Patient Information Leaflet: Package Insert

TECEOS 13 mg Diagnostic Kit for Radiopharmaceutical Preparation

Butedronate Tetrasodium

Read this leaflet carefully before this medicine is administered to you, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear physician, who will oversee the procedure.
• If you experience any adverse effects, consult your nuclear physician, even if they are not listed in this leaflet. See section4.

1.What is TECEOS and how is it used

2.What you need to know before TECEOS administration

3.How to use TECEOS

4.Possible adverse effects

5.Storage of TECEOS

6.Content of the container and additional information

This medication is a radiopharmaceutical for diagnostic use only.

TECEOS contains tetrasodium butedronate, which is used in combination with the radioactive element technetium (99mTc) to obtain an injectable solution of technetium-99m butedronate.

When this solution is injected into a vein, it temporarily accumulates in the skeleton and is then mainly eliminated by the kidneys. Due to the small amount of radioactivity in the radiopharmaceutical, it can be detected from the outside of the body using a special medical device called a gamma camera, and an image, known as a gamma scan, can be obtained.

After administration of TECEOS labeled with technetium-99m, images of the bones or heart (known as bone or cardiac gamma scans, respectively) can be obtained, which will provide very valuable information to determine if there is any anomaly in the bones or heart.

The administration of TECEOS 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.

No use TECEOS:

If you are allergic to sodium technetium Tc 99m pertechnetate, other bisphosphonates, or any of the other components of this medication (listed in section6) or any of the components of the radiopharmaceutical marked.

Warnings and precautions

Consult your nuclear medicine specialist before starting to use TECEOS:

• If you have allergies, as there have been some cases of allergic reactions after administration of sodium technetium Tc 99m pertechnetate.
• If you have recently undergone a gamma scan.
• If you have any kidney disease, as renal insufficiency increases exposure to radiation.
• If you are pregnant or think you may be.
• If you are breastfeeding.

Before administration of TECEOS you must:

• Drink plenty of water before starting the examination so that you urinate as frequently as possible during the first hours after the examination.
• Avoid any strenuous physical activity to avoid accumulation of TECEOS in the muscles.

Children and adolescents

If you are under 18 years of age, speak with your nuclear medicine specialist, as after exposure to radiation, damage to bone growth areas may be observed.

Other medications and TECEOS

Inform your nuclear medicine specialist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription, as they may interfere with image interpretation.

Inform your doctor if you are taking or have been givenany of the following medications or compounds:

• Iron-containing medications(used to treat anemia).
• Bisphosphonates(medications used to treat osteoporosis).
• Cytotoxic and immunosuppressive medications(used to treat cancer).
• Aluminum salts(used to treat gastrointestinal disorders).
• Radiological contrasts.
• Antibiotics(used to treat infections).
• Corticosteroids(used to treat inflammation).
• Calcium gluconate(administered via injection to treat calcium deficiencies).
• Calcium heparin(anticoagulant treatment).
• Acid?-amino-caproic(treatment of excessive bleeding).
• Antiandrogenssuch as bicalutamide (cancer treatment of the prostate).
• Estrógenos
• Hematopoietic growth factors
• Nifedipino(treatment of hypertension and to prevent angina pectoris).

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your nuclear medicine specialist before using this medication.

If there is a possibility you are pregnant, if you experience a delay in menstruation, or are breastfeeding, inform your nuclear medicine specialist before TECEOS administration.

It is essential to consult your nuclear medicine specialist in case of doubt, who will oversee the procedure.

If you are pregnant, your nuclear medicine specialist will administer this medication only if the expected benefit outweighs the risks.

If you are breastfeeding, your doctor will assess the possibility of postponing the administration of this medication until you have finished breastfeeding. If administration is necessary, you should suspend breastfeeding for 4 hours and discard the milk expressed during that period. Your doctor will inform you when you can resume breastfeeding.

The possible effect of this medication on fertility is unknown.

Driving and operating machinery

The effects of this medication on the ability to drive or operate machinery have not been studied.

TECEOS contains sodium

Depending on the volume injected, the sodium content may exceed 1 mmol (23 mg) per dose administered, which should be taken into account in patients with low-sodium diets.

There are strict norms regarding the use, handling, and disposal of radiopharmaceuticals. 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 TECEOS to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose to administer to a normal adult typically ranges between 300 and 700 MBq depending on your weight. (MBq: the megabequerel is the unit used to express radioactivity).

Use in children and adolescents

The administered dose will be adjusted according to your body weight in children and adolescents.

Administration of TECEOS and procedure performance

TECEOS is administered through an injection into a vein in the arm.

One injection is sufficient to perform the procedure that your doctor needs.

During the administration of the medication, you should avoid moving to prevent inflammation around the injection site that may occur if the medication is administered subcutaneously (under the skin) accidentally.

Procedure duration

The examination may last from two to 24 hours, depending on the type of examination being performed. Your nuclear physician will inform you about the usual duration of the procedure.

After TECEOS administration, you must:

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

Rare cases ofallergic reactions(which may affect up to 1 in 10,000 people), accompanied byflushing(a sudden increase in temperature),uncomfortable sensation(nausea),eruption(skin rash), andpruritus(itching) have been reported.

The onset of these reactions maydelay 4-24 hours after injection.

Any of these reactions may be a sign of an allergy (anaphylactic reaction).Seek immediate contact with your doctor in this case.

This radiopharmaceutical will administer small amounts of ionizing radiation, which is associated with the risk of cancer and hereditary defects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nuclear medicine specialist, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usewww.notificaram.es.

Reporting adverse effects can help provide more information on 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 appropriate 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.

Do not use TECEOS after the expiration date that appears on the box and the vial after CAD.

Composition of TECEOS

• The active principle is butedronate tetrasodium. Each vial contains 13 mg of butedronate tetrasodium.
• The other components are: N-(4-aminobenzoil)-L-glutamic acid, monosodium salt and tin (II) oxide

Appearance of the product and contents of the packaging

Presentations: 5-dose multidose vial pack with 13 mg ofbutedronate tetrasodiumeach.

Holder of the marketing authorization and responsible for manufacturing:

CIS bio international

RN 306

B.P. 32 F-91 192 Gif sur Yvette Cedex

France

For more information about this medication, 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 the last review of this leaflet:January 2025

Other sources of information

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

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This information is intended solely for healthcare professionals:

The complete technical file of TECEOS is included in a separate document in this leaflet,in order to provide healthcare professionals with additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please, consult the technical file[the technical file must be included in the box].