FLUDESOXIGLUCOSE (18F) CURIUM 185 MBq/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Fludeoxyglucose (18F)-Curium 185 MBq/ml, Solution for Injection

Fludeoxyglucose (18F)

Read all of this leaflet carefully before you start receiving this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your nuclear medicine specialist who will be supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine specialist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Fludeoxyglucose (18F)-Curium and what is it used for.
2. What you need to know before you start using Fludeoxyglucose (18F)-Curium.
3. How to use Fludeoxyglucose (18F)-Curium.
4. Possible side effects.
5. Storage of Fludeoxyglucose (18F)-Curium.
6. Contents of the pack and further information.

1. What is Fludeoxyglucose (18F)-Curium and what is it used for

This medicinal product is a radiopharmaceutical for diagnostic use only.

The active substance in Fludeoxyglucose (18F)-Curium is designed for acquiring diagnostic images of certain parts of the body.

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

2. What you need to know before you start using Fludeoxyglucose (18F)-Curium

Do not use Fludeoxyglucose (18F)-Curium

• if you are allergic to fludeoxyglucose (18F) or any of the other ingredients of this medicinal product (listed in section 6).

Warnings and Precautions

Talk to your nuclear medicine specialist before receiving Fludeoxyglucose (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 your nuclear medicine specialist in the following cases:

• If you are pregnant or think you may be pregnant.
• If you are breast-feeding.

Before administration of fludeoxyglucose (18F) you should:

• 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 your nuclear medicine specialist if you are under 18 years old.

Using Fludeoxyglucose (18F)-Curium with other Medicines

Tell your nuclear medicine specialist if you are taking, have recently taken or might take any other medicines, as they may interfere with the interpretation of the images by your doctor:

• Any medicine that may cause a change in blood sugar levels (glycemia), such as medicines to reduce inflammation (corticosteroids), medicines for seizures (valproate, carbamazepine, phenytoin, phenobarbital), medicines that affect the nervous system (epinephrine, norepinephrine, dopamine…)
• Glucose
• Insulin
• Medicines used to increase blood cell production

Using Fludeoxyglucose (18F)-Curium with Food and Drinks

You should fast for at least four hours before receiving this medicinal product. You should drink plenty of water and avoid consuming liquids that contain sugars. Your doctor will measure your blood glucose levels before administering the medicinal product; as a high glucose level in the blood (hyperglycemia) may make it difficult for the nuclear medicine specialist to interpret the images.

Pregnancy and Breast-feeding

You should inform your nuclear medicine specialist before administration of Fludeoxyglucose (18F)-Curium if there is any possibility that you may be pregnant, if you have missed your period or if you are breast-feeding.

If there is any doubt that you may be pregnant, it is important to consult your nuclear medicine specialist who will be supervising the procedure.

If you are pregnant

Your nuclear medicine specialist will only administer this medicinal product during pregnancy if the expected benefits outweigh the risks.

If you are breast-feeding

You should stop breast-feeding your child for 12 hours after the injection and discard the expressed milk during this period.

The decision to restart breast-feeding should be taken in agreement with your nuclear medicine specialist who will be supervising the procedure.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine specialist for advice before using this medicinal product.

Driving and Using Machines

It is considered unlikely that Fludeoxyglucose (18F)-Curium will affect your ability to drive and use machines.

Fludeoxyglucose (18F)-Curium contains Sodium and Ethanol.

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

3. How to use Fludeoxyglucose (18F)-Curium

There is strict legislation on the use, handling, and disposal of radiopharmaceuticals. Fludeoxyglucose (18F)-Curium should only be used in controlled areas. Only personnel with training and experience in the safe use of this medicinal product may handle and administer it. These persons will take the necessary precautions to use this medicinal product safely and will keep you informed of their actions.

Your nuclear medicine specialist will decide the amount of Fludeoxyglucose (18F)-Curium to be used in your case, which will always be the smallest amount necessary to obtain the desired information.

The recommended amount for an adult is usually between 100 and 400 MBq (depending on the patient's body weight, the type of camera used for image acquisition, and the acquisition mode). The megabecquerel (MBq) is the unit used to express radioactivity.

Use in Children and Adolescents

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

Administration of Fludeoxyglucose (18F)-Curium and Performance of the Procedure

Fludeoxyglucose (18F) is administered by intravenous injection.

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

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

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

Duration of the Procedure:

Your nuclear medicine specialist will inform you of the usual duration of the procedure.

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

After Administration of Fludeoxyglucose (18F)-Curium, you should:

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

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

It is unlikely that you will be given an overdose because you will only receive a precisely controlled dose of Fludeoxyglucose (18F)-Curium from your nuclear medicine specialist. However, in case of overdose, you will receive the appropriate treatment. In particular, your nuclear medicine specialist may recommend that you drink plenty of water to facilitate the elimination of Fludeoxyglucose (18F)-Curium from your body (since the main route of elimination of this medicinal product is renal, i.e., in the urine).

If you have any further questions on the use of Fludeoxyglucose (18F)-Curium, ask your nuclear medicine specialist who will be supervising the procedure.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Allergic reactions, including severe allergic reactions such as shock and cardiac arrest, which can be fatal, with symptoms such as:

• Difficulty breathing
• Shortness of breath
• Slow heart rate
• Rash (including erythematous rash, pruritic rash, maculopapular rash)
• Urticaria, itching, dermatitis
• Redness of the skin (erythema)
• Swelling in various locations, swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema), localized fluid accumulation (edema)
• Ocular irritation, eye disorders
• Cough
• Nausea and vomiting

The 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 range from mild (such as rash, itching) requiring supportive treatment to severe requiring emergency assistance (hospitalization).

Before administration, your doctor should ask you about your history of allergies, medical history, and current medication. A new exposure to the medicinal product 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 genetic 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 of Side Effects

If you experience any side effects, talk to your nuclear medicine specialist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of Fludeoxyglucose (18F)-Curium

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

The following information is intended for healthcare professionals only.

Do not use this medicinal product after the expiry date stated on the label after {EXP}

6. Contents of the Pack and Further Information

Composition of Fludeoxyglucose (18F)-Curium

• The active substance is fludeoxyglucose (18F). Each ml of the solution for injection contains 185 MBq at the time of calibration.
• The other ingredients are sodium chloride, ethanol, and water for injections (see section 2 “Fludeoxyglucose (18F)-Curium contains sodium and ethanol”).

Appearance of the Product 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 Brussels Belgium

Manufacturer:

BETA PLUS PHARMA s.A.

Avenue Hippocrate 10/1527

1200 Brussels - Belgium

CURIUM PET FRANCE

Parc scientifique et technique G.Besse

180, Allée 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-Lévêque

33600 Pessac - France

CURIUM PET FRANCE

Centre Eugène 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-lès-Nancy – France

CYCLOTRON REUNION OCEAN INDIEN – CYROI

2 Rue Maxime Rivière

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 Rome – 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 Milan – 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. - Seville

Parque Tecnológico Cartuja’93

Avda. Thomas A. Edison, 7

41092 Seville – Spain

Curium Pharma Spain S.A – Madrid

Polígono Compisa; C/ Veguillas, 2, Nave 16

28864 Ajalvir (Madrid)

You can request more information about this medicinal product from the local representative of the Marketing Authorisation Holder:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Phone: 91 4841989

This medicinal product is authorized in the Member States of the European Economic Area under 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

Date of last revision of this leaflet: October 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only.

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

Consult the SPC.