Tektrotyd 16 micrograms radiopharmaceutical preparation kit
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
TEKTROTYD 16 micrograms kit for radiopharmaceutical preparation
TFA salt HYNIC-[D-Phe1, Tyr3-octreotide]
EDDA (ethylenediamine-N-N’-diacetic acid)
Read the entire leaflet carefully before you start using this medicine, 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 medicine physician who supervises the procedure.
- If you experience any adverse reactions, consult your nuclear medicine physician, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents:
- What TEKTROTYD is and what it is used for
- What you need to know before you use TEKTROTYD
- How to use TEKTROTYD
- Possible side effects
- How to store TEKTROTYD
- Contents of the pack and other information
1. What TEKTROTYD is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
It is used to obtain images of specific cells in the stomach, intestines, and pancreas, such as:
- abnormal tissue or
- tumours
Administration of TEKTROTYD involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the radiopharmaceutical procedure outweighs the radiation risk.
2. What you need to know before using TEKTROTYD
TEKTROTYD must not be used if you are allergic to TFA HYNIC-[D-Phe1, Tyr3-octreotide] salt, EDDA (ethylenediamine-N-N'-diacetic acid), or to any of the excipients of this medicine (listed in section 6), or to sodium pertecnetate (99mTc) injectable solution.
Warnings and precautions
Take special care with TEKTROTYD
- if you are pregnant or think you might be pregnant
- if you are breastfeeding
- if you have been diagnosed with renal insufficiency
Inform your nuclear medicine physician if any of the above apply to you.
Before using TEKTROTYD
To obtain images of the best possible quality, it is necessary to adequately prepare the patient before administering the radiopharmaceutical.
Unless your doctor advises otherwise, it is recommended to follow a bland diet for the two days prior to the study.
Your doctor may instruct you to use laxatives the day before the study.
On the day of the study, you must remain fasting until the first set of images has been completed.
The patient preparation method may vary depending on the study protocol used and the location of the lesions to be imaged. Your doctor will determine the necessary preparation.
Children and adolescents
Inform your nuclear medicine physician if you are under 18 years of age.
Use of TEKTROTYD with other medicines
Certain drugs may adversely affect the outcome of the planned study. Therefore, it is recommended to consult your doctor about which medications should be discontinued before the study and when they should be resumed.
Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as some medicines may interfere with image interpretation.
Pregnancy and breastfeeding
You must inform the nuclear medicine physician before administration of TEKTROTYD if there is any possibility you could be pregnant, if you have missed a period, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine physician supervising the procedure.
If you are pregnant
The nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.
If you are breastfeeding
Please consult your nuclear medicine physician regarding when you can resume breastfeeding.
Driving and use of machines
There are no studies on the effects of TEKTROTYD on the ability to drive and use machines.
TEKTROTYD is considered unlikely to affect the ability to drive or use machines.
TEKTROTYD contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial and is therefore considered essentially "sodium-free".
3. How to use TEKTROTYD
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. TEKTROTYD will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take particular care in ensuring the safe use of this product and will keep you informed of their actions.
The nuclear medicine physician supervising the procedure will determine the amount of TEKTROTYD to be used in your case. This will be the minimum quantity necessary to obtain the required information.
The amount generally recommended for administration to an adult ranges between 370 and 740 MBq (megabecquerel, the unit used to express radioactivity).
Administration of TEKTROTYD and performance of the procedure
After radiolabeling, the drug is administered as a single intravenous injection. This medicine is not intended for regular or continuous administration.
After the injection, you will be offered a drink and will be asked to urinate immediately before starting the procedure.
Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.
After administration of TEKTROTYD, you should
Urinate frequently to eliminate the product from your body.
The nuclear medicine physician will inform you whether you need to take special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any other questions.
If you have been given more TEKTROTYD than you should
An overdose is unlikely, as you will receive a single dose of TEKTROTYD, precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, you will receive appropriate treatment to enhance the elimination of the radionuclide from the body, e.g., administration of fluids and frequent bladder emptying.
If you have any further questions about the use of TEKTROTYD, consult the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following frequency data are used as the basis when assessing adverse effects:
very common: more than 1 in 10 people
common: 1 to 10 in 100 people
uncommon: 1 to 10 in 1,000 people
rare: 1 to 10 in 10,000 people
very rare: less than 1 in 10,000 people
unknown: cannot be estimated from the available data
Very rarely, transient headache or epigastric pain may occur after administration of TEKTROTYD.
Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation. It is very rare for this to be associated with a risk of developing cancer or hereditary defects.
Reporting of adverse effects
If you experience any side effects, please consult your nuclear medicine physician, even if they are side effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of TEKTROTYD
You will not be required 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 concerning radioactive materials.
The following information is intended for the specialist only.
Do not use TEKTROTYD after the expiry date stated on the labels.
6. Contents of the pack and other information
Composition of TEKTROTYD
Vials 1 and 2 contain the components for the preparation of technetium (99mTc) labelled TEKTROTYD.
Vial 1:
The active substance is TFA salt HYNIC-[D-Phe1, Tyr3-octreotide].
The excipients are:
stannous chloride dihydrate, tricine (N-[tris(hydroxymethyl)methyl]glycine), mannitol and nitrogen.
Vial 2:
The active substance is EDDA (ethylenediamine-N-N’-diacetic acid).
The excipients are:
disodium hydrogen phosphate dodecahydrate, sodium hydroxide and nitrogen.
Appearance of TEKTROTYD and contents of the pack
The pack contains two different 10 ml glass vials in a cardboard box.
Each vial contains a white or almost white lyophilisate for the preparation of an injectable solution.
Pack size: 2 vials for combined administration
Marketing Authorization Holder
ROTOP Pharmaka GmbH
Bautzner Landstrasse 400
01328 Dresden, Germany
Telephone: +49 351 26 31 02 10
Fax: +49 351 26 31 03 13
Email: [email protected]
Manufacturer
National Centre for Nuclear Research
Andrzej Soltan 7, 05-400 Otwock-Swierk
Poland
+48 22 718 07 00
+48 22 718 03 50
Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:
Curium Pharma Spain S.A.
Avda. Doctor Severo Ochoa, 29
28100 Alcobendas, Madrid
Spain
Date of the most recent review of this leaflet: 12/2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://wwww-aemps.gob.
This information is intended exclusively for physicians or healthcare professionals:
The Summary of Product Characteristics (SmPC) for TEKTROTYD is included as a separate document in the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please consult the Summary of Product Characteristics.