AMYVID 800 MBq/mL Injectable solution

Зміст інструкції

1. Amyvid 1.900 MBq/ml injectable solution, 800 MBq/ml injectable solution
   1. What is Amyvid and what is it used for
   2. What you need to know before using Amyvid
   3. How Amyvid will be used
   4. Possible side effects
   5. How to store Amyvid
   6. Contents of the pack and other information

Amyvid 1.900 MBq/ml injectable solution, 800 MBq/ml injectable solution

florbetapir (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 physician responsible for performing the examination.
• If any side effects occur, including any not listed in this leaflet, tell 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 you are given Amyvid
• 3. How Amyvid will be given
• 4. Possible side effects
• 5. How to store Amyvid
• 6. Contents of the pack and other information

1. What is Amyvid and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.
Amyvid contains the active substance florbetapir (F).
Amyvid is administered to adults with memory problems to allow the doctor to acquire a type of
brain image called a PET scan. Amyvid, together with other tests used to evaluate brain
function, can help the doctor find the reason for your memory problems. A PET scan
with Amyvid can help the doctor determine if you may or may not have amyloid-beta plaques in the
brain. Amyloid-beta plaques are deposits found in the brains of people with Alzheimer's disease,
but they can also be present in the brains of people with other dementias.
You should discuss the results of the examination with the doctor who requested the scan.
The use of Amyvid involves exposure to small amounts of radioactivity. Your doctor and the nuclear
medicine physician have considered that the benefit of this examination using a radiopharmaceutical
outweighs the risk of radiation exposure.

2. What you need to know before using Amyvid

Do not use Amyvid

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

Warnings and precautions
Tell the nuclear medicine physician before you are given Amyvid if:

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

Children and adolescents
Amyvid is not intended for use in children and adolescents.

Other medicines and Amyvid
Tell the nuclear medicine physician if you are taking, have recently taken or might take any other
medicine as they could interfere with the interpretation of the images obtained with the PET
brain scan.

Pregnancy and breastfeeding
You must tell the nuclear medicine physician before you are given Amyvid if there is a possibility that
you may 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 responsible for performing the examination.
If you are pregnant
The nuclear medicine physician will only give you this medicine during pregnancy if the expected benefit outweighs
the risks.
If you are breastfeeding
You must stop breastfeeding for 24 hours after the injection and discard any breast milk produced. Resumption of
breastfeeding must occur in agreement with the nuclear medicine physician supervising the examination.
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, ask
your nuclear medicine physician for advice before you are given this medicine.

Driving and using machines
Amyvid does not impair the ability to drive vehicles and use machines.

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 have any noticeable effects.
This medicine contains up to 37 mg of sodium (the main component of table salt) per dose.
This is equivalent to 1.85 % of the maximum daily recommended intake with the diet of an adult.

3. How Amyvid will be used

There are strict laws regarding the use, handling and disposal of radioactive products.
Amyvid will only be used in specifically controlled areas. This medicine will only be handled and administered by
trained and qualified personnel capable of using it safely. The staff will ensure to
use this medicine safely and will keep you informed about how they will perform the examination.

Dose
The nuclear medicine physician responsible for performing the examination will decide the amount of Amyvid to use in your case.
It will be the minimum amount necessary to obtain the desired 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 injection into a vein (intravenous injection) 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 needed by the doctor.

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

After the administration of Amyvid, you must
Avoid close contact with children and pregnant women for 24 hours after
the injection.
The nuclear medicine physician will inform you if you need to take any particular precautions after receiving this
medicine. Contact the nuclear medicine physician if you have any doubts.

If you have been given too much Amyvid
An overdose is unlikely as you will only receive a single dose of Amyvid carefully controlled
by a nuclear medicine physician who is 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 you with the means to
increase elimination through urine and feces in order to help eliminate the radioactivity
from the body.
If you have any doubts about the use of this medicine, contact the nuclear medicine physician who is supervising the examination.

4. 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 of nausea,
• altered taste,
• hot flushes,
• itching,
• skin rash, bleeding or pain at the injection site or skin rash in other parts of the body. This radiopharmaceutical will release small amounts of ionizing radiation associated with a minimal risk of cancer and hereditary abnormalities (i.e. genetic diseases). See also paragraph 1.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
nuclear medicine physician. You can also report side effects directly through the national reporting system
described in Appendix V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Amyvid

You must not store this medicine. This medicine is stored under the responsibility of the
specialist in appropriate locations. The storage of radiopharmaceuticals will take place in accordance with
national regulations on radioactive products.
The following information is only for the specialist.
Amyvid must not be used after the expiry date which is reported on the label of the shielded container
after Expiry.

6. Contents of the pack and other information

What Amyvid contains

• The active ingredient 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 contents of the pack
Amyvid is a clear, colorless injectable solution. It is supplied in a transparent glass vial of 10 ml
or 15 ml.

Pack
Amyvid 1.900 MBq/ml: A multi-dose 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.
A multi-dose 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: A multi-dose 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. A multi-dose 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, Netherlands

Manufacturer
For information on the manufacturer see the label of the shielded container and the vial.
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

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

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 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) 1661 4377
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .
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The following information is intended exclusively for healthcare professionals:
The Summary of Product Characteristics of Amyvid is provided as a separate document within
the medicinal product packaging, with the aim of providing healthcare professionals with further
scientific and practical information on the administration and use of this radiopharmaceutical.
See the Summary of Product Characteristics {the SmPC must be included in the packaging}.