Omnipaque

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Omnipaque and what is it 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 is Omnipaque and what is it used for

Product intended exclusively for diagnostic purposes.
Radiological contrast agent for administration in adult patients and children in the following diagnostic procedures: cardioangiography, arteriography, urography, phlebography, computed tomography (in adults).
After subarachnoid administration, it is used in lumbar, thoracic, and cervical myelography, as well as in computed tomography of the brain ventricles.
The medicine is also used in arthrography, retrograde endoscopic pancreatography (ERP), retrograde endoscopic cholangiopancreatography (ERCP), herniography, hysterosalpingography, sialography, and gastrointestinal tract examinations.
The medicine may also be used in contrast-enhanced mammography (CEM) in adult patients to evaluate and detect confirmed or suspected breast changes, as a supplement to mammography (with or without ultrasound) or as an alternative examination to magnetic resonance imaging (MRI), when there are contraindications or it is not possible to perform this examination.

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 hyperthyroidism with visible symptoms.

Warnings and precautions

Before starting to use Omnipaque, you should discuss it with your doctor.
During or shortly after the end of the imaging procedure, a transient disturbance of brain function, called encephalopathy, may occur. If the patient notices any symptoms related to this disease, described in section 4, they should immediately inform their doctor.
General warnings regarding the use of all non-ionic contrast agents
Allergic reactions
Patients with a history of allergy, asthma, and unfavorable, unforeseen reactions to iodine contrast agents require special attention. In connection with this, each use of contrast agents should be preceded by a detailed medical history. In patients with a tendency to allergies and in patients with known hypersensitivity reactions, Omnipaque should be used only in absolute indications.
In patients at risk of intolerance, the use of premedication with corticosteroids or histamine H1 and H2 receptor blockers should be considered. However, they may not prevent anaphylactic shock and may also mask its initial symptoms. In patients with bronchial asthma, the risk of bronchospasm is particularly increased.
It is believed that the risk of severe reactions after administration of Omnipaque is small. However, it should be remembered that iodine contrast agents can cause severe, life-threatening, or fatal anaphylactic and (or) anaphylactoid reactions or other hypersensitivity symptoms. Regardless of the amount and route of administration, symptoms such as angioedema, conjunctivitis, cough, itching, rhinitis, sneezing, and urticaria may indicate a serious anaphylactoid reaction requiring treatment. In connection with this, it is necessary to plan and prepare the necessary medications and equipment in advance to use in such a situation and to ensure the availability of qualified and experienced medical personnel. In a pre-shock state, the administration of the contrast agent should be stopped immediately, and if necessary, appropriate treatment should be started intravenously. Throughout the radiological examination, a venous cannula or catheter should be maintained to ensure immediate intravenous access.
Patients taking beta-adrenergic receptor blockers may have atypical symptoms of anaphylaxis, which may be mistaken for symptoms from the parasympathetic nervous system (vagal reaction).
Usually, hypersensitivity symptoms are mild respiratory and skin disorders, such as mild breathing difficulties, skin redness (flush), urticaria, itching, or facial swelling.
Severe symptoms, such as angioedema, laryngeal edema, bronchospasm, and shock, occur rarely. These reactions usually occur within an hour of contrast agent administration.
In rare cases, hypersensitivity may occur with a delay (after several hours or days), but such cases rarely threaten the patient's life and mostly concern the skin.
Observation time of the patient after administration of Omnipaque
After administration of the contrast agent, the patient should be observed for 30 minutes, as most severe adverse reactions occur during this time. However, it should be remembered that delayed reactions are possible.
Coagulopathy
During cardioangiographic procedures using both ionic and non-ionic contrast agents, serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported. During procedures using vascular catheters, attention should be paid to angiography technique and the need for frequent catheter flushing (e.g., with heparinized saline) to minimize the risk of thrombosis or embolism related to the examination.
