Taioftal

PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

FLUORODEOXYGLUCOSE ( F) ITEL 250 MBq/mL, injectable solution
Fluorodeoxyglucose ( F)
Please read this leaflet carefully before you are given this medicine because it contains important information for you.

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

Contents of this leaflet:

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

1. What Fluorodeoxyglucose (F) ITEL is and what it is used for

This medicinal product is a radiopharmaceutical used solely for diagnostic purposes.
The active substance contained in Fluorodeoxyglucose (F) ITEL is fluorodeoxyglucose (F), and it is indicated for obtaining diagnostic images of certain parts of the body.
After a small amount of Fluorodeoxyglucose (F) ITEL is injected, images acquired using a special machine allow the physician to observe the location and progression of the disease.

2. What you need to know before being given Fluorodeoxyglucose (F) ITEL

Do not use Fluorodeoxyglucose ( F) ITEL

• if you are allergic to fluorodeoxyglucose (F) or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Talk to the nuclear medicine physician before you are given Fluorodeoxyglucose (F) ITEL

• if you have diabetes and your diabetes is not currently under control
• if you have an infection or inflammatory disease
• if you have kidney problems

Inform the nuclear medicine physician in the following cases:

• if you are pregnant or suspect you may be pregnant
• if you are breastfeeding

Before receiving Fluorodeoxyglucose ( F) ITEL you must:

• drink plenty of water before the examination begins, so that you urinate as frequently as possible during the first few hours after the scan
• avoid all strenuous physical activity
• fast 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) ITEL
Inform the nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, because they may interfere with the physician's interpretation of the images:

• any medicine that may cause changes in blood sugar levels (glycaemia), such as anti-inflammatory drugs (corticosteroids), anticonvulsant drugs (valproate, carbamazepine, phenytoin, phenobarbital), drugs acting on the nervous system (adrenaline, noradrenaline, dopamine, etc.),
• glucose,
• insulin,
• medicines used to increase red blood cell production. Fluorodeoxyglucose ( F) ITEL with food and drinks Before receiving the product, you must fast for at least 4 hours. You should drink plenty of water and avoid beverages containing sugars. Before administration, the nuclear medicine physician will measure your blood glucose level, as high glucose concentration in the blood (hyperglycaemia) may make it more difficult for the physician to interpret the results.

Pregnancy and breastfeeding
If there is any possibility that you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding, inform the nuclear medicine physician before being given Fluorodeoxyglucose (F) ITEL.
If in doubt, it is important that you consult the nuclear medicine physician supervising the procedure.
If you are pregnant
The nuclear medicine physician will only administer this product during pregnancy if the expected benefit outweighs the potential risks.
If you are breastfeeding
You must stop breastfeeding for 12 hours after the injection, and breast milk expressed during this period must be discarded.
Resuming breastfeeding should be discussed with the nuclear medicine physician supervising the procedure.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, please consult your nuclear medicine physician before receiving this medicine.
Driving and using machines
Fluorodeoxyglucose (F) ITEL is unlikely to affect your ability to drive or operate machinery.
Fluorodeoxyglucose ( F) ITEL contains sodium
This product contains more than 1 mmol of sodium (23 mg). This should be taken into consideration if you are on a low-sodium diet.

3. How Fluorodeoxyglucose (F) ITEL is used

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
Fluorodeoxyglucose (F) ITEL will only be used in designated controlled areas. The product must be handled and administered exclusively by trained and qualified personnel who are skilled in its safe use.
These individuals will pay special attention to the safe use of the product and will keep you informed about what they are doing.

The nuclear medicine physician supervising the procedure will determine the amount of Fluorodeoxyglucose (F) ITEL to be used in your case, which will correspond to the minimum quantity necessary to obtain the required diagnostic information.

The normally recommended administered amount for an adult ranges between 100 and 400 MBq (depending on the patient's body weight, the type of imaging device used, and the imaging protocol). Megabecquerel (MBq) is the unit of measurement used for radioactivity.

