TECEOS 13 MG Kit for Radiopharmaceutical Preparation

Introduction

Package Leaflet: Information for the Patient

TECEOS 13 mg reagent kit for radiopharmaceutical preparation

Tetrasodium butedronate

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

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

Contents of the Package Leaflet:

1. What is TECEOS and what is it used for

2. What you need to know before TECEOS is administered

3. How to use TECEOS

4. Possible side effects

5. Storage of TECEOS

6. Package Contents and Additional Information

1. What is TECEOS and what is it used for

This medicine 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 (99mTc) butedronate.

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

After administration of TECEOS labeled with technetium (99mTc), images of the bones or heart (known as bone or cardiac scintigrams, respectively) can be obtained, which will provide very valuable information to determine if there are any abnormalities in the bones or heart.

Administration of TECEOS involves receiving a small amount 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.

2. What you need to know before TECEOS is administered

Do not use TECEOS:

If you are allergic to sodium butedronate, other bisphosphonates, or any of the other components of this medicine (listed in section 6) or any of the components of the labeled radiopharmaceutical.

Warnings and Precautions

Consult your nuclear medicine specialist before starting to use TECEOS:

• If you have allergies, as some cases of allergic reactions have been reported after administration of technetium (99mTc) butedronate.
• If you have recently undergone a scintigram.
• If you have any kidney disease, as renal failure increases radiation exposure.
• If you are pregnant or think you may be pregnant.
• 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 significant physical activity to avoid accumulation of TECEOS in the muscles.

Children and Adolescents

If you are under 18 years of age, talk to your nuclear medicine specialist, as radiation exposure may cause damage to the bone growth areas.

Other Medicines and TECEOS

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

Tell your doctor if you are taking or have been administeredany of the following medicines or compounds:

• Iron-containing drugs(used to treat anemia).
• Bisphosphonates(medicines used to treat osteoporosis).
• Cytostatic and immunosuppressive drugs(used to treat cancer).
• Drugs containing aluminum salts(used to treat gastric disorders).
• Radiological contrasts.
• Antibiotics(used to treat infections).
• Corticosteroids(used to treat inflammation).
• Calcium gluconate(administered by injection to treat calcium deficiencies).
• Calcium heparin(anticoagulant treatment).
• Amino-caproic acid(treatment for excessive bleeding).
• Anti-androgenssuch as bicalutamide (treatment for prostate cancer).
• Estrogens
• Hematopoietic growth factors
• Nifedipine(treatment for arterial hypertension and to prevent angina pectoris).

Pregnancy, Breastfeeding, and Fertility

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

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

In case of doubt, it is essential that you consult your nuclear medicine specialist who will supervise the procedure.

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

If you are breastfeeding, your doctor will assess the possibility of delaying administration of this medicine until breastfeeding is finished. If administration is necessary, you must stop breastfeeding for 4 hours and discard the expressed milk during this period. Your doctor will tell you when you can resume breastfeeding.

The potential effect of administration of this medicine on fertility is unknown.

Driving and Using Machines

The effects of this medicine on the ability to drive or use machines have not been studied.

TECEOS contains sodium

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

3. How to use TECEOS

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. 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 who supervises the procedure will decide 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 amount for administration to a normal adult usually ranges between 300 and 700 MBq, depending on your weight. (MBq: megabecquerel is the unit used to express radioactivity).

Use in Children and Adolescents

In children and adolescents, the administered dose will be adjusted according to their body weight.

Administration of TECEOS and Performance of the Procedure

TECEOS is administered by injection into a vein in the arm.

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

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

Duration of the Procedure

The examination may last from 2 to 24 hours, depending on the type of examination performed. Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After Administration of TECEOS, you must:

• Avoid close contact with small children and pregnant women within the first 4 hours after injection.
• Urinate frequently to eliminate the medicine from the body.

Your nuclear medicine doctor will inform you if you need to take special precautions after administration of this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been administered more TECEOS than you should:

Overdose is unlikely because you will receive a single, precisely controlled dose of TECEOS from the supervising nuclear medicine doctor. However, in case of overdose, you will receive appropriate treatment. If you have any doubts about the use of TECEOS, ask your nuclear medicine doctor who supervises the procedure.

4. Possible Side Effects

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

Very rare cases of allergic reactions(may affect up to 1 in 10,000 people) have been reported, accompanied by flushing(a sudden increase in temperature), feeling of discomfort(nausea), rash(skin rash), and pruritus(itching).

The onset of these reactions may be delayed 4-24 hours after injection.

Any of these may be a sign of an allergy (anaphylactic reaction). In this case, contact your doctor immediately.

This radiopharmaceutical will administer small amounts of ionizing radiation associated with the risk of cancer and genetic defects.

Reporting of Side Effects

If you experience any side effects, consult your doctor or nuclear medicine specialist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TECEOS

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.

The following information is intended only for healthcare professionals.

Do not use TECEOS after the expiration date stated on the carton and vial after CAD.

6. Package Contents and Additional Information

Composition of TECEOS

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

Appearance of the Product and Package Contents

Presentation: box of 5 multidose vials with 13 mg of tetrasodium butedronate each.

Marketing Authorization Holder and Manufacturer:

CIS bio international

RN 306

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

France

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 Package Leaflet:January 2025

Other Sources of Information

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

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This information is intended only for healthcare professionals:

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

Please consult the technical data sheet [the technical data sheet must be included in the box].