Somakit Toc

Package leaflet: Information for the user

SomaKit TOC 40 micrograms radiopharmaceutical preparation kit

edotreotide
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the supervising nuclear medicine physician.
• If you experience any adverse reactions, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet

1. What SomaKit TOC is and what it is used for
2. What you need to know before using SomaKit TOC
3. How to use SomaKit TOC
4. Possible side effects
5. How to store SomaKit TOC
6. Contents of the pack and other information

1. What SomaKit TOC is and what it is used for

This medicinal product is a radiopharmaceutical intended solely for diagnostic use. It contains the active substance edotreotide.
Before use, the powder in the vial is mixed with a radioactive substance called gallium (⁶⁸Ga) chloride to obtain gallium (⁶⁸Ga) edotreotide (this process is known as radiolabelling).
Gallium (⁶⁸Ga) edotreotide contains a small amount of radioactivity. After being injected into a vein, this medicinal product enables the physician to visualize certain parts of the body during an imaging procedure known as positron emission tomography (PET). This medical procedure provides images of your organs that help locate abnormal or tumour cells, supplying important information about your disease.
The use of SomaKit TOC involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine physician have determined that the benefits derived from the radiopharmaceutical procedure outweigh the risks associated with radiation exposure.

2. What you need to know before using SomaKit TOC

SomaKit TOC must not be used

• if you are allergic to edotreotide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to the nuclear medicine physician before receiving SomaKit TOC:

• if you have experienced any signs of an allergic reaction (listed in section 4) after a previous administration of SomaKit TOC;
• if you have kidney or liver problems (kidney or liver disease);
• if you are under 18 years of age;
• if you show signs of dehydration before or after the examination;
• if you have other medical conditions, such as high cortisol levels (Cushing's syndrome), inflammation, thyroid diseases, other types of tumors (in the pituitary, lungs, brain, breast, immune system, thyroid, adrenal glands, or other areas), or spleen disorders (including prior trauma or surgery involving the spleen). These conditions may be visible and may affect the interpretation of images. Therefore, the physician may perform additional scans and tests to confirm the results of gallium (⁶⁸Ga) edotreotide imaging;
• if you have recently been vaccinated. Enlarged lymph nodes due to vaccination may become visible during gallium (⁶⁸Ga) edotreotide imaging;
• if you are taking other medicines, such as somatostatin analogs and glucocorticoids, which may interact with SomaKit TOC;
• if you are pregnant or suspect you may be pregnant;
• if you are breastfeeding.

The nuclear medicine physician will inform you if any specific precautions are required before or after using SomaKit TOC.
Before administration of SomaKit TOC
You should drink plenty of water before starting the examination. This will make you urinate frequently during the first few hours after the procedure, allowing faster elimination of SomaKit TOC from your body.
Children and adolescents
This medicine is not recommended for patients under 18 years of age, as safety and efficacy have not been established in this patient population.
Other medicines and SomaKit TOC
Inform the nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, including somatostatin analogs or glucocorticoids (also known as corticosteroids), as they may interfere with image interpretation. If you are taking a somatostatin analog, you may be asked to temporarily discontinue therapy.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult the nuclear medicine physician before administration of this medicine.
If there is a possibility you are pregnant, if you have missed a menstrual period, or if you are breastfeeding, inform the nuclear medicine physician before administration of SomaKit TOC.
In case of doubt, it is important to consult the nuclear medicine physician responsible for the procedure.
There is no available information on the safety and efficacy of this medicine during pregnancy. During pregnancy, diagnostic procedures should only be performed when strictly necessary and only when the potential benefit clearly outweighs the risk to the mother and fetus associated with the procedure.
If you are breastfeeding, the nuclear medicine physician may delay the procedure until after the breastfeeding period ends, or may ask you to stop breastfeeding and discard all breast milk produced until all radioactivity has been eliminated from your body (12 hours after administration of SomaKit TOC).
Ask the nuclear medicine physician when you can resume breastfeeding.
Driving and using machines
SomaKit TOC is unlikely to affect your ability to drive or use machines.
SomaKit TOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to use SomaKit TOC

Laws regarding the use, handling, and disposal of radiopharmaceuticals are very strict. SomaKit TOC
will only be used in specially controlled areas. This medicinal product will be handled and administered
only by personnel specifically trained and qualified to use it safely. These individuals will pay particular attention to using this medicinal product safely and will inform you about the measures taken.
The nuclear medicine physician responsible for the procedure will determine the amount of SomaKit
TOC to be used in your case. You will be given the minimum quantity necessary to obtain the required information.
The usual recommended administered amount for an adult ranges from 100 MBq to 200 MBq
(megabecquerel, the unit of measurement used to express radioactivity).

Administration of SomaKit TOC and conduct of the procedure
After labelling, SomaKit TOC is administered by intravenous injection.
A single injection is sufficient to perform the test required by the physician.
After the injection, you will be offered something to drink and will be asked to urinate immediately before the test.

Duration of the procedure
The nuclear medicine physician will inform you about the expected duration of the procedure.

After administration of SomaKit TOC, you must:

• avoid close contact with young children and pregnant women for 12 hours after the injection
• urinate frequently to eliminate the medicinal product from your body.

The nuclear medicine physician will inform you if any specific precautions are required after receiving this medicinal product. For any questions, please contact the nuclear medicine physician.

If you have been given more SomaKit TOC than you should have
Since you will receive only a single dose under controlled conditions by the nuclear medicine physician responsible for the procedure, the likelihood of an overdose is very low. However, in the event of an overdose, appropriate treatment will be given. Drinking fluids and emptying the bladder frequently will help remove the radioactive substance from the body more quickly.

