Iodinated norcholesterol (131 I) CIS Bio International 7,5-15 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Norcholesterol iodinated (131I) Cis bio international 7.5-15 MBq/ml solution for injection

Iodinated norcholesterol (131I)

Read the entire leaflet carefully before you are administered this medicine because it contains important information for you.

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

Leaflet contents

1. What Norcholesterol iodinated (131I) Cis bio international is and what it is used for
2. What you need to know before using Norcholesterol iodinated (131I) Cis bio international
3. How to use Norcholesterol iodinated (131I) Cis bio international
4. Possible side effects
5. How to store Norcholesterol iodinated (131I) Cis bio international

Pack contents and other information

1. What Norcholesterol Iodinated (131I) Cis bio international is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

The active substance is Iodinated Norcholesterol (131I).

Norcholesterol Iodinated (131I) Cis bio international is an injectable solution used to assess the function and condition of the adrenal glands, and for the diagnosis of certain types of cancer.

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

2. What you need to know before using Norcholesterol iodinated (131I) Cis bio international

Norcholesterol iodinated (131I) Cis bio international must not be used:

• If you are allergic to the active substance or to any of the other components of this medicinal product (listed in section 6).
• If you are pregnant or think you might be pregnant.
• If you are breastfeeding.
• In premature infants and newborns under 1 month of age due to the presence of ethanol and benzyl alcohol.

Take special care with Norcholesterol iodinated (131I) Cis bio international:

• If you are allergic, as allergic reactions have been observed following administration of Norcholesterol iodinated (131I) Cis bio international.
• If you have excessive aldosterone secretion (hyperaldosteronism) or excessive secretion of masculinizing hormones (hyperandrogenism), pretreatment with dexamethasone should be administered 7 days prior to the examination.
• If you are under 18 years of age, because radiation exposure is proportionally higher than in adults.

Consult your nuclear medicine specialist physician before using this medicinal product if any of the above apply to you. Norcholesterol iodinated (131I) Cis bio international may not be suitable for you.

Before administration of Norcholesterol iodinated (131I) Cis bio international you must:

• Begin blocking your thyroid gland several hours before administration of this medicinal product and continue for at least 7 days thereafter. Thyroid blockade can be achieved using potassium iodide.
• It may be advisable to administer bisacodyl (a laxative) during the duration of the diagnostic examination and image acquisition.
• Drink plenty of water before starting the procedure to ensure frequent urination during the first hours after completion.

Children and adolescents

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

Other medicines and Norcholesterol iodinated (131I) Cis bio international:

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, as some medicines may interfere with image interpretation.

The following medicines should be discontinued at least 48 hours before administration of this product, as they may interact and alter uptake of this medicinal product:

• Oral contraceptives (medicines that prevent pregnancy)
• Inhibitors of adrenal corticosteroid biosynthesis: ketoconazole (used to treat fungal infections), metyrapone (used in the diagnosis of Cushing's syndrome), and mitotane, aminoglutethimide (cancer treatments)
• Adrenal corticosteroids, including their synthetic analogues (e.g., dexamethasone) (medicines used to treat inflammation)
• Diuretics acting at the adrenal cortex level (e.g., spironolactone) (medicines to increase urine production)
• Cholesterol-lowering medicines, which should also be discontinued, or if discontinuation is not possible, this should be taken into account when interpreting images correctly.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicinal product.

You must inform the nuclear medicine physician before administration of Norcholesterol iodinated (131I) Cis bio international if there is any possibility you could be pregnant, if you have missed a period, or if you are breastfeeding.

If in doubt, it is important to consult your nuclear medicine physician so they can supervise the procedure.

If you are pregnant, Norcholesterol iodinated (131I) Cis bio international is contraindicated during pregnancy as it may harm the unborn baby.

If you are breastfeeding, the examination should be postponed until breastfeeding has ended. If the examination is necessary, breastfeeding must be replaced with artificial feeding.

