DaTSCAN - patient leaflet, side effects, dosage

1. What DaTSCAN is and what it is used for

DaTSCAN contains the active substance ioflupane (123I) which is used to help identify (diagnose) conditions 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 collects in a specific organ or area of the body for a short time.
• Because it contains a small amount of radioactivity it can be detected from outside the body using

special cameras.

• A picture, known as a scan, can be taken. This scan will show exactly where the radioactivity is inside the organ and the body. This can give the doctor valuable information about how that organ is working.

When DaTSCAN is injected into an adult, it is carried around the body in the blood. It collects in a small area of your brain. Changes in this area of the brain occur in:

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

A scan will give your doctor information about any changes in this area of your brain. Your doctor may feel that the scan would help in finding out more about your condition and deciding on possible treatment.

When DaTSCAN is used, you are exposed to small amounts of radioactivity. This exposure is less than in some types of X-ray investigation. Your doctor and the nuclear medicine doctor have considered that the clinical benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to these small amounts of radiation.

This medicine is used for diagnostic use only. It is used only to identify illness.

2. What you need to know before DaTSCAN is used

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 precautions

Talk to your nuclear medicine doctor before using DaTSCAN if you have a moderate or severe problem with your kidneys or liver.

Children and adolescents

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.

Some medicines or substances can affect the way that DaTSCAN works.

These include:

• buproprion (used to treat depression (sadness))
• benzatropine (used to treat Parkinson’s di­sease)
• mazindol (reduces appetite, as a means to treat obesity)
• sertraline (used to treat depression (sadness))
• methylphenidate (used to treat hyperactivity in children and narcolepsy (excessive sleepiness))
• phentermine (reduces appetite, as a means to treat obesity)
• amfetamine (used to treat hyperactivity in children and narcolepsy (excessive sleepiness); also a drug of abuse)
• cocaine (sometimes used as an anaesthetic for nose surgery; also a drug of abuse)

Some medicines may reduce the quality of the picture obtained. The doctor may ask you to stop taking them for a short time before you receive DaTSCAN.

Pregnancy and breast-feeding

Do not use DaTSCAN if you are pregnant or think you may possibly be pregnant. This is because the child may receive some of the radioactivity. Tell your nuclear medicine doctor if you think you might be pregnant. Alternative techniques which do not involve radioactivity should be considered.

If you are breast-feeding, your nuclear medicine doctor may delay the use of DaTSCAN, or ask you to stop breast-feeding. It is not known whether ioflupane (123I) is passed into breast milk.

• You should not breast-feed your child for 3 days after DaTSCAN is given.
• Instead use formula feed for your child. Express your breast milk regularly and throw away any

breast milk you have expressed.

• You will need to continue to do this for 3 days, until the radioactivity is no longer in your body.

Driving and using machines

DaTSCAN has no known influence on the ability to drive and use machines.

DaTSCAN contains alcohol (ethanol) 5 % by volume. Each dose contains up to 197 mg alcohol. This is about the same as 5 ml beer, or 2 ml wine. This is harmful for those suffering from alcoholism and needs to be taken into account in 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 DaTSCAN is used

There are strict laws on the use, handling and disposal of radioactivity. DaTSCAN will always be used in a hospital or a similar place. It will only be handled and given to you by people who are trained and qualified to use it safely. They should tell you anything you need to do for the safe use of this medicine. Your nuclear medicine doctor will decide the dose that is best for you.

Before you receive DaTSCAN, your nuclear medicine doctor will ask you to take some tablets or liquid that contain iodine. These stop the radioactivity building-up in your thyroid gland. It is important that you take the tablets or liquid as the doctor tells you.

DaTSCAN is given to you as an injection, usually into a vein in your arm. The recommended radioactivity given by injection is between 111 to 185 MBq (megabequerel or MBq is a unit used to measure radioactivity). A single injection is enough. The camera pictures are usually taken 3 to 6 hours after the injection of DaTSCAN.

If you are given more DaTSCAN than you should

Since DaTSCAN is given by a doctor under controlled conditions, it is unlikely that you will get an overdose. Your nuclear medicine doctor will suggest that you drink plenty of fluids to help the body get rid of the medicine. You will need to be careful with the water (urine) that you pass – your doctor will tell you what to do. This is normal practice with medicines like DaTSCAN. Any ioflupane (123I) which remains in your body will naturally lose its radioactivity.

