Label: information for the user

Fludesoxiglucosa (18F)-Curium 185 MBq/ml, injectable solution

Fludesoxiglucosa(18F)

Read this label carefully before starting to receive this medication, because it contains important information for you.

• Keep this label. You may need to read it again.
• If you have any questions, consult the nuclear medicine specialist who will oversee the procedure.
• If you experience any adverse effects, consult the nuclear medicine specialist, even if they are not listed in this label.See section 4.

This medication is a radiopharmaceutical for diagnostic use only.

The active principle contained in Fludesoxiglucosa (18F)-Curium is designed for the acquisition of diagnostic images of certain parts of the body.

Once a small amount of Fludesoxiglucosa (18F)-Curium has been injected, medical images obtained with a special camera will allow the doctor to obtain images and determine the location of your disease and its progression.

No use Fludesoxiglucosa (18F)-Curium

• if you are allergic to fludesoxiglucosa (18F) or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult with the nuclear medicine specialist before receiving Fludesoxiglucosa (18F)-Curium:

• If you are diabetic and your diabetes is currently uncontrolled.
• 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 believe you may be pregnant
• If you are breastfeeding

Before the administration of fludesoxiglucosa (18F) you must:

• Drink plenty of water before the start of the examination to urinate as frequently as possible during the first hours after the study.
• Avoid any strenuous physical activity before the test.
• Fast for at least four hours.

Children and adolescents

Consult with the nuclear medicine specialist if you are under 18 years old.

Use of Fludesoxiglucosa (18F)-Curium with other medications

Inform the nuclear medicine specialist that you are taking, have taken recently, or may need to take any other medication, as they may interfere with the interpretation of the images by the doctor:

• Any medication that may cause a modification in blood sugar concentration (glucose), such as anti-inflammatory medications (corticosteroids), medications for seizures (valproate, carbamazepine, phenytoin, phenobarbital), medications affecting the nervous system (epinephrine, norepinephrine, dopamine…)
• Glucose
• Insulin
• Medications used to increase blood cell production

Use of Fludesoxiglucosa (18F)-Curium with food and drinks

You must fast for at least four hours before receiving this medication. You should drink plenty of water and avoid consuming liquids with sugar. Your doctor should measure your glucose level before administering the medication; as, in fact, a high concentration of glucose in the blood (hyperglycemia) may make it difficult for the nuclear medicine specialist to interpret the images.

Pregnancy and lactation

You must inform the nuclear medicine specialist before administering Fludesoxiglucosa (18F)-Curium if there is any possibility that you may be pregnant, if you experience delayed menstruation, or if you are breastfeeding.

If there is any doubt that you may be pregnant, it is essential to consult with the nuclear medicine specialist who will oversee the procedure.

If you are pregnant

The nuclear medicine specialist will only administer this medication during pregnancy if the expected benefits outweigh the risks.

If you are breastfeeding

You should stop breastfeeding your child for 12 hours after the injection and discard any expressed milk during that period.

The decision to resume breastfeeding should be made in consultation with the nuclear medicine specialist who will oversee the procedure.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult with the nuclear medicine specialist before using this medication.

Driving and operating machinery

It is unlikely that Fludesoxiglucosa (18F)-Curium will affect your ability to drive and operate machinery.

Fludesoxiglucosa (18F)-Curium contains sodium and ethanol.

This medication 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 medication contains small amounts of ethanol (alcohol), less than 100 mg per administration.

There is very strict legislation regarding the use, manipulation, and disposal of radiopharmaceuticals. Fludesoxiglucosa (18F)-Curium should only be used in special controlled areas. Only personnel with the necessary training and experience in its safe use will be able to manipulate and administer this medication. These individuals will take the necessary precautions to use this medication safely and will keep you informed of their actions.

The nuclear medicine specialist overseeing the procedure will decide on the amount of Fludesoxiglucosa (18F)-Curium to be used in your case, which will always be the minimum amount necessary to obtain the desired information.

The recommended dose for an adult typically ranges from 100 to 400 MBq (depending on the patient's body mass, the type of camera used to obtain images, and the image acquisition mode). The megabecquerel (MBq) is the unit used to express radioactivity.

Use in children and adolescents

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

Administration of Fludesoxiglucosa (18F)-Curium and procedure performance

Fludesoxiglucosa (18F) is administered intravenously.

A single injection is sufficient to perform the procedure your doctor needs to perform.

After the injection, you must be completely at rest, without reading or speaking. You will also be offered something to drink and asked to urinate immediately before the procedure.

While images are being taken, you must be completely at rest. Do not move or speak.

Procedure duration:

The nuclear medicine specialist will inform you of the typical duration of the procedure.

