Amyvid - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Amyvid 1,900 MBq/mL solution for injection Amyvid 800 MBq/mL solution for injection florbetapir (18F)

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.

• – If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Amyvid is and what it is used for

• 2. What you need to know before Amyvid is used

• 3. How Amyvid will be used

• 4. Possible side effects

• 5 How Amyvid is stored

• 6. Contents of the pack and other information

1. What Amyvid is and what it is used for

This medicine is a radiopharmaceutical product for diagnostic use only.

Amyvid contains the active substance florbetapir (18F).

Amyvid is given to adults with memory problems so that doctors can perform a type of brain scan, called a PET scan. Amyvid, along with other brain function tests, may help your doctor find the reason for your memory problems. An Amyvid PET scan can help your doctor determine whether or not you may have P-amyloid plaques in your brain. P-amyloid plaques are deposits present in the brains of people with Alzheimer’s di­sease, but may also be present in the brain of people with other dementias. You should discuss the results of the test with the doctor that requested the scan.

The use of Amyvid does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.

2. What you need to know before Amyvid is used

Amyvid must not be used

• – if you are allergic to florbetapir (18F) or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Talk to your nuclear medicine doctor before you are given Amyvid if you:

• – have kidney problems

• – have liver problems

• – are pregnant or think you may be pregnant

• – are breast-feeding

Children and adolescents

Amyvid is not intended for use in children and adolescents.

Other medicines and Amyvid

Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the interpretation of the images obtained from the brain scan.

Pregnancy and breast-feeding

You must inform the nuclear medicine doctor before you are given Amyvid if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding. When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

The nuclear medicine doctor will only give this medicine during pregnancy if a benefit is expected which would outweigh the risks.

If you are breast-feeding

You must stop breast-feeding for 24 hours after the injection and the maternal milk pumped must be discarded. Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.

Driving and using machines

Amyvid will not affect your ability to drive or to 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 an adult with 70 kg). The amount in 10 mL of this medicine is equivalent to less than 20 mL beer or 8 mL wine.

The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine also contains up to 37 mg sodium (main component of cooking/table salt) in each dose.

This is equivalent to 1.85 % of the recommended maximum daily dietary intake of sodium for an adult.

• 3. How Amyvid will be used

There are strict laws on the use, handling and disposal of radiopharmaceutical products.

Amyvid will only be used in specially controlled areas. This medicine will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this medicine and will keep you informed of their actions.

Dose

The nuclear medicine doctor supervising the procedure will decide on the quantity of Amyvid to be used in your case. It will be the smallest quantity necessary to get the desired information.

The usual amount recommended for an adult is 370 MBq. Megabecquerel (MBq) is the unit used to express radioactivity.

Administration of Amyvid and conduct of the procedure

Amyvid is given as an injection into your vein (intravenous injection) followed by a flush of sodium chloride solution to ensure full delivery of the dose.

One injection is usually sufficient to carry out the scan that your doctor needs.

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.

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 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

If you get any side effects talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. Y ou 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.

• 5. 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.

6. Contents of the pack and other information

What Amyvid Contains

• – 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”).

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/Belgi­e/Belgien Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32-(0)2 548 84 84	Lietuva Eli Lilly Lietuva Tel. +370 (5) 2649600
Efc^rapufl Tn „E.ih ^hhh Hegep.iaHg“ E.B. – Etarapua mea. + 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
EZZáSa GAPMAZEPB-AIAAY A.E.B.E. Tql: +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

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

Detailed information on this medicine is available on the European Medicines Agency web site:

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}.

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