Fluorodeoxyglucose (18F) Itelpharma

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Fluorodeoxyglucose (F) Itelpharma 1 GBq/mL solution for injection

Fluorodeoxyglucose (F)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine physician who will supervise the procedure.
• If you experience any side effect, even if not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet:

1. What Fluorodeoxyglucose (F) Itelpharma is and what it is used for
2. What you must know before being administered Fluorodeoxyglucose (F) Itelpharma
3. How Fluorodeoxyglucose (F) Itelpharma is used
4. Possible side effects
5. How Fluorodeoxyglucose (F) Itelpharma is stored
6. Contents of the pack and other information

1. What Fluodesossiglucosio ( F) Itelpharma is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
The active substance contained in Fluodesossiglucosio ( F) Itelpharma is fluordesoxyglucose ( F), which is indicated for diagnostic imaging of certain parts of the body.
After administration of a small amount of Fluodesossiglucosio ( F) Itelpharma, the images obtained during the examination will help the physician to locate your disease or monitor its progression.

2. What you should know before using Fluorodeoxyglucose (F) Itelpharma

Fluorodeoxyglucose (F) Itelpharma must not be used
if you are allergic to fluorodeoxyglucose (F) or to any of the other ingredients of this medicine (listed
in section 6).
Warnings and precautions
Inform the nuclear medicine physician before you are administered Fluorodeoxyglucose (F) Itelpharma:

• if you have diabetes and your diabetes is currently not under control
• if you have an infection or an inflammatory disease
• if you have kidney problems
• if you are pregnant or suspect you might be
• if you are breastfeeding. Before administration of Fluorodeoxyglucose (F) Itelpharma you must:
• avoid any strenuous physical activity.
• drink plenty of water before the examination begins, so as to urinate as frequently as possible during the first 4 hours following the study.
• remain fasting for at least 4 hours. Children and adolescents Inform the nuclear medicine physician if you are under 18 years of age. Other medicines and Fluorodeoxyglucose (F) Itelpharma Inform the nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, as they could interfere with the physician's interpretation of the images, particularly:
• any medicine that can alter your blood sugar levels (glycaemia), such as medicines acting on inflammation (e.g. corticosteroids), anti-convulsant medicines (e.g. valproic acid, carbamazepine, phenytoin, phenobarbital), medicines acting on the nervous system (e.g. adrenaline, noradrenaline, dopamine)
• glucose
• insulin
• medicines that increase the production of blood cells (red blood cells). Fluorodeoxyglucose (F) Itelpharma with food and drink Before the procedure:
  1. You must remain fasting for at least 4 hours before administration of the product.
  2. You must drink plenty of water and avoid sugary drinks.
  3. Your physician will measure your blood glucose level before administering Fluorodeoxyglucose (F) Itelpharma, since high glucose levels in the blood (hyperglycaemia) could make it more difficult for the physician to interpret the results. Pregnancy and breastfeeding Inform the nuclear medicine physician before administration of Fluorodeoxyglucose (F) Itelpharma if there is any possibility you might be pregnant, if you have missed your menstrual period, or if you are breastfeeding. If in doubt, it is important to consult the nuclear medicine physician supervising the procedure. If you are pregnant
     If you are pregnant, the nuclear medicine physician will consider performing this examination only if strictly necessary and if the expected benefit outweighs the risks. If you are breastfeeding
• You must interrupt breastfeeding for 12 hours after the injection.
• You must express breast milk and discard it.
• Ask your physician when you can resume breastfeeding. If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning a pregnancy, ask your nuclear medicine physician for advice before being administered this product. Driving and using machines It is unlikely that Fluorodeoxyglucose (F) Itelpharma will affect your ability to drive or use machinery. Fluorodeoxyglucose (F) Itelpharma contains sodium This product may contain more than 1 mmol of sodium (23 mg). This should be taken into consideration if you are on a low-sodium diet. Fluorodeoxyglucose (F) Itelpharma contains ethanol This medicine contains 0.1 mg of alcohol (ethanol) per ml of solution. The amount of alcohol in millilitres in this medicine is equivalent to less than 0.01 ml of beer or 0.002 ml of wine. The small amount of alcohol in this medicine will not produce any significant effects.