If you have any further questions about the use of SomaKit TOC, please consult the nuclear medicine physician responsible for the procedure.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everyone gets them.
Although allergic reactions (hypersensitivity) due to SomaKit TOC have not been reported, there is still a potential risk. Symptoms may include: hot flushes, skin redness, swelling, itching, nausea, and breathing difficulties. In case of allergic reactions, medical staff will provide appropriate treatment.
Not known (frequency cannot be estimated from the available data):

• prickling pain near the injection site

The spleen is an organ located in the abdomen (belly). Some people are born with an extra spleen (an accessory spleen). Extra splenic tissue may also be found in the abdomen following surgery or trauma to the spleen (this is known as splenosis). Gallium ( Ga) edotreotide may make an accessory spleen or splenosis visible during medical imaging. There have been reports where this has been mistaken for a tumour. Your doctor may therefore carry out further scans and tests to confirm the results of gallium ( Ga) edotreotide imaging (see section 2).
This radiopharmaceutical will deliver low levels of ionising radiation associated with a minimal risk of cancer and hereditary abnormalities.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your nuclear medicine physician. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SomaKit TOC

Do not store this medicine yourself. This medicine is stored under the responsibility of a specialist in suitable premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive products.
The following information is intended for specialists only.
Keep this medicine out of the sight and reach of children.
Do not use SomaKit TOC after the expiry date stated on the container. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Keep in the original packaging to protect the medicine from light.
After labelling, SomaKit TOC must be used within 4 hours. After labelling, do not store at temperatures above 25 °C.
Do not use SomaKit TOC if there are any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Before discarding radioactive products, wait until their level of radioactivity has adequately decayed. This will help protect the environment.

6. Package contents and other information

What SomaKit TOC contains

• The active substance is edotreotide. Each vial of powder for injectable solution contains 40 micrograms of edotreotide.
• The other components are: 1,10-phenanthroline, gentisic acid, mannitol, formic acid, sodium hydroxide, water for injections. After labelling, the resulting solution also contains hydrochloric acid.

Description of the appearance of SomaKit TOC and contents of the pack
SomaKit TOC is a kit for radiopharmaceutical preparation containing:

• A glass vial with black flip-off cap containing a white powder.
• A cyclic olefin polymer vial with yellow flip-off cap containing a clear, colourless solution.

The radioactive substance is not included in the kit and must 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 Crescentino snc,
13040 Saluggia (VC),
Italy
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Novartis Pharma N.V. SAM Nordic
Tél/Tel: +32 2 246 16 11 Švedija
Tel: +46 8 720 58 22
България Luxembourg/Luxemburg
Novartis Bulgaria EOOD Novartis Pharma N.V.
Тел: +359 2 489 98 28 Tél/Tel: +32 2 246 16 11
Česká republika Magyarország
M.G.P. spol. s r.o. Novartis Hungária Kft.
Tel: +420 602 303 094 Tel.: +36 1 457 65 00
Danmark Malta
SAM Nordic Novartis Pharma Services Inc.
Sverige Tel: +356 2122 2872
Tel: +46 8 720 58 22
Deutschland Nederland
Novartis Radiopharmaceuticals GmbH Novartis Pharma B.V.
Tel: +49 911 273 0 Tel: +31 88 04 52 111
Eesti Norge
SAM Nordic SAM Nordic
Rootsi Sverige
Tel: +46 8 720 58 22 Tlf: +46 8 720 58 22
Ελλάδα Österreich
ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ Novartis Pharma GmbH
Τηλ: +30 22920 63900 Tel: +43 1 86 6570
España Polska
Advanced Accelerator Applications Ibérica, S.L.U. Advanced Accelerator Applications Polska Sp. z o.o.
Tel: +34 97 6600 126 Tel.: +48 22 275 56 47
France Portugal
Advanced Accelerator Applications Novartis Farma - Produtos Farmacêuticos, S.A.
Tél: +33 1 55 47 63 00 Tel: +351 21 000 8600
Hrvatska România
Novartis Hrvatska d.o.o. Novartis Pharma Services Romania SRL
Tel. +385 1 6274 220 Tel: +40 21 31299 01
Ireland Slovenija
Novartis Ireland Limited Advanced Accelerator Applications
Tel: +353 1 260 12 55 Francija
Tel: +33 1 55 47 63 00
Ísland Slovenská republika
SAM Nordic MGP, spol. s r.o.
Svíþjóð Tel: +421 254 654 841
Sími: +46 8 720 58 22
Italia Suomi/Finland
Advanced Accelerator Applications (Italy) S.r.l SAM Nordic
Tel: +39 0125 561211 Ruotsi/Sverige
Puh/Tel: +46 8 720 58 22
Κύπρος Sverige
ΒΙΟΚΟΣΜΟΣ ΑΕΒΕ SAM Nordic
Ελλάδα Tel: +46 8 720 58 22
Τηλ: +30 22920 63900
Latvija United Kingdom (Northern Ireland)
SAM Nordic Novartis Ireland Limited
Zviedrija Tel: +44 1276 698370
Tel: +46 8 720 58 22
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

The complete Summary of Product Characteristics (SmPC) for SomaKit TOC is provided as a
separate document in the medicinal product package, with the aim of providing healthcare professionals
with additional scientific and practical information on the administration and use of this
radiopharmaceutical.
Refer to the SmPC.