Datscan 74 mbq/ml solucion inyectable

Label: Information for the User

DaTSCAN 74 MBq/ml injectable solution

Ioflupano (123I)

Read this label carefully before this medication is administered to you, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who is supervising the procedure.
• If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this label. See section 4.

What this label includes

1. What you need to know before starting to use DaTSCAN
   1. How to use DaTSCAN
   2. Possible adverse effects
   3. Storage of DaTSCAN

1. Contents of the package and additional information

DaTSCAN contains the active ingredient ioflupane (123I) which is used to help identify (diagnose) diseases in the brain. It belongs to a group of medications called “radiopharmaceuticals”, which contain a small amount of radioactivity.

• When a radiopharmaceutical is injected, it accumulates in a specific organ or area of the body for a short period of time.
• Due to the small amount of radioactivity it contains, it can be detected from the outside of the body using a specialized medical device called a gamma camera.
• An image, known as a gamma scan, can be obtained. This gamma scan will show exactly the distribution of the radiopharmaceutical in a specific organ and in the body. This can provide valuable information to the doctor about the structure of that organ.

When DaTSCAN is injected into an adult, it distributes throughout the body through the blood. It accumulates in a small area of the brain. Changes in this area of the brain occur in:

• Parkinsonism (including Parkinson's disease) and
• Lewy body dementia.

The image will provide information to your doctor about any changes in this area of your brain. This image will help your doctor to know more about your disease and decide on possible treatment.

When DaTSCAN is used, you are exposed to small amounts of radioactivity. This exposure is less than in some types of radiographic exploration. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of being exposed to small amounts of radiation.

This medication is used solely for diagnostic use. It is used solely to identify the disease.

DaTSCAN should not be used

• if you are allergic to ioflupane or any of the other components of this medication (listed in section 6).

• if you are pregnant.

Warnings and precautions

Consult your nuclear medicine doctor before receiving DaTSCAN if you have moderate or severe kidney or liver problems.

Children and adolescents

DaTSCAN is not recommended for children aged 0 to 18 years.

Other medications and DaTSCAN

Inform your nuclear medicine doctor if you are using or have recently used other medications. Some medications and substances may affect how DaTSCAN works. These medications include:

• buproprion (used to treat depression)
• benzatropine (used to treat Parkinson's disease)
• mazindol (reduces appetite, used to treat obesity)
• sertraline (used to treat depression)
• methylphenidate (used to treat hyperactivity in children and narcolepsy)
• fentermine (reduces appetite, used to treat obesity)
• amphetamine (used to treat hyperactivity in children and narcolepsy; also used recreationally)
• cocaine (sometimes used as an anesthetic for nasal surgery; also used recreationally)

Some medications may reduce the quality of the image obtained. Your doctor may ask you to stop using them for a short period of time before receiving DaTSCAN.

Pregnancy and breastfeeding

Do not use DaTSCAN if you are pregnant or think you may be pregnant. This is because the baby may receive some radiation. Inform your nuclear medicine doctor if you think you may be pregnant. Alternative techniques that do not involve radiation should be considered.

If you are breastfeeding, your nuclear medicine doctor may postpone the use of DaTSCAN, or ask you to stop breastfeeding. It is unknown whether ioflupane (123I) passes into breast milk.

• Do not breastfeed your child for 3 days after receiving DaTSCAN.

• Use formula to feed your child. Express and discard breast milk periodically.
• You will need to do this for 3 days, until there is no radiation in your body.

Driving and operating machinery

DaTSCAN has no known influence on the ability to drive and operate machinery.

DaTSCAN containsalcohol (ethanol) at 5% by volume. Each dose contains up to 197 mg ofalcohol, almost the same as 5 ml of beer or 2 ml of wine. This is harmful to those with alcoholism and should be taken into account in pregnant women, breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy. Inform your doctor if this applies to you.

There are strict laws regarding the use, handling, and disposal of radioactivity. DaTSCAN will always be used in a hospital or a similar setting. Only trained and qualified personnel will handle and administer it safely. These individuals will inform you on how to use this medication safely. Your nuclear medicine doctor will decide on the best dose for you.

Before you receive DaTSCAN, your nuclear medicine doctor will ask you to take some tablets or liquids containing iodine. This will help prevent the accumulation of radioactivity in your thyroid gland. It is essential that you take the tablets or liquids as instructed by your doctor.

DaTSCAN is administered as an injection, usually into a vein in your arm. The recommended dose of radioactivity administered via injection is between 111 and 185 MBq (megabequerelios or MBq is a unit used to measure radioactivity). A single injection is sufficient. Images with the camera are typically taken between 3 and 6 hours after the DaTSCAN injection.

If you are administered more DaTSCAN than you should

Since DaTSCAN is administered by a doctor in strictly controlled conditions, it is unlikely that you will receive an overdose. Your nuclear medicine doctor will recommend that you drink plenty of liquids to speed up the elimination of the medication from your body. You will need to be careful with the urine you expel: your doctor will tell you what to do. This is a common occurrence with medications like DaTSCAN. Any remaining ioflupane (123I) retained in your body will naturally lose its radioactivity.

If you have any other questions about the use of this medication, ask the nuclear medicine doctor overseeing the procedure.

Like all medications, DaTSCAN may have adverse effects, although not everyone will experience them.

The frequency of adverse effects is:

Frequent: may affect up to 1 in 10 people

• Headache

Less frequent: may affect up to 1 in 100 people

• Increased appetite
• Dizziness
• Alteration of taste
• Nausea
• Dry mouth
• Dizziness
• A brief sensation of irritation similar to that of pins and needles on the skin (tingling)
• Intense pain (or burning sensation) at the injection site. This has been reported by patients who received DaTSCAN in a small vein

Unknown frequency: cannot be estimated from available data

• Hypersensitivity (allergic)
• Shortness of breath
• Redness of the skin
• Itching
• Rash
• Hives (urticaria)
• Excessive sweating

• Vomiting
• Low blood pressure
• Sensation of heat

The amount of radioactivity in the body as a result of the DaTSCAN injection is very small and will be eliminated from the body in a few days without the need for special precautions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear medicine physician, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly throughthe national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by the patient. This medication is stored under the responsibility of the specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist:

• Keep this medication out of the sight and reach of children.
• Do not store at a temperature above 25 °C.
• Do not freeze.

Do not use this medication after the expiration date appearing on the packaging and the vial after CAD. The expiration date corresponds to the last day of the specified month. Hospital staff will ensure that the product is stored and disposed of correctly and that it is not used once the expiration date shown on the label has passed.

DaTSCAN Composition

• The active ingredient is ioflupane (123I). Each milliliter of solution contains ioflupane (123I) 74 MBq at the date of calibration (0.07 to 0.13 μg/ml of ioflupane).
• The other components are acetic acid, sodium acetate, ethanol, and water forinjectable preparations

Appearance of the product and contents of the container

DaTSCAN is an incolored injectable solution of 2.5 or 5 ml, supplied in a single 10 ml colorless glass vial sealed with a rubber stopper and a metallic overcap.

Marketing authorization holder and manufacturer responsible

GE Healthcare B.V.

De Rondom 8

5612 AP, Eindhoven

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization holder.

This leaflet was revised in <{MM/AAAA}>

The detailed information about this medication is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the website of the European Medicines Agency.