubt in obtaining good contrast, including an examination of elderly patients or patients with chronic renal insufficiency, it is allowed to increase the dose of contrast medium to 1.6 ml / kg of body weight.

    CT scan head - 65-150 ml, CT scan torso - 65-150 ml. In elderly patients, dose adjustment is not required.

    Children: angiography of the brain - 1-3 ml / kg, peripheral vascular angiography 1-3 ml / kg, angiography of the vessels of the abdominal cavity 1-3 ml / kg, intravenous urography 2 ml / kg (in children over 1 year old) and 3 ml / kg (in children under 1 year).

    Joversol (350 mg / ml)

    Angiography of peripheral vessels: aortic branching - 60-90 ml, common iliac or femoral artery - 10-50 ml, subclavian / brachial artery - 15-30 ml.

    Angiography of the vessels of the abdominal cavity: celiac artery - 12-60 ml, the superior mesenteric artery - 15-60 ml, the inferior mesenteric artery - 6-15 ml.

    Angiography of the kidneys - 6-15 ml.

    Aortography - 10-80 ml.

    Coronary arteriography - 4-10 ml.

    Left ventriculography - 30-50 ml.

    Digital subtractive intra-arterial angiography - 5-80 ml, digital subtracting intravenous angiography - 30-50 ml.

    Venography - 50-100 ml.

    Intravenous urography - 50-75 ml.

    CT scan head - 50-150 ml. CT scan trunks - 25-150 ml.

    Side effects:

    From the cardiovascular system: peripheral vasodilation, marked decrease in arterial pressure, collapse, tachycardia, shortness of breath, agitation, cyanosis, loss of consciousness, transient bradycardia. When used in cardiology - angina, arrhythmias, changes on the ECG. Inadequate right heart and pulmonary hypertension - bradycardia and lowering blood pressure.

    From the side of the central nervous system: visual impairment, confusion, convulsions, hemiparesis (mainly after administration of the drug in the arteries of the brain).

    From the urinary system: renal impairment, including acute renal failure (in patients with chronic renal failure, combined liver and kidney disease, anuria, diabetes mellitus, sickle cell disease, multiple myeloma, macroglobulinemia, especially when administered in high doses).

    Allergic reactions: less than 0.1% - dyspnea, bronchospasm, skin rash, erythema, urticaria, skin itching, Quincke's edema, laryngeal edema, pulmonary edema. Allergic manifestations can occur either immediately after the administration of the contrast agent, and after a few days. There are reports of toxic skin reactions. Very rarely - anaphylactic reactions (in patients with a predisposition to allergy, and also taking beta-blockers).

    Local reactions: spasm of blood vessels, necrosis of underlying tissues (when extravasation occurs).

    Common reactions: a feeling of discomfort, heat or cold, pain (depending on the dose, the concentration of contrast medium and the site of the body where the injection was performed).

    Other: pseudoallergic reactions - nausea, urticaria, vomiting.

    Overdose:

    Symptoms: violation of the functions of the cardiovascular system, respiratory system, kidneys.

    Treatment: symptomatic. Conduction of hemodialysis. There is no specific antidote.

    Interaction:

    Antipsychotic drugs, analgesics and antidepressants can reduce the convulsive threshold, increasing the risk of adverse reactions.

    Biguanides increase the risk of transient renal and lactic acidosis.It is necessary to stop taking biguanides 48 hours before the introduction of contrast medium. To resume the administration of biguanides, you should ensure that there is no impairment of kidney function.

    Beta-adrenoblockers increase the risk of developing hypersensitivity reactions. Interleukin increases the risk of delayed reactions (fever, rash, itching, arthralgia, flu-like syndrome).

    Oral preparations for cholecystography - the development of nephrotoxic action is possible.

    When the intra-arterial administration of radiopaque substance after the use of vasoconstrictors increases the risk of neurotoxic action.

    Do not mix with other medicines.

    Special instructions:

    Do not use for intrathecal administration. Premises where procedures are performed using radiocontrast preparations should be provided with equipment and medicines for emergency care (oxygen cylinders, antihistamines and vasoconstrictors, glucocorticosteroids). Diagnostic procedures using iodine-containing contrast agents for intravascular injection are necessaryconduct under the guidance of personnel who have received training and who have experience in the implementation of this survey.

