NEURACEQ 300 MBq/mL Инъекционный раствор

Содержание инструкции

1. Neuraceq 300 MBq/mL injectable solution
   1. What is Neuraceq and what is it 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

Neuraceq 300 MBq/mL injectable solution

florbetaben (F)

Read this leaflet carefully before you are given this medicine as 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 supervising the procedure.
• If any side effects occur, including any not listed in this leaflet, tell your nuclear medicine doctor. 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 is Neuraceq and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.
Neuraceq contains the active substance florbetaben (F).
Neuraceq is administered to people with memory problems to allow the doctor to acquire
a type of brain image, called a PET scan. A PET scan with Neuraceq, together with
other tests that assess brain function, can help the doctor determine if you may or may not
have amyloid plaques in the brain. This medicine is intended for adults only.
You should discuss the results of the examination with the doctor who requested the scan.
The use of Neuraceq involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician
have considered that the clinical benefit of the procedure with the radiopharmaceutical
outweighs the risk due to 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 your nuclear medicine doctor before Neuraceq is administered to you if:

• you have kidney problems
• you have liver problems
• you are pregnant or suspect you may 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
Tell your nuclear medicine doctor if you are taking, have recently taken or might
take any other medicines as this could interfere with the interpretation of the
PET images.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your nuclear medicine doctor for advice before Neuraceq is
administered to you.
You must inform your nuclear medicine doctor before the administration of Neuraceq if there is a
possibility that you may be pregnant, if you have missed a menstrual period or if you are
breastfeeding. If you have any doubts, it is important to consult your nuclear medicine doctor who will
perform the procedure.
Pregnancy
Your nuclear medicine doctor will only administer this medicine during pregnancy if the
expected benefit outweighs the risks.
Breastfeeding
You must stop breastfeeding for 24 hours after the injection. During this period you should express and
discard the milk. Resumption of breastfeeding must occur in agreement with the nuclear medicine
doctor who will perform the procedure.

Driving and using machines
Neuraceq has no influence on the ability to drive vehicles or use machines.

Neuraceq contains ethanol and sodium ascorbate.

• This medicine contains up to 1200 mg of alcohol (ethanol) in each 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.

The amount of alcohol in this medicine is unlikely to have an effect on adults and
adolescents and its effects in children are not evident. Some effects may occur in small
children, for example feeling sleepy.
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 an alcohol dependence, talk to your doctor before taking this
medicine.

• This medicine contains up to 33 mg of sodium (the main component of table salt) per dose. This is equivalent to 1.6% of the maximum recommended daily intake of sodium with the diet of an adult.

3. How Neuraceq will be used

There are strict laws regulating the use, handling and disposal of radiopharmaceuticals. Neuraceq will only be used in dedicated controlled areas. This medicine will only be handled and administered by trained and qualified personnel to use it respecting safety criteria. The staff will pay particular attention to the safe use of this medicine and will keep you informed about how they will perform the examination.

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

Administration of Neuraceq and procedure execution
Neuraceq is administered by intravenous injection (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 the doctor needs.

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

After the administration of Neuraceq you must:
Avoid close contact with children and pregnant women for the 24 hours following the injection.
The nuclear medicine physician will inform you about any particular precautions you must take after receiving this medicine. If you have any doubts, please consult the nuclear medicine physician.

If you have been given more Neuraceq than you should
An overdose is unlikely as you will only receive a single dose of Neuraceq carefully controlled by the nuclear medicine physician who supervises the procedure.
However, in case of overdose, you will receive appropriate treatment. In particular, the nuclear medicine physician responsible for the procedure will provide you with the means to increase the elimination of urine and feces in order to help eliminate radioactivity from the body.
If you have further doubts about the use of this medicine, please consult the nuclear medicine physician who supervises 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/application site)

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

• Burning sensation, headache, neuralgia (intense pain, usually intermittent along a nerve), tremor (involuntary shaking movement)
• Blood vessels: flushing (sudden redness of the face and/or neck), hematoma (a bruise, a black and blue spot), hypotension (low blood pressure)
• Stomach: diarrhea, nausea (feeling unwell)
• Liver: abnormal liver function
• Skin: hyperhidrosis (excessive sweating), rash, toxic rash (acute skin conditions with measles-like skin erythema, with potential blister and ulcer formation)
• Muscles and bones: limb discomfort, pain in the extremities
• Conditions related to the injection site: irritation at the injection site, pain and discomfort around the injection site, hematoma at the injection site (a bruise, a black and blue spot at the injection site), warmth at the injection site, fatigue, feeling of heat, pyrexia (increase in body temperature, fever)
• Abnormal blood tests: increased blood creatinine (reduced kidney function)

This radiopharmaceutical will deliver low doses of ionizing radiation associated with the lowest possible risk of cancer and hereditary abnormalities.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your nuclear medicine doctor. You can also report side effects directly through the national reporting system detailed 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 medicine. This medicine is stored under the responsibility
of the specialist in appropriate facilities. Radiopharmaceuticals will be stored in accordance with national regulations
on radioactive materials.
The following information is intended for specialists only:

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the carton, on the label of the shielding container or on the vial label after Scad the expiry date.
• This medicine does not require any special storage conditions.
• Unused medicine and waste derived from this medicine must be disposed of in accordance with current local regulations.

6. Contents of the pack 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 ingredients are ascorbic acid, anhydrous ethanol, macrogol 400, sodium ascorbate, 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 and colourless injectable solution. It is supplied in colourless glass vials of
15 mL, closed with a stopper and an aluminium seal.
Each multi-dose vial contains from 1 to 10 mL of solution, corresponding to 300-3000 MBq of
florbetaben ( F) at the date and time of calibration.
Pack of 1 vial

Marketing Authorisation Holder
Life Molecular Imaging GmbH
Tegeler Strasse 6-7
Wedding
Berlin
13353
Germany
e-mail: [email protected]

Manufacturer
BV Cyclotron VU
De Boelelaan 1081
1081 HV Amsterdam
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
12489
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
Netherlands
Karolinska University Hospital
Akademiska Straket 1
Solna
Stockholms Lan
171 64
Sweden
For further information on this medicinal product, contact the marketing authorisation holder:
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
The following information is intended exclusively for physicians and healthcare professionals:
The complete SPC of Neuraceq is provided in the pack as a separate document, with the purpose of
providing healthcare professionals with further scientific and practical information on the administration and
use of this radiopharmaceutical. Refer to the SPC {The SPC must be included in the box}.