Glunektik

PATIENT INFORMATION LEAFLET

ENCLOSED PACKAGE LEAFLET: PATIENT INFORMATION

GLUNEKTIK 1 GBq/mL, solution for injection

Fludeoxyglucose (F)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a specialist doctor in nuclear medicine who supervises the treatment.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in the leaflet, they should inform the specialist doctor in nuclear medicine. See section 4.

Table of contents of the leaflet:

• 1. What is GLUNEKTIK and what is it used for
• 2. Important information before using GLUNEKTIK
• 3. How to use GLUNEKTIK
• 4. Possible side effects
• 5. How to store GLUNEKTIK
• 6. Package contents and other information

1. What is GLUNEKTIK and what is it used for

This medicine is a radiopharmaceutical preparation intended exclusively for diagnostic purposes.
GLUNEKTIK contains the radioactive substance fludeoxyglucose (F), which enables the performance of imaging diagnostics for certain parts of the body.
After administering a small amount of GLUNEKTIK, the doctor will take pictures using a special device (tomograph), based on which they will assess the patient's condition and the progress of the disease treatment.

2. Important information before using GLUNEKTIK

When not to use GLUNEKTIK

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

Warnings and precautions

Before starting to use GLUNEKTIK, consult a specialist doctor in nuclear medicine:

• if the patient has uncontrolled diabetes despite treatment
• if the patient has been diagnosed with an infection or inflammatory disease
• if the patient has been diagnosed with kidney disease.

Inform the specialist doctor in nuclear medicine:

• if the patient is pregnant or suspects pregnancy
• if the patient is breastfeeding.

Before administering GLUNEKTIK:

• drink a large amount of water before the examination to urinate as often as possible during the first 4 hours after its completion
• avoid physical exertion
• do not eat for at least 4 hours.

Children and adolescents

Tell the specialist doctor in nuclear medicine if the patient is under 18 years old.

GLUNEKTIK and other medicines

Tell the specialist doctor in nuclear medicine about all medicines being taken currently or recently, as well as any plans to take medicines in the future, as other medicines may affect the assessment of the examination results.
This applies to the following medicines:

• medicines that may change blood glucose levels, such as anti-inflammatory medicines (corticosteroids), antiepileptic medicines (valproic acid, carbamazepine, phenytoin, phenobarbital), or medicines acting on the central nervous system (adrenaline, noradrenaline, dopamine, etc.)
• glucose
• insulin
• medicines that stimulate the production of red blood cells.

GLUNEKTIK with food and drink

Do not consume any food for at least 4 hours before receiving GLUNEKTIK. During this time, drink plenty of water and avoid sugary drinks.
Before administering GLUNEKTIK, the specialist doctor in nuclear medicine will check the patient's blood glucose levels, as high glucose levels may hinder the assessment of the examination results.

Pregnancy and breastfeeding

If the patient may be pregnant, is breastfeeding, or has not had their last menstrual period, they must inform the specialist doctor in nuclear medicine.
In case of doubts, consult the specialist doctor in nuclear medicine performing the examination.
Pregnant patients
The specialist doctor in nuclear medicine will administer the medicine only if the benefits of its use outweigh the risks.
Breastfeeding patients
Stop breastfeeding for 12 hours after GLUNEKTIK injection and discard the expressed milk during this time.
Resume breastfeeding after consulting the specialist doctor in nuclear medicine who performed the examination.
Consult the specialist doctor in nuclear medicine before receiving this medicine if the patient is breastfeeding, is currently pregnant, suspects pregnancy, or plans to become pregnant.

Driving and using machines

GLUNEKTIK is unlikely to affect the ability to drive or use machines.

GLUNEKTIK contains sodium

The medicine contains at least 23 mg (1 mmol) of sodium. This should be taken into account for patients on a low-sodium diet.

3. How to take GLUNEKTIK

The use, handling, and disposal of radiopharmaceutical preparations are strictly regulated by relevant regulations. GLUNEKTIK will be used only in specially controlled rooms and administered to patients in accordance with radiological protection rules by trained and qualified medical staff. The staff will strictly follow the rules for safe use of the medicine and inform the patient about the procedures being performed.
The specialist doctor in nuclear medicine supervising the examination will select the appropriate dose of GLUNEKTIK for each patient. This will be the smallest amount of medicine that allows the examination to be performed.
In adult patients, the most commonly used dose is 100 to 400 MBq (megabecquerels). Megabecquerel is a unit of radioactive substance activity. The activity dose is selected based on the patient's body weight, the type of equipment, and the examination mode.

Use in children and adolescents

In children and adolescents, the dose is selected based on body weight.

Administration of GLUNEKTIK and performance of the examination

GLUNEKTIK is administered intravenously.
The examination is performed after injecting a single dose of the medicine.
After injection, the patient should remain still, not talk, or read. Just before the examination, the patient will be given a liquid to drink and will be asked to urinate.
During the examination, the patient should lie still.

Do not move or talk.

Examination duration

The specialist doctor in nuclear medicine will inform the patient how long the examination will take.
GLUNEKTIK is injected into a vein 45-60 minutes before the start of the examination, and then the examination is performed, which takes about 30-60 minutes.

After administering GLUNEKTIK:

• avoid close contact with small children and pregnant women for 12 hours after injection.
• urinate frequently to accelerate the removal of the medicine from the patient's body.

Overdose of GLUNEKTIK

Overdose is very unlikely, as the patient receives a single dose of GLUNEKTIK under the strict control of the specialist doctor in nuclear medicine performing the examination. However, if an overdose occurs, the patient will receive appropriate treatment. In such a case, the specialist doctor in nuclear medicine may recommend drinking large amounts of fluids to accelerate the elimination of GLUNEKTIK from the body. GLUNEKTIK is mainly excreted through the kidneys with urine.
In case of any additional questions about the use of GLUNEKTIK, consult the specialist doctor in nuclear medicine.

4. Possible side effects

Like all medicines, GLUNEKTIK can cause side effects, although not everybody gets them.
The radiopharmaceutical preparation emits a small amount of radioactive radiation and may cause cancer and congenital disorders, but the risk of their occurrence is very small.
The doctor will administer the medicine only if the benefits of using the radiopharmaceutical are greater than the risks associated with exposure to ionizing radiation.

Reporting side effects

If any adverse reactions occur, including any possible adverse reactions not listed in the leaflet, inform the doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store GLUNEKTIK

The medicine will not be stored by patients, but by specialized personnel in a special room. Radiopharmaceutical preparations are stored in accordance with national regulations on radioactive materials.
The following information is intended only for specialized medical personnel.
Do not use the medicine after the expiration date stated on the label: {DD MM YYYY, time: gg:mm}.

6. Package contents and other information

What GLUNEKTIK contains

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

What GLUNEKTIK looks like and what the package contains

The activity of one vial of the solution is between 0.2 and 20.0 GBq (according to the measurement at the time of calibration).

Marketing authorization holder and manufacturer

Marketing authorization holder

SYNEKTIK S.A.

ul. Józefa Piusa Dziekońskiego 3
00-728 Warsaw
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 Warsaw
Poland

This medicinal product has been authorized in the Member States of the European Economic Area 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

Date of leaflet approval: 02.12.2024

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 .
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Information intended only for healthcare professionals:
The package leaflet includes a separate complete Summary of Product Characteristics for GLUNEKTIK, containing additional scientific and practical information for healthcare professionals on the use and dosing of this radiopharmaceutical preparation.
Further information is available in the Summary of Product Characteristics enclosed with the product packaging.