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

Driving and use of machines

No effects on the ability to drive or operate machinery have been reported.

Norcholesterol iodinated (131I) Cis bio international contains benzyl alcohol

This medicinal product contains 9.4 mg of benzyl alcohol per millilitre.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome"), in children, especially in newborns (up to 4 weeks of age).

Norcholesterol iodinated (131I) Cis bio international contains benzyl alcohol and ethanol

This medicinal product contains 9.4 mg of benzyl alcohol per mL of solution.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome"), in children.

This medicinal product contains 80 mg of alcohol (ethanol) per mL of solution. The amount in 1 mL of this medicinal product is equivalent to less than 2 mL of beer or 1 mL of wine.

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

3. How to use Norcholesterol iodinated (131I) Cis bio international

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Norcholesterol iodinated (131I) Cis bio international will be used only in special controlled areas. This product will be handled and administered solely by trained and qualified personnel capable of using it safely. These individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Norcholesterol iodinated (131I) Cis bio international to be used in your case.

This will be the minimum quantity necessary to obtain the required information. The generally recommended dose for administration in adults is 20 MBq, with a possible increase up to 40 MBq (megabecquerel, a unit used to express radioactivity).

Use in children and adolescents

Except under specific circumstances, administration of Norcholesterol iodinated (131I) Cis bio international is contraindicated in newborns and premature infants.

If used in children older than 1 month, the administered dose will be adjusted according to body weight.

Administration of Norcholesterol iodinated (131I) Cis bio international and performance of the procedure:

Norcholesterol iodinated (131I) Cis bio international is always administered intravenously and slowly. A single injection is sufficient to perform the procedure required by your physician. Drink water to urinate immediately before starting the examination.

For specific diagnostic procedures (hyperaldosteronism or hyperandrogenism), administration of dexamethasone may be necessary, starting 7 days before the radiopharmaceutical administration and continuing throughout the image acquisition period.

Duration of the procedure

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

After administration of Norcholesterol iodinated (131I) Cis bio international, you should:

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

If you are administered more Norcholesterol iodinated (131I) Cis bio international than you should receive

An overdose is unlikely, as you will receive a single precisely controlled dose of Norcholesterol iodinated (131I) Cis bio international, administered under the supervision of the nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be given.

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

If you have any further questions about the use of this medicine, ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The following adverse reactions have been reported: anaphylactoid (allergy-like) reactions with sensation of heat, urticaria, nausea, back pain, hypertension, hypotension, chest discomfort, and also potentially severe symptoms such as bronchoconstriction and circulatory collapse. These reactions are usually immediate, but may also occur within 15 minutes after injection.

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

Reactions at the injection site may occur if the medicine deposits outside the blood vessels.

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, carrying a very low risk of developing cancer and hereditary defects.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Norcolesterol iodado (131I) Cis bio international

You will not be required to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations concerning radioactive materials.

6. Contents of the pack and other information

Composition of Norcholesterol iodinated (131I) Cis bio international

• The active substance is Norcholesterol iodinated (131I).
• The other components are ethanol, polysorbate 80, benzyl alcohol, and water for injectable preparations.

Presentation of the product and contents of the pack

You will not have to handle the packaging of Norcholesterol iodinated (131I) Cis bio international. This medicinal product is presented as an injectable solution. A vial contains a colourless or slightly yellow solution, with an activity of 37 to 74 MBq at the date and time of calibration.

Marketing Authorization Holder:

Cis bio international
BP 32 - 91192 Gif sur Yvette Cedex
France

Manufacturer:

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)

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Curium Pharma Spain, S.A.
Avda. Dr. Severo Ochoa, 29
28100 Alcobendas
Tel.: 91 4841989

Date of most recent review of this summary: January 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (http://www.aemps.es)

This information is intended for healthcare professionals only:

The complete Summary of Product Characteristics for Norcholesterol iodinated (131I) Cis bio international is supplied as a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics.