Patient Information Leaflet

Striascan 74 MBq/ml injectable solution EFG

Ioflupane (123I)

Please read this leaflet carefully before you receive this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine doctor who will oversee the procedure.
• If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

This medication is a radiopharmaceutical for diagnostic use only.

Striascan 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 the doctor with valuable information about the structure of that organ.

Striascan is used solely for identification of the disease. When this medication is injected into a patient, it distributes throughout the body via the bloodstream and accumulates in a small area of the brain. Changes in this area of the brain occur in:

• parkinsonism (including Parkinson's disease) and
• Levodopa-induced Parkinsonism
• demencia con cuerpos de Lewy.

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

When Striascan 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.

Do not use Striascan

• 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 using Striascan if you havemoderate or severekidney or liver problems.

Before administration of Striascan, you must:

drinkmuch water before the procedure to urinate as frequently as possible during the first 48 hours after its completion.

Children and adolescents

Striascan is not recommended for children and adolescents from 0 to 18 years.

Other medications and Striascan

Inform your nuclear medicine doctor if you are using or have recently used any other medication.

Some medications or substances may affect the way this medication works.

These medications include:

• bupropion (used to treat depression or to quit smoking)
• sertraline, paroxetine, citalopram, escitalopram, fluoxetine, fluvoxamine (used to treat depression)
• methylphenidate, dextroamphetamine (used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy (excessive sleep))
• phentermine (reduces appetite, as a means to treat obesity)
• amphetamine
• cocaine (sometimes used as an anesthetic for nasal surgery)
• modafinil (used to treat narcolepsy (excessive sleep) and other sleep disorders)
• codeine (used to relieve mild to moderate pain and to dry up a persistent cough)

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your nuclear medicine doctor before receiving this medication.

You must inform your nuclear medicine doctor before administration of Striascan if there is any possibility of pregnancy, if you have a delayed period, or if you are breastfeeding. In case of doubt, it is essential to consult your nuclear medicine doctor, who will oversee the procedure.

If you are pregnant,do not use Striascan. This is because the child may receive someradioactivity. Alternative techniques that do not involve radioactivity should be considered.

If you are breastfeeding,your nuclear medicine doctor may postpone the use of this product, or ask you tointerrupt breastfeeding. The amount of ioflupane (123I) administered to you is unknown to pass into breast milk.

• Do not breastfeed your child for the 3 days following receipt of this product.
• Use formula milk to feed your child. Express and discard breast milk periodically.
• You will have to do this for 3 days, until there is no radioactivity in your body.

Driving and operating machinery

It is considered unlikely that Striascan will affect your ability to drive or operate machinery.

Striascan contains alcohol(ethanol): up to 197 mg of alcohol per dose, equivalent to 39.5 mg/ml (5% by volume). The amount in 5 ml of this medication is equivalent to 5 ml of beer or 2 ml of wine. The small amount of alcohol present in this medication will have no appreciable effect.

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially “sodium-free”.

Laws are strict regarding the use, handling, and disposal of radioactivity. Striascan will be used always in a hospital or a similar place. Only trained and qualified individuals will handle and administer it safely. These individuals will inform you on how to use it safely.

The nuclear physician overseeing the procedure will decide on the amount of Striascan to be used in your case, which will be the minimum amount necessary to obtain the desired information.

The generally recommended dose for an adult is 110 to 185 MBq (megabequerel or MBq, the unit used to express radioactivity).

Administration of Striascan and procedure performance

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

Striascan is administered as an injection, usually into a vein in your arm. A single injection is sufficient.

Procedure duration

The images with the camera are typically taken between 3 and 6 hours after the injection of this product. Your nuclear physician will inform you about the usual duration of the procedure.

After Striascan administration, you should urinate frequently to eliminate the product from your body.

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

If you are administered more Striascan than you should

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

If you have any other questions about using this medication, ask your nuclear physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The frequency of adverse effects is:

Frequent: may affect up to 1 in 10 people

• Headache

Rare: 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 ants on the skin (tingling)
• Intense pain (or burning sensation) at the injection site. This has been reported by patients who received this product 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 administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear physician, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational 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. Radioactive pharmaceutical storage will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist:

• Do not store at a temperature above 25 °C.
• Do not freeze.

Do not use this medication after the expiration date that appears on the labels after CAD. Hospital staff will ensure that the product is stored and disposed of correctly and that it is not used once the expiration date on the label has passed.

Composition of Striascan

• The active principle is ioflupano (123I).

Each ml of solution contains 74 MBq of ioflupano (123I) at the date of calibration.

• The other components are glacial acetic acid (E 260), sodium acetate trihydrate (E 262), anhydrous ethanol (E 1510), concentrated phosphoric acid (E 338) and water for injectable preparations.

Appearance of the product and contents of the packaging

Striascan is an colourless injectable solution, supplied in a single amber glass vial of 15 ml sealed with a rubber stopper and a metallic overcap.

Presentation: 1 vial containing 2.5 ml or 5 ml of solution.

Holder of the marketing authorization and responsible manufacturer

CIS bio international

RN 306 – Saclay

B.P. 32

F-91192 Gif-sur-Yvette Cedex

FRANCE

Last review date of this leaflet:02/10/2024.

Other sources of information

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

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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This information is intended solely for healthcare professionals:

The complete technical datasheet for Striascan is supplied as a separate document in the packaging of the product, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical datasheet.