GalliaPharm

Patient Information Leaflet

Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm 1.11 GBq radionuclide generator
gallium ( Ga) chloride solution
Please read this leaflet carefully before this medicine is administered to you, 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 who will supervise the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet

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

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

Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm is a radionuclide generator of
germanium ( Ge)/gallium ( Ga), a device used to obtain a solution of gallium ( Ga) chloride.
Gallium ( Ga) chloride is a radioactive substance, handled by specialist physicians (nuclear medicine physicians) and pharmacists trained in working with radioactive materials. Gallium ( Ga) chloride is not intended for direct use in patients, but is used for radiolabelling, a technique whereby a substance is labelled (radiolabelled) with a radioactive compound, in this case Ga.
Only medicinal products specifically manufactured and approved for radiolabelling with Ga undergo the radiolabelling procedure using gallium ( Ga) chloride. These radiolabelled medicinal products can recognize specific types of cells in the body, bind to them, and deliver the radioactive Ga to these cells. The small amount of radioactivity present in the Ga-radiolabelled medicinal product can be detected outside the body using special equipment. This may assist the physician in diagnosis. For further information, please refer to the package leaflet of the medicinal product to be radiolabelled with gallium ( Ga) chloride.
The nuclear medicine specialist will explain to you in more detail what type of examination will be performed.
The use of a medicinal product labelled with Ga involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine specialist consider that the clinical benefit obtained from the procedure using the Ga-labelled medicinal product outweighs the risk associated with radiation exposure.

2. What you need to know before the gallium (Ga) chloride solution obtained from

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
The gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm 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 radiolabelled Ga-containing medicine, please read the contraindications information in the package leaflet of the radiolabelled medicine.
Warnings and precautions
For information on special warnings and precautions for use of Ga-labelled medicines, consult the package leaflet of the radiolabelled medicine.
Children and adolescents
If you or your child is under 18 years of age, please consult a nuclear medicine specialist.
Other medicines and the gallium (Ga) chloride solution
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other medicines, as they could interfere with image interpretation.
It is not known whether the gallium (Ga) chloride solution may interact with other medicines, as specific studies have not been conducted. You will not receive an injection of gallium (Ga) chloride itself, but another medicine radiolabelled with Ga.
For information on interactions associated with the use of Ga-labelled medicines, refer to the package leaflet of the radiolabelled medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your nuclear medicine specialist before receiving Ga-labelled medicines.
You must inform the nuclear medicine specialist before administration of Ga-labelled medicines if there is any possibility of pregnancy, if you have missed your period, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist who will perform the procedure.
If you are pregnant
The nuclear medicine specialist will administer a Ga-labelled medicine during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding
You will be asked to interrupt breastfeeding. Ask your nuclear medicine specialist when you can resume breastfeeding.
Driving and using machines
Effects on your ability to drive and use machines may occur due to the use of Ga-labelled medicines. Please read the package leaflet of these medicines carefully.

3. How the gallium (68Ga) chloride solution produced with germanium chloride is used

(68Ge)/Gallium chloride (68Ga) GalliaPharm
There are strict rules regarding the use, handling, and disposal of radiopharmaceuticals. Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm is used only in areas under special control. The production of the gallium (68Ga) chloride solution, the radiolabelling of a specific carrier medicinal product, as well as the administration of the radiolabelled medicinal product, will be managed by experienced and qualified personnel trained to handle it safely. These individuals will take great care in the safe use of this medicinal product and will inform you about their actions.
The amount of the 68Ga-radiolabelled medicinal product to be used in your case will be determined by the nuclear medicine specialist performing the procedure. This amount will be the lowest possible necessary to achieve the appropriate diagnostic result.

Administration of the gallium (68Ga) chloride solution and performance of the procedure
You will not receive the gallium (68Ga) chloride solution directly, but another medicinal product that has been linked (radiolabelled) with the gallium (68Ga) chloride solution.

Duration of the procedure
The nuclear medicine specialist will inform you about the usual duration of the procedure using the 68Ga-labelled medicinal product. For further information, please read the package leaflet of the medicinal product to be radiolabelled.

