Vizamyl 400 MBq/ml solution for injection flutemetamol (18F)

Package Leaflet: Information for the user

Introduction

Package Leaflet: Information for the patient

VIZAMYL 400 MBq/ml solution for injection

flutemetamol (18F)

Read the entire leaflet carefully before you are administered this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any further questions, consult your nuclear medicine physician who supervises the procedure.

• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What VIZAMYL is and what it is used for
2. What you need to know before being administered VIZAMYL
3. How VIZAMYL is administered
4. Possible side effects
5. How VIZAMYL is stored
6. Contents of the pack and other information

1. What VIZAMYL is and what it is used for

VIZAMYL contains the active substance flutemetamol (18F) and is used to help diagnose Alzheimer's disease and other causes of memory loss. This medicine is a radiopharmaceutical intended solely for diagnostic use.

VIZAMYL is used to help diagnose Alzheimer's disease and other causes of memory loss. It is given to adults with memory problems before undergoing a type of brain scan known as positron emission tomography (PET) imaging. This imaging study, together with other tests of brain function, may help your doctor determine whether or not you have β-amyloid plaques in your brain. β-amyloid pla游戏副本

2. What you need to know before using VIZAMYL

VIZAMYL must not be used:

• If you are allergic to flutemetamol (18F) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your nuclear medicine physician before receiving VIZAMYL if:

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

Children and adolescents

VIZAMYL is not indicated for use in children and adolescents under 18 years of age.

Use of VIZAMYL with other medicines

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as some medicines may interfere with the images obtained from the brain scan.

Pregnancy and breastfeeding

You must inform the nuclear medicine physician before administration of VIZAMYL if there is any possibility 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 supervising the procedure.

If you are pregnant

The nuclear medicine physician will administer this medicine during pregnancy only if the expected benefit outweighs the potential risk.

If you are breastfeeding

You must interrupt breastfeeding for 24 hours after the injection. Express and discard the breast milk produced during this period. Breastfeeding may be resumed as directed by the nuclear medicine physician supervising the procedure.

You should avoid close contact with young children for 24 hours after the injection.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.

Driving and use of machines

VIZAMYL may cause transient dizziness or vertigo, which may affect your ability to drive or operate machinery.

You should not drive, operate complex machinery, or perform other potentially hazardous activities until these effects have completely subsided.

VIZAMYL contains alcohol (ethanol) and sodium

VIZAMYL contains 7% of its volume as alcohol (ethanol); this corresponds to up to 552 mg of alcohol, equivalent to 14 ml of beer or 6 ml of wine. This amount may be harmful for patients with alcoholism and should be taken into account in pregnant and breastfeeding women, as well as in individuals with liver problems or epilepsy.

VIZAMYL contains up to 41 mg of sodium (a main component of table/cooking salt) per dose. This is equivalent to 2% of the maximum daily recommended sodium intake for an adult. Patients on low-sodium diets should be aware that this medicine contains up to 41 mg of sodium per dose.

3. How to use VIZAMYL

There are strict regulations regarding the handling, use, and disposal of radiopharmaceuticals.

VIZAMYL will be used only in specially controlled areas. This product will be handled and administered only by trained and qualified professionals who are skilled in its safe use. They will provide you with the necessary information about the procedure.

Your nuclear medicine physician may instruct you to drink plenty of fluids before starting the examination and during the 24 hours following the examination, to urinate frequently and help eliminate the product from your body more quickly.

Dosage

The nuclear medicine physician supervising the procedure will determine the amount of VIZAMYL to be used in your case. The physician will use the minimum amount necessary to obtain the required information.

The amount generally recommended for administration to an adult is 185 MBq (Megabecquerels, the unit used to measure radioactivity).

Administration of VIZAMYL and performance of the procedure

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

One injection is sufficient to perform the procedure required by your physician.

Duration of the procedure

The brain scan is usually performed 90 minutes after the administration of VIZAMYL. Your nuclear medicine physician will inform you about the typical duration of the procedure.

After administration of VIZAMYL

You should avoid close contact with young children and pregnant women during the 24 hours following the injection.

Your nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any questions.

If you have been administered more VIZAMYL than you should have

An overdose is unlikely, as you will receive a single dose of VIZAMYL from your nuclear medicine physician under controlled conditions.

However, in the event of an overdose, appropriate treatment would be given. This treatment consists of increasing elimination via urine and feces to help remove radioactivity from the body.

If you have any further questions about the use of this medicine, ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The following adverse effects may occur with this medicine:

Serious adverse effects

Inform your doctor immediately if you notice any of the following symptoms, as you may require urgent medical treatment:

• Allergic reactions: signs may include swelling of the face or eyes, pallor, skin itching or tightness, skin rash, feeling short of breath, chest tightness, throat irritation or general malaise. These effects are uncommon and may affect up to 1 in 100 people.

Inform your doctor immediately if you experience any of the above symptoms.

Other adverse effects include

Frequent: may affect up to 1 in 10 people

• facial flushing
• increased blood pressure

Uncommon: may affect up to 1 in 100 people. You may experience the following uncommon adverse effects:

• headache
• dizziness
• anxiety
• general discomfort (nausea)
• chest discomfort
• low blood sugar (symptoms: hunger, headache)
• back pain
• sensation of cold or heat
• increased respiratory rate
• pain at injection site
• palpitations
• muscle or bone pain
• tremors
• swollen and inflamed skin
• fever
• hyperventilation
• change in taste (taste alteration)
• sensation of spinning (vertigo)
• reduced sensation or sense of touch
• feeling of tiredness or weakness
• inability to achieve or maintain an erection
• indigestion, stomach pain or mouth pain
• vomiting
• reduced sensation or sensitivity, especially in the skin or face
• increased levels of lactate dehydrogenase in blood or increased neutrophil count in blood tests
• skin tightness

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, which is associated with a very low risk of developing cancer and hereditary defects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your nuclear medicine physician, even if they are adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VIZAMYL

You will not be required to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations regarding radioactive materials.

The following information is intended for specialists only.

Do not use this medicine after the expiry date and time stated on the label following "EXP".

Do not use this medicine if the vial is damaged, if the solution contains suspended particles, or if it is discolored.

6. Contents of the pack and other information

Composition of VIZAMYL

• The active substance is flutemetamol (18F). Each ml of solution contains 400 MBq of
  flutemetamol (18F) at the time and date of calibration.

• The other components are: sodium chloride, anhydrous ethanol, polysorbate 80, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, and water for injections, see section 2.

Nature of the product and pack contents

• VIZAMYL is a clear, colourless to slightly yellow, injectable solution.

• VIZAMYL is supplied in 10 ml or 15 ml glass vials. Each vial is stored in a container.

• Only some pack sizes may be marketed.

Marketing Authorization Holder

GE Healthcare AS
Nycoveien 1
NO-0485 Oslo
Norway

Manufacturer responsible for manufacturing

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the most recent review of this summary: {month YYYY}.

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

This information is intended for healthcare professionals only:

The full product information for VIZAMYL is included as a separate document in the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the product information [the product information must be included in the package].