Universal reference book for medicines
Product name: OPTIRAY (OPTIRAY)

Active substance: ioversol

Type: Radiopaque non-ionic diagnostic preparation for intravascular injection

Manufacturer: TYCO HEALTHCARE (Canada)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
Nonionic radiopaque substance. With intravascular injection, a blood stream containing a contrast agent becomes opaque to X-rays, which provides visualization of the circulatory system of organs until the concentration of contrast medium is reduced to a certain level.
PHARMACOKINETICS
Binding to plasma proteins is less than 2%. When i / in the introduction is quickly distributed in the extracellular fluid and quickly eliminated from the body by the kidneys through glomerular filtration. Tmax - 1 h after infusion. Does not penetrate the BBB; in small amounts penetrates through the placental barrier and into breast milk. It is not practically metabolized and does not undergo deiodination. T1 / 2 after the administration of 50 and 150 ml - 113 ± 8.4 and 104 ± 15 min, respectively. More than 95% of the administered dose is excreted within the first 24 hours. Removal of the drug with mildew masses is negligible.
INDICATIONS
Adults: angiography of the brain, angiography of peripheral vessels and vessels of the abdominal cavity, incl. with digital subtracting in / a and / or angiography (VA-CVA and BB-CVA), venography, intravenous urography and computed tomography (CT) of the patient's head and body.
Children: angiography of the brain, peripheral vessels and vessels of the abdominal cavity, iv urography.
DOSING MODE
In / in or in / a, 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): BA-CVA - 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.
VA-CVA - 5-40 ml, VV-CVA - 30-50 ml. If necessary, repeated administration of a single dose is possible.
Venography - 30-80 ml. In / in urography - 65-80 ml. In case of doubt in obtaining good contrast, incl. When examining elderly patients or patients with chronic renal failure, an increase in the dose of contrast medium to 1.6 ml / kg of body weight is allowed.
CT of the head - 65-150 ml, CT of the trunk - 65-150 ml. In elderly patients, dose adjustment is not required.
Children: angiography of the brain 1-3 ml / kg, angiography of peripheral vessels 1-3 ml / kg, angiography of the vessels of the abdominal cavity 1-3 ml / kg, iv urography 2 ml / kg (in children over 1 year) 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.
VA-CVA - 5-80 ml. VV-CVA - 30-50 ml.
Venography - 50-100 ml.
In / in the urography - 50-75 ml.
CT of the head - 50-150 ml. CT is 25-150 ml.
SIDE EFFECT
From the side of the cardiovascular system: peripheral vasodilation, marked decrease in blood 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 side of the urinary system: renal dysfunction, incl. 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: vasospasm, necrosis of underlying tissues (when extravasation occurs).
General reactions: a feeling of discomfort, heat or cold (10-50%), pain (depending on the dose, the concentration of contrast medium and the area of ​​the body where the injection was performed).
Other: pseudoallergic reactions - nausea (0.4%), urticaria (0.3%), vomiting (0.1%).
CONTRAINDICATIONS
Severe thyrotoxicosis, decompensated renal and / or liver failure, severe cardiovascular disease, epilepsy, multiple myeloma, intrathecal injection, lactation period. Acute inflammatory diseases of the pelvic organs, pregnancy - for hysterosalpingography. Acute pancreatitis - for endoscopic retrograde cholangiopancreatography.
Hypersensitivity (including to other iodine-containing contrast substances).
PREGNANCY AND LACTATION
Use with caution in pregnancy.
If it is necessary to use the mother during lactation, breastfeeding should be interrupted for 24 hours.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in decompensated renal failure. Use with caution in renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in decompensated hepatic insufficiency. Use with caution in liver failure

APPLICATION FOR CHILDREN
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.
APPLICATION IN ELDERLY PATIENTS
Particular attention should be given to elderly patients due to an increased risk of developing bradycardia, increasing or lowering blood pressure.
In elderly patients, before the study, the disturbance of the water-electrolyte balance should be eliminated and sufficient fluid and electrolytes should be supplied.
SPECIAL INSTRUCTIONS
Do not use for intrathecal administration. Premises in which procedures are performed using radiopaque preparations should be provided with equipment and medicines for emergency care (oxygen cylinders, antihistamines and vasoconstrictors, GCS). Diagnostic procedures using iodine-containing contrast agents for intravascular administration should be conducted under the supervision of personnel who have received training and who have experience in performing this survey.
Use with caution in renal and / or hepatic insufficiency, diseases of the heart-vessel system, pulmonary emphysema, severe general condition, severe cerebral arteriosclerosis, decompensated diabetes mellitus, latent hyperthyroidism, nodular goiter of mild and moderate severity, sickle cell anemia, pheochromocytoma, for introduction into the right heart cavity in newborns with pulmonary hypertension and heart failure.
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 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 GCS, 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 to perform a control analysis of the level of TSH and T4 after 7-10 days and 1 month after the administration of iodine-containing contrast medium.
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 the hypotonic action 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 examination 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 when large doses are administered, a sufficient amount of liquid must be injected before using the drug, kidney function.
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 paid 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 probability of occurrence of adverse reactions to drivers of motor vehicles and other technical means, it is recommended to refrain from driving vehicles for 1 hour after the introduction.
DRUG 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.
With the / a introduction of radiopaque substance after the use of vasoconstrictors, the risk of neurotoxic action increases.
Do not mix with other medicines.
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