Visipaque

Leaflet accompanying the packaging: information for the user

Visipaque,550 mg/ml,(270 mg I/ml),solution for injection,
Visipaque,652 mg/ml,(320 mg I/ml),solution for injection
Iodixanol

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.
• If you have 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 as yours.
• If the patient experiences any side effects, including any 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 Visipaque and what is it used for
• 2. Important information before using Visipaque
• 3. How to use Visipaque
• 4. Possible side effects
• 5. How to store Visipaque
• 6. Contents of the packaging and other information

1. What is Visipaque and what is it used for

Product intended exclusively for diagnostic purposes.
Visipaque is used for cardioangiography, cerebral angiography (conventional),
peripheral arteriography (conventional), abdominal angiography (including DSA - digital subtraction angiography), urography, phlebography, in contrast-enhanced computed tomography.
Lumbar, thoracic and cervical myelography.

2. Important information before using Visipaque

When not to use Visipaque:

• if the patient is allergic to iodixanol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has thyrotoxicosis with visible symptoms;
• if the patient has had confirmed severe reactions to Visipaque.

Warnings and precautions

Before starting to use Visipaque, you should discuss it with your doctor, pharmacist or nurse.
General warnings regarding the use of all non-ionic contrast media
Hypersensitivity reactions
Particular attention should be paid to patients with a history of allergies, asthma, and unfavorable, unforeseen reactions to iodine contrast media.
In such cases, it is recommended to consider the use of premedication with glucocorticoids or histamine H1 and H2 receptor blockers.
It is believed that the risk of severe reactions after administration of Visipaque is small. However, it should be remembered that iodine contrast media can cause anaphylactoid reactions or other hypersensitivity symptoms. Therefore, it is recommended to plan and prepare the necessary medications and equipment in advance, which would be necessary to use in such a situation. Throughout the radiological examination, a venous cannula or catheter should be maintained to ensure immediate access.
One should always consider the possibility of hypersensitivity reactions, including serious, life-threatening, and fatal anaphylactic or anaphylactoid reactions. Most severe adverse reactions occur within the first 30 minutes after administration of the contrast medium. There is also a possibility of delayed hypersensitivity reactions (occurring 1 hour after administration or later).
Patients should be observed for at least 30 minutes after administration of Visipaque.
Patients taking beta-adrenergic receptor blockers may have atypical symptoms of hypersensitivity reactions, which may be mistaken for symptoms related to vagus nerve stimulation.
The use of beta-adrenergic receptor blockers may cause a greater tendency to bronchospasm after administration of contrast media in patients with asthma and may reduce the response to adrenaline treatment.
Coagulopathy
Compared to ionic contrast media, non-ionic media have a lesser effect on the coagulation system in vitro.
Cases of blood clotting after contact with syringes containing contrast media, including non-ionic media, have been reported. The use of plastic syringes instead of glass syringes reduces the likelihood of blood clotting in vitro, but does not eliminate it completely.
Severe, rarely fatal, cases of thromboembolic complications leading to myocardial infarction and stroke have been reported during angiocardiological procedures using both ionic and non-ionic contrast media.
The development of thromboembolic complications may also be influenced by many other factors, including the duration of the procedure, the material from which the catheter and syringe are made, the stage of the underlying disease, and concomitantly used medications. For this reason, it is necessary to carefully follow the proper technique of performing angiography, paying particular attention to proper catheter and guidewire manipulation, the use of branching systems and (or) three-way stopcocks, the need for frequent flushing of the catheter with heparinized saline, and minimizing the duration of the procedure, in order to reduce the risk of thrombosis or embolism related to the examination.
Immediate access to necessary, advanced life-saving measures should be ensured.
Patients with homocystinuria (risk of thromboembolic complications) should be under care.
Hydration
Before and after administration of the contrast medium, proper hydration of the patient should be ensured.
This is especially important for patients with leukemia, diabetes, renal function disorders, as well as infants, young children, and the elderly. Infants (under 1 year of age), especially newborns, are sensitive to electrolyte balance disorders and hemodynamic changes.
Cardiovascular disorders
Particular attention should also be paid to patients with severe heart diseases and pulmonary hypertension. They may experience hemodynamic disorders and arrhythmias.
Rarely, severe, life-threatening reactions or deaths have occurred due to cardiovascular disorders such as cardiac arrest, circulatory arrest and respiratory arrest, and myocardial infarction.
Central nervous system disorders
Patients with acute cerebral pathologies, a history of tumors or epilepsy, and those with a history of alcohol or drug abuse, should be under special care due to the increased risk of seizures. Also, patients with a history of alcohol or drug abuse have a lowered seizure threshold and a lowered threshold for neurological reactions. In the case of intravascular administration, patients with acute stroke or acute intracranial hemorrhage, as well as patients with changes in the blood-brain barrier, cerebral edema, or acute demyelination, should be under care.
During or shortly after the imaging procedure, a transient disturbance of brain function, called encephalopathy, may occur. If the patient notices any symptoms related to this condition, described in section 4, they should immediately inform their doctor.
Renal disorders
The primary risk factor for the development of contrast-induced nephropathy is pre-existing renal disorders. Diabetes and the volume of iodine contrast medium administered are additional risk factors for the development of this condition in patients with existing renal disorders. Other risk factors include dehydration, advanced arteriosclerosis, reduced renal blood flow, and the presence of other potentially nephrotoxic factors, such as certain medications or extensive surgical procedures.
To prevent the occurrence of acute renal failure after administration of contrast media, special care should also be taken for patients with pre-existing renal failure and diabetes.
Patients with paraproteinemias (multiple myeloma, Waldenström's macroglobulinemia) are also at increased risk.
Preventive measures:

