Amyvid

Patient Information Leaflet

Amyvid 1,900 MBq/ml solution for injection, 800 MBq/ml solution for injection

florbetapir (F)
Please 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 physician performing the examination.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet:

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

1. What Amyvid is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
Amyvid contains the active substance florbetapir (F).
Amyvid is given to adults with memory problems so that the doctor can obtain a type of brain image called a PET scan. Amyvid, together with other tests used to assess brain function, may help the doctor identify the reason for memory problems. A PET scan with Amyvid may help the doctor determine whether or not you have β-amyloid plaques in the brain. β-amyloid pla游戏副本

2. What you need to know before using Amyvid

Do not use Amyvid

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

Warnings and precautions
Inform the nuclear medicine physician before being administered Amyvid if you:

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

Children and adolescents
Amyvid is not intended for use in children and adolescents.
Other medicines and Amyvid
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 the images obtained from the brain PET scan.
Pregnancy and breastfeeding
You must inform the nuclear medicine physician before being administered Amyvid if there is any possibility
you could be 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 in charge of performing the examination.
If you are pregnant
The nuclear medicine physician will administer this medicine during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding
You must interrupt breastfeeding for 24 hours after the injection and discard the breast milk produced during this period. Resumption of breastfeeding should occur in agreement with the nuclear medicine physician supervising the examination.
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning a pregnancy, please seek advice from the nuclear medicine physician before being administered this medicine.
Driving and using machines
Amyvid does not impair the ability to drive vehicles or operate machinery.
Amyvid contains ethanol and sodium
This medicine contains 790 mg of alcohol (ethanol) in each 10 ml dose, which is equivalent to 11.3 mg/kg (administered to a 70 kg adult). The amount in 10 ml of this medicine is equivalent to less than 20 ml of beer or 8 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains up to 37 mg of sodium (a main component of table salt) per dose.
This corresponds to 1.85% of the maximum recommended daily dietary intake of sodium for an adult.

3. How Amyvid will be used

There are strict regulations regarding the use, handling, and disposal of radioactive substances.
Amyvid will only be used in designated controlled areas. This medicinal product will be handled and administered only
by trained and qualified personnel who are able to use it safely. The staff will take care to
use this medicine safely and will inform you about how the examination will be performed.

Dose
The nuclear medicine physician conducting the examination will determine the amount of Amyvid to be used in your case.
It will be the minimum quantity necessary to obtain the required information.
The recommended amount for an adult is normally 370 MBq. The megabecquerel (MBq) is the unit of
measurement used to express radioactivity.

Administration of Amyvid and performance of the examination
Amyvid is administered by intravenous injection (injection into a vein), followed by a flush with
a sodium chloride solution to ensure complete administration of the dose.
A single injection is usually sufficient to perform the scan required by the physician.

Duration of the examination
The nuclear medicine physician will inform you how long the examination usually takes. A brain scan is normally
performed approximately 30–50 minutes after the Amyvid injection.

After receiving Amyvid, you must
Avoid close contact with children and pregnant women during the 24 hours following
the injection.
The nuclear medicine physician will inform you if you need to take any special precautions after receiving this
medicinal product. Please consult the nuclear medicine physician if you have any doubts.

If you have been given more Amyvid than you should have
An overdose is unlikely because you will receive only a single, precisely controlled dose of Amyvid administered
by a nuclear medicine physician supervising the examination. However, in the event of an overdose, you will receive appropriate treatment. In particular, the nuclear medicine physician responsible for the examination will provide measures to increase elimination via urine and feces in order to help remove radioactivity from the body.

If you have any doubts about the use of this medicinal product, please consult the nuclear medicine physician supervising the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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):

• nausea,
• altered taste,
• hot flushes,
• itching,
• skin rash, bleeding or pain at the injection site, or skin rash at other body sites.

This radiopharmaceutical will emit small amounts of ionising radiation, which is associated with a minimal risk of cancer and hereditary abnormalities (i.e. genetic diseases). See also section 1.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your nuclear medicine physician. You can 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 to store Amyvid

You will not store this medicinal product. This medicinal product is stored under the responsibility of a specialist in appropriate conditions. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for specialists only.
Amyvid must not be used after the expiry date stated on the label of the shielded container after Exp.

6. Package contents and other information

What Amyvid contains

• The active substance is florbetapir (F). Amyvid 1,900 MBq/ml: 1 ml of injectable solution contains 1,900 MBq of florbetapir (F) at the date and time of calibration. Amyvid 800 MBq/ml: 1 ml of injectable solution contains 800 MBq of florbetapir (F) 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”).

Description of the appearance of Amyvid and package contents
Amyvid is a clear, colourless injectable solution. It is supplied in a 10 ml or 15 ml transparent glass vial.
Packaging
Amyvid 1,900 MBq/ml: One multidose vial with a capacity of 10 ml containing 1 to 10 ml of solution, corresponding to 1,900–19,000 MBq at the date and time of calibration.
One multidose vial with a capacity of 15 ml containing 1 to 15 ml of solution, corresponding to 1,900–28,500 MBq at the date and time of calibration.
Amyvid 800 MBq/ml: One multidose vial with a capacity of 10 ml containing 1 to 10 ml of solution, corresponding to 800–8,000 MBq at the date and time of calibration.
One multidose vial with a capacity of 15 ml containing 1 to 15 ml of solution, corresponding to 800–12,000 MBq at the 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 the label on the shielded container and the vial.
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel. +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija United Kingdom (Northern Ireland)
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Eli Lilly and Company (Ireland) Limited
Tel: + 371 67364000 Tel: + 353-(0) 1661 4377

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
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The following information is intended for healthcare professionals only:
The complete Product Characteristics Summary of Amyvid is provided as a separate document inside the medicinal product package, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
See the Product Characteristics Summary {the SmPC must be included in the package}.