Iodixanol unik
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IODIXANOL-UNIQUE (IODIXANOL-UNIQUE)
Composition:
Active substance: iodixanol;
1 ml of injection solution contains iodixanol equivalent to iodine 320 mg;
Excipients: trometamol; calcium disodium edetate; sodium chloride; calcium chloride dihydrate; concentrated hydrochloric acid (for pH adjustment); water for injections.
Pharmaceutical form. Injection solution.
Main physicochemical properties: clear, colorless solution, free from foreign particles.
Pharmacotherapeutic group.
Iodine-containing X-ray contrast agents. Water-soluble, low-osmolar, non-ionic X-ray contrast agents. ATC code V08AB09.
Pharmacological properties.
Pharmacodynamics.
Iodixanol is a non-ionic, dimeric, hexaiodinated, water-soluble X-ray contrast agent.
After injection, the organically bound iodine present in the vessels and tissues absorbs radiation.
It has been documented that following intravenous administration of iodixanol, no significant alterations in most hemodynamic, clinical-biochemical, or coagulation parameters were observed. Changes in certain laboratory parameters were minor and are not considered clinically significant.
The agent has only a minimal effect on renal function. Administration of the agent in diabetic patients with serum creatinine levels of 1.3–3.5 mg/dL was associated with an increase in creatinine levels by ≥ 0.5 mg/dL, but no patient showed an increase of ≥ 1 mg/dL. When the agent was administered, enzyme excretion (alkaline phosphatase and N-acetyl-ß-glucosaminidase) in the proximal renal tubules was lower than after administration of non-ionic monomeric contrast agents and similar to that observed after administration of ionic dimeric contrast agents.
The medicinal product Iodixanol-Unik does not affect renal function.
Cardiovascular parameters such as left ventricular end-diastolic pressure, left ventricular systolic pressure, heart rate, QT interval, and flow velocity in the femoral artery were less altered after administration of Iodixanol-Unik compared to other contrast agents.
Pharmacokinetics.
Iodixanol is rapidly distributed throughout the body. The distribution half-life averages 21 minutes. The volume of distribution corresponds to the volume of extracellular fluid (0.26 L/kg body weight), indicating that iodixanol distributes only into the extracellular fluid. No metabolites have been identified. Plasma protein binding is less than 2%.
The elimination half-life of the drug is approximately 2 hours. Iodixanol is predominantly excreted by the kidneys via glomerular filtration. In patients with normal renal function, about 80% of the administered dose is excreted in the urine within 4 hours after intravenous injection, and about 97% within 24 hours. Approximately 1.2% of the administered dose is excreted in feces over 72 hours. Maximum urinary concentration of iodixanol is reached 1 hour after injection.
Within the recommended dose range, the pharmacokinetics of iodixanol are not dose-dependent. Pharmacokinetic studies of the use of the agent in body cavities have not been conducted.
Clinical characteristics.
Indications.
Iodixanol-UNIK is intended for diagnostic use only.
The radiographic contrast agent is administered to adult patients for performing cardioangiography, cerebral angiography, peripheral angiography, abdominal angiography, including intra-arterial digital subtraction angiography (DSA), urography, venography, contrast enhancement in computed tomography (CT), and gastrointestinal tract examinations.
Lumbar, thoracic, and cervical myelography.
Arthrography, hysterosalpingography (HSG).
The agent is administered to children for cardioangiography, urography, contrast enhancement in computed tomography (CT), and gastrointestinal tract examinations.
Contraindications.
Hypersensitivity to the components of the medicinal product.
Manifest thyrotoxicosis.
Safety precautions.
Vials are intended for single use only. Any unused portions of the medicinal product must be discarded.
Before administration, visually inspect the solution for the presence of insoluble particles, color changes, or packaging defects.
The solution should be drawn into a syringe immediately before use. The contrast agent must be warmed to body temperature prior to administration.
Additional instructions for auto-injector/pump.
Puncture the vial only once.
The catheter connecting the auto-injector/pump to the patient must be replaced after each use. Any unused contrast agent remaining in the vial and in all connecting tubing after the procedure must be discarded at the end of the working day.
Follow the manufacturer's instructions for the auto-injector/pump.
Any unused medicinal product or waste material must be disposed of in accordance with local requirements.
Interaction with other medicinal products and other forms of interactions.