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

Iodine contrast media can be administered to patients undergoing hemodialysis, as these media are removed during dialysis.
Patients with diabetes taking metformin
To avoid lactic acidosis in diabetic patients taking metformin, serum creatinine levels should be determined before administration of contrast media.
Metformin should be discontinued at the time of or prior to contrast media administration and withheld for 48 hours subsequent to the procedure and reinstituted only after renal function has been re-evaluated and found to be normal.
Renal and hepatic disorders
Particular attention should be paid to patients with concurrent severe renal and hepatic disorders, as the clearance of the medicine may be significantly prolonged. Patients undergoing dialysis may be given contrast media. The timing of contrast media administration and dialysis is not critical.
Myasthenia
Administration of contrast media may exacerbate symptoms in patients with myasthenia.
Pheochromocytoma
Caution should be exercised when administering iodine contrast media to patients with pheochromocytoma or suspected pheochromocytoma.
Patients with pheochromocytoma undergoing procedures should be given alpha-receptor blockers before the start of the examination to avoid a hypertensive crisis.
Thyroid disorders
Patients with visible but undiagnosed hyperthyroidism, patients with latent hyperthyroidism (e.g., those with nodular goiter), and patients with functional autonomy (often, for example, elderly patients, especially from regions with iodine deficiency) are more susceptible to acute thyrotoxicosis after the use of iodine contrast media. In such patients, the additional risk should be assessed before using iodine contrast media.
In patients with suspected hyperthyroidism, before administration of contrast media, it is recommended to consider performing thyroid function tests and (or) using prophylactic antithyroid treatment. Patients at risk should be monitored for the development of thyrotoxicosis in the following weeks after injection of the product.
Cases of thyroid function tests indicating hypothyroidism or decreased thyroid function after administration of iodine contrast media to adults and children, including infants, have been reported. Some patients were treated for hypothyroidism.
After administration of Visipaque to children and adults, thyroid function disorders may occur.
Infants may also be exposed to the effect of the medicine through their mothers during pregnancy.
The doctor may order thyroid function tests before and (or) after administration of Visipaque.
Children and adolescents
Particular attention should be paid to children treated under the age of 3, 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 reported frequency of hypothyroidism in patients under 3 years of age who were exposed to iodine contrast media ranged from 1.3% to 15%, depending on the age of the examined patients and the dose of iodine contrast medium, and this hypothyroidism was more frequently observed in newborns and premature infants. Newborns may also be exposed to iodine contrast media through their mothers during pregnancy. In all children under 3 years of age after exposure to iodine contrast media, thyroid function should be evaluated. If hypothyroidism is detected, the need for treatment and monitoring of thyroid function until it normalizes should be considered.
Extravascular administration of Visipaque
The effects of accidental extravascular administration of Visipaque have not been described. The medicine is isotonic and it seems that pain and swelling should be less severe than after accidental extravascular administration of hyperosmolar agents.
If accidental extravascular administration occurs, it is recommended to cool and elevate the limb. In case of compartment syndrome, surgical decompression may be necessary.
Observation time after administration of Visipaque
After administration of the contrast medium, the patient should be observed for at least 30 minutes, as most adverse reactions occur during this time. Experience indicates that it is also possible for delayed hypersensitivity reactions to occur, appearing up to several hours or days after administration of the medicine.
Intrathecal 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 warned 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 12 to 24 hours.
Hysterosalpingography
Hysterosalpingography should not be performed in pregnant women or women with acute pelvic inflammatory disease (PID).

