GLUSCAN 600 MBq/mL Injectable solution

Зміст інструкції

1. GLUSCAN 600 MBq/ml Injectable Solution
   1. What is GLUSCAN and what is it used for?
   2. What you need to know before GLUSCAN is administered to you?
   3. How GLUSCAN will be used
   4. Possible side effects
   5. How GLUSCAN is stored
   6. Package Contents and Other Information

GLUSCAN 600 MBq/ml Injectable Solution

Fluorodeoxyglucose (F)
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 doctor who will assist with your examination.
• If any undesirable effects occur, consult your Nuclear Medicine doctor.

See section 4.

Contents of this leaflet:

• 1. What is GLUSCAN and what is it used for?
• 2. What you need to know before GLUSCAN is administered to you?
• 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 is GLUSCAN and what is it used for?

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

2. What you need to know before GLUSCAN is administered to you?

Do not use Gluscan

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

Warnings and precautions
Consult your Nuclear Medicine doctor before GLUSCAN is administered to you

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

Inform the specialist doctor in Nuclear Medicine 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 plenty of water before the start of the examination so as to urinate as much as possible during the first 4 hours after the examination
• avoid any intense physical activity;
• be fasting for at least 4 hours.

Children and adolescents
If you are under 18 years of age, consult the specialist doctor in Nuclear Medicine

Other medicines and GLUSCAN
Inform the specialist doctor in Nuclear Medicine if you are taking, have recently taken or
may take any other medicine, as it may interfere with the interpretation of the
images:

• any medicine that could induce a change in blood sugar levels (glycemia), such as medicines that have an anti-inflammatory effect (corticosteroids), medicines against convulsions (valproate, carbamazepine, phenytoin, phenobarbital), medicines that affect the nervous system (adrenaline, noradrenaline, dopamine…),
• glucose,
• insulin,
• medicines used to increase the production of blood cells

GLUSCAN with food and drink
You must remain fasting for at least 4 hours before the administration of the product and drink plenty of
water avoiding beverages containing sugar.
Your Nuclear Medicine doctor will measure your blood sugar level before administering
the product; in fact, a high concentration of glucose in the blood (hyperglycemia) can make it difficult
to interpret the results by the doctor.

Pregnancy and breastfeeding
Before the administration of GLUSCAN you must inform the specialist doctor in Nuclear Medicine
if there is a possibility that you may be pregnant, if you have missed a menstrual period or if you are
breastfeeding.
In case of doubt, it is important to consult the Nuclear Medicine doctor who will perform the
examination.
If you are pregnant
The Nuclear Medicine doctor will administer the product during pregnancy only if the expected benefit
outweighs the risks.
If you are breastfeeding
You must stop breastfeeding for 12 hours after the injection and discard the breast milk
produced.
Resumption of breastfeeding should be decided in agreement with the Nuclear Medicine doctor
supervising the examination.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your Nuclear Medicine doctor for advice before this
medicine is administered to you.

Driving and operating machinery
It is unlikely that GLUSCAN will affect your ability to drive vehicles or operate machinery.

GLUSCAN contains sodium
This product may contain more than 1 mmol of sodium (23 mg). Keep this in mind if you are following
a low-sodium diet.

3. How GLUSCAN will be used

Strict regulations govern the handling, use and disposal of radiopharmaceuticals. GLUSCAN
will only be used in specifically controlled areas.
This medicinal product must only be handled and administered by qualified personnel for its safe use.
The personnel will take the necessary precautions for safe use of the medicine and will inform you about the actions
taken.
The specialist doctor in Nuclear Medicine supervising the examination 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 amount to be administered is usually recommended for an adult between 100 and 400 MBq
(depending on the patient's body mass, the type of equipment used for image recording
and the acquisition mode).
Megabecquerel (MBq) is the unit of measure used to express radioactivity.

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

Administration of GLUSCAN and performance of the examination
GLUSCAN is administered intravenously.
A single injection is sufficient to perform the investigations that the doctor needs.
After the injection, you must remain completely at rest, without reading or talking. You will also be invited
to drink and will be asked to urinate immediately before the examination.

You must remain completely at restduring image acquisition. You must not move or
talk.
Duration of the examination
The specialist doctor in nuclear medicine will inform you about the usual duration of the examination.
GLUSCAN is administered as a single injection intravenously, 45-60 minutes before
image acquisition. The image acquisition performed using a specific
device lasts from 30 to 60 minutes.

After the administration of GLUSCAN, you must:

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

If you have been given more GLUSCAN than you should
An overdose is unlikely, because you will be given a single dose of GLUSCAN,
carefully controlled by the specialist doctor in Nuclear Medicine who will follow the examination. However, in
the event of an overdose, you will receive appropriate therapy. In particular, the specialist in
Nuclear Medicine in charge of performing the examination may recommend that you drink
plenty of fluids to facilitate the elimination of GLUSCAN from the body (in fact, the main
route of elimination of this product is renal, in the urine).
If you have any doubts about the use of GLUSCAN, please contact the Nuclear Medicine doctor who will follow
the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
This product delivers low amounts of ionising radiation with a very low risk of cancer and
hereditary abnormalities.
The doctor has considered that the clinical benefits you will obtain from this examination with the radiopharmaceutical are
greater than the risks caused by the radiation.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact
your Nuclear Medicine physician. You can also report side effects directly via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

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. The storage of radiopharmaceuticals will take place in accordance with national regulations on radioactive materials.
The following information is intended solely for the specialist.
This product must not be used after the expiry date which is reported on the label {DD/MM/YYYY hh:mm UTC}.

6. Package Contents and Other Information

What GLUSCAN contains

• The active ingredient is fluorodeoxyglucose (F). 1 ml of injectable solution contains 600 MBq of fluorodeoxyglucose (F) at the date and time of calibration.
• Other ingredients are: Disodium hydrogen citrate, trisodium citrate, sodium chloride, sodium acetate, ethanol and water for injections

Description of the appearance of GLUSCAN and package contents
The activity per vial is 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

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.
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 Monaco
Germany
More detailed information on this medicine 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 with the
following denominations:
Belgium, France, Italy, Luxembourg, Spain, Germany, Poland, Portugal: GLUSCAN 600
MBq/mL solution for injection.
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---------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)