NEURACEQ 300 MBq/ml injectable solution

2. What you need to know before you start using Neuraceq

Do not use Neuraceq

• if you are allergic to florbetaben (18F) or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Talk to your nuclear medicine doctor before you start using Neuraceq if:

• You have kidney problems.

• You have liver problems.

• You are pregnant or think you may be pregnant.

• You are breast-feeding.

Children and Adolescents

Neuraceq should not be used in children and adolescents under 18 years of age.

Other Medicines and Neuraceq

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, as they may interfere with the interpretation of the PET images.

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, talk to your nuclear medicine doctor before using this medicine.

You must tell your nuclear medicine doctor before Neuraceq is given to you if there is any chance you may be pregnant, if you have a delayed menstrual period, or if you are breast-feeding. If in doubt, it is important to ask your nuclear medicine doctor who will be supervising the procedure.

Pregnancy

Your nuclear medicine doctor will only give you this medicine during pregnancy if the expected benefit outweighs the risks.

Breast-feeding

You should stop breast-feeding for 24 hours after the injection. Express milk during this time and discard it. You should discuss restarting breast-feeding with your nuclear medicine doctor, who will be supervising the procedure.

Driving and Using Machines

Neuraceq does not affect your ability to drive or use machines.

Neuraceq contains ethanol and sodium ascorbate

• This medicine contains up to 1200 mg of alcohol (ethanol) per dose, which is equivalent to 17 mg/kg. The amount per dose of this medicine is equivalent to less than 30 ml of beer or 12.5 ml of wine.

It is unlikely that the amount of alcohol in this medicine will have any noticeable effect in adults or adolescents. It may have some effects in small children, such as drowsiness.

The amount of alcohol in this medicine may alter the effect of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.

• This medicine contains 33 mg of sodium (a major component of table salt/cooking salt) per dose, which is equivalent to 1.6% of the maximum recommended daily intake of sodium for an adult.

3. How to use Neuraceq

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Neuraceq should only be used in controlled facilities. This medicine will only be handled and administered by qualified personnel trained to use it safely. These people will take special care to use this medicine safely and will inform you of their actions.

Dose

The nuclear medicine doctor supervising the procedure will decide the amount of Neuraceq to be used in your case, which will be the minimum amount necessary to obtain the desired information.

The recommended dose to be administered to an adult is 300 MBq (megabecquerel, the unit used to express radioactivity).

Administration of Neuraceq and Performance of the Procedure

Neuraceq is administered by injection into a vein (intravenous injection) followed by flushing with a sodium chloride solution to ensure that the entire dose is administered. One injection is sufficient to perform the scan that your doctor needs.

Duration of the Procedure

A brain scan is usually performed 90 minutes after administration of Neuraceq.

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

After Administration of Neuraceq, you should

Avoid close contact with small children and pregnant women for 24 hours after the injection.

Your nuclear medicine doctor will inform you if you need to take special precautions after receiving this medicine. If in doubt, ask your nuclear medicine doctor.

If you have received more Neuraceq than you should

It is unlikely that you will be given an overdose because you will only receive a precisely calculated dose of Neuraceq by the nuclear medicine doctor supervising the procedure.

However, in case of overdose, you will receive appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure may offer you methods to increase diuresis and defecation to help you eliminate the radioactivity from your body.

If you have any further questions about the use of this medicine, ask your nuclear medicine doctor who will be supervising the procedure.

4. Possible Side Effects

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

Possible side effects include:

Common(may affect up to 1 in 10 people):

• Reactions at the injection site: pain at the injection site, redness of the skin at the injection site (erythema at the injection site/application site)

Uncommon(may affect up to 1 in 100 people):

• Feeling of pricking, headache, neuralgia (severe and typically intermittent pain along a nerve), tremor (an involuntary shaking movement)

• Blood vessels: flushing (sudden redness of the face and/or neck), hematoma (a bruise, a black and blue mark), hypotension (low blood pressure)

• Stomach: diarrhea, nausea (discomfort)

• Liver: abnormal liver function

• Skin: hyperhidrosis (excessive sweating), rash, toxic skin eruption (acute skin conditions with morbilliform erythema that may include blisters and ulcers)

• Muscles and bones: discomfort in the limbs, pain in the limbs

• Disorders at the injection site: irritation at the injection site, pain and discomfort at the site adjacent to the injection site, hematoma at the injection site (a bruise, a black and blue mark at the injection site), warmth at the injection site, pain at the vascular puncture site, fatigue, feeling of warmth, and pyrexia (elevated body temperature, fever).

