Omnipaque

Package leaflet: Information for the patient

Omnipaque, 518 mg/ml (240 mg I/ml), solution for injection
Omnipaque, 647 mg/ml (300 mg I/ml), solution for injection
Omnipaque, 755 mg/ml (350 mg I/ml), solution for injection
Iohexol
Please read carefully all the information in this leaflet before the medicine is used, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Omnipaque is and what it is used for
2. Important information before using Omnipaque
3. How to use Omnipaque
4. Possible side effects
5. How to store Omnipaque
6. Contents of the pack and other information

1. What Omnipaque is and what it is used for

This product is intended for diagnostic use only.
A radiographic contrast medium for administration in adult patients and children undergoing the following diagnostic procedures: cardioangiography, arteriography, urography, phlebography, and computed tomography (in adults).
When administered intrathecally, it is used in lumbar, thoracic, and cervical myelography, as well as in computed tomography of the basal cisterns of the brain.
The medicine is also used in arthrography, retrograde endoscopic pancreatography (REP), retrograde endoscopic cholangiopancreatography (ERCP), herniography, hysterosalpingography, sialography, and gastrointestinal tract examinations.

2. Important information before using Omnipaque

When not to use Omnipaque:

• if the patient is allergic to iohexol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe, symptomatic hyperthyroidism.

Warnings and precautions
Before starting Omnipaque, discuss this with your doctor.
Transient brain dysfunction, known as encephalopathy, may occur during or shortly after the imaging procedure. If the patient experiences any symptoms related to this condition, described in section 4, the doctor should be informed immediately.

General warnings for all non-ionic contrast media
Hypersensitivity reactions
Particular attention is required in patients with a history of allergy, asthma, or previous adverse reactions to iodinated contrast agents. Therefore, every administration of contrast agents should be preceded by a thorough medical history. Omnipaque should be used in patients with a history of allergies or known hypersensitivity reactions only when absolutely necessary.
In patients at risk of intolerance, premedication with corticosteroids or H and H histamine receptor blockers may be considered. However, these may not prevent anaphylactic shock and may mask its initial symptoms. Patients with bronchial asthma are at particularly increased risk of bronchospasm.
The risk of severe reactions after administration of Omnipaque is considered low. However, iodinated contrast agents may cause severe, life-threatening or fatal anaphylactic and/or anaphylactoid reactions or other hypersensitivity symptoms. Regardless of dose or route of administration, symptoms such as angioedema, conjunctivitis, cough, itching, rhinitis, sneezing, and urticaria may indicate a serious anaphylactoid reaction requiring treatment. Therefore, necessary medications and equipment should be prepared in advance, and access to qualified and experienced medical personnel must be ensured. In a pre-shock state, administration of the contrast agent should be stopped immediately, and if necessary, appropriate intravenous treatment should be initiated. An intravenous cannula or catheter ensuring immediate venous access should be maintained throughout the radiological examination.
Patients taking β-adrenergic receptor-blocking drugs may present atypical symptoms of anaphylaxis, which may be mistaken for parasympathetic nervous system responses (vagal reactions).
Typical hypersensitivity reactions usually include mild respiratory and skin symptoms such as mild respiratory disturbances, skin redness (flushing), urticaria, itching, or facial swelling.
Serious symptoms such as angioedema, subglottic edema, bronchospasm, and shock are rare. These reactions usually occur within one hour after administration of the contrast agent.
In rare cases, hypersensitivity may be delayed (after several hours or days), although such cases rarely threaten the patient's life and usually involve the skin.

Observation period after Omnipaque administration
After administration of the contrast agent, the patient should be observed for 30 minutes, as most severe adverse reactions occur within this time. However, delayed reactions are still possible.

Coagulopathy
Serious, rarely fatal, thromboembolic events leading to myocardial infarction and stroke have been reported during angiocardiographic procedures using both ionic and non-ionic contrast agents. During vascular catheterization procedures, attention should be paid to angiographic technique and the need for frequent catheter flushing (e.g., with heparinized saline) to minimize the risk of thrombosis or embolism related to the procedure.
During catheterization, multiple factors beyond the contrast agent may contribute to thromboembolic complications, including duration of the procedure, number of injections, catheter type, syringe material, underlying diseases, and concomitant medications.
The procedure should be as short as possible.
Caution is advised in patients with homocystinuria (risk of thromboembolic complications).
Non-ionic contrast agents exhibit weaker in vitro anticoagulant effects compared to ionic contrast agents.

