Tektrotid

Leaflet included in the packaging: information for the user

Tektrotyd, 20 micrograms, kit for the preparation of a radiopharmaceutical preparation

Hynic-[D-Phe ,Tyr -Oktreotyd] trifluorooctan
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or a specialist in nuclear medicine who is supervising the examination.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or a specialist in nuclear medicine.

Table of contents of the leaflet:

• 1. What is Tektrotyd and what is it used for
• 2. Important information before using Tektrotyd
• 3. How to use Tektrotyd
• 4. Possible adverse reactions
• 5. How to store Tektrotyd
• 6. Contents of the packaging and other information

1. What is Tektrotyd and what is it used for

Product intended exclusively for diagnostic purposes.
It is used to visualize a specific type of cells in the spleen, intestine, and pancreas, such as:

• abnormal tissues
• tumors

Tektrotyd, combined with a radioactive isotope, binds to abnormal cells or tumor cells that have the appropriate receptors (somatostatin receptors). Then, a device that measures radioactivity (gamma camera) detects this radiation and shows the location of these abnormal or tumor cells in the body.
Due to the combination with a radioactive isotope of technetium Tc, the use of Tektrotyd is associated with exposure to a small dose of radiation. Your doctor and the nuclear medicine specialist have decided that the benefits of the examination outweigh the potential risks associated with ionizing radiation.

2. Important information before using Tektrotyd

When not to use the Tektrotyd kit

If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) or the solution for injections of sodium pertechnetate (Tc).
If the patient is pregnant or suspects that she may be pregnant.
If the patient is breastfeeding (see section Pregnancy and breastfeeding below).

Warnings and precautions

Special caution should be exercised when using Tektrotyd if the patient has been diagnosed with kidney failure.
If any of the above information applies to the patient, they should immediately inform their doctor.

Before administering Tektrotyd

In order to obtain the best possible quality of the scintigraphic image, the patient requires proper preparation before the administration of the radiopharmaceutical.
Unless the doctor recommends otherwise, a liquid diet is recommended for two days before the examination.
The doctor may recommend the administration of laxatives on the day before the examination.
On the day of the examination, the patient should remain on a liquid diet until the first images are taken. However, it is recommended to drink plenty of fluids before the examination and to urinate frequently in the first hours after the examination to limit the radiation exposure of the body.
The doctor may recommend a different preparation method for the patient, depending on the method of examination and the location of the imaged changes.

Children and adolescents

The patient should inform the nuclear medicine specialist if they are under 18 years old.

Tektrotyd and other medicines

Many medicines can significantly affect the result of the planned examination. The patient should discuss with their doctor which medicines should not be taken before the examination and when they can be taken again.
Before the planned examination, the patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Patients treated with so-called "somatostatin analogs" (used in the therapy of neuroendocrine tumors) should inform their doctor, as these medicines may strongly affect the result of the examination.

Pregnancy and breastfeeding

The patient should consult their doctor if they suspect they may be pregnant, in case of missed menstruation, or during breastfeeding.
This is important, so that the doctor can be consulted in case of any doubts.
Pregnancy
Tektrotyd should not be used during pregnancy due to the potential risk associated with ionizing radiation for the mother and fetus.
Breastfeeding
The patient should inform their doctor if they are breastfeeding. The doctor may decide to postpone the examination until after breastfeeding is stopped or recommend stopping breastfeeding and expressing milk from the breast until the medicine is completely eliminated from the woman's body.
Please ask the nuclear medicine specialist when you can resume breastfeeding.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive vehicles and operate machinery.
However, it is not expected that Tektrotyd will affect the ability to drive vehicles and operate machinery.

