Omnipaq

Table 1

Values of osmolality and viscosity of the drug

* Method: vapor phase osmometry.

1 ml of the product contains 0.012 mg of sodium, i.e., essentially sodium-free.

Pharmacotherapeutic group. Iodine-containing X-ray contrast agents. Water-soluble low-osmolar nephrotropic X-ray contrast agents. ATC code V08A B02.

Pharmacological properties.

Pharmacodynamics.

Iohexol is a non-ionic, monomeric, tri-iodinated, water-soluble X-ray contrast agent.

In studies of healthy volunteers after intravenous injection of iohexol, no significant deviations in most hemodynamic, clinical-biochemical, or coagulation parameters were observed. Changes in some laboratory parameters were minor and are not considered clinically significant.

Pharmacokinetics.

Approximately 100% of iohexol administered intravenously is excreted unchanged by normally functioning kidneys within 24 hours. The elimination half-life of the drug in patients with normal renal function is 2 hours. No metabolites of the drug have been identified.

Protein binding of Omnipaque to plasma proteins is so low (less than 2%) that it is not clinically significant and can be disregarded.

Clinical characteristics.

Indications.

Omnipaque is intended only for diagnostic procedures.

A radiopaque contrast agent for use in children and adults for angiography, urography, phlebography, and contrast enhancement in computed tomography (CT).

Subarachnoid administration for lumbar, thoracic, and cervical myelography and CT of basal cisterns.

Arthrography, endoscopic retrograde pancreatography (ERP), endoscopic retrograde cholangiopancreatography (ERCP), herniography, hysterosalpingography, sialography, and gastrointestinal tract studies.

Contraindications.

• Increased sensitivity to the active substance or to other components of the drug.
• Severe thyrotoxicosis.

Special safety precautions. As with all parenteral preparations, Omnipaque should be visually inspected before administration for the presence of insoluble particles, color change, or package integrity defects. Since the drug contains no preservatives, Omnipaque should be drawn into a syringe immediately before use. Vials are intended for single use only. Unused portions of the drug must be discarded.

Any unused medication or waste material should be disposed of in accordance with local requirements.

Additional instructions for autoinjector/pump. The 500 ml vial of contrast agent should be used only with autoinjectors/pumps designed for this volume. The vial should be punctured only once. The catheter connecting the autoinjector/pump to the patient must be replaced after each use.

Unused contrast agent remaining in the vial and all connecting tubing after the examination must be discarded at the end of the workday. Smaller volume vials may be used for convenience. The manufacturer's instructions for the autoinjector/pump must be followed.

Interaction with other medicinal products and other forms of interaction.

Use of iodine-containing contrast agents in diabetic patients receiving metformin may lead to reversible renal impairment and lactic acidosis (see section "Special precautions for use").

Patients who have received interleukin-2 less than 2 weeks prior to the examination are prone to delayed adverse reactions (erythema, flu-like symptoms, or skin reactions).

Concomitant use of certain neuroleptics or tricyclic antidepressants may lower the seizure threshold and thus increase the risk of seizures associated with contrast agent administration.

Simultaneous use of contrast agents with β-blockers may reduce the threshold for hypersensitivity reactions and may require higher doses of β-agonists in the treatment of hypersensitivity reactions.

β-blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, and angiotensin receptor antagonists may reduce the effectiveness of cardiovascular compensatory mechanisms for blood pressure changes.

All iodine-containing contrast agents may interfere with diagnostic tests assessing thyroid function; thus, the thyroid gland's ability to bind iodine may be reduced for several weeks.

High concentrations of contrast agents in blood serum and urine may affect laboratory results for bilirubin, proteins, and inorganic compounds (e.g., iron, copper, calcium, phosphates); therefore, laboratory tests should not be performed on the same day.

Special precautions for use.

General special precautions for non-ionic monomeric contrast agents.
Hypersensitivity. A history of allergy, asthma, or adverse reactions to iodine-containing contrast agents requires heightened vigilance. Therefore, a detailed medical history must be obtained before administering contrast agents. Patients with allergic diathesis or known hypersensitivity reactions should receive the drug only if absolutely indicated.

In cases of contrast agent intolerance, premedication with corticosteroids or H1- and H2-histamine receptor antagonists may be considered, although these do not prevent anaphylactic shock and may mask its initial symptoms.