Visipaque and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
All iodine contrast media can interfere with thyroid function tests. Therefore, the ability of the thyroid gland to bind iodine may be reduced for several weeks after the examination.
High concentrations of contrast medium in serum and urine can affect laboratory test results, including bilirubin, protein, and inorganic substances such as iron, copper, calcium, and phosphates. Therefore, these substances should not be measured on the day of the radiological examination.
Administration of iodine contrast media may cause transient renal function disorders, which can lead to acidosis in diabetic patients taking metformin.
In patients who took interleukin-2 less than 2 weeks before the examination with iodine contrast media, there is an increased risk of delayed reactions, such as skin reactions and flu-like symptoms.
There is evidence that the use of beta-adrenergic receptor blockers is a risk factor for anaphylactoid reactions after administration of contrast media used in radiodiagnostics (cases of acute hypertension have been observed after administration of contrast media to patients taking beta-adrenergic receptor blockers).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
There are no clinical data on the use of Visipaque in pregnant women.
Animal studies do not show direct or indirect harmful effects on reproduction, embryonic or fetal development, pregnancy, or postnatal development.
Animal studies on reproduction are not always applicable to humans, so the product should be used in pregnant women only if necessary.
Since, if possible, exposure to X-rays should be avoided in pregnant women, it should be considered whether the benefits of the radiological examination, with or without contrast medium, outweigh the potential risk.
Visipaque should not be used in pregnant women unless the benefits outweigh the risks and the doctor considers the examination necessary.
In newborns who were exposed to iodine contrast media in utero, it is recommended to monitor thyroid function (see section Warnings and precautions).
Breastfeeding
The contrast medium passes into breast milk in small amounts and is absorbed by the gut in small amounts. Breastfeeding can be continued while the contrast medium is being administered to the mother.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. However, it is not recommended to drive vehicles or operate machines for 24 hours after intravascular administration of the medicine.
Intrathecal administration may affect the ability to drive vehicles.
The risk of severe reactions after administration of Visipaque is considered low. However, it should be remembered that iodine contrast media can cause anaphylactic or other hypersensitivity reactions.

Visipaque contains sodium

Visipaque (550 mg/ml)contains 0.76 mg of sodium (the main component of common salt) per milliliter of solution. This corresponds to 0.038% of the maximum recommended daily intake of sodium in the diet for adults.
Visipaque (652 mg/ml)contains 0.45 mg of sodium (the main component of common salt) per milliliter of solution. This corresponds to 0.023% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Visipaque

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Dosage may vary depending on the type of examination, age, weight, cardiac output, and general condition of the patient, as well as the technique of administration. Usually, the same concentrations and volumes of iodine are used as for other commonly used iodine contrast media, but in some types of examinations, slightly lower concentrations of iodine can provide clinically useful information. Before and after administration of the medicine, proper hydration of the patient should be ensured, just like when using other contrast media.
Visipaque is intended for intravenous, intra-arterial, and intrathecal use.
The recommended dosage of the medicine is given in the table. The doses for intra-arterial injections refer to a single injection, which can be repeated.

Intravenous administration

Intrathecal administration

• (1)Both concentrations have been studied, but a concentration of 270 mg I/ml is recommended in most cases.
• (2)During urography, a larger dose can be used if necessary.
• (3)To minimize the risk of adverse reactions, the total dose of iodine should not exceed 3.2 g, and symptomatic treatment should be used.

Elderly patients: the same dosage as for other adults.

Use of a higher than recommended dose of Visipaque

In patients with normal renal function, overdose is unlikely.
The examination time is crucial in the case of tolerance of large doses of the contrast medium by the kidneys (the elimination time of the medicine is about 2 hours).
In the event of accidental overdose, water and electrolytes should be supplemented intravenously. Renal function should be monitored for at least 3 subsequent days.
If necessary, iodixanol can be removed from the circulatory system by hemodialysis.
There is no specific antidote for this medicine.

