STRIASCAN 74 MBq/mL Injectable Solution

Introduction

Package Leaflet: Information for the Patient

Striascan 74 MBq/ml Solution for Injection EFG

ioflupane (123I)

Read this package leaflet carefully before this medicine is administered to you, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Striascan and what is it used for
2. What you need to know before using Striascan
3. How to use Striascan
4. Possible side effects
5. Storage of Striascan
6. Package Contents and Additional Information

1. What is Striascan and what is it used for

This medicine 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 medicines 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.
• Because it contains a small amount of radioactivity, it can be detected from outside the body using a special medical device called a gamma camera.

• An image, known as a scintigram, can be obtained. This scintigram will show exactly the distribution of the radiopharmaceutical in a particular organ and in the body. This can give your doctor valuable information about the structure of that organ.

Striascan is used solely for diagnostic purposes. When this medicine is injected into a patient, it is distributed 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
• Lewy body dementia.

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

When using Striascan, you are exposed to small amounts of radioactivity. This exposure is less than in some types of radiographic examinations. Your doctor and 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.

2. What you need to know before using Striascan

Striascan should not be used

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

Warnings and Precautions

Consult your nuclear medicine doctor before using Striascan if you have moderate orseverekidney or liver problems.

Before administration of Striascan, you should:

drink plenty of 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 Medicines and Striascan

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

Some medicines or substances may affect the way this medicine works.

These medicines 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 sleepiness])
• phentermine (reduces appetite, as a means to treat obesity)
• amphetamine
• cocaine (sometimes used as an anesthetic for nose surgery)
• modafinil (used to treat narcolepsy [excessive sleepiness] and other sleep disorders)
• codeine (used to relieve mild to moderate pain and to relieve dry cough)

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

Pregnancy and Breastfeeding

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

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

If you are pregnant,do not use Striascan. This is because the baby may receive some radioactivity. 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 to interrupt breastfeeding. It is not known if ioflupane (123I) administered to you passes into breast milk.

• You should not breastfeed your child for 3 days after receiving this product.
• Use artificial milk to feed your child. Express breast milk periodically and discard it.
• You will need to do this for 3 days, until there is no radioactivity in your body.

Driving and Using Machines

It is considered unlikely that Striascan will affect your ability to drive or use machines.

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

This medicine contains less than 1 mmol of sodium (23 mg) per vial; i.e., it is essentially "sodium-free".

3. How to use Striascan

There are strict laws regarding the use, handling, and disposal of radioactivity. Striascan will always be used in a hospital or similar setting. It will only be handled and administered by trained and qualified personnel to use it safely. These personnel will inform you about what you need to do for the safe use of this medicine.

The nuclear medicine doctor supervising the procedure will decide 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 amount to administer to an adult is 110 to 185 MBq (megabecquerel, the unit used to express radioactivity).

Administration of Striascan and Performance of the Procedure

Before you receive Striascan, your nuclear medicine doctor will ask you to take some tablets or liquids containing iodine. This slows down the accumulation of radioactivity in your thyroid gland. It is essential that you take the tablets or liquids your doctor tells you to.

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

Duration of the Procedure

Images with the camera are usually taken between 3 and 6 hours after injection of this product. Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of Striascan, you shouldurinate frequently to eliminate the product from your body.

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

If you are given more Striascan than you should

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

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 frequency of side effects is:

Frequent: may affect up to 1 in 10 people

• Headache

Uncommon: may affect up to 1 in 100 people

• Increased appetite
• Dizziness
• Altered sense of taste
• Nausea
• Dry mouth
• Dizziness
• A brief sensation of irritation similar to that of ants on the skin (tingling)
• Severe pain (or burning sensation) at the injection site. This has been reported in patients who received this product in a small vein

Frequency not known: cannot be estimated from the available data

• Hypersensitivity (allergic)
• Shortness of breath
• Redness of the skin
• Itching
• Rash
• Hives on the skin (urticaria)
• Excessive sweating
• Vomiting
• Low blood pressure
• Feeling of heat

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

Reporting of Side Effects

If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Striascan

You will not need to store this medicine. This medicine is stored under the responsibility of the 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 only for healthcare professionals:

• Do not store above 25°C.
• Do not freeze.

Do not use this medicine after the expiry date stated on the labels after EXP. Hospital staff will ensure that the product is stored and disposed of correctly and not used after the expiry date stated on the label.

6. Package Contents and Additional Information

Composition of Striascan

• The active ingredient is ioflupane (123I).

Each ml of solution contains 74 MBq of ioflupane (123I) at the time 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 Package Contents

Striascan is a colorless injectable solution, supplied in a single 15 ml amber glass vial sealed with a rubber stopper and a metal overseal.

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

Marketing Authorization Holder and Manufacturer

CIS bio international

RN 306 – Saclay

B.P. 32

F-91192 Gif-sur-Yvette Cedex

FRANCE

Date of Last Revision of this Package Leaflet:02/10/2024.

Other Sources of Information

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

On the European Medicines Agency website, you can find this package leaflet in all languages of the European Union/European Economic Area.

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This information is intended only for healthcare professionals:

The complete technical data sheet for Striascan is provided as a separate document in the product packaging, 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 data sheet.