Amyvid
florbetapir (18F)
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.
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.
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.
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.
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.
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.
The active substance is florbetapir (18F).
Amyvid 1,900 MBq/mL: 1 mL of solution for injection contains 1,900 MBq of florbetapir (18F) at the date and time of calibration.
Amyvid 800 MBq/mL: 1 mL of solution for injection contains 800 MBq of florbetapir (18F) at the date and time of calibration.
The other ingredients are anhydrous ethanol, sodium ascorbate, sodium chloride, water for
injections (see section 2 “Amyvid contains ethanol and sodium”).
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.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
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.
Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32-(0)2 548 84 84
Eli Lilly Lietuva
Tel. +370 (5) 2649600
ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111
Lilly Hungária Kft. Tel: + 36 1 328 5100
Eli Lilly Danmark A/S Tlf: +45 45 26 60 00
Charles de Giorgio Ltd. Tel: + 356 25600 500
Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222
Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Eli Lilly Nederland B.V. Tel: +372 6 817 280
Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Τηλ: +30 210 629 4600
Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780
Lilly S.A.
Tel: + 34-91 663 50 00
Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 00
Lilly France
Tél: +33-(0) 1 55 49 34 34
Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600
Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999
Eli Lilly România S.R.L. Tel: + 40 21 4023000
Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377
Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10
Icepharma hf.
Sími + 354 540 8000
Eli Lilly Italia S.p.A. Tel: + 39- 055 42571
Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250
Phadisco Ltd
Τηλ: +357 22 715000
Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000
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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}.