Efdege

PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

EFDEGE 1.0 GBq/mL, injectable solution

Fluorodeoxyglucose (F)
Please read this leaflet carefully before using this medicinal product
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 specialist who will supervise the procedure.
• If you experience any adverse reactions, including those not listed in this leaflet, contact the nuclear medicine specialist.

Contents of this leaflet:

1. What EFDEGE is and what it is used for
2. What you need to know before using EFDEGE
3. How to use EFDEGE
4. Possible side effects
5. How to store EFDEGE
6. Contents of the packaging and other information

1. What EFDEGE is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
The active substance in EFDEGE is fluorodeoxyglucose (F), which is indicated for obtaining diagnostic images of certain parts of the body.
After a small amount of EFDEGE is injected, images obtained using a special machine allow the physician to observe the location and progression of the disease.

2. What you should know before using EFDEGE

Do not use EFDEGE

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

Warnings and precautions
Talk to the nuclear medicine specialist before EFDEGE is administered to you.

• if you have diabetes that is currently unbalanced
• if you have an infection or inflammatory disease
• if you have kidney problems.

Inform the nuclear medicine specialist in the following cases:

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

Before administration of EFDEGE you must:

• drink plenty of water before the examination begins, so as to urinate as frequently as possible during the first 4 hours after the study.
• avoid all strenuous physical activity
• fast for at least 4 hours

Children and adolescents
Inform the nuclear medicine specialist if you are under 18 years of age.
Other medicines and EFDEGE
Inform the nuclear medicine specialist 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 medicines (corticosteroids), anti-epileptic medicines (valproate, carbamazepine, phenytoin, phenobarbital), medicines acting on the nervous system (adrenaline, noradrenaline, dopamine, etc.),
• glucose,
• insulin,
• medicines used to increase red blood cell production.

EFDEGE with food and drinks
Before administration of the product, you must fast for at least 4 hours. You should drink plenty of water and avoid drinks containing sugars.
Before administration of the product, the nuclear medicine specialist will measure your blood glucose level, as high glucose concentration in the blood (hyperglycaemia) could 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 specialist before EFDEGE is administered.
If in doubt, it is important that you consult your doctor or the nuclear medicine specialist supervising the procedure.
If you are pregnant
The nuclear medicine specialist will administer this product during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding
You must interrupt breastfeeding for 12 hours after the injection, and the breast milk collected during this period must be discarded.
Resumption of breastfeeding should be discussed with the nuclear medicine specialist supervising the procedure.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, please consult the nuclear medicine specialist before this medicine is administered to you.
Driving and using machines
EFDEGE is unlikely to affect your ability to drive vehicles or operate machinery.
EFDEGE contains sodium
This product may contain more than 1 mmol of sodium (23 mg), which should be taken into consideration if you are on a low-sodium diet.

3. How to use EFDEGE

The laws governing the use, handling, and disposal of radiopharmaceuticals are very strict. EFDEGE will
only be used in designated controlled areas. The product must be handled and administered only by
trained and qualified personnel who are skilled in its safe use. These individuals will pay particular
attention to the safe use of the product and will keep you informed about what they are doing.
The nuclear medicine specialist supervising the procedure will determine the amount of EFDEGE to be
used in your case, which will correspond to the minimum quantity necessary to obtain the required
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 camera used, and the acquisition mode).
The 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 EFDEGE and performance of the procedure
EFDEGE is administered intravenously.
A single injection is sufficient to carry out the examination required by the physician.
After the injection, you must remain completely at rest; you must not read or speak. In addition, 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 specialist will inform you about the usual duration of the procedure.
EFDEGE is administered as a single intravenous injection 45–60 minutes before the start of image
acquisition. Image acquisition with a camera lasts between 30 and 60 minutes.
After administration of EFDEGE, you must:

• avoid any 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 EFDEGE than you should
An overdose is almost impossible, as you will receive only one dose of EFDEGE under the close
supervision of the nuclear medicine specialist overseeing the procedure. However, in the event of an
overdose, appropriate treatment will be given. In particular, the nuclear medicine specialist in charge of
the procedure might recommend that you drink plenty of fluids to facilitate the elimination of EFDEGE
from your body (since the main route of elimination of the product is renal, through urine).
If you have any doubts about the use of EFDEGE, consult the nuclear medicine specialist supervising the
procedure.

4. Possible side effects

Like all medicines, EFDEGE can cause side effects, although not everyone experiences them.
Side effects with unknown frequency (cannot be estimated from available data):
Allergic reactions have been reported, including severe allergic reactions such as shock and cardiac arrest, which can be life-threatening, with symptoms such as:

• Difficulty breathing
• Shortness of breath
• Low blood pressure
• Skin rash (including erythematous rash, pruritic rash, maculopapular rash)
• Urticaria, itching, dermatitis
• Skin redness (erythema)
• Swelling at various sites, facial swelling, swelling of the lips, tongue and/or throat with difficulty swallowing or breathing (angioedema), localized fluid accumulation (edema)
• Eye irritation, ocular disorders
• Cough
• Nausea and vomiting

Symptoms may appear with a latency ranging from immediate to 10 days, with a median latency of 3 hours. In most cases, the latency has been 24 hours or less. Allergic reactions range from mild (such as rash, itching), requiring supportive treatment, to severe allergic reactions that may require emergency intervention (hospitalization).
Before administration, the physician should obtain information about your allergy history, clinical history, and concomitant medications. Re-exposure to the drug carries the risk of a recurrent reaction.
The radiopharmaceutical emits a small amount of ionizing radiation, which entails a very low risk of cancer and hereditary defects.
Your physician has determined that the clinical benefit obtained from the procedure using the radiopharmaceutical outweighs the risk due to radiation exposure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact the nuclear medicine physician. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EFDEGE

This medicinal product must not be stored by the user. Storage of the product is the responsibility of a specialist in appropriate facilities. Radiopharmaceuticals must be stored in accordance with national regulations concerning radioactive products.
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 EFDEGE 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.
• The other components are: water for injections, disodium hydrogen citrate 1.5 hydrate extra pure; trisodium citrate dihydrate extra pure; sodium chloride.

Description of the appearance of EFDEGE and contents of the pack
A 15 mL vial contains from 0.2 mL to 15.0 mL of solution corresponding to 0.2–11.0 GBq per
vial at the date and time of calibration.
A 25 mL vial contains from 0.2 mL to 20.0 mL of solution corresponding to 0.2–20.0
GBq per vial at the date and time of calibration.
Marketing Authorization Holder
Curium Austria GmbH
Grazer strasse 18
A-8071 Hausmannstaetten
Austria
Tel: 0043-(0)316-284 300
Fax: 0043-(0)316-284 300-114
e-mail: [email protected]
Manufacturer
Curium Austria GmbH
St. Veiter Str. 47
9020 Klagenfurt
Austria
Curium Austria GmbH
Seilerstaette 4
4020 Linz
Austria
This medicinal product is authorized in the European Economic Area (EEA) Member States
under the following names:
France EFDEGE, solution for injection
Austria EFDEGE– Injektionslösung
Germany EFDEGE Injektionslösung
Italy EFDEGE soluzione iniettabile
Malta EFDEGE 1.0 GBq/mL, solution for injection
Slovenia EFDEGE raztopina za injiciranje
This patient information leaflet was approved -
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 exclusively for physicians or healthcare professionals: The complete product characteristics summary (SmPC) for EFDEGE is included in the package as a separate document, aimed at providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please refer to the SmPC (which must be included in the package).