1900 MBq / ml, 800 MBq / ml injection solution 
Florbetapir ( 18 F)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have further questions, please contact the specialist in nuclear medicine (the isotope doctor), who will lead the examination.

– If you get any side effects, talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Amyvid is and what it is used for 
2. What you need to know before you use Amyvid 
3. How to use Amyvid 
4. Possible side effects 
5. How to store Amyvid 
6. Contents of the packaging and other information 

1. What Amyvid is and what it is used for

This is a radioactive medicine intended for diagnostic use only.

Amyvid contains the active substance florbetapir ( 18 F).

Amyvid is given to adults who have memory problems, so that doctors can do a kind of scan of the brain, called a PET scan. Amyvid, combined with other tests of brain function, can help your doctor find the cause of your memory problems. A PET scan with Amyvid can help your doctor determine if you may have beta-amyloid plaques in your brain. Beta-amyloid plaques occur in the brain of people with Alzheimer’s disease, but they can also be found in the brain of people with other dementia diseases.

You should discuss the results of the examination with the doctor who prescribed the scan.

When Amyvid is used, it is exposed to small amounts of radioactivity. Your doctor and isotope doctor have assessed that the benefit of the examination with the radioactive substance outweighs the risk of being exposed to radiation.

2. What you need to know before using Amyvid

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 cautions

Talk to your isotope doctor before getting Amyvid if you

  • have kidney problems
  • have liver problems
  • is pregnant or thinks you may be pregnant
  • Ammar.

Children and young people

Amyvid should not be used in children and adolescents.

Other medicines and Amyvid

Tell your isotope physician if you are taking, have recently taken or might take any other medicines as they may interfere with the interpretation of the images from the brain scan.

Pregnancy and breastfeeding

It is important that you tell the isotope doctor before you receive Amyvid if there is any possibility that you are pregnant, if you have missed your period or if you are breast-feeding. If you are unsure, it is important that you discuss with the isotope doctor who will lead the examination.

If you are pregnant

The isotope doctor will only give you this product during pregnancy if the expected benefits outweigh the risks.

If you are breast-feeding

You must stop breast-feeding for 24 hours after using Amyvid and discard breast milk that has been pumped out during this period. Ask your isotope doctor when you can start breastfeeding again.

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

Driving and using machines

Amyvid does not affect your ability to drive or use machines.

Amyvid contains ethanol and sodium

This medicine contains 10% v / v ethanol (alcohol), which means up to 790 mg per dose , equivalent to 20 ml of beer or 8 ml of wine. This can be harmful for people who are addicted to alcohol. The

should be considered for pregnant or lactating women and for high-risk groups such as patients with liver disease or epilepsy .

This medicine also contains up to 37 mg sodium per dose (such as sodium ascorbate and sodium chloride). This should be considered by patients on a low-salt diet.

3. How to use Amyvid

There are strict regulations on the use, handling and destruction of radioactive drugs.

Amyvid will only be used in specially controlled areas. The product is handled and given to you by people who are trained and qualified to use it safely. These people will be especially careful with security and will inform you about everything they do.

Dose

The isotope doctor who leads the examination decides how much Amyvid you should receive. It will be the smallest amount needed to get the desired information.

The most commonly recommended amount for an adult is 370 MBq (mega becquerel, the device used to indicate radioactivity).

How Amyvid is given and how the examination is performed

Amyvid is given as an injection into a vein ( intravenous injection ), followed by saline so that the entire dose is safely delivered.

An injection is usually enough for the examination that your doctor needs.

Duration of the survey

The isotope doctor will inform you about how long the examination usually lasts. After Amyvid injection one takes it about 30 50 minutes before one can do a brain scan.

Once you have received an Amyvid injection, you should:

Avoid close contact with young children and pregnant women for 24 hours after injection.

The isotope doctor will tell you if you need to take any special precautions once you have received this medicine. Contact your isotope doctor if you have any questions.

If you take more Amyvid than you should

It is unlikely that you will receive an overdose, as you will only receive a single dose of Amyvid closely monitored by the isotope physician leading the examination. Should an overdose occur, after all, you will receive appropriate treatment? This may mean that the isotope doctor responsible for the examination accelerates the passage of urine and feces, so that the radioactivity disappears from your body as quickly as possible.

If you have any further questions on the use of Amyvid, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects of Amyvid are common (may affect up to 1 in 10 people):

  • headache.

The following adverse reactions are of Amyvid is less common (may affect up to 1 in 100 people):

  • nausea,
  • changed taste,
  • redness ,
  • itching,
  • skin rash, bleeding or pain where injection is given or skin rash elsewhere.

This radioactive drug emits low amounts of ionizing radiation, which is linked to the lowest risk of cancer and congenital defects (ie genetic diseases). See also section 1.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Amyvid

You do not need to store this medicine yourself. The isotope physician is responsible for storing the medicine in a suitable place. Storage of radioactive drugs takes place in accordance with national rules on radioactive materials.

The following information is intended for the isotope physician only.

Amyvid must not be used after the expiry date which is stated on the protective container label after EXP.

6. Contents of the packaging and other information

What Amyvid contains

  • The active substance is florbetapir ( 18 F). 
    Amyvid 1,900 MBq / ml: 1 ml solution for injection contains 1,900 MBq of floret paper ( 18 F) at the day and time of calibration. 
    Amyvid 800 MBq / ml: 1 ml solution for injection contains 800 MBq of floret paper ( 18 F) at the day and time of calibration.
  • The other ingredients are ethanol , sodium ascorbate, sodium chloride and water for injections (see section 2 “Amyvid contains alcohol and sodium”).

What the medicine looks like and the contents of the pack

Amyvid is a clear, colorless solution for injection. It is supplied in 10 ml or 15 ml clear 1 vial.

Pack size

Amyvid 1,900 MBq / ml: A multiple-dose 10 ml vial containing 1 to 10 ml solution, equivalent to 1,900 to 19,000 MBq at the day and time of calibration.

A multi-dose 15 ml vial containing 1 to 15 ml solution, equivalent to 1,900 to 28,500 MBq at the day and time of calibration.

Amyvid 800 MBq / ml: A multi-dose 10 ml vial containing 1 to 10 ml solution, equivalent to 800 to 8,000 MBq at the day and time of calibration.

A multi-dose 15 ml vial containing 1 to 15 ml solution, equivalent to 800 to 12,000 MBq at the day and time of calibration.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Muhammad Nadeem

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