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AstraZeneca

Amyvid
florbetapir (18F)

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure. A brain scan is usually taken about 30 to 50 minutes after the Amyvid injection is given.


After administration of Amyvid, you should

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


The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor if you have any questions.


If you have been given more Amyvid than you should

An overdose is unlikely because you will only receive a single dose of Amyvid precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure may provide ways to increase the passing of urine and stools in order to help remove radioactivity from your body.


If you have any further question on the use of Amyvid, please ask your nuclear medicine doctor who supervises the procedure.


  1. Possible side effects

    Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effect of Amyvid is common (may affect up to 1 in 10 people):

    • headache

      The following side effects of Amyvid are uncommon (may affect up to 1 in 100 people):

    • feeling sick,

    • altered taste,

    • flushing,

    • itching,

    • rash, bleeding or pain where the injection is given or rash in other places.


      This radiopharmaceutical will deliver low amounts of ionising radiation associated with the least risk of cancer and hereditary abnormalities (i.e. genetic diseases). See also section 1.


      Reporting of side effects

      image

      If you get any side effects talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of

      this medicine.


  2. How Amyvid is stored


    You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.


    The following information is intended for the specialist only.

    Amyvid must not be used after the expiry date which is stated on the shield label after EXP.

  3. Contents of the pack and other information


What Amyvid Contains

injections (see section 2 “Amyvid contains ethanol and sodium”).


What Amyvid looks like and contents of the pack

Amyvid is a clear, colourless solution for injection. It is supplied in a 10 mL or 15 mL clear glass vial.


Pack size

Amyvid 1,900 MBq/mL: One multidose vial of 10 mL capacity containing 1 to 10 mL of solution, corresponding to 1,900 to 19,000 MBq at date and time of calibration.

One multidose vial of 15 mL capacity containing 1 to 15 mL of solution, corresponding to 1,900 to 28,500 MBq at date and time of calibration.

Amyvid 800 MBq/mL: One multidose vial of 10 mL capacity containing 1 to 10 mL of solution, corresponding to 800 to 8,000 MBq at date and time of calibration.

One multidose vial of 15 mL capacity containing 1 to 15 mL of solution, corresponding to 800 to 12,000 MBq at date and time of calibration.


Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands


Manufacturer

For information on the manufacturer, see vial and shield label.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.


Belgique/België/Belgien

Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Lietuva

Tel. +370 (5) 2649600


България

ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40

Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32-(0)2 548 84 84


Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft. Tel: + 36 1 328 5100


Danmark

Eli Lilly Danmark A/S Tlf: +45 45 26 60 00

Malta

Charles de Giorgio Ltd. Tel: + 356 25600 500


Deutschland

Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800


Eesti

Eli Lilly Nederland B.V. Tel: +372 6 817 280

Norge

Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00


Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780


España

Lilly S.A.

Tel: + 34-91 663 50 00

Polska

Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 00


France

Lilly France

Tél: +33-(0) 1 55 49 34 34

Portugal

Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600


Hrvatska

Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999

România

Eli Lilly România S.R.L. Tel: + 40 21 4023000


Ireland

Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377

Slovenija

Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10


Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 111


Italia

Eli Lilly Italia S.p.A. Tel: + 39- 055 42571

Suomi/Finland

Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800


Latvija

Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā

Tel: +371 67364000

United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377


This leaflet was last revised in {MM/YYYY}.



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The following information is intended for medical or healthcare professionals only:


The complete SmPC of Amyvid is provided as a separate document in the medicinal product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.


Please refer to the SmPC {SmPC should be included in the box}.