Ioflupane (123i) Rotop

Leaflet attached to the packaging: Patient Information

Ioflupane (I) ROTOP, 74 MBq/ml, solution for injection

Ioflupane (I)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult the nuclear medicine doctor who will supervise the procedure.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the nuclear medicine doctor. See section 4.

Table of contents of the leaflet:

• 1. What is Ioflupane (I) ROTOP and what is it used for
• 2. Important information before using Ioflupane (I) ROTOP
• 3. How to use Ioflupane (I) ROTOP
• 4. Possible side effects
• 5. How to store Ioflupane (I) ROTOP
• 6. Contents of the packaging and other information

1. What is Ioflupane (I) ROTOP and what is it used for

This medicine is a radiopharmaceutical product intended for diagnostic use only.
Ioflupane (I) ROTOP contains the active substance ioflupane (I), used to facilitate the diagnosis of certain brain diseases. The medicine belongs to a group of substances with low radioactivity, known as radiopharmaceuticals.

• After injection, this radiopharmaceutical accumulates in specific organs or areas of the body for a short time.
• Since it contains a small amount of radioactive substance, it can be detected from outside the body using special cameras.
• A picture, called a "scan", can be taken. The scan shows the exact location of radioactivity within the organ and body. This allows the doctor to obtain valuable information about the functioning of the organ. After injection into an adult patient, Ioflupane (I) ROTOP is distributed throughout the body with the blood. It accumulates in a small area of the brain. Changes in this brain area occur in the following disorders:
• Parkinson's disease (including Parkinson's disease) and
• Lewy body dementia.

The scan will provide the doctor with information about any changes in this brain area of the patient.
The treating doctor may find that the information obtained from the scan will be helpful in better understanding the patient's disease and in making decisions about possible treatment.
After taking Ioflupane (I) ROTOP, the patient is exposed to a small dose of radiation.
This dose is smaller than that used in some X-ray examinations. The patient's treating doctor and the nuclear medicine doctor have determined that the benefits of this examination using a radiopharmaceutical outweigh the risk of exposure to these small amounts of radiation.

2. Important information before using Ioflupane (I) ROTOP

When not to use Ioflupane (I) ROTOP

Warnings and precautions

Before starting treatment with Ioflupane (I) ROTOP, discuss with the nuclear medicine doctor if the patient has moderate or severe kidney or liver disease.

Before taking Ioflupane (I) ROTOP and starting the examination, the patient should

drink a large amount of water to urinate as frequently as possible during the first hours after the examination.

Children and adolescents

Ioflupane (I) ROTOP should not be given to children from 0 to 18 years of age.

Ioflupane (I) ROTOP and other medicines

Tell the nuclear medicine doctor about all medicines the patient is taking or has recently taken. Some medicines or substances may affect the action of this medicine. These include:

• bupropion (used to treat depression),
• benzatropine (used to treat Parkinson's disease),
• mazindol (reduces appetite, used to treat obesity),
• sertraline (used to treat depression),
• methylphenidate (used to treat hyperactivity in children and narcolepsy),
• phentermine (reduces appetite, used to treat obesity),
• amphetamine (used to treat hyperactivity in children and narcolepsy; also an illegal psychoactive substance),
• cocaine (sometimes used as an anesthetic before nose surgery; also an illegal psychoactive substance).

Some medicines may worsen the quality of the images obtained. The doctor may advise the patient to stop taking such medicines shortly before taking Ioflupane (I) ROTOP.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult the nuclear medicine doctor before taking this medicine.
If there is a possibility that the patient is pregnant, if her menstrual bleeding is delayed, or if she is breastfeeding, she should inform the nuclear medicine doctor before taking Ioflupane (I) ROTOP.
In case of doubts, consult the nuclear medicine doctor who will supervise the examination.
If the patient is pregnant, Ioflupane (I) ROTOP should not be used. Otherwise, the child may receive a certain dose of radioactivity. Other techniques that do not use ionizing radiation should be considered.
If the patient is breastfeeding, the nuclear medicine doctor may delay the use of Ioflupane (I) ROTOP or advise the patient to stop breastfeeding. It is not known whether ioflupane (I) passes into breast milk.

• The patient should not breastfeed for 3 days after taking Ioflupane (I) ROTOP.
• During this time, the baby should be fed with a milk substitute. Breast milk should be expressed and discarded at regular intervals.
• This should be continued for 3 days, until there is no longer any radioactivity in the patient's body.

Driving and using machines

The effect of Ioflupane (I) ROTOP on the ability to drive and use machines is not known.
Ioflupane (I) ROTOP contains4% v/v alcohol (ethanol).
This medicine contains up to 158 mg of alcohol per dose. The amount of alcohol in a dose of this medicine is equivalent to less than 4 ml of beer or 1.6 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
The medicine containsless than 1 mmol (23 mg) of sodium per vial, which means that the medicine is considered "sodium-free".

