Visipaque

Package leaflet: 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

Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific patient only. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Visipaque is and what it is 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 pack and other information

1. What Visipaque is and what it is used for

Diagnostic agent intended for use only in diagnostic procedures.
Visipaque is used for cardiovascular angiography, cerebral angiography (conventional),
peripheral arteriography (conventional), abdominal angiography (including DSA – digital subtraction angiography), urography, venography, and 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 ioxaglate or any of the other ingredients of this medicine (listed in section 6);
• if the patient has symptomatic thyrotoxicosis;
• if the patient has had confirmed severe reactions to Visipaque.

Warnings and precautions
Before starting treatment with Visipaque, discuss this with your doctor, pharmacist, or
nurse.
General warnings regarding the use of all non-ionic contrast media
Hypersensitivity reactions
Particular attention is required for patients with a history of allergy, asthma, or adverse
unpredictable reactions to iodinated contrast media.
In such cases, premedication with glucocorticosteroids or H and H receptor-blocking agents
should be considered.
The risk of severe reactions following administration of Visipaque is considered low. However,
iodinated contrast media may trigger anaphylactoid reactions or other hypersensitivity symptoms.
Therefore, necessary medications and equipment for managing such situations should be prepared
in advance. An intravenous cannula or catheter ensuring immediate vascular access should be
maintained throughout the radiological examination.
The possibility of hypersensitivity reactions, including serious, life-threatening, and fatal
anaphylactic or anaphylactoid reactions, must always be considered. Most severe adverse
reactions occur within the first 30 minutes after contrast administration. Delayed hypersensitivity
reactions (occurring 1 hour or later after administration) are also possible.
Patients should be observed for at least 30 minutes after administration of Visipaque.
Patients concurrently taking β-adrenergic receptor-blocking agents may exhibit atypical
hypersensitivity symptoms that could be mistaken for vagus nerve stimulation symptoms.
β-adrenergic receptor-blocking agents may increase susceptibility to bronchospasm after
administration of contrast media in asthmatic patients and may reduce response to adrenaline
treatment.
Coagulopathy
Compared to ionic contrast media, non-ionic agents have less effect on the coagulation system in vitro.
Cases of blood clotting after contact with syringes containing contrast media, including non-ionic
agents, have been reported. Using plastic syringes instead of glass ones reduces the likelihood of
in vitro blood clotting, although it does not eliminate it completely.
Severe, occasionally fatal, thromboembolic complications leading to myocardial infarction and
cerebral stroke have been reported during angiocardiographic procedures using both ionic and
non-ionic contrast media.
Many other factors may contribute to the development of thromboembolic complications, including
procedure duration, catheter and syringe material, severity of underlying disease, and concomitantly
administered medications. Therefore, meticulous adherence to proper angiography technique is
essential, with special attention to proper catheter and guidewire manipulation, use of Y-sites and/or
three-way stopcocks, frequent flushing of the catheter with heparinized saline, and minimizing
procedure duration to reduce the risk of thrombosis or embolism related to the examination.
Immediate access to necessary, advanced life-saving interventions must be ensured.
Special care should be taken for patients suffering from homocystinuria (risk of thromboembolic
complications).
Hydration
Adequate hydration should be ensured before and after administration of the contrast agent.
This is particularly important for patients with leukemia, diabetes, renal dysfunction, as well as
infants, young children, and elderly individuals. Infants (under 1 year of age), especially newborns,
are sensitive to electrolyte imbalances and hemodynamic changes.
Cardiovascular disorders
Particular attention should also be paid to patients with severe heart disease and pulmonary
hypertension. Hemodynamic disturbances and cardiac arrhythmias may occur.
In rare cases, severe, life-threatening reactions or deaths due to cardiovascular disorders such as
cardiac arrest, circulatory and respiratory arrest, and myocardial infarction have been observed.
Central nervous system disorders
Special attention should also be given to patients with acute brain pathologies, history of brain
tumors or epilepsy, due to increased risk of seizures. Alcohol- or drug-dependent individuals also
have a lowered seizure threshold and reduced threshold for neurological reactions. Patients with
acute stroke, acute intracranial hemorrhage, blood-brain barrier disruption, cerebral edema, or
acute demyelination should also be closely monitored.
Transient brain dysfunction, known as encephalopathy, may occur during or shortly after the imaging
procedure. If the patient notices any of the symptoms related to this condition described in section 4,
the doctor should be informed immediately.
Renal function disorders
The main risk factor for contrast-induced nephropathy is pre-existing renal impairment. Diabetes
and the volume of administered iodinated contrast medium are additional predisposing factors for
this condition in patients with existing renal dysfunction. Other predisposing factors include
dehydration, advanced atherosclerosis, reduced renal blood flow, and presence of other potentially
nephrotoxic agents, such as certain medications or extensive surgical procedures.
To prevent acute renal failure following administration of contrast media, special care should also be
provided to patients with pre-existing renal insufficiency and diabetes.
Patients with paraproteinemias (myeloma, Waldenström’s macroglobulinemia) are also at increased
risk.
Preventive measures:

