Celsunax - patient leaflet, side effects, dosage

Patient leaflet - Celsunax

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Celsunax 74 MBq/mL solution for injection Ioflupane (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, ask your nuclear medicine doctor who will supervise the procedure.
– If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Celsunax is and what it is used for

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

Celsunax 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 Celsunax 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 Celsunax 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.

2. What you need to know before Celsunax is used

Celsunax 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 this medicine if you have a moderate or severe problem with your kidneys or liver.

Before you are given Celsunax you should drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the study.

Children and adolescents

Celsunax is not recommended for children and adolescents below 18 years.

Other medicines and Celsunax

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 this medicine 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 substance of abuse),
– cocaine (sometimes used as an anaesthetic for nose surgery; also a substance 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 Celsunax.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given this medicine.

Do not use Celsunax if you are pregnant or think you may possibly be pregnant. This is because the child may receive some of the radioactivity. Alternative techniques which do not involve radioactivity should be considered.

If you are breast-feeding, your nuclear medicine doctor may delay the use of Celsunax, 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 Celsunax 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

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

Celsunax contains alcohol (ethanol): up to 197 mg of alcohol in each dose which is equivalent to

3 9.5 mg/mL (5% by volume). The amount in 5 mL of this medicine is equivalent to 5 mL beer or 2 mL wine. The small amount of alcohol in this medicine will not have any noticeable effects.

3. How Celsunax is used

There are strict laws on the use, handling and disposal of radiopharmaceutical medicines. Celsunax 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 which dose of Celsunax is best for you. It will be the smallest quantity necessary to get the desired information.

Before you receive Celsunax, 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.

Administration of Celsunax and conduct of the procedure

Celsunax is given to you as an injection, usually into a vein in your arm. The recommended radioactivity given by injection is between 110 to 185 MBq (megabequerel or MBq is a unit used to measure radioactivity). A single injection is enough.

Duration of the procedure

The camera pictures are usually taken 3 to 6 hours after the injection of this medicine. Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of Celsunax , you should urinate frequently in order to eliminate the medicine from your body.

The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor, if you have any questions.

If you are given more Celsunax than you should

Since Celsunax 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 Celsunax. 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, this medicine 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 Celsunax 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 Celsunax is very small. This low amount of ionising radiation is associated with the least risk of cancer and hereditary abnormalities. 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 By reporting side effects you can help provide more information on the safety of this medicine.

5. How Celsunax 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. Hospital staff will ensure that the product is stored and thrown away correctly and not used after the expiry date stated on the label.

The following information is intended for the specialist only:

– Keep this medicine out of the sight and reach of children.
– Do not use this medicine after the expiry date, which is stated on the carton and vial after EXP and is 24 hours from the end of the synthesis (EOS) time stated on the label.
– Do not store above 25 °C.
– Do not freeze.
– Store in the original lead shielding. Store in accordance with national regulation on radioactive materials.

6. Contents of the pack and other information

What Celsunax contains

– The active substance is ioflupane (123I). Each mL of solution contains 74 MBq of ioflupane (123I) at reference time (0.07 to 0.13 qg/mL of ioflupane).

What Celsunax looks like and contents of the pack

Celsunax is a 2.5 or 5 mL colourless solution for injection, supplied in a 10 mL glass vial (Type I) with a rubber stopper and a flip cap.

Marketing Authorisation Holder

Pinax Pharma GmbH

Lausitz Mühlenweg 5

04924 Bad Liebenwerda

Germany

Manufacturer

Seibersdorf Labor GmbH

Grundstück Nr. 482/2 EZ 98 KG

2444 Seibersdorf

Austria

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

CLINICAL PARTICULARS

4.1 Therapeutic indications

This medicinal product is for diagnostic use only.

Celsunax is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:

– In adult patients with clinically uncertain parkinsonian syndromes, for example those with early symptoms, in order to help differentiate essential tremor from parkinsonian syndromes related to idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy. Celsunax is unable to discriminate between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy.

– In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer’s disease.

Celsunax is unable to discriminate between dementia with Lewy bodies and Parkinson’s disease dementia.

4.2 Posology and method of administration

Prior to administration appropriate resuscitation equipment should be available.

Celsunax should only be used in adult patients referred by physicians experienced in the management of movement disorders and/or dementia. Celsunax should only be used by qualified personnel with the

appropriate government authorisation for the use and manipulation of radionuclides within a designated