Neuraceq 300 mbq/ml solucion inyectable

Patient Information Leaflet

Neuraceq 300 MBq/ml injectable solution

florbetaben (18F)

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult the nuclear medicine physician who will supervise the procedure.

• If you experience any side effects, consult the nuclear medicine physician, even if they are not listed in this leaflet. See section 4.

1. What you need to know before using Neuraceq

1. How to use Neuraceq

1. Possible side effects

1. Storage of Neuraceq

1. Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

Neuraceq contains the active ingredient florbetaben (18F).

Neuraceq is administered to individuals with memory problems so that doctors can perform a type of brain examination called a PET study. A PET study with Neuraceq, along with other brain function tests, may help your doctor determine if you have β-amloid plaques in the brain. This medication should only be administered to adults.

You may discuss the test results with the doctor who requested the examination.

The use of Neuraceq involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of exposure to radiation.

No use Neuraceq

• If you are allergic to florbetaben (18F) or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your nuclear medicine doctor before starting to use Neuraceq if:

• You have kidney problems.

• You have liver problems.

• You are pregnant or think you may be pregnant.

• You are breastfeeding.

Children and Adolescents

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

Other Medications and Neuraceq

Inform your nuclear medicine doctor if you are taking, have taken recently, or may need to take any other medication, as it could interfere with the interpretation of PET images.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your nuclear medicine doctor before using this medication.

You must inform your nuclear medicine doctor before the administration of Neuraceq if there is any possibility that you are pregnant, if you have a missed period or if you are breastfeeding. In case of doubt, it is essential to ask your nuclear medicine doctor who will supervise the procedure.

Pregnant

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

Breastfeeding

You must interrupt breastfeeding for 24 hours after the injection. Express the milk during this period and discard it. The resumption of breastfeeding should be agreed with your nuclear medicine doctor, who will supervise the procedure.

Driving and Operating Machines

Neuraceq has no influence on the ability to drive and operate machines.

Neuraceq contains ethanol and sodium ascorbate

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

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

The amount of alcohol contained in this medication may alter the effect of other medications. Consult your doctor or pharmacist if you are taking other medications.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medication.

• This medication contains 33 mg of sodium (main component of table salt/for cooking) in each dose. This is equivalent to 1.6% of the maximum daily sodium intake recommended for an adult.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Neuraceq should only be used in specially controlled facilities. This medication will only be handled and administered by personnel with the necessary training and qualifications to use it safely. These individuals will take special care in the safe use of this medication and will inform you of their actions.

Dose

The nuclear medicine physician overseeing the procedure will decide on 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 for an adult is typically 300 MBq (megabecquerel is the unit used to express radioactivity).

Administration of Neuraceq and procedure performance

Neuraceq is administered via injection into a vein (intravenous injection) followed by an irrigation with sodium chloride solution to ensure that the entire dose is administered. A single injection is sufficient to perform the examination your doctor needs.

Procedure duration

Typically, a brain scan is performed 90 minutes after the administration of Neuraceq.

The nuclear medicine physician will inform you about the typical duration of the procedure.

After receiving Neuraceq, you should

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

The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medication. If you have any doubts, ask the nuclear medicine physician.

If you have received more Neuraceq than you should

It is unlikely that you will receive an overdose because you will only receive a precisely calculated dose of Neuraceq by the nuclear medicine physician overseeing the procedure.

However, in the event of an overdose, you will receive the necessary treatment. Specifically, the nuclear medicine physician in charge of the procedure may offer methods to increase diuresis and defecation to help you eliminate the radioactivity from your body.

If you have any other questions about the use of this medication, ask the nuclear medicine physician who will oversee the procedure.

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

The possible adverse effects include:

Frequent(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/applicatio site)

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

• Burning sensation, headache, neuralgia (intense and typically intermittent pain along the course of a nerve), tremor (an involuntary movement of agitation)

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

• Stomach: diarrhea, nausea (discomfort)

• Liver: abnormal liver function

• Skin: hyperhidrosis (excessive sweating), urticaria, toxic skin eruption (acute skin disorders with erythema morbiliforme that may include blisters and ulcers)

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

• Injection site disorders: irritation at the injection site, pain and discomfort in the area adjacent to the injection site, hematoma at the injection site (a bruise, a black and blue mark at the injection site), heat at the injection site, pain at the vascular puncture site, fatigue, sensation of heat and pyrexia (elevated body temperature, fever).

• Abnormal results in blood tests: increase in serum creatinine concentrations (reduction in renal function)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult the nuclear physician, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This information is intended solely for the specialist:

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

• Do not use this medication after the expiration date that appears on the box, the blister packaging label, or the vial label after CAD.

• No special conservation conditions are required.

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

Neuraceq Composition

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

Appearance of the product and contents of the package

Neuraceq is a clear and colorless injectable solution. It is marketed in a 15 ml colorless 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 time and date of calibration.

Vial packaging.

Marketing Authorization Holder

Life Molecular Imaging GmbH

Tegeler Strasse 6-7

Wedding

Berlin

13353

Germany

Email: gra@life-mi.com

Responsible for manufacturing

BV Cyclotron VU

De Boelelaan 1081

1081 HV Amsterdam

Netherlands

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 Brusselss

Belgium

Institut Radiofarmacia Aplicada Barcelona-IRAB

c/Doctor Aiguader 88, planta -1

08003 Barcelona

Spain

Biokosmos S.A.

Lakkoma Industrial Area

Nea 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:

Last review date of this leaflet: {month YYYY}

The detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

The complete technical file 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 see the technical file {the technical file must be included in the packaging}.