3. How to use Ioflupane (I) ROTOP

There are strict regulations regarding the use, transfer, and disposal of radiopharmaceutical products. Ioflupane (I) ROTOP will always be used in a hospital or similar facility. This medicine will be prepared and administered to patients only by personnel who are properly trained and authorized to use it safely. These personnel will tell the patient everything they need to do to use this medicine safely.
The nuclear medicine doctor supervising the examination will determine the dose of Ioflupane (I) ROTOP suitable for the patient. This will be the smallest dose necessary to obtain the necessary information.
Before taking Ioflupane (I) ROTOP, the doctor will advise the patient to take tablets or a liquid containing iodine. This will prevent the accumulation of radioactivity in the thyroid gland. It is essential to take the tablets or liquid exactly as advised by the doctor.

Administration of Ioflupane (I) ROTOP and performance of the examination

Ioflupane (I) ROTOP is administered by injection, usually into a vein in the arm. The recommended dose for adults is between 111 and 185 MBq (MBq = megabecquerel, a unit of measurement of radioactivity). One injection is sufficient.

Duration of the examination

A scan using a special camera is usually performed 3 to 6 hours after injection of Ioflupane (I) ROTOP.
The nuclear medicine doctor will inform the patient about the usual duration of the examination.
After taking Ioflupane (I) ROTOP, the patient shouldurinate frequently to quickly remove the medicine from the body.
The nuclear medicine doctor will inform the patient if any special precautions are necessary after receiving this medicine. If the patient has any questions, they should consult the nuclear medicine doctor.

Use of a higher than recommended dose of Ioflupane (I) ROTOP

Since Ioflupane (I) ROTOP is administered by a doctor in controlled conditions, it is unlikely that the patient will receive too high a dose. The nuclear medicine doctor will advise the patient to drink plenty of fluids to facilitate the removal of the medicine from the body. During urination, it will be necessary to take appropriate precautions - the doctor will advise what to do. This is standard practice for the use of medicines such as Ioflupane (I) ROTOP.
Any remaining Ioflupane (I) ROTOP in the patient's body will lose its radioactivity on its own.
If the patient has any further doubts about the use of this medicine, they should consult the nuclear medicine doctor supervising the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is as follows:
Common: may affect up to 1 in 10 people

• headache

Uncommon: may affect up to 1 in 100 people

• increased appetite
• dizziness
• taste disorders
• nausea
• dry mouth
• feeling of spinning
• short-term irritating sensation of tingling
• severe pain (or burning sensation) at the injection site. This side effect has been observed in patients who received Ioflupane (I) ROTOP into a small vein.

Frequency not known (frequency cannot be estimated from the available data)

• hypersensitivity (allergy)
• shortness of breath
• redness of the skin
• itching
• rash
• hives
• excessive sweating
• vomiting
• low blood pressure
• feeling of heat.

This radiopharmaceutical product delivers a small amount of ionizing radiation, which is associated with a very small risk of cancer and congenital anomalies.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, tell the nuclear medicine doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of this medicine.

5. How to store Ioflupane (I) ROTOP

The patient will not store this medicine. This medicine will be stored by medical personnel in appropriate facilities. Radiopharmaceutical products are stored in accordance with local regulations regarding radioactive substances.
The following information is intended only for medical personnel.
Do not use this medicine after the expiry date stated on the label.
Hospital personnel will ensure proper storage and disposal of the product and will not use it after the expiry date stated on the label.

6. Contents of the packaging and other information

What Ioflupane (I) ROTOP contains

• The active substance of the medicine is ioflupane (I). Each milliliter of solution contains 74 MBq of ioflupane (I) on the date and time of reference (from 0.07 to 0.13 μg/ml of ioflupane).
• The other ingredients are: glacial acetic acid, sodium acetate trihydrate, anhydrous ethanol, and water for injections.

What Ioflupane (I) ROTOP looks like and contents of the pack

Ioflupane (I) ROTOP is a colorless solution for injection. 2.5 ml or 5 ml of this solution is supplied in a 10 ml glass vial of type I, with a rubber stopper of type I, with an aluminum flip-off cap, in a lead container.

Marketing authorization holder and manufacturer

ROTOP Radiopharmacy GmbH
Bautzner Landstrasse 400
01328 Dresden
Germany
Phone:
+49 (0)351 26 31 01 00
Fax:
+49 (0)351 26 31 03 03
Email:
[email protected]

Date of last revision of the leaflet: 03/2023

Information intended only for medical personnel:
The full Summary of Product Characteristics (SPC) of Ioflupane (I) ROTOP is provided in the form of a detachable part at the end of the printed leaflet attached to the product packaging, in order to provide medical personnel with additional scientific and practical information on the administration and use of this radiopharmaceutical product. See SPC.