If you have any further questions on the use of this medicine, ask your nuclear medicine doctor who supervises the procedure.

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 people

• – Headache

Uncommon: may affect up to 1 in 100 people

• – Increased appetite

• – Dizziness

• – Taste disturbance

• – Nausea

• – Dry mouth

• – Vertigo

• – A brief irritating feeling similar to ants crawling over your skin (formication)

• – Intense pain (or burning sensation) at the injection site. This has been reported among patients receiving DaTSCAN into a small vein.

Not known: frequency cannot be estimated from the available data.

• - Hypersensitivity (allergic)

• – Shortness of breath

• – Redness of the skin

• – Itching

• – Rash

• – Hives (urticaria)

• – Excessive sweating

• – Vomiting

• – Low blood pressure

• – Feeling hot

The amount of radioactivity in the body from DaTSCAN is very small. It will be passed out of the body in a few days without need for you to take special precautions.

Reporting of side effects

If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

• 5. How DaTSCAN is stored

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmace­uticals will be in accordance with national regulation on radioactive materials.

The following information is intended for the specialist only:

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C.
• Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month. Hospital staff will ensure that the product is stored and thrown away correctly and not used after the expiry date stated on the label.

6. Contents of the pack and other information

What DaTSCAN contains

• The active substance is ioflupane (123I). Each ml of solution contains ioflupane (123I) 74 MBq at reference time (0.07 to 0.13 ^g/ml of ioflupane).
• The other ingredients are acetic acid, sodium acetate, ethanol and water for injections.

What DaTSCAN looks like and contents of the pack

DaTSCAN is a 2.5 or 5 ml colourless solution for injection, supplied in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal.

Marketing Authorisation Holder and Manufacturer

GE Healthcare B.V.

De Rondom 8

5612 AP, Eindhoven

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Česká republika M.G.P. spol. s r.o. Tel.: +420 577 212 140	Magyarország Radizone Diagnost-X Kft. Tel: +36 1 787–5720
Danmark GE Healthcare A/S Tlf: +45 70 2222 03	Malta Pharma-Cos Ltd. Tel: + 356 22266300
Deutschland GE Healthcare Buchler GmbH & Co. KG Tel: +49 (0) 5 307 93 00	Nederland GE Healthcare B.V. Tel: +31 (0) 40 299 10 00
Eesti GE Healthcare Estonia OÜ Tel: +372 6260 061	Norge GE Healthcare AS Tlf: +47 23 18 50 50
EXÀàôa GE Healthcare A.E. Tql: +30 210 8930600	Österreich GE Healthcare Handels GmbH Tel: +43 (0) 1 97272–0
España GE Healthcare Bio-Sciences, S.A.U Tel: +34 91 663 25 00	Polska GE Medical Systems Polska Sp. z o.o. Tel: +4822 330 83 00
France GE Healthcare SAS Tél: +33 1 34 49 54 54	Portugal Satis – GE Healthcare Tel: +351 214251352
Hrvatska BIOVIT d.o.o. Tel: + 385 42 260 001	România MagnaPharm Marketing & Sales Romania S.R.L. Tel: + 40 372 502 221
Ireland GE Healthcare Limited UK Tel: +44 (0) 1494 54 5306	Slovenija Biomedis M.B. trgovina d.o.o. Tel: +386 2 4716300
Ísland Icepharma Sími: + 354 540 8000	Slovenská republika MGP, spol. s r. o. Tel: +421 2 5465 4841
Italia GE Healthcare S.r.l. Tel: +39 02 26001 111	Suomi/Finland Oy GE Healthcare Bio-Sciences Ab Puh/Tel: +358 10 39411
Kùnpoç Phadisco Ltd Tql: +357 22 715000	Sverige GE Healthcare AB Tel: +46 (0) 8 559 504 00
Latvija General Electric International Inc. Tel: +371 6780 7086	United Kingdom (Northern Ireland) GE Healthcare Limited Tel: +44(0)1494 54 5306

This leaflet was last revised in <{MM/YYYY}

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

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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