FLUOTRACER, 1110 MBq/ml, INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUOTRACER 1110 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, 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 pack:

1. What FLUOTRACER 1110 MBq/ml solution for injection is and what it is used for
2. What you need to know before you are given FLUOTRACER 1110 MBq/ml solution for injection
3. How FLUOTRACER 1110 MBq/ml solution for injection is used
4. Possible side effects

5 Storage of FLUOTRACER 1110 MBq/ml solution for injection

1. Contents of the pack and further information

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

This medicine is a radiopharmaceutical for diagnostic use only.

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

Once a small amount of FLUOTRACER 1110 MBq/ml solution for injection 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 FLUOTRACER 1110 MBq/ml solution for injection

Do not use Fluotracer

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your nuclear medicine doctor before receiving Fluotracer:

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

Tell your nuclear medicine doctor in the following cases:

• if you are pregnant or think you may be pregnant
• if you are breast-feeding

Before the administration of Fluotracer, 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

Other medicines and Fluotracer

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

Use of Fluotracer with food and drinks

You should fast for at least four 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) can make it difficult for your nuclear medicine doctor to interpret the images.

Pregnancy and breast-feeding

You should inform your nuclear medicine doctor before the administration of Fluotracer 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 give you 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 you are given this medicine.

Driving and using machines

It is considered unlikely that Fluotracer will affect your ability to drive or use machines.

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 is equivalent to 14.75% of the maximum recommended daily intake of sodium for an adult.

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

3. HOW TO USE FLUOTRACER 1110 MBq/ml solution for injection

There are strict rules on the use, handling, and disposal of radiopharmaceuticals.

FLUOTRACER 1110 MBq/ml solution for injection 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 who supervises the procedure will decide the amount of FLUOTRACER 1110 MBq/ml solution for injection to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended amount to administer to an adult ranges from 100 to 400 MBq (depending on the patient's body weight, the type of camera used for image acquisition, and the mode of image acquisition). 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 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 that your doctor needs.

After the injection, you should 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 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.

FLUOTRACER 1110 MBq/ml solution for injection 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 the administration of FLUOTRACER 1110 MBq/ml solution for injection, 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 FLUOTRACER 1110 MBq/ml solution for injection than you should

Overdose is unlikely because you will receive a precisely controlled single dose of FLUOTRACER 1110 MBq/ml solution for injection 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 FLUOTRACER 1110 MBq/ml solution for injection 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 FLUOTRACER 1110 MBq/ml solution for injection, ask your nuclear medicine doctor.

4. Possible side effects

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

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) 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: www.notificaRAM.es.

By reporting side 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 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 the specialist.

Do not use FLUOTRACER 1110 MBq/ml solution for injection after the expiry date stated on the label of the container.

6. Contents of the pack and further 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 date and time of calibration.
• The other ingredients are Hydrochloric acid diluted, Sodium citrate, Sodium hydrogencitrate, Sodium chloride, Anhydrous ethanol, Water for injections.

Appearance and pack contents

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

Marketing authorisation holder and manufacturer

Marketing authorisation 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 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.

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This information is intended only for healthcare professionals:

The full technical data sheet of FLUOTRACER 1110 MBq/ml solution for injection 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].