• identification of at-risk groups;
• ensuring adequate hydration; if necessary, intravenous infusion should be initiated before the procedure and maintained until complete elimination of the contrast agent by the kidneys;
• avoiding additional renal burden 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 has been completely eliminated from the body;
• minimizing the dose of contrast agent;
• delaying repeat administration of contrast agent until renal function parameters return to baseline values.

Iodinated contrast media can be administered to patients undergoing hemodialysis, as these agents
are removed during dialysis.
Diabetic patients taking metformin
To avoid lactic acidosis in diabetic patients taking metformin, serum creatinine levels should be
assessed before administering contrast media.
(1) Patients with eGFR ≥ 60 ml/min/1.73 m (stage 1 and 2 of chronic kidney disease) may
continue their prescribed metformin regimen.
(2) Patients with eGFR 30–59 ml/min/1.73 m (stage 3 of chronic kidney disease)

• Patients receiving intravenous contrast agent with eGFR ≥ 45 ml/min/1.73 m may continue their prescribed metformin regimen.
• For patients receiving intra-arterial contrast agent or intravenous contrast agent with eGFR 30–44 ml/min/1.73 m, metformin should be discontinued 48 hours before contrast administration and not restarted until 48 hours after administration, and only after confirming that renal function has not deteriorated.

(3) In patients with eGFR < 30 ml/min/1.73 m (stage 4 and 5 of chronic kidney disease) or with coexisting liver disease or hypoxia, metformin is contraindicated. Iodinated contrast media should not be administered.
(4) In emergency cases involving patients with renal dysfunction or uncertain renal status, the
physician should assess the benefit-risk ratio before administering contrast medium. Metformin
should be discontinued at the time 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 has not changed compared to pre-procedure
levels.
Renal and hepatic function disorders
Special attention should be paid to patients with concomitant severe renal and hepatic dysfunction,
as drug clearance may be significantly prolonged. Patients undergoing dialysis may receive contrast
agents. The timing of contrast administration relative to dialysis is not essential.
Myasthenia
Administration of contrast agent may exacerbate symptoms in patients with myasthenia gravis.
Pheochromocytoma
Caution should be exercised when administering iodinated contrast media to patients with
pheochromocytoma or suspected pheochromocytoma.
Patients with pheochromocytoma undergoing procedures should receive α-receptor blocking agents
before the start of the examination to prevent hypertensive crisis.
Thyroid function disorders
Patients with clinically apparent but undiagnosed hyperthyroidism, patients with subclinical
hyperthyroidism (e.g., with nodular goiter), and patients with functional autonomy (often elderly
patients, particularly from iodine-deficient regions) are at higher risk of acute thyrotoxicosis after
administration of iodinated contrast media. The additional risk should be evaluated before
administering iodinated contrast media to such patients.
In patients suspected of hyperthyroidism, thyroid function tests and/or prophylactic antithyroid
treatment may be considered before contrast administration. Patients at risk should be monitored
for development of thyrotoxicosis in the weeks following injection.
Cases of thyroid function tests showing hypothyroidism or reduced thyroid function have been
reported in adults and children, including infants, after administration of iodinated contrast media.
Some patients required treatment for hypothyroidism.
Thyroid dysfunction may occur in children and adults after administration of Visipaque.
Infants may also be exposed to the drug indirectly via the mother 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 under 3 years of age, as hypothyroidism in early life
may impair motor, hearing, and cognitive development and may require temporary replacement
therapy with T4.
Reported incidence of hypothyroidism in patients under 3 years of age exposed to iodinated contrast
media ranges from 1.3% to 15%, depending on age and dose of contrast agent, with higher frequency
observed in newborns and preterm infants. Newborns may also be exposed to iodinated contrast
media indirectly via the mother during pregnancy. Thyroid function should be evaluated in all
children under 3 years of age after exposure to iodinated contrast media. If hypothyroidism is
detected, treatment should be considered and thyroid function monitored until normalization.
Extravasation of Visipaque