After administration of the medicinal product radiolabelled with gallium (68Ga) chloride solution
The nuclear medicine specialist will inform you whether you need to take special precautions after receiving the 68Ga-labelled medicinal product. If you have any doubts, please consult the nuclear medicine specialist.

If you have received more of the medicinal product radiolabelled with gallium (68Ga) chloride solution than you should have, or if you have accidentally received a direct injection of gallium (68Ga) chloride
An overdose or accidental direct injection of the gallium (68Ga) chloride solution is unlikely, as you will receive the 68Ga-labelled medicinal product only under the strict supervision of the nuclear medicine specialist responsible for the procedure. However, in the event of an overdose or accidental direct injection, you will receive appropriate treatment.

If you have any questions about the use of this medicinal product, please consult the nuclear medicine specialist performing the procedure.

4. Possible side effects

Like all medicines, this gallium-labelled medicine may cause side effects, although not everybody gets them.
After administration, the gallium-labelled medicine will produce small amounts of ionising radiation, with a minimal risk of cancer and hereditary abnormalities.
For further information, please read the package leaflet of the radiolabelled medicine.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, inform your nuclear medicine specialist. You may also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm

You will not be responsible for storing this medicinal product. It will be stored under the responsibility of the specialist, in appropriate premises. Storage of radiopharmaceuticals will comply with national regulations concerning radioactive products.
The following information is intended exclusively for the specialist.
The radionuclide generator must not be used after the expiry date stated on the container following "Exp.".
Do not dismantle the shielded container.
The gallium (Ga) chloride solution obtained with Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm must be used immediately.

6. Package contents and other information

What Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm contains

• The active substance consists of germanium (68Ge) chloride and gallium (68Ga) chloride dissolved in sterile ultra-pure hydrochloric acid 0.1 mol/L. Germanium (68Ge) is irreversibly retained within the radionuclide generator and decays into its daughter radionuclide gallium (68Ga), which is obtained from the generator as gallium (68Ga) chloride.
• The other components are: titanium dioxide (matrix), sterile ultra-pure hydrochloric acid 0.1 mol/L (elution solution).

A radionuclide generator is supplied with:

1. 1 PP container with eluent, 250 mL of sterile ultra-pure hydrochloric acid 0.1 mol/L (including a separate PP vial holder; PP = polypropylene)
2. 1 vented spike (ABS = acrylonitrile-butadiene-styrene / PE = polyethylene)
3. 2 adapters 1/16" for LUER male (PEEK)
4. 2 tubes 60 cm (PEEK)
5. 1 tube 40 cm (PEEK)
6. 1 tube 20 cm (PEEK)
7. 3 manual tightening connectors 1/16" 10-32 (PEEK)
8. 1 manual tightening connector 1/16" M6 (PEEK)
9. 1 connector with taps (TPX = polymethylpentene / HDPE = high-density polyethylene)
10. 1 LUER male connector (PP)

Description of the appearance of Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm and
package contents
You will not need to obtain or handle this medicine yourself.

Marketing Authorisation Holder and Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

---

The following information is intended for healthcare professionals only:

The full SmPC of Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is provided
as a separate document in the product packaging, in order to offer healthcare professionals
additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.

Patient Information Leaflet

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm 1.48 GBq radionuclide generator
gallium (Ga) chloride solution
Please read this leaflet carefully before you are administered 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 who will supervise 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 chloride (Ge)/Gallium chloride (Ga) GalliaPharm is and what it is used for
2. What you need to know before the gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is used
3. How the gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is used
4. Possible side effects
5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
6. Package contents and other information

