GALLIAPHARM 1.48 GBq RADIONUCLIDE GENERATOR

Introduction

Package Leaflet: Information for the Patient

GalliaPharm 1.48GBq Radionuclide Generator

Solution of gallium chloride (68Ga)

Read all of this leaflet carefully before you receive this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine specialist who will be supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine specialist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is GalliaPharm and what is it used for
2. What you need to know before you start using the gallium chloride (68Ga) solution obtained with GalliaPharm
3. How to use the gallium chloride (68Ga) solution obtained with GalliaPharm
4. Possible side effects
5. Storage of GalliaPharm
6. Package Contents and Further Information

1. What is GalliaPharm and what is it used for

GalliaPharm is a germanium (68Ge)/gallium (68Ga) radionuclide generator, a device used to obtain a solution of gallium chloride (68Ga). Gallium chloride (68Ga) is a substance whose handling is the responsibility of specialized physicians (nuclear medicine specialists) and pharmacists with the necessary training to work with radioactive materials. Gallium chloride (68Ga) is not intended for direct use in patients, but is used for radiolabeling, a technique in which a substance is labeled (radiolabeled) with a radioactive compound, in this case, 68Ga.

Only medications that have been specifically developed and approved for radiolabeling with 68Ga are subjected to the radiolabeling procedure with gallium chloride (68Ga). These radiolabeled medications can recognize and bind to particular types of body cells and carry the radioactive 68Ga to these body cells. The small amount of radioactivity present in the radiolabeled medication can be detected from outside the body using special cameras. This can help your doctor with diagnosis. For more information, see the package leaflet of the medication to be radiolabeled with gallium chloride (68Ga).

Your nuclear medicine specialist will explain the type of examination to be performed in more detail.

The use of a medication labeled with 68Ga involves receiving a small amount of radioactivity. Your doctor and nuclear medicine specialist have considered that the clinical benefit you will gain from the procedure with the medication labeled with 68Ga outweighs the risk of radiation.

2. What you need to know before you start using the gallium chloride (68Ga) solution obtained with GalliaPharm

The gallium chloride (68Ga) solution obtained with GalliaPharm must not be administered

• if you are allergic to gallium chloride (68Ga) or to any of the other components of this medication (listed in section 6).

If you are using a medication labeled with 68Ga, you should read the information about contraindications included in the package leaflet of the medication to be radiolabeled.

Warnings and Precautions

For information on special warnings and precautions for the use of medications labeled with 68Ga, see the package leaflet of the medication to be radiolabeled.

Children and Adolescents

Tell your nuclear medicine specialist if you or your child are under 18 years old.

Other Medications and the Gallium Chloride (68Ga) Solution

Tell your nuclear medicine specialist if you are taking, have recently taken, or might take any other medication, as some medications may interfere with the interpretation of images by your doctor.

It is not known if the gallium chloride (68Ga) solution can interact with other medications, as specific studies have not been conducted. You will not receive an injection of gallium chloride (68Ga), but a medication that has been combined (radiolabeled) with a solution of gallium chloride (68Ga).

For information on other medications in combination with the use of medications labeled with 68Ga, see the package leaflet of the radiolabeled medication.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your nuclear medicine specialist for advice before you are given medications labeled with 68Ga.

If there is any possibility that you may be pregnant, if you have missed a period, or if you are breast-feeding, inform your nuclear medicine specialist before administration of medications labeled with 68Ga.

In case of doubt, it is important that you consult your nuclear medicine specialist who will be supervising the procedure.

If you are pregnant

Your nuclear medicine specialist will only give you this medication labeled with 68Ga during pregnancy if the expected benefit outweighs the risk.

If you are breast-feeding

You will be asked to stop breast-feeding. Ask your nuclear medicine specialist when you can restart breast-feeding.

Driving and Using Machines

There may be effects on the ability to drive and use machines due to the use of medications labeled with 68Ga. Read the package leaflets of those medications carefully.