Hydration
Adequate hydration of the patient should be ensured before and after administration of the contrast agent. If necessary, intravenous hydration should be maintained until the contrast agent is completely eliminated. This particularly applies to patients with dysproteinemia and paraproteinemia (e.g., multiple myeloma, diabetes, renal dysfunction, hyperuricemia), as well as infants, young children, elderly individuals, and patients in poor general condition. In high-risk patients, water and electrolyte metabolism should be monitored, along with symptoms of decreased serum calcium levels.
Due to the risk of dehydration associated with diuretic use, hydration and electrolyte replacement are essential to reduce the risk of acute kidney injury.

Cardiovascular reactions
Particular attention should be paid to patients with severe heart disease, cardiovascular disorders, or pulmonary hypertension. Hemodynamic disturbances and cardiac arrhythmias may occur, especially after intra-arterial, left or right ventricular administration of the contrast agent.
Patients with heart failure, severe coronary artery disease, unstable angina pectoris, valvular heart disease, previous myocardial infarction, pulmonary hypertension, or prior coronary artery bypass grafting are particularly susceptible to cardiac complications.
ECG changes and arrhythmias occur more frequently in elderly patients and those with prior ischemic heart disease.
Intravenous administration of contrast agent in patients with heart failure may cause pulmonary edema.

Central nervous system disorders
Particular attention should also be given to patients with acute brain pathologies, brain tumors, or a history of epilepsy due to increased risk of seizures. The risk of neurological reactions and seizures is also increased in individuals with alcohol or drug dependence.
Caution is advised when administering contrast agent intravenously to patients with acute stroke or acute intracranial hemorrhage, as well as those with diseases impairing the blood-brain barrier, cerebral edema, acute demyelinating disease, or advanced cerebral atherosclerosis.
Neurological symptoms caused by metastases, degenerative, or inflammatory processes may worsen after contrast agent administration.
Patients with symptomatic cerebrovascular disease, previous strokes, or frequent transient ischemic attacks are particularly susceptible to neurological complications following intra-arterial contrast injection. Intra-arterial injection may induce vasospasm, potentially leading to cerebral ischemia.
Transient hearing loss and even deafness have been reported in a few patients after myelography, likely related to decreased cerebrospinal fluid pressure following lumbar puncture.

Renal function disorders
Iodinated contrast agents may increase serum creatinine levels and cause acute kidney injury. Special care should be taken in patients with pre-existing renal impairment and diabetes, who are at risk of contrast-induced nephropathy.
Other predisposing factors include: previous contrast-induced renal impairment, history of kidney disease, age over 60 years, dehydration, advanced atherosclerosis, decompensated heart failure, high or repeated doses of contrast agent, direct injection into the renal artery, exposure to other nephrotoxic substances, severe chronic hypertension, hyperuricemia, paraproteinemia (multiple myeloma, Waldenström’s macroglobulinemia, plasmacytoma), or dysproteinemia.

Preventive measures:

• Identify high-risk groups;
• Ensure adequate hydration; if necessary, intravenous infusion should begin before the procedure and continue until the contrast agent is completely eliminated by the kidneys;
• Avoid additional renal stress, such as concomitant use of potentially nephrotoxic drugs, oral cholecystographic agents, vascular clamps, renal artery angioplasty, or other extensive surgical procedures, until the contrast agent is fully eliminated;
• Minimize the contrast dose;
• Delay repeat contrast administration until renal function parameters return to baseline.

Patients undergoing hemodialysis may receive contrast agent for radiological examinations. There is no need to coordinate the timing of contrast administration and hemodialysis.

Diabetic patients taking metformin
In diabetic patients treated with metformin, especially those with renal dysfunction, there is a risk of lactic acidosis following administration of iodinated contrast agents.
Before intravascular administration of contrast agents in diabetic patients taking metformin, serum creatinine levels should be measured to reduce the risk of lactic acidosis. The following precautions should be taken:

(1) Patients with estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73 m² (stages 1 and 2 of chronic kidney disease) may continue normal metformin use.

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

• Patients receiving intravenous contrast agent with eGFR ≥ 45 ml/min/1.73 m² may continue normal metformin use.
• In patients receiving intra-arterial contrast agent or intravenous contrast agent with eGFR between 30 and 44 ml/min/1.73 m², metformin should be discontinued 48 hours before contrast administration and restarted 48 hours after, provided renal function has not deteriorated.

