FluoTracer 1110 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUOTRACER 1110 MBq/ml solution for injection

Fluorodeoxyglucose (18F)

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your nuclear medicine physician who is supervising 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.

Leaflet contents:

1. What FLUOTRACER 1110 MBq/ml solution for injection is and what it is used for
2. What you need to know before being given FLUOTRACER 1110 MBq/ml solution for injection
3. How to use FLUOTRACER 1110 MBq/ml solution for injection
4. Possible side effects
5. How to store FLUOTRACER 1110 MBq/ml solution for injection
6. Contents of the pack and other information

1. What FLUOTRACER 1110 MBq/ml injection solution is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.

The active substance in FLUOTRACER 1110 MBq/ml injection solution is Fludeoxyglucose (18F), designed for obtaining diagnostic images of certain parts of the body.

After a small amount of FLUOTRACER 1110 MBq/ml injection solution is administered, medical images obtained using a special camera will enable the physician to visualize and determine the location or progression of your disease.

2. WHAT YOU NEED TO KNOW BEFORE USING FLUOTRACER 1110 MBq/ml injectable solution

Do not use Fluotracer

• if you are allergic to the active substance 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 Fluotracer:

• if you have diabetes and your condition is currently uncontrolled
• if you have an infection or 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 receiving Fluotracer you must:

• drink plenty of water before starting the procedure to ensure frequent urination 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.

Other medicines and Fluotracer

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 image interpretation by your physician:

• any medicine that may alter blood sugar levels (glycemia), such as anti-inflammatory drugs (corticosteroids), anticonvulsants (valproate, carbamazepine, phenytoin, phenobarbital), drugs affecting the nervous system (epinephrine, norepinephrine, dopamine…)
• glucose
• insulin
• medicines used to increase blood cell production

Use of Fluotracer with food and drink

You must fast for at least four 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 (hyperglycemia) may interfere with image interpretation by your nuclear medicine physician.

Pregnancy and breastfeeding

You must inform the nuclear medicine physician before administration of Fluotracer if there is any possibility you might be pregnant, if you have missed a menstrual period, or if you are breastfeeding.

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

If you are pregnant

The 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 for 12 hours after the injection and discard any 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 may be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.

Driving and use of machines

Fluotracer is considered unlikely to affect your ability to drive or operate machinery.

Fluotracer contains sodium

This medicine may contain up to a maximum of 295 mg of sodium (main component of table/cooking salt) per ml. This corresponds to 14.75% of the maximum recommended daily sodium intake for an adult.

This medicine may contain up to 3.59 mg of ethanol (alcohol) per ml.

3. How to USE FLUOTRACER 1110 MBq/ml solution for injection

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.

FLUOTRACER 1110 MBq/ml solution for injection will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel experienced in the safe use of such products. These individuals will take special care in ensuring the safe use of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of FLUOTRACER 1110 MBq/ml solution for injection to be used in your case. This amount will be the minimum necessary to obtain the required diagnostic 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 dose will be adjusted according to body weight.

Administration of FLUOTRACER 1110 MBq/ml solution for injection and performance of the procedure

FLUOTRACER 1110 MBq/ml solution for injection 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 talking.

Additionally, 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.

FLUOTRACER 1110 MBq/ml solution for injection is given as a single intravenous injection 45 to 60 minutes before image acquisition. The actual imaging session lasts between 30 and 60 minutes.

After administration of FLUOTRACER 1110 MBq/ml solution for injection, you should:

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

If you have been administered more FLUOTRACER 1110 MBq/ml solution for injection than you should have received

An overdose is unlikely, as you will receive a single, precisely controlled dose of FLUOTRACER 1110 MBq/ml solution for injection determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be provided. Specifically, your nuclear medicine physician may recommend that you drink plenty of fluids to facilitate the elimination of FLUOTRACER 1110 MBq/ml solution for injection 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 FLUOTRACER 1110 MBq/ml solution for injection, please consult the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicine may have adverse effects, although not everyone will experience them.

Like all medicines, this medicine can cause adverse effects, although not all individuals will experience 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 heart rate
• Skin 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)
• Eye irritation, ocular disorders
• Cough
• Nausea and vomiting

Symptoms may appear with a latency ranging from immediately up 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), requiring supportive treatment, to severe reactions that may require emergency intervention (hospitalization).

Before administration, your doctor should ask you about your history of allergies, medical history, and current medications. A new 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 procedure with the radiopharmaceutical outweigh the risks due to radiation exposure.

Reporting of adverse effects:

If you experience any type of adverse effect, consult the nuclear medicine specialist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

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

5. Storage of FLUOTRACER 1110 MBq/ml solution for injection

You will not be required to store this medicine. This medicine is stored under the responsibility of the 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 FLUOTRACER 1110 MBq/ml solution for injection after the expiry date stated on the container label.

6. Contents of the pack and other information

Composition of FLUOTRACER 1110 MBq/ml solution for injection

• The active substance is fludeoxyglucose (18F). Each ml of solution for injection contains 1110 MBq of fludeoxyglucose (18F) at the time and date of calibration.
• The other components are Dilute hydrochloric acid, Sodium citrate, Sodium hydrogen citrate, Sodium chloride, Anhydrous ethanol, Water for injections.

Appearance of the product and contents of the container

The activity per vial ranges from 555 MBq to 9,990 MBq at the time and date of calibration for the 11 ml vial and from 555 MBq to 25,863 MBq for the 25 ml vial at the time and date of calibration.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Curium Pharma Spain, S.A.

Avenida Dr. Severo Ochoa, 29

28100 Alcobendas (Madrid) – Spain

Manufacturer:

Curium Pharma Spain, S.A.

C/ Manuel Bartolomé Cossío, 10

28040 Madrid – Spain

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

Date of the most recent revision of this summary: 12/2023.

This information is intended for healthcare professionals only:

The complete Summary of Product Characteristics for FLUOTRACER 1110 MBq/ml solution for injection is included as a separate document within 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].