3. How to use the gallium chloride (68Ga) solution obtained with GalliaPharm

The use, handling, and disposal of radiopharmaceuticals are subject to very strict rules. GalliaPharm will only be used in special controlled areas. The production of the gallium chloride (68Ga) solution, as well as the radiolabeling of a specific carrier medication and the administration of a medication labeled with 68Ga, will be the exclusive responsibility of properly trained and qualified personnel to use it safely. These personnel will take special care in the safe use of this medication and will inform you of their actions.

Your nuclear medicine specialist who will be supervising the procedure will decide on the amount of medication labeled with 68Ga to be used in your case. This will be the minimum amount necessary to obtain the desired information.

Administration of the Gallium Chloride (68Ga) Solution and Performance of the Procedure

You will not be given the gallium chloride (68Ga) solution, but another medication that has been combined (radiolabeled) with a solution of gallium chloride (68Ga).

Duration of the Procedure

Your nuclear medicine specialist will inform you about the usual duration of the procedure with the medication labeled with 68Ga. For more information, see the package leaflet of the radiolabeled medication.

After Administration of the Medication Labeled with Gallium Chloride (68Ga) Solution

Your nuclear medicine specialist will inform you if you need to take special precautions after you have been given the medication labeled with 68Ga. Ask your nuclear medicine specialist if you have any doubts.

If You Have Been Given More Medication Labeled with Gallium Chloride (68Ga) Solution Than You Should, or if You Have Received a Direct Injection of Gallium Chloride (68Ga) Solution by Accident

It is unlikely that an overdose or accidental direct injection of a gallium chloride (68Ga) solution will occur, because you will only receive the medication labeled with 68Ga under the precise control of your nuclear medicine specialist who is supervising the procedure. Nevertheless, in case of overdose or accidental direct injection, you will receive appropriate care.

If you have any further questions on the use of this medication, ask your nuclear medicine specialist who is supervising the procedure.

4. Possible Side Effects

Like all medications, the medication labeled with 68Ga can cause side effects, although not everybody gets them.

After administration of the medication labeled with 68Ga, you will be given low amounts of ionizing radiation with the lowest risk of cancer and congenital anomalies.

For more information on possible side effects, see the package leaflet of the radiolabeled medication.

Reporting of Side Effects

If you experience any side effects, talk to your nuclear medicine specialist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of GalliaPharm

You will not need to store this medication. This medication is stored under the responsibility of your specialist in suitable premises. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

This information is intended for healthcare professionals only.

The radionuclide generator must not be used after the expiry date stated on the container after «EXP».

Do not dismantle the box.

The gallium chloride (68Ga) solution obtained with GalliaPharm must be used immediately.

6. Package Contents and Further Information

Composition of GalliaPharm:

• The active substances are germanium (68Ge) and gallium (68Ga) chloride dissolved in sterile ultrapure hydrochloric acid at a concentration of 0.1 mol/l. The germanium (68Ge) is irreversibly trapped within the radionuclide generator and decays into its daughter nuclide (68Ga), which is obtained from the generator as gallium (68Ga) chloride.

A radionuclide generator is supplied with:

1. 1 PP container containing the eluate, 250 ml of sterile ultrapure hydrochloric acid at a concentration of 0.1 mol/l (including a separate hanger for PP vials; PP: polypropylene)
2. 1 ventilated puncture device (ABS: acrylonitrile butadiene styrene/PE: polyethylene)
3. 2 1/16” male LUER adapters (PEEK)
4. 2 tubes (60 cm) (PEEK)
5. 1 tube (40 cm) (PEEK)
6. 1 tube (20 cm) (PEEK)
7. 3 1/16” 10-32 Fingertight connectors (PEEK)
8. 1 1/16” M6 Fingertight connector (PEEK)
9. 1 key box (TPX: polymethylpentene/HDPE: high-density polyethylene)
10. 1 male LUER union (PP)

Appearance and Package Contents

You will not receive or handle this medication.

Marketing Authorization Holder and Manufacturer

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Str. 10

13125 Berlin

Germany

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.

On the European Medicines Agency website, this leaflet can be found in all languages of the European Union/European Economic Area.

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This information is intended for healthcare professionals only:

The full summary of product characteristics of GalliaPharm is provided in a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

See the summary of product characteristics or package leaflet.