Galliad

Package Leaflet: Information for the Patient

Galliad, 0.74–1.85 GBq, Radionuclide Generator
Gallium Chloride (Ga) Solution

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

• Keep this package leaflet, so you can read it again if you need to.
• If you have any further questions about the use of this medicine, ask your nuclear medicine doctor who will supervise the procedure.
• If you experience any side effects, including those not listed in this package leaflet, tell your nuclear medicine doctor. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Galliad and what is it used for
• 2. Important information before using Gallium Chloride (Ga) Solution obtained with Galliad
• 3. How to use Gallium Chloride (Ga) Solution obtained with Galliad
• 4. Possible side effects
• 5. How to store Galliad
• 6. Package contents and other information

1. What is Galliad and what is it used for

This medicine is a radiopharmaceutical product that is not intended for direct use in patients.
Galliad is a Germanium (Ge) / Gallium (Ga) radionuclide generator that allows the preparation of Gallium Chloride (Ga) Solution.
The prepared Gallium Chloride (Ga) Solution is used for radiolabeling, a technique where a substance is labeled (radiolabeled) with a radioactive compound, in this case Ga.
Galliad is used to label certain medicines that have been specifically developed and approved for use with the active substance Gallium Chloride (Ga). These medicines act as carriers that transport the radioactive Ga to the areas that require it. They may be substances developed to detect a specific type of cell in the body, including cancer cells. The small amount of radiation administered can be detected outside the body using special cameras.
You should read the package leaflet for the patient for the medicine that will be radiolabeled with Gallium Chloride (68Ga).
Your nuclear medicine doctor will explain what kind of examination will be performed using this product.
The use of the medicine radiolabeled with Ga involves exposure to small amounts of radiation. Your treating doctor and nuclear medicine doctor have determined that the clinical benefits of the procedure using the radiopharmaceutical product outweigh the risk associated with radiation.

2. Important information before using Gallium Chloride (Ga) Solution obtained with Galliad

Galliad

Do not use Gallium Chloride (Ga) Solution obtained with Galliad,

• if you are allergic to Gallium Chloride (Ga) or any of the other ingredients of this medicine (listed in section 6). When using a medicine radiolabeled with Ga, read the information on contraindications in the package leaflet of the medicine intended for radiolabeling.

Warnings and precautions

Information on special warnings and precautions for the use of medicines radiolabeled with Ga can be found in the package leaflet of the medicine intended for radiolabeling.

Children and adolescents

If you are under 18 years old (or your child is under 18 years old), talk to your nuclear medicine doctor.

Gallium Chloride (Ga) Solution and other medicines

Tell your nuclear medicine doctor about all medicines you are taking or have recently taken or may take in the future, as they may affect the interpretation of images.
It is not known whether Gallium Chloride (Ga) interacts with other medicines, as no relevant studies have been conducted.
Information on interactions related to the use of medicines radiolabeled with Ga can be found in the package leaflet of the medicine intended for radiolabeling.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your nuclear medicine doctor before using medicines radiolabeled with Galliad.
Before administering medicines radiolabeled with Galliad, tell your nuclear medicine doctor if you are pregnant, have missed a menstrual period, or are breastfeeding.
If in doubt, consult your nuclear medicine doctor who will supervise the procedure.
If you are pregnant
Your nuclear medicine doctor will only give you this medicine during pregnancy if the expected benefits of the medicine outweigh the risk to the baby.
If you are breastfeeding
You will be asked to stop breastfeeding. Ask your nuclear medicine doctor when you can restart breastfeeding.

Driving and using machines

The medicine used with Galliad may affect your ability to drive and use machines. Read carefully the package leaflet for the patient for that medicine.

3. How to use Gallium Chloride (Ga) Solution obtained with Galliad

There are strict regulations regarding the use, handling, and disposal of radiopharmaceutical products.
Galliad will only be used in controlled areas. The medicine will be handled and administered to the patient only by trained and qualified personnel. These personnel will take special precautions to safely use this medicine and will inform the user about their actions.
Your nuclear medicine doctor who will supervise the procedure will decide on the amount of medicine radiolabeled with Galliad to be used for a specific patient. This will be the smallest amount necessary to achieve the desired result, depending on the radiolabeled medicine and its purpose. For more information, read the package leaflet for the patient for the medicine that will be radiolabeled.

Administration of Gallium Chloride (Ga) Solution obtained with Galliad and procedure

You will not receive Gallium Chloride (Ga) Solution, but another medicine radiolabeled with Galliad.
Gallium Chloride (Ga) Solution must only be used in combination with another medicine that has been specifically developed for use after radiolabeling with Galliad. You will only receive the final radiolabeled medicine.

Duration of the procedure

Your nuclear medicine doctor will inform you about the standard duration of the procedure after administration of the medicine radiolabeled with Galliad.

After administration of the medicine radiolabeled with Galliad

Your nuclear medicine doctor will inform you about the need for special precautions after receiving the medicine radiolabeled with Galliad. If you have any questions, contact your nuclear medicine doctor.

Overdose of the medicine radiolabeled with Galliad

Overdose is unlikely, as you will only receive the medicine radiolabeled with Galliad under the strict control of your nuclear medicine doctor who supervises the procedure. However, in case of overdose, you will receive appropriate treatment.
If you have any questions about the use of this product, talk to your nuclear medicine doctor who will supervise the procedure.

4. Possible side effects

The medicine radiolabeled with Galliad, like any other medicine, may cause side effects, although not everybody gets them.
After administration of the medicine radiolabeled with Galliad, it will deliver small amounts of ionizing radiation with minimal risk of cancer and genetic abnormalities.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your nuclear medicine doctor. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Galliad

Storage of this medicine will not be necessary. The responsibility for storage of this medicine lies with the medical personnel in the respective center. Storage of radiopharmaceutical products will be carried out in accordance with national regulations on radioactive materials.
The following information is intended only for healthcare professionals:
Do not use the radionuclide generator after the expiration date stated on the container after "EXP".
Do not dismantle the plastic housing. Do not store above 25°C.
The Gallium Chloride (Ga) Solution obtained with Galliad must be used immediately.

6. Package contents and other information

What Galliad contains

The active substance is Gallium Chloride (Ga) Solution
The other ingredients are:
Titanium dioxide (E 171) (matrix)
Sterile hydrochloric acid 0.1 N (eluate solution)

What Galliad looks like and contents of the package

It is not necessary for you to handle or use this medicine.

Marketing authorization holder and manufacturer

IRE ELiT
Avenue de l’Espérance 1
6220 Fleurus
Belgium
Email: [email protected]

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

Date of last revision of the package leaflet

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Information intended only for healthcare professionals or healthcare workers:

The full Summary of Product Characteristics (SmPC) of the Galliad 0.74–1.85 GBq radionuclide generator is provided as a separate document in the product packaging to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
Read the SmPC.