Effects of accidental extravasation of Visipaque have not been described. The product is isotonic and
appears to cause less pain and swelling than accidental extravasation of hyperosmolar agents.
If accidental extravasation occurs, cooling and elevation of the limb are recommended. Surgical
decompression may be necessary if compartment syndrome develops.
Duration of patient observation after Visipaque administration
After administration of contrast medium, the patient should be observed for at least 30 minutes,
since most adverse reactions occur within this period. Experience indicates that delayed
hypersensitivity reactions may also occur, appearing several hours or days after administration.
Administration into the spinal canal
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. Outpatient patients should not be left
unattended for 12 to 24 hours.
Hysterosalpingography
Hysterosalpingography should not be performed in pregnant women or in women with acute
pelvic inflammatory disease (PID).
Visipaque and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned
for future use.
All iodinated contrast media may interfere with thyroid function tests. Therefore, thyroid iodine
uptake capacity may be reduced for several weeks after the examination.
High concentrations of contrast medium in serum and urine may affect laboratory test results,
including bilirubin, protein, and inorganic substances such as iron, copper, calcium, and phosphates.
Therefore, concentrations of these substances should not be measured on the day of radiological
examination.
Administration of iodinated contrast media may cause transient renal dysfunction, potentially
leading to lactic acidosis in diabetic patients taking metformin.
Patients who have received interleukin-2 less than 2 weeks before an iodinated contrast medium
examination have an increased risk of delayed reactions such as skin reactions and flu-like symptoms.
Evidence suggests that β-adrenergic receptor-blocking agents constitute a risk factor for
anaphylactoid reactions after administration of contrast media used in radiodiagnosis (cases of
acute hypertension after contrast administration in patients taking β-blockers have been observed).
Pregnancy and breastfeeding
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 Visipaque in pregnant women.
Animal studies do not indicate direct or indirect harmful effects on reproduction, embryo or fetal
development, pregnancy course, or perinatal and postnatal development.
Animal reproductive studies do not always predict human response; therefore, the product should
be used in pregnant women only if clearly necessary.
Since exposure to X-ray radiation should be avoided in pregnant women whenever possible, the
benefits of radiological examination, with or without contrast medium, should be weighed against
potential risks.
Visipaque should not be used in pregnant women unless benefits outweigh risks and the physician
considers the examination necessary.
Newborns exposed to iodinated contrast media 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.
Driving and operating machinery
No studies have been conducted on the effect of the medicine on the ability to drive and operate
machinery. However, driving and operating machinery are not recommended within 24 hours
after intravascular administration of the medicine.
Administration into the spinal canal may affect the ability to drive.
The risk of severe reactions after administration of Visipaque is considered low. However, iodinated
contrast media may trigger anaphylactic or other hypersensitivity reactions.
Visipaque contains sodium
Visipaque (550 mg/ml) contains 0.76 mg of sodium (main component of table salt) in each
millilitre of solution. This corresponds to 0.038% of the maximum recommended daily sodium intake
in the diet of adults.
Visipaque (652 mg/ml) contains 0.45 mg of sodium (main component of table salt) in each
millilitre of solution. This corresponds to 0.023% of the maximum recommended daily sodium intake
in the diet of adults.

3. How to use Visipaque

This medicine should always be used exactly as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
The dosage 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; however, in certain types of examinations,
clinically useful information may be obtained using slightly lower iodine concentrations.
Adequate patient hydration must be ensured both before and after administration of the medicine, as is necessary
with other contrast agents.
Visipaque is intended for intravenous, intra-arterial, and intracavitary use.
The table below provides recommended dosages. Intra-arterial doses refer to a single injection,
which may be repeated.
Intra-arterial administration

