Label: information for the user

SomaKit TOC 40microgram kit for radiopharmaceutical preparation

edotreotide

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 nuclear medicine physician who will oversee the procedure.
• If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this label. See section 4.

1.What SomaKit TOC is and how it is used

2.What you need to know before starting to use SomaKit TOC

3.How to use SomaKit TOC

4.Possible adverse effects

5.Storage of SomaKit TOC

6.Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only. It contains the active ingredient edotreotide. Before it can be used, the powder from the vial is mixed with a radioactive substance called gallium chloride (Ga68) to produce gallium (68Ga)-edotreotide (this process is known as radioactive labeling).

Gallium (68Ga)-edotreotide contains a small amount of radioactivity. After injection into a vein, it allows the doctor to visualize certain body areas during an imaging test called positron emission tomography (PET). Through this medical procedure, images of organs are obtained to help locate abnormal cells or tumors, obtaining valuable information about the disease.

The administration of SomaKit TOC involves receiving small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

Do not use SomaKit TOC

• If you are allergic to edotreotida or any of the other components of this medication (listed in section6).

Warnings and precautions

Before SomaKit TOC is administered to you, talk to the nuclear medicine doctor:

• If you experience any signs of an allergic reaction (listed in section 4) after previous administration of SomaKit TOC;
• If you have kidney or liver problems (renal or hepatic disease);
• If you are under 18 years of age;
• If you show signs of dehydration before and after the examination;
• If you have other conditions, such as high cortisol levels in the body (Cushing's syndrome), inflammation, thyroid disease, another type of tumor (of the pituitary gland, lungs, brain, breast, immune system, thyroid, adrenal glands, or other type) or spleen disease (including previous trauma or surgery affecting the spleen). Such conditions may be visible and affect the interpretation of the images. Therefore, your doctor may perform additional examinations and tests to confirm the findings in the gallium (68Ga)-edotreotida images.
• If you have recently been vaccinated. Inflamed lymph nodes due to vaccination may become visible during gallium (68Ga)-edotreotida imaging;
• If you have taken other medications, such as somatostatin analogs or glucocorticoids, that may interact with SomaKit TOC;
• If you are pregnant or believe you may be pregnant;
• If you are breastfeeding.

Your nuclear medicine doctor will inform you if you need to take any other special precautions before or after using SomaKit TOC.

Before administration of SomaKit TOC

You shoulddrink a lot of water before starting the procedure to urinate very frequently during the first hours after its completion, to ensure that your body eliminates SomaKit TOC as quickly as possible.

Children and adolescents

This medication is not recommended for patients under 18years of age, as its safety and efficacy have not been established in this patient population.

Other medications and SomaKit TOC

Inform your nuclear medicine doctor if you are taking, have recently taken, or may need to take any other medication, including somatostatin analogs or glucocorticoids (also known as corticosteroids), as some medications may interfere with image interpretation. If you are taking somatostatin analogs, you may be asked to suspend treatment for a short period of time.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you believe you may be pregnant, consult your nuclear medicine doctor before using this medication.

You should inform your nuclear medicine doctor before administration of SomaKit TOC if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding.

In case of doubt, it is essential to consult your nuclear medicine doctor who oversees the procedure.

No information is available regarding the safety and efficacy of using this medication during pregnancy. During pregnancy, only essential tests will be performed, when the probable benefit is clearly greater than the possible risks for the mother and fetus.

If you are breastfeeding, your nuclear medicine doctor may postpone the medical procedure until you are no longer breastfeeding or ask you not to breastfeed and discard the milk until the radioactivity has disappeared from your body (12hours after administration of SomaKit TOC).

Consult your nuclear medicine doctor when you can resume breastfeeding.

Driving and operating machinery

It is considered unlikely that SomaKit TOC will affect the ability to drive or operate machinery.

SomaKit TOC contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; this is, essentially “sodium-free”.