Patients with bronchial asthma have an increased risk of bronchospasm.

The risk of severe adverse reactions to Omnipaque is very low. However, iodine-containing contrast agents may cause life-threatening, fatal anaphylactic/anaphylactoid reactions or other manifestations of hypersensitivity. Regardless of the amount or route of administration, symptoms such as angioedema, conjunctivitis, cough, pruritus, rhinitis, sneezing, and urticaria may indicate a serious anaphylactoid reaction requiring treatment. Therefore, emergency treatment procedures should be planned in advance, and necessary medications, equipment, and qualified medical personnel should be available to provide immediate assistance. In the event of shock, contrast agent administration must be stopped immediately, and specific intravenous treatment initiated if necessary. It is recommended to use a permanent cannula or catheter to ensure rapid intravenous access during the radiographic contrast procedure.

Patients receiving beta-adrenergic blockers, especially asthmatics, may have a lower threshold for bronchospasm and may be less responsive to treatment with beta-agonists and adrenaline, potentially requiring higher doses. In addition, anaphylactic reactions in these patients may present atypically and be mistaken for vagal reactions.

Hypersensitivity reactions typically manifest as mild respiratory or cutaneous symptoms such as slightly labored breathing, skin redness (erythema), urticaria, pruritus, or facial swelling. Severe reactions such as angioedema, subglottic edema, bronchial spasm, and shock are rare.

These reactions usually occur within one hour after contrast agent administration. In rare cases, hypersensitivity may be delayed (after several hours or days), although such delayed reactions rarely threaten life and primarily affect the skin.

Coagulopathy. Serious, rarely fatal, thromboembolic complications leading to myocardial infarction and stroke have been reported during angiocardiographic procedures using both ionic and non-ionic contrast agents. When performing catheterization procedures, angiographic techniques must be strictly followed, and catheters should be frequently flushed (e.g., with sodium chloride solution containing heparin) to minimize the risk of thrombosis and embolism associated with the procedure.

During catheterization, factors other than the contrast agent that may contribute to thromboembolic complications should be considered, including duration of the examination, number of injections, catheter type and syringe material, underlying diseases, and concomitant medication use.

The examination procedure should be as short as possible.

Patients with homocystinuria (risk of thromboembolism) should be monitored.

Unlike ionic contrast agents, non-ionic contrast agents have a weaker in vitro inhibitory effect on coagulation.

Hydration. Adequate hydration (hydration) of the patient must be ensured before and after administration of the contrast agent. If necessary, hydration should be administered intravenously until excretion of the contrast agent is complete.

This is particularly important for patients with dys- and paraproteinemia, multiple myeloma, diabetes mellitus, renal dysfunction, hyperuricemia, as well as infants, young children, elderly patients, and patients in poor general condition.

In patients at increased risk, fluid and electrolyte balance should be monitored, and symptoms of decreased serum calcium levels should be observed.

Due to the risk of diuretic-induced dehydration, fluid and electrolyte rehydration should be performed first to prevent the risk of acute kidney injury.

Cardiovascular reactions. Caution is advised when examining patients with severe cardiovascular diseases and pulmonary hypertension due to the risk of arrhythmia or hemodynamic disturbances, especially with intracoronary, left and right ventricular administration of contrast agents (see section "Adverse reactions").

Patients particularly susceptible to cardiac complications include those with heart failure, severe ischemic heart disease, unstable angina, valvular diseases, previous myocardial infarction, coronary bypass surgery, and pulmonary hypertension.

Reactions with ischemic ECG changes and arrhythmias occur more frequently in elderly patients and patients with a history of heart disease.

Intravascular administration of contrast agents in patients with heart failure may cause pulmonary edema.

CNS disorders.

Cases of encephalopathy have been reported with contrast agents such as iohexol (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, unconsciousness, coma, and cerebral edema. Symptoms usually appear within minutes or hours after iohexol administration and typically resolve within a few days.

