Fluorodeoxyglucose [18F] Curium

Package leaflet: Information for the user

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 who will supervise the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet:

1. What Fluorodeoxyglucose (F)-Curium is and what it is used for.
2. What you need to know before Fluorodeoxyglucose (F)-Curium is used.
3. How to use Fluorodeoxyglucose (F)-Curium.
4. Possible side effects.
5. How Fluorodeoxyglucose (F)-Curium is stored.
6. Contents of the pack and other information.

1. What Fluodeoxyglucose ( F)-Curium is and what it is used for.

This medicinal product is a diagnostic radiopharmaceutical.
The active substance contained in Fluodeoxyglucose ( F)-Curium is designed to produce radiographic images of certain parts of your body.
After a small amount of Fluodeoxyglucose ( F)-Curium has been injected, the medical images obtained using a special camera will allow the physician to visualize and assess the location of your disease or monitor its progression.

2. What you need to know before Fluorodeoxyglucose (F)-Curium is used.

Fluorodeoxyglucose (F)-Curium 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)-Curium:

• If you have diabetes and your diabetes is currently unstable.
• 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 think you might be pregnant.
• If you are breastfeeding.

Before administration of Fluorodeoxyglucose (F)-Curium you must:

• Drink plenty of water before starting the examination to urinate as much as possible during the first hour after the study.
• Avoid all strenuous physical activity.
• Fast for at least 4 hours.

Children and adolescents
Consult the nuclear medicine physician if you are under 18 years of age.
Other medicines and Fluorodeoxyglucose (F)-Curium
Inform the nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, as they may interfere with the interpretation of images by the physician:

• Any medicine that alters blood sugar levels (glycaemia), such as medicines affecting inflammation (corticosteroids), anticonvulsant medicines (valproate, carbamazepine, phenytoin, phenobarbital), medicines affecting the nervous system (adrenaline, noradrenaline, dopamine, etc.),
• Glucose
• Insulin
• Medicines used to increase blood cell production.

Fluorodeoxyglucose (F)-Curium with food and drinks:
You must fast for at least 4 hours before administration of this medicine. You should drink plenty of water and avoid drinking liquids containing sugar.
The nuclear medicine physician must measure your blood sugar level before administering the medicine; indeed, high glucose concentration in the blood (hyperglycaemia) may make it more difficult for the nuclear medicine physician to interpret the images.
Pregnancy and breastfeeding
You must inform the nuclear medicine physician before administration of Fluorodeoxyglucose (F)-Curium if there is any possibility you might be pregnant, if you have missed your 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
The nuclear medicine physician will administer this medicine 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 breast milk expressed during this period must be discarded.
Ask the nuclear medicine physician supervising the procedure when you may resume breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult the nuclear medicine physician before this medicine is administered to you.
Driving and using machines:
It is unlikely that Fluorodeoxyglucose (F)-Curium will affect your ability to drive or use machinery.
Fluorodeoxyglucose (F)-Curium contains sodium and ethanol
This medicine may contain more than 1 mmol of sodium (23 mg). You should take this into account if you are on a low-sodium diet.
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per administration.

3. How to use Fluorodeoxyglucose (F)-Curium

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.
Fluorodeoxyglucose (F)-Curium will only be used in specially controlled areas. This medicine will be
handled and administered by personnel trained and qualified to use it safely. These individuals will take
special precautions for safety and will keep you informed about their actions.
The nuclear medicine physician supervising the procedure will determine the amount of Fluorodeoxyglucose
(F)-Curium to be used in your case. The minimum necessary dose required to obtain the desired information
will be administered.
The recommended administered activity for adults is generally 100–400 MBq (depending on the patient's body
weight, the type of imaging camera used, and the acquisition method).
The megabecquerel (MBq) is the unit of measurement used to express radioactivity.

Use in children and adolescents
In children and adolescents, the administered amount is adjusted according to the child's body weight.

**Administration of Fluorodeoxyglucose (**F)-Curium and performance of the procedure
Fluorodeoxyglucose (F)-Curium is administered intravenously.
A single injection is sufficient to perform the examination requested by the physician.
After the injection, you must remain completely at rest, without reading or talking. In addition, you will be
offered fluids and asked to urinate shortly before the examination.
While images are being acquired, you must remain completely still. You must not move or talk.

Duration of the procedure
The nuclear medicine physician will inform you about the usual duration of the procedure.
Fluorodeoxyglucose (F)-Curium is administered as a single intravenous injection, 45–60 minutes before image
acquisition begins. Image acquisition, using a camera, lasts 30–60 minutes.

