Label: information for the user

XENETIX 300 mg Iodo/ml injectable solution

XENETIX 350 mg Iodo/ml injectable solution

Iobitridol

Read this label carefully before starting to use this medication, as it contains important information for you.

- Keep this label, as you may need to refer to it again.

If you have any questions, consult your doctor or pharmacist.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Contents of the package and additional information

XENETIX is an iodinated radiographic contrast medium (opacity properties), water-soluble, non-ionic, low osmolality, for radiological examinations of the kidneys and renal pathways (urography), the entire body and brain (tomography), the heart (angiocardiography), venous blood vessels (angiography) or arterial (arteriography) and the breasts (mammography with contrast).

This medication is solely for diagnostic use.

No use Xenetix:

• If you have had a severe skin eruption or skin peeling, blisters, or mouth sores after receiving Xenetix.
• If you are allergic to the active ingredient (iobitridol) or any of the other components of this medication (listed in section 6).
• If you have had a severe cutaneous allergic reaction, immediate or delayed, when you were administered XENETIX in previous examinations (see section4. Possible Adverse Effects)
• If you have hyperthyroidism (manifest thyrotoxicosis).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use XENETIX.

Like all iodinated contrast media, regardless of the route of administration and dose, all iodinated contrast media can induce mild, severe, or even fatal reactions. These reactions can occur within the first hour or, less frequently, within 7 days after administration. These reactions are unpredictable and more frequent if you have already experienced a reaction after receiving an iodinated contrast medium (see section4. Possible effects Adverse). Therefore, you must inform the radiologist performing the examination if you have had an allergic reaction during a previous examination with an iodinated contrast medium.

Inform your doctor performing the examination if you have any disease so that he can take all necessary precautions, especially:

• If you have had previous reactions to an iodinated contrast medium during an examination.
• If you have had a severe skin eruption or skin peeling, blisters, or mouth sores after receiving Xenetix or another iodinated contrast medium.
• If you have kidney insufficiency (kidney function alteration) or diabetes or if you are undergoing dialysis, as iodinated contrast media can induce a transient alteration of renal function or worsen pre-existing renal insufficiency.
• If you have both renal and hepatic insufficiency (liver function alteration), as it increases the risk of contrast retention.
• If you are asthmatic and/or have had an asthma attack within 8 days prior to the examination, as it increases the risk of bronchospasm (involuntary contraction of the bronchial muscles).
• If you have a thyroid disorder or a history of thyroid disease, as it may exacerbate hyperthyroidism or develop hypothyroidism. Inform your doctor equally if you are to undergo a subsequent thyroid examination or treatment with radioactive iodine.
• If you have heart failure (heart function alteration), coronary insufficiency, or any other severe cardiovascular disease, as the risk of certain adverse reactions increases.
• If you have neurological disorders, cerebral edema, recent history of intracranial hemorrhage, acute cerebral infarction, transient ischemic attacks, epilepsy, or if you are addicted to alcohol or medications, as the benefit/risk of undergoing the test must be evaluated.
• If you have pheochromocytoma (elevated hormone secretion causing severe hypertension), you must be monitored to prevent the development of a hypertensive crisis.
• If you have myasthenia gravis (autoimmune muscle disease), as symptoms may worsen.
• If you feel anxious, agitated, or have fear of the examination, do not hesitate to inform your doctor, as in these situations, possible adverse effects may be intensified.
• If you have pancreatic disease (acute pancreatitis).
• If you have bone marrow disease (monoclonal gammopathy, multiple myeloma, or Waldenström macroglobulinemia)

Be especially careful with Xenetix

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (Lyell syndrome or NET), and acute exanthematous pustulosis (PEGA) that can be fatal, have been reported with the use of Xenetix.

Children

Thyroid disorders may be observed after administration of Xenetix. Special attention should be paid to newborns, including those whose mother received Xenetix during pregnancy, and premature and young children. Doctors should check the thyroid function of the child.

Use of XENETIX with other medications

Please inform your doctor or pharmacist if you have any other disease or:

• If you are taking Metformin (diabetes medication), as lactic acidosis may occur.
• If you are taking beta-blockers, vasodilators, ACE inhibitors, or angiotensin receptor antagonists, as these medications reduce the cardiovascular compensation mechanism that activates when a hemodynamic disorder occurs.
• If you are being treated with diuretics, as there is a risk of dehydration and the doctor should proceed with saline rehydration before administering the contrast.
• If you have recently received interleukin-2 intravenously, as it increases the risk of developing a reaction to contrast media.
• If you are to undergo tests with radioactive drugs in which iodine may interfere.
• If you are to undergo blood or urine tests.
• If you are taking or have taken recently or may need to take other medications, although they do not require a prescription, inform your doctor or pharmacist.