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

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is a radionuclide generator of
germanium (Ge)/gallium (Ga), a device used to obtain a solution of gallium (Ga) chloride.
Gallium (Ga) chloride is a radioactive substance, handled by specialist physicians (nuclear medicine physicians) and pharmacists trained in working with radioactive materials. Gallium (Ga) chloride
is not intended for direct use in patients, but is used for radiolabelling, a technique whereby a substance is labelled (radiolabelled) with a radioactive compound—in this case, Ga.
Only medicinal products specifically developed and approved for radiolabelling with Ga are subjected to the radiolabelling procedure with gallium (Ga) chloride. These radiolabelled medicinal products can recognize specific types of cells in the body, bind to them, and deliver the radioactive Ga to these cells. The small amount of radioactivity present in the Ga-radiolabelled medicinal product can be detected outside the body using special equipment. This may assist the physician in diagnosis. For further information, please refer to the package leaflet of the medicinal product to be radiolabelled with gallium (Ga) chloride.
The nuclear medicine specialist will explain to you in more detail what type of examination will be performed.
The use of a medicinal product labelled with Ga involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine specialist consider that the clinical benefit obtained from the procedure using the Ga-labelled medicinal product outweighs the risk associated with radiation exposure.

2. What you need to know before the gallium (Ga) chloride solution obtained from

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
The gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga)
GalliaPharm must not be used

• if you are allergic to gallium (Ga) chloride or to any of the other ingredients of this medicinal product (listed in section 6).

If you are using a medicine labelled with Ga, please read the information on contraindications in the
package leaflet of the radiolabelled medicine.
Warnings and precautions
For information on special warnings and precautions for use of Ga-labelled medicines,
please consult the package leaflet of the radiolabelled medicine.
Children and adolescents
If you or your child is under 18 years of age, please consult a nuclear medicine specialist.
Other medicines and the gallium (Ga) chloride solution
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other
medicines, as they could interfere with the interpretation of images.
It is not known whether the gallium (Ga) chloride solution may interact with other medicines, as no
specific studies have been conducted. You will not receive an injection of gallium (Ga) chloride, but
another medicine radiolabelled with Ga.
For information on interactions associated with the use of Ga-labelled medicines, please consult the
package leaflet of the radiolabelled medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
please consult the nuclear medicine specialist before receiving Ga-labelled medicines.
You must inform the nuclear medicine specialist before administration of Ga-labelled medicines if
there is any possibility of pregnancy, if menstruation has not occurred, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist who will perform the procedure.
If you are pregnant
The nuclear medicine specialist will administer a Ga-labelled medicine during pregnancy only if the
expected benefit outweighs the risks.
If you are breastfeeding
You will be asked to stop breastfeeding. Ask the nuclear medicine specialist when you can resume
breastfeeding.
Driving and using machines
Effects on your ability to drive and use machines may occur due to the use of Ga-labelled medicines.
Please read the package leaflet of these medicines carefully.

3. How the gallium (⁶⁸Ga) chloride solution produced with germanium chloride is used

(⁶⁸Ge)/Gallium chloride (⁶⁸Ga) GalliaPharm
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Germanium chloride (⁶⁸Ge)/gallium chloride (⁶⁸Ga) GalliaPharm is used only in areas under special control. The preparation of the gallium (⁶⁸Ga) chloride solution, the radiolabelling of a specific carrier medicinal product, as well as the administration of the radiolabelled medicinal product, will be carried out by experienced and qualified personnel trained to handle it safely. These individuals will take great care in the safe use of this medicinal product and will inform you of their actions.
The amount of the Ga-radiolabelled medicinal product to be used in your case will be determined by the nuclear medicine specialist performing the procedure. This amount will be the lowest possible necessary to achieve the appropriate diagnostic result.

Administration of the gallium (⁶⁸Ga) chloride solution and performance of the procedure
You will not receive the gallium (⁶⁸Ga) chloride solution directly, but rather another medicinal product that has been linked (radiolabelled) with the gallium (⁶⁸Ga) chloride solution.

Duration of the procedure
The nuclear medicine specialist will inform you about the usual duration of the procedure using the Ga-radiolabelled medicinal product. For further information, please read the package leaflet of the medicinal product to be radiolabelled.

After administration of the medicinal product radiolabelled with gallium (⁶⁸Ga) chloride
The nuclear medicine specialist will inform you whether you need to take any special precautions after receiving the Ga-radiolabelled medicinal product. If you have any doubts, please consult the nuclear medicine specialist.