3. How Fluodeoxyglucose (F) Itelpharma is used

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
Fluorodeoxyglucose (F) Itelpharma must be handled and administered only by trained and qualified personnel who are experienced in its safe use.
The staff will ensure that the product is used safely and will inform you about the measures taken.
The nuclear medicine physician supervising the procedure will determine the amount of Fluorodeoxyglucose (F) Itelpharma to be used in your case. The minimum necessary dose required to obtain the desired information will be used.
The normally recommended administered amount for an adult ranges between 100 and 400 MBq. The megabecquerel (MBq) is the unit of measurement of radioactivity.

Use in children and adolescents
The administered amount for a child or adolescent depends on body weight.

Administration of Fluorodeoxyglucose (F) Itelpharma and performance of the procedure
Fluorodeoxyglucose (F) Itelpharma is administered intravenously.
For the examination requested by the physician, one injection is sufficient. You will need to wait 45–60 minutes before undergoing the scan.
After the injection, you will be asked to drink water and to urinate immediately before the examination.
During the examination, you must remain completely still, lying in a comfortable position, without moving or talking.

Duration of the procedure
Your doctor will inform you about the duration of the examination.
The examination usually lasts between 30 and 60 minutes.

After receiving Fluorodeoxyglucose (F) Itelpharma, you must:

• avoid close contact with young children and pregnant women during the first 12 hours after injection;
• urinate frequently to help eliminate Fluorodeoxyglucose (F) Itelpharma from your body.

If you have been given more Fluorodeoxyglucose (F) Itelpharma than you should have
Cases of overdose are unlikely because you will receive a single dose of Fluorodeoxyglucose (F) Itelpharma carefully controlled by the physician supervising the procedure. However, in the event of an overdose, you will receive appropriate treatment. The physician in charge of the procedure may advise you to drink plenty of fluids to help eliminate Fluorodeoxyglucose (F) Itelpharma from your body.
If you have any doubts about the use of Fluorodeoxyglucose (F) Itelpharma, please consult your nuclear medicine physician.

4. Possible side effects

Like all medicines, Fluorodeoxyglucose (F) Itelpharma may cause side effects, although not everybody experiences them.
With Fluorodeoxyglucose (F) Itelpharma, you will receive a small amount of ionizing radiation, carrying a very low risk of developing cancer or hereditary abnormalities.
Your doctor has determined that the clinical benefit you will obtain from the procedure using this radiopharmaceutical outweighs the risk associated with radiation exposure.
Reporting of side effects
If you experience any of the side effects listed, or if you notice any unlisted side effects not mentioned in this leaflet, inform the nuclear medicine physician.
You may also report side effects directly through the national reporting system (https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse). By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store Fluorodeoxyglucose (F) Itelpharma

You must not store this medicinal product. Storage of the product is the responsibility of the specialist in
appropriate facilities. Radiopharmaceuticals must be stored in accordance with national regulations concerning
radioactive materials.
The following information is intended exclusively for specialists.
This medicinal product must not be used after the expiry date stated on the label.

6. Package contents and other information

What Fluodesoxiglucose (F) Itelpharma contains
The active substance is fluorodeoxyglucose (F). 1 ml of injectable solution contains 1 GBq of fluorodeoxyglucose (F) at the date and time of calibration.

• Other components are disodium hydrogen citrate, trisodium citrate, sodium chloride, sodium acetate, ethanol, and water for injectable preparations.

Description of the appearance of Fluorodeoxyglucose (F) Itelpharma and contents of the pack
Fluorodeoxyglucose (F) Itelpharma is supplied in a single transparent glass multidose vial containing a variable volume of injectable solution between 1 mL and 10 mL, corresponding to an activity ranging from 1 GBq to 10 GBq at the date and time of calibration.

Marketing Authorization Holder
ITEL Telecomunicazioni S.r.l.
Via A. Labriola Z.I. SNC
70037 Ruvo Di Puglia (BA)
Italy

Manufacturer
ITEL Telecomunicazioni S.r.l.
Via A. Labriola Z.I. SNC
70037 Ruvo Di Puglia (BA)
Italy

This Patient Information Leaflet was last revised on
The following information is intended exclusively for physicians or healthcare professionals:
The complete Product Characteristics Summary of Fluorodeoxyglucose (F) Itelpharma is included as a separate document in the product packaging, aimed at providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please refer to the Product Characteristics Summary included in the packaging.