Diagnosis of thyroid disorders using any iodine-containing contrast agents may be complicated due to reduced iodine-binding capacity of thyroid tissue for up to several weeks, thereby affecting tests measuring iodine uptake (using radioactive iodine).
High concentrations of contrast agents in blood plasma and urine may interfere with laboratory tests measuring bilirubin, protein, or inorganic compound levels (e.g., iron, copper, calcium, and phosphates). Such tests should not be performed on the day of the examination.
Administration of iodine-containing contrast agents to diabetic patients receiving metformin may lead to reversible renal function impairment and lactic acidosis (see section "Special precautions for use").
Patients who have received interleukin-2 less than 2 weeks prior to injection of an iodine-containing contrast agent are predisposed to delayed adverse reactions (flu-like symptoms or skin reactions).
Data indicate that the use of β-blockers is a risk factor for developing anaphylactoid reactions to radiographic contrast agents (severe arterial hypotension has been observed with radiographic contrast agents in patients taking β-blockers).
Patients with asthma have an increased risk when receiving concomitant beta-blocker therapy (see section "Special precautions for use").
Special precautions for use.
General precautions for non-ionic contrast media.
Hypersensitivity. A history of allergies, asthma, or adverse reactions to iodine-containing contrast agents requires heightened vigilance. In such cases, premedication with corticosteroids and H1- and H2-histamine receptor antagonists should be considered.
The risk of severe adverse reactions to the agent is very low. However, iodine-containing contrast agents may cause anaphylactoid reactions or other manifestations of hypersensitivity. For this reason, emergency treatment procedures should be planned in advance, and necessary medications and equipment for emergency therapy must be readily available. It is recommended to always use a permanent cannula or catheter during radiographic contrast procedures to facilitate rapid intravenous administration of medications if needed.
Serious, life-threatening, or fatal anaphylactic/anaphylactoid reactions must always be considered as possible. Most serious adverse reactions occur within the first 30 minutes after administration. Delayed hypersensitivity reactions may occur (1 hour or more after administration).
After administration of the medicinal product Iodixanol-Uniq, patients should be observed for at least 30 minutes. In patients receiving β-blockers, manifestations of hypersensitivity reactions may be atypical and mistakenly interpreted as vagal reactions.
The use of β-adrenergic blockers lowers the threshold and increases the severity of contrast reactions, and also reduces sensitivity to epinephrine treatment of anaphylactoid reactions.
Patients with asthma are at higher risk when concurrently receiving β-blockers (see section "Interaction with other medicinal products and other forms of interaction").
Coagulopathy. Compared to ionic agents, non-ionic iodine-containing contrast media have less in vitro effect on the blood coagulation system. Cases of blood clotting have been reported when blood came into contact with syringes containing contrast agents, including non-ionic ones. Data suggest that using plastic syringes instead of glass ones may reduce, but not eliminate, the likelihood of in vitro blood clotting.
During angiographic procedures using ionic or non-ionic contrast agents, serious, rarely fatal, thromboembolic complications have been reported, leading to myocardial infarction or stroke. Therefore, careful intravascular administration, especially during angiographic procedures, is essential to minimize the risk of thromboembolic complications.
Numerous factors may contribute to the development of thromboembolic complications, including duration of the procedure, material of the catheter and syringe, underlying disease condition, and concomitant medication use. For these reasons, strict adherence to angiographic techniques is required, including careful handling of catheters and tubing, use of multi-component systems and/or three-way stopcocks, frequent flushing of catheters with heparinized sodium chloride solution, and minimizing procedure duration to reduce the risk of intervention-related thrombosis and embolism.
Modern life-support equipment must be immediately accessible.
Caution is advised when examining patients with homocystinuria (due to the risk of thromboembolism).
Hydration. Adequate hydration (fluid loading) of the patient before and after administration of the contrast agent is essential. This is particularly important for patients with myeloma, diabetes mellitus, impaired renal function, as well as infants, young children, and elderly patients. In children under 1 year of age, especially newborns, disturbances in hemodynamics and electrolyte balance occur particularly easily.
Cardiovascular diseases. Caution is advised when examining patients with severe cardiovascular diseases and pulmonary hypertension due to the risk of arrhythmias or hemodynamic disturbances. Rarely, severe, life-threatening, or fatal cardiovascular events such as cardiac arrest, combined cardiac and respiratory arrest, or myocardial infarction have occurred.
Disorders of the central nervous system.
