Label: information for the patient

Norcolesterol iodated (131I) Cis bio international 7.5-15 MBq/ml injectable solution

Norcolesterol iodated (131I)

Read this label carefully before this medication is administered because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who will oversee the procedure.
• If you experience any adverse effects, consult with your nuclear medicine physician, even if they are not listed in this label. See section 4.

Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

The active substance is Iodinated Norcolesterol (131I).

Iodinated Norcolesterol (131I) Cis bio international is an injectable solution used to explore the function and state of the adrenal glands, and for the diagnosis of some types of cancer.

The administration of Iodinated Norcolesterol (131I) Cis bio international involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

Norcolesterol iodado (131I) Cis bio internationalshould not be used:

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.
• In premature and newborn babies under 1 month due to the presence of ethanol and benzyl alcohol.

Be especially careful withNorcolesterol iodado (131I) Cis bio international:

• If you are allergic, because some cases of allergic reactions have been observed after administration of Norcolesterol iodado (131I) Cis bio international.
• If you have excessive aldosterone secretion (hyperaldosteronism) or masculinizing hormones (hyperandrogenism), administer a pre-treatment with dexamethasone 7 days before the examination.
• If you are under 18 years of age because the exposure to radiation is proportionally greater than in adults.

Consult your nuclear medicine specialist before starting to use this medication if any of the above cases apply to you. Norcolesterol iodado (131I) CIS bio international may not be suitable for you.

Before administration of Norcolesterol iodado (131I) Cis bio international you must:

• Before administering this medication, initiate the blockade of your thyroid gland in some hours before and continue for at least 7 days. The blockade can be performed with potassium.
• It may be recommended to administer bisacodyl (a laxative) during the time of the diagnostic examination and image acquisition.
• Drink plenty of water before starting the procedure to urinate very frequently during the first hours after its completion.

Children and adolescents

If you are under 18 years of age, inform your nuclear medicine specialist.

Other medications and Norcolesterol iodado (131I) Cis bio international:

Inform your nuclear medicine specialist if you are taking, have taken recently, or may need to take any other medication, including those acquired without a prescription, as some medications may interfere with the interpretation of images.

You must discontinue the administration of the following medications at least 48 hours before administration of this product, as they may interact and modify the capture of this medication:

• oral contraceptives (medications that prevent pregnancy)
• inhibitors of the biosynthesis of adrenocortical steroids: ketoconazole (treatment of fungal disease), metirapone (medication used in the diagnosis of Cushing's syndrome) and mitotane, aminoglutethimide (cancer treatments)
• adrenocortical steroids, including synthetic analogs (e.g., dexamethasone) (medications used to treat inflammation)
• diuretics active at the adrenal cortex (e.g., spironolactone) (medications to increase urine production)
• medications that reduce cholesterol, so they should also be suppressed, or if this is not possible, take it into account to interpret the images correctly.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your nuclear medicine specialist before this medication is administered.

You must inform your nuclear medicine specialist before administration of Norcolesterol iodado (131I) Cis bio international if there is any possibility of pregnancy, if you have a delayed period, or if you are breastfeeding.

In case of doubt, it is essential to consult your nuclear medicine specialist to supervise the procedure.

If you are pregnant, Norcolesterol iodado (131I) Cis bio international is contraindicated with pregnancy as it may harm the fetus.

If you are breastfeeding, the examination should be postponed until breastfeeding is completed. If the examination is necessary, breastfeeding should be replaced by artificial feeding.

Additionally, you should avoid close contact with your baby for 24 hours after the test.

Driving and using machines

No effects have been described on the ability to drive or use machines.

Norcolesterol iodado (131I) Cis bio international contains benzyl alcohol

This medication contains 9.4 mg per milliliter of benzyl alcohol

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children, especially in newborns (up to 4 weeks of age).

Norcolesterol iodado (131I) Cis bio international contains benzyl alcohol and ethanol

This medication contains 9.4 mg per milliliter of benzyl alcohol in each mL of solution.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children.

This medication contains 80 mg of ethanol in each mL of solution. The amount in 1 mL of this medication is equivalent to less than 2 mL of beer or 1 mL of wine.

The small amount of alcohol contained in this medication does not produce any noticeable effect.

There are strict regulations regarding the use, handling, and disposal of radioactive medications. Norcolesterol iodado (131I) Cis bio international will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear physician overseeing the procedure will decide on the amount of Norcolesterol iodado (131I) Cis bio international to be used in your case.

This will be the minimum amount necessary to obtain the desired information. The generally recommended dose for an adult is 20 MBq, which may reach 40 MBq (megabequerel, the unit used to express radioactivity).

Use in children and adolescents

Except in specific circumstances, the administration of Norcolesterol iodado (131I) Cis bio international is contraindicated in newborns and premature infants.

In the case of using it in children over 1 month old, the dose to be administered will be adjusted according to their body weight.

Administration of Norcolesterol iodado (131I) Cis bio international and procedure performance:

Norcolesterol iodado (131I) Cis bio international is administered through a vein and at a slow pace. A single injection is sufficient to perform the procedure your doctor needs. Drink water to urinate immediately before starting the examination.

For specific diagnostic procedures (hyperaldosteronism or hyperandrogenism), it may be necessary to administer dexamethasone starting 7 days before the administration of the radioactive medication and continuing during the image acquisition period.

Procedure duration

Your nuclear physician will inform you about the usual duration of the procedure.

After the administration of Norcolesterol iodado (131I) Cis bio international, you must:

• urinate frequently during the first hours after the test.
• avoid direct contact with young children and pregnant women during the first 24 hours after the injection.

If you are administered more Norcolesterol iodado (131I) Cis bio international than you should

A overdose is unlikely because you will receive a controlled and precise dose of Norcolesterol iodado (131I) Cis bio international supervised by the nuclear physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

Specifically, the nuclear physician may recommend that you drink plenty of water and may prescribe a laxative to eliminate radioactivity from your body.

If you have any other questions about the use of this medication, ask the nuclear physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse reactions have been reported: anaphylactoid reaction (allergic type) with a sensation of heat, urticaria, nausea, back pain, hypertension, hypotension, chest discomfort, but also severe symptoms such as bronchoconstriction and circulatory collapse. These reactions usually occur immediately, but may also occur 15 minutes after the injection.

In these cases, your doctor will administer antihistamines, corticosteroids, and if necessary, adrenaline.

Reactions may occur at the injection site if a deposit of the medication forms outside the blood vessels.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

You will not need to store this medication. This medication will be stored under the responsibility of the specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

Norcolesterol iodado ( 131 I) Cis bio international

• The active principle is Norcolesterol iodado ( 131 I).
• The other components are ethanol, polisorbato 80, benzyl alcohol, and water for injectable preparations.

Appearance of the product and contents of the packaging

You will not have to handle the packaging of Norcolesterol iodado ( 131 I) Cis bio international. This medication is presented in the form of an injectable solution.

A vial contains a colorless or yellowish solution, with an activity of 37 to 74 MBq on the date and time of calibration.

Holder of the marketing authorization:

Cis bio international

BP 32 - 91192 Gif sur Yvette Cedex

France

Responsible for manufacturing:

CIS bio international

BP 32 - 91192 Gif sur Yvette Cedex

FRANCE

INSTITUTE OF ISOTOPES CO., LTD

Konkoly Thege ut 29-33

H-1121. Budapest (Hungary)

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Tel.: 91 4841989

Date of the last review of this prospectus: January 2023

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

This information is intended solely for healthcare professionals:

The complete technical file of Norcolesterol iodado ( 131 I) Cis bio international is supplied as a separate document in the packaging of the product, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please, consult the technical file.