Package leaflet: Information for the patient

V-NaF 2 GBq/mL solution for injection
Sodium fluoride ( F)
Please read the entire leaflet before using this medicinal product.

Keep this leaflet, as you may need to read it again.
Consult your doctor if you have any further questions.
If any adverse reactions occur or worsen, including those not listed in this leaflet, inform the nuclear medicine physician supervising the examination.

Table of contents

What V-NaF is and what it is used for
Important information before using V-NaF
How to use V-NaF
Possible side effects
How to store V-NaF
Further information

1. What V-NaF is and what it is used for

V-NaF contains the active substance sodium fluoride ( F).
This medicinal product is a radiopharmaceutical (a radioactive medicinal product) intended solely for diagnostic purposes. V-NaF is used diagnostically in positron emission tomography (PET) imaging procedures and is administered prior to such an examination.
The radioactive substance contained in V-NaF (which enables visualization of bone metabolism) is detected during the PET scan and appears on the resulting images.
Positron emission tomography is an imaging technique used in nuclear medicine to obtain cross-sectional images of living organisms. A very small amount of radioactive pharmaceutical is required to perform a PET scan, enabling quantitative and accurate images reflecting metabolic processes in the body. PET imaging is performed to determine the appropriate treatment approach for a disease confirmed or suspected in the patient.
Administration of V-NaF to the patient results in exposure to a small amount of radiation. Therefore, performing a PET scan using this product is only carried out when the patient's attending physician and the nuclear medicine specialist agree that the clinical benefits to the patient from undergoing this examination will outweigh the risks associated with radiation exposure.

2. Important information before using V-NaF

V-NaF must not be administered

if the patient is allergic to sodium (F)fluoride or to any of the other components of this product (listed in section 6);
if the patient is pregnant or suspects she may be pregnant.

Warnings and precautions
Special caution must be observed when using V-NaF. The nuclear medicine specialist should be informed in the following situations:

if the patient is pregnant or suspects she may be pregnant;
if the patient is breastfeeding;
if the patient is under 18 years of age.

Before administration of V-NaF, the patient should:

Drink plenty of water to ensure adequate hydration at the time of the scan and urinate as frequently as possible during the first few hours after completion of the procedure.

V-NaF and other medicines
Inform the nuclear medicine specialist performing the scan about all medications currently taken or recently used, as they may interfere with the interpretation of the obtained images.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a nuclear medicine specialist before receiving this product.
Before administration of V-NaF, inform the nuclear medicine specialist if there is any possibility that the patient may be pregnant, if menstruation has not occurred, or if the patient is breastfeeding.
In case of doubt, it is important to consult the referring physician or the nuclear medicine specialist supervising the examination.

If the patient is pregnant
V-NaF must not be administered if the patient is pregnant.
The physician will consider performing this examination during pregnancy only if absolutely necessary.

If the patient is breastfeeding
If administration of the medicinal product is necessary during breastfeeding, breast milk should be expressed and stored for later use prior to injection. Breastfeeding must be interrupted for at least 8 hours. Breast milk expressed during this period must be discarded.

Driving and operating machinery
It is considered unlikely that V-NaF will affect the ability to drive or operate machinery.

V-NaF contains sodium
This medicine may contain more than 1 mmol (23 mg) of sodium. This should be taken into account if the patient is on a low-sodium diet.

3. How to use V-NaF

V-NaF is used only in authorized medical facilities, where it is prepared and administered exclusively by personnel with appropriate training and qualifications regarding safe use. These personnel will ensure that the medicine is used safely and will inform the patient how the medicine is administered.
The nuclear medicine specialist supervising the examination will determine the amount of V-NaF to be used in the individual case. This will be the smallest amount necessary to obtain the required diagnostic information.
The usual recommended dose in adults ranges from 100 MBq to 400 MBq (depending on the patient's body weight, type of equipment, and method of examination). MBq—megabecquerel—is the unit of measurement for radioactive activity.

Children and adolescents
In children and adolescents, the amount of product administered is adjusted according to body weight.

Administration of V-NaF and course of the examination
V-NaF is administered as a single intravenous injection.
One injection of the product is sufficient for performing one examination, for which the patient has been referred by their physician. After receiving the injection, the patient will be given water to drink and will be asked to empty the urinary bladder immediately before the examination begins.

Duration of the examination
The physician will inform the patient about the typical duration of the examination.

After administration of V-NaF, the patient should

avoid close contact with small children and pregnant women for 12 hours after the injection,
urinate frequently to eliminate the administered product from the body.

Administration of a higher than recommended dose of V-NaF
Overdose is almost impossible, as the patient will receive the dose of V-NaF under the strict supervision of the specialist physician overseeing the examination. However, in the event of an overdose, appropriate treatment will be administered. If there are any further doubts regarding the use of V-NaF, please consult the referring physician or the nuclear medicine specialist supervising the examination.

4. Possible adverse reactions

Like any medicine, V-NaF may cause adverse reactions, although not everyone experiences them.
No serious adverse reactions have been reported to date.
Administration of V-NaF involves a small dose of ionizing radiation, posing a very low risk of radiation-related adverse effects.
The treating physician has determined that the clinical benefit of the investigation using this radiopharmaceutical product outweighs the radiation risk.

Reporting adverse reactions
If any adverse symptoms occur, inform your doctor or nurse. This includes any adverse symptoms not listed in this leaflet.
Adverse reactions can also be reported directly to:
Department for Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicinal product V-NaF

There are no special storage requirements for this medicinal product. Do not freeze.
The patient will not store this product. This medicinal product is stored under the supervision of a nuclear medicine specialist in appropriate facilities. The product should be kept out of sight and reach of children.
Radiopharmaceuticals must be stored in accordance with current regulations concerning radioactive materials.
Do not use the medicinal product after the expiry date stated on the label after EXP (day and hour).

6. Other information

What V-NaF contains
The active substance is ( F)-sodium fluoride. 1 mL of solution contains 2 GBq of ( F)-sodium fluoride at the reference date and time.
Other components: sodium chloride, water for injections.

What V-NaF looks like and contents of the pack
The patient does not need to purchase this medicine independently, nor is it necessary to handle the packaging or the vial. The following information is provided for informational purposes only.
V-NaF is a clear, colourless solution.
Packaging: a colourless glass vial (type I) with a capacity of 15 mL, closed with a chlorobutyl rubber stopper and an aluminium seal, placed in a tungsten or lead shielding container.
Activity per vial ranges from 1 GBq to 30 GBq.

Marketing Authorisation Holder
Voxel S.A.,
ul. Wielicka 265,
30-663 Kraków
Tel. +48 32 6060500

Manufacturer
Voxel S.A.,
ul. Wielicka 265,
30-663 Kraków

Date of the most recent revision:

Information intended only for medical professionals:
The full Product Information for V-NaF, 2 GBq/mL, solution for injection is available as a separate document intended to provide healthcare professionals with additional scientific evidence and practical information regarding the administration and use of this radiopharmaceutical product.
Please consult the Summary of Product Characteristics (SmPC, available in the package).