Factors increasing blood-brain barrier permeability facilitate the transfer of contrast agents into brain tissue and may lead to possible CNS reactions, such as encephalopathy. Intravascular administration of the drug should be used cautiously in patients with acute ischemic stroke or acute intracranial hemorrhage, as well as in patients with diseases involving blood-brain barrier disruption, cerebral edema, acute demyelination, or progressive cerebral atherosclerosis. If contrast-induced encephalopathy is suspected, iohexol administration should be discontinued and appropriate medical treatment initiated.

Neurological symptoms caused by metastases, degenerative or inflammatory processes may be exacerbated by contrast agents.

Patients with symptomatic cerebrovascular diseases, history of stroke, or frequent transient ischemic attacks have an increased risk of induced neurological complications after intra-arterial injection of contrast agents. Intra-arterial injection of contrast agents may cause vasospasm with subsequent cerebral ischemic complications.

Patients with acute cerebral pathology, brain tumors, and epilepsy are prone to seizures and require special attention. Increased risk of seizures and neurological reactions is observed in alcohol- and drug-dependent patients. In isolated cases, temporary hearing loss or deafness has been observed after myelography, which is believed to be related to decreased cerebrospinal fluid pressure following lumbar puncture.

Renal reactions. Special caution is required when examining patients at risk for contrast-induced nephropathy and elevated serum creatinine levels: diabetic patients and patients with renal dysfunction.

Other risk factors for adverse renal reactions: previous renal insufficiency after contrast agent administration, history of kidney disease, age over 60 years, dehydration, progressive atherosclerosis, decompensated heart failure, high doses of contrast agents and multiple injections, direct administration of contrast agents into the renal artery, exposure to additional nephrotoxins, severe and chronic hypertension, hyperuricemia, paraproteinemia (myeloma, Waldenström's macroglobulinemia), or dysproteinemia.

Measures to prevent adverse reactions:

• identification of patients at risk;
• ensuring adequate hydration, if necessary, by intravenous infusion initiated before contrast agent administration and continued until its renal excretion;
• avoiding additional renal burden by avoiding nephrotoxic drugs, oral cholecystographic agents, arterial compression, renal arterial angioplasty, and major surgical interventions until the contrast agent is eliminated from the body; minimizing the dose;
• postponing repeat contrast studies until renal function recovers to levels observed before the last contrast administration. Contrast agents may be prescribed for radiological procedures in patients undergoing hemodialysis.

There is no need to adjust the time interval between contrast agent injection and hemodialysis session.

Diabetic patients receiving metformin therapy. Use of iodine-containing contrast agents in diabetic patients receiving metformin, especially those with renal dysfunction, may lead to lactic acidosis.

To prevent lactic acidosis in diabetic patients receiving metformin therapy, serum creatinine levels should be measured before intravascular administration of iodine-containing contrast agents, and preventive measures should be taken in the cases specified below.

(1) Patients with estimated glomerular filtration rate (eGFR)
≥ 60 ml/min/1.73 m² (corresponding to chronic kidney disease (CKD) stages 1 or 2) do not require changes in metformin regimen.

(2) Patients with eGFR 30–59 ml/min/1.73 m² (CKD stage 3):

• patients with eGFR ≥ 45 ml/min/1.73 m² do not require changes in metformin regimen during intravenous contrast agent administration;
• patients receiving contrast agent via intra-arterial injection, and patients with eGFR 30–44 ml/min/1.73 m² receiving contrast agent intravenously, should discontinue metformin 48 hours before contrast agent administration. Metformin should be resumed no earlier than 48 hours after contrast agent administration, provided no deterioration in renal function is observed.

(3) Patients with eGFR < 30 ml/min/1.73 m² (CKD stages 4 and 5) or with concomitant conditions provoking decreased liver function or hypoxia should not receive metformin. These patients should avoid administration of iodine-containing contrast agents.

(4) In emergency patients with impaired or unknown renal function, the physician must assess the risk-benefit ratio of contrast agent examination. Metformin should be discontinued at the time of contrast agent administration. After the procedure, the patient should be monitored for signs of lactic acidosis. If serum creatinine/eGFR values remain unchanged compared to pre-examination levels, metformin may be resumed 48 hours after contrast agent administration.

Patients with impaired renal and hepatic function. Special attention should be paid to patients with severe impairment of both renal and hepatic function, as significant delay in contrast agent clearance may occur. Patients on hemodialysis may receive contrast agents for radiological procedures.