There are strict regulations regarding the use, handling, and disposal of radioactive medications. SomaKit TOC will only be used in specially controlled areas. This medication 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 medication and will inform you of their actions.

The nuclear physician overseeing the procedure will decide how much SomaKit TOC to use in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult is 100 MBq to 200 MBq (MegaBecquerel, the unit used to express radioactivity).

Administration of SomaKit TOC and procedure performance

After radioactive labeling, SomaKit TOC is administered via intravenous injection.

A single injection is sufficient to perform the test your doctor requires.

After the injection, you will be offered a drink and asked to urinate immediately before performing the test.

Procedure duration

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

After SomaKit TOC administration, you should:

• avoid close contact with children and pregnant women during the 12 hours after the injection
• urinate frequently to eliminate the medication from your body.

Your nuclear physician will inform you if you need to take any special precautions after receiving this medication. Consult with your nuclear physician if you have any doubts.

If you have been administered more SomaKit TOC than you should

It is unlikely to have an overdose because you will receive a single controlled dose of SomaKit TOC by the nuclear physician overseeing the procedure. However, in case of an overdose, you will receive the appropriate treatment. Drinking and urinating frequently will help you eliminate the radioactive substance from your body more quickly.

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

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

Although no secondary effects have been reported, with SomaKit TOC there is a potential risk of allergic reactions (hypersensitivity). Symptoms may include: hot flashes, skin redness, swelling, itching, nausea, and difficulty breathing. In the event of an allergic reaction, medical staff will provide the appropriate treatment.

Unknown Frequency(cannot be estimated from available data):

• Itching near the injection site

The spleen is an organ located in the abdomen (belly). Some people are born with an additional spleen (an accessory spleen). Additional spleen tissue may also be found in the abdomen after surgery or trauma to the spleen (this is known as esplenosis). Gallium (68Ga)-edotreotide may make an accessory spleen or esplenosis visible during medical imaging. There have been reports where this has been mistaken for a tumor. Therefore, your doctor may perform additional explorations and tests to confirm the results of gallium (68Ga)-edotreotide imaging (see section 2).

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 nuclear medicine doctor, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly throughthe national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored. This medication is 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.

The following information is intended solely for the specialist.

Keep this medication out of sight and reach of children.

Do not use SomaKit TOC after the expiration date that appears on the box. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

Keep in the original packaging to protect it from light.

SomaKit TOC must be used within 4 hours after radioactive marking. Do not store at a temperature above 25°C after radioactive marking.

Do not use SomaKit TOC if you observe signs of deterioration.

Medicines should not be disposed of through drainsor in the trash. Before disposing of a radioactive product, wait for the radioactivity level to decrease adequately. These measures will help protect the environment.

Content of SomaKit TOC

• The active ingredient is edotreotide.Cada vial of powder for injectable solution contains 40micrograms of edotreotide.
• The other components are: 1,10-fenantrolina, gentisic acid, mannitol, formic acid, sodium hydroxide, water for injectable preparations.

After radioactive labeling, the obtained solution also contains hydrochloric acid.

Appearance of SomaKit TOC and packaging contents

SomaKit TOC 40micrograms is a kit for the preparation of radiopharmaceuticals that contains:

• A glass vial with a black easy-open (flip-off) closure containing a white powder.
• A vial of cyclic olefin polymer with a yellow easy-open (flip-off) closure containing a transparent and colorless solution.

The radioactive substance does not form part of the kit and should be added during the preparation steps prior to injection.

Marketing Authorization Holder:

Advanced Accelerator Applications

8-10 Rue Henri Sainte-Claire Deville

92500 Rueil-Malmaison

France

Manufacturer

Advanced Accelerator Applications(Italy)S.r.l.

Via Crescentinosnc,

13040 Saluggia (VC),

Italy

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last update date of this leaflet:

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu

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This information is intended solely for healthcare professionals:

The complete technical dossier of SomaKit TOC is included as a separate document in the packaging of themedication, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the technical dossier.