    The use of an iodine-contrast agent may affect the results of studies of iodine associated with protein and studies of the uptake of radioactive iodine within 16 days after administration.

    Before the introduction of a contrast agent, it is necessary to obtain accurate information about the patient, including laboratory data (serum creatinine, ECG), allergic anamnesis, pregnancy. Before the study, the disturbance of the water-electrolyte balance should be eliminated and sufficient fluid and electrolytes should be supplied, especially in patients with multiple myeloma, diabetes, polyuria, oliguria or gout, as well as newborns, infants and young children, and elderly patients. The meal should be stopped 2 hours before the procedure.

    It is not recommended to conduct a preliminary determination of individual sensitivity using small doses of the drug due to the risk of severe allergic reactions. When the drug is administered, the patient should be in a horizontal position.

    Patients with fear of waiting need premedication.Patients with a predisposition to allergic reactions should be under constant supervision. To prevent or reduce the severity of the course of allergic reactions when administering the drug should consider the advisability of pre-introduction of antihistamines and glucocorticosteroids, which does not always prevent the occurrence of serious adverse reactions.

    Within 30 minutes after the end of the procedure, the patient is monitored. To provide immediate assistance in case of adverse reactions, safe access to the vessel (permanent cannula) should be ensured.

    The patient should be warned that allergic reactions can develop not immediately, but in a few days after the administration of the drug, and in this case it is necessary to immediately consult a doctor.

    For the timely detection of delayed hemodynamic disorders associated with a temporary increase in the osmotic load on the cardiovascular system, follow-up of patients with chronic heart failure should continue for several hours after the procedure.In connection with the danger of hypertensive crisis in patients suffering from pheochromocytoma, it is recommended to pre-enter alpha-blockers before the introduction of contrast medium.

    Given the likelihood of developing hypothyroidism in newborns, especially in preterm infants, it is recommended that a control analysis of the level thyrotropic hormone and thyroxine after 7-10 days and 1 month after the administration of the iodine-containing contrast medium.

    In newborns, infants and young children, the disturbance of the electrolyte balance should be eliminated before the study, and sufficient fluid and electrolyte supply should be ensured.

    When examining some patients with a contrast agent, general anesthesia can be indicated. In these cases, it should be borne in mind that adverse reactions in patients may be associated with hypotonic effects of drugs for general anesthesia.

    When angiography should be taken into account the probability of damage to the vessel during manipulations with the catheter and with the introduction of contrast media. In order to avoid thromboembolism, it is necessary to carefully work out the technique of examination, especially with arteriography.The use of special guides for the catheter, a three-way stopcock, frequent rinsing of the catheter with saline solution with the addition of heparin and the timely completion of the survey can reduce the risk of thromboembolism. If possible, angiographic screening for patients with homocystinuria due to an increased risk of thrombosis or embolism should not be prescribed. 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 in the absence of right heart and pulmonary hypertension can cause bradycardia and a decrease in blood pressure. In this regard, 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 used in patients with chronic renal failure of severe degree, combined liver and kidney disease, anuria, diabetes mellitus, sickle-cell anemia, multiple myeloma, macroglobulinemia,especially with the introduction of large doses, it is necessary to introduce a sufficient amount of liquid before using the drug, which will reduce the chance of renal dysfunction.

    Anaphylactoid reactions can occur regardless of the dose and mode of administration. In this case, the introduction of a contrast agent should be stopped immediately and emergency therapy should be started if necessary.

    Particular attention should be given to patients suffering from progressive atherosclerosis, severe arterial hypertension, heart failure, with thrombosis, cerebral embolism or migraine in the anamnesis, as well as elderly patients due to an increased risk of bradycardia, an increase or decrease in blood pressure. When conducting venography in patients with suspected phlebitis, local inflammation, severe ischemia or complete obliteration of the venous system, special care should be taken. To avoid the occurrence of extravasate when a contrast agent is administered, it is recommended to monitor the process with fluoroscopy. When angiography of peripheral vessels should be checked for pulsation on the artery, which is injected with radiopaque preparation.Carrying out of angiography in patients with obliterating thromboangiitis or ascending infection in combination with severe ischemia, special care should be taken.

    Impact on the ability to drive vehicles and manage mechanisms

    In connection with the likelihood of occurrence of adverse reactions to drivers of cars and other technical means, it is recommended to refrain from driving vehicles for 1 hour after the introduction.

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