Prospecto: information for the user

FLUORSCAN 3000 MBq/ml injectable solution

Fludesoxiglucosa (18F)

Read this prospectus carefully before this medication is administered because it contains important information for you

• Keep this prospectus, as you may need to read it again
• If you have any doubts, consult your nuclear medicine physician who supervises the procedure.
• If you experience adverse effects, consult your nuclear medicine physician,even if they are not listed in this prospectus.See section 4.

Content of this prospectus:

1. What FLUORSCAN 3000 MBq/ml is and for what it is used
2. What you need to know before starting to use FLUORSCAN 3000 MBq/ml
3. How to use FLUORSCAN 3000 MBq/ml
4. Possible adverse effects.
5. Storage of FLUORSCAN 3000 MBq/ml.
6. Contents of the package and additional information.

This medication is a radiopharmaceutical for diagnostic use only.

The active ingredient contained in FLUORSCAN 3000 MBq/mlis fludesoxiglucosa (18F) and is designed for the acquisition of diagnostic images of certain body parts.

Once a small amount of FLUORSCAN 3000 MBq/mlhas been injected, medical images obtained with a special camera will allow the doctor to obtain images and determine the location or progression of your disease

Fluorscan 3000 MBq/ml should not be used:

• if you are allergic (hypersensitive) to Fludesoxiglucosa (18F) or to any of the other components of this medication(including in section 6)

Warnings and precautions

Speak with your nuclear medicine doctor before receivingFLUORSCAN 3000 MBq/ml:

• Ifyou 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 doctor in the following cases:

• If you are pregnant or think you may be pregnant
• If you are breastfeeding

Before the administration ofFLUORSCAN 3000 MBq/mlyou must:

• drink a lot of water before starting the procedure to urinate very frequently during the first hours after its completion.
• avoid all intense physical activity
• be fasting for at least 4 hours

Children and adolescents

Inform your nuclear medicine doctor if you are under 18 years old

Use of FLUORSCAN 3000 MBq/ml with other medications.

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

-any medication that may cause a modification in the concentration of sugar in the blood (glucose), such as medications to reduce inflammation (corticosteroids), medications for seizures (valproate, carbamazepine, phenytoin, phenobarbital), medications affecting the nervous system (epinephrine, norepinephrine, dopamine…)

-glucose

-insulin

-medications used to increase the production of blood cells

Use of FLUORSCAN 3000 MBq/ml with food and drinks.

You must fast for at least 4 hours before receiving this medication, You must drink a lot of water and avoid consuming liquids that contain sugars.

Your doctor must 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 your nuclear medicine doctor to interpret the images.

Pregnancy and lactation.

You must inform your nuclear medicine doctor before administering FLUORSCAN 3000 MBq/ml if there is any possibility that you may be pregnant, if you experience a delay in your period or if you are breastfeeding.

In case of doubt, it is essential that you consult your nuclear medicine doctor who will supervise the procedure

If you are pregnant

Your nuclear medicine doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

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

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

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consultyour nuclear medicine doctor before this medication is administered

Driving and operating machinery.

It is considered unlikely that FLUORSCAN 3000 MBq/ml will affect your ability to drive and operate machinery.

FLUORSCAN 3000 MBq/mlcontains sodium

Patients with low-sodium diets should note that this medication contains 23 mg (1 mmol) of sodium per dose.

This medication contains a maximum of 0.13% V/V of ethanol (alcohol), which corresponds to 15.8 mg.

There are strict regulations regarding the use, handling, and disposal of radioactive substances.FLUORSCAN 3000 MBq/mlwill be used exclusively in specially controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. Those individuals will take special care in the safe use of this product and will inform you of their actions

The nuclear physician who supervises the procedure will decide on the amount of FLUORSCAN 3000 MBq/ml to be used in your case. This will be the minimum amount necessary to obtain the desired information. The generally recommended dose for an adult 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 children and adolescents, the dose to be administered will be adjusted according to their body weight.

Administration ofFLUORSCAN 3000 MBq/mland procedure performance

FLUORSCAN 3000 MBq/ml is administered intravenously.

One injection is sufficient to perform the procedure your doctor needs.

After the injection, you must remain completely still, without reading or speaking. Additionally, you will be offered a drink and asked to urinate immediately before starting the procedure.

During image acquisition,you must remain completely still. Do not move or speak

Procedure duration

Your nuclear physician will inform you about the usual duration of the procedure.

FLUORSCAN 3000 MBq/ml is administered as a single injection in a vein between 45 and 60 minutes before image acquisition. The image acquisition with the camera lasts between 30 and 60 minutes.

After administration of FLUORSCAN 3000 MBq/ml, you must:

-avoid direct contact with small children and pregnant women during the 12 hours after the injection

-urinate frequently to eliminate the product from your body

If you have been administered more FLUORSCAN 3000 MBq/ml than you should

It is unlikely to have an overdose because you will receive a controlled and precise dose of FLUORSCAN 3000 MBq/ml from the nuclear physician who supervises the procedure. However, in case of an overdose, you will receive the appropriate treatment. Specifically, your nuclear physician may recommend that you drink a lot of water to facilitate the elimination of FLUORSCAN 3000 MBq/ml from your body (since the main route of elimination of this medication is renal, that is, through urine).

If you have any other questions about the use of FLUORSCAN 3000 MBq/ml, ask the nuclear physician who supervises the procedure.

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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 may 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 swelling, tongue swelling, 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 your 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, consult the 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 the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by the patient. This medication is stored under the responsibility of the specialist in appropriate facilities. Radioactive material storage will be carried out in accordance with national regulations.

The following information is intended solely for the specialist.

Do not use FLUORSCAN 3000 MBq/ml after the expiration date appearing on the packaging.

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Composition of FLUORSCAN 3000 MBq/ml.

• The active principle is fludesoxiglucosa (18F). Each ml ofinjectable solutioncontains 3000 MBq offludesoxiglucosa(18F)at the time and date of calibration.
• The other components are sodium chloride, water for injection, dihydrogen phosphate disodium dihydrate, and anhydrous ethanol.

Appearance of the product and contents of the packaging

The activity per vial ranges from 3,000 MBq to 30,000 MBq at the time and date of calibration.

Holder of the marketing authorization

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100– Alcobendas (Madrid)

Spain

Responsible for manufacturing

Curium Pharma Spain S.A - Santander

Avda. M. de Valdecilla, 25

39008 Santander

Curium Pharma Spain S.A - San Sebastián

Paseo Miramón 182

20009 San Sebastián (Guipúzcoa)

Curium Pharma Spain S.A - Madrid

Polígono Compisa; C/ Veguillas, 2, Nave 16

28864 Ajalvir (Madrid)

Curium Pharma Spain S.A - Capuchinos

Ronda de Capuchinos, 11

41009 Sevilla

Curium Pharma Spain S.A – Málaga

C/ Marqués de Beccaría, 3,

Campo Universitario Teatinos, s/n (Universidad de Málaga-Centro)

29100 Málaga

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

Last review date of this leaflet:12/2023

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This information is intended solely for healthcare professionals:

The complete technical file of FLUORSCAN 3000 MBq/ml is includedas a separate documentin the packaging of the product, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical file [the technical file must be included in the box].