(3) In patients with eGFR < 30 ml/min/1.73 m² (stages 4 and 5 chronic kidney disease) or with concomitant conditions causing liver dysfunction or hypoxia, metformin is contraindicated. Iodinated contrast agents should not be administered.

(4) In emergency situations where renal function is impaired or unknown, the physician should weigh the risks and benefits of contrast-enhanced imaging. Metformin should be discontinued from the moment of contrast administration. After the procedure, the patient should be monitored for symptoms of lactic acidosis. Metformin may be restarted 48 hours after contrast administration if serum creatinine/eGFR remains unchanged from pre-procedure values.

Concomitant liver and kidney dysfunction
Special attention should be paid to patients with severe concurrent liver and kidney dysfunction, as contrast agent clearance may be significantly prolonged.

Myasthenia
Administration of contrast agent may exacerbate symptoms in patients with myasthenia.

Pheochromocytoma
Patients with pheochromocytoma or suspected pheochromocytoma should receive α-receptor blocking drugs before the procedure to prevent hypertensive crisis.

Thyroid function disorders
Due to the presence of free iodide in the solution and additional iodide released during deiodination, iodinated contrast agents affect thyroid function. This may lead to hyperthyroidism or even thyroid storm in predisposed patients. Patients with undiagnosed but active hyperthyroidism (high-risk group), latent hyperthyroidism (e.g., with nodular goiter), or autonomous thyroid function (often elderly patients, particularly in iodine-deficient regions) should have thyroid function evaluated before the procedure.

Before administering iodinated contrast agent, ensure the patient will not undergo thyroid imaging, thyroid function tests, or radioactive iodine therapy in the near future. Administration of iodinated contrast agent, regardless of route, affects thyroid hormone assays, thyroid iodine uptake, or detection of thyroid cancer metastases until urinary iodine excretion returns to normal.

After Omnipaque administration, thyroid disorders may occur in children and adults. Infants may also be exposed via the mother during pregnancy. The doctor may order thyroid function tests before and/or after Omnipaque administration.

Anxiety
Sedatives may be used in cases of significant anxiety.

Sickle cell anemia
Intravenous and intra-arterial contrast agents may promote sickling of red blood cells in patients with homozygous sickle cell anemia.

Additional risk factors
In patients with autoimmune diseases, cases of severe vasculitis and Stevens-Johnson-like symptoms have been observed.
Severe vascular and neurological diseases, especially in elderly patients, are risk factors for contrast agent reactions.

Extravascular administration of Omnipaque
Extravasation of contrast agent may rarely cause pain, swelling, and redness at the injection site. Symptoms are usually transient and resolve without consequences. However, inflammatory reactions and tissue necrosis have also been observed. As routine preventive measures, elevation and cooling of the affected area should be applied. Surgical decompression may be necessary in cases of compartment syndrome.

Children and adolescents
Particular attention should be paid to children under 3 years of age, as early-life hypothyroidism may impair motor, hearing, and cognitive development and may require temporary T4 replacement therapy. The incidence of hypothyroidism in patients under 3 years exposed to iodinated contrast agents ranges from 1.3% to 15%, depending on age and dose, and is more frequently observed in newborns and preterm infants. Newborns may also be exposed to iodinated contrast agents via the mother during pregnancy. Thyroid function should be evaluated in all children under 3 years after exposure to iodinated contrast agents. If hypothyroidism is detected, thyroid function should be monitored until normalization.

In infants and young children, adequate hydration before and after contrast administration should be ensured. Nephrotoxic drugs should be discontinued. Age-dependent glomerular filtration rate (GFR), which is reduced in this age group, may be responsible for delayed elimination of contrast agents.

Infants (<1 year), especially newborns, are sensitive to electrolyte imbalances and hemodynamic changes.

Intrathecal administration
After myelography, the patient should rest for 1 hour with the head and chest elevated by 20 degrees. The patient may then leave the examination room but should be warned not to bend forward. If remaining in bed, the head and chest should remain elevated for 6 hours. Patients with a low seizure threshold should be closely monitored during this time. Outpatients should not be left unattended for 24 hours.

Cerebral angiography
Cardiovascular reactions such as bradycardia, elevated or decreased blood pressure may occur more frequently in patients with advanced atherosclerosis, severe hypertension, heart decompensation, advanced age, prior stroke or cerebral embolism, or migraine.

