NORCOLESTEROL IODINATED (131 I) CIS BIO INTERNATIONAL 7.5-15 MBq/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Norcholesterol Iodine (131I) Cis Bio International 7.5-15 MBq/ml Injectable Solution

Norcholesterol Iodine (131I)

Read all of this leaflet carefully before this medicine is administered to you because it contains important information for you.

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

Contents of the Package Leaflet

1. What is Norcholesterol Iodine (131I) Cis Bio International and what is it used for
2. What you need to know before using Norcholesterol Iodine (131I) Cis Bio International
3. How to use Norcholesterol Iodine (131I) Cis Bio International
4. Possible side effects
5. Storage of Norcholesterol Iodine (131I) Cis Bio International

Package Contents and Additional Information

1. What is Norcholesterol Iodine (131I) Cis Bio International and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

The active substance is Norcholesterol Iodine (131I).

Norcholesterol Iodine (131I) Cis Bio International is an injectable solution used to explore the function and condition of the adrenal glands, and for the diagnosis of certain types of cancer.

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

2. What you need to know before using Norcholesterol Iodine (131I) Cis Bio International

Norcholesterol Iodine (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 medicine (listed in section 6).
• If you are pregnant or think you may be pregnant.
• If you are breast-feeding.
• In premature infants and newborns under 1 month of age due to the presence of ethanol and benzyl alcohol.

Be especially careful with Norcholesterol Iodine (131I) Cis Bio International:

• If you are allergic, as some cases of allergic reactions have been observed after administration of Norcholesterol Iodine (131I) Cis Bio International.
• If you have excessive aldosterone secretion (hyperaldosteronism) or masculinizing hormones (hyperandrogenism), you should be pre-treated with dexamethasone 7 days before the examination.
• If you are under 18 years of age because radiation exposure is proportionally greater than in adults.

Consult your nuclear medicine doctor before starting to use this medicine if any of the above applies to you. Norcholesterol Iodine (131I) Cis Bio International may not be suitable for you.

Before administration of Norcholesterol Iodine (131I) Cis Bio International, you should:

• Start thyroid gland blockade a few hours before and continue for at least 7 days. Blockade can be done with potassium.
• It may be recommended to administer bisacodyl (a laxative) during the diagnostic examination and image acquisition.
• Drink plenty of water before starting the procedure to urinate frequently during the first hours after completion.

Children and Adolescents

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

Other medicines and Norcholesterol Iodine (131I) Cis Bio International:

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, including those bought 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 by modifying the uptake of this medicine:

• oral contraceptives (medicines that prevent pregnancy)
• inhibitors of adrenal corticosteroid biosynthesis: ketoconazole (treatment of fungal disease), metyrapone (medicine used in the diagnosis of Cushing's syndrome), and mitotane, aminoglutethimide (cancer treatments)
• adrenal corticosteroids, including their synthetic analogs (e.g., dexamethasone) (medicines used to treat inflammation)
• diuretics acting on the adrenal cortex (e.g., spironolactone) (medicines to increase urine production)
• medicines that reduce cholesterol, which should also be discontinued, or if this is not possible, taken into account for correct image interpretation.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before this medicine is administered to you.

You should inform your nuclear medicine doctor before administration of Norcholesterol Iodine (131I) Cis Bio International if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding.

In case of doubt, it is important that you consult your nuclear medicine doctor to supervise the procedure.

If you are pregnant, Norcholesterol Iodine (131I) Cis Bio International is contraindicated in pregnancy as it may harm the unborn baby.

If you are breast-feeding, the examination should be delayed until breast-feeding is stopped. If the examination is necessary, you should switch to artificial feeding.

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

Driving and Using Machines

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

Norcholesterol Iodine (131I) Cis Bio International contains Benzyl Alcohol

This medicine contains 9.4 mg per milliliter of benzyl alcohol.

Benzyl alcohol may cause allergic reactions.

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

Norcholesterol Iodine (131I) Cis Bio International contains Benzyl Alcohol and Ethanol

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

Benzyl alcohol may cause allergic reactions.

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

This medicine contains 80 mg of alcohol (ethanol) in each milliliter of solution. The amount in 1 milliliter of this medicine is equivalent to less than 2 milliliters of beer or 1 milliliter of wine.

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

3. How to use Norcholesterol Iodine (131I) Cis Bio International

There are strict rules on the use, handling, and disposal of radiopharmaceuticals. Norcholesterol Iodine (131I) Cis Bio International will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of Norcholesterol Iodine (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 amount for administration to an adult is 20 MBq, which may be up to 40 MBq (megabecquerel, unit used to express radioactivity).

Use in Children and Adolescents

Except in specific circumstances, the administration of Norcholesterol Iodine (131I) Cis Bio International is contraindicated in newborns and premature infants.

If used in children over 1 month of age, the amount to be administered will be adjusted according to their body weight.

Administration of Norcholesterol Iodine (131I) Cis Bio International and Performance of the Procedure:

Norcholesterol Iodine (131I) Cis Bio International is always administered in a vein and slowly. One 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 administration of the radiopharmaceutical and continuing during the image acquisition period.

Duration of the Procedure

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

After Administration of Norcholesterol Iodine (131I) Cis Bio International, you should:

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

If you are given more Norcholesterol Iodine (131I) Cis Bio International than you should

Overdose is unlikely because you will receive a single dose of Norcholesterol Iodine (131I) Cis Bio International precisely controlled by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive appropriate treatment.

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic defects.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Norcholesterol Iodine (131I) Cis Bio International

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

6. Package Contents and Additional Information

Composition of Norcholesterol Iodine (131I) Cis Bio International

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

Appearance of the Product and Package Contents

You will not need to handle the packaging of Norcholesterol Iodine (131I) Cis Bio International. This medicine is presented as an injectable solution. One vial contains a colorless or yellowish solution, with an activity of 37 to 74 MBq on the calibration date and time.

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)

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

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Phone: 91 4841989

Date of Last Revision of this Leaflet: January 2023

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

This information is intended only for healthcare professionals:

The complete technical specifications of Norcholesterol Iodine (131I) Cis Bio International are provided as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical specifications.