If you have received more of the medicinal product radiolabelled with gallium (⁶⁸Ga) chloride than you should,
or if you have accidentally received a direct injection of gallium (⁶⁸Ga) chloride
An overdose or accidental direct injection of gallium (⁶⁸Ga) chloride solution is unlikely, as you will receive the Ga-radiolabelled medicinal product only under the strict supervision of the nuclear medicine specialist responsible for the procedure. However, in the event of an overdose or accidental direct injection, you will receive appropriate treatment.

If you have any questions about the use of this medicinal product, please consult the nuclear medicine specialist performing the procedure.

4. Possible side effects

Like all medicines, this Ga-labelled medicine can cause side effects, although
not everybody will experience them.
After administration, the Ga-labelled medicine will produce small amounts of
ionising radiation, with a minimal risk of cancer and hereditary abnormalities.
For further information, please read the package leaflet of the radiolabelling medicinal product.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. You may also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm

You will not be responsible for storing this medicinal product. It will be stored under the responsibility of the specialist, in suitable premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended exclusively for the specialist.
The radionuclide generator must not be used after the expiry date stated on the container following "Exp.".
Do not dismantle the box.
The solution of gallium (Ga) chloride obtained with Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm must be used immediately.

6. Package contents and other information

What Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm contains

• The active substance consists of germanium (Ge) chloride and gallium (Ga) chloride dissolved in sterile ultra-pure hydrochloric acid 0.1 mol/L. Germanium (Ge) is irreversibly retained within the radionuclide generator and decays into its daughter radionuclide gallium (Ga), which is obtained from the generator as gallium (Ga) chloride.
• The other components are: titanium dioxide (matrix), sterile ultra-pure hydrochloric acid 0.1 mol/L (elution solution).

A radionuclide generator is supplied with:

1. 1 PP container with eluent, 250 mL of sterile ultra-pure hydrochloric acid 0.1 mol/L (including a separate hook for PP vials; PP = polypropylene)
2. 1 vented piercing device (ABS = acrylonitrile-butadiene-styrene / PE = polyethylene)
3. 2 adapters 1/16" for male LUER (PEEK)
4. 2 tubes 60 cm (PEEK)
5. 1 tube 40 cm (PEEK)
6. 1 tube 20 cm (PEEK)
7. 3 manual clamp connectors 1/16" 10-32 (PEEK)
8. 1 manual clamp connector 1/16" M6 (PEEK)
9. 1 connector with stopcocks (TPX = polymethylpentene / HDPE = high-density polyethylene)
10. 1 male LUER connector (PP)

Description of the appearance of Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm and
contents of the pack
You do not need to obtain or handle this medicinal product.
Marketing Authorization Holder and Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany
Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

---

The following information is intended for healthcare professionals only:

The full SmPC of Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is provided as a
separate document in the product package, in order to supply healthcare professionals with additional
scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.

Package leaflet: Information for the patient

Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm 1.85 GBq radionuclide generator
gallium ( Ga) chloride solution
Please read this leaflet carefully before this medicine is administered to you because
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 who will supervise 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 chloride (**Ge)/Gallium chloride (**Ga) GalliaPharm is and what it is used for
2. What you need to know before the gallium (**Ga) chloride solution obtained from Germanium chloride (**Ge)/Gallium chloride (**Ga) GalliaPharm is used
3. How the gallium (**Ga) chloride solution obtained from Germanium chloride (**Ge)/Gallium chloride (**Ga) GalliaPharm is used
4. Possible side effects
5. How to store Germanium chloride (**Ge)/Gallium chloride (**Ga) GalliaPharm
6. Contents of the pack and other information

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

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is a radionuclide generator of
germanium (Ge)/gallium (Ga), a device used to obtain a solution of gallium (Ga) chloride.
Gallium (Ga) chloride is a radioactive substance, handled by specialist physicians (nuclear medicine physicians) and pharmacists trained in working with radioactive materials. Gallium (Ga) chloride
is not intended to be used directly in patients, but is used for radiolabelling, a technique whereby a substance is labelled (radiolabelled) with a radioactive compound, in this case Ga.
Only medicinal products specifically developed and approved for radiolabelling with Ga are subjected to the radiolabelling procedure with gallium (Ga) chloride. These radiolabelled medicinal products can recognize specific types of cells in the body, bind to them, and deliver the radioactive Ga to these cells. The small amount of radioactivity present in the Ga-radiolabelled medicinal product can be detected outside the body using special equipment. This may assist the physician in diagnosis. For further information, please refer to the package leaflet of the medicinal product to be radiolabelled with gallium (Ga) chloride.
The nuclear medicine specialist will explain in greater detail which type of examination will be performed.
The use of a medicinal product labelled with Ga involves exposure to small amounts of radioactivity. The physician and nuclear medicine specialist consider that the clinical benefit obtained from the procedure using the Ga-labelled medicinal product outweighs the risk due to radiation exposure.

