GLUSCAN 600 MBq/mL INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

GLUSCAN 600 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 Package Leaflet

1. What is GLUSCAN and what is it used for
2. What you need to know before you are given GLUSCAN
3. How to use GLUSCAN
4. Possible side effects
5. Storage of GLUSCAN
6. Package Contents and Further Information

1. What is GLUSCAN and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

The active ingredient in GLUSCAN is fludeoxyglucose (18F) and it is designed for the acquisition of diagnostic images of certain parts of the body.

Once a small amount of GLUSCAN 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 GLUSCAN

GLUSCAN must not be used

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

Warnings and Precautions

Talk 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

Tell your nuclear medicine doctor:

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

Before administration of GLUSCAN, you should:

• drink plenty of water before starting the procedure to urinate frequently during the first few 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.

Using GLUSCAN with other medicines

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 change in blood sugar levels (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.

Using GLUSCAN 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 level in the blood (hyperglycemia) can make it difficult for your nuclear medicine doctor to interpret the images.

Pregnancy and Breast-feeding

You should tell your nuclear medicine doctor before administration of GLUSCAN 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 GLUSCAN will affect your ability to drive or use machines.

GLUSCAN contains sodium

Patients on a low-sodium diet should be aware that this medicine contains 23 mg (1 mmol) of sodium per dose.

3. How to use GLUSCAN

There are strict rules on 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. These people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor supervising 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 recommended amount for administration to an adult is between 100 and 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 GLUSCAN and Performance of the Procedure:

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

During the acquisition of images, you will have to be 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.

GLUSCAN 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 administration of GLUSCAN, 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 GLUSCAN than you should

Overdose is unlikely because you will receive a precisely controlled single dose of GLUSCAN by the nuclear medicine doctor supervising the procedure. 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 GLUSCAN 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 on the use of GLUSCAN, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible Side Effects

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

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.

Your doctor has considered that the clinical benefit you will get from the test with the radiopharmaceutical outweighs the risk due to radiation.

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 side effects 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 GLUSCAN

You will not need to store this medicine. This medicine 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 for healthcare professionals only:

Do not use GLUSCAN after the expiry date stated on the label of the package.

6. Package Contents and Further Information

Composition of GLUSCAN

• The active ingredient is fludeoxyglucose (18F). Each mL of solution for injection contains 600 MBq of fludeoxyglucose (18F) at the date and time of calibration.
• The other ingredients are: Disodium hydrogen citrate, trisodium citrate, sodium chloride, sodium acetate, ethanol, and water for injections.

Appearance of the Product and Package Contents

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Advanced Accelerator Applications Molecular Imaging France SAS

20 rue Diesel

01630 Saint Genis Pouilly

France

Manufacturer

Advanced Accelerator Applications Molecular 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 Applications Molecular Imaging France SAS

Technopole de l’Aube

14, rue Gustave Eiffel

10430 Rosières Près Troyes

France

Advanced Accelerator Applications Molecular 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 Applications Molecular Imaging France SAS

3, rue Charles Lauer

92210 Saint-Cloud

France

Advanced Accelerator Applications Portugal Unipessoal Lda

Rua Fonte das Sete Bicas, 170, Matosinhos

4460-203 Matosinhos

Portugal

Advanced Accelerator Applications Molecular Imaging France SAS

27 boulevard Jean Moulin

13005 Marseille

France

Advanced Accelerator Applications Germany

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 medicine by contacting the local representative of the Marketing Authorisation Holder:

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

C/ Josep Anselm Clavé, 100

08950 Esplugues de Llobregat (Barcelona)

Spain

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS).

This medicine is authorised in the Member States of the European Economic Area under the following names:

France, Italy, Spain, Germany, Portugal: GLUSCAN

Date of last revision of this leaflet: October 2017

--------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

The full technical data sheet of GLUSCAN 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)