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

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

**If you have been given more Fluorodeoxyglucose (F)-Curium than you should have received
Overdose is unlikely, as you will receive only a single precisely controlled dose of Fluorodeoxyglucose
(F)-Curium, administered under the supervision of the nuclear medicine physician. 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)-Curium from your body (since the primary route of elimination of this medicine is renal, via urine).
If you have any doubts about the use of Fluorodeoxyglucose (F)-Curium, please consult the nuclear medicine
physician supervising the procedure.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everybody will experience them.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
Allergic reactions, including severe allergic reactions such as shock and cardiac arrest with potentially fatal outcome, 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 accumulation of fluid (edema)
• Eye irritation, eye disorders
• Cough
• Nausea and vomiting

Symptoms may occur with a latency ranging from immediately up to 10 days, with an average of 3 hours. In most cases, the latency period was 24 hours or less.
Allergic reactions may vary from mild (such as rash, itching), requiring supportive treatment, to severe allergic reactions that may require emergency support (hospitalization).
Before administration, the physician will ask you about your allergy history, medical history, and the medicines you are currently taking. Re-exposure to the drug may carry the risk of recurrence of the reaction.
This radiopharmaceutical will emit a low amount of ionizing radiation, associated with a minimal risk of cancer or hereditary abnormalities.
Your doctor has considered that the clinical benefit you will obtain from the procedure using the radiopharmaceutical outweighs the risk related to radiation exposure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform the nuclear medicine physician. You may also report side effects directly via the national reporting system at the following website: 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 Fluorodeoxyglucose (F)-Curium is stored

Do not store this medicinal product. This medicinal product must be stored by the specialist under their responsibility in suitable premises. Storage of radiopharmaceuticals must comply 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 Fluodeossiglucosio (F)-Curium contains

• The active substance is fluordeoxyglucose (F). 1 ml of injectable solution contains 185 MBq at the date and time of calibration.
• The other components are: sodium chloride, ethanol and water for injections (See section 2, "Fluodeossiglucosio (F)-Curium contains sodium and ethanol").

Description of the appearance of Fluodeossiglucosio (F)-Curium and contents of the pack
The activity per vial ranges from 90 MBq to 1850 MBq at the date and time of calibration.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
CURIUM INTERNATIONAL
BOULEVARD BISCHOFFSHEIM 39 BOÎTE 4
1000 Bruxelles - BELGIUM

Manufacturers:
BETA PLUS PHARMA S.A.
AVENUE HIPPOCRATE 10/1527
1200 BRUXELLES - BELGIUM
CURIUM PET FRANCE
PARC SCIENTIFIQUE ET TECHNIQUE G.BESSE
180, ALLEE VON NEUMANN
30035 NÎMES CEDEX 1 - FRANCE
CURIUM PET FRANCE
ASSISTANCE PUBLIQUE DES HÔPITAUX DE PARIS, SAINT-LOUIS
14 RUE DE LA GRANGE AUX BELLES
75010 PARIS - FRANCE
CURIUM PET FRANCE
HÔPITAL XAVIER ARNOZAN
AVENUE DU HAUT LEVÊQUE
33600 PESSAC - FRANCE
CURIUM PET FRANCE
CENTRE EUGENE MARQUIS
AVENUE DE LA BATAILLE FLANDRES DUNKERQUE
35042 RENNES CEDEX - FRANCE
CURIUM PET FRANCE
10 AVENUE CHARLES PEGUY
95200 SARCELLES - FRANCE
CURIUM PET FRANCE
CHU DE BRABOIS
4 RUE DU MORVAN
54500 VANDOEUVRE-LES-NANCY - FRANCE
CYCLOTRON REUNION OCEAN INDIEN - CYROI
2 RUE MAXIME RIVIERE
97490 SAINTE CLOTILDE (REUNION) - FRANCE
CURIUM ITALY S.R.L.
VIA PERGOLESI 33,
20900 MONZA - ITALY
CURIUM ITALY S.R.L.
VIALE OXFORD 81,
00133 ROMA - ITALY
CURIUM ITALY S.R.L.
PIAZZALE SANTA MARIA DELLA MISERICORDIA 15,
33100 UDINE - ITALY
CURIUM ITALY S.R.L.
VIA G. RIPAMONTI 435,
20141 MILANO - ITALY
OFFICINA FARMACEUTICA
ISTITUTO DI FISIOLOGIA CLINICA DEL CNR
VIA MORUZZI, 1
56124 PISA - ITALY
B.V. CYCLOTRON VU
DE BOELELAAN 1081
1081 HV AMSTERDAM - NETHERLANDS
CYCLOTRON VU
VAN DER BOECHORSTSTRAAT 6A
1081 BT AMSTERDAM - NETHERLANDS
CURIUM PHARMA SPAIN, S.A.
PARQUE TECNOLÓGICO CARTUJA’93
AVDA. THOMAS ALVA EDISON, 7
41092 SEVILLA - SPAIN
CURIUM PHARMA SPAIN, S.A., AJALVIR
POL. LND. CONPISA, C/VEGUILLAS
2 NAVE 16,
28864 AJALVIR, MADRID - SPAIN
CURIUM PET LIEGE
Allee Du Six-Aout, 8
4000 LIEGE - BELGIUM

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria
[ F] Fludeoxyglucose Curium
Belgium, France, Luxembourg
Fludésoxyglucose ( F) IBA
Portugal, Malta
Fludeoxyglucose ( F) Curium
Italy
Fluodeossiglucosio ( F) Curium
Netherlands
Fludeoxyglucose ( F) Curium-international
Spain
Fludesoxiglucosa ( F) Curium
Slovenia
Fludeoksiglukoza ( F)- Curium

This patient information leaflet was last approved in 03/2026

The following information is intended exclusively for physicians and healthcare professionals:
The full Summary of Product Characteristics for Fluodeossiglucosio (F) Curium is provided in a separate document within the product packaging, intended to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please consult the Summary of Product Characteristics.