TEKTROTYD 16 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the Patient

TEKTROTYD 16 micrograms kit for radiopharmaceutical preparation

TFA HYNIC-[D-Phe1, Tyr3-octreotide] salt

EDDA (ethylenediamine-N-N'-diacetic acid)

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of the package leaflet:

1. What TEKTROTYD is and what it is used for
2. What you need to know before you start using TEKTROTYD
3. How to use TEKTROTYD
4. Possible side effects
5. Storage of TEKTROTYD
6. Contents of the pack and further 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
• tumors

Administration of TEKTROTYD involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will gain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before you start using TEKTROTYD

TEKTROTYD must not be usedif you are allergic to TFA HYNIC-[D-Phe1, Tyr3-octreotide] salt, EDDA (ethylenediamine-N-N'-diacetic acid), or any of the excipients of this medicine (listed in section 6), or to the injectable solution of sodium pertechnetate (99mTc).

Warnings and precautions

Be careful with TEKTROTYD

• if you are pregnant or think you may be pregnant
• if you are breast-feeding
• if you have been diagnosed with kidney failure

Tell your nuclear medicine doctor if any of the above applies to you.

Before using TEKTROTYD

To obtain images of the best quality, it is necessary to prepare the patient properly before administering the radiopharmaceutical.

Unless your doctor tells you otherwise, it is recommended to follow a soft diet for two days before the study.

Your doctor may recommend the use of laxatives the day before the study.

On the day of the study, you must fast until the first images are taken.

The method for preparing the patient may be different, 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

Tell your nuclear medicine doctor if you are under 18 years old.

Using TEKTROTYD with other medicines

Certain medicines may adversely affect the outcome of the scheduled study. Therefore, it is recommended to consult with your doctor about which medicines should be discontinued before the study and when they should be resumed.

Tell your nuclear medicine doctor if you are taking, have recently taken, or may need to take any other medicine, as some medicines may interfere with the interpretation of the images.

Pregnancy and breast-feeding

You must inform your nuclear medicine doctor before administration of TEKTROTYD if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding.

In case of doubt, it is important to consult your nuclear medicine doctor who is supervising the procedure.

If you are pregnant

Your nuclear medicine doctor will only give you this medicine during pregnancy if the expected benefit outweighs the risk.

If you are breast-feeding

Please consult your nuclear medicine doctor when you can resume breast-feeding.

Driving and using machines

There are no studies on the effects of TEKTROTYD on the ability to drive and use machines.

It is considered unlikely that TEKTROTYD will affect your ability to drive or use machines.

TEKTROTYD contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, so it is considered essentially 'sodium-free'.

3. How to use TEKTROTYD

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. TEKTROTYD will only be used in special controlled areas. 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 keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of TEKTROTYD to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The recommended amount for administration to an adult is usually between 370 and 740 MBq (megabecquerel, the unit used to express radioactivity).

Administration of TEKTROTYD and performance of the procedure

After radiolabeling, the medicine 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 asked to urinate immediately before starting the procedure.

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of TEKTROTYD, you must

Urinate frequently to eliminate the product from your 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 further questions.

If you have been given more TEKTROTYD than you should

Overdose is unlikely because you will receive a single dose of TEKTROTYD, precisely controlled by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive appropriate treatment to increase the elimination of the radionuclide from the body, e.g., administration of fluids and frequent emptying of the bladder.

If you have any further questions about the use of TEKTROTYD, consult your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

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

During the assessment of side effects, the following frequency data are taken into account:

very common: more than 1 patient in 10

common: 1 to 10 patients in 100

uncommon: 1 to 10 patients in 1,000

rare: 1 to 10 patients in 10,000

very rare: less than 1 patient in 10,000

not known: cannot be estimated from the available data

On very rare occasions, transient headache or epigastric pain may occur after administration of TEKTROTYD.

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation. It is very rare that this is associated with a risk of developing cancer and genetic disorders.

Reporting of side effects

If you experience side effects, consult your nuclear medicine doctor, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TEKTROTYD

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 the specialist.

Do not use TEKTROTYD after the expiry date stated on the labels.

6. Contents of the pack and further information

Composition of TEKTROTYD

Vials 1 and 2 contain the components for the preparation of TEKTROTYD labeled with technetium (99mTc).

Vial 1:

The active substance is TFA HYNIC-[D-Phe1, Tyr3-octreotide] salt

The excipients are:

tin(II) 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 2 different 10 ml glass vials in a cardboard box.

Each vial contains a white or almost white lyophilisate for preparation of an injectable solution.

Pack size: 2 vials for joint administration

Marketing authorisation holder

ROTOP Pharmaka GmbH

Bautzner Landstrasse 400

01328 Dresden, Germany

Phone: +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

[email protected]

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Curium Pharma Spain S.A.

Avda. Doctor Severo Ochoa, 29

28100 Alcobendas. Madrid

Spain

Date of last revision of this package leaflet: 12/2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.

This information is intended only for healthcare professionals:

The complete Summary of Product Characteristics of TEKTROTYD is included as a separate document in the product pack, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics.