Radio-flu

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Radio-Flu, 0.1–4 GBq/ml, solution for injection
Sodium fluoride (¹⁸F)
Please read carefully all the information in this leaflet before receiving 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 examination. If you experience any adverse reactions, including those not listed in this leaflet, inform the nuclear medicine specialist immediately. See section 4.

Table of contents:

1. What Radio-Flu is and what it is used for
2. Important information before use of Radio-Flu
3. How to use Radio-Flu
4. Possible side effects
5. How to store Radio-Flu
6. Contents of the packaging and other information

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

Radio-Flu contains the active substance sodium fluoride (¹⁸F).
This medicine is a radiopharmaceutical intended for diagnostic use only.
Radio-Flu is used in positron emission tomography (PET) imaging.
Positron emission tomography is a nuclear medicine imaging technique that produces images of functional processes in the body. A very small amount of a radioactive element is used to visualize specific processes within the body. This technique helps in making decisions regarding the treatment of a disease the patient has or is suspected to have.
The radioactive element contained in Radio-Flu enables visualization of abnormal changes in bones.
Radio-Flu is particularly used for:

• detecting and localizing metastases (spread of cancer cells) in bones in adults with confirmed malignant tumors
• assisting in the diagnosis of back pain of unknown origin
• assisting in the detection of bone abnormalities suspected to be caused by child abuse

The use of Radio-Flu involves exposure to a small dose of radioactivity. Your referring physician and the nuclear medicine specialist have determined that the clinical benefit obtained from the radiopharmaceutical procedure outweighs the radiation risk.

2. IMPORTANT INFORMATION BEFORE USING RADIO-FLU

When not to use Radio-Flu

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

Warnings and precautions
When to exercise particular 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 receiving Radio-Flu, the patient should

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

Children and adolescents
Patients under 18 years of age should consult with a nuclear medicine specialist physician.
Radio-Flu and other medicines
The patient must tell the nuclear medicine specialist physician about any medicines currently being taken, recently taken, or planned to be taken.
Pregnancy, breastfeeding and fertility
Before receiving Radio-Flu, the patient must inform the nuclear medicine specialist physician if there is any possibility that she is pregnant, if her menstrual period has not occurred, if she plans to have a child, or if she is breastfeeding. In case of doubt, it is important to consult the nuclear medicine specialist physician who will supervise the examination.
If the patient is pregnant
Radio-Flu must not be used during pregnancy.
If the patient is breastfeeding
In case of breastfeeding, breast milk may be expressed and stored before the planned injection. Breastfeeding should be discontinued for at least 12 hours before the scheduled injection. Any milk produced during this time should not be used.
The patient should ask the nuclear medicine specialist physician when she 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 machinery.
Radio-Flu contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per ml, meaning the medicine is considered "sodium-free".
Depending on the time of administration, the amount of sodium delivered to the patient with Radio-Flu may in some cases exceed 1 mmol. This should be taken into account in patients who are monitoring sodium intake in their diet.

3. HOW RADIO-FLU IS USED

Strict regulations govern the use, handling, and disposal of radiopharmaceuticals. Radio-Flu will only be used in specially controlled areas. This medicine will be administered only by trained and qualified personnel competent in its safe use. Such personnel will take special precautions to ensure safe use of this medicine and will inform the patient about their actions.
The nuclear medicine specialist physician supervising the examination will decide on the amount of Radio-Flu to be administered in the individual case. This will be the smallest amount necessary to obtain the required information.
The amount usually recommended for an adult is 100 to 400 MBq (megabecquerels, a unit of measurement of radioactivity).

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

Administration of Radio-Flu and performance of the examination
Radio-Flu is administered intravenously (into a vein).

Duration of the examination
The nuclear medicine specialist physician will inform the patient of the estimated duration of the examination. Depending on the procedure, the PET scan is usually performed between one and three hours after injection.
After the injection, the patient will be offered something to drink and asked to urinate shortly before the examination.

After receiving Radio-Flu, the patient should

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

The nuclear medicine specialist physician will inform the patient if any special precautions are necessary after receiving this medicine. If in doubt, the patient should contact the nuclear medicine specialist physician supervising the examination.

Administration of a higher than recommended dose of Radio-Flu
Overdose is unlikely because the patient will receive Radio-Flu under strict supervision of the physician overseeing the examination. However, in the event of an overdose, appropriate treatment will be administered. In particular, the physician responsible for the examination may advise the patient to drink large amounts of fluids to facilitate elimination of Radio-Flu from the body.
If there are any further doubts regarding the use of Radio-Flu, the patient should contact the nuclear medicine specialist physician supervising the examination.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this one may cause adverse reactions, although not everyone will experience them.
No serious side effects have been observed to date.
No serious adverse reactions have been reported.
This radiopharmaceutical product will deliver small amounts of ionizing radiation, with a very low risk of causing malignant tumors and hereditary abnormalities.
The treating physician has determined that the clinical benefit obtained from the examination using the radiopharmaceutical product outweighs the radiation risk.

Reporting of 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 of the 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 . Reporting adverse reactions helps to provide more information on the safety 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. Radiopharmaceuticals will be stored in accordance with national regulations concerning radioactive materials.

Information intended exclusively for healthcare professionals:
Do not use Radio-Flu after the expiry date stated on the label following “EXP”.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Radio-Flu contains

• The active substance is: sodium fluoride ( F).
• The other components are: sodium chloride, water for injections.

What Radio-Flu looks like and contents of the pack
The patient does not need to purchase the medicine independently or handle the packaging or vial. The following information is provided for informational purposes only.
Radio-Flu is a sterile, clear and colourless solution with a pH of 5.0 to 8.5.
One ml of Radio-Flu contains 0.1–4 GBq of sodium fluoride ( F) at the date and time of calibration.
Radio-Flu is supplied in a multidose vial filled with a volume of 1.0–13 ml.
Therefore, the total activity per vial ranges from 0.1 GBq to 52 GBq at the date and time of calibration.
Marketing Authorisation Holder
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
The Netherlands
This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names:

Information intended exclusively for medical personnel or healthcare professionals:

The complete Product Information for Radio-Flu is provided as a separate document
within the product documentation package. Its purpose is to provide healthcare professionals
with additional scientific and practical information regarding the administration and use of Radio-0Flu.