Missed dose of Visipaque

A double dose should not be used to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following are possible side effects that may occur during the radiographic examination, including the use of Visipaque.
Side effects related to the use of Visipaque are usually mild or moderate and transient. Severe side effects, including fatal cases, have been observed very rarely. These included chronic, exacerbated renal failure, acute renal failure, anaphylactic or anaphylactoid shock, cardiac symptoms during hypersensitivity reactions (Kounis syndrome), cardiac arrest or circulatory and respiratory arrest, and myocardial infarction. The occurrence of cardiac symptoms may be contributed to by the underlying disease or the procedure.
Hypersensitivity reactions may occur in the form of respiratory symptoms and skin reactions. They may include dyspnea, rash, flushing, urticaria, itching, and angioedema.
They may occur immediately after administration of the contrast medium or several days later. Severe reactions, such as laryngeal edema, bronchospasm, or pulmonary edema, may occur.
Anaphylactoid reactions may be dose-dependent and may occur regardless of the route of administration. Mild symptoms may be the first sign of severe anaphylactoid reactions or anaphylactoid shock. In this case, administration of the contrast medium should be stopped immediately, and if necessary, intravenous treatment should be started. In patients taking beta-adrenergic receptor blockers, atypical symptoms of anaphylaxis may occur, which may be mistaken for symptoms related to vagus nerve stimulation.
After administration of iodine contrast media, a small, transient increase in serum creatinine is often observed, which usually has no clinical significance.
The frequency of possible side effects related to the use of Visipaque is classified 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);
• not known: (frequency cannot be estimated from the available data).

The frequency of side effects is based on clinical documentation and published study results, involving more than 57,705 patients.

Intravascular administration (intravenous and intra-arterial)

Side effects after administration of iodine contrast media are usually mild or moderate, transient, and less frequent after administration of non-ionic media than after administration of ionic media. Severe side effects, as well as fatal cases, are observed very rarely.
Blood and lymphatic system disorders
Frequency not known: thrombocytopenia.
Immune system disorders
Uncommon: hypersensitivity reactions.
Frequency not known: anaphylactic/anaphylactoid shock, anaphylactic/anaphylactoid reactions, including life-threatening or fatal anaphylaxis.
Endocrine disorders
Frequency not known: hyperthyroidism, transient hypothyroidism.
Psychiatric disorders
Very rare: excitement, anxiety.
Frequency not known: confusion.
Nervous system disorders
Uncommon: headache.
Rare: dizziness, sensory disturbances, including taste disturbances, paresthesia, smell disturbances.
Very rare: stroke, syncope, tremor (transient), hypesthesia. Iodixanol can cross the blood-brain barrier, which allows it to be taken up by the cerebral cortex and is visible on the CT image the next day after the examination. This may cause transient confusion and cortical blindness.
Frequency not known: coma, transient cerebral dysfunction (encephalopathy), which can cause confusion, memory loss, hallucinations, visual disturbances, loss of vision, seizures, loss of coordination, loss of motor function on one side of the body, speech difficulties, and loss of consciousness.
Eye disorders
Very rare: cortical blindness (transient), transient visual disturbances (including double vision, blurred vision), eyelid edema.
Cardiac disorders
Rare: arrhythmia (including bradycardia and tachycardia), myocardial infarction.
Very rare: cardiac arrest, palpitations.
Frequency not known: heart failure, circulatory and respiratory arrest, conduction disorders, hypokinesia of the ventricles, coronary artery thrombosis, angina pectoris, coronary artery spasm.
Vascular disorders
Uncommon: flushing.
Rare: decrease in blood pressure.
Very rare: hypertension, hypoperfusion.
Frequency not known: arterial spasm, thrombosis, thrombophlebitis, shock.
Respiratory, thoracic, and mediastinal disorders
Rare: cough, sneezing.
Very rare: dyspnea, throat irritation, laryngeal edema, pharyngeal edema.
Frequency not known: pulmonary edema, bronchospasm, throat tightness, respiratory arrest, respiratory failure.
Gastrointestinal disorders
Uncommon: nausea, vomiting.
Very rare: discomfort or pain in the abdominal cavity, diarrhea.
Frequency not known: acute pancreatitis, exacerbation of pancreatitis, salivary gland enlargement.
Skin and subcutaneous tissue disorders
Uncommon: rash or drug eruption, itching, urticaria.
Rare: flushing.
Very rare: angioedema, excessive sweating.
Frequency not known: blistering or exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms.
Musculoskeletal and connective tissue disorders
Rare: pain in the peripheral part of a limb.
Very rare: back pain, muscle cramps.
Frequency not known: joint pain.
Renal and urinary disorders
Common: transient increase in creatinine values after administration of iodine contrast media, which usually has no clinical significance.
Uncommon: acute kidney injury or toxic nephropathy (contrast-induced nephropathy, CIN).
Very rare: renal failure, including acute renal failure. Fatal cases have been reported in high-risk patients.
Frequency not known: elevated serum creatinine levels.
General disorders and administration site conditions
Very common: mild sensation of heat and cold, sensation of heat during peripheral angiography.
Uncommon: sensation of heat, chest pain.
Rare: pain, discomfort, chills (shivering), fever, reactions at the injection site, including bruising, sensation of cold.
Very rare: weakness (e.g., fatigue, malaise), facial edema, localized edema.
Frequency not known: swelling.
Injury, poisoning, and procedural complications
Frequency not known: iodism. This syndrome is characterized by swelling and increased tension of the salivary glands, which can last up to 10 days after the examination.
Hypersensitivity reactions
Rare: dyspnea, rash, flushing, urticaria, itching, or angioedema.
Symptoms may occur immediately after administration of the contrast medium or several days later. There may be a decrease in blood pressure and fever.
Rare: acute to toxic skin reactions.
Very rare: severe reactions, such as laryngeal edema, bronchospasm, or pulmonary edema.