Tektrotyd contains sodium

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

3. How to use Tektrotyd

Radiopharmaceuticals can only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals. Tektrotyd is used exclusively in appropriate clinical conditions and only by qualified personnel. These personnel take special precautions to ensure the safe use of the medicine and will inform the patient about their actions.
The nuclear medicine specialist supervising the procedure decides on the dose of the medicine to be used in a given case. This will be the minimum dose necessary to obtain the expected diagnostic information. Depending on the type of examination, the recommended dose ranges from 370 to 740 MBq (MBq = megabecquerel, a unit of measurement of radioactivity).

Administration of the medicine and performance of the examination

The ready-to-use solution for injection will be administered once intravenously before the examination.
This medicine is not intended for regular or continuous use.
After injection of the medicine, the patient will be given fluids to drink and will be asked to urinate before the start of imaging.

Duration of the procedure

The doctor will inform the patient about the standard duration of the procedure.
After administration of Tektrotyd, the patient should:

• avoid close contact with small children and pregnant women for the first 24 hours after injection
• urinate frequently to eliminate the medicine from the body

The doctor supervising the examination will inform the patient about the need to take special precautions after administration of the medicine. In case of doubts, the patient should consult their doctor or the nuclear medicine specialist.

Use of a higher dose of Tektrotyd than recommended

Overdose is unlikely, as the dose of the medicine administered to the patient is strictly controlled by the nuclear medicine specialist supervising the examination. However, in case of overdose, the doctor may recommend drinking more fluids to eliminate the radiopharmaceutical from the body through frequent urination.
In case of any further doubts related to the use of the medicine, the patient should consult their doctor or the nuclear medicine specialist supervising the examination.

4. Possible adverse reactions

Like all medicines, Tektrotyd can cause adverse reactions, although not everybody gets them.
Very rarely (affects less than 1 in 10,000 administrations), shortly after administration, a transient headache or abdominal pain may occur.
Administration of this radiopharmaceutical results in exposure to a small dose of ionizing radiation, which is associated with the risk of causing cancer and congenital anomalies.
Current evidence suggests that the likelihood of such adverse reactions occurring in the case of diagnostic examinations in nuclear medicine is low.

Reporting adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in the leaflet, the patient should inform their doctor or the nuclear medicine specialist.
Adverse reactions can be reported directly to the Department for Monitoring of Adverse Reactions of Medicinal Products, Urzad Rejestracji Produktow Leczniczych, Wyrobów Medycznych i Produktow Biobójczych, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected].
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information can be collected on the safety of the medicine.

5. How to store Tektrotyd

The patient will not need to store this medicine.
Radiopharmaceuticals are stored exclusively by authorized personnel in appropriate clinical conditions. The storage of radiopharmaceuticals is carried out in accordance with local regulations regarding radioactive substances.
The following information is intended exclusively for healthcare professionals.
Tektrotyd should not be used after the expiry date stated on the packaging.

6. Contents of the packaging and other information

What Tektrotyd contains

Vials I and II contain the ingredients of Tektrotyd.
Vial I:
Active substance: Hynic-[D-Phe ,Tyr -Oktreotyd] trifluorooctan,
Excipients: N-[Tris(hydroxymethyl)methyl]glycine (tricine), tin(II) chloride dihydrate, mannitol, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), nitrogen.
Vial II:
Excipients: ethylenediamine-N,N'-diacetic acid (EDDA), disodium phosphate dodecahydrate, sodium hydroxide, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), nitrogen.

What Tektrotyd looks like and what the pack contains

The kit consists of two different glass vials with a capacity of 10 ml, in a cardboard box.
Each vial contains a white or off-white lyophilizate for the preparation of a solution for injection.
Pack size: 2 vials for combined use.

Marketing authorization holder and manufacturer

National Centre for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 7180700
Fax: 22 7180350
e-mail: [email protected]

Date of last revision of the leaflet:

The following information is intended exclusively for healthcare professionals:

The Full Prescribing Information (FPI) for Tektrotyd is attached as a separate document to the packaging of the radiopharmaceutical preparation, in order to provide healthcare professionals with additional scientific and practical information regarding

the administration and use of this radiopharmaceutical preparation.