V-pet

PATIENT LEAFLET: INFORMATION FOR THE USER

V-PET

1 GBq/ml, solution for injection

Fludeoxyglucose (F)

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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

Table of contents of the leaflet:

• 1. What is V-PET and what is it used for
• 2. Important information before using V-PET
• 3. How to use V-PET
• 4. Possible side effects
• 5. How to store V-PET
• 6. Contents of the pack and other information

1. WHAT IS V-PET AND WHAT IS IT USED FOR

This medicine is a radiopharmaceutical product intended for diagnostic use only.
V-PET is used for diagnostic purposes in positron emission tomography (PET/CT) examinations and is administered before the examination.
The active substance of V-PET is called fludeoxyglucose (F) and it enables imaging of increased uptake of natural substances, glucose, by altered organs or tissues, which is detected in the PET examination and shown as an image.
Positron emission tomography is an imaging technique used in nuclear medicine, which provides cross-sectional images of living organisms. A very small amount of radiopharmaceutical product is used to obtain quantitative and precise images of specific metabolic processes in the body. The examination is intended to help make decisions about the treatment of diagnosed or suspected disease.

2. IMPORTANT INFORMATION BEFORE USING V-PET

When not to use V-PET

• If the patient is allergic (hypersensitive) to Fludeoxyglucose (F) or any of the other ingredients of this medicine (listed in section 5).

When to exercise special caution when using V-PET

• In case of contact with small children: it is recommended to avoid close contact between the patient and small children for the first 12 hours after injection.

In the following cases, inform the nuclear medicine specialist:

• if the patient has diabetes that is not being effectively treated;
• if the patient has an infection or inflammatory disease;
• if the patient has kidney disease;
• if the patient is pregnant or thinks she may be pregnant;
• if the patient is breastfeeding.

Before administering V-PET, avoid any intense physical exertion.

Children and adolescents

Patient who have not reached 18 years of age should inform the nuclear medicine specialist.

Using other medicines

Tell your doctor and the nuclear medicine specialist who will supervise the examination about all medicines you are currently taking or have recently taken, including those that are available without a prescription, as they may have a negative impact on image interpretation by the doctor, in particular:

• all medicines that may affect blood sugar levels, such as medicines that reduce inflammation (e.g. corticosteroids), prevent seizures (e.g. valproate, carbamazepine, phenytoin, phenobarbital), affect the nervous system (e.g. adrenaline, noradrenaline, dopamine),
• glucose,
• insulin,
• medicines used to increase blood cell production. In case of doubt, consult your doctor or the nuclear medicine specialist who will perform the PET examination for further information.

Using V-PET with food and drink

Before the examination:

• the patient should avoid drinking beverages containing a type of sugar called glucose,
• the patient should drink plenty of water (or other glucose-free fluids) in any amount,
• the patient should fast (for at least 4 hours) before injection,
• the doctor will measure the patient's blood glucose level before administering the medicine.

Pregnancy and breastfeeding

Before administering V-PET, inform the nuclear medicine specialist if there is a possibility that the patient is pregnant, has not had a menstrual period, or is breastfeeding.
In case of doubt, it is essential to ask the doctor or the nuclear medicine specialist who will supervise the examination.

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 the medicine while breastfeeding, the patient should express milk before injection and store it for later use. The patient should stop breastfeeding for at least 12 hours after administration, give the baby a milk substitute, and discard the expressed breast milk.
Resuming breastfeeding should be discussed with the doctor.

Before administering V-PET:

• drink plenty of water 4 hours before the examination to be well-hydrated before the start of the examination,
• do not eat for at least 4 hours.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. It is unlikely that V-PET will affect the ability to drive and use machines.

3. HOW TO USE V-PET

V-PET 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 the medicine is administered.
The nuclear medicine specialist supervising the examination will decide on the amount of V-PET to be used in individual cases. This will be the smallest amount necessary to obtain the desired information.
The recommended dose for an adult is from 100 to 400 MBq. Megabecquerel (MBq) is a metric unit of measurement of radioactivity.

Administration of V-PET and performance of the examination

V-PET is administered in a single intravenous injection.

Use in children and adolescents

The amount administered to children and adolescents will depend on their body weight.

Administration of V-PET and performance of the examination

V-PET is administered in a single intravenous injection.
A single injection is sufficient to perform the examination ordered by the doctor. The medicine is administered 45-60 minutes before the start of the examination.
After injection, the patient will be asked to drink water and then, immediately before the start of the examination, to urinate.
During the examination, the patient should rest in a comfortable lying position. The patient should not read or talk.

Duration of the examination

The doctor will inform the patient about the exact duration of the examination.
The examination usually lasts from 30 to 60 minutes.

After administering V-PET:

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

Use of a higher than recommended dose of V-PET

Overdose is unlikely, as the patient receives only one dose of V-PET, carefully prepared under the control of the doctor performing the examination. However, in case of overdose, the doctor will initiate appropriate treatment. The doctor supervising the procedure may recommend drinking large amounts of fluids, which will facilitate the removal of V-PET from the body.
In case of any further questions about the use of V-PET, consult the doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, V-PET can cause side effects, although not everybody gets them.
V-PET delivers a small amount of ionizing radiation with a very low risk of causing cancer or genetic disorders.
The doctor has decided that the clinical benefit of the examination with the use of the radiopharmaceutical product outweighs the risk associated with radiation.

Reporting side effects

If you experience any side effects, inform your doctor or nurse.
This includes any side effects not listed in the leaflet. You can also report side effects 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
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE V-PET

No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the label after: EXP.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

The active substance of V-PET is fludeoxyglucose (F).

• 1 ml of the solution for injection contains 1 GBq of fludeoxyglucose (F) on the date and time of reference.
• The other ingredients are: disodium phosphate dihydrate, sodium hydroxide, water for injections.

What V-PET looks like and what the pack contains

The patient does not purchase the medicine themselves and does not come into contact with the packaging or vial.

The following information is provided for informational purposes only.

V-PET is a clear and colorless solution supplied in a multidose vial made of colorless glass containing 0.2 - 15 ml of the solution for injection.

Marketing authorization holder

VOXEL S.A.

ul. Wielicka 265
30-663 Krakow
Poland

Manufacturer

VOXEL S.A.

ul. Wielicka 265
30-663 Krakow
Poland
Date of leaflet approval:{MM/YYYY}
Information intended for healthcare professionals only:
The complete summary of product characteristics of V-PET (SmPC) is provided as a separate document in the product packaging to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
Read the SmPC (the SmPC should be attached to the packaging).