• Abnormal blood test results: increased serum creatinine concentrations (reduced kidney function)

This radiopharmaceutical will emit low levels of ionizing radiation, which is associated with a minimal risk of cancer and the possibility of causing hereditary anomalies.

Reporting of Side Effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this package leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Neuraceq

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

This information is intended only for the specialist:

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the carton, the label on the shield, or the label on the vial after EXP.

• No special storage conditions are required.

• Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

6. Package Contents and Further Information

Composition of Neuraceq

• The active substance is florbetaben (18F). Each milliliter of the solution for injection contains 300 MBq of florbetaben (18F) at the date and time of calibration. The activity per vial is between 300 MBq and 3000 MBq at the date and time of calibration.

• The other excipients are ascorbic acid, anhydrous ethanol, macrogol 400, sodium ascorbate, and water for injections (see section 2, "Neuraceq contains ethanol and sodium ascorbate").

Appearance and Package Contents

Neuraceq is a clear and colorless solution for injection. It is supplied in a 15 ml glass vial, closed with a rubber stopper and an aluminum seal.

Each multidose vial contains 1 to 10 ml of solution, corresponding to an activity of 300 to 3000 MBq of florbetaben (18F) at the date and time of calibration.

Package of one vial.

Marketing Authorization Holder

Life Molecular Imaging GmbH

Tegeler Strasse 6-7

Wedding

Berlin

13353

Germany

Email: [email protected]

Manufacturer

Curium PET France

CHU de Brabois

4 rue du Morvan

54500 Vandoeuvre les Nancy

France

Curium PET France

Parc scientifique Georges Besse

180 Allée Von Neumann

30000 Nimes

France

Curium PET France

14, rue de la Grange aux Belles

75010 Paris

France

Curium PET France

avenue de la Bataille Flandres Dunkerque, CS 44229

35000 Rennes

France

Curium PET France

CHU Xavier Arnozan

avenue du Haut-Lévèque

33604 Pessac

France

Alliance Medical RP Berlin GmbH

Max-Planck-Strasse 4

Adlershof

Berlin

12489

Germany

Alliance Medical sp. z o.o.

ul. Szeligowska 3

05-850 Szeligi

Poland

Alliance Medical RP GmbH

Spessartstr. 9

53119 Bonn

Germany

Curium Italy S.R.L.

via Pergolesi, 33

20900 Monza

Italy

Curium Italy S.R.L.

Viale Oxford 81 (loc. Tor Vergata)

00133 Rome

Italy

Curium Italy S.R.L.

Piazzale Santa Maria della Misericordia, 15

33100 Udine

Italy

ITEL Telecomunicazioni S.R.L.

Via Antonio Labriola Zona Industriale SNC

70037 Ruvo di Puglia (BA)

Italy

Curium Pharma Ireland Limited

Blackrock Clinic

Blackrock

Co. Dublin, A94 E4X7

Ireland

Curium Pharma Spain, S.A.

Thomas Alba Edison, s/n

41092 Seville

Spain

Curium Pharma Spain, S.A.

Pol. Ind. Conpisa,

C/Veguillas – 2 Nave 16,

Ajalvir 28864 (Madrid)

Spain

Seibersdorf Labor GmbH

Grundstueck Nr. 482/2 EZ 98 KG

2444 Seibersdorf

Austria

BetaPlus Pharma SA

Avenue Hippocrate 10 bte 1527

1200 Brussels

Belgium

Institut Radiofarmacia Aplicada Barcelona-IRAB

c/Doctor Aiguader 88, planta -1

08003 Barcelona

Spain

Biokosmos S.A.

Lakkoma Industrial Area

Νea Propontida

Halkidiki

630 80

Greece

Biokosmos S.A.

Thesi Panormos

Lavrio

Athens

195 00

Greece

Radboud Translational Medicine B.V.

Geert Grooteplein Noord 21

Route 142

Nijmegen

Gelderland

6525 EZ

Netherlands

Karolinska University Hospital

Akademiska Straket 1

Solna

Stockholms Lan

171 64

Sweden

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

Date of the last revision of this package leaflet: {month YYYY}

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

The full summary of product characteristics of Neuraceq 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 summary of product characteristics {the summary of product characteristics must be included in the packaging}.