Myasthenia. Administration of iodine-containing radiographic contrast agents may exacerbate symptoms of myasthenia.

Pheochromocytoma. Prophylactic use of alpha-blockers is necessary in patients with pheochromocytoma undergoing invasive procedures to prevent hypertensive crises.

Thyroid gland dysfunction. Iodine-containing contrast agents affect thyroid function due to their free iodide content and additional iodide released during deiodination. This may cause hyperthyroidism or even thyrotoxic crisis in predisposed patients.

Patients with existing but undiagnosed hyperthyroidism are at risk; therefore, patients with latent hyperthyroidism (e.g., nodular goiter) and patients with functional autonomy (often elderly patients, especially in iodine-deficient regions) should have thyroid function evaluated before examination if the above conditions are suspected.

Before administering an iodine-containing contrast agent, it must be ensured that the patient does not plan thyroid scanning, thyroid function tests, or radioactive iodine therapy, as administration of iodine-containing contrast agents, regardless of route, affects test results for hormone levels and iodine uptake by the thyroid gland or thyroid cancer metastases until urinary iodine excretion normalizes (see section "Interaction with other medicinal products and other forms of interaction").

Studies of thyroid function after administration of iodine-containing contrast agents in adult and pediatric patients (including infants) indicate a risk of hypothyroidism or transient suppression of thyroid function. Some patients required treatment for hypothyroidism.

Anxiety states. In cases of severe anxiety, a sedative may be prescribed.

Sickle cell anemia. Contrast agents may promote sickling in individuals homozygous for sickle cell anemia following intravenous or intra-arterial administration.

Other risk factors. Severe vasculitis or Stevens-Johnson-like syndromes have been reported in patients with autoimmune diseases.

Severe vascular and neurological diseases, especially in elderly patients, are risk factors for reactions to contrast agent administration.

Extravasation. Leakage of contrast agent from blood vessels (extravasation) rarely caused local pain, swelling, and erythema, which usually resolved without consequences. However, cases of inflammation and even tissue necrosis have been documented. As general measures, elevation and cooling of the injection site are recommended when possible. In case of compartment syndrome, surgical decompression may be necessary.

Patient monitoring. After administration of the contrast agent, the patient should be observed for at least 30 minutes, as most serious adverse reactions occur within this period. The patient should remain in the hospital (but not necessarily in the radiology department) for one hour after the last contrast agent administration and return to the radiology department if any symptoms develop.

Intrathecal administration. After myelography, the patient should remain at rest for at least 1 hour, lying with the head and chest elevated at 20°. After this, the patient may be discharged for outpatient care, but should avoid bending. If bed rest is required, the elevated head and chest position should be maintained for the first 6 hours. Patients suspected of having a low seizure threshold should be monitored during this period. Outpatient patients should not be left unattended during the first 24 hours after the examination.

Special use in children. Particular attention should be paid to children under 3 years of age, as cases of impaired thyroid function at an early age may adversely affect motor skills, hearing, and cognitive development and may require temporary T4 replacement therapy. The incidence of hypothyroidism in patients under 3 years of age receiving iodine-containing contrast agents has been reported to range from 1.3% to 15%, depending on subject age and dose of iodine-containing contrast agent, and is more frequently observed in newborns and premature infants. Newborns may also be negatively affected by iodine-containing agents through the mother during pregnancy. Thyroid function should be evaluated in patients under 3 years of age after administration of iodine-containing contrast agents. If hypothyroidism is detected, appropriate treatment should be considered, and thyroid function monitored until normalization.

Infants require adequate hydration before and after contrast agent administration. Treatment of nephrotoxicity should be carefully considered. Glomerular filtration rate decreases with age in infants, which may lead to delayed excretion of contrast agents.

Hemodynamic and electrolyte imbalances occur particularly easily in children under 1 year of age and especially in newborns.

Cerebral angiography. Cardiovascular reactions such as bradycardia and increased or decreased blood pressure may occur more frequently in patients with progressive atherosclerosis, severe hypertension, decompensated cardiac function, elderly patients, history of stroke or embolism, and headache.

Arteriography. During the procedure, injury to the artery, vein, aorta, and adjacent organs, pleurocentesis, retroperitoneal hemorrhage, spinal cord injury, and symptoms of paraplegia may occur.