Angiography
Due to the procedure, complications such as arterial, venous, or aortic injury, adjacent organ damage, pleural puncture, retroperitoneal hemorrhage, spinal cord injury, and paraplegia may occur.

Omnipaque and other medicines
Inform your doctor about all medicines currently or recently used, as well as any medicines planned for use.
Inform your doctor if the patient is taking β-adrenergic receptor-blocking drugs, which may increase the risk of breathing difficulties and affect treatment of severe allergic reactions related to Omnipaque.

Although no incompatibilities have been reported, Omnipaque should not be mixed directly with other medicines and should be administered from a separate syringe.

Administration of iodinated contrast agents may cause transient renal dysfunction, potentially leading to lactic acidosis in diabetic patients taking metformin (see section 2, subsection "Warnings and precautions").

In patients who have received interleukin-2 or interferon less than 2 weeks before the examination, there is an increased risk of delayed reactions such as flushing, skin reactions, and flu-like symptoms.

Concomitant use of certain neuroleptics and tricyclic antidepressants may lower the seizure threshold, increasing the risk of contrast-induced seizures.

Treatment with β-adrenergic receptor-blocking drugs may lower the threshold for hypersensitivity reactions and may require higher doses of β-agonists to treat established hypersensitivity reactions.

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

All iodinated contrast agents interfere with thyroid function tests. Thyroid iodine binding capacity may be reduced for several weeks after the examination.

High concentrations of contrast agents in serum and urine may affect laboratory test results, including bilirubin, protein, and inorganic compounds such as iron, copper, calcium, and phosphates. These substances should not be measured on the day of radiological examination.

Omnipaque with food, drink, and alcohol
Not applicable.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
There are no clinical data on the use of iohexol during pregnancy.
Animal studies have not shown direct or indirect harmful effects on reproduction, embryonic or fetal development, pregnancy course, or perinatal and postnatal development.
Since exposure to X-rays should be avoided in pregnant women whenever possible, the benefit of radiological examination with or without contrast agent should be weighed against the risk.
Omnipaque should not be used in pregnant women unless the benefits outweigh the risks and the doctor considers the examination necessary. In addition to avoiding fetal exposure to radiation, the sensitivity of the fetal thyroid gland to iodine should be considered when evaluating benefits and risks.
Newborns exposed to iodinated contrast agents in utero should have thyroid function monitored (see section "Warnings and precautions").

Breastfeeding
The contrast agent passes into breast milk in small amounts and is minimally absorbed by the intestines. Breastfeeding may continue when the contrast agent is administered to the mother. In one study, the amount of iohexol excreted in breast milk 24 hours after administration was 0.5% of the dose adjusted for body weight. The amount of iohexol ingested by the infant 24 hours after intravenous administration was 0.2% of the pediatric dose.

Driving and operating machinery
Omnipaque has a significant effect on the ability to drive and operate machinery.
Driving and operating machinery should be avoided for 1 hour after the last injection or for 24 hours after intrathecal administration of the drug.

Omnipaque contains trometamol, edetate disodium calcium, hydrochloric acid (for pH adjustment), and water for injections.

Omnipaque contains less than 1 mmol (23 mg) of sodium per 1 ml, meaning the medicine is considered "sodium-free".

The risk of severe reactions after Omnipaque administration is considered low. However, iodinated contrast agents may trigger severe, life-threatening or fatal anaphylactic and/or anaphylactoid reactions or other hypersensitivity symptoms.

3. How to use Omnipaque

This medicine should always be used according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
The dose may vary depending on the type of examination, age, body weight, cardiac output,
the patient's general condition, and the administration technique. Usually, the same iodine concentrations and volumes are used as with other commonly used iodinated contrast agents. Proper patient hydration should be ensured before and after administration of the product. The recommended dosing of the product is provided in the tables below.
Intravenous administration

Intra-arterial administration

Intrathecal administration

To minimize the risk of adverse effects, the total dose of iodine should not exceed 3 g.
Body cavity examination

Use of a higher than recommended dose of Omnipaque
Preclinical studies indicate a wide safety margin for the use of Omnipaque. An upper dose limit has not been established for routine intravascular administration. Symptomatic overdose is unlikely in patients with normal renal function, provided that the dose of 2000 mg I/kg body weight is not exceeded within a given time period. When large doses of contrast agent are administered, renal tolerance is influenced by the duration of the procedure (t ~2 hours).

