74 MBq / ml injection solution
Ioflupane ( 123 I)
1. What DaTSCAN is and what it is used for
DaTSCAN contains the active substance isoflurane ( 123 I) which is used to diagnose conditions in the brain. It belongs to a group of medicines called radiopharmaceuticals, and they contain a small amount of radioactivity.
• When radiopharmaceuticals are injected, the product accumulates briefly in a specific organ or area of the body.
• Because the product contains a small amount of radioactivity, it can be easily tracked using a special camera.
• An image, a so-called scan, can be taken. This scan shows exactly where the radioactivity is inside the organ in question and the body. This can give the doctor valuable information about how that particular organ works.
When DaTSCAN is injected into an adult, it is excreted into the body by the blood. The drug accumulates in a small area of the brain. Changes in this area of the brain occur when:
• Parkinson’s disease and
• Lewy Body dementia.
A scan gives your doctor information about changes in this part of the brain. Your doctor may have good help from a scan when it comes to finding out more about your condition and deciding what treatment to get.
When using DaTSCAN, you are exposed to small amounts of radioactivity. The exposure is less than in certain types of X-ray examination. The doctor and nuclear medicine doctor have judged that the benefit of the examination with the radioactive substance outweighs the risk of being exposed to these small amounts of radiation.
Intended for diagnostics only. The drug is used only to diagnose disease, not for treatment.
2. What you need to know before you receive DaTSCAN
DaTSCAN must not be used
If you are allergic to ioflupane or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant
Warnings and cautions
Talk to your isotope physician before receiving DaTSCAN if you have moderate or severe kidney or liver problems.
Children and young people
DaTSCAN is not recommended for children aged 0 to 18 years.
Other medicines and DaTSCAN
Tell your nuclear medicine doctor if you are taking or have recently taken any other medicines. There are some medications or substances that may affect the way DaTSCAN works.
These include:
Buproprion (used to treat depression)
• benzatropine (used to treat Parkinson’s disease )
• mazindol (reduces appetite as a way to treat obesity)
• sertraline (used to treat depression)
Methylphenidate (used to treat hyperactivity in children and narcolepsy (abnormal daytime sleepiness))
• phentermine (reduces appetite as a way to treat obesity)
• amphetamine (used to treat hyperactivity in children and narcolepsy (abnormal daytime sleepiness), also an addictive drug)
• cocaine (sometimes used as an anesthetic for nasal surgery, also an addictive drug).
Some medications can impair the quality of the image you get. Your doctor may ask you to stop taking such medicines for a short time before you receive DaTSCAN.
Pregnancy and breastfeeding
Do not use DaTSCAN if you are pregnant or think you may be. This is because the child may be exposed to some radioactivity. Tell your isotope doctor if there is a possibility that you are pregnant. Alternative methods that do not contain radioactivity should be considered.
If you are breast-feeding, the isotope doctor may postpone the examination with DaTSCAN or ask you to stop breast-feeding. It is not known whether ioflupane ( 123 I) is excreted in human milk.
• You should not breast-feed your baby for 3 days after receiving DaTSCAN.
• Use breast milk substitute for your baby instead. Pump out the breast milk at regular intervals and discard all pumped milk.
• You will need to continue doing this for 3 days until you no longer have any radioactivity left in your body.
Driving and using machines
DaTSCAN has no known effect on the ability to drive or use machines.
DaTSCAN contains alcohol ( ethanol ) 5% by volume. Each dose contains up to 197 mg of alcohol. This is about the same as in 5 ml of beer or 2 ml of wine. It is harmful to people suffering from alcoholism and this should be considered for pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy. Tell your doctor if any of these apply to you.
3. How to use DaTSCAN
The use, handling, and disposal of radioactive materials are subject to strict legislation. DaTSCAN is always used in hospitals or other healthcare facilities. It may only be handled and given by persons who are competent to use it safely. The staff will tell you everything you need to know for the safe use of the medicine. The isotope doctor will decide which dose is best for you.
Before receiving DaTSCAN, your isotope doctor will ask you to take tablets or oral solutions containing iodine. This prevents radioactivity from accumulating in the thyroid gland. You must take the tablets or oral solution according to your doctor’s instructions.
DaTSCAN is given as an injection, usually into a vein in the arm. The recommended radioactivity given by injection is between 111 and 185 MBq (mega becquerel or MBq is a device used to measure radioactivity). A single injection is enough. Imaging usually takes place 3–6 hours after injection of DaTSCAN.
If you take more DaTSCAN then you should
Because DaTSCAN is given by a doctor under controlled conditions, it is unlikely that the drug will have overdosed. The isotope doctor will suggest that you drink plenty of fluids to help your body get rid of the medicine. When urinating, you need to take special care with your urine – your doctor will tell you how to do it. This is routine when using DaTSCAN-type drugs. The ioflupane ( 123 I) that may remain in your body loses its radioactivity naturally (by itself).
If you have any further questions on the use of this product, ask your doctor.
4. Possible side effects
Like all medicines, DaTSCAN can cause side effects, although not everybody gets them. The frequency of side effects is:
Common: may affect up to 1 in 10 users
– Headache
Uncommon: may affect up to 1 in 100 people
– Increased appetite
– Dizziness, scams
– Taste changes
– Nausea
– Dry mouth
– A short-lived, irritating feeling of ants crawling on the skin (and crawls)
– Intense pain (or burning sensation) at the injection site. This has been reported in patients receiving DaTSCAN in a small vein
No known frequency: the frequency can not be calculated from the available data.
– Hypersensitivity ( allergy )
– Shortness of breath
– Redness of the skin
– Itching
– Rash
– hives ( urticaria )
– Excessive sweating
Vomiting
– Low blood pressure
– Feeling of warmth
The amount of radioactivity added to the body by DaTSCAN is very small. It disappears from the body within a few days without you having to take any special precautions.
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
Läkemedelsverket
Box 26
751 03 Uppsala
www.lakemedelsverket.se
5. How to store DaTSCAN
You do not need to store this medicine yourself. The isotope physician is responsible for storing the medicine in a suitable place. Storage of radiopharmaceuticals takes place by national rules on radioactive materials.
The following information is intended for isotope physicians only:
• Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
• Do not freeze.
Use this medicine before the expiry date which is stated on the carton and bottle after EXP. The expiration date is the last day of the specified month. The hospital staff ensures that the product is stored and disposed of correctly and that it is not used after the expiry date on the label.
6. Contents of the packaging and other information
Content declaration
- The active substance is ioflupane ( 123 L ). One ml solution contains ioflupane ( 123L) 74MBq at the reference time (0.07 to 0.13 μg / ml ioflupane).
- The other ingredients are acetic acid, sodium acetate, ethanol, and water for injections.
What the medicine looks like and the contents of the pack
DaTSCAN is a 2.5 or 5 ml colorless solution for injection delivered in a colorless 10 ml glass vial, sealed with a rubber stopper, and sealed with a metal cap.
Marketing Authorization Holder and Manufacturer
GE Healthcare BV
The Dolch 2
NL-5612 AZ, Eindhoven
Netherlands
Further information on this medicine can be obtained from the representative of the marketing authorization holder.