2. What you need to know before the gallium (Ga) chloride solution obtained from

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
The gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga)
GalliaPharm 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 medicinal product labelled with Ga, please read the information on contraindications in the package leaflet of the radiolabelled medicinal product.
Warnings and precautions
For information on special warnings and precautions for use of Ga-labelled medicinal products, consult the package leaflet of the radiolabelled medicinal product.
Children and adolescents
If you or your child is under 18 years of age, please consult the nuclear medicine specialist.
Other medicines and the gallium (Ga) chloride solution
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other medicines, as they could interfere with image interpretation.
It is not known whether the gallium (Ga) chloride solution may interact with other medicines, as specific studies have not been conducted. You will not receive an injection of gallium (Ga) chloride itself, but another medicinal product radiolabelled with Ga.
For information on interactions related to the use of Ga-labelled medicinal products, refer to the package leaflet of the radiolabelled medicinal product.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult the nuclear medicine specialist before receiving Ga-labelled medicinal products.
You must inform the nuclear medicine specialist before administration of Ga-labelled medicinal products if there is any possibility of pregnancy, if your menstrual period is overdue, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist who will perform the procedure.
If you are pregnant
The nuclear medicine specialist will administer a Ga-labelled medicinal product during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding
You will be asked to interrupt breastfeeding. Ask the nuclear medicine specialist when you may resume breastfeeding.
Driving and using machines
Effects on your ability to drive and use machines may occur due to the use of Ga-labelled medicinal products. Please read the package leaflet of these medicinal products carefully.

3. How the gallium (Ga) chloride solution produced with Germanium chloride is used

( Ge)/Gallium chloride ( Ga) GalliaPharm
There are strict rules regarding the use, handling, and disposal of radiopharmaceuticals. Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm is used only in areas under special control. The preparation of the gallium ( **Ga) chloride solution, the radiolabelling of a specific carrier medicinal product, as well as the administration of the radiolabelled medicinal product, will be managed by experienced and qualified personnel trained to handle it safely. These individuals will take great care in the safe use of this medicinal product and will inform you about their actions.
The amount of the Ga radiolabelled medicinal product to be used in your case will be determined by the nuclear medicine specialist performing the procedure. This amount will be the lowest possible necessary to achieve the appropriate diagnostic result.

Administration of the gallium ( Ga) chloride solution and performance of the procedure
You will not receive the gallium ( **Ga) chloride solution directly, but rather another medicinal product that has been linked (radiolabelled) with the gallium ( **Ga) chloride solution.

Duration of the procedure
The nuclear medicine specialist will inform you about the usual duration of the procedure using the Ga radiolabelled medicinal product. For further information, please read the package leaflet of the medicinal product to be radiolabelled.

After administration of the medicinal product radiolabelled with gallium ( Ga) chloride
The nuclear medicine specialist will inform you whether you need to take any special precautions after receiving the Ga radiolabelled medicinal product. If you have any doubts, consult the nuclear medicine specialist.

If you have received more Ga radiolabelled medicinal product than you should, or if you have accidentally received a direct injection of gallium ( Ga) chloride
An overdose or accidental direct injection of gallium ( **Ga) chloride solution is unlikely, as you will receive the Ga radiolabelled medicinal product only under the strict supervision of the nuclear medicine specialist responsible for the procedure. However, in the event of an overdose or accidental direct injection, you will receive appropriate treatment.

If you have any doubts about the use of this medicinal product, consult the nuclear medicine specialist performing the procedure.