Cases of encephalopathy have been reported with the use of iodixanol (see section "Adverse reactions"). Contrast-induced encephalopathy may present with symptoms and signs of neurological dysfunction, such as headache, visual disturbances, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, loss of consciousness, coma, and cerebral edema. Symptoms usually appear within minutes or hours after administration of iohexol and typically resolve within a few days.
Factors that increase the permeability of the blood-brain barrier facilitate the transfer of contrast agents into brain tissue and may lead to central nervous system reactions, such as encephalopathy.
Patients with acute cerebral pathology, brain tumors, or a history of epilepsy are prone to seizures and require special attention. Increased risk of seizures and neurological reactions is observed in individuals with alcohol or drug dependence. Particular caution during intravenous administration is required in patients with acute stroke or acute intracranial hemorrhage, as well as in patients with blood-brain barrier damage, cerebral edema, or acute demyelinating processes.
If contrast-induced encephalopathy is suspected, administration of iodixanol should be discontinued and appropriate medical treatment initiated.
Renal diseases. The main risk factor for contrast-induced nephropathy is pre-existing renal impairment. Diabetes mellitus and the volume of iodine-containing contrast agent administered are factors influencing the development of renal dysfunction. Additional risk factors include dehydration, progressive atherosclerosis, low renal perfusion, and the presence of other nephrotoxic factors such as certain medications or surgical procedures.
Special caution is required when examining patients with pre-existing renal impairment and diabetes mellitus, who belong to a high-risk group, to prevent contrast-induced acute renal failure. The same applies to patients with paraproteinemias (myeloma, Waldenström's macroglobulinemia).
Measures to prevent adverse reactions:
- identification of patients belonging to high-risk groups;
- ensuring adequate hydration; if necessary, this may be achieved by continuous intravenous infusion initiated before contrast agent administration and continued until its renal excretion;
- avoiding additional renal stress from nephrotoxic drugs, oral cholecystographic agents, renal artery compression, renal angioplasty, or surgical procedures—prior to contrast agent elimination;
- minimizing the contrast dose;
- repeat radiographic contrast examinations should be performed only after full normalization of renal function following the previous administration.
Iodine-containing contrast agents may be used in patients undergoing hemodialysis, as these agents are eliminated by hemodialysis.
Diabetic patients receiving metformin. Intravascular contrast procedures with iodine-containing contrast agents may lead to acute changes in renal function and may be associated with lactic acidosis in patients with renal impairment receiving metformin.
To prevent lactic acidosis in diabetic patients receiving metformin therapy, serum creatinine levels must be measured before intravascular administration of iodine-containing contrast agents.
- Patients with normal serum creatinine or ≥60 mL/min/1.73 m² (chronic kidney disease [CKD] stage 1 and 2) may continue metformin normally.
- Patients with serum creatinine levels of 30–59 mL/min/1.73 m² (CKD stage 3):
a. Patients receiving contrast agent intravenously with serum creatinine ≥45 mL/min/1.73 m² may continue metformin normally.
b. Patients receiving contrast agent intra-arterially or intravenously with serum creatinine levels of 30–44 mL/min/1.73 m² should discontinue metformin at the time of contrast administration and not resume until 48 hours later or until renal function/serum creatinine returns to normal.
- Metformin is contraindicated in patients with serum creatinine <30 mL/min/1.73 m² (CKD stage 4 and 5) or with intercurrent illness causing hepatic impairment or hypoxia; the use of iodine-containing contrast agents should be avoided.
4. In emergency situations where renal function is impaired or unknown, the physician must assess the risk-benefit ratio for the patient and take preventive measures: discontinue metformin, hydrate the patient, monitor renal function, and observe for symptoms of lactic acidosis. Symptoms of lactic acidosis include vomiting, somnolence, nausea, epigastric pain, anorexia, hyperpnea, lethargy, diarrhea, and thirst. Metformin therapy should be resumed only if renal function/serum creatinine levels remain unchanged.
Impaired renal and hepatic function. Extreme caution is required in patients with severe combined renal and hepatic impairment, as they exhibit significantly reduced clearance of contrast agents. Patients on hemodialysis may receive contrast agents for radiological procedures. There is no need to coordinate the timing between contrast agent injection and hemodialysis session, as there is no evidence that hemodialysis prevents contrast-induced nephropathy in patients with renal impairment.
