V-GA68

Package leaflet: Information for the patient

V-Ga68 500 MBq/ml radiopharmaceutical precursor, solution
Gallii ( Ga) chloridum
Please read all of this leaflet before the medicine is administered.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your nuclear medicine physician.
• If you experience any side effects, including those not listed in this leaflet, please inform the nuclear medicine physician supervising your examination.

Contents of the leaflet:

1. What V-Ga68 is and what it is used for
2. Important information before administration of a medicine labelled with V-Ga68
3. How to use V-Ga68
4. Possible side effects
5. How to store V-Ga68
6. Contents of the pack and other information

1. What V-Ga68 is and what it is used for

V-Ga68 is not intended for direct administration to patients.
V-Ga68 is a special type of medicine called a radiopharmaceutical precursor. It contains the active substance Gallii ( Ga) chloridum (gallium ( Ga) chloride) and belongs to the pharmacotherapeutic class "Other diagnostic radiopharmaceuticals".
V-Ga68 is intended for radiolabelling a carrier medicine. The carrier medicine transports radioactive gallium atoms to diseased organs.
The gallium-labelled carrier medicine is used for diagnostic purposes during positron emission tomography (PET) scans and is administered prior to such imaging. The radioactive substance contained in the labelled carrier medicine is detected during the PET scan and visualized in 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 imaging reflecting metabolic processes in the body. PET scans are performed to determine the appropriate treatment approach for a condition confirmed or suspected in the patient.
Administration of a gallium-labelled carrier medicine results in patient exposure to a small amount of radiation. Therefore, a PET scan using this medicine is only performed when the patient's treating physician and the nuclear medicine specialist agree that the clinical benefits to the patient outweigh the risks associated with radiation exposure.
Information regarding the medicine intended for gallium labelling is provided in the package leaflet accompanying that medicine.

2. Important information before administration of a medicine labelled with V-Ga68

Medicines labelled with V-Ga68 must not be administered

• if the patient is allergic to gallium or any of the other components of this product (listed in section 6);
• if the patient is pregnant or suspects she may be pregnant;
• in situations contraindicated in the leaflet of the medicinal product intended for gallium labelling.

Warnings and precautions
Particular caution must be exercised when using gallium-labelled medicines.
The nuclear medicine specialist performing the examination should be informed if:

• the patient is pregnant or suspects she may be pregnant;
• the patient is breastfeeding;
• the patient has kidney problems.

Before receiving a medicine labelled with V-Ga68, the patient should:

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

Children and adolescents
If the patient is under 18 years of age, consultation with the nuclear medicine specialist to whom the patient has been referred is required.

Medicines labelled with V-Ga68 and other medicines
Inform the nuclear medicine specialist performing the examination about all medicines currently taken or recently taken, as they may interfere with the interpretation of the obtained images.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the nuclear medicine specialist before receiving this medicine.
If the patient is pregnant, a medicine labelled with V-Ga68 must not be administered.
Before receiving a medicine labelled with V-Ga68, the patient must inform the nuclear medicine specialist if there is any possibility she may be pregnant, if her menstrual period is delayed, or if she is breastfeeding.
In case of any doubts, please consult the nuclear medicine specialist supervising the planned examination.
For breastfeeding women:
Breast milk may be expressed and stored for later use before injection of the medicine labelled with V-Ga68. Breastfeeding must be interrupted for at least 4 hours after injection of the medicine. Breast milk expressed during this period should not be used.
The patient should ask the nuclear medicine specialist when she can resume breastfeeding.
Close contact with infants should be avoided for the first 4 hours after administration of the medicine to the patient.

Driving and operating machinery
It is considered unlikely that administration of a medicine labelled with V-Ga68 will affect the ability to drive or operate machinery.
Important information regarding the medicine intended for labelling with V-Ga68 is also provided in the package leaflet accompanying that medicine.

3. How to use a medicine labelled with V-Ga68

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. V-Ga68 is used only in authorized medical facilities and is prepared and administered exclusively by personnel with appropriate training and qualifications in radiation safety. These personnel will ensure the medicine is used safely and will inform the patient how it is administered.
The nuclear medicine specialist supervising the examination will determine the amount of medicine labelled with V-Ga68 to be administered to the patient. This will be the smallest amount necessary to obtain the required diagnostic information.

Use in children and adolescents
In children and adolescents, the administered amount is adjusted according to body weight.

Administration of the medicine labelled with V-Ga68 and the course of the examination
The medicine labelled with V-Ga68 is administered as a single intravenous injection.

Duration of the examination
The nuclear medicine specialist supervising the examination will inform the patient about the typical duration of such a scan. The duration depends on the type of scanner and the procedure used. After receiving the injection, the patient will be given water to drink and asked to empty the bladder immediately before the scan begins.

After receiving the medicine labelled with V-Ga68, the patient should

• avoid close contact with young children and pregnant women for 4 hours after injection;
• urinate frequently to eliminate the administered product from the body.
  If any special precautions are required after receiving this product, the patient will be informed by the nuclear medicine specialist performing the examination. If the patient has any questions, they should contact the nuclear medicine specialist who performed the examination.

If the patient has received too much medicine labelled with V-Ga68
Overdose is almost impossible, as the patient receives only a single dose of V-Ga68-labelled medicine, precisely controlled beforehand by the nuclear medicine specialist supervising the examination. Nevertheless, if overdose occurs, the patient will receive appropriate treatment. Elimination of radioactive substances from the body should be maximized. For this purpose, the patient should drink maximum amounts of fluids and urinate as frequently as possible. Diuretic medicines may be required.
If you have any further questions about the use of V-Ga68, please consult the nuclear medicine specialist supervising your examination.

4. Possible adverse reactions

Like all medicines, the V-Ga68 radiolabelled medicinal product may cause adverse reactions, although
not everyone will experience them.
Additional information can be found in the package leaflet of the V-Ga68 radiolabelled medicinal product.
The administered radiopharmaceutical will emit a small amount of ionizing radiation into the patient's body, which is associated with a very low risk of developing malignant tumors and congenital abnormalities in offspring. The treating physician has determined that the clinical benefit of the examination using the V-Ga68 radiolabelled medicinal product outweighs the radiation-related risk.
Reporting of adverse reactions
If any adverse reactions occur, inform your doctor or nurse. This includes any adverse reactions not listed in the package leaflet.
Adverse reactions can also be reported directly to:
Department for Monitoring Adverse Reactions of Medicinal Products, 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 adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store V-Ga68

Patients must not store this medicinal product. It will be stored under the supervision of a specialist in an appropriate location. Radiopharmaceuticals are stored in accordance with national regulations concerning radioactive materials.
The following information is intended for specialists only.
V-Ga68 medicinal product and medicinal products labelled with V-Ga68 must not be used after the expiry date stated on the label after EXP.

6. Contents of the packaging and other information

What V-Ga68 contains
The active substance is gallium ( Ga) chloride. 1 ml of solution contains 500 MBq of gallium ( Ga) chloride at
the reference date and hour.
The other component is 0.1M hydrochloric acid.

What V-Ga68 looks like and contents of the pack
A colourless type I glass vial with a capacity of 15 mL, closed with a type I bromobutyl rubber stopper coated with FluoroTec® and an aluminium seal.
One 15 mL vial contains 1–5 mL of solution, corresponding to an activity of 500–2500 MBq at the reference date and time.

Marketing Authorisation Holder
Voxel S.A.,
ul. Wielicka 265,
30-663 Kraków
Email: [email protected]

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

Other sources of information
Detailed information on this product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://www.urpl.gov.pl.