4. Possible side effects

Like all medicines, this gallium-labelled medicine may cause side effects, although
not everybody will experience them.
After administration, the gallium-labelled medicine will produce small amounts of
ionising radiation, with a minimal risk of cancer and hereditary abnormalities.
For further information, please read the package leaflet of the radiopharmaceutical.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. You may also report side effects directly
via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm

You will not be responsible for storing this medicinal product. It will be stored under the supervision of a specialist in appropriate facilities. Storage of radiopharmaceuticals will comply with national regulations concerning radioactive materials.
The following information is intended exclusively for the specialist.
The radionuclide generator must not be used after the expiry date stated on the container after "Exp.".
Do not dismantle the cassette.
The gallium (Ga) chloride solution obtained with Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm must be used immediately.

6. Package contents and other information

What Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm contains

• The active substance consists of germanium (68Ge) chloride and gallium (68Ga) chloride dissolved in sterile ultra-pure hydrochloric acid 0.1 mol/L. Germanium (68Ge) is irreversibly retained within the radionuclide generator and decays into its daughter radionuclide gallium (68Ga), which is obtained from the generator as gallium (68Ga) chloride.
• The other components are: titanium dioxide (matrix), sterile ultra-pure hydrochloric acid 0.1 mol/L (elution solution).

A radionuclide generator is supplied with:

1. 1 PP container with eluent, 250 mL of sterile ultra-pure hydrochloric acid 0.1 mol/L (including a separate hook for PP vials; PP = polypropylene)
2. 1 vented piercing device (ABS = acrylonitrile-butadiene-styrene / PE = polyethylene)
3. 2 adapters 1/16" for male LUER (PEEK)
4. 2 tubes 60 cm (PEEK)
5. 1 tube 40 cm (PEEK)
6. 1 tube 20 cm (PEEK)
7. 3 manual tightening fittings 1/16" 10-32 (PEEK)
8. 1 manual tightening fitting 1/16" M6 (PEEK)
9. 1 connector with stopcocks (TPX = polymethylpentene / HDPE = high-density polyethylene)
10. 1 male LUER connector (PP)

Description of the appearance of Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm and
contents of the pack
You do not need to obtain or handle this medicinal product.
Marketing Authorization Holder and Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

---

The following information is intended for healthcare professionals only:

The full SmPC of Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is provided as a
separate document in the product packaging, in order to supply healthcare professionals with
additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.

Package leaflet: Information for the patient

Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm 2.22 GBq radionuclide generator
gallium ( Ga) chloride solution
Please read this leaflet carefully before you are given this medicine because 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 who will supervise 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 chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm is and what it is used for
2. What you need to know before the gallium ( Ga) chloride solution obtained from Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm is used
3. How the gallium ( Ga) chloride solution obtained from Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm is used
4. Possible side effects
5. How to store Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm
6. Contents of the pack and other information

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

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is a radionuclide generator of
germanium (Ge)/gallium (Ga), a device used to obtain a solution of gallium (Ga) chloride.
Gallium (Ga) chloride is a radioactive substance, handled by specialist physicians (nuclear medicine physicians) and pharmacists trained in working with radioactive materials. Gallium (Ga) chloride
is not intended to be used directly in patients, but is used for radiolabelling, a technique whereby a substance is labelled (radiolabelled) with a radioactive compound—in this case, Ga.
Only medicinal products specifically developed and approved for radiolabelling with Ga undergo the radiolabelling procedure using gallium (Ga) chloride. These radiolabelled medicinal products can recognize specific types of cells in the body, bind to them, and deliver the radioactive Ga to these cells. The small amount of radioactivity present in the Ga-radiolabelled medicinal product can be detected outside the body using special equipment. This may assist the physician in diagnosis. For further information, please refer to the package leaflet of the medicinal product intended for radiolabelling with gallium (Ga) chloride.
The nuclear medicine specialist will provide you with more detailed information about the type of examination to be performed.
The use of a Ga-labelled medicinal product involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine specialist consider that the clinical benefit obtained from the procedure using the Ga-labelled medicinal product outweighs the risk associated with radiation exposure.

2. What you need to know before the gallium (Ga) chloride solution obtained from

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
The gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm must not be used

• if you are allergic to gallium (Ga) chloride or to any of the other ingredients of this medicinal product (listed in section 6).