During catheterization, it should be considered that, in addition to the contrast agent, many other factors can influence the development of thromboembolic complications. These include the duration of the examination, the number of injections, the type of catheter, and the syringe material, as well as underlying diseases and concomitantly used medications.
The examination should be as short as possible.
Care should be taken in patients with homocystinuria (risk of thromboembolic complications).
Non-ionic contrast agents have weaker anticoagulant effects in vitro than ionic contrast agents.
Hydration
Before and after administration of the contrast agent, proper hydration of the patient should be ensured.
If necessary, the patient should be hydrated intravenously until the contrast agent is completely eliminated. This is especially important for patients with dysproteinemia and paraproteinemia, such as multiple myeloma, diabetes, renal impairment, hyperuricemia, as well as infants, young children, elderly patients, and patients in poor general condition. In patients at risk, water and electrolyte metabolism should be monitored, as well as symptoms of decreased serum calcium levels.
Due to the risk of dehydration during diuretic use, it is first necessary to hydrate the patient and administer electrolytes to reduce the risk of acute kidney injury.
Cardiovascular reactions
Particular attention should also be paid to patients with severe heart diseases, cardiovascular diseases, and pulmonary hypertension. They may experience hemodynamic disturbances and arrhythmias. This is especially true for intracoronary administration of the contrast agent, into the left and right ventricles.
Patients with heart failure, severe coronary artery disease, unstable angina, valvular disease, previous myocardial infarction, pulmonary hypertension, and previous coronary artery bypass grafting are particularly at risk of cardiovascular disturbances.
Changes in ECG and arrhythmia occur more frequently in elderly patients and in patients with a history of heart disease with ischemic changes.
In patients with heart failure, intracoronary administration of the contrast agent may cause pulmonary edema.
Central nervous system disorders
Particular attention should also be paid to patients with acute cerebral pathologies, with a history of tumors or epilepsy, due to the increased risk of seizures. Also, in individuals dependent on alcohol or drugs, the risk of neurological reactions and seizures is increased.
Care should be taken when administering the contrast agent intravascularly to patients with acute stroke or acute intracranial hemorrhage, as well as to patients with diseases that disrupt the blood-brain barrier, and to patients with cerebral edema, acute demyelinating disease, and advanced cerebral atherosclerosis.
Neurological symptoms caused by metastases, degenerative processes, or inflammatory processes may worsen with the use of the contrast agent.
Patients with symptomatic cerebral vascular diseases, after strokes, and with frequent transient ischemic attacks are particularly at risk of neurological disturbances caused by intravascular administration of the contrast agent. Intravascular administration of the contrast agent may induce vasospasm, which can lead to cerebral ischemia.
In a few patients after myelography, transient hearing loss, and even deafness, have been described. This was probably related to the decrease in cerebrospinal fluid pressure after lumbar puncture.
Renal disorders
The use of iodine contrast agents can cause an increase in serum creatinine levels and acute kidney injury. To prevent the occurrence of these diseases after administration of the contrast agent, special care should be taken in patients with existing kidney impairment and diabetes, who are at risk. These patients are at risk of contrast-induced nephropathy.
Other predisposing factors include: the occurrence of kidney impairment after previous administration of the contrast agent, a history of kidney disease, age over 60, dehydration, advanced atherosclerosis, decompensated heart failure, high doses, and multiple injections of the contrast agent, direct administration of the contrast agent into the renal artery, exposure to other nephrotoxic substances, severe and chronic hypertension, hyperuricemia, paraproteinemia (multiple myeloma, Waldenström's macroglobulinemia, plasmacytoma), or dysproteinemia.
Preventive measures:

