StriAscan

Package leaflet: Information for the patient

Striascan 74 MBq/mL solution for injection

ioflupane ( I)
Please read this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the nuclear medicine specialist responsible for performing the examination.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet

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

1. What Striascan is and what it is used for

This medicinal product is a radiopharmaceutical intended exclusively for diagnostic use.
Striascan contains the active substance ioflupane ( I), which is used to help identify (diagnose) brain disorders. It belongs to a group of medicines known as "radiopharmaceuticals", which contain a small amount of radioactivity.

• When a radiopharmaceutical is injected, it accumulates briefly in an organ or part of the body.
• Because it contains a small amount of radioactivity, its presence can be detected from outside the body using special imaging cameras.
• These can produce an image called a scan. The scan will show exactly where the radioactivity is located within the organ and body. This provides the doctor with valuable information about the functioning of that organ.

Striascan is used solely to help identify diseases. When this medicine is injected into a patient, it is carried by the blood throughout the body and accumulates in a small area of the brain. Changes occur in this area of the brain in the case of:

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

The scan enables the doctor to obtain information about changes that have occurred in this area of the brain. The information obtained from the scan can help the doctor to diagnose the disease and decide on appropriate treatment.
During the use of Striascan, you are exposed to a small amount of radioactivity. This exposure is lower than that encountered in some types of X-rays. Your doctor and the nuclear medicine specialist have assessed that the clinical benefit of this examination performed with a radiopharmaceutical outweighs the risk associated with exposure to these small amounts of radiation.

2. What you need to know before Striascan is used

Striascan must not be used

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

Warnings and precautions
Talk to the nuclear medicine specialist before you are given this medicine
if you have moderate or severe liver or kidney problems.
Before receiving Striascan you must

• drink plenty of water to ensure you are well hydrated before and after the scan, and urinate as frequently as possible during the first 48 hours following the procedure.

Children and adolescents
Striascan is not recommended for children and adolescents aged between 0 and 18 years.
Other medicines and Striascan
Inform the nuclear medicine specialist if you are currently taking, have recently taken, or might take any other medicines. Some medicines and substances may affect how this medicine works, including:

• bupropion (used to treat depression or to stop smoking)
• sertraline, paroxetine, citalopram, escitalopram, fluoxetine, fluvoxamine (used to treat depression)
• methylphenidate, dexamphetamine (used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy (excessive sleepiness))
• phentermine (appetite suppressant, used in the treatment of obesity)
• amphetamine
• cocaine (sometimes used as an anaesthetic for nasal surgery)
• modafinil (used to treat narcolepsy (excessive sleepiness) and other sleep disorders)
• codeine (used to relieve mild to moderate pain and to suppress dry cough)

Some medicines may reduce the quality of the resulting images. Your doctor may ask you to temporarily stop taking them before receiving Striascan.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, please consult the nuclear medicine specialist before receiving this medicine.
You must inform the nuclear medicine specialist before receiving Striascan if there is any possibility you may be pregnant, if you have missed your menstrual period, or if you are breastfeeding. If in doubt, it is important to consult the nuclear medicine specialist responsible for performing the procedure.
If you are pregnant, do not use Striascan, as the unborn child could be exposed to radiation. The use of alternative diagnostic techniques that do not involve radiation should always be considered.
If you are breastfeeding, your doctor may delay the use of this medicine or advise you to stop breastfeeding. It is not known whether ioflupane (I) administered to you passes into breast milk.

• You must not breastfeed for 3 days after receiving this medicine.
• Replace breastfeeding with infant formula. Breast milk should be expressed at regular intervals and discarded.
• You must continue this procedure for 3 days, until radioactivity is no longer present in your body.

Driving and using machines
Striascan is unlikely to affect your ability to drive or operate machinery.
Striascan contains alcohol (ethanol): up to 197 mg of alcohol (ethanol) per dose, 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 in this medicine will have no noticeable effect.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially 'sodium-free'.