Overdose may occur accidentally in children, particularly during comprehensive angiography involving repeated administration of a highly concentrated agent.

In case of overdose, correct disturbances in fluid and electrolyte balance. Renal function should be monitored for the next three days. If necessary, the excess contrast agent may be removed from the body by hemodialysis.
There is no specific antidote for this medicinal product.

Omission of Omnipaque administration
The medicinal product is administered by trained medical personnel, therefore omission of administration is unlikely.

If you have any further doubts regarding the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicinal product can cause adverse reactions, although not everyone will experience them.
General (concerning all iodinated contrast agents)
Below are the probable general adverse reactions that may occur during radiographic examinations, including after administration of non-ionic, monomeric contrast agents.
Adverse reactions specifically related to the route of administration are described below.
Hypersensitivity reactions may occur regardless of dose or route of administration. Mild symptoms may be the first sign of severe anaphylactoid and/or shock reactions. In such cases, administration of the medicinal product should be stopped immediately, and appropriate treatment should be initiated, if necessary, via an intravascular cannula placed beforehand.
After administration of iodinated contrast agents, transient increase in serum creatinine concentration may be observed. Furthermore, contrast-induced nephropathy may occur.
Iodine poisoning (so-called "iodide mumps") is a very rare complication occurring after administration of iodinated contrast agents. Symptoms include swelling and increased tension of the salivary glands, which may persist for up to 10 days after the examination.
The frequencies of adverse reactions are based on clinical documentation and published study results. In total, adverse reactions observed in studies involving over 200,000 patients have been included.
The frequency of adverse reactions associated with the use of Omnipaque is defined as follows:

• very common: (occurs in more than 1 in 10 people);
• common: (occurs in 1 to 10 in 100 people);
• uncommon: (occurs in 1 to 10 in 1,000 people);
• rare: (occurs in 1 to 10 in 10,000 people);
• very rare: (occurs in less than 1 in 10,000 people);
• unknown: (frequency cannot be estimated from available data).

Immune system disorders
Rare: hypersensitivity (may be life-threatening or fatal), including dyspnoea, rash, erythema, urticaria, pruritus, skin reactions, conjunctivitis, cough, rhinitis, sneezing, vasculitis, angioedema, laryngeal oedema, laryngospasm, bronchospasm, non-cardiogenic pulmonary oedema. Adverse reactions may occur immediately after injection and may indicate the onset of shock. Hypersensitivity-related skin reactions may appear up to several days after injection.
Very rare: anaphylactic and/or anaphylactoid reaction (may be life-threatening or fatal).
Unknown: anaphylactic and/or anaphylactoid shock (may be life-threatening or fatal).

Nervous system disorders
Uncommon: headache.
Very rare: taste disturbances (transient metallic taste), vasovagal syncope.

Cardiac disorders
Rare: bradycardia.

Vascular disorders
Very rare: hypertension, hypotension.

Gastrointestinal disorders
Uncommon: nausea.
Rare: vomiting, abdominal pain.
Very rare: diarrhoea.
Unknown: salivary gland enlargement.

General disorders and administration site conditions
Common: sensation of warmth.
Uncommon: excessive sweating, sensation of cold, vasovagal reactions.
Rare: fever.
Very rare: chills.

Intravascular administration (intravenous or intra-arterial)
First refer to the adverse reactions described in the "General" section. Below are described only those adverse reactions (with their frequency of occurrence) specific to intravascular administration of a non-ionic, monomeric contrast agent.
Observed adverse reactions, particularly after intra-arterial administration, depend on the site and dose of contrast agent administered. During selective arteriography or other procedures, when the contrast agent reaches an organ in high concentration, complications may affect that organ.

Blood and lymphatic system disorders
Unknown: thrombocytopenia.

Endocrine disorders
Unknown: hyperthyroidism, transient hypothyroidism.

Psychiatric disorders
Unknown: confusion, restlessness, nervousness, anxiety, disorientation.

Nervous system disorders
Rare: dizziness, paresis, paralysis.
Very rare: seizures, impaired consciousness, stroke, dementia, sensory disturbances (including hypoesthesia), paresthesia, tremor.
Unknown: amnesia, transient motor disturbances (including speech disorders, aphasia, dysarthria), contrast-induced encephalopathy.