Myasthenia. Administration of iodine-containing radiographic contrast agents may exacerbate symptoms of myasthenia.
Pheochromocytoma. When performing invasive procedures in patients with pheochromocytoma, prophylactic use of α-blockers is required to prevent hypertensive crises.
Thyroid function disorders. Patients at risk of thyrotoxicosis should be carefully evaluated before administration of iodine-containing contrast agents. Special caution is required when examining patients with hyperthyroidism. In patients with multinodular goiter, there is a risk of hyperthyroidism after administration of iodine-containing contrast agents.
Tests of thyroid function have shown hypothyroidism or transient suppression of thyroid function after administration of iodine-containing contrast agents in adults and pediatric patients, including infants. Some patients required treatment for hypothyroidism.
Children. The possibility of transient hypothyroidism in preterm infants after administration of contrast agents should be considered. If iodine-containing radiographic contrast agents are administered to a woman during pregnancy, thyroid function in the newborn should be evaluated within the first week of life. Repeat evaluation of thyroid function should be performed at 2–6 weeks of life, especially in low-birth-weight and preterm infants (see section "Use during pregnancy or breastfeeding").
Extravasation. Due to its isotonicity, Iodixanol-Uniq is likely to cause less local pain and swelling than hyperosmolar contrast agents. In case of extravasation, the injection site should be elevated and cooled. Surgical decompression may be necessary if compartment syndrome develops.
The medicinal product may contain more than 23 mg of sodium per dose, depending on the indication. This should be considered if the patient is on a sodium-restricted diet.
Patient monitoring. After administration of the contrast agent, patients should be observed for at least 30 minutes, as most serious adverse reactions occur during this period. However, hypersensitivity reactions may develop hours or days after injection.
Intrathecal administration. After myelography, the patient should remain at rest for at least 1 hour, lying with the head and chest elevated at 20º. After this period, the patient may be transferred to ambulatory care, but bending should be avoided. During bed rest, the head and chest should remain elevated for the first 6 hours. In patients with a suspected low seizure threshold, monitoring is required during this period. Ambulatory patients should not be left unattended during the first 24 hours after the procedure.
Hysterosalpingography. Hysterosalpingography should not be performed during pregnancy or in the presence of acute pelvic peritonitis.
Use during pregnancy or breastfeeding.
Pregnancy. The safety of using the medicinal product during pregnancy has not been established. Results of experimental preclinical studies on fertility, embryonic or fetal development, pregnancy course, and peri- and postnatal development do not indicate direct or indirect harmful effects. Radiation exposure during pregnancy should be avoided whenever possible, and X-ray examinations, with or without contrast agents, should be prescribed only after careful risk-benefit assessment. The agent may be used during pregnancy only in cases of extreme necessity, according to physician recommendations and after thorough benefit-risk evaluation.
If iodine-containing radiographic contrast agents are administered to a woman during pregnancy, thyroid function in the newborn should be evaluated within the first week of life.
Repeat evaluation of thyroid function should be performed at 2–6 weeks of life, especially in low-birth-weight and preterm infants.
Breastfeeding. Contrast agents pass into breast milk in small amounts, and minimal quantities are absorbed in the intestine. Breastfeeding may continue after administration of iodine-containing radiographic contrast agents.
Fertility. The effect of the medicinal product Iodixanol-Uniq on human reproductive function has not been established. Results of experimental animal studies do not indicate direct or indirect harmful effects on reproduction.
Ability to affect reaction speed when driving or operating machinery.
No studies on the effect of the medicinal product on the ability to drive or operate machinery have been conducted. Driving and operating complex machinery are not recommended during the first 24 hours after intrathecal administration of contrast agents.
Route of administration and dosage.
For intra-arterial, intravenous, intrathecal, and intracavitary administration.
The dose depends on the type of examination, age, body weight, cardiac output, patient's general condition, and the technique of application. Usually, the same concentration and volume of iodine should be used as with other commonly accepted iodine-containing contrast agents. Diagnostic data have been obtained regarding injection of ioxaglucamine with a lower concentration of iodine. Adequate hydration of the patient should be ensured before and after administration of the contrast agent, as with other contrast media.
The doses indicated for intra-arterial administration are intended for single injections, which may be repeated if necessary.
Recommended dosing regimen:
| Intra-arterial (i.a.) administration
Intravenous (i.v.) administration
Intrathecal administration
Intracavitary administration The dose should be individually adjusted for optimal visualization.