If you are using a radiolabelled Ga-containing medicine, please read the contraindications information in the package leaflet of the radiolabelled medicine.
Warnings and precautions
For information on special warnings and precautions for use of Ga-labelled medicines, consult the package leaflet of the radiolabelled medicine.
Children and adolescents
If you or your child is under 18 years of age, please consult a nuclear medicine specialist.
Other medicines and the gallium (Ga) chloride solution
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other medicines, as they could interfere with image interpretation.
It is not known whether gallium (Ga) chloride solution may interact with other medicines, as specific studies have not been conducted. You will not receive an injection of gallium (Ga) chloride itself, but rather another medicine radiolabelled with Ga.
For information on interactions related to the use of Ga-labelled medicines, refer to the package leaflet of the radiolabelled medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult a nuclear medicine specialist before receiving Ga-labelled medicines.
You must inform the nuclear medicine specialist before administration of Ga-labelled medicines if there is any possibility of pregnancy, if your menstrual period is overdue, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist who will perform the procedure.
If you are pregnant
The nuclear medicine specialist will administer a Ga-labelled medicine during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding
You will be asked to interrupt breastfeeding. Ask the nuclear medicine specialist when you may resume breastfeeding.
Driving and using machines
Effects on your ability to drive and use machines may occur due to the use of Ga-labelled medicines. Please read the package leaflet of these medicines carefully.

3. How the gallium (Ga) chloride solution produced with Germanium chloride is used

( Ge)/Gallium chloride ( Ga) GalliaPharm
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm is used only in areas under special control. The preparation of the gallium ( **Ga) chloride solution, the radiolabelling of a specific carrier medicinal product, as well as the administration of the radiolabelled medicinal product, will be carried out by experienced and qualified personnel trained to handle it safely. These individuals will take great care in the safe use of this medicinal product and will inform you about their actions.
The amount of the Ga-radiolabelled medicinal product to be used in your case will be determined by the nuclear medicine specialist performing the procedure. This amount will be the lowest possible necessary to achieve the appropriate diagnostic result.

Administration of the gallium ( Ga) chloride solution and performance of the procedure
You will not receive the gallium ( **Ga) chloride solution directly, but another medicinal product that has been linked (radiolabelled) with the gallium ( **Ga) chloride solution.

Duration of the procedure
The nuclear medicine specialist will inform you about the usual duration of the procedure using the Ga-radiolabelled medicinal product. For further information, please read the package leaflet of the medicinal product to be radiolabelled.

After administration of the medicinal product radiolabelled with gallium ( Ga) chloride
The nuclear medicine specialist will inform you whether you need to take special precautions after receiving the Ga-radiolabelled medicinal product. If you have any doubts, please consult the nuclear medicine specialist.

If you have received more of the medicinal product radiolabelled with gallium ( Ga) chloride than intended, or if you accidentally received a direct injection of gallium ( Ga) chloride
An overdose or accidental direct injection of gallium ( **Ga) chloride solution is unlikely, as you will receive the Ga-radiolabelled medicinal product only under the strict supervision of the nuclear medicine specialist responsible for the procedure. However, in the event of an overdose or accidental direct injection, you will receive appropriate treatment.

If you have any doubts about the use of this medicinal product, please consult the nuclear medicine specialist performing the procedure.

4. Possible side effects

Like all medicines, this gallium-labelled medicine can cause side effects, although
not everybody gets them.
After administration, the gallium-labelled medicine will produce small amounts of
ionising radiation, with a minimal risk of cancer and hereditary abnormalities.
For further information, please read the package leaflet of the radiolabelled medicine.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. You may also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm

You will not be responsible for storing this medicinal product. It will be stored under the responsibility of the specialist, in appropriate premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended exclusively for the specialist.
The radionuclide generator must not be used after the expiry date stated on the container following "Exp.".
Do not dismantle the shielded container.
The solution of gallium (Ga) chloride obtained with Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm must be used immediately.

6. Package contents and other information

What Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm contains

• The active substance consists of germanium (68Ge) chloride and gallium (68Ga) chloