Itrapol

Package Leaflet: Information for the User

ItraPol, Radiopharmaceutical Precursor, Solution

Yttrium (Y) Chloride

Read the package leaflet carefully before using 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 a nuclear medicine specialist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, inform the nuclear medicine specialist. See section 4.

Table of Contents of the Leaflet

What is ItraPol and what is it used for
Important information before using ItraPol
How to use ItraPol
Possible side effects
How to store ItraPol
Contents of the pack and other information

1. What is ItraPol and what is it used for

ItraPol is a radiopharmaceutical product intended for therapy only after combination with another medicinal product that targets specific cells in the body. After reaching the target, small doses of ionizing radiation from the ItraPol product are delivered to these cells.
More information on the use and possible side effects of the medicinal product labeled with Yttrium (Y) is available in the package leaflet of the specific medicinal product intended for labeling.

2. Important information before using ItraPol

When not to use ItraPol:

if the patient is allergic to Yttrium (Y) chloride or any of the other ingredients of this product (listed in section 6);
if the patient is pregnant or suspected to be pregnant (see below)
if the patient is breastfeeding.

Warnings and precautions

ItraPol is a radiopharmaceutical product used only in combination with another medicinal product.
It is not intended for direct administration to patients.

Children and adolescents

Special precautions should be taken when administering radiopharmaceutical products to children and adolescents (aged 2 to 16).

ItraPol and other medicines

Inform the nuclear medicine specialist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions between Yttrium (Y) chloride and other medicines are known, as no clinical trial results are available.

Pregnancy and breastfeeding

The radiopharmaceutical product ItraPol is contraindicated during pregnancy.
Before administration, inform the nuclear medicine specialist if:

• pregnancy is suspected in the patient,
• menstruation has not occurred at the expected time,
• the patient is breastfeeding. In case of doubts, consult a nuclear medicine specialist.

The doctor will consider an alternative therapy that does not involve ionizing radiation.
Women of childbearing age must use effective contraception during and for a short period after treatment.
In case of breastfeeding and the need for radiopharmaceutical administration, the doctor will recommend stopping breastfeeding.

Before using any medicine, consult a nuclear medicine specialist.

Driving and using machines

No data available.

2. How to use ItraPol

Radiopharmaceutical products can only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceutical products. ItraPol is used only in appropriate clinical conditions and only by qualified personnel. These personnel will take special precautions to ensure safe use of the product and will keep the patient informed about their actions.

The doctor does not administer ItraPol directly to the patient.

Dose

The nuclear medicine specialist decides on the dose of ItraPol to be used for a specific patient. This will be the minimum dose necessary to achieve the expected therapeutic effect.

Method of administration

ItraPol is a radiopharmaceutical product used only in combination with another medicinal product that targets specific cells in the body and is administered by a doctor.
ItraPol is intended for labeling medicinal products that are subsequently administered to the patient by a specific route for the treatment of specific diseases.

Using a higher dose of ItraPol than recommended

Overdose is practically impossible, as the dose of the product administered to the patient is strictly controlled by the nuclear medicine specialist. However, in case of overdose, the doctor will use appropriate treatment.
In case of any further doubts about the use of this medicine, consult a nuclear medicine specialist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Exposure to ionizing radiation may lead to increased cancer incidence (in the case of high radioisotope activities) or genetic defects.
More information on possible side effects caused by the administration of the medicinal product labeled with Yttrium (Y) is available in the package leaflet of the specific medicinal product intended for labeling.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, inform the doctor or pharmacist. 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
02-222 Warsaw
tel. +48 22 492-13-01,
fax +48 22 492-13-09
e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store ItraPol

The patient will not need to store this medicinal product.
Radiopharmaceutical products are stored only by authorized personnel in appropriate clinical conditions. Storage of radiopharmaceuticals is carried out in accordance with local regulations regarding radioactive substances.
The following information is intended only for medical personnel.
The medicine should be stored out of sight and reach of children.
Do not use the product after the expiry date stated on the packaging.

6. Contents of the pack and other information

What ItraPol contains

The active substance of the product is Yttrium (Y) chloride.
The vial contains, on a specific day and at a specific time, 0.925–37 GBq of Yttrium (Y) (which corresponds to 46–1840 nanograms of Yttrium in the form of Yttrium chloride). The other ingredients are: hydrochloric acid and water for injections.

• The vial contains, on a specific day and at a specific time, 0.925–37 GBq of Yttrium (Y) (which corresponds to 46–1840 nanograms of Yttrium in the form of Yttrium chloride). The other ingredients are: hydrochloric acid and water for injections.

What ItraPol looks like and what the pack contains

A colorless glass vial of type I with a capacity of 2 ml, closed with a rubber stopper and protected with an aluminum cap, in a lead shielding container.
Radiopharmaceutical precursor, solution.
A clear, colorless solution.

Marketing authorization holder and manufacturer

National Centre for Nuclear Research
ul. Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 718 07 00
Fax: 22 718 03 50
e-mail: polatom@polatom.pl

Date of last revision of the leaflet:

The full Summary of Product Characteristics (SPC) of ItraPol is attached as a separate document to the packaging of the product, in order to provide healthcare professionals with additional, scientific, and practical information on the administration and use of this radiopharmaceutical.