V-pet

V-PET
1 GBq/ml, solution for injection
Fludeoxyglucose ( F)
Read the entire package leaflet before using this medicinal product.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor if you have any further questions.
• If any of the side effects worsens or if you notice any side effects not listed in this leaflet, inform your doctor or nurse.

Package leaflet contents:

1. What V-PET is and what it is 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 V-PET IS AND WHAT IT IS USED FOR

This medicinal product is a radiopharmaceutical intended for diagnostic use only.
V-PET is used for diagnostic purposes in positron emission tomography (PET/CT) imaging and is administered prior to the scan.
The active substance in V-PET is fludeoxyglucose (F), which enables imaging of increased uptake of glucose—a natural substance—by abnormal organs or tissues. This increased uptake is detected during PET scanning and displayed as an image.
Positron emission tomography is an imaging technique used in nuclear medicine that produces cross-sectional images of living organisms. A very small amount of radiopharmaceutical is used to obtain quantitative and precise images of specific metabolic processes in the body. This examination is intended to assist in making decisions regarding the management of a diagnosed or suspected disease.

2. IMPORTANT INFORMATION BEFORE USING V-PET

When not to use V-PET

• If the patient has an allergy (hypersensitivity) to Fludeoxyglucose ( F ) or to any of the other components of this medicine (listed in section 5).

When to exercise special caution with V-PET

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

The following conditions should be reported to the nuclear medicine specialist:

• if the patient has diabetes that is not currently well controlled;
• if the patient has an infection or inflammatory disease;
• if the patient has kidney disease;
• if the patient is pregnant or suspects she may be pregnant;
• if the patient is breastfeeding.

Before administration of V-PET, all strenuous physical activity should be avoided.
Children and adolescents
Patients under 18 years of age should inform the nuclear medicine specialist.
Use of other medicines
Inform your referring physician and the nuclear medicine specialist supervising the examination about all medicines currently taken or recently used, including those available without prescription, as they may negatively affect image interpretation by the physician, particularly:

• all medicines that may alter blood glucose levels, such as:
  • anti-inflammatory drugs (e.g. corticosteroids),
  • anticonvulsants (e.g. valproate, carbamazepine, phenytoin, phenobarbital),
  • drugs affecting the nervous system (e.g. adrenaline, noradrenaline, dopamine),
• glucose,
• insulin,
• medicines used to increase blood cell production.
  If in doubt, consult your referring physician or the nuclear medicine specialist performing the PET examination for further information.

Use of V-PET with food and drink
In the period preceding the examination:

• the patient should avoid drinking beverages containing glucose,
• the patient should drink large amounts of water (or other fluids not containing glucose) freely,
• the patient should remain fasting (for at least 4 hours) before injection of the medicine,
• the physician will measure blood glucose concentration before administration of the medicine.

Pregnancy and breastfeeding
Before administration of V-PET, inform the nuclear medicine specialist if there is any possibility that the patient is pregnant, has missed a menstrual period, or is breastfeeding.
If in doubt, it is important to consult the referring physician or the nuclear medicine specialist supervising the examination.
If the patient is pregnant
The referring physician will consider performing this examination during pregnancy only if absolutely necessary.
If the patient is breastfeeding
If administration of the medicine during breastfeeding is necessary, breast milk should be expressed and stored for later use before injection. Breastfeeding should be interrupted for at least 12 hours after administration of the medicine; infant formula should be given during this time, and the expressed milk should be discarded.
Resuming breastfeeding should be discussed with the physician.

Before administration of V-PET, the patient should:

• drink large amounts of water during the 4 hours before the examination to ensure adequate hydration before the start of the procedure,
• refrain from eating for at least 4 hours.

Driving and operating machinery
No studies have been conducted on the effects of the medicine on the ability to drive vehicles or operate machinery. It is unlikely that V-PET will affect the ability to drive or operate machinery.

3. HOW TO USE V-PET
V-PET is administered 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 the medicine is administered.
The nuclear medicine specialist supervising the examination will determine the appropriate dose of V-PET for the individual patient. This will be the smallest amount necessary to obtain the required diagnostic information.
The recommended dose for adults is 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 as a single intravenous injection.
Use in children and adolescents
The dose administered to children and adolescents will depend on body weight.
Administration of V-PET and performance of the examination
V-PET is administered as a single intravenous injection.
One injection is sufficient for the examination ordered by the physician. 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 empty the bladder.
During the examination, the patient should rest in a comfortable lying position. Reading or talking should be avoided.

Duration of the examination
The physician will inform the patient of the exact duration of the examination.
The examination usually lasts between 30 and 60 minutes.

After administration of V-PET, the patient should:

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

Administration of a higher than recommended dose of V-PET
Overdose is unlikely, as the patient receives only a single dose of V-PET, carefully prepared under the supervision of the physician performing the examination. However, in the event of an overdose, the physician will initiate appropriate treatment. The supervising physician may recommend drinking large amounts of fluids to facilitate elimination of V-PET from the body.
For any further questions regarding the use of V-PET, please consult your physician.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, V-PET may cause adverse reactions, although not everyone will experience them.
V-PET delivers a small amount of ionizing radiation, associated with a very low risk of developing malignant tumors and hereditary abnormalities.
The treating physician has determined that the clinical benefit derived from the examination using this radiopharmaceutical product outweighs the risk associated with radiation exposure.

Reporting of adverse reactions
If any adverse symptoms occur, inform your doctor or nurse. This includes any adverse effects not listed in this leaflet. Adverse reactions can also be reported directly to:
Department for Monitoring Adverse Drug Reactions
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
e-mail: [email protected]

Adverse reactions may also be reported to the responsible entity.
Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. HOW TO STORE V-PET MEDICINAL PRODUCT

No special storage instructions for this medicinal product.
Do not use this medicinal product after the expiry date stated on the label following: EXP.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

The active substance is fluorodeoxyglucose (F).

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

What V-PET looks like and contents of the pack
The patient does not purchase the medicine independently and has no contact with the packaging or vial.
The following information is provided for informational purposes only.
V-PET is a clear, colourless solution supplied in a multidose vial made of colourless glass containing 0.2–15 ml of injection solution.
Marketing Authorisation Holder
VOXEL S.A.
ul. Wielicka 265
30-663 Kraków
Poland
Manufacturer
VOXEL S.A.
ul. Wielicka 265
30-663 Kraków
Poland
Information intended exclusively for medical personnel:
The complete product information for V-PET (SmPC) is supplied as a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
Please consult the SmPC (the SmPC should be included in the package).