AMYVID 1900 MBq/mL injectable solution

Introduction

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 is supervising the procedure.

• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Amyvid and what is it used for
2. What you need to know before you are given Amyvid
3. How to use Amyvid

1. Possible side effects
2. Storage of Amyvid
3. Package Contents and Further 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 (18F).

Amyvid is given to adults with memory problems so that doctors can perform a type of brain scan called a PET study. Amyvid, along with other tests of brain function, can help your doctor find the cause of your memory problems. A PET study with Amyvid can help your doctor determine if you may or may not have β-amyloid plaques in your brain. β-amyloid 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 test with the doctor who requested the PET study.

Administration of Amyvid involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before you are given Amyvid

Do not use Amyvid

• if you are allergic to florbetapir (18F) or any of the other components 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 indicated in children and adolescents.

Other Medicines and Amyvid

Tell your nuclear medicine doctor if you are using, have recently used, or might use any other medicines, as some medicines may interfere with the interpretation of the images obtained from a brain scan.

Pregnancy and Breast-feeding

You must tell the nuclear medicine doctor before administration of Amyvid if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breast-feeding. In case of doubt, it is important that you consult your nuclear medicine doctor who is supervising the procedure.

If you are pregnant

The nuclear medicine doctor will only give you this medicine during pregnancy if the benefit is expected to outweigh the risk.

If you are breast-feeding

You must stop breast-feeding for 24 hours after the injection and the breast milk must be discarded.

Breast-feeding will be resumed in accordance with the nuclear medicine doctor who supervises the procedure.

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before receiving this medicine.

Driving and Using Machines

Amyvid will not affect your ability to drive or 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 weighing 70 kg). 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 does not produce any noticeable effect.

This medicine also contains up to 37 mg of sodium (a major component of table salt/cooking salt) in each dose. This is equivalent to 1.85% of the maximum recommended daily intake of sodium for an adult.

3. How to use Amyvid

There are strict rules about the use, handling, and disposal of radiopharmaceuticals. Amyvid will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel who are authorized to use it safely. These individuals will take special care in the safe use of this product and will inform you of their actions.

Dose

The nuclear medicine doctor supervising the procedure will decide the amount of Amyvid to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The recommended dose for administration to an adult is 370 MBq (Megabecquerels, the unit used to express radioactivity).

Administration of Amyvid and Performance of the Procedure

Amyvid is administered as an injection into your vein (intravenous injection) followed by a flow of sodium chloride solution to ensure complete administration of the dose.

One injection is sufficient to perform the procedure that your doctor needs.

Duration of the Procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure. A brain PET study usually lasts from 30 to 50 minutes after administration of an Amyvid injection.

After Administration of Amyvid, you must

Avoid direct contact with small children and pregnant women for 24 hours after the injection.

Your nuclear medicine doctor will inform you if you need to take special precautions after you are given this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more Amyvid than you should

Overdose is unlikely because you will receive a precisely controlled single dose of Amyvid by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive appropriate treatment. In particular, the nuclear medicine doctor responsible for the procedure may instruct you to take measures to increase urine and feces to help eliminate the radioactivity from your body.

If you have any further questions about the use of Amyvid, ask your nuclear medicine doctor who is supervising 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):

• dizziness,
• altered taste,
• redness,

• itching,
• rash, bleeding, or pain at the injection site or rash on other parts of the body.

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders (i.e., genetic diseases). See also section 1.

Reporting of Side Effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of Amyvid

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended for healthcare professionals only.

Do not use Amyvid after the expiry date stated on the label of the shield after EXP.

6. Package Contents and Further Information

Composition of Amyvid

• 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").

Appearance and Package Contents

Amyvid is a clear and colorless solution for injection. It is available in a 10 ml or 15 ml glass vial.

Package Size

Amyvid 1.900 MBq/ml: A 10 ml multidose vial contains 1 to 10 ml of solution, which corresponds to 1.900 to 19.000 MBq at the date and time of calibration.

A 15 ml multidose vial contains 1 to 15 ml of solution, which corresponds to 1.900 to 28.500 MBq at the date and time of calibration.

Amyvid 800 MBq/ml: A 10 ml multidose vial contains 1 to 10 ml of solution, which corresponds to 800 to 8.000 MBq at the date and time of calibration.

A 15 ml multidose vial contains 1 to 15 ml of solution, which corresponds to 800 to 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 more information on the manufacturer, see the label on the shield and the vial.

You can obtain more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

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This information is intended for healthcare professionals only:

The full Summary of Product Characteristics of Amyvid is included as a separate document in the package of the medicine, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the Summary of Product Characteristics [the Summary of Product Characteristics must be included in the box].