Intrathecal administration

Side effects after intrathecal administration may occur with a delay and after several hours or even days after the examination. The frequency of their occurrence is similar to that after diagnostic lumbar puncture.
After administration of other non-ionic contrast media, symptoms of meningeal irritation have been observed, occurring in the form of photophobia, meningeal reaction, and chemical meningitis. The possibility of infectious meningitis should be considered.
Immune system disorders
Frequency not known: hypersensitivity reactions, including anaphylactic or anaphylactoid reactions.
Nervous system disorders
Uncommon: headache (which can be severe and prolonged).
The above side effect can be attributed to the loss of cerebrospinal fluid due to lumbar puncture. In some cases, headaches can last for several days. During lumbar puncture performed during myelography, loss of cerebrospinal fluid should be avoided.
Rare: after administration of other non-ionic iodine contrast media, symptoms of meningeal irritation have been observed, occurring in the form of photophobia or neck stiffness. In case of such symptoms, the possibility of infectious meningitis should also be considered.
Very rare: after administration of other non-ionic iodine contrast media, transient cerebral dysfunction has been observed: seizures, transient confusion, sensory or motor disturbances. In some of these patients, changes in the electroencephalogram (EEG) were observed.
Frequency not known: dizziness, transient cerebral dysfunction (encephalopathy), which can cause confusion, memory loss, hallucinations, visual disturbances, loss of vision, seizures, loss of coordination, loss of motor function on one side of the body, speech difficulties, and loss of consciousness.
Gastrointestinal disorders
Uncommon: vomiting.
Frequency not known: nausea.
Musculoskeletal and connective tissue disorders
Frequency not known: muscle cramps.
General disorders and administration site conditions
Frequency not known: chills, local pain or radicular pain at the lumbar puncture site.

Hysterosalpingography (HSG)

Immune system disorders
Frequency not known: hypersensitivity reactions, including anaphylactic or anaphylactoid reactions.
Nervous system disorders
Uncommon: headache.
Gastrointestinal disorders
Uncommon: vomiting.
Frequency not known: nausea, abdominal pain.
Reproductive system and breast disorders
Very common: vaginal bleeding.
General disorders and administration site conditions
Common: fever.
Frequency not known: chills, local reactions.

Arthrography

Immune system disorders
Frequency not known: hypersensitivity reactions, including anaphylactic or anaphylactoid reactions.
General disorders and administration site conditions
Common: local pain.
Frequency not known: chills, local reactions.

Gastrointestinal tract examination

Immune system disorders
Frequency not known: hypersensitivity reactions, including anaphylactic or anaphylactoid reactions.
Gastrointestinal disorders
Common: diarrhea.
Uncommon: vomiting.
Frequency not known: nausea.
General disorders and administration site conditions
Frequency not known: chills, local reactions.

Reporting of side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Visipaque

Store at a temperature below 25°C.
The medicine can be stored at 37°C for 1 month.
Protect from light and secondary X-ray radiation.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the month stated.
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. Contents of the packaging and other information

What Visipaque contains

• The active substance of the medicine is iodixanol.
• The other ingredients are: trometamol, sodium chloride, calcium chloride, sodium calcium edetate, hydrochloric acid (for pH adjustment), water for injections.

What Visipaque looks like and what the pack contains

Vials and bottles made of colorless glass, closed with black chlorobutyl rubber or grey bromobutyl rubber stoppers or aluminium caps and polypropylene caps, in a cardboard box. Polypropylene bottles (USB), in a cardboard box.
Visipaque (550 mg/ml and 652 mg/ml)is available in glass packaging: 10 vials of 20 ml, 10 bottles of 50 ml, 10 bottles of 100 ml, and 6 bottles of 200 ml.
Visipaque (550 mg/ml)is available in polypropylene packaging: 10 bottles of 50 ml, 10 bottles of 100 ml.
Visipaque (652 mg/ml)is available in polypropylene packaging: 10 bottles of 50 ml, 10 bottles of 100 ml, 10 bottles of 150 ml, 10 bottles of 200 ml, 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
To obtain 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
Phone: + 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

Date of last revision of the leaflet: April 2022