Eye disorders
Rare: visual disturbances (including diplopia, blurred vision), photophobia.
Unknown: transient cortical blindness.

Ear and labyrinth disorders
Unknown: transient hearing loss.

Cardiac disorders
Rare: cardiac arrhythmias (including bradycardia and tachycardia).
Very rare: circulatory depression or ischaemia, thrombosis or embolism after phlebography, myocardial infarction, chest pain.
Unknown: severe cardiac complications (cardiac arrest, circulatory and respiratory arrest), heart failure, coronary artery spasm, cyanosis. After administration into the coronary, cerebral, or renal arteries, arterial spasm may occur, resulting in transient ischaemia.

Vascular disorders
Very rare: hot flushes.
Unknown: shock, arterial spasm, thrombophlebitis, venous thrombosis.

Respiratory, thoracic and mediastinal disorders
Common: transient changes in respiratory rate, respiratory failure.
Rare: cough, respiratory arrest.
Very rare: dyspnoea.
Unknown: severe subjective and objective symptoms of respiratory tract infection, pulmonary oedema, acute respiratory distress syndrome, bronchospasm, laryngospasm, apnoea, tachypnoea and shallow breathing, asthma attack.

Skin and subcutaneous tissue disorders
Rare: rash, pruritus, urticaria.
Unknown: bullous dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalised exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS), psoriasis flare-up, erythema, drug eruptions, skin desquamation.

Gastrointestinal disorders
Rare: diarrhoea.
Unknown: exacerbation of pancreatitis.

Musculoskeletal and connective tissue disorders
Very rare: joint pain, muscle weakness, skeletal muscle cramps, back pain.

Renal and urinary disorders
Uncommon: acute kidney injury.
Unknown: increased blood creatinine concentration.

General disorders and administration site conditions
Common: distal pain (during peripheral arteriography).
Uncommon: pain and discomfort.
Rare: weakness (including malaise, fatigue).
Unknown: reactions at the site of administration.

Injury, poisoning and procedural complications
Unknown: iodism.

Intrathecal administration
First refer to the adverse reactions described in the "General" section. Below are described only those adverse reactions (with their frequency of occurrence) specific to intrathecal administration of a non-ionic, monomeric contrast agent.
Adverse reactions after intrathecal administration of contrast agent may be delayed and may appear several hours or even days after the procedure. The frequency of occurrence is similar to that after lumbar puncture. Headache, nausea, vomiting, or dizziness are largely attributable to decreased pressure in the subarachnoid space, resulting from leakage of cerebrospinal fluid at the puncture site. To minimize reduction in spinal canal pressure, excessive drainage of cerebrospinal fluid should be avoided.

Psychiatric disorders
Unknown: confusion, restlessness, anxiety, disorientation.

Nervous system disorders
Very common: headache (may be severe and prolonged).
Uncommon: aseptic meningitis (including chemical meningitis).
Rare: seizures, dizziness.
Unknown: meningeal reaction, status epilepticus, brain disorders (encephalopathy) after contrast agent administration, motor disturbances (including speech disorders), sensory disturbances.

Eye disorders
Unknown: transient cortical blindness, photophobia.

Ear and labyrinth disorders
Unknown: transient hearing loss.

Gastrointestinal disorders
Common: nausea, vomiting.

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

General disorders and administration site conditions
Rare: limb pain.
Unknown: local site reactions.

Administration into body cavities
First refer to the adverse reactions described in the "General" section. Below are described only those adverse reactions (with their frequency of occurrence) specific to administration of a non-ionic, monomeric contrast agent into body cavities.

Endoscopic retrograde cholangiopancreatography (ERCP)
Gastrointestinal disorders
Common: pancreatitis, increased blood amylase activity.

Oral administration
Gastrointestinal disorders
Very common: diarrhoea.
Common: nausea, vomiting.
Uncommon: abdominal pain.

Hysterosalpingography
Gastrointestinal disorders
Very common: lower abdominal pain.

Arthrography
Musculoskeletal and connective tissue disorders
Unknown: arthritis.

General disorders and administration site conditions
Very common: pain.

Herniography
General disorders and administration site conditions
Unknown: post-herniography pain.