• identification of the high-risk group;
• ensuring proper hydration; if necessary, intravenous infusion should be started before the procedure and maintained until the contrast agent is completely eliminated by the kidneys;
• avoiding additional kidney strain, such as concomitant use of potentially nephrotoxic medications, oral medications used during cholecystography, vascular clamps, renal artery angioplasty, or other extensive surgical procedures, until the contrast agent is completely eliminated from the body;
• limiting the dose of the contrast agent to a minimum;
• delaying repeated administration of the contrast agent until kidney function parameters return to baseline values.

Patients undergoing hemodialysis can be administered the contrast agent for radiological examination. The timing of contrast agent administration and hemodialysis performance is not necessary.
Patients with diabetes taking metformin
In patients with diabetes taking metformin, especially those who also have kidney impairment, there is a risk of lactic acidosis, resulting from the administration of iodine contrast agents.
In patients with diabetes taking metformin, serum creatinine levels should be determined before intravascular administration of contrast agents to reduce the likelihood of lactic acidosis. The following precautions should be taken in the following situations:

• (1) Patients with an estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73 m² or higher (stage 1 and 2 chronic kidney disease) may continue to take metformin as usual.
• (2) Patients with an eGFR of 30-59 ml/min/1.73 m² (stage 3 chronic kidney disease)
• Patients receiving intravenous contrast agent with an eGFR of 45 ml/min/1.73 m² or higher may continue to take metformin as usual.
• In patients receiving intra-arterial contrast agent and in patients receiving intravenous contrast agent with an eGFR between 30 and 44 ml/min/1.73 m², metformin administration should be discontinued 48 hours before contrast agent administration and restarted 48 hours after contrast agent administration, provided that kidney function has not deteriorated.
• (3) In patients with an eGFR below 30 ml/min/1.73 m² (stage 4 and 5 chronic kidney disease) or with concomitant disease causing impaired liver function or hypoxia, metformin is contraindicated. Iodine contrast agents should not be administered.
• (4) In patients with acute conditions, in whom kidney function is impaired or unknown, the doctor should weigh the risks and benefits of the examination with contrast agent use. Metformin should be discontinued from the time of contrast agent administration. After the procedure, the patient should be monitored for signs of lactic acidosis. Metformin should be restarted 48 hours after contrast agent administration, provided that serum creatinine levels/eGFR have not changed compared to pre-examination values.

48 hours after administration of the contrast agent, if serum creatinine levels/eGFR have not changed compared to pre-examination values.
Concomitant liver and kidney disorders
Particular attention should be paid to patients with concomitant severe impairment of both liver and kidney function, as the clearance of the contrast agent may be significantly prolonged.
Myasthenia
Administration of the contrast agent may exacerbate symptoms in patients with myasthenia.
Pheochromocytoma
Patients with pheochromocytoma and those suspected of having this disease should be given alpha-receptor blockers before the examination to avoid a hypertensive crisis.
Thyroid disorders
Due to the presence of free iodides in the solution and additional iodides released during the deionization process, iodine contrast agents affect thyroid function. As a result, hyperthyroidism may occur in predisposed patients, and even a thyroid crisis. In patients with active, but undiagnosed, hyperthyroidism (patients at risk) and in patients with latent hyperthyroidism (e.g., with a nodular goiter) and patients with functional autonomy (often elderly patients, especially those living in iodine-deficient areas), thyroid function should be evaluated before the examination to check for these diseases.
Before administration of the iodine contrast agent, it should be ensured that the patient will not undergo thyroid imaging, thyroid function tests, or radioactive iodine treatment in the near future. The use of an iodine contrast agent, regardless of the route of administration, affects the results of hormone assays, iodine uptake by the thyroid gland, or metastases from thyroid cancer until iodine excretion in the urine returns to normal.
After administration of Omnipaque in children and adults, thyroid diseases may occur. Infants may also be exposed to the contrast agent through their mother during pregnancy. The doctor may order thyroid function tests before and/or after administration of Omnipaque.
Anxiety states
In case of pronounced anxiety, sedatives can be used.
Sickle cell anemia
Intravenous and intra-arterial contrast agents may contribute to sickling of red blood cells in patients with homozygous sickle cell anemia genotype.
Additional risk factors
Among patients with autoimmune diseases, cases of severe vasculitis and symptoms similar to Stevens-Johnson syndrome have been observed.
Severe vascular and neurological diseases, especially in the elderly, are risk factors for reactions to the contrast agent.
Extravascular administration of Omnipaque
Extravasation of the contrast agent can rarely cause pain, swelling, and redness at the injection site. Symptoms are usually transient and resolve without consequences. However, inflammatory symptoms and tissue necrosis have also been observed. As a routine precaution, the affected area should be elevated and cooled. In case of compartment syndrome, surgical decompression may be necessary.
Children and adolescents
Particular attention should be paid to children under 3 years of age, as the occurrence of hypothyroidism in early life can be harmful to motor, auditory, and cognitive development and may require temporary replacement therapy with T4. The frequency of hypothyroidism in patients under 3 years of age who were exposed to iodine contrast agents ranged from 1.3% to 15%, depending on the age of the examined patients and the dose of the iodine contrast agent, and was more frequently observed in newborns and premature infants. Newborns may also be exposed to the contrast agent through their mother during pregnancy. In all children under 3 years of age after exposure to iodine contrast agents, thyroid function should be evaluated.
Particular attention should be paid to infants and young children to ensure proper hydration before and after administration of the contrast agent. Medications with nephrotoxic effects should be discontinued.
The age-dependent glomerular filtration rate (GFR), which is reduced in this age group, may be responsible for delayed elimination of contrast agents from the body.
Infants (under 1 year of age), especially newborns, are sensitive to electrolyte imbalance and hemodynamic changes.
Subarachnoid administration
After myelography, the patient should rest for 1 hour with their head and chest elevated by 20 degrees. Then, the patient can leave the room but should be advised not to bend. If they remain in bed, in a lying position, their head and chest should be elevated for 6 hours. During this time, patients with a low seizure threshold should be closely monitored.
Outpatients should not be left unattended for 24 hours.
Cerebral arteriography
Cardiovascular reactions, such as bradycardia, increased or decreased blood pressure, may occur more frequently in patients with advanced atherosclerosis, severe hypertension, decompensated heart failure, advanced age, a history of stroke or embolism, and migraine.
Arteriography
Due to the examination procedure used, the following may occur: arterial, venous, or aortic damage, as well as damage to adjacent organs, and puncture of the pleura, retroperitoneal bleeding, spinal cord injury, and symptoms of paraplegia.
Contrast-enhanced mammography (CEM)
Contrast-enhanced mammography results in greater exposure to ionizing radiation than standard mammography. The radiation dose depends on breast thickness, the type of mammography device, and system settings. The total radiation dose of CEM remains below the threshold specified in international mammography guidelines (below 3 mGy).

