Neuraceq

Package leaflet: Information for the patient

Neuraceq 300 MBq/mL solution for injection

florbetaben (F)
Please read 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 supervising the procedure.
• If you experience any side effects, including those not listed in this leaflet, tell the nuclear medicine physician. See section 4.

Contents of this leaflet:

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

1. What Neuraceq is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
Neuraceq contains the active substance florbetaben ( F).
Neuraceq is given to individuals with memory problems to enable the physician to obtain a type of brain image called a PET scan. A PET scan with Neuraceq, together with other tests assessing brain function, may help the physician determine whether or not you have β-amyloid plaques in the brain. This medicine is intended for adults only.
You should discuss the results of the scan with the physician who ordered the examination.
Use of Neuraceq involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine physician have determined that the clinical benefit of the procedure with the radiopharmaceutical outweighs the risk associated with radiation exposure.

2. What you need to know before Neuraceq is used

Neuraceq must not be used

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

Warnings and precautions
Talk to the nuclear medicine physician before you are given Neuraceq if:

• you have kidney problems
• you have liver problems
• you are pregnant or suspect you might be pregnant
• you are breastfeeding

Children and adolescents
Neuraceq is not intended for use in children and adolescents under 18 years of age.
Other medicines and Neuraceq
Inform the nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, as they could interfere with the interpretation of PET images.
Pregnancy and breastfeeding
If you are pregnant, suspect you might be pregnant, plan to become pregnant, or are breastfeeding, consult the nuclear medicine physician before receiving this medicine.
You must inform the nuclear medicine physician before Neuraceq administration if there is any possibility that you are 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 procedure.
Pregnancy
The nuclear medicine physician will administer this medicine during pregnancy only if the expected benefit outweighs the potential risks.
Breastfeeding
You must interrupt breastfeeding for 24 hours after the injection. During this period, you should express milk and discard it. Resumption of breastfeeding should be done in agreement with the nuclear medicine physician performing the procedure.
Driving and using machines
Neuraceq has no influence on the ability to drive or operate machinery.
Neuraceq contains ethanol and sodium ascorbate.

• This medicine contains up to 1200 mg of alcohol (ethanol) per dose, 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.

The amount of alcohol in this medicine does not appear to have an effect on adults and adolescents, and its effects in children are not well known. Some effects may occur in young children, for example, feeling drowsy.
The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.
If you are pregnant or breastfeeding, talk to your doctor or pharmacist before taking this medicine.
If you have alcohol dependence, talk to your doctor before taking this medicine.

• This medicine contains up to 33 mg of sodium (a main component of table salt) per dose. This corresponds to 1.6% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Neuraceq will be used

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals. Neuraceq will be used only in designated controlled areas. This medicinal product will be handled and administered exclusively by trained and qualified personnel who are experienced in its safe use. The staff will take particular care in the safe use of this medicinal product and will inform you about how the examination will be performed.

Dose
The nuclear medicine physician performing the procedure will determine the amount of Neuraceq to be used in your case. The smallest necessary amount required to obtain the desired information will be used.
The recommended usual amount for an adult is 300 MBq (the megabecquerel is the unit used to express radioactivity).

Administration of Neuraceq and performance of the procedure
Neuraceq is administered by intravenous injection, followed by a flush with a sodium chloride solution to ensure complete delivery of the dose.
A single injection is sufficient to perform the scan required by the physician.

Duration of the procedure
A brain scan is generally performed 90 minutes after administration of Neuraceq. Your nuclear medicine physician will inform you about the usual duration of the procedure.

After administration of Neuraceq, you must:
Avoid close contact with children and pregnant women for 24 hours following the injection.
Your nuclear medicine physician will inform you of any special precautions you need to take after receiving this medicinal product. If you have any doubts, please consult your nuclear medicine physician.

If you have been given more Neuraceq than you should have received
An overdose is unlikely, as you will receive only a single dose of Neuraceq, carefully controlled by the nuclear medicine physician supervising the procedure.
However, in the event of an overdose, appropriate treatment will be provided. In particular, the nuclear medicine physician responsible for the procedure will provide measures to increase urinary and fecal elimination, thereby helping to remove radioactivity from the body.

If you have any further questions about the use of this medicinal product, please consult the nuclear medicine physician supervising the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Possible side effects include:
Common (may affect up to 1 in 10 people):

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

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

• Burning sensation, headache, neuralgia (intense, usually intermittent pain along a nerve), tremor (involuntary trembling movement)
• Blood vessels: flush (sudden reddening of the face and/or neck), haematoma (bruise, black and blue mark), hypotension (low blood pressure)
• Stomach: diarrhoea, nausea (feeling unwell)
• Liver: abnormal liver function
• Skin: hyperhidrosis (excessive sweating), rash, toxic skin eruption (acute skin disorders with measles-like skin erythema, potentially leading to blistering and ulcers)
• Muscles and bones: limb discomfort, pain in extremities
• Injection site-related conditions: injection site irritation, pain and discomfort around the injection site, injection site haematoma (bruise, black and blue mark at the injection site), warmth at injection site, fatigue, feeling of warmth, pyrexia (elevated body temperature, fever)
• Abnormal blood tests: increased blood creatinine (reduced kidney function)

This radiopharmaceutical will deliver low levels of ionising radiation, associated with a minimal risk
of cancer and hereditary abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your nuclear medicine physician. You may also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How Neuraceq is stored

You must not store this medicinal product. This medicinal product is stored under the responsibility of the specialist in appropriate facilities. Radioactive pharmaceuticals will be stored in accordance with national regulations concerning radioactive materials.
The following information is intended exclusively for specialists:

• Keep this medicinal product out of the sight and reach of children.
• Do not use this medicinal product after the expiry date stated on the carton, on the label of the shielded container, or on the vial label after "Exp".
• This medicinal product requires no special storage conditions.
• Any unused medicinal product and waste material arising from this medicinal product must be disposed of in accordance with local regulations.

6. Package contents and other information

What Neuraceq contains

• The active substance is florbetaben (18F). Each mL of injectable solution contains 300 MBq of florbetaben (18F) at the date and time of calibration. The activity per vial ranges from 300 MBq to 3,000 MBq at the date and time of calibration.
• The other components are acidum ascorbicum, ethanol anhydride, macrogol 400, natrium ascorbicum, and water for injections (see section 2 "Neuraceq contains ethanol and sodium ascorbate").

Description of the appearance of Neuraceq and contents of the pack
Neuraceq is a clear, colourless injectable solution. It is supplied in 15 mL colourless glass vials, closed with a stopper and an aluminium seal.
Each multidose vial contains 1 to 10 mL of solution, corresponding to 300–3,000 MBq of florbetaben (18F) at the date and time of calibration.
Pack containing 1 vial.

Marketing Authorisation Holder
Life Molecular Imaging GmbH
Tegeler Strasse 6-7
Wedding
Berlin
Germany
e-mail: [email protected]

Manufacturer
BV Cyclotron VU
De Boelelaan 1081
1081 HV Amsterdam
The Netherlands
Curium PET France
CHU Brabois
4 rue du Morvan
54500 Vandoeuvre les Nancy
France
Curium PET France
Parc scientifique Georges Besse
180 allée Von Neumann
30000 Nîmes
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
Germany
Alliance Medical RP 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
The Netherlands
Karolinska University Hospital
Akademiska Straket 1
Solna
Stockholms Lan
171 64
Sweden

For further information about this medicinal product, please contact the Marketing Authorisation Holder:
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:
The complete SmPC (Summary of Product Characteristics) of Neuraceq is provided in the package as a separate document, intended to provide 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 package}.