Intravenous administration

Administration into the spinal canal

(1) Both concentrations have been studied, but the 270 mg I/ml concentration is recommended in most cases.
(2) During urography, a higher dose may be used when required.
(3) To reduce the risk of adverse effects, the administered total dose of the drug should not exceed 3.2 g of iodine; symptomatic treatment should be applied.
Elderly patients: dosage as for other adults.
Use of a higher than recommended dose of Visipaque
In patients with normal renal function, overdose is unlikely.
The duration of the examination is crucial regarding kidney tolerance to high doses of the agent (elimination half-life of the drug is approximately 2 hours).
In case of accidental overdose, water and electrolytes should be replenished via intravenous infusion. Renal function should be monitored for at least the following 3 days.
If necessary, ioxilan can be removed from the systemic circulation by hemodialysis.
There is no specific antidote for this medicinal product.
Missed dose of Visipaque
Do not use a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicinal product, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following are possible adverse reactions that may occur during radiographic examination, including when using Visipaque.
Adverse reactions associated with the use of Visipaque are usually mild or moderate and transient. Severe adverse reactions, 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 arrest of circulation and respiration, and myocardial infarction. Underlying disease or the procedure itself may contribute to the occurrence of cardiac reactions.
Hypersensitivity reactions may present as respiratory symptoms and/or skin reactions. These may include dyspnea, rash, erythema, urticaria, pruritus, severe skin reactions, angioedema, hypotension, fever, laryngeal edema, bronchospasm, or pulmonary edema. In patients with autoimmune diseases, cases of vasculitis and symptoms resembling Stevens-Johnson syndrome have been observed.
These reactions may occur immediately after administration of the contrast agent or several days later.
Hypersensitivity reactions may occur regardless of dose or route of administration. Mild symptoms may be the first sign of severe anaphylactoid reactions or anaphylactoid shock. In such cases, administration of the contrast agent should be stopped immediately and appropriate intravenous treatment initiated if necessary. In patients receiving β-adrenergic receptor blocking agents, atypical symptoms of hypersensitivity reactions may occur, which may be confused with symptoms related to vagus nerve stimulation.
A small, transient increase in serum creatinine concentration is frequently observed after administration of iodinated contrast agents, which is usually not clinically significant.
The frequency of possible adverse reactions associated with the use of Visipaque is classified as follows:

