Package leaflet: Information for the user

Tc-Tektrotyd, 16 micrograms, kit for the preparation of a radiopharmaceutical preparation
Hynic-[D-Phe,Tyr\ -Oktreotyd]·TFA
Please read all of this leaflet carefully before the medicine is administered, as it
contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your treating physician or the nuclear medicine specialist supervising the examination.
If you experience any adverse reactions, including any not listed in this leaflet, inform the nuclear medicine specialist immediately.

Contents of the leaflet:

What Tc-Tektrotyd kit is and what it is used for
Important information before using the Tc-Tektrotyd kit
How to use the Tc-Tektrotyd kit
Possible side effects
How to store the Tc-Tektrotyd kit
Contents of the pack and other information

1. What Tc-Tektrotyd kit is and what it is used for

Tc-Tektrotyd, kit for the preparation of a radiopharmaceutical preparation, is intended
exclusively for diagnostic imaging. After intravenous administration, it accumulates in areas
expressing somatostatin receptors. These receptors are present in healthy individuals, but are
overexpressed in various pathological conditions. Detection of sites with increased somatostatin
receptor expression may assist the physician in selecting the most effective therapeutic approach.
Tc-Tektrotyd is radioactive; therefore, its accumulation in tissues is detected by specialized
imaging devices, allowing visualization of the distribution of radioactivity in the body. These images
precisely show the sites of radioactivity accumulation from the administered preparation, providing
the physician with important information, such as the presence and localization of pathological lesions.
Scintigraphy, i.e. radionuclide imaging, is a well-established diagnostic method used to evaluate the functional status of various organs in numerous diseases.

2. Important information before using the Tc-Tektrotyd kit

When not to use the Tc-Tektrotyd kit

if the patient has a known allergy (hypersensitivity) to Hynic-[D-Phe, Tyr - Octreotide]·TFA or to any of the other components of the medicinal product Tc-Tektrotyd (in practice, allergic reactions after administration of the product are not observed);
if the patient is pregnant;
if the patient is breastfeeding, breastfeeding must be discontinued for at least 72 hours after administration of the radiopharmaceutical due to the potential risk to the infant's health. Breast milk should be expressed during this time but must not be given to the child.

Warnings and precautions
Special caution is required when using Tc-Tektrotyd:

if the patient has been diagnosed with renal impairment;
if the patient has been diagnosed with liver disease.

If any of the above information applies to the patient, the physician must be informed immediately.
Children and adolescents
The use of Tc-Tektrotyd is not recommended in patients under 18 years of age,
as clinical studies have not been conducted in this age group.
Administration of Tc-Tektrotyd involves exposure to a small radiation dose; however, the physician ordering the examination will evaluate the benefits versus the risks associated with its use.
To reduce the radiation dose absorbed by the bladder wall, patients should drink plenty of fluids and urinate as frequently as possible during the first few hours after the examination.

Tc-Tektrotyd and other medicines
Patients receiving somatostatin analogues (both non-radiolabelled "cold" analogues and radiolabelled ones) should discontinue these medications:

short-acting analogues – at least 3 days before the scheduled examination;
long-acting analogues:
- lanreotide – at least 3 weeks before the scheduled examination;
- octreotide – at least 5 weeks before the scheduled examination.
  If any of the above information applies to the patient, the physician must be informed immediately.

There is limited data available on potential interactions with other medicinal products. Before the scheduled examination, patients should inform their physician about all medicines currently used or recently taken, as well as any medicines they plan to use.

Tc-Tektrotyd, food and drink
To achieve optimal scintigraphic image quality, the patient requires appropriate preparation before administration of the radiopharmaceutical. Unless otherwise directed by the physician, a light diet is recommended the day before the examination. The physician may recommend administration of bowel cleansing agents the day before the examination. On the day of the examination, the patient should remain fasting until completion of the initial image acquisition.
The treating physician may recommend a different patient preparation protocol. In case of doubt, this should be clarified with the responsible physician.

Pregnancy and breastfeeding
Pregnancy is an absolute contraindication.
Before using any medicinal product, patients should consult a physician or pharmacist.

Driving and using machines
Studies on the effect of the product on the ability to drive motor vehicles or operate machinery have not been conducted.
However, Tc-Tektrotyd is not expected to affect the ability to drive or operate machinery.

3. How to use Tc-Tektrotyd kit

Dosage and method of administration
Tc-Tektrotyd should be used in individuals over 18 years of age.
The recommended dose for one examination in an adult ranges from 370 to 925 MBq.
Tc-Tektrotyd, labelled with radioactive sodium pertechnetate(VII) [Tc], is administered as a single intravenous injection prior to scintigraphy.
Scintigraphy should begin 2 to 4 hours after administration of Tc-Tektrotyd. Depending on the physician's decision, imaging may also start 10 minutes, 1 hour, or 24 hours after administration of Tc-Tektrotyd.
Residual particles of radiolabelled Tc-Tektrotyd in the body will spontaneously lose their radioactivity within 2–3 days after administration.
Storage, use, and disposal of radioactive preparations are regulated by special regulations. Therefore, Tc-Tektrotyd can only be used in specialized facilities by personnel trained in this field.
Administration of a higher than recommended dose of Tc-Tektrotyd
In case of overdose with Tc-Tektrotyd, the physician may advise the patient to drink large amounts of fluids and to urinate frequently in order to eliminate the excess radioactive preparation.

4. Possible adverse reactions

Like all medicines, Tc-Tektrotyd may cause adverse reactions, although not everyone experiences them. Very rarely, transient headache or epigastric pain may occur shortly after administration.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or a nuclear medicine specialist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax number of the above-mentioned Department}
e-mail: [email protected].
By reporting adverse reactions, additional information regarding the safety of the medicine can be collected.

5. How to store the Tc-Tektrotyd kit

Keep out of the reach and sight of children.
Store in a refrigerator (2°C–8°C).
During transport, temperatures up to 35°C are permitted for not longer than 7 days.
After radiolabelling, the prepared radiopharmaceutical should be stored for no longer than 6 hours, at a temperature below 25°C, shielded with radiation-absorbing material.
Storage of radiopharmaceuticals must comply with applicable regulations.
Storage conditions and expiry date are indicated on the packaging. Do not use the Tc-Tektrotyd medicinal product after the expiry date stated on the label.
Trained personnel at a specialized facility will ensure appropriate storage conditions for the Tc-Tektrotyd kit for preparing the radiopharmaceutical preparation.

6. Contents of the package and other information

What the Tc-Tektrotyd kit contains
Vial I: Hynic-[D-Phe, Tyr-Octreotide]·TFA,
tricine (N-[tris(hydroxymethyl)methyl]glycine), tin(II) chloride dihydrate, mannitol, nitrogen.
Vial II: EDDA (ethylenediamine-N,N’-diacetic acid), disodium hydrogen phosphate dodecahydrate, sodium hydroxide, nitrogen.
The active substance of the medicinal product is HYNIC-[D-Phe, Tyr-Octreotide]·TFA.

What the Tc-Tektrotyd kit looks like and contents of the pack
The pack contains a set of two 10 ml glass vials (Vial I and Vial II). Each vial is closed with a rubber stopper and an aluminium cap. The vials are packed in cardboard boxes. Vials I and II contain components for the preparation of the radiopharmaceutical Tc-Tektrotyd.

Marketing authorisation holder and manufacturer
National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 7180700
Fax: 22 7180350
e-mail: [email protected]