FLUORSCAN 3000 MBq/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

FLUORSCAN 3000 MBq/ml Solution for Injection

Fludeoxyglucose (18F)

Read all of this leaflet carefully before this medicine is administered to you 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 doctor who is supervising the procedure
• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4

Contents of the package leaflet:

1. What FLUORSCAN 3000 MBq/ml is and what it is used for
2. What you need to know before you are given FLUORSCAN 3000 MBq/ml
3. How FLUORSCAN 3000 MBq/ml is used
4. Possible side effects
5. Storage of FLUORSCAN 3000 MBq/ml
6. Contents of the pack and further information

1. What FLUORSCAN 3000 MBq/ml is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

The active substance in FLUORSCAN 3000 MBq/ml is fludeoxyglucose (18F) and it is designed for the acquisition of diagnostic images of certain parts of the body.

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

2. What you need to know before you are given FLUORSCAN 3000 MBq/ml

FLUORSCAN 3000 MBq/ml must not be used:

Warnings and precautions

Talk to your nuclear medicine doctor before receiving FLUORSCAN 3000 MBq/ml:

Tell your nuclear medicine doctor:

Before administration of FLUORSCAN 3000 MBq/ml, you should:

• drink plenty of water before starting the procedure to urinate frequently during the first hours after its completion
• avoid intense physical activity
• fast for at least 4 hours

Children and adolescents

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

Using FLUORSCAN 3000 MBq/ml with other medicines

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

• any medicine that may cause a modification in blood sugar concentration (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 FLUORSCAN 3000 MBq/ml with food and drinks

You should fast for at least 4 hours before receiving this medicine. You should drink plenty of water and avoid consuming liquids that contain sugars

Your doctor should measure your blood glucose level before administering the medicine, as a high glucose concentration in the blood (hyperglycemia) may make it difficult for your nuclear medicine doctor to interpret the images

Pregnancy and breast-feeding

You should tell your nuclear medicine doctor before administration of FLUORSCAN 3000 MBq/ml if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding

In case of doubt, it is important that you consult your nuclear medicine doctor who is supervising the procedure

If you are pregnant

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

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 resume breast-feeding should be made in agreement with the specialist in nuclear medicine who will supervise the procedure

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before this medicine is administered to you

Driving and using machines

It is considered unlikely that FLUORSCAN 3000 MBq/ml will affect your ability to drive and use machines

FLUORSCAN 3000 MBq/mlcontains sodium

Patients on low-sodium diets should be aware that this medicine contains 23 mg (1 mmol) of sodium per dose

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

3. How to use FLUORSCAN 3000 MBq/ml

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. FLUORSCAN 3000 MBq/ml will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this product and will inform you of their actions

The nuclear medicine doctor supervising the procedure will decide 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 recommended amount for administration to an adult is 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 children and adolescents, the amount to be administered will be adjusted according to their body weight

Administration ofFLUORSCAN 3000 MBq/mland performance of the procedure

FLUORSCAN 3000 MBq/ml is administered intravenously

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

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

During image acquisition, you must remain completely at rest. Do not move or talk

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure

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

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

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

• urinate frequently to eliminate the product from your body

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

Overdose is unlikely because you will receive a precisely controlled single dose of FLUORSCAN 3000 MBq/ml by your nuclear medicine doctor. However, in case of overdose, you will receive appropriate treatment. In particular, your nuclear medicine doctor may recommend that you drink plenty of water to facilitate the elimination of FLUORSCAN 3000 MBq/ml from the body (since the main route of elimination of this medicine is renal, i.e., in the urine)

If you have any further questions about the use of FLUORSCAN 3000 MBq/ml, ask your nuclear medicine doctor

.

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 heartbeat
• Skin rash (including erythematous rash, pruritic rash, maculopapular rash)
• Hives, 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)
• Eye irritation, eye disorders
• Cough
• 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 range from mild (such as rash, itching) that require supportive treatment to severe that may require 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 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 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 doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine

5. Storage of FLUORSCAN 3000 MBq/ml

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials

The following information is intended only for healthcare professionals:

Do not use FLUORSCAN 3000 MBq/ml after the expiry date stated on the packaging

.

6. Contents of the pack and further information

Composition of FLUORSCAN 3000 MBq/ml

• The active substance is fludeoxyglucose (18F). Each ml of solution for injection contains 3000 MBq of fludeoxyglucose (18F) at the date and time of calibration
• The other components are sodium chloride, water for injections, sodium dihydrogen phosphate dihydrate, and anhydrous ethanol

Appearance and pack contents

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

Marketing authorisation holder

Curium Pharma Spain, S.A

Avda. Dr. Severo Ochoa, 29

28100 – Alcobendas (Madrid)

Spain

Manufacturer

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

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

Date of last revision of this leaflet:12/2023

-----------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

The full technical data sheet for FLUORSCAN 3000 MBq/ml is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical

Please consult the technical data sheet [the technical data sheet should be included in the box]