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

Frequencies of adverse reactions are based on clinical documentation and published study results involving more than 57,705 patients.
Intravascular administration (intravenous and intra-arterial)
Adverse reactions after administration of iodinated contrast agents are usually mild or moderate, transient, and less frequent with non-ionic agents than with ionic agents. Severe adverse reactions, including fatal cases, are observed very rarely.
Blood and lymphatic system disorders
Unknown frequency: thrombocytopenia.
Immune system disorders
Uncommon: hypersensitivity reactions.
Unknown frequency: anaphylactic/anaphylactoid shock, anaphylactic/anaphylactoid reactions, including life-threatening or fatal anaphylaxis.
Endocrine disorders
Unknown frequency: hyperthyroidism, transient hypothyroidism.
Psychiatric disorders
Very rare: restlessness, anxiety.
Unknown frequency: confusion.
Nervous system disorders
Uncommon: headache.
Rare: dizziness, sensory disturbances, including taste disturbances, paresthesia, smell disturbances.
Very rare: cerebral stroke, fainting, transient tremor, hypoesthesia. Iodixanol may cross the blood-brain barrier, allowing uptake by the cerebral cortex, visible on CT images the day after the examination. This may cause transient confusion and cortical blindness.
Unknown frequency: coma, transient brain dysfunction (encephalopathy), which may cause confusion, memory loss, hallucinations, visual disturbances, loss of vision, seizures, loss of coordination, hemiplegia, 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.
Unknown frequency: heart failure, arrest of circulation and respiration, cardiac conduction disorders, ventricular hypokinesis, coronary artery thrombosis, angina pectoris, coronary artery spasm.
Vascular disorders
Uncommon: hot flushes.
Rare: decrease in blood pressure.
Very rare: hypertension, ischemia.
Unknown frequency: arterial spasm, thrombosis, thrombophlebitis, shock.
Respiratory, thoracic and mediastinal disorders
Rare: cough, sneezing.
Very rare: dyspnea, throat irritation, laryngeal edema, pharyngeal edema.
Unknown frequency: pulmonary edema, bronchospasm, throat tightness, respiratory arrest, respiratory failure.
Gastrointestinal disorders
Uncommon: nausea, vomiting.
Very rare: discomfort or abdominal pain, diarrhea.
Unknown frequency: acute pancreatitis, exacerbation of pancreatitis, salivary gland enlargement.
Skin and subcutaneous tissue disorders
Uncommon: rash or drug eruption, pruritus, urticaria.
Rare: erythema.
Very rare: angioedema, excessive sweating.
Unknown frequency: bullous or exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS).
Musculoskeletal and connective tissue disorders
Rare: pain in the peripheral part of the limb.
Very rare: back pain, muscle cramps.
Unknown frequency: joint pain.
Renal and urinary disorders
Common: transient increase in creatinine values after administration of iodinated contrast agents, usually not clinically significant.
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.
Unknown frequency: elevated blood creatinine levels.
General disorders and administration site conditions
Very common: mild sensation of warmth 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 petechiae, sensation of cold.
Very rare: weakness (e.g., fatigue, malaise), facial swelling, localized swelling.
Unknown frequency: edema.
Injury, poisoning and procedural complications
Unknown frequency: iodism. This syndrome is characterized by swelling and increased tension of the salivary glands, lasting up to 10 days after the examination.
Hypersensitivity-type reactions
Rare: dyspnea, rash, erythema, urticaria, pruritus, or angioedema.
Symptoms may occur immediately after administration of the agent or several days later. Hypotension and fever may occur.
Rare: acute to toxic skin reactions.
Very rare: severe reactions such as laryngeal edema, bronchospasm, pulmonary edema.
Anaphylactoid reactions
May be dose- and route-dependent. Mild symptoms may be the first sign of a possible acute reaction. Administration of the agent should be stopped immediately and treatment initiated via an established intravenous cannula. In patients receiving β-adrenergic receptor blockers, atypical anaphylaxis symptoms may occur, which may be confused with parasympathetic nervous system symptoms.
Intrathecal administration
Adverse reactions after intrathecal administration may be delayed and occur hours or even days after completion of the examination. Their frequency is similar to that after diagnostic lumbar puncture.
After administration of other non-ionic contrast agents, symptoms of irritation of the meninges have been observed, presenting as photophobia, meningeal reaction, or chemical meningitis. The possibility of infectious meningitis should also be considered.
Immune system disorders
Unknown frequency: hypersensitivity reactions, including anaphylactic or anaphylactoid reactions.
Nervous system disorders
Uncommon: headache (may be severe and prolonged).
This adverse reaction may be attributed to loss of fluid from the subarachnoid space due to lumbar puncture. In some cases, headaches may persist for several days. During lumbar puncture performed as part of a myelographic examination, loss of cerebrospinal fluid should be avoided.
Rare: after administration of other non-ionic iodinated contrast agents, symptoms of irritation of the meninges have been observed, presenting as photophobia or neck stiffness. In case such symptoms occur, infectious meningitis should also be considered.
Very rare: after administration of other non-ionic iodinated contrast agents, transient brain dysfunction has been observed: seizures, transient confusion, sensory or motor disturbances. In some of these patients, changes in electroencephalogram (EEG) recordings have been noted.
Unknown frequency: dizziness, transient brain dysfunction (encephalopathy), which may cause confusion, memory loss, hallucinations, visual disturbances, loss of vision, seizures, loss of coordination, hemiplegia, speech difficulties, and loss of consciousness.
Gastrointestinal disorders
Uncommon: vomiting.
Unknown frequency: nausea.
Musculoskeletal and connective tissue disorders
Unknown frequency: muscle cramps.
General disorders and administration site conditions
Unknown frequency: chills, local pain, or radicular-type pain at the lumbar puncture site.
Hysterosalpingography (HSG)
Immune system disorders
Unknown frequency: hypersensitivity reactions, including anaphylactic/anaphylactoid reactions.
Nervous system disorders
Uncommon: headache.
Gastrointestinal disorders
Uncommon: vomiting.
Unknown frequency: nausea, abdominal pain.
Reproductive system and breast disorders
Very common: vaginal bleeding.
General disorders and administration site conditions
Common: fever.
Unknown frequency: chills, local reactions.
Arthrography
Immune system disorders
Unknown frequency: hypersensitivity reactions, including anaphylactic or anaphylactoid reactions.
General disorders and administration site conditions
Common: local pain.
Unknown frequency: chills, local reactions.
Examination of the gastrointestinal tract
Immune system disorders
Unknown frequency: hypersensitivity reactions, including anaphylactic or anaphylactoid reactions.
Gastrointestinal disorders
Common: diarrhea.
Uncommon: vomiting.
Unknown frequency: nausea.
General disorders and administration site conditions
Unknown frequency: chills, local reactions.
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 Reactions of Medicinal Products
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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Visipaque

Store below 25°C.
The medicine can be stored at 37°C for one month.
Protect from light and secondary X-ray radiation.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures will help protect the environment.

6. Contents of the package and other information

What Visipaque contains

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

What Visipaque looks like and contents of the pack
Vials and bottles made of colorless glass, closed with stoppers of black chlorobutyl rubber or grey bromobutyl rubber, or with aluminum seals and polypropylene caps, packed in a cardboard box. Polypropylene bottles (USB), packed 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 AS
Nycoveien 1
0485 Oslo
Norway

For further information, 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 AS
Nycoveien 1
0485 Oslo
Norway
GE Healthcare Ireland Limited
IDA Business Park
Carrigtohill,
Co. Cork,
Ireland