Gluscan

Package leaflet: Information for the user

GLUSCAN 600 MBq/ml Solution for injection

Fluorodesoxyglucose ( F)
Please 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 questions, ask the Nuclear Medicine physician who will perform your examination.
• If you get any side effects, talk to the Nuclear Medicine physician. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What GLUSCAN is and what it is used for
2. What you need to know before you are given GLUSCAN
3. How GLUSCAN will be used
4. Possible side effects
5. How GLUSCAN is stored
6. Contents of the pack and other information

1. What GLUSCAN is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
The active substance contained in GLUSCAN is fluorodeoxyglucose (F), and it is intended to obtain diagnostic images of certain parts of your body.
After administration of a small amount of GLUSCAN, images obtained using a special machine will allow your doctor to see where your disease is located or how it is progressing.

2. What you should know before being administered GLUSCAN

Do not use GLUSCAN

• if you are allergic to fluorodeoxyglucose (F) or to any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions
Consult your Nuclear Medicine physician before being administered GLUSCAN

• if you have diabetes and your diabetes is currently not under control;
• if you have an infection or an inflammatory condition;
• if you have kidney problems.

Inform your Nuclear Medicine specialist in the following cases:

• if you are pregnant or think you might be pregnant;
• if you are breastfeeding.

Before administration of GLUSCAN you must:

• Drink plenty of water before the examination begins, so as to urinate as frequently as possible during the first 4 hours after the examination;
• avoid any strenuous physical activity;
• fast for at least 4 hours.

Children and adolescents
If you are under 18 years of age, consult your Nuclear Medicine specialist.
Other medicines and GLUSCAN
Inform your Nuclear Medicine specialist if you are taking, have recently taken, or might take any other medicines, as they could interfere with the interpretation of imaging results:

• any medicine that could alter blood sugar levels (glycaemia), such as anti-inflammatory medicines (corticosteroids), anticonvulsant medicines (valproate, carbamazepine, phenytoin, phenobarbital), medicines affecting the nervous system (adrenaline, noradrenaline, dopamine…);
• glucose;
• insulin;
• medicines used to increase blood cell production.

GLUSCAN with food and drinks
You must fast for at least 4 hours before administration of the product and drink plenty of water, avoiding beverages containing sugar.
Your Nuclear Medicine physician will measure your blood sugar level before administering the product; indeed, high blood glucose levels (hyperglycaemia) may make it difficult for the physician to interpret the results.
Pregnancy and breastfeeding
Before administration of GLUSCAN, you must inform the Nuclear Medicine specialist if you might be pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If in doubt, it is important to consult the Nuclear Medicine physician who will perform the examination.
If you are pregnant
The Nuclear Medicine physician will administer the product during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding
You must interrupt breastfeeding for 12 hours after the injection and discard the breast milk produced during this period.
Resumption of breastfeeding should be decided in consultation with the Nuclear Medicine physician supervising the examination.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, please seek advice from your Nuclear Medicine physician before being administered this medicinal product.
Driving and using machines
It is unlikely that GLUSCAN will affect your ability to drive or operate machinery.
GLUSCAN contains sodium
This product may contain more than 1 mmol of sodium (23 mg). Take this into account if you are on a low-sodium diet.

3. How GLUSCAN will be used

Strict regulations govern the handling, use, and disposal of radiopharmaceuticals. GLUSCAN
will be used only in designated controlled areas.
This medicinal product must be handled and administered exclusively by qualified personnel trained in its safe use.
The personnel will take appropriate precautions for the safe use of the medicine and will inform you about the measures taken.
The nuclear medicine specialist supervising the examination will determine the amount of GLUSCAN to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information.
The recommended administered activity for an adult usually ranges between 100 and 400 MBq (depending on the patient's body weight, the type of imaging equipment used, and the acquisition protocol).
Megabecquerel (MBq) is the unit of measurement used to express radioactivity.

Use in children and adolescents
If used in children and adolescents, the administered amount will be adjusted according to body weight.

Administration of GLUSCAN and performance of the examination
GLUSCAN is administered intravenously.
A single injection is sufficient to perform all the investigations required by the physician.
After the injection, you must remain completely at rest, without reading or talking. In addition, you will be encouraged to drink fluids and asked to urinate shortly before the examination.
You must remain in complete rest during image acquisition. You must not move or talk.

Duration of the examination
The nuclear medicine specialist will inform you about the expected duration of the examination.
GLUSCAN is administered as a single intravenous injection, 45–60 minutes before image acquisition. Image acquisition, performed using specialized equipment, lasts between 30 and 60 minutes.

After receiving GLUSCAN, you must:

• avoid any contact with children and pregnant women for up to 12 hours after injection;
• urinate frequently to help eliminate the product from your body.

If you have been given more GLUSCAN than you should have received
Overdose is unlikely, as you will receive only one carefully controlled dose of GLUSCAN, administered under the supervision of the nuclear medicine specialist performing the examination. However, if an overdose does occur, you will receive appropriate therapy. In particular, the nuclear medicine specialist in charge of the examination may recommend that you drink plenty of fluids to promote the elimination of GLUSCAN from the body (since the primary route of elimination of this product is renal, via urine).
If you have any doubts about the use of GLUSCAN, please consult the nuclear medicine physician who will perform your examination.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everybody will experience them.
This product delivers low amounts of ionizing radiation, with a very low risk of cancer and hereditary abnormalities.
Your doctor has determined that the clinical benefits you will obtain from this examination with the radiopharmaceutical outweigh the risks associated with radiation exposure.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your Nuclear Medicine physician. You may also report side effects directly via https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide further information on the safety of this medicinal product.

5. How GLUSCAN is stored

You will not be responsible for storing this product. This product is stored in suitable premises under the responsibility of the specialist. Storage of radiopharmaceuticals will comply with national regulations concerning radioactive materials.
The following information is intended for the specialist only.
This product must not be used after the expiry date stated on the label {DD/MM/YYYY hh:mm UTC}.

6. Package contents and other information

What GLUSCAN contains

• The active substance is fluorodeoxyglucose (F). 1 ml of injectable solution contains 600 MBq of fluorodeoxyglucose (F) at the date and time of calibration.
• The other components are: disodium hydrogen citrate, trisodium citrate, sodium chloride, sodium acetate, ethanol, and water for injectable preparations.

Description of the appearance of GLUSCAN and contents of the container
The activity per vial ranges between 300 MBq and 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

Manufacturers
Advanced Accelerator Applications Molecular Imaging France SAS
20 rue Diesel
01630 Saint-Genis-Pouilly
France
Advanced Accelerator Applications Molecular Imaging Italy S.r.l.
Prima Traversa
Viale Dell’Industria
86077 Pozzilli (IS)
Italy
Advanced Accelerator Applications S.r.l.
Via Ribes 5
10010 Colleretto Giacosa (TO)
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
47014 Meldola (FC)
Italy
Advanced Accelerator Applications Ibérica S.L.U
Polígono Industrial La Cuesta - Sector 3, Parcelas 1-2
50100 La Almunia de Doña Godina (Zaragoza)
Spain
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 n.º 170
4460-203 Senhora da Hora
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 Ibérica 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

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium, France, Italy, Luxembourg, Spain, Germany, Poland, Portugal: GLUSCAN 600 MBq/mL solution for injection.

---------The following information is intended exclusively for physicians or healthcare professionals:
The full Summary of Product Characteristics (SmPC) of GLUSCAN is included as a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC (the SmPC must be included in the packaging).