Use of XENETIX with food, drinks, and alcohol

Ask your doctor or pharmacist if you need to abstain from eating or drinking before the examination.

Inform your doctor if you consume large amounts of alcohol (see section 2. Warnings and Precautions).

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or have missed your menstrual period, inform your doctor before the radiological examination.

Exposure to X-rays during pregnancy should be avoided, although it may be justified after a careful evaluation by your doctor, considering the benefit that is expected to be obtained from the examination against the risk it implies.

Consult your doctor or pharmacist before taking a medication.

If this medication is administered to a woman during pregnancy, or to a newborn, the doctor should check the thyroid function of the newborn, as they may have temporarily lower activity of this gland (hypothyroidism).

Breastfeeding

It is recommended to suspend breastfeeding for at least 24 hours after administration of the iodinated contrast agent.

Consult your doctor or pharmacist before taking a medication.

Driving and operating machinery

No effect of this medication on the ability to drive vehicles and use machines is known.

If you do not feel well after the examination, you should not drive or use machines.

XENETIX contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 100 ml, so it is considered essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

The recommended doses must be adapted to the examination and territories to be opacified, as well as the patient's weight and renal function, especially in children.

Your doctor will determine the injected dose, which may vary depending on the type of examination, the technique used, your weight, cardiac performance, and overall health.

Xenetix is an injectable solution. The product must be administered via intravenous or intraarterial route.

If more XENETIX than prescribed is used

Iobitridol is primarily eliminated through the renal route, without modification. Iobitridol is dialyzable.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20.

Like all medicines, XENETIX can cause side effects, although not everyone will experience them.

Most side effects occur during the injection or in the first hour after administration. Some effects may occur after several days of the Xenetix injection.

Xenetix side effects are generally mild or moderate and temporary.

There is a small risk that rare allergic reactions may occur, which can be severe and, exceptionally, cause shock (In very rare cases, an allergic reaction can put your life in danger).

Any of the following symptoms may be the first signs of shock. Immediately report to your doctor or healthcare professional if you have any of them:

• Swelling of the face, mouth, or throat that may cause difficulty swallowing or breathing

• Low blood pressure (hypotension)

• Difficulty breathing

• Labored breathing

• Coughing

• Itching

• Swelling of the nasal passages (rhinitis)

• Runny nose

• Redness of the skin

• Itching (localized or widespread urticaria)

• Urticaria

• Severe and intense skin rash with blisters all over the body (Stevens-Johnson syndrome or Lyell syndrome), red, scaly, and widespread rash with blisters under the skin and accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis) or generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and alteration of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See section 2).
• Effects on the heart and blood vessels: low blood pressure (hypotension), dizziness, vertigo, discomfort, heart rhythm disturbances, blue skin discoloration due to low oxygen levels in the blood (cyanosis), cardiac arrest.

The side effects described with Xenetix are as follows:

• Uncommon (may affect up to 1 in 100 people): nausea and sensation of heat

• Rare (may affect up to 1 in 1,000 people) swelling of several parts of the body, including the face, throat, low blood pressure (hypotension), high blood pressure, difficulty breathing, labored breathing, coughing, runny nose, eye irritation, dizziness (sensation of dizziness or vertigo), discomfort (sensation of discomfort or indisposition), vomiting, heart rhythm disturbances (tachycardia), urticaria (intense redness and itching of the skin), other skin reactions, pain at the injection site, chills, tremors, presyncope (dizziness), paresthesia (sensation of pinpricks and tingling in a limb).

• Very rare (may affect up to 1 in 10,000 people): thyroid disorders, coma*, convulsions*, confusion*, visual disturbances*, memory loss*, photophobia* (fear of light), transient blindness*, drowsiness*, agitation*, sensation of agitation*, headache, hearing difficulties, cardiac arrest, elevated creatinine levels in the blood, heart rhythm disturbances, angina or cardiac arrest (severe chest pain radiating to the left arm), heart and blood vessel dysfunction, infarction, abdominal pain, renal impairment, difficulty breathing caused by airway or lung congestion, throat swelling, eczema, severe skin allergic reaction including blisters.

