AMYVID 1.900 MBq/ml injectable solution
How to use AMYVID 1.900 MBq/ml injectable solution
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Patient Information: Summary of Product Characteristics
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 pack
- What is Amyvid and what is it used for
- What you need to know before you are given Amyvid
- How to use Amyvid
- Possible side effects
- Storage of Amyvid
- Contents of the pack 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 beta-amyloid plaques in your brain. Beta-amyloid plaques are deposits found in the brain of people with Alzheimer's disease, but they can also be present in the brain 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 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 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 should tell your nuclear medicine doctor before administration of Amyvid if you are pregnant, have missed a period, or 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
Your 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 should stop breast-feeding for 24 hours after the injection and the breast milk should be discarded.
Breast-feeding can be resumed in agreement with your 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 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 does not produce any noticeable effect.
This medicine also contains up to 37 mg of sodium (the main component of table/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 for 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 persons 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 should
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 administration of 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 appropriate 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 vial after EXP.
6. Contents of the pack 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 pack size
Amyvid is a clear and colorless solution for injection. It is available in a 10 ml or 15 ml glass vial.
Pack 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 of the vial and the outer packaging.
You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:
Belgium/België/Belgien Eli Lilly Benelux S.A./N.V. Tel: + 32-(0)2 548 84 84 | Lithuania Eli Lilly Lietuva Tel: +370 (5) 2649600 |
| Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V. Tel: + 32-(0)2 548 84 84 |
Czech Republic ELI LILLY CR, s.r.o. Tel: + 420 234 664 111 | Hungary Lilly Hungária Kft. Tel: + 36 1 328 5100 |
Denmark Eli Lilly Danmark A/S Tel: +45 45 26 60 00 | Malta Charles de Giorgio Ltd. Tel: + 356 25600 500 |
Germany Lilly Deutschland GmbH Tel: + 49-(0) 6172 273 2222 | Netherlands Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800 |
Estonia Eli Lilly Nederland B.V. Tel: +372 6 817 280 | Norway Eli Lilly Norge A.S. Tel: + 47 22 88 18 00 |
Greece ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Tel: +30 210 629 4600 | Austria Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780 |
Spain Lilly S.A. Tel: + 34-91 663 50 00 | Poland Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 00 |
France Lilly France Tel: +33-(0) 1 55 49 34 34 | Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600 |
Croatia Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999 | Romania Eli Lilly România S.R.L. Tel: + 40 21 4023000 |
Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 | Slovenia Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10 |
Iceland Icepharma hf. Tel: + 354 540 8000 | Slovakia Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 111 |
Italy Eli Lilly Italia S.p.A. Tel: + 39- 055 42571 | Finland Oy Eli Lilly Finland Ab Tel: + 358-(0) 9 85 45 250 |
Cyprus Phadisco Ltd Tel: +357 22 715000 | Sweden Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800 |
Latvia Eli Lilly (Suisse) S.A Parstavnieciba Latvija Tel: +371 67364000 | United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 |
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 pack 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].
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to AMYVID 1.900 MBq/ml injectable solutionDosage form: INJECTABLE, 1900 MBq/mlActive substance: florbetapir (18F)Manufacturer: Eli Lilly Nederland B.V.Prescription requiredDosage form: INJECTABLE, 800 MBq/ml of Florbetapir (18F)Active substance: florbetapir (18F)Manufacturer: Eli Lilly Nederland B.V.Prescription requiredDosage form: INJECTABLE, 800 MBq/mlActive substance: florbetapir (18F)Manufacturer: Eli Lilly Nederland B.V.Prescription required
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