Patient Information Leaflet

ItraPol, radiopharmaceutical precursor, solution
Yttrium (Y) chloride
Please read this leaflet carefully before use, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your nuclear medicine specialist physician.
If you experience any adverse reactions, including those not listed in this leaflet, inform your nuclear medicine specialist physician immediately. See section 4.

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

1. What ItraPol is and what it is used for

ItraPol is a radiopharmaceutical product intended for therapy only after combination with another medicinal product that targets specific cells in the body. Once the target is reached, small doses of ionizing radiation originating from ItraPol are delivered to these cells.
Further information regarding the use and possible adverse effects associated with administration of the medicinal product labeled with yttrium (Y) can be found in the package leaflet of the respective medicinal product intended for labeling.

2. Important information before using ItraPol

When not to use ItraPol:
if the patient is allergic to yttrium chloride (Y) or to any of the other components of this
product (listed in section 6);
if the patient is pregnant or pregnancy is suspected (see below);
if the patient is breastfeeding.

Warnings and precautions
ItraPol is a radiopharmaceutical product, intended for use only in combination with another
medicinal product.
It is not intended for direct administration to patients.

Children and adolescents
Special precautions must be taken when administering radiopharmaceuticals to children and adolescents (aged 2 to 16 years).

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 use.
No interactions between yttrium chloride (Y) and other medicinal products are known, as no clinical study results are available.

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

pregnancy is suspected in the patient,
the patient has missed her expected menstrual period,
the patient is breastfeeding. In case of doubt, a consultation with a nuclear medicine specialist is necessary.

The physician will consider alternative therapy methods that do not involve emission of ionizing radiation.
Women of childbearing potential must use an effective method of contraception during treatment and for a short period after completion of treatment.
In case of breastfeeding and when administration of a radiopharmaceutical is necessary, the physician will advise to discontinue breastfeeding.

Before using any medicinal product, consult a nuclear medicine specialist.

Driving and operating machinery
No data available.

2. How to use ItraPol

Radiopharmaceutical products may only be administered by authorized personnel.
There are strict regulations regarding the use, transfer, and disposal of radiopharmaceuticals. ItraPol is used exclusively under appropriate clinical conditions and only by appropriately qualified individuals. These individuals will take special precautions to ensure the safe use of the product and will continuously report on their activities.
The physician does not administer the ItraPol product directly to the patient.
Dosage
The physician determines the dose of ItraPol to be administered to a specific patient. This will be the minimum dose necessary to achieve the desired 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 which is administered by a physician. ItraPol is intended for labeling medicinal products that are subsequently administered to the patient via a defined route in the treatment of specific diseases.
Use of a higher than recommended dose of ItraPol
Overdose is practically impossible because the dose administered to the patient is strictly controlled by a nuclear medicine specialist physician. However, in the event of an overdose, the physician will apply appropriate treatment.
If there are any further doubts regarding the use of this medicinal product, consult a nuclear medicine specialist physician.
4 Possible adverse reactions
Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
Exposure to ionizing radiation may lead to an increased risk of cancer (in the case of using high activities of radioactive isotopes) or may lead to the development of hereditary defects.
More information on possible adverse reactions caused by administration of a medicinal product labeled with yttrium (Y) is available in the package leaflet of the medicinal product intended for labeling.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your physician or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions enables continued monitoring of the safety of the medicinal product.

5. How to store ItraPol

The patient will not be required to store this medicinal product.
Radiopharmaceuticals are stored exclusively by authorized personnel under appropriate clinical conditions. Storage of radiopharmaceuticals must comply with local regulations regarding radioactive substances.
The following information is intended for healthcare personnel only.
Keep the medicine out of the sight and reach of children.
Do not use the product after the expiry date stated on the packaging.

6. Contents of the package and other information

What ItraPol contains
The active substance in ItraPol is yttrium (Y) chloride.
Each vial contains 0.925–37 GBq of yttrium (Y) on a specified day and at a specified time (corresponding to 46–1840 nanograms of yttrium as yttrium chloride).
The other components are: concentrated hydrochloric acid and water for injections.

What ItraPol looks like and contents of the pack
A colourless vial made of type I glass with a capacity of 2 ml, closed with a rubber stopper and sealed with an aluminium cap, placed in a lead shielding container.
Radiopharmaceutical precursor, solution.
Clear, colourless solution.

Marketing Authorisation Holder and Manufacturer
National Centre for Nuclear Research
Andrzeja Sołtana 7
05-400 Otwock
Tel: 22 718 07 00
Fax: 22 718 03 50
e-mail: [email protected]

The full Product Information (SmPC) for ItraPol is included as a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.