PATIENT INFORMATION LEAFLET

FLUOTRACER 1110 MBq/ml injectable solution

Fludesoxiglucosa (18F)

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

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

2. What you need to know before starting to use FLUOTRACER 1110 MBq/ml injectable solution

3. How to use FLUOTRACER 1110 MBq/ml injectable solution

4. Possible side effects

5. Storage of FLUOTRACER 1110 MBq/ml injectable solution

6. Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

The active ingredient contained in FLUOTRACER 1110 MBq/ml injectable solution is Fludesoxiglucosa (18F) and is designed for the acquisition of diagnostic images of certain body parts.

Once a small amount of FLUOTRACER 1110 MBq/ml injectable solution is injected, medical images obtained with a special camera will allow the doctor to obtain images and determine the location or progression of your disease.

No use Fluotracer

• if you areallergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Speak with 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

Inform your nuclear medicine doctor in the following cases:

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

Before Fluotracer administration, you must:

• drink a lot of water before starting the procedure to urinate frequently during the first hours after its completion.
• avoid 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

Other Medications and Fluotracer

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 doctor:

• any medication that may cause a modification in blood sugar concentration (glucose), such as anti-inflammatory medications (corticosteroids), seizure medications (valproate, carbamazepine, phenytoin, phenobarbital), medications affecting the nervous system (epinephrine, norepinephrine, dopamine…)
• glucose
• insulin
• medications used to increase blood cell production

Use of Fluotracer with Food and Beverages

You must fast for at least four hours before receiving this medication. You should drink a lot of water and avoid consuming liquids with sugars.

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

Pregnancy and Lactation

You should inform your nuclear medicine doctor before Fluotracer administration if there is any possibility of pregnancy, if you have a delayed period, or if you are breastfeeding.

In case of doubt, it is essential to consult with 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 should 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 consultation 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, consult with your nuclear medicine doctor before receiving this medication.

Driving and Operating Machines

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

Fluotracer Contains Sodium

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

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

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

FLUOTRACER 1110 1.0 MBq/ml injectable solution will be used exclusively in special 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 medicine physician supervising the procedure will decide on the amount of FLUOTRACER 1110

1.0 MBq/ml injectable solution 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 weight, 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

The dose to be administered will be adjusted according to the child's or adolescent's body weight.

Administration of FLUOTRACER 1110 1.0 MBq/ml injectable solution and procedure

FLUOTRACER 1110 1.0 MBq/ml injectable solution 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.

You will also be offered a drink and asked to urinate immediately before the procedure begins.

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

Procedure duration

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

FLUOTRACER 1110 1.0 MBq/ml injectable solution 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 FLUOTRACER 1110 1.0 MBq/ml injectable solution, 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 FLUOTRACER 1110 1.0 MBq/ml injectable solution than you should

It is unlikely to experience an overdose because you will receive a controlled and precise dose of FLUOTRACER 1110

1.0 MBq/ml injectable solution supervised by the nuclear medicine physician in charge of the procedure. However, in the event of an overdose, you will receive the appropriate treatment. Specifically, your nuclear medicine physician may recommend that you drink plenty of water to facilitate the elimination of FLUOTRACER 1110 1.0 MBq/ml injectable solution from your body (since the main route of elimination of this medication is renal, i.e., through urine).

If you have any other questions about the use of FLUOTRACER 1110 1.0 MBq/ml injectable solution, ask the nuclear medicine physician supervising the procedure.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Unknown frequency side effects (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
• Skin redness (erythema)
• Swelling in various locations, facial swelling, lip, tongue, and/or throat swelling 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.

Reactions to hypersensitivity vary from mild (such as rash, itching) that require supportive treatment to severe that may require emergency assistance (hospitalization).

Before administration, your doctor should 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 of side effects:

If you experience any type of side effect, consult the nuclear medicine specialist, even if it is possible side 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:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not need to be stored. This medication is stored under the responsibility of the specialist in appropriate facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use FLUOTRACER 1110 MBq/ml injectable solution after the expiration date that appears on the label of the container.

Composition of FLUOTRACER 1110 MBq/ml injectable solution

• The active principle is fludesoxiglucosa (18F). Each ml of injectable solution contains 1110 MBq of fludesoxiglucosa (18F) at the time and date of calibration.
• The other components are Diluted hydrochloric acid, Sodium citrate, Sodium hydrogen citrate, Sodium chloride, Anhydrous ethanol, Water for injectable preparations.

Appearance of the product and contents of the packaging

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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Curium Pharma Spain, S.A.

Avenida Dr. Severo Ochoa, 29

28100 Alcobendas (Madrid) – Spain

Responsible for manufacturing:

Curium Pharma Spain, S.A.

C/ Manuel Bartolomé Cossío, 10

28040 Madrid-Spain

The detailed and updated information on 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 prospectus: 12/2023.

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This information is intended solely for healthcare professionals:

The complete technical data sheet of FLUOTRACER 1110 MBq/ml injectable solution 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 must be included in the box].