Omnipaque and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor if you are taking beta-adrenergic receptor blockers, which may increase the risk of breathing difficulties and may affect the treatment of severe allergic reactions related to the use of Omnipaque.
Although no incompatibilities have been found, Omnipaque should not be used directly with other medicines; it should be administered from a separate syringe.
Administration of iodine contrast agents may cause transient kidney function disorders, which may lead to lactic acidosis in patients with diabetes taking metformin (see section 2, subsection "Warnings and precautions").
In patients who took interleukin-2 and interferon less than 2 weeks before the examination, there is an increased risk of delayed reactions, such as redness, skin reactions, and flu-like symptoms.
Concomitant use of certain neuroleptics and tricyclic antidepressants may lower the seizure threshold, thus increasing the risk of seizures induced by the contrast agent.
Treatment with beta-adrenergic receptor blockers may lower the threshold for hypersensitivity reactions and require the use of higher doses of beta-agonists in the treatment of hypersensitivity reactions that occur.
Beta-adrenergic receptor blockers, vasoactive substances, angiotensin-converting enzyme inhibitors, and angiotensin receptor antagonists may reduce the effectiveness of cardiovascular compensatory mechanisms in response to changes in blood pressure.
All iodine contrast agents disrupt thyroid function tests. The ability of the thyroid gland to bind iodine may be reduced for several weeks after the examination.
High concentrations of contrast agents in serum and urine may affect the results of laboratory tests, including bilirubin, protein, and inorganic compounds such as iron, copper, calcium, and phosphates. These substances should not be assayed on the day of the radiological examination.

Omnipaque with food, drink, and alcohol

This is not applicable.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
There are no clinical data on the use of iohexol in pregnant women.
Animal studies do not show direct or indirect harmful effects on reproduction, embryonic or fetal development, pregnancy, or perinatal and postnatal development.
Since, if possible, pregnant women should avoid exposure to X-rays, it should be considered whether the benefits of the radiological examination, with or without contrast agent administration, outweigh the risks.
Omnipaque should not be used in pregnant women unless the benefits outweigh the risks, and the doctor considers the examination necessary. Apart from the need to avoid fetal exposure to radiation, when weighing the benefits and risks, the sensitivity of the fetal thyroid gland to iodine should be taken into account.
Infants who were exposed to iodine contrast agents in utero should be monitored for thyroid function (see section "Warnings and precautions").
Breastfeeding
The contrast agent passes into breast milk in small amounts and is absorbed by the gut in small amounts. Breastfeeding can be continued when the contrast agent is administered to the mother. In a study, the amount of iohexol that passed into breast milk 24 hours after administration was 0.5% of the administered dose, adjusted for body weight. The amount of iohexol absorbed by the child in the first 24 hours after administration was 0.2% of the dose used in children.

