Galliapharm

Leaflet attached to the packaging: patient information

GalliaPharm, 0.74 - 1.85 GBq, radionuclide generator
Gallium (Ga) chloride solution

This medicinal product will be subject to additional monitoring. This will allow for the quick
identification of new safety information. The user of the medicinal product can also help by reporting
any adverse reactions that occur after taking the medicinal product.
To find out how to report adverse reactions, see section 4.

It is essential to carefully read the contents of the leaflet before administering the medicinal product, as it contains important information for the patient.

• The leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, the patient should consult the nuclear medicine doctor supervising the procedure.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform the nuclear medicine doctor. See section 4.

Table of contents of the leaflet:

• 1. What is GalliaPharm and what is it used for
• 2. Important information before using the gallium (Ga) chloride solution obtained with GalliaPharm
• 3. How to use the gallium (Ga) chloride solution obtained with GalliaPharm
• 4. Possible adverse reactions
• 5. How to store GalliaPharm
• 6. Package contents and other information

1. What is GalliaPharm and what is it used for

GalliaPharm is a radiopharmaceutical product used exclusively for diagnostic purposes.
This is a radiopharmaceutical product not intended for direct use in patients.
GalliaPharm is a generator of the radionuclide germanium (Ge) / gallium (Ga), a device
used to obtain a gallium (Ga) chloride solution.
The obtained gallium (Ga) chloride solution is used for radiolabeling, a technique in which
a substance is labeled (radiolabeled) with a radioactive substance, in this case gallium (Ga).
GalliaPharm is used to label specific medicinal products specially developed and approved for use with the active substance: gallium (Ga) chloride.
These medicinal products act as carriers that deliver the radioactive gallium (Ga) where it is needed. They may be substances developed to recognize specific types of cells in the body, including cancer cells. A small amount of the administered radioactive compounds can be detected from outside the body using special cameras, obtaining images of the body. The patient should read the Patient Leaflet of the medicinal product that will be radiolabeled with gallium (Ga) chloride.
The nuclear medicine doctor will explain the nature of the examination to be performed using this product to the patient.
The use of a medicinal product labeled with Ga involves exposure to a small level of radioactivity. The treating doctor and the nuclear medicine doctor have decided that the clinical benefit to the patient obtained as a result of the procedure using the radiopharmaceutical outweighs the risk associated with radiation.

2. Important information before using the gallium (Ga) chloride solution obtained with GalliaPharm

The gallium (Ga) chloride solution obtained with GalliaPharm should not be used

If the patient is allergic to gallium (Ga) or any of the other ingredients of this medicinal product (listed in section 6). When using a medicinal product labeled with Ga, the patient should read the information on contraindications contained in the Patient Leaflet of the medicinal product that will be radiolabeled.

• If the patient has an allergy to gallium (Ga) or any of the other ingredients of this medicinal product (listed in section 6), the gallium (Ga) chloride solution obtained with GalliaPharm should not be used.

Warnings and precautions

To obtain information on warnings and precautions related to the medicinal product labeled with Ga, the patient should read the Patient Leaflet of the medicinal product that will be radiolabeled.

Children and adolescents

Persons under 18 years of age or their parents should consult the nuclear medicine doctor.

Gallium (Ga) chloride solution and other medicinal products

The patient should tell the nuclear medicine doctor about all medicinal products they are currently taking or have recently taken, as well as any medicinal products they plan to take, as they may interfere with the interpretation of the images.
It is not known whether the gallium (Ga) chloride solution interacts with other medicinal products, as no relevant studies have been conducted.
To obtain information on interactions related to the use of medicinal products labeled with Ga, the patient should read the Patient Leaflet of the medicinal product that will be radiolabeled.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult the nuclear medicine doctor before receiving medicinal products radiolabeled with GalliaPharm.
The patient must inform the nuclear medicine doctor before receiving medicinal products radiolabeled with GalliaPharm if there is a possibility that they are pregnant, if their menstrual period is delayed, or if they are breastfeeding.
In case of doubts, the patient should consult the nuclear medicine doctor who will supervise the procedure.
Pregnant women
The nuclear medicine doctor will administer the medicinal product during pregnancy only if the expected benefit outweighs the risk.
Breastfeeding women
The patient will have to stop breastfeeding. The nuclear medicine doctor will inform them when they can start breastfeeding again.