(1) Both concentrations can be used, but 270 mg iodine/ml is recommended in most cases. (2) In individual cases, administration of higher doses is possible. (3) To minimize the risk of adverse reactions, the total iodine dose should not exceed 3.2 g. Elderly patients do not require dose adjustment. Patients with hepatic and/or renal insufficiency do not require dose adjustment. |
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| Children. The medicinal product can be used in children for performing cardioangiography, urography, contrast enhancement in computed tomography (CT), and gastrointestinal tract examinations. Recommended doses are provided in the section "Administration and dosage". |
Overdose.
Overdose is unlikely in patients with normal renal function. Prolonged procedures involving high doses of the medicinal product may affect renal function (elimination half-life is 2 hours). In case of accidental overdose, correction of fluid and electrolyte imbalances should be performed using infusion therapy. Renal function should be monitored for the following 3 days. If necessary, excess of the drug can be removed by hemodialysis. There is no specific antidote. Symptomatic treatment should be applied in case of overdose.
Adverse Reactions
Below are possible adverse effects associated with radiological procedures involving the use of the medicinal product Iodixanol-Uniq.
Unwanted reactions caused by the use of the drug are usually mild to moderate in clinical severity and reversible. Serious reactions and fatal outcomes occur only rarely. These may include: acute chronic renal failure, acute renal failure, anaphylactic or anaphylactoid shock, hypersensitivity reactions accompanied by cardiac events (acute coronary syndrome), cardiac arrest, cardiac and respiratory arrest, and myocardial infarction.
Cardiac reactions may be caused by underlying disease or the procedure itself.
Hypersensitivity reactions may occur, typically manifesting as respiratory and cutaneous symptoms such as dyspnea, rash, erythema, urticaria, pruritus, severe skin reactions, angioedema, arterial hypotension, fever, laryngeal edema, bronchospasm, and pulmonary edema. In patients with autoimmune diseases, cases of vasculitis and signs of Stevens-Johnson syndrome have been observed. These reactions may develop immediately after administration or several days later. Hypersensitivity reactions may occur regardless of dose or route of administration. Mild symptoms may be early signs of a serious anaphylactic reaction/shock. Administration of the contrast agent should be stopped immediately, and specific therapy initiated as needed, including intravascular administration of medications. In patients receiving β-blockers, manifestations of hypersensitivity reactions may be atypical and may be mistaken for vagal reactions.
A minor transient increase in serum creatinine levels is a common occurrence after administration of iodinated contrast agents. This is usually not clinically significant.
Adverse effects are classified by frequency of occurrence into the following categories: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), and not known (frequency cannot be estimated from available data).
Adverse reactions associated with intravascular administration.
Blood and lymphatic system disorders.
Not known: thrombocytopenia.
Immune system disorders.
Uncommon: hypersensitivity reactions.
Not known: anaphylactic/anaphylactoid reactions, anaphylactic/anaphylactoid shock, including life-threatening or fatal anaphylaxis.
Endocrine system disorders.
Not known: hyperthyroidism, hypothyroidism.
Psychiatric disorders.
Very rare: agitation, anxiety.
Not known: confusion.
Nervous system disorders.
Uncommon: headache.
Rare: dizziness, sensory disturbances including dysgeusia, paresthesia, parosmia.
Very rare: stroke, amnesia, syncope, transient tremor, hypoesthesia.
Not known: coma, disturbances in consciousness, seizures, transient contrast-induced encephalopathy*, caused by extravasation of contrast agents, which may present as sensory, motor, or general neurological dysfunction.
* Transient contrast-induced encephalopathy: the contrast agent may cross the blood-brain barrier, leading to uptake of the contrast agent in the cerebral cortex and may cause contrast encephalopathy. Symptoms may include restlessness, transient cortical blindness, amnesia, hallucinations, paralysis, paresis, disorientation, transient speech disturbances, aphasia, dysarthria.
Eye disorders.
Very rare: cortical blindness (transient), visual disturbances including diplopia, blurred vision, eyelid edema.
Cardiac disorders.
Rare: arrhythmia (including bradycardia, tachycardia), myocardial infarction.
Very rare: cardiac arrest, palpitations.
Not known: heart failure, ventricular hypokinesia, coronary artery spasm, cardiac and respiratory arrest, conduction disorders, coronary thrombosis, angina pectoris.
Vascular disorders.
