Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - celsunax

Document Subject

Generated Narrative: MedicinalProductDefinition mpf364d278d54ddbe0f130b25e10418f63

identifier: http://ema.europa.eu/identifier/EU/1/21/1560/001 (2.5 mL)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Celsunax 74 MBq/mL solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f364d278d54ddbe0f130b25e10418f63

identifier: http://ema.europa.eu/identifier/EU/1/21/1560/001 (2.5 mL)

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - celsunax

Attesters

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

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.

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 39.5 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.

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.

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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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 g/mL of ioflupane). Each 2.5 mL single dose vial contains 185 MBq ioflupane (123I) (specific activity range 2.5 to 4.5 x 1014 Bq/mmol) at reference time. Each 5 mL single dose vial contains 370 MBq ioflupane (123I) (specific activity range 2.5 to 4.5 x 1014 Bq/mmol) at reference time. Iodine-123 has a physical half-life of 13.2 hours. It decays emitting gamma radiation with a predominant energy of 159 keV and X-rays of 27 keV.
• The other ingredients are acetic acid, glacial (E260), sodium acetate trihydrate (E262), ethanol (96%) (E1510) and water for injections.

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 M hlenweg 5 04924 Bad Liebenwerda Germany

Manufacturer Seibersdorf Labor GmbH Grundst ck 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: http://www.ema.europa.eu.