Driving and using machines

The medicinal product used in combination with GalliaPharm may affect the ability to drive and use machines. The patient should carefully read the Patient Leaflet of this medicinal product.

3. How to use the gallium (Ga) chloride solution obtained with GalliaPharm

GalliaPharm

There are strict regulations regarding the use, handling, and disposal of radiopharmaceutical products. GalliaPharm will be used exclusively in special controlled areas. The product will be prepared and administered to the patient exclusively by persons who are trained and qualified to do so in a safe manner. These persons will take all necessary precautions to use the product safely and to inform the patient about the actions taken.
The nuclear medicine doctor supervising the procedure will decide on the amount of the medicinal product radiolabeled with GalliaPharm to be used in a given case. This will be the smallest dose necessary to achieve the expected result, depending on the final product and its intended use. To obtain more detailed information, the patient should read the Patient Leaflet of the medicinal product that will be radiolabeled.

Administration of the gallium (Ga) chloride solution and performance of the procedure

The patient will not receive the gallium (Ga) chloride solution, but another radiopharmaceutical product obtained with GalliaPharm. The gallium (Ga) chloride solution may be used only in combination with another medicinal product that has been specially developed and approved for use (radiolabeling) with GalliaPharm.
The patient will receive only the final radiolabeled product.

Duration of the procedure

The nuclear medicine doctor will inform the patient about how long the procedure usually takes after administration of the medicinal product radiolabeled with GalliaPharm.

After administration of the medicinal product radiolabeled with GalliaPharm

The nuclear medicine doctor will inform the patient whether any special precautions are necessary after receiving the medicinal product radiolabeled with GalliaPharm. In case of any questions, the patient should contact the nuclear medicine doctor.

Use of a higher than recommended dose of the medicinal product radiolabeled with GalliaPharm

GalliaPharm

Overdose is unlikely, as the patient will receive a dose of the medicinal product radiolabeled with GalliaPharm that is precisely controlled by the nuclear medicine doctor supervising the procedure. In case of overdose, the patient will receive appropriate treatment.
In case of questions about the use of this product, the patient should consult the nuclear medicine doctor who supervises the procedure.

4. Possible adverse reactions

Like all medicinal products, the medicinal product radiolabeled with GalliaPharm can cause adverse reactions, although not everybody gets them.
Administration of the medicinal product radiolabeled with GalliaPharm results in a small emission of ionizing radiation carrying the lowest possible risk of cancer and genetic disorders.

Reporting adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in the leaflet, the patient should inform the nuclear medicine doctor.
Adverse reactions can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions will allow for the collection of more information on the safety of the medicinal product.

5. How to store GalliaPharm

The patient will not store this product. A specialist in a nuclear medicine facility is responsible for its storage. The storage of radiopharmaceutical products will be carried out in accordance with national regulations on the storage of radioactive materials.
The following information is intended only for specialists.
The radionuclide generator should not be used after the expiry date stated on the packaging after: "EXP".
Do not disassemble the housing. Do not store at a temperature above 25°C.
The gallium (Ga) chloride solution obtained with GalliaPharm is intended for immediate use.

6. Package contents and other information

What GalliaPharm contains

The active substance of GalliaPharm is gallium (Ga) chloride solution.
The other ingredients are:
titanium dioxide (column filling)
sterile ultrapure hydrochloric acid 0.1 mol/l (elution solution)

What GalliaPharm looks like and what the package contains

The patient will not receive or prepare this product.

Marketing authorization holder and manufacturer

Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 12/2018.

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Information intended exclusively for healthcare professionals:

The full Summary of Product Characteristics of GalliaPharm is provided as a separate document in the product packaging. Its purpose is to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
The Summary of Product Characteristics should be read.