Label: information for the user

GLUSCAN 600 MBq/mL injectable solution

Fludesoxiglucosa (18F)

Read this label carefully before this medicine is administered to you because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who is supervising the procedure.
• If you experience any adverse effects,consult your nuclear medicine physician,eveniftheyare not listed in this label.See section 4.

1. What GLUSCAN is and for what it is used

2. What you need to knowbeforestarting to use GLUSCAN

3. How to use GLUSCAN

4. Possible adverse effects

5. Storage of GLUSCAN

6. Contents of the container and additional informationl

This medication is a radiopharmaceutical for diagnostic use only.

The active principle contained in GLUSCAN is fludesoxiglucosa (18F) and is designed for diagnostic image acquisitionof certain body parts.

Once a small amount of GLUSCAN 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.

GLUSCAN should not be used

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

Warnings and precautions

Speak to your nuclear medicine doctor before receiving GLUSCAN:

• 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 the administration of GLUSCAN you must:

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

Use of GLUSCAN with other medicines

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

• any medicine that may cause a modification in the concentration of sugar in the blood (glucose), such as anti-inflammatory medicines (corticosteroids), medicines for seizures (valproate, carbamazepine, phenytoin, phenobarbital), medicines affecting the nervous system (epinephrine, norepinephrine, dopamine…)
• glucose,
• insulin,
• medicines used to increase the production of blood cells.

Use of GLUSCAN with food and drinks

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

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

Pregnancy and breastfeeding

You must inform your nuclear medicine doctor before the administration of GLUSCAN if there is any possibility that you may be pregnant, if you have a delayed period or if you are breastfeeding.

It is essential to consult your nuclear medicine doctor who will supervise the procedure in case of doubt.

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 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, or think you may be pregnant, or intend to become pregnant, consult your nuclear medicine doctor before receiving this medicine.

Driving and operating machinery

It is considered unlikely that GLUSCAN will affect your ability to drive or operate machinery.

GLUSCAN contains sodium

Patients with low-sodium diets should note that this medicine contains 23 mg (1 mmol) of sodium per dose.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. GLUSCAN 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. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine physician overseeing the procedure will decide the amount of GLUSCAN 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 mass, the type of camera used to obtain images, and the image acquisition mode)MegaBecquerel (MBq) is the unit used to express radioactivity.

Use in children and adolescents

In children and adolescents, the dose to be administered will be adjusted according to their body weight.

Administration of GLUSCAN and procedure performance:

GLUSCAN 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. Additionally,you will be offered a drink and askedto urinate immediately before starting the procedure.

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

Procedure duration

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

GLUSCAN is administered as a single injection into a vein 45 to 60minutes before image acquisition. The image acquisition with the camera lasts between 30 and 60minutes.

After GLUSCAN administration, 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 GLUSCAN than necessary

It is unlikely to have an overdose because you will receive a controlled and precise dose of GLUSCAN from the nuclear medicine doctor overseeing the procedure. However, in case of an overdose, you will receive the appropriate treatment.Specifically, your nuclear medicine doctor may recommend that you drink a lot of water to facilitate the elimination of GLUSCAN from your body (since the main route of elimination of this medication is renal, that is, through urine).

If you have any other questions about the use of GLUSCAN, ask the nuclear medicine doctor overseeing the procedure

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Your doctor has taken into account that the clinical benefit you will obtain from the test with the radiopharmaceutical exceeds the risk due to radiation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear medicine doctor, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication

This medication does not need to be stored by the patient. This medication will be stored under the responsibility of the specialist in suitable facilities. Radioactive medication storage will be performed in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use GLUSCAN after the expiration date appearing on the label of the packaging.

Composition of GLUSCAN

• The active principle is fludesoxiglucosa (18F). Each mL of injectable solution contains 600 MBq of fludesoxiglucosa (18F) at the date and time of calibration.
• The other components are:Sodium citrate, trisodium citrate, sodium chloride, sodium acetate, ethanoland water for injection preparations.

Appearance of the product and contents of the package

The total activity per vial ranges from 300 MBq to 6000 MBq at the date and time of calibration.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Advanced Accelerator Applications Molecular Imaging France SAS

20 rue Diesel

01630 Saint Genis Pouilly

France

Responsible for manufacturing

Advanced Accelerator ApplicationsMolecular Imaging France SAS

20 rue Diesel

01630 Saint-Genis-Pouilly

France

Advanced Accelerator Applications Molecular Imaging Italy S.r.l.

Viale Dell’Industria

86077 Pozzilli (IS)

Italy

Advanced Accelerator ApplicationsMolecular Imaging France SAS

Technopole de l’Aube

14, rue Gustave Eiffel

10430 Rosières Près Troyes

France

Advanced Accelerator ApplicationsMolecular Imaging France SAS

126 Rocade Sud

62660 Beuvry

France

Advanced Accelerator Applications Molecular Imaging Italy S.r.l.

Via Piero Maroncelli 40/42

47014 Meldola (FO)

Italy

Advanced Accelerator ApplicationsMolecular Imaging France SAS

3, rue Charles Lauer

92210 Saint-Cloud

France

Advanced Accelerator ApplicationsPortugal Unipessoal Lda

Rua Fonte das Sete Bicas, 170, Matosinhos

4460-203 Matosinhos

Matosinhos

Portugal

Advanced Accelerator ApplicationsMolecular Imaging France SAS

27 boulevard Jean Moulin

13005 Marseille

France

Advanced Accelerator ApplicationsGermany

Saime Genc-Ring 18

53121 Bonn

Germany

Advanced Accelerator Applications Molecular Imaging Iberica, S.L.U

Hospital Clínico Universitario Virgen de la Arrixaca,

Ctra. Madrid-Cartagena, s/n,

El Palmar, 30120 Murcia

Spain

ITEL Telecomunicazioni S.r.l

Via Antonio Labriola (Zona Industriale)

Snc - 70037 Ruvo Di Puglia (Ba)

Italy

Advanced Accelerator Applications Germany GmbH

Marchioninistrasse 67

81377 Munich

Germany

Advanced Accelerator Applications Molecular Imaging Iberica, S.L.U.

C/ Josep Anselm Clavé, 100

08950 Esplugues de Llobregat (Barcelona)

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Advanced Accelerator Applications Molecular Imaging Iberica, S.L.U.

C/ Josep Anselm Clavé, 100

08950 Esplugues de Llobregat (Barcelona)

Spain

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS).

This medication is authorized in the member states of the European Economic Area with the following names:

France, Italy, Spain, Germany, Portugal: GLUSCAN

Revision date of this prospectus: October 2017

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This information is intended solely for healthcare professionals:

The complete technical file of GLUSCAN is includedas a separate documentin 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 file(the technical file must be included in the box)