Use during pregnancy or breastfeeding.

Pregnancy. The safety of using the drug during pregnancy has not been established. Results of experimental preclinical studies on reproductive performance, embryonic or fetal development, pregnancy course, and perinatal and postnatal development do not indicate any direct or indirect harmful effects.

Radiation exposure should be avoided during pregnancy whenever possible, and X-ray examinations with or without contrast agents should be prescribed only after careful risk-benefit assessment due to potential risks.

Omnipaque may be used during pregnancy only if absolutely necessary, according to physician recommendations and after careful benefit-risk assessment.

In addition to avoiding radiation exposure, the sensitivity of the fetal thyroid gland to iodine should be considered when assessing benefit-risk.

Newborns exposed to iodine-containing contrast agents during intrauterine development should have their thyroid function monitored.

Breastfeeding. Contrast agents pass into breast milk in small amounts and are minimally absorbed in the infant's intestine. Therefore, the likelihood of risk to the infant is low.

Women may continue breastfeeding after administration of iodine-containing contrast agents. In a study, the amount of iohexol excreted in breast milk within the first 24 hours after administration was 0.5% of the dose adjusted for body weight. The amount of iohexol entering the infant's body within the first 24 hours after administration is only 0.2% of the infant's dose.

Ability to affect reaction speed when driving vehicles or operating machinery. Driving vehicles and operating complex machinery are not recommended during the first 24 hours after intrathecal administration of contrast agents (see section "Special precautions for use"). If symptoms occur after myelography, decisions should be made individually.

Method of administration and dosage.

The dose of the drug depends on the examination method, age, body weight, cardiac output, patient's general condition, and technique of drug administration. Typically, the same iodine concentration and volume are used as for other iodine-containing radiographic contrast agents. As with other radiographic contrast agents, adequate hydration of the body must be ensured before and after administration of the contrast agent.

The drug is intended for intravenous, intra-arterial, intrathecal, and intracavitary administration.

Table 2

Concentrations and doses of the drug used

*To minimize the risk of adverse reactions, the total iodine dose should not exceed 3 g.

Children. The drug is used in children.

One should be aware of the possibility of developing transient hypothyroidism in preterm infants, newborns, and other children following administration of iodine-containing contrast agents.

Preterm infants have increased sensitivity to iodine. Cases of transient hypothyroidism have been reported in breastfed infants whose mothers had repeatedly received Omnipaque (see section "Special precautions").

Infants and young children must be adequately hydrated before and after administration of the contrast agent. Nephrotoxic drugs should be discontinued. Age-related reduction in glomerular filtration rate in infants may also lead to delayed elimination of the contrast agent.

Overdose.

Preclinical data indicate a wide therapeutic window for Omnipaque and no upper limit of standard acceptable doses for intravascular administration. Symptomatic overdose is unlikely in patients with normal renal function unless the patient receives more than 2000 mg/kg body weight of iodine within a short period of time. Prolonged administration of high doses may affect kidney function (elimination half-life – 2 hours). Accidental overdose may occur during complex angiographic procedures in children, especially with repeated administration of high doses.

In case of overdose, correction of fluid and electrolyte imbalances should be performed. Renal function should be monitored for the next 3 days. Hemodialysis should be applied if necessary to remove excess drug. There is no specific antidote.

Adverse reactions.

General types of adverse reactions (common to all iodine-containing X-ray contrast agents). The following are possible major adverse effects associated with radiological procedures using non-ionic contrast agents.

Hypersensitivity reactions may occur regardless of the administered dose and route of administration. Mild symptoms may be the first signs of a serious anaphylactic reaction/shock. Administration of the contrast agent should be immediately stopped and, if necessary, specific therapy with intravenous drugs should be initiated.

Transient increase in S-creatinine is a common occurrence after administration of iodine-containing X-ray contrast agents, increasing the risk of contrast-induced nephropathy.

Iodism or iodine parotitis is a very rare reaction to administration of iodine-containing X-ray contrast agents. It may manifest as swelling and pain in the salivary glands within a period up to 10 days after the procedure.

The frequency of adverse reactions is based on internal clinical documentation and published results of large-scale studies involving over 200,000 patients.