Fludesoxiglucosa (18F)-Curium is administered as a single injection into a vein 45 to 60 minutes before image acquisition. The image acquisition with the camera lasts between 30 and 60 minutes.

After the administration of Fludesoxiglucosa (18F)-Curium, you must:

• Avoid close contact with young children and pregnant women for 12 hours after the injection.
• Urinate frequently to eliminate the medication from your body.

If you have received more Fludesoxiglucosa (18F)-Curium than you should

It is unlikely that you will receive an overdose because you will only receive a controlled dose of Fludesoxiglucosa (18F)-Curium precisely controlled by the nuclear medicine specialist overseeing the procedure. However, in the event of an overdose, you will receive the necessary treatment. Specifically, the nuclear medicine specialist in charge of the procedure may recommend that you drink a lot of water to facilitate the elimination of Fludesoxiglucosa (18F)-Curium from your body (since the primary route of elimination of this medication is renal, that is, through urine).

If you have any other questions about the use of Fludesoxiglucosa (18F)-Curium, ask the nuclear medicine specialist overseeing the procedure.

Like all medications, this medication may produce adverse effects,although not all people will experience them.

Adverse effects of unknown frequency (cannot be estimated from available data):

Severe allergic reactions, including anaphylaxis and cardiac arrest, which can be fatal, have been reported with symptoms such as:

• Difficulty breathing
• Lack of breath
• Slow heart rate
• Skin rash(including erythematous rash, pruritic rash, maculopapular rash)
• Urticaria, itching, dermatitis
• Redness of the skin (erythema)
• Swelling in various locations, facial swelling, lip, tongue, and/or throat swelling with difficulty swallowing or breathing (angioedema), localized fluid accumulation (edema)
• Eye irritation, eye disorders
• Coughing
• Nausea and vomiting

Symptoms may appear with a latency ranging from immediately to 10 days, with a median latency of 3 hours. In most cases, the latency was 24 hours or less.

Hypersensitivity reactions vary from mild (such as rash, itching) that require supportive treatment to severe that may require emergency assistance (hospitalization).

Before administration, your doctor must ask about allergy history, medical history, and current medication. A new exposure to the drug will carry the risk of a recurrent reaction.

This radiopharmaceutical will release a small amount of ionizing radiation associated with a minimal risk of cancer and hereditary defects.

Your doctor has considered that the clinical benefits you will obtain from the procedure with the radiopharmaceutical outweigh the risks due to radiation exposure.

Reporting Adverse Effects

If you experience any type of adverse effect, consulta nuclear medicine specialist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

You do not need to conserve this medication. This medication will be stored under the responsibility of the specialist in the appropriate facilities.The conservation of radiopharmaceuticals must be carried out in accordance with national regulations on radioactive materials.

The following information is directed solely to the specialist.

Do not use this medication after the expiration date that appears on the label after {CAD}

Composition ofFludesoxiglucosa (18F)-Curium

• The active principle is fludesoxiglucosa (18F). Each ml of injectable solution contains 185 MBq at the time of calibration.
• The other components are sodium chloride, ethanol, and water for injection (see section 2 “Fludesoxiglucosa (18F)-Curium contains sodium and ethanol”).

Appearance of the product and contents of the container

The activity per vial ranges from 90 MBq to 1850 MBq on the date and time of calibration.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

Curium International

Boulevard Bischoffsheim 39 boîte 4

1000 Bruxelles Belgium

Manufacturer:

BETA PLUS PHARMA s.A.

Avenue Hippocrate 10/1527

1200 Brussels - 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

Curium Pharma Spain, S.A. - Sevilla

Parque Tecnológico Cartuja’93

Avda. Thomas A. Edison, 7

41092 Sevilla – Spain

Curium Pharma Spain S.A – Madrid

Polígono Compisa; C/ Veguillas, 2, Nave 16

28864 Ajalvir (Madrid)

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Tel.: 91 4841989

This medication is authorized in the member states of the European Economic Area with the following names:

Austria:

[18F] Fludeoxyglucose Curium

Portugal, Malta:

Fludeoxyglucose (18F) Curium

Belgium, France, Luxembourg:

Fludésoxyglucose (18F) Curium

Italy:

Fluodeossiglucosio (18F) Curium

Netherlands:

Fluorodesoxyglucose (18F) Curium-international

Spain:

Fludesoxiglucosa (18F) Curium

Slovenia:

[18F]fludeoksiglukoza Curium

Last review date of this leaflet: October 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/).

This information is intended solely for healthcare professionals

The full Product Characteristics (RCP) document of Fludesoxiglucosa (18F)-Curium is attached in a separate document in the packaging to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Consult the RCP.