V-ga68

PATIENT INFORMATION LEAFLET

Leaflet enclosed with the packaging: information for the patient

V-Ga68 500 MBq/ml radiopharmaceutical precursor, solution

Gallium (Ga) chloride

Read the leaflet carefully before using the medicine.

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

Table of contents of the leaflet:

• 1. What is V-Ga68 and what is it used for
• 2. Important information before using the medicine labeled with V-Ga68
• 3. How to use the medicine V-Ga68
• 4. Possible side effects.
• 5. How to store the medicine V-Ga68
• 6. Package contents and other information.

1. What is V-Ga68 and what is it 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 Gallium (Ga) chloride (gallium (Ga) chloride) and belongs to the pharmacotherapeutic class
"Other diagnostic radiopharmaceuticals".
V-Ga68 is intended for radiolabeling of a carrier medicine. The carrier medicine carries
radioactive gallium atoms to diseased organs.
The gallium-labeled carrier medicine is used for diagnostic purposes during examinations
performed using positron emission tomography (PET) and is administered before
starting such an examination. The radioactive substance contained in the labeled carrier medicine is detected during the PET examination and visualized on the images obtained as a result of this
examination.
Positron emission tomography is an imaging method used in nuclear medicine that involves
obtaining cross-sectional images of living organisms. To perform a PET examination, a very small amount of radioactive pharmaceutical is needed 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 disease diagnosed or suspected in the patient.
Administering the gallium-labeled carrier medicine to the patient involves exposing them to a small amount of radiation. Therefore, a PET examination using this medicine is only performed when the patient's attending physician and nuclear medicine specialist agree that the clinical benefits to the patient from undergoing this examination will outweigh the risk associated with radiation exposure.
Information about the medicine intended for radiolabeling with V-Ga68 can be found in the leaflet enclosed with the packaging of that medicine.

2. Important information before using the medicine labeled with V-Ga68

Medicines labeled with V-Ga68 must not be administered

• if the patient is allergic to gallium or any of the other ingredients of this product (listed in section 6);
• if the patient is pregnant or thinks she may be pregnant.
• in situations indicated in the leaflet of the medicinal product intended for radiolabeling with V-Ga68

Warnings and precautions

When using medicines labeled with V-Ga68, special caution should be exercised.
The nuclear medicine specialist who will perform the examination should be informed if:

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

Before receiving the medicine labeled with V-Ga68, 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.

Children and adolescents

If the patient is under 18 years old, they should consult a nuclear medicine specialist to whom they have been referred.

Medicines labeled with V-Ga68 and other medicines

The patient should tell the nuclear medicine specialist performing the examination 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 medicine.
If the patient is pregnant, the medicine labeled with V-Ga68 must not be administered to her.
Before receiving the medicine labeled with V-Ga68, the patient must inform the nuclear medicine specialist if she thinks she may be pregnant, if her menstrual period is delayed, or if she is breastfeeding.
In case of any doubts, the patient should consult the nuclear medicine specialist who will supervise the examination planned for her.
Regarding breastfeeding women:
Before injecting the medicine labeled with V-Ga68, breast milk can be expressed and stored for later use. Breastfeeding should be interrupted for at least 4 hours after the injection. The expressed milk during this time should not be given to the baby.
The patient should ask the nuclear medicine specialist when she can resume breastfeeding.
It is recommended to avoid close contact with infants for the first 4 hours after administering the medicine to the patient.

Driving and using machines

It is considered unlikely that the administration of the medicine labeled with V-Ga68 will affect the patient's ability to drive or operate machinery.
Important information about the medicine intended for radiolabeling with V-Ga68 can also be found in the leaflet enclosed with the packaging of that medicine.

3. How to use the medicine labeled with V-Ga68

There are
strict
regulations
regarding
the use,
handling
and
disposal
of radiopharmaceuticals. The medicine V-Ga68 is used only in authorized medical facilities,
where it is prepared and administered exclusively by persons with the necessary training
and qualifications in the field of safety of use. These persons will ensure that the medicine is used
safely and will inform the patient how it is administered.
The nuclear medicine specialist supervising the examination will decide what dose of the medicine labeled with V-Ga68 should be administered to the patient. This will be the smallest dose necessary to obtain the required diagnostic information.

Use in children and adolescents

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

Administration of the medicine labeled with V-Ga68 and the course of the examination

The medicine labeled with V-Ga68 is administered in a single intravenous injection.

Duration of the examination

The nuclear medicine specialist supervising the examination will inform the patient about the usual duration of this type of examination. The duration of the examination depends on the type of scanner and the procedure used. After receiving the injection, the patient will be given water to drink and will be asked to empty their bladder immediately before the start of the examination.

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

• avoid close contact with small children and pregnant women for 4 hours after the injection,
• urinate frequently to remove the administered product from the body. If it is necessary for the patient to take any special precautions after receiving the product, they 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 received too much of the medicine labeled with V-Ga68

Overdose is almost impossible, as the patient receives only one dose of the medicine labeled with V-Ga68, previously precisely controlled by the nuclear medicine specialist who will supervise the examination. If an overdose occurs, the patient will receive appropriate treatment. The removal of radioactive substances from the body should be maximally accelerated. To this end, the patient should drink as much fluid as possible and urinate as frequently as possible. It may be necessary to take diuretic medicines.
In case of any further questions about the use of V-Ga68, the patient should consult the nuclear medicine specialist supervising the examination performed on them.

4. Possible side effects

Like all medicines, the medicine labeled with V-Ga68 can cause side effects, although they may not occur in every patient.
Additional information can be found in the leaflet of the medicine labeled with V-Ga68.
The administered pharmaceutical will emit a small amount of ionizing radiation after administration to the patient, which is associated with a very low risk of developing malignant tumors and congenital defects in offspring. The patient's doctor has determined that the clinical benefit of the examination using the medicine labeled with V-Ga68 outweighs the risk associated with radiation exposure.

Reporting side effects

In case of any side effects, the patient 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
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store the medicine V-Ga68

The patient does not store this medicine. It will be stored under the supervision of a specialist in a suitable place. Radiopharmaceuticals are stored in accordance with national regulations regarding radioactive materials.
The following information is intended only for specialists.
The medicine V-Ga68 and medicines labeled with V-Ga68 must not be used after the expiry date stated on the label after EXP.

6. Package contents and other information

What V-Ga68 contains

The active substance is gallium (Ga) chloride. 1 ml of the solution contains 500 MBq of gallium (Ga) chloride on the reference date and time.
The other ingredients are 0.1M hydrochloric acid.

What V-Ga68 looks like and what the package contains

A 15 mL glass vial of type I, closed with a type I rubber stopper coated with FluoroTec® and an aluminum seal.
One 15 mL vial contains 1-5 mL of solution, corresponding to an activity of 500-2500 MBq on the reference date and time.

Marketing authorization holder

Voxel S.A.,

ul. Wielicka 265,
30-663 Krakow
Email: [email protected]

Manufacturer

Voxel S.A.,

ul. Wielicka 265,
30-663 Krakow

Date of last revision of the leaflet:

Other sources of information

Detailed information about this product can be found on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://www.urpl.gov.pl.