If Xenetix is accidentally injected outside the vein, it may cause pain at the injection site with swelling, inflammation, and local redness or necrosis (tissue degeneration), abnormal heartbeats (torsades de pointes), transient discomfort or pain caused by transient spasm of one or more coronary arteries of the heart.

• Unknown frequency (cannot be estimated from available data): transient neonatal hypothyroidism, hypothyroidism*, dizziness in cases of hypersensitivity, blue skin discoloration due to low oxygen levels in the blood (cyanosis).

Additional side effects in children

* Cases of transient low thyroid gland activity (hypothyroidism) have been described in young children after exposure to similar iodinated contrast media.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:

www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle or bag after CAD. The expiration date is the last day of the month indicated.

Store protected from light.

For presentations in bottles, do not store at a temperature above30 °C. However, stability tests have shown that the product can be stored at temperatures below35 °C.

Do not use Xenetix after the expiration date indicated on the packaging.

Do not use this medication if you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the materials that you no longer need. In this way, you will help protect the environment.

Composition of XENETIX

-The active ingredient is: iobitridol

XENETIX 300mg Iodo/ml injectable solution

1 ml of injectable solution contains 658.1mg of iobitridol/ml, which is equivalent to 300mg of iodine.

100 ml of injectable solution contains65.81 gof iobitridol, which is equivalent to30 gof iodine

XENETIX 350mg Iodo/ml injectable solution

1 ml of injectable solution contains 767.8mg of iobitridol/ml, which is equivalent to 350mg of iodine.

100 ml of injectable solution contains76.78 gof iobitridol, which is equivalent to35 gof iodine

• The other components are: calcium and sodium EDTA, trometamol, trometamol hydrochloride, sodium hydroxide or hydrochloric acid (to adjust the pH), nitrogen and water for injections.

Appearance of the product and contents of the package

XENETIX is an iodinated radiological contrast medium (opacity properties), water-soluble, non-ionic, low osmolality, for radiological examinations.

XENETIX injectable solution is a clear, colorless or light yellow solution that contains iodine.

Package sizes :

XENETIX 300 mg Iodo/ml injectable solution is presented in vials of 50, 100 (single-dose) and 500 ml (multi-dose)or polypropylene bags of 100, 150, 200 (single-dose) and 500 ml (multi-dose).

XENETIX 350 mg Iodo/ml injectable solution is presented in vials of 50, 100, 150, 200 (single-dose) and 500 ml (multi-dose) or polypropylene bags of 100, 150, 200 (single-dose) and 500 ml (multi-dose).

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Guerbet

BP 57400

95943ROISSY CDG Cedex - France

Local representative of the holder:

Laboratorios Farmacéuticos Guerbet, S.A.

Pº de la Castellana, 91, 3ª planta

28046 Madrid

+ (34) 91 504 50 00

Last review date of this leaflet: March 2023

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/ .

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This information is intended solely for healthcare professionals:

Instructions for filling the syringes of the injector:Use a specific transfer or filling equipment, as well as suitable disposable material, and dispose of it when necessary, strictly following the instructions of its manufacturer.

Specific precautions for the use of 500 ml containers:It is recommended that the contrast medium be extracted after piercing the cap with an appropriate device. Follow the usage instructions provided by the manufacturer of all disposable materials. At the end of the day, any unused or excess product should be disposed of in accordance with local legislation.

Instructions for administration if single-dose vials are used:

- The product must be introduced into the syringe immediately before use.

- After disinfecting the cap, the solution must be extracted through the cap using a single-use syringe and sterile single-use needles.

- Any amount of contrast medium not used that remains in the single-dose vial must

be discarded after each examination.

Instructions for administration if multi-dose vials are used:

- Multi-dose vials should only be used connected to autoinjectors/pumps.

- Autoinjectors/pumps should not be used in small children.

- A single perforation should be made.

- The connection line can only be maintained for a working day ( 8 hours) if the usage instructions allow it and after each patient, the connection line to the patient should be changed following the usage instructions of the manufacturer .

- The excess contrast medium remaining in the vial, as well as the connection tubes and all disposable elements of the injection system, must be discarded at the end of the working day.

- It is essential to strictly follow the additional instructions provided by the manufacturer of the autoinjector/pump as well as the disposable elements.