Driving and using machines

Omnipaque has a significant impact on the ability to drive and use machines.
It is not recommended to drive or use machines for 1 hour after the last injection or during the 24 hours after subarachnoid administration of the medicine.
Omnipaque containstrometamol, calcium disodium edetate, hydrochloric acid (to adjust pH), and water for injections.
Omnipaque containsless than 1 mmol (23 mg) of sodium per 1 ml, which means the medicine is considered "sodium-free".
The risk of severe reactions after administration of Omnipaque is considered small. However, it should be remembered that iodine contrast agents can cause 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 as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Dosage may vary depending on the type of examination, age, body weight, cardiac output, patient's general condition, and administration technique. Usually, the same concentrations and volumes of iodine are used as with other commonly used iodine contrast agents. Before and after administration of the product, proper hydration of the patient should be ensured. The recommended dosages are listed in the tables below.

Intravenous administration

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

Use of a higher than recommended dose of Omnipaque

Preliminary studies indicate a large safety margin for the use of Omnipaque. The upper dose limit of the medicine has not been established for routine intravascular administration. In patients with normal kidney function, symptomatic overdose is unlikely if the dose of 2000 mg I/kg body weight is not exceeded within a given time. If large doses of the contrast agent are administered, the tolerance of the kidneys depends on the duration of the procedure (t ~2 hours).
Accidental overdose is possible in children, especially during complex angiography with multiple administrations of a highly concentrated contrast agent.
In case of overdose, water and electrolyte balance should be corrected. Kidney function should be monitored for 3 consecutive days. If necessary, the overdosed contrast agent can be removed from the body by hemodialysis.
There is no specific antidote for this medicine.

Missed dose of Omnipaque

The medicine is administered by medical personnel, and missing a dose is unlikely.
In case of any further doubts regarding the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Omnipaque can cause side effects, although not everybody gets them.

General (applicable to all iodine contrast agents)

The following are possible general side effects that may occur during radiographic examinations, including those using non-ionic, monomeric contrast agents.
Side effects specifically related to the route of administration are described below.
Allergic reactions may occur regardless of the dose and route of administration. Mild symptoms may be the first sign of severe anaphylactoid reactions and (or) shock. In this case, the administration of the medicine should be stopped immediately, and if necessary, appropriate treatment should be started through a previously inserted intravascular cannula.
After administration of iodine contrast agents, a transient increase in serum creatinine levels may be observed. Additionally, contrast-induced nephropathy may occur.
Iodine poisoning (so-called "iodine rash") is a very rare complication occurring after administration of iodine contrast agents. Symptoms of this complication include swelling and increased tension of the salivary glands, which persist for up to 10 days after the examination.
The frequency of side effects is based on clinical documentation and published study results. In total, side effects that occurred in studies involving over 200,000 patients have been taken into account.
The frequency of side effects related to the use of Omnipaque has been determined as follows:

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

Immune system disorders
Rare: hypersensitivity (may be life-threatening or fatal) including dyspnea, rash, flushing, urticaria, itching, skin reactions, conjunctivitis, cough, rhinitis, sneezing, vasculitis, angioedema, laryngeal edema, bronchospasm, and non-cardiogenic pulmonary edema. Side effects may occur immediately after injection, as well as indicate the onset of shock. Skin reactions related to hypersensitivity 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: diarrhea.
Unknown: salivary gland enlargement.
General disorders and administration site conditions
Common: feeling of heat.
Uncommon: excessive sweating, feeling of cold, vasovagal reactions.
Rare: fever.
Very rare: chills.

5. How to Store Omnipaque

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

6. Package Contents and Other Information

What Omnipaque Contains

The active substance is iohexol.

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

What Omnipaque Looks Like and Contents of the Package

Omnipaque is available in vials or bottles made of clear glass or polypropylene bottles in a cardboard box.
The vials and bottles are made of clear, borosilicate glass (Ph. Eur. type I), closed with a grey chlorobutyl rubber stopper or black bromobutyl rubber stopper (Ph. Eur. type I) and secured with a thin, plastic cap.
The second type of packaging is polypropylene bottles, closed with a grey chlorobutyl rubber stopper or black bromobutyl rubber stopper (Ph. Eur. type I), secured 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 Authorization Holder and Manufacturer

Marketing Authorization Holder:
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway
To obtain more detailed information, please contact the representative of the Marketing Authorization Holder:
GE Medical Systems Polska Sp. z o.o.
Wołoska Street 9
02-583 Warsaw
Tel: +48 22 330 83 00
Manufacturer:
GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway
GE Healthcare Ireland Limited
IDA Business Park, Carrigtohill, Co.
Cork
Ireland

Date of Last Update of the Leaflet: February 2024