Fluorscan 3000 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

FLUORSCAN 3000 MBq/ml solution for injection

Fludeoxyglucose (18F)

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

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

Contents of this leaflet:

1. What FLUORSCAN 3000 MBq/ml is and what it is used for
2. What you need to know before being given FLUORSCAN 3000 MBq/ml
3. How FLUORSCAN 3000 MBq/ml is administered
4. Possible side effects
5. How FLUORSCAN 3000 MBq/ml is stored
6. Contents of the pack and other 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 obtaining diagnostic images of certain parts of the body.

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

2. What you need to know before starting to use Fluorscan 3000 MBq/ml.

FLUORSCAN 3000 MBq/ml must not be used:

• if you are allergic (hypersensitive) to fludeoxyglucose (18F) or to any of the other components of this medicine (listed in section 6)

Warnings and precautions

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

• If you are diabetic and your diabetes is currently uncontrolled
• If you have an infection or an inflammatory disease
• If you have kidney problems

Inform your nuclear medicine physician in the following cases:

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

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

• Drink plenty of water before starting the procedure and urinate frequently during the first hours after completion.
• Avoid any strenuous physical activity
• Fast for at least 4 hours

Children and adolescents

Inform your nuclear medicine physician if you are under 18 years of age

Use of FLUORSCAN 3000 MBq/ml with other medicines

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

• Any medicine that may alter blood glucose levels (glycaemia), 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 blood cell production

Use of FLUORSCAN 3000 MBq/ml with food and drinks

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

Your physician must measure your blood glucose level before administering the medicine, since high blood glucose levels (hyperglycaemia) may interfere with the interpretation of the images by your nuclear medicine physician.

Pregnancy and breastfeeding

You must inform your nuclear medicine physician before administration of FLUORSCAN 3000 MBq/ml if there is any possibility you might be pregnant, if you have missed a period, or if you are breastfeeding.

If in doubt, it is important that you consult your nuclear medicine physician who will supervise the procedure.

If you are pregnant

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

If you are breastfeeding

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

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

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.

Driving and use of machines

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

FLUORSCAN 3000 MBq/ml contains sodium

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

This medicinal product contains a maximum of 0.13% V/V ethanol (alcohol), this small amount corresponds to 15.8 mg.

3. How to use FLUORSCAN 3000 MBq/ml

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. FLUORSCAN 3000 MBq/ml will only be used in specially controlled areas. This product will be handled and administered solely by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of FLUORSCAN 3000 MBq/ml to be used in your case. This will be the minimum quantity necessary to obtain the required information. The generally recommended dose for administration in adults ranges between 100 and 400 MBq (depending on the patient's body weight, the type of imaging camera used, 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 administered amount will be adjusted according to body weight.

Administration of FLUORSCAN 3000 MBq/ml and performance of the procedure

FLUORSCAN 3000 MBq/ml is administered intravenously.

A single injection is sufficient to perform the procedure required by your physician.

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

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

Duration of the procedure

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

FLUORSCAN 3000 MBq/ml is administered as a single intravenous injection 45 to 60 minutes before image acquisition. The actual imaging session with the camera lasts between 30 and 60 minutes.

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

• avoid direct contact with young children and pregnant women during the 12 hours following injection
• urinate frequently to help eliminate the product from your body

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

An overdose is unlikely, as you will receive a single dose of FLUORSCAN 3000 MBq/ml precisely controlled by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered. Specifically, your nuclear medicine physician may recommend that you drink plenty of fluids to facilitate the elimination of FLUORSCAN 3000 MBq/ml from the body (since the primary route of elimination of this medicinal product is renal, i.e., via urine).

If you have any further questions about the use of FLUORSCAN 3000 MBq/ml, please consult the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Allergic reactions have been reported, including severe allergic reactions such as shock and cardiac arrest, which may 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 parts of the body, swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema), localized accumulation of fluid (edema)
• Eye irritation, ocular disorders
• Cough
• Nausea and vomiting

Symptoms may appear from immediately up to 10 days after administration, 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), requiring supportive treatment, to severe reactions that may require emergency intervention (hospitalization).

Before administration, your doctor should ask you about your allergy history, medical history, and current medications. Re-exposure to the drug carries 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 determined that the clinical benefits you will obtain from the radiopharmaceutical procedure outweigh the risks associated with radiation exposure.

Reporting of adverse effects:

If you experience any type of adverse effect, consult the nuclear medicine specialist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

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

5. Storage of FLUORSCAN 3000 MBq/ml

You will not be required to store this medicinal product. This medicine is stored under the responsibility of a specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended for specialists only.

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

6. Contents of the container and other information

Composition of FLUORSCAN 3000 MBq/ml.

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

Appearance of the product and contents of the container

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

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

Date of the most recent review of this summary: 12/2023

This information is intended for healthcare professionals only:

The full Summary of Product Characteristics for FLUORSCAN 3000 MBq/ml is included as a separate document in the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the Summary of Product Characteristics [the Summary of Product Characteristics must be included in the package].