VIZAMYL 400 MBq/ml injectable solution Flutemetamol (18F)

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

VIZAMYL must not be used:

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

Warnings and precautions

Consult your nuclear medicine doctor before you are given VIZAMYL if:

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

• You are breast-feeding

Children and adolescents

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

Using VIZAMYL with other medicines

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 images obtained from the brain scan.

Pregnancy and breast-feeding

You must inform your nuclear medicine doctor before administration of VIZAMYL 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

Your nuclear medicine doctor will only administer this medicine during pregnancy if the expected benefit outweighs the risk.

If you are breast-feeding

You must stop breast-feeding for 24 hours after the injection. Express and discard the breast milk produced during this period. Breast-feeding can be resumed when indicated by your nuclear medicine doctor.

You must avoid close contact with small children during the 24 hours after the injection.

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

VIZAMYL may cause dizziness or transient vertigo, which may affect your ability to drive or use machines.

Do not drive, use complex machines, or engage in other potentially hazardous activities until the effects have completely disappeared.

VIZAMYL contains alcohol (ethanol) and sodium

VIZAMYL contains 7% of its volume of alcohol (ethanol); this is up to 552 mg of alcohol, equivalent to 14 ml of beer or 6 ml of wine. This amount may be harmful to those patients who suffer from alcoholism and should be taken into account in pregnant women and during breast-feeding, as well as in patients with liver problems or epilepsy.

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

3. How VIZAMYL is used

There are strict rules on the use, handling, and disposal of radiopharmaceuticals.

VIZAMYL will only be used in special controlled areas. This product will only be handled and administered by trained and qualified professionals who are able to use it safely. They will provide you with the necessary information about the procedure.

Your nuclear medicine doctor may advise you to drink plenty of liquid before starting the examination and during the 24 hours after the examination to urinate frequently and help eliminate the product from your body more quickly.

Dose

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

The recommended dose 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 a sodium chloride solution to ensure complete administration of the dose.

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

Duration of the procedure

The brain study is usually performed 90 minutes after administration of VIZAMYL. Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of VIZAMYL

You must avoid close contact with small children and pregnant women during the 24 hours after the injection.

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

If you have been given more VIZAMYL than you should

Overdose is unlikely because you will receive a single dose of VIZAMYL from your nuclear medicine doctor in controlled conditions.

However, in case of overdose, you will receive appropriate treatment. The treatment consists of increasing elimination through urine and feces to help eliminate the radioactivity from the body.

If you have any further questions about the use of this medicine, 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 effects may occur with this medicine:

Serious side effects

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

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

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

Other side effects include

Common:may affect up to 1 in 10 people

• flushing
• increased blood pressure

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

• headache
• dizziness
• anxiety
• general discomfort (nausea)
• chest discomfort

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

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation that is associated with a very low risk of developing cancer and genetic defects.

Reporting of side effects

If you experience any side effects, consult 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 Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of VIZAMYL

You will not need to store this medicine. This medicine is stored under the responsibility of a 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 this medicine after the expiry date and time stated on the label after "EXP".

Do not use this medicine if you notice that the vial is damaged, the solution contains particles in suspension, or if it is discolored.

6. Contents of the pack and further information

Composition of VIZAMYL

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

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

Appearance and pack of the product

• VIZAMYL is a clear, colorless to slightly yellowish solution for injection.
• VIZAMYL is supplied in a 10 ml or 15 ml glass vial. Each vial is stored in a container.

• Not all pack sizes may be marketed.

Marketing Authorisation Holder

GE Healthcare AS

Nycoveien 1

NO-0485 Oslo

Norway

Manufacturer

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet{month YYYY}.

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

This information is intended for healthcare professionals only:

The full summary of product characteristics of VIZAMYL is included as a separate document in the product pack, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the summary of product characteristics [the summary of product characteristics must be included in the box].