PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

GLUNEKTIK 1 GBq/mL, solution for injection
fludeoxyglucosum ( F)
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult the nuclear medicine specialist supervising your treatment.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your nuclear medicine specialist immediately. See section 4.

Table of contents of the leaflet:

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

1. What GLUNEKTIK is and what it is used for

This medicine is a radiopharmaceutical preparation intended solely for diagnostic use.
GLUNEKTIK contains the radioactive substance fludeoxyglucose (F), which enables imaging procedures in specific areas of the body.
After administration of a small amount of GLUNEKTIK, the physician will perform imaging using a special device (tomograph), based on which the patient's condition and progress in disease treatment will be assessed.

2. Important information before using GLUNEKTIK

When not to use GLUNEKTIK

if the patient is allergic to fludeoxyglucose (F) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with GLUNEKTIK, consult a nuclear medicine specialist:

if the patient has diabetes that is not fully controlled despite treatment
if the patient has an infection or inflammatory disease
if the patient has a kidney disease.

Inform the nuclear medicine specialist:

if the patient is pregnant or suspects she may be pregnant
if the patient is breastfeeding.

Before administration of GLUNEKTIK:

drink plenty of water before the examination begins, to urinate as frequently as possible during the first 4 hours after completion
avoid physical exertion
do not eat for at least 4 hours.

Children and adolescents
Inform the nuclear medicine specialist if the patient is under 18 years of age.
GLUNEKTIK and other medicines
Tell the nuclear medicine specialist about all medicines currently used, recently used, or planned for future use, as other medicines may affect the interpretation of the scan results.
This includes the following medicines:

medicines that may alter blood glucose levels, such as anti-inflammatory drugs (corticosteroids), anticonvulsants (valproic acid, carbamazepine, phenytoin, phenobarbital), or those acting on the central nervous system (adrenaline, noradrenaline, dopamine, etc.)
glucose
insulin
medicines stimulating red blood cell production.

GLUNEKTIK with food and drink
For at least 4 hours before receiving GLUNEKTIK, no food should be consumed. During this time, drink plenty of water and avoid beverages containing sugar.
Before administering GLUNEKTIK, the nuclear medicine specialist will check blood glucose levels, as excessively high glucose levels may interfere with the interpretation of scan results.
Pregnancy and breastfeeding
If the patient may be pregnant, is breastfeeding, or has missed her last menstrual period, she must inform the nuclear medicine specialist.
In case of doubt, consult the nuclear medicine specialist performing the examination.
Pregnant patients
The nuclear medicine specialist will administer the medicine only if the benefits outweigh the potential risks.
Breastfeeding patients
Breastfeeding must be interrupted for 12 hours after injection of GLUNEKTIK, and milk expressed during this time must be discarded.
Resuming breastfeeding should be discussed with the nuclear medicine specialist who performed the examination.
Before administering this medicine, consult a nuclear medicine specialist if the patient is breastfeeding, currently pregnant, suspects pregnancy, or plans to become pregnant.
Driving and operating machinery
GLUNEKTIK is unlikely to affect the ability to drive or operate machinery.
GLUNEKTIK contains sodium
This medicine contains at least 23 mg (1 mmol) of sodium. This should be taken into account in patients on a low-sodium diet.

3. How to use GLUNEKTIK
The use, handling, and disposal of radiopharmaceuticals are strictly regulated by appropriate regulations. GLUNEKTIK will be administered only in specially controlled facilities and given to patients in accordance with radiation protection principles by trained and qualified medical personnel. Staff will strictly follow safety procedures for using the medicine and will inform the patient about all procedures performed.
The nuclear medicine specialist supervising the examination will determine the appropriate dose of GLUNEKTIK for each patient. This will be the smallest amount of medicine necessary to perform the examination.
In adult patients, the administered activity is typically between 100 and 400 MBq (megabecquerels).
The megabecquerel is a unit of radioactivity. The administered activity is adjusted according to the patient's body weight, type of equipment, and scanning mode.
Use in children and adolescents
In children and adolescents, the dose is adjusted according to body weight.
Administration of GLUNEKTIK and performance of the examination
GLUNEKTIK is administered intravenously.
The examination is performed after injection of a single dose of the medicine.
After injection, the patient should remain still, avoid talking, and refrain from reading. Just before the examination, the patient will be given a drink and asked to urinate.
During the examination, the patient must lie still.
Movement and talking are not allowed.
Duration of the examination
The nuclear medicine specialist will inform the patient how long the examination will take.
GLUNEKTIK is injected intravenously 45–60 minutes before the start of the examination, followed by a scan lasting approximately 30–60 minutes.
After administration of GLUNEKTIK:

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

Use of a higher than recommended dose of GLUNEKTIK
Overdose is highly unlikely, as the patient will receive a single dose of GLUNEKTIK under strict supervision of the nuclear medicine specialist performing the examination. However, if overdose occurs, appropriate treatment will be provided. In such cases, the nuclear medicine specialist may recommend drinking large amounts of fluids to accelerate elimination of GLUNEKTIK from the body. GLUNEKTIK is primarily excreted via the kidneys in urine.
For any additional questions regarding the use of GLUNEKTIK, consult the nuclear medicine specialist.

4. Possible adverse reactions

Like all medicines, GLUNEKTIK may cause adverse reactions, although not everyone experiences them.
The radiopharmaceutical emits a small amount of radioactive radiation and may cause tumours and congenital diseases; however, the risk of their occurrence is very low.
The doctor will administer the medicine only if the benefits of using the radiopharmaceutical outweigh the risks associated with exposure to ionising radiation.
Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
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
PL-02 222 Warsaw
Tel.: +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 marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store GLUNEKTIK

The medicine will not be stored by patients, but by specialist personnel in a designated room. Radiopharmaceuticals must be stored in accordance with national regulations concerning radioactive materials.
The following information is intended solely for specialist medical personnel.
Do not use the medicine after the expiry date stated on the label after: {DD MM YYYY hh:mm}.

6. Contents of the packaging and other information

What GLUNEKTIK contains

The active substance is fludeoxyglucose ( F). The activity of 1 mL of fludeoxyglucose ( F) injection solution is 1 GBq (measured at calibration time).
The other components are: water for injections, disodium hydrogen citrate sesquihydrate, trisodium citrate dihydrate, sodium chloride.

What GLUNEKTIK looks like and contents of the pack
The activity per vial of the solution ranges from 0.2 to 20.0 GBq (according to measurement at calibration time).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SYNEKTIK S.A.
ul. Józefa Piusa Dziekońskiego 3
00-728 Warszawa
Poland

Manufacturer
Synektik Pharma Sp. z o.o.
ul. Artwińskiego 3
25-734 Kielce
Poland
Synektik Pharma Sp. z o.o.
ul. Szaserów 128
04-349 Warszawa
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Lithuania Fludeoxyglucose ( F) Synektik 1.0 GBq/mL, injekcinis tirpalas
Poland GLUNEKTIK
Czech Republic Glunektik 1 GBq/ml, injekční roztok
Slovakia FLUDEOXYGLUKÓZA ( F) SYNEKTIK 1.0 GBq/mL, injekčný roztok

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

Information intended solely for professional medical personnel:

The package insert includes a separate, complete Product Information Leaflet for
GLUNEKTIK, containing additional scientific and practical information for medical professionals
regarding the use and dosing of this radiopharmaceutical preparation.
Further information is available in the Product Information Leaflet included in the
product's packaging.