3. How to use Striascan

There are strict regulations regarding the use, handling, and disposal of radioactive materials.
Striascan must always be used in a hospital or similar facility. It must be handled and
administered only by trained and qualified personnel who are able to use it safely. The medical staff will provide you with all necessary instructions for the safe use of this medicine.
The nuclear medicine specialist performing the procedure will determine the amount of Striascan to be administered in your case. This will be the smallest quantity necessary to obtain the required diagnostic information.
The usually recommended administered activity for an adult is between 110 and 185 MBq
(megabecquerel, the unit used to measure radioactivity).

Administration of Striascan and procedure performance
Before receiving Striascan, your doctor will ask you to take certain tablets or liquid containing iodine to prevent accumulation of radioactivity in the thyroid gland. It is important that you take these tablets or liquid exactly as instructed by your doctor.
Striascan is administered by injection, usually into a vein in the arm. A single injection is sufficient.

Duration of the procedure
Imaging is usually performed between 3 and 6 hours after injection of this medicine.
The nuclear medicine specialist will inform you about the expected duration of the procedure.

After administration of Striascan, you should urinate frequently to help eliminate the product from your body.
The nuclear medicine specialist will inform you of any special precautions to follow after administration of the medicine. Please consult your nuclear medicine specialist if you have any questions.

If you are given more Striascan than you should
Since this medicine is administered by a doctor under strict control, it is unlikely that you will receive an excessive dose. The nuclear medicine specialist will advise you to drink large amounts of fluids to help your body eliminate the medicine. You will need to take special care when urinating; your doctor will give you specific instructions about this. This is a normal procedure with medicines such as Striascan. Any residual ioflupane (¹²³I) remaining in the body will naturally lose its radioactivity over time.

If you have any further questions about the use of this medicine, please consult the nuclear medicine specialist in charge of your examination.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everyone experiences them.
The frequency of side effects is as follows:
Common: may affect up to 1 in 10 people

• Headache

Uncommon: may affect up to 1 in 100 people

• Increased appetite
• Dizziness
• Taste disturbance
• Nausea
• Dry mouth
• Vertigo
• Brief sensation of irritation resembling ants crawling on the skin (tingling)
• Intense pain (or burning sensation) at the injection site. This has been reported in patients in whom the injection of this medicinal product is administered into a small vein. Note: frequency cannot be estimated from the available data.
• Hypersensitivity (allergy)
• Difficulty breathing
• Skin redness
• Itching
• Skin rash
• Hives (urticaria)
• Excessive sweating
• Vomiting
• Low blood pressure
• Feeling of warmth

This radiopharmaceutical will emit small amounts of ionizing radiation, which is associated with a minimal risk of cancer and hereditary abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your nuclear medicine specialist. You may 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 medicinal product.

5. How to store Striascan

You should not store this medicinal product. This medicine is stored under the responsibility of a specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive products.
The following information is intended for specialists only:

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

Do not use this medicinal product after the expiry date stated on the label after "Exp". Hospital staff will ensure that the product is properly stored and disposed of correctly, and that it is not used after the expiry date indicated on the label.

6. Package contents and other information

What Striascan contains

• The active substance is ioflupane ( I). Each mL of solution contains 74 MBq of ioflupane ( I) at the reference date and time.
• The excipients are glacial acetic acid (E 260), sodium acetate trihydrate (E 262), anhydrous ethanol (E 1510), concentrated phosphoric acid (E 338), and water for injections.

Description of the appearance of Striascan and package contents
Striascan is a colourless injectable solution supplied in a single amber glass vial of 15 mL, sealed with a rubber stopper and metal cap.
Pack: 1 vial containing 2.5 mL or 5 mL of solution.
Marketing Authorisation Holder and Manufacturer
CIS bio international
RN 306 – Saclay
F-91192 Gif-sur-Yvette Cedex
FRANCE
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This package leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.
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The following information is intended for healthcare professionals only:
The complete Product Information (SmPC) for Striascan is provided as a separate document at the end of the package leaflet inside the product packaging, intended to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.