StriAscan 74 MBq/ml solution for injection EFG
SpainTable of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Striascan 74 MBq/ml solution for injection EFG
ioflupano (123I)
Read all of 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 further questions, consult your nuclear medicine physician who will supervise the procedure.
- If you experience any side effects, talk to your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.
Leaflet Contents
- What Striascan is and what it is used for
- What you need to know before being given Striascan
- How Striascan is given
- Possible side effects
- How to store Striascan
- Contents of the pack and other information
1. What Striascan is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
Striascan contains the active substance ioflupane (123I), which is used to help identify (diagnose) brain disorders. It belongs to a group of medicines called "radiopharmaceuticals", which contain a small amount of radioactivity.
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When a radiopharmaceutical is injected, it accumulates in a specific organ or area of the body for a short period of time.
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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.
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An image, known as a scintigram, can then be obtained. This scintigram will show exactly how the radiopharmaceutical is distributed in a particular organ and in the body. This can provide the doctor with valuable information about the structure and function of that organ.
Striascan is used solely to identify disease. When this medicine is injected into a patient, it travels through 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
- Dementia with Lewy bodies.
The resulting 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 condition and decide on appropriate treatment options.
When Striascan is used, you are exposed to small amounts of radiation. This exposure is lower than that of some types of X-ray examinations. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the radiopharmaceutical procedure outweighs the risk of exposure to small amounts of radiation.
2. What you need to know before using Striascan
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 your nuclear medicine physician before using Striascan if you have moderate or severe kidney or liver problems.
Before administration of Striascan you must:
drink plenty of water before the procedure and urinate as frequently as possible during the first 48 hours after the procedure.
Children and adolescents
Striascan is not recommended for children and adolescents aged 0 to 18 years.
Other medicines and Striascan
Inform your nuclear medicine physician if you are taking, have recently taken, or might take any other medicines.
Some medicines or substances may affect how this medicine works.
These medicines include:
- bupropion (used to treat depression or to help 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 as a treatment for obesity)
- amphetamine
- cocaine (sometimes used as an anesthetic 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 images obtained. Your physician may ask you to stop taking them for a short period before receiving Striascan.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your nuclear medicine physician before receiving this medicine.
You must inform the nuclear medicine physician before administration of Striascan if there is any possibility you could be pregnant, if you have missed a period, or if you are breastfeeding. If in doubt, it is important to consult your nuclear medicine physician, who will supervise the procedure.
If you are pregnant, do not use Striascan. This is because the unborn child may be exposed to radiation. Alternative techniques that do not involve radiation should be considered.
If you are breastfeeding, your nuclear medicine physician may delay the use of this product or advise you to stop breastfeeding. It is not known whether ioflupane (123I) passes into breast milk.
- You must not breastfeed your child for 3 days after receiving this product.
- Use infant formula to feed your child. Express breast milk regularly and discard it.
- You must do this for 3 days, until there is no radioactivity remaining in your body.
Driving and using machines
Striascan is considered unlikely to 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 medicine is equivalent to 5 ml of beer or 2 ml of wine. The small amount of alcohol present in this medicine will not have any noticeable effect.
This medicine contains less than 1 mmol of sodium (23 mg) per vial; i.e., essentially “sodium-free”.
3. How to use Striascan
There are strict regulations regarding the use, handling, and disposal of radioactive materials. Striascan will always be used in a hospital or similar facility. It will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will inform you about what you need to do to ensure the safe use of this medicine.
The nuclear medicine physician supervising the procedure will determine the amount of Striascan to be used in your case, which will be the minimum necessary to obtain the required information.
The amount generally recommended for administration in an adult is 110 to 185 MBq (megabecquerel or MBq, the unit used to express radioactivity).
Administration of Striascan and performance of the procedure
Before you receive Striascan, your nuclear medicine physician will ask you to take certain tablets or liquids containing iodine. This helps prevent the accumulation of radioactivity in your thyroid gland. It is important that you take the tablets or liquids as directed by your physician.
Striascan is administered as an injection, usually into a vein in the arm. A single injection is sufficient.
Duration of the procedure
Images taken with the camera are typically acquired between 3 and 6 hours after injection of this product. Your nuclear medicine physician will inform you about the usual duration of the procedure.
After administration of Striascan, you should urinate frequently to help eliminate the product from your body.
The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicine. Please consult your nuclear medicine physician if you have any questions.
If you are given more Striascan than you should
Since this product is administered by a physician under strictly controlled conditions, it is unlikely that you will receive an overdose. Your nuclear medicine physician will recommend that you drink plenty of fluids to help eliminate the medicine from your body. You will need to take care with your urine: the physician will tell you what you need to do. This is standard practice with medicines such as Striascan. Any residual ioflupane (123I) remaining in your body will naturally lose its radioactivity over time.
If you have any further questions about the use of this medicine, ask your supervising nuclear medicine physician.
4. Possible adverse effects
Like all medicines, this medicinal product can produce adverse effects, although not everyone experiences them.
The frequency of adverse effects is:
Frequent: may affect up to 1 in 10 people
- Headache
Uncommon: may affect up to 1 in 100 people
- Increased appetite
- Dizziness
- Disturbance of taste sensation
- Nausea
- Dry mouth
- Vertigo
- A brief sensation of irritation similar to ants crawling on the skin (tingling)
- Severe pain (or burning sensation) at the injection site. This has been reported among patients who received this product in a small vein
Frequency not known: cannot be estimated from the available data
- Hypersensitivity (allergic)
- Shortness of breath
- Skin redness
- Itching
- Rash
- Skin hives (urticaria)
- Excessive sweating
- Vomiting
- Low blood pressure
- Feeling of warmth
Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.
Reporting of adverse effects
If you experience any type of adverse effect, consult your nuclear medicine physician, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V.
By reporting adverse effects, you can help provide more information on the safety of this medicinal product.
5. Storage of Striascan
You will not be required to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will comply with national regulations concerning radioactive materials.
The following information is intended for specialists only:
- 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 properly stored and disposed of, and that it is not used beyond the expiry date indicated on the label.
6. Contents of the pack and other information
Composition of Striascan
- The active substance 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 injections.
Appearance of the product and contents of the pack
Striascan is a colourless 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 Authorisation Holder and Manufacturer
CIS bio international
RN 306 – Saclay
B.P. 32
F-91192 Gif-sur-Yvette Cedex
FRANCE
Date of the most recent revision of this leaflet: 02/10/2024.
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
This leaflet is available on the European Medicines Agency website in all languages of the European Union/European Economic Area.
This information is intended for healthcare professionals only:
The complete Summary of Product Characteristics for Striascan is provided as a separate document within the product packaging, intended to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please consult the Summary of Product Characteristics.