Description of selected adverse reactions
Thromboembolic complications have been reported in patients undergoing contrast angiography of the coronary, cerebral, renal, and peripheral arteries. The administration of contrast agent may have contributed to these complications.
Cardiac complications, including acute myocardial infarction, have been reported during or after completion of coronary angiography. The risk of such complications is increased in elderly patients or patients with severe coronary artery disease, unstable angina, and left ventricular dysfunction.
Very rarely, the contrast agent may cross the blood-brain barrier, leading to uptake by the cerebral cortex and potentially causing contrast-induced encephalopathy. Symptoms may include headache, visual disturbances, cortical blindness, seizures, confusion, disorientation, drowsiness, loss of consciousness, coma, loss of coordination, hemiparesis, speech disturbances, aphasia, amnesia, and cerebral oedema. Symptoms typically appear within minutes to 24 hours after administration. In most reported cases, the reaction lasted from several hours to 72 hours.
Anaphylactoid reactions and anaphylactoid shock may lead to significant hypotension and associated symptoms such as hypoxic encephalopathy, renal and hepatic failure. In several reported cases, extravasation of the contrast agent caused local pain and swelling.
Pain and swelling usually resolved without clinical sequelae. In addition, inflammatory conditions, tissue necrosis, and compartment syndrome have been reported.

Additional adverse reactions in children
Transient hypothyroidism has been reported in premature infants, neonates, and other children after administration of contrast agent. Premature infants are particularly sensitive to iodine. Cases of transient hypothyroidism have also been reported in breastfed infants whose mothers received multiple doses of Omnipaque.
Particular attention should be paid to adequate hydration before and after the examination, especially in infants and young children. Concomitant nephrotoxic drugs should be discontinued. The age-dependent glomerular filtration rate (which is reduced in this age group) may be responsible for delayed elimination of contrast agents from the body.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181C,
02-222 Warsaw,
Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Omnipaque

Keep this medicine out of sight and reach of children.
Store below 30 °C. Keep in the outer packaging to protect from light.
The medicine, whether in glass or polypropylene bottles, may be stored in a warming cabinet at 37 °C for 1 month.
Do not use this medicine after the expiry date stated on the label.
Do not use this medicine if visible signs of decomposition are observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Omnipaque contains
The active substance is iohexol.

• Other ingredients: trometamol, edetate disodium calcium, hydrochloric acid (for pH adjustment) and water for injections.

What Omnipaque looks like and contents of the pack
Omnipaque is available in vials or bottles made of colourless glass or USB bottles made of polypropylene, packed in cardboard boxes.
The vials and bottles are made of colourless, borosilicate glass (Ph. Eur. type I), closed with a stopper made of grey chlorobutyl rubber or black bromobutyl rubber (Ph. Eur. type I), protected with a thin plastic cap. The second type of packaging consists of polypropylene bottles closed with a stopper made of grey chlorobutyl rubber or black bromobutyl rubber (Ph. Eur. type I), protected with a plastic cover.

Omnipaque (518 mg/ml) is available in glass packaging: 10 vials of 10 ml, 6 vials of 20 ml, 25 vials of 20 ml, 10 bottles of 50 ml and 6 bottles of 200 ml, and in polypropylene packaging: 10 bottles of 50 ml.

Omnipaque (647 mg/ml) is available in glass packaging: 10 vials of 10 ml, 6 vials of 20 ml, 25 vials of 20 ml, 10 bottles of 50 ml, 10 bottles of 100 ml, and in polypropylene packaging: 10 bottles of 50 ml, 10 bottles of 75 ml, 10 bottles of 100 ml, 10 bottles of 200 ml and 6 bottles of 500 ml.

Omnipaque (755 mg/ml) is available in glass packaging: 6 vials of 20 ml, 25 vials of 20 ml, 10 bottles of 50 ml, 10 bottles of 100 ml and 6 bottles of 200 ml, and in polypropylene packaging: 10 bottles of 50 ml, 10 bottles of 75 ml, 10 bottles of 100 ml, 10 bottles of 200 ml and 6 bottles of 500 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GE Healthcare A.S.
Nycoveien 1
NO-0485 Oslo
Norway

For further information, please contact the representative of the Marketing Authorisation Holder:
GE Medical Systems Polska Sp. z o.o.
ul. Wołoska 9
02-583 Warsaw
Tel: +48 22 330 83 00

Manufacturer:
GE Healthcare A.S.
Nycoveien 1
NO-0485 Oslo
Norway
GE Healthcare Ireland Limited
IDA Business Park, Carrigtohill, Co.
Cork
Ireland