Adverse effects are classified by frequency as follows:

very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), unknown (data insufficient to estimate frequency).

Immune system disorders.

Rare: hypersensitivity reactions (which may be life-threatening or fatal), including dyspnea, rash, erythema, urticaria, pruritus, skin reactions, vasculitis, conjunctivitis, cough, rhinitis, sneezing, angioedema, laryngeal edema, laryngospasm, bronchospasm, or non-cardiogenic pulmonary edema. These may develop immediately after administration or several days later and may indicate development of shock. Skin reactions may occur several days after administration.

Very rare: anaphylactic/anaphylactoid reactions (may be life-threatening or fatal).

Unknown: anaphylactic/anaphylactoid shock (may be life-threatening or fatal).

Nervous system disorders.

Uncommon: headache.

Very rare: dysgeusia (transient metallic taste), vasovagal syncope.

Cardiovascular system disorders.
Rare: bradycardia.
Very rare: arterial hypertension, arterial hypotension.

Gastrointestinal disorders.

Uncommon: nausea.

Rare: vomiting, abdominal pain.

Very rare: diarrhea.

Unknown: enlargement of salivary glands.

General disorders.

Common: feeling of warmth.

Uncommon: hyperhidrosis, feeling of cold, vasovagal reactions.

Rare: pyrexia.

Very rare: tremor (chills).

Injuries, poisonings and procedural complications.
Unknown: iodism.

Adverse reactions associated with intravascular (intra-arterial and intravenous) administration.

Please read first the subsection "General types of adverse reactions". The frequency of adverse reactions listed below refers only to intravascular administration of non-ionic monomeric contrast agents.

The development of adverse reactions that may occur during intra-arterial administration depends on the injection site and the dose of the drug. During selective angiography and other procedures where the contrast agent at high concentration reaches the organ under investigation, organ dysfunction may occur.

Blood and lymphatic system disorders.

Unknown: thrombocytopenia

Endocrine system disorders.

Unknown: thyrotoxicosis, transient hypothyroidism.

Psychiatric disorders.

Unknown: confusion, excitement, restlessness, anxiety.

Nervous system disorders.

Rare: dizziness, paresis, paralysis, photophobia, somnolence.

Very rare: seizures, impaired consciousness, cerebrovascular disorder, stupor, sensory disturbances (including hypesthesia), paresthesia, tremor.

Unknown: transient motor dysfunction (including speech disorders, aphasia, dysarthria), transient contrast-induced encephalopathy (including temporary memory loss, disorientation, coma, retrograde amnesia, hemiparesis, and cerebral edema).

Eye disorders.

Rare: visual disturbances (including diplopia and blurred vision).

Unknown: transient cortical blindness.

Ear and labyrinth disorders.

Unknown: transient hearing loss.

Cardiovascular system disorders.

Rare: arrhythmia (including bradycardia, tachycardia).

Very rare: myocardial infarction, flushing, chest pain.

Unknown: severe cardiac complications (including cardiac arrest, cardiopulmonary arrest), heart failure, coronary artery spasm, cyanosis, shock, arterial spasm, thrombophlebitis, and thrombosis.

Respiratory system disorders.

Common: transient changes in respiratory rate, respiratory distress.

Rare: cough, respiratory arrest.

Very rare: dyspnea.

Unknown: severe respiratory symptoms and signs, pulmonary edema, acute respiratory distress syndrome, bronchospasm, laryngospasm, apnea, asthma attack due to aspiration.

Gastrointestinal disorders.

Rare: diarrhea.

Unknown: exacerbation of pancreatitis.

Skin and subcutaneous tissue disorders.

Rare: rash, pruritus, urticaria

Unknown: bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis; acute generalized exanthematous pustulosis; drug rash with eosinophilia and systemic symptoms; exacerbation of psoriasis; erythema; drug-related dermatitis; skin desquamation.

Musculoskeletal and connective tissue disorders.

Unknown: arthralgia, muscle weakness, musculoskeletal spasm, back pain.

Renal and urinary disorders.

Uncommon: acute kidney injury.

Unknown: increased blood creatinine levels.

General disorders and administration site conditions.

Uncommon: pain and discomfort.

Rare: asthenic state (including malaise, fatigue).

Unknown: reactions at the injection site, including extravasation.

