Radio-flu

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Radio-Flu, 0.1 4 GBq/ml, solution for injection
Sodium fluoride (F)

You should carefully read the contents of the leaflet before receiving the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

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

1. WHAT IS RADIO-FLU AND WHAT IS IT USED FOR

Radio-Flu contains the active substance sodium fluoride (18F).
This medicine is a radiopharmaceutical product intended exclusively for diagnostic purposes.
Radio-Flu is used in examinations using positron emission tomography (PET).
Positron emission tomography is an imaging technique used in nuclear medicine, which provides an image of functional processes in the body. A very small amount of radioactive material is used to visualize specific processes in the body. This technique helps in making decisions about the treatment of the disease that the patient is suffering from or is suspected of having.
The radioactive material contained in Radio-Flu allows for the visualization of abnormal changes in bones.
Radio-Flu is particularly used for

• detecting and locating metastases (spread of cancer cells) in bones in adults with confirmed malignant tumors
• helping in the diagnosis of back pain of unknown origin
• helping in the detection of bone changes related to suspected child abuse

The use of Radio-Flu is associated with exposure to a small dose of radioactivity. The doctor in charge and the specialist doctor in nuclear medicine have decided that the clinical benefit resulting from the examination with the use of the radiopharmaceutical product outweighs the risk associated with radiation.

2. IMPORTANT INFORMATION BEFORE USING RADIO-FLU

When not to use Radio-Flu

• if the patient is allergic to sodium fluoride (F) or any of the other ingredients of this medicine (listed in section 6).
• if the patient is pregnant. If the patient suspects that she may be pregnant, she should inform the nuclear medicine doctor.

Warnings and precautions

When to exercise special caution when using Radio-Flu

• if the patient is breastfeeding.
• if the patient is under 18 years of age.
• if the patient has any kidney problems.

Before administering Radio-Flu, the patient should

• drink plenty of water before the examination to urinate as frequently as possible during the first hours after the examination.

Children and adolescents

Patients under 18 years of age should consult a specialist doctor in nuclear medicine.

Radio-Flu and other medicines

The patient should tell the specialist doctor in nuclear medicine about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

Before administering Radio-Flu, the patient should inform the specialist doctor in nuclear medicine if there is a possibility that she is pregnant, has not had her period, or plans to have a child, or if she is breastfeeding. In case of doubts, it is essential to consult a specialist doctor in nuclear medicine who will supervise the examination.

If the patient is pregnant

Radio-Flu should not be used during pregnancy.

If the patient is breastfeeding

In the case of breastfeeding, breast milk may be expressed and stored for later use before injection. Breastfeeding should be interrupted for at least 12 hours before the planned injection. Any milk produced during this time should not be used.
The patient should ask the specialist doctor in nuclear medicine when they can resume breastfeeding.
It is recommended to avoid close contact with infants during the first 12 hours after receiving the injection.

Driving and using machines

It is unlikely that Radio-Flu will affect the ability to drive or operate machines.

Radio-Flu contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per ml, which means that the medicine is considered "sodium-free". Depending on the time of administration of Radio-Flu, the amount of sodium administered to the patient may be higher than 1 mmol in some cases. This should be taken into account in patients who control their sodium intake.

3. HOW TO USE RADIO-FLU

There are strict regulations regarding the use, handling, and disposal of radiopharmaceutical products. Radio-Flu will only be used in specially controlled areas. This medicine will be administered to the patient only by trained and qualified personnel. Such personnel will exercise special caution to ensure the safe use of this medicine and will inform the patient about their actions.
The specialist doctor in nuclear medicine supervising the examination will decide on the amount of Radio-Flu to be used in individual cases. This will be the smallest amount necessary to obtain the desired information.
The amount to be administered, usually recommended for an adult, is between 100 and 400 MBq (megabecquerels, a unit of measurement of radioactivity).

Use in children and adolescents

In the case of children and adolescents, the amount to be administered will be adjusted according to the child's body weight.

Administration of Radio-Flu and performance of the examination

Radio-Flu is administered intravenously.

Duration of the examination

The specialist doctor in nuclear medicine will inform the patient about the estimated duration of the examination.
Depending on the procedure, the PET examination is usually performed after 1 to 3 hours after injection.
After injection, the patient will be offered something to drink and will be asked to urinate just before the examination.

After administration of Radio-Flu, the patient should

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

The specialist doctor in nuclear medicine will inform the patient if any special precautions are necessary after receiving this medicine. In case of questions, the patient should consult the specialist doctor in nuclear medicine.

Administration of a higher dose of Radio-Flu than recommended

Overdose is unlikely, as the patient will receive Radio-Flu under the strict control of the supervising doctor. However, in the event of an overdose, the patient will receive appropriate treatment. In particular, the doctor responsible for the examination may recommend that the patient drink plenty of fluids to facilitate the elimination of Radio-Flu from the body.
In case of any further doubts related to the use of Radio-Flu, the patient should consult the specialist doctor in nuclear medicine who supervises the examination.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Radio-Flu can cause side effects, although not everybody gets them.
No serious side effects have been observed so far.
No serious adverse reactions have been observed.
This radiopharmaceutical product will deliver small amounts of ionizing radiation with a very low risk of developing malignant tumors and genetic disorders.
The doctor in charge has decided that the clinical benefit resulting from the examination with the use of the radiopharmaceutical product outweighs the risk associated with radiation.

Reporting side effects

If any adverse reactions occur, including any adverse reactions not listed in the leaflet, the patient should inform the doctor or pharmacist. Adverse reactions 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, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the use of the medicine.

5. HOW TO STORE RADIO-FLU

The patient does not need to store this medicine. This medicine is stored under the supervision of a specialist in appropriate facilities. Radiopharmaceutical products will be stored in accordance with national regulations regarding radioactive materials.
Information intended exclusively for healthcare professionals:
Do not use Radio-Flu after the expiry date stated on the label after "EXP".

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Radio-Flu contains

• The active substance of the medicine is: sodium fluoride (F).
• The other ingredients are: sodium chloride, water for injections.

What Radio-Flu looks like and what the package contains

The patient does not need to purchase the medicine or handle the packaging or bottle themselves. The following information is provided for informational purposes only.
Radio-Flu is a sterile, clear, and colorless solution with a pH between 5.0 and 8.5.
One ml of Radio-Flu contains 0.1-4 GBq of sodium fluoride (F) on the day and time of calibration.
Radio-Flu is supplied in a multidose vial filled with a volume of 1.0-13 ml.
The activity per vial is therefore between 0.1 GBq and 52 GBq on the day and time of calibration.

Responsible entity

Alliance Medical RP Berlin GmbH
Max-Planck-Str. 4
12489 Berlin
Germany

Manufacturer

Alliance Medical RP Berlin GmbH
Max-Planck-Str. 4
12489 Berlin
Germany
Radboud Translational Medicine B.V.
Route 142
Geert Grooteplein Noord 21
Nijmegen 6525 EZ
Netherlands

This medicinal product is authorized in the Member States of the European

Economic Area under the following names:

Date of last revision of the leaflet: 15.05.2024

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Information intended exclusively for medical personnel or healthcare workers:
The full Summary of Product Characteristics for Radio-Flu is provided as a separate document in the product documentation package. Its purpose is to provide healthcare professionals with additional scientific and practical information on the administration and use of Radio-Flu.