Uncommon: flushing.
Rare: arterial hypotension.
Very rare: arterial hypertension, ischemia.
Not known: shock, arterial spasm, thrombosis, thrombophlebitis.
Respiratory, thoracic and mediastinal disorders.
Rare: cough, sneezing.
Very rare: dyspnea, throat irritation, laryngeal edema.
Not known: non-cardiogenic pulmonary edema, respiratory arrest, respiratory failure, bronchospasm, throat obstruction, pharyngeal edema.
Gastrointestinal disorders.
Uncommon: nausea, vomiting.
Very rare: abdominal pain/discomfort, diarrhea.
Not known: acute pancreatitis, exacerbation of pancreatitis, salivary gland enlargement.
Skin and subcutaneous tissue disorders.
Uncommon: rash or toxicoderma, pruritus, urticaria.
Very rare: angioedema, erythema, hyperthyroidism.
Not known: bullous dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms (DRESS).
Musculoskeletal and connective tissue disorders.
Very rare: back pain, muscle spasms.
Not known: arthralgia.
Renal and urinary disorders.
Uncommon: renal function impairment, including acute renal failure and nephrotoxicity (contrast-induced nephropathy).
Not known: increased blood creatinine levels.
General disorders and administration site conditions.
Uncommon: chest pain, sensation of altered body temperature.
Rare: tremor (chills), hyperthermia, injection site reactions including extravasation, sensation of cold, pain and discomfort.
Very rare: asthenic condition (e.g., malaise, increased fatigue), facial swelling, localized edema.
Not known: edema.
Injury, poisoning and procedural complications.
Not known: iodism.
Adverse reactions associated with intrathecal administration.
Adverse reactions are delayed and may occur several hours or days after intrathecal administration. Their frequency is approximately comparable to the complication rate following lumbar punctures without contrast agent administration. When other non-ionic contrast agents are used, signs of meningeal irritation such as photophobia, meningism, and chemical meningitis may occur. Infectious meningitis should also be considered as a possible differential diagnosis.
Immune system disorders.
Not known: hypersensitivity reactions, including anaphylactic/anaphylactoid reactions.
Nervous system disorders.
Uncommon: headache (may be severe and prolonged).
Not known: dizziness, transient contrast-induced encephalopathy (including hallucinations, amnesia, confusion, and other neurological symptoms).
Gastrointestinal disorders.
Uncommon: vomiting.
Rare: nausea.
Musculoskeletal and connective tissue disorders.
Not known: muscle spasms.
General disorders and administration site conditions.
Not known: tremor, injection site pain.
Adverse reactions associated with hysterosalpingography (HSG).
Immune system disorders.
Not known: hypersensitivity reactions.
Nervous system disorders.
Common: headache.
Gastrointestinal disorders.
Very common: abdominal pain.
Common: nausea.
Not known: vomiting.
Reproductive system disorders.
Very common: vaginal bleeding.
General disorders and administration site conditions.
Common: hyperthermia.
Not known: tremor, injection site reaction.
Adverse reactions associated with arthrography.
Immune system disorders.
Not known: hypersensitivity reactions, including anaphylactic/anaphylactoid reactions.
General disorders and administration site conditions.
Common: injection site pain.
Not known: tremor.
Adverse reactions associated with intracavitary administration.
Immune system disorders.
Not known: hypersensitivity reactions, including anaphylactic/anaphylactoid reactions.
Gastrointestinal disorders.
Common: diarrhea, abdominal pain, nausea.
Uncommon: vomiting.
General disorders and administration site conditions.
Not known: tremor.
Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua/".
Shelf life. 2 years.
Storage conditions.
Store at temperatures not exceeding 25 °C in the original packaging.
Store in a place protected from secondary X-ray exposure.
Keep out of reach of children.
Incompatibilities.
Data on compatibility of the drug with other medicinal products are lacking; therefore, a separate syringe should be used for administration of Iodixanol-Uniq, and it should not be mixed with other medicinal products.
Packaging.
50 mL or 100 mL in a vial; 1 vial in a cardboard package.
Prescription status. Prescription only.
Manufacturer: "Uniq Pharmaceutical Laboratories" (a division of "J. B. Chemicals and Pharmaceuticals Ltd.").
Manufacturer's address and place of business.
Plot No. 4, Phase-IV, G.I.D.C. Industrial Estate, Panoli - 394 116, Bharuch District, India.