Flt(18f) synektik

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

FLT( F) Synektik, 1000 MBq/ml, solution for injection
fluorodeoxythymidine ( F)
Please read carefully all the information in this leaflet before the administration of the medicinal product, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult the nuclear medicine specialist supervising your examination.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your nuclear medicine specialist immediately. See section 4.

Leaflet contents:

1. What FLT ( F) Synektik is and what it is used for
2. Important information before administration of FLT ( F) Synektik
3. How to use FLT ( F) Synektik
4. Possible side effects
5. How to store FLT ( F) Synektik
6. Contents of the pack and other information

1. What FLT ( F) Synektik is and what it is used for

This medicinal product is intended solely for diagnostic purposes.
FLT ( F) Synektik is used to identify the location of malignant tumours by detecting cells with high rates of division.
FLT ( F) Synektik contains a radioactive substance, fluorodeoxythymidine ( F), and is used in positron emission tomography (PET) imaging. The medicinal product is administered prior to the scan.
After injection of a small amount of FLT ( F) Synektik, the physician will acquire images using a special device (a PET scanner), which will allow assessment of the patient's condition and treatment progress.
The physician will administer the medicinal product only if the expected clinical benefit outweighs the risks associated with exposure to ionizing radiation.

2. Important information before using FLT(18F) Synektik

When not to use FLT(18F) Synektik

• If the patient is allergic to fluorothymidine (18F) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Special caution is required when using FLT(18F) Synektik:

• if the patient is pregnant or suspects she may be pregnant;
• if the patient is breastfeeding;
• if the patient's kidneys are not functioning properly; in such a case, careful consideration of the indication for the examination is required, as the patient may be exposed to increased radiation;

Before administration of FLT(18F) Synektik:

• the patient will receive instructions from the physician to drink plenty of fluids and to urinate frequently.

After administration of FLT(18F) Synektik:

• during the first 12 hours after injection, the patient should avoid close contact with young children and pregnant women.

Children and adolescents
This medicine is intended for use in adult patients only.

FLT(18F) Synektik and other medicines
Inform the nuclear medicine specialist about any medicines the patient is currently taking, has recently taken, or plans to take, as other medicines may affect the interpretation of the imaging results.

FLT(18F) Synektik with food and drink
There are no known restrictions regarding types of food or drink.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult a nuclear medicine physician before using this medicine.

Pregnant patients
The nuclear medicine physician will decide whether to administer FLT(18F) Synektik to a woman with a positive pregnancy test only if the expected benefits of the procedure outweigh the potential risks to the fetus. Administration of the radiopharmaceutical may be considered acceptable in justified cases if the estimated fetal dose is less than 1 mSv.

Breastfeeding patients
After injection of FLT(18F) Synektik, breastfeeding must be interrupted for 12 hours, and milk expressed during this period must be discarded.
Resumption of breastfeeding should be discussed with the nuclear medicine specialist performing the examination. Prior to administration of the radiopharmaceutical, an adequate amount of breast milk may be expressed and stored for later use.
Breastfeeding women are advised to avoid close contact with young children for 12 hours after administration of fluorothymidine (18F).

Driving and operating machinery
FLT(18F) Synektik has no effect or has negligible effect on the ability to drive and operate machinery.

FLT(18F) Synektik contains sodium
This medicine in the maximum dose of 10 ml may contain up to 33.5 mg of sodium, equivalent to 1.7% of the WHO recommended maximum daily intake of sodium for adults (2 g). This should be taken into account in patients on a low-sodium diet.

FLT(18F) Synektik contains ethanol
This medicine in the maximum dose (10 ml) contains 790 mg of alcohol (ethanol), equivalent to 20 ml of beer or 8 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use FLT(18F) Synektik

The use, handling, and disposal of radiopharmaceuticals are strictly regulated by appropriate regulations. FLT(18F) Synektik will be administered only in specially controlled facilities and given to patients in accordance with radiation protection principles by trained and qualified medical personnel. These personnel will strictly adhere to safety rules for the use of the medicinal product and will inform the patient about the procedures being performed.

The nuclear medicine specialist supervising the examination will determine the appropriate dose of FLT(18F) Synektik for each patient. This will be the smallest amount of the medicinal product that allows the examination to be performed.

The recommended activity for an adult patient with a body weight of 70 kg is 150 to 600 MBq of fluorodeoxythymidine (18F) (the dose should be individually adjusted according to body weight and/or imaging technique used, clinical picture, patient's condition, and information gathered during the medical interview).

Administration of FLT(18F) Synektik and performance of the examination
The medicinal product FLT(18F) Synektik is administered by direct intravenous injection.
The examination is performed 15–30 minutes after intravenous administration.

Prior to administration, the patient will receive instructions from the physician to drink plenty of fluids and to urinate frequently. This is intended to reduce radiation exposure to the urinary system.

Duration of the examination
The nuclear medicine specialist will inform the patient how long the examination will take.

After administration of FLT(18F) Synektik, the patient should:

• avoid close contact with young children and pregnant women for 12 hours after injection;
• urinate frequently to accelerate elimination of the medicinal product from the body.

The nuclear medicine specialist will provide the patient with appropriate information regarding special post-administration instructions, if necessary.

Administration of a higher than recommended dose of FLT(18F) Synektik
This medicinal product is administered under strict supervision of a nuclear medicine physician; therefore, overdose is highly unlikely. However, if an overdose occurs, the patient will receive appropriate treatment.

If there are any further questions about the use of this medicinal product, the patient should consult the nuclear medicine specialist who will supervise the examination.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone will experience them.
FLT(18F) Synektik emits a small amount of radioactive radiation, which is associated with a small risk of developing tumors and congenital malformations.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the nuclear medicine specialist physician.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicinal product.

5. How to store FLT(18F) Synektik

The patient will not store this medicinal product. Radiopharmaceuticals must be stored in accordance
with national regulations concerning radioactive materials.
The information below is intended solely for healthcare professionals.
Store below 25°C. Do not freeze.
Expiry date: 14 hours from the end of synthesis.
After first puncture, store below 25°C and use within 8 hours, not exceeding the expiry date indicated on the label.
Do not use this medicinal product after the expiry date stated on the label following:
Expiry date (EXP): {DD MM YYYY HH:MM}.
Use only a clear solution free from visible particles.

6. Contents of the packaging and other information

What FLT(18F) Synektik contains
1 vial contains:
Active substance: fludeoxythymidine (18F) 1000 MBq/ml at the date and time of calibration.
Excipients: water for injections, citrate buffer* at pH 5.2, ethanol.
*Disodium hydrogen citrate, sodium citrate, hydrochloric acid, water for injections, sodium chloride.

What FLT(18F) Synektik looks like and contents of the pack
FLT(18F) Synektik is a clear, colourless or yellow solution free from visible particles.
Multidose vial with a capacity of 25 ml made of colourless glass of type I, closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
The vial contains between 1 ml and 20 ml of solution, corresponding to an activity between 1000 and 20,000 MBq per vial at the date and time of calibration.
Expiry date (EXP)
Batch number (Lot)

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Synektik Pharma Sp. z o.o.
Józefa Piusa Dziekońskiego 3
00-728 Warsaw
Poland
e-mail: [email protected]

Manufacturer
Synektik Pharma Sp. z o.o.
Artwińskiego 3
25-734 Kielce
Poland

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: https://www.urpl.gov.pl.

Information intended exclusively for medical professionals:
To provide medical professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product, the full Summary of Product Characteristics (SmPC) for FLT(18F) Synektik is included within the packaging.