Injuries, poisonings and procedural complications.

Unknown: iodism.

Intrathecal administration.

Please read first the subsection "General types of adverse reactions". The frequency of adverse reactions listed below refers only to intrathecal administration of non-ionic monomeric contrast agents.

Adverse reactions may occur several hours or days after intrathecal administration. Their frequency approximately corresponds to the frequency of complications after lumbar puncture without contrast agent administration. To minimize pressure drop, excessive removal of cerebrospinal fluid should be avoided.

Psychiatric disorders.
Unknown: confusion, excitement, anxiety.

Nervous system disorders.
Very common: headache (may be severe and prolonged).
Uncommon: aseptic meningitis (including chemical meningitis).
Rare: seizures, dizziness.

Unknown: abnormal electroencephalogram, meningeal syndrome, epileptic status, transient contrast-induced encephalopathy, including transient memory loss, coma, stupor, retrograde amnesia, hemiparesis, disorientation, motor dysfunction (including speech disorders, aphasia, dysarthria), paresthesias, hypesthesias, and sensory disturbances.

Eye disorders.
Unknown: transient cortical blindness, photophobia.

Ear and labyrinth disorders.

Unknown: transient hearing loss.

Gastrointestinal disorders.
Common: abdominal pain, vomiting.

Musculoskeletal and connective tissue disorders.
Rare: neck pain, back pain.
Unknown: muscle spasms.

General disorders and administration site conditions.
Rare: limb pain.
Unknown: changes at the injection site.

Adverse reactions associated with intracavitary administration.

Please read first the subsection "General types of adverse reactions". The frequency of adverse reactions listed below refers only to intracavitary administration of non-ionic monomeric contrast agents.

Endoscopic retrograde cholangiopancreatography (ERCP).

Gastrointestinal disorders.

General: pancreatitis, increased blood amylase.

Oral administration.

Gastrointestinal disorders.

Very common: diarrhea.

Common: nausea, vomiting.
Rare: abdominal pain.

Hysterosalpingography (HSG).
Gastrointestinal disorders.

Very common: lower abdominal pain.

Arthrography.

Musculoskeletal and connective tissue disorders.

Unknown: arthritis.

General disorders and administration site conditions.
Very common: pain.

Myelography.

General disorders and changes at the administration site.

Unknown: post-procedural pain.

Specific adverse reactions.

Thromboembolic complications have been reported following contrast angiography of coronary, cerebral, renal, and peripheral arteries. The contrast agent may contribute to the development of complications (see section "Special precautions"). Cardiac complications, including acute myocardial infarction, have been reported during or after contrast coronary angiography. Elderly patients or patients with severe ischemic heart disease, unstable angina, and left ventricular dysfunction had a higher risk of complications (see section "Special precautions").

In isolated cases, the contrast agent may cross the blood-brain barrier, resulting in accumulation of the drug in the cerebral cortex, which may cause neurological reactions, including seizures, transient motor or sensory disturbances, transient impairment of consciousness, transient memory loss, and encephalopathy (see section "Special precautions").

Anaphylactoid reactions and anaphylactoid shock may lead to profound hypotension and associated symptoms, including hypoxic encephalopathy, renal and hepatic failure (see section "Special precautions").

In some cases, transudation (extravasation) of the contrast agent causes local pain and swelling, which usually resolve without complications. Cases of inflammation, tissue necrosis, and compartment syndrome have been documented (see section "Special precautions").

Shelf life. 3 years.

Storage conditions. Store in original packaging, protected from secondary X-ray radiation, at a temperature not exceeding 30 °C. Keep out of reach of children!

Incompatibility. Data on compatibility of the drug with other agents are lacking; therefore, a separate syringe should be used for administration of Omnipaque, and it should not be mixed with other medicinal products.

Packaging.

300 mg iodine/mL: 50 mL or 100 mL in polypropylene vial; 10 vials per cardboard box.

350 mg iodine/mL: 50 mL, 100 mL, 200 mL, or 500 mL in polypropylene vial; 10 vials per cardboard box.

Prescription status. Prescription only.

Manufacturer. GE Healthcare Ireland Limited, Ireland.

Manufacturer's address. IDA Business Park, Carrigtohill, Co. Cork, Ireland.