Germanium (68GE) chloride / gallium (68GA) chloride Ire-Elit 0.74-1.85 GBq radionuclide generator

Package leaflet: Information for the patient

Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT 0.74–1.85 GBq radionuclide generator
Gallium (Ga) chloride solution
Please read this leaflet carefully before receiving this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the nuclear medicine specialist supervising the procedure.
• If you experience any side effects, including those not listed in this leaflet, inform the nuclear medicine specialist. See section 4.

Contents of this leaflet:

1. What Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT is and what it is used for
2. What you need to know before using the gallium (Ga) chloride solution obtained with Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT
3. How to use the gallium (Ga) chloride solution obtained with Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT
4. Possible side effects
5. How to store Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT
6. Contents of the pack and other information

1. What Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT is and what it is used for

The medicine is a radiopharmaceutical product not intended for direct use in the patient.
Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT is a germanium (Ge)/gallium (Ga) radionuclide generator, a device used to obtain a gallium (Ga) chloride solution.
The obtained gallium (Ga) chloride solution is used for radiolabelling, a technique in which a substance is labelled (radiolabelled) with a radioactive compound—in this case, Ga.
Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT is used to label certain medicinal products that have been specifically developed and approved for use with the active substance gallium (Ga) chloride.
These medicinal products act as carriers to deliver the radioactive Ga to the required site. They may include substances designed to recognize a specific type of cell in the body, including tumour cells (cancer).
The small amount of radioactivity administered can be detected from outside the body using special cameras.
Please consult the package leaflet of the medicinal product that is to be radiolabelled with gallium (Ga) chloride. The nuclear medicine specialist will explain to you what type of examination will be performed with this medicinal product.
Using a medicine labelled with Ga involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine specialist have determined that the clinical benefit you will receive from the procedure using this radiopharmaceutical outweighs the risk associated with radiation exposure.

2. What you need to know before using the gallium (Ga) chloride solution obtained with Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT

The gallium (Ga) chloride solution obtained with Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT must not be used

• if you are allergic to gallium (Ga) chloride or to any of the other ingredients of this medicine
  (listed in section 6).
  If you are using a medicine labelled with Ga, you must read the information regarding contraindications in the

Patient Information Leaflet of the medicinal product to be radiolabelled.

Warnings and precautions
For information on special warnings and particular precautions for the use of medicinal products labelled with Ga,
please refer to the Patient Information Leaflet of the medicinal product to be radiolabelled.
Children and adolescents
Please consult the nuclear medicine specialist if you or your child is under 18 years of age.
Other medicines and gallium ( Ga) chloride solution
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other medicine,
as it could interfere with the interpretation of images.
It is not known whether gallium (Ga) chloride may interact with other medicines, as no specific studies have been conducted.
For information on interactions related to the use of medicinal products labelled with Ga, please refer to the
Patient Information Leaflet of the medicinal product to be radiolabelled.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, please seek
advice from the nuclear medicine specialist before receiving radiolabelled medicinal products containing
Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT.
If you suspect you are pregnant, have missed a menstrual period, or are breastfeeding, inform the nuclear medicine
specialist before administration of radiolabelled medicinal products containing Germanium (Ge) chloride / Gallium (Ga)
chloride IRE-ELiT.
If you have any doubts, it is important to consult the nuclear medicine specialist supervising the procedure.
If you are pregnant
The nuclear medicine specialist will administer the product only if the expected benefits outweigh the risks.
If you are breastfeeding
You will be advised to discontinue breastfeeding. Ask the nuclear medicine specialist when you may resume breastfeeding.
Driving and using machines
The medicinal product used in combination with Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT
may affect your ability to drive and use machinery. Please read the Patient Information Leaflet of that medicinal product carefully.

3. How to use the gallium ( Ga) chloride solution obtained with Germanium ( Ge) chloride / Gallium ( Ga) chloride IRE-ELiT
   There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT will only be used in designated controlled areas. This product will be handled and administered exclusively by trained and qualified personnel competent in its safe use. Such personnel will pay particular attention to the safe handling of this product and will inform you about the actions taken.

The nuclear medicine specialist supervising the procedure will determine the amount of medicinal product
radiolabelled with Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT to be used in your case. This will be
the minimum amount necessary to achieve the desired result, depending on the medicinal product to be labelled and its intended use. For further information, please read the Patient Information Leaflet of the medicinal product to be radiolabelled.
Administration of the gallium ( Ga) chloride solution obtained with Germanium ( Ge) chloride / Gallium ( Ga) chloride IRE-ELiT and performance of the procedure
You will not receive the gallium (Ga) chloride solution directly, but rather another medicinal product radiolabelled with Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT.
The gallium (Ga) chloride solution must only be used in combination with another medicinal product specifically developed to be combined (radiolabelled) with Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT. You will receive only the final radiolabelled medicinal product.
Duration of the procedure
The nuclear medicine specialist will inform you about the expected duration of the procedure following administration of the radiolabelled medicinal product containing Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT.
After administration of the radiolabelled medicinal product containing Germanium ( Ge) chloride / Gallium ( Ga) chloride IRE-ELiT
The nuclear medicine specialist will inform you whether you need to take any special precautions after receiving the radiolabelled medicinal product containing Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT. For any questions, please consult the nuclear medicine specialist.
If you have received more of the radiolabelled medicinal product containing Germanium ( Ge) chloride / Gallium ( Ga) chloride IRE-ELiT than you should have
Overdose is unlikely, as the nuclear medicine specialist supervising the procedure will administer only a precisely controlled dose of the radiolabelled medicinal product containing Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT. However, in the event of an overdose, your doctor will provide appropriate treatment.
If you have any further questions about the use of this medicinal product, please consult the nuclear medicine specialist supervising the procedure.

4. Possible side effects

Like all medicines, the radiolabelled medicinal product Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT can cause side effects, although not everybody experiences them.
After administration of the radiolabelled medicinal product Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT, low amounts of ionizing radiation are emitted, carrying a minimal risk of cancer and hereditary abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your nuclear medicine specialist. You may also report side effects directly via the national reporting system at the following address: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT

It is not your responsibility to store this medicinal product. This medicinal product is stored under the responsibility of a specialist in appropriate locations. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for the specialist:
The radionuclide generator must not be used after the expiry date indicated on the container following "EXP".
Do not disassemble the plastic housing. Do not store at temperatures above 25 °C.
The Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT solution must be used immediately.

6. Package contents and other information

What Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT contains
The active substance is a solution of gallium (Ga) chloride.
The other components are: Titanium dioxide (matrix).
Sterile 0.1 N hydrochloric acid (elution solution).

Description of the appearance of Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT and contents of the
package
It is not your responsibility to obtain or handle this medicine.

Marketing Authorization Holder and Manufacturer
IRE-Elit
Avenue de l’Espérance
B-6220 Fleurus
Belgium

This medicine is authorized in the European Economic Area member states under the following
names:

The following information is intended exclusively for medical or healthcare personnel:

The full SmPC (Summary of Product Characteristics) for Germanium (Ge) chloride / Gallium (Ga) chloride IRE-ELiT 0.74-1.85 GBq radionuclide generator is provided as a separate document within the product packaging, with the aim of supplying healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.