Use in children and adolescents
In the case of use in children and adolescents, the administered amount will be adjusted according to the child's body weight.

**Administration of Fluorodeoxyglucose (**F) ITEL and performance of the procedure
Fluorodeoxyglucose (F) ITEL is administered intravenously.
A single injection is sufficient to perform the examination required by the physician.
After the injection, you must remain completely at rest and must not read or talk. Additionally, you will be asked to drink fluids and to urinate immediately before the procedure.
During image acquisition, you must remain completely at rest.
You must not move or speak.

Duration of the procedure
The nuclear medicine physician will inform you about the expected duration of the procedure.
Fluorodeoxyglucose (F) ITEL is administered as a single intravenous injection 45–60 minutes before the start of image acquisition. Image acquisition with a scanner lasts between 30 and 60 minutes.

**After administration of Fluorodeoxyglucose (**F) ITEL, you must:

• avoid close contact with young children and pregnant women for the 12 hours following the injection;
• urinate frequently to help eliminate the product from your body.

**If you receive more Fluorodeoxyglucose (F) ITEL than you should
An overdose is unlikely, as you will receive only one dose of Fluorodeoxyglucose (F) ITEL under the strict supervision of the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, appropriate treatment will be provided. In particular, the nuclear medicine physician in charge of the procedure may recommend that you drink plenty of fluids to facilitate the elimination of Fluorodeoxyglucose (F) ITEL from your body (since the primary route of elimination of the product is renal, through urine).

If you have any doubts about the use of Fluorodeoxyglucose (F) ITEL, please consult the nuclear medicine physician supervising the procedure.

4. Possible adverse reactions

Like all medicines, Fluodesossiglucosio ( F) ITEL can cause adverse reactions, although not everyone experiences them.
The radiopharmaceutical emits a small amount of ionizing radiation, which carries a very low risk of cancer and hereditary defects.
Your doctor has determined that the clinical benefit obtained from the procedure performed with the radiopharmaceutical outweighs the risk due to radiation exposure.
Post-marketing data with unknown frequency:
Immune system disorders
Hypersensitivity reactions (e.g. pruritus, edema and skin rash)
Cardiovascular effects
Transient hypotension
Endocrine/metabolic effects
Abnormal blood glucose levels (e.g. hypoglycemia or hyperglycemia)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact the nuclear medicine physician. You may also report adverse reactions directly through the national reporting system (https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse).
By reporting adverse reactions, you can help provide further information on the safety of this medicine.

5. How Fluorodeoxyglucose (F) ITEL is stored

Do 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 the specialist.
The product must not be used after the expiry date stated on the label, indicated as {DD MM YYYY at hh:mm}.

6. Package contents and other information

What Fluodesossiglucosio (F) ITEL contains

• The active substance is fluordeoxyglucose (F). 1 mL of injectable solution contains 250 MBq of fluorodeoxyglucose (F) at the date and time of calibration.
• The other components are monosodium phosphate dihydrate, sodium hydroxide and water for injections.

Description of the appearance of Fluodesossiglucosio (F) ITEL and contents of the pack
Fluorodeoxyglucose (F) ITEL is supplied in a single multidose transparent glass vial containing a variable volume of injectable solution between 1 mL and 10 mL.

Marketing Authorization Holder
ITEL Telecomunicazioni S.r.l.
Via A. Labriola, lotto 39 (Z.I.)
70037 Ruvo Di Puglia (BA)
Italy

Manufacturer
ITEL Telecomunicazioni S.r.l.
Via A. Labriola, lotto 40 (Z.I.)
70037 Ruvo Di Puglia (BA)
Italy

This Patient Information Leaflet was last revised on XX/XXXX
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA): http://www.agenziafarmaco.gov.it.

The following information is intended for healthcare professionals only:
The complete Product Characteristics Summary of Fluorodeoxyglucose (F) ITEL 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.
Refer to the Product Characteristics Summary included in the package.