Teceos 13 mg radiopharmaceutical preparation kit reagent equipment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
TECEOS 13 mg kit for radiopharmaceutical preparation
Butedronate tetrasodium
Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your nuclear medicine physician, who is the person supervising the procedure.
- If you experience any side effects, talk to your nuclear medicine physician, even if they are side effects not listed in this leaflet. See section 4.
Contents of this leaflet:
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What TECEOS is and what it is used for
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What you need to know before administration of TECEOS
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How TECEOS is used
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Possible side effects
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How to store TECEOS
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Contents of the pack and other information
1. What TECEOS is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
TECEOS contains butyldronate tetrasodium, which is used in combination with the radioactive element technetium (99mTc) to obtain an injectable solution of technetium (99mTc) butyldronate.
When this solution is injected into a vein, it temporarily accumulates in the skeleton and is then primarily eliminated through 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, allowing an image—known as a scintigram—to be obtained.
After administration of TECEOS labeled with radioactive technetium (99mTc), images of the bones or heart (known as bone or cardiac scintigraphy, respectively) can be obtained, providing valuable information to determine whether there are any abnormalities in the bones or heart.
Administration of TECEOS involves exposure to a small amount of radiation. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from this radiopharmaceutical procedure outweighs the radiation risk.
2. What you need to know before receiving TECEOS
Do not use TECEOS:
If you are allergic to sodium butedronate, to other bisphosphonates, to any of the other components of this medicine (listed in section 6), or to any component of the radiopharmaceutical.
Warnings and precautions
Talk to your nuclear medicine specialist before starting treatment with 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 scintigraphy.
- If you have kidney disease, as renal insufficiency increases radiation exposure.
- If you are pregnant or think you might be pregnant.
- If you are breastfeeding.
Before receiving TECEOS, you should:
- Drink plenty of water before starting the examination to ensure frequent urination during the first hours after the procedure.
- Avoid any significant physical activity to prevent accumulation of TECEOS in the muscles.
Children and adolescents
If you are under 18 years of age, speak with your nuclear medicine specialist, as radiation exposure may cause damage to bone growth areas.
Other medicines and TECEOS
Inform your nuclear medicine specialist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, as they could interfere with the interpretation of images.
Inform your doctor if you are taking or have been given any of the following medicines or compounds:
- Iron-containing drugs (used to treat anemia).
- Bisphosphonates (medicines used in the treatment of osteoporosis).
- Cytostatic and immunosuppressive drugs (used to treat cancer).
- Medicines containing aluminum salts (used to treat gastric disorders).
- Radiological contrast agents.
- Antibiotics (used to treat infections).
- Corticosteroids (used to treat inflammation).
- Calcium gluconate (administered by injection to treat calcium deficiencies).
- Calcium heparin (anticoagulant treatment).
- Aminocaproic acid (treatment for excessive bleeding).
- Antiandrogens such as bicalutamide (treatment for prostate cancer).
- Estrogens
- Hematopoietic growth factors
- Nifedipine (treatment for high blood pressure and prevention of angina pectoris).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine specialist before using this medicine.
If you might be pregnant, have a delayed menstrual period, or are breastfeeding, you must inform your nuclear medicine specialist before receiving TECEOS.
In case of doubt, it is important to 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 whether administration of this medicine should be delayed until breastfeeding ends. If administration is necessary, breastfeeding must be interrupted for 4 hours, and milk expressed during this period must be discarded. Your doctor will advise you when you can resume breastfeeding.
The potential effect of this medicine on fertility is unknown.
Driving and use of machines
The effects of this medicine on the ability to drive or operate machinery 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 considered in patients on low-sodium diets.
3. How to use TECEOS
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this product and will inform you of their actions.
The nuclear medicine physician supervising the procedure will determine the amount of TECEOS to be used in your case. This will be the minimum quantity necessary to obtain the required information.
The amount generally recommended for administration in an adult typically ranges between 300 and 700 MBq, depending on body weight. (MBq: the 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 body weight.
Administration of TECEOS and performance of the procedure
TECEOS is administered by intravenous injection into a vein of the arm.
A single injection is sufficient to perform the procedure required by your physician.
During administration of the medication, you must avoid moving in order to prevent inflammation around the injection site that may occur if the medication is accidentally administered subcutaneously (under the skin).
Duration of the procedure
The scan may last from two to 24 hours, depending on the type of examination being performed. Your nuclear medicine physician will inform you about the usual duration of the procedure.
After administration of TECEOS you should:
- Avoid close contact with young children and pregnant women during the first 4 hours after injection.
- Urinate frequently to help eliminate the medication from your body.
The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medication. Consult your nuclear medicine physician if you have any doubts.
If you have been given more TECEOS than you should:
An overdose is unlikely, as you will receive a single, precisely controlled dose of TECEOS determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered. If you have any doubts about the use of TECEOS, consult your supervising nuclear medicine physician.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
Very rare cases of allergic reactions (may affect up to 1 in 10,000 people) have been reported, accompanied by hot flushes (a sudden increase in body temperature), feeling unwell (nausea), rash (skin eruption), and pruritus (itching).
The onset of these reactions may be delayed 4–24 hours after injection.
Any of these symptoms may be signs of an allergy (anaphylactic reaction). In such case, contact your doctor immediately.
This radiopharmaceutical will expose you to small amounts of ionizing radiation, which is associated with a risk of cancer and hereditary defects.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or a specialist in nuclear medicine, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Conservation of TECEOS
You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.
The following information is intended for healthcare professionals only.
Do not use TECEOS after the expiry date stated on the carton and vial following EXP.
6. Contents of the container and additional information
Composition of TECEOS
- The active substance is butedronate tetrasodium. Each vial contains 13 mg of butedronate tetrasodium.
- The other components are: N-(4-aminobenzoyl)-L-glutamic acid, monosodium salt and tin(II) oxide.
Appearance of the product and contents of the pack
Presentation: pack of 5 multidose vials containing 13 mg of butedronate tetrasodium each.
Marketing Authorization Holder and Manufacturer:
CIS bio international
RN 306
B.P. 32 F-91 192 Gif sur Yvette Cedex
France
Further information on this medicinal product can be requested from 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 most recent review of this summary: January 2025
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/
This information is intended for healthcare professionals only:
The complete Summary of Product Characteristics (SmPC) for TECEOS is included as a separate document within this package leaflet, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please refer to the Summary of Product Characteristics [the Summary of Product Characteristics must be included in the package].