V-naf

Package Leaflet: Information for the Patient

V-NaF 2 GBq/mL Solution for Injection

Sodium Fluoride (F)

Read the package leaflet carefully before using the medicine.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nuclear medicine specialist.
• If you experience any side effects, including those not listed in this leaflet, tell your nuclear medicine specialist.

Table of Contents of the Package Leaflet

• 1. What is V-NaF and what is it used for
• 2. Important information before using V-NaF
• 3. How to use V-NaF
• 4. Possible side effects.
• 5. How to store V-NaF
• 6. Other information.

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

V-NaF contains the active substance (F)-sodium fluoride.
This medicine is a radiopharmaceutical (radioactive medicine) intended solely for diagnostic purposes. V-NaF is used for diagnostic purposes during examinations performed using positron emission tomography (PET) and is administered before the start of such an examination.
The radioactive substance contained in V-NaF (enabling the visualization of bone metabolism) is detected during the PET examination and visualized on the images obtained from this examination.
Positron emission tomography is an imaging method used in nuclear medicine that involves obtaining cross-sectional images of living organisms. A very small amount of radioactive medicine is required to perform the PET examination to obtain quantitative and accurate images reflecting the metabolic processes occurring in the body. The PET examination is performed to determine the treatment of a diagnosed or suspected disease in the patient.
Administering V-NaF to the patient involves exposing them to a small amount of radiation.
Therefore, the PET examination with this product is performed only when the patient's doctor and nuclear medicine specialist agree that the clinical benefits to the patient from undergoing this examination will outweigh the risk associated with radiation exposure.

2. Important information before using V-NaF

V-NaF must not be administered

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

Warnings and precautions

When using V-NaF, special caution should be exercised.
In the following cases, the nuclear medicine specialist should be informed:

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

Before administering V-NaF, the patient should:

• drink plenty of water, so that at the time of the examination, they are well-hydrated and urinate as frequently as possible during the first few hours after the examination.

V-NaF and other medicines

The patient should tell the nuclear medicine specialist about all medicines they are currently taking or have recently taken, as they may interfere with the interpretation of the images obtained.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a nuclear medicine specialist before receiving this product.
Before administering V-NaF, the patient should inform the nuclear medicine specialist if there is a possibility that she is pregnant, has not had her period, or is breastfeeding.
In case of doubt, it is essential to ask the doctor or nuclear medicine specialist who will supervise the examination.

If the patient is pregnant

V-NaF should not be administered if the patient is pregnant.
The doctor will consider performing this examination during pregnancy only if it is absolutely necessary.

If the patient is breastfeeding

If it is necessary to administer V-NaF during breastfeeding, the patient should express milk before injection and store it for later use. Breastfeeding should be interrupted for at least 8 hours. The milk obtained during this time should be discarded.

Driving and using machines

It is considered unlikely that V-NaF will affect the ability to drive and use machines.

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 persons with appropriate training and qualifications in the field of safety of use. These persons will ensure that the medicine is used safely and inform the patient how the medicine is administered.
The nuclear medicine specialist supervising the examination will decide on the amount of V-NaF to be used in individual cases. This will be the smallest amount necessary to obtain the necessary diagnostic information.
The recommended dose in adults is usually between 100 MBq and 400 MBq (depending on the patient's weight, type of device, and method of examination). MBq - megabecquerel - is a unit of measurement of radioactive activity.

Children and adolescents

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

Administration of V-NaF and the course of the examination

V-NaF is administered in a single intravenous injection.
A single injection of the product is sufficient to perform one examination, for which the patient has been referred by their doctor. After receiving the injection, the patient will be given water to drink and asked to empty their bladder immediately before the start of the examination.

Duration of the examination

The doctor will inform the patient about the usual duration of the examination.

After administering V-NaF, the patient should

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

Overdose of V-NaF

Overdose is almost impossible, as the patient receives a dose of V-NaF under the strict control of the supervising nuclear medicine specialist. However, in case of overdose, the patient will receive appropriate treatment.
In case of any further doubts regarding the use of V-NaF, the patient should consult their doctor or nuclear medicine specialist who supervises the examination.

4. Possible side effects

Like all medicines, V-NaF can cause side effects, although not everybody gets them.
No serious side effects have been reported so far.
Administration of V-NaF provides a small dose of ionizing radiation with a very low risk of causing unwanted effects related to radiation.
The doctor has decided that the clinical benefit of the examination with the use of the radiopharmaceutical product outweighs the risk associated with radiation exposure.

Reporting side effects

If the patient experiences any side effects, they should inform their doctor or nurse. This includes any side effects not listed in this leaflet.
Side effects can also be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store V-NaF

There are no special precautions for storage. Do not freeze.
The patient will not store this medicine. This medicine is stored under the supervision of a nuclear medicine specialist in appropriate facilities. The medicine should be stored out of sight and reach of children.
Radiopharmaceuticals should be stored in accordance with the regulations regarding radioactive materials.
Do not use the medicine after the expiry date, i.e., the day and hour stated on the label after EXP.

6. Other information

What V-NaF contains

The active substance is (F)-sodium fluoride. 1 mL of the solution contains 2 GBq of (F)-sodium fluoride on the reference date.
The other ingredients are: sodium chloride, water for injections.

What V-NaF looks like and what the pack contains

The patient does not need to purchase this medicine themselves, nor is it necessary to deal with the packaging or vial. The following information is provided for informational purposes only.

V-NaF is a clear and colorless solution.
Packaging: a vial made of colorless glass (type I) with a capacity of 15 mL, closed with a chlorobutyl rubber stopper and an aluminum seal, placed in a tungsten or lead shield.
The activity per vial is between 1 GBq and 30 GBq.

Marketing authorization holder

Voxel S.A.,

ul. Wielicka 265,
30-663 Kraków
Phone: +48 32 6060500

Manufacturer

Voxel S.A.,

ul. Wielicka 265,
30-663 Kraków

Date of last revision:

Information intended for healthcare professionals only:

The full Summary of Product Characteristics for V-NaF, 2 GBq/mL, solution for injection is available as a separate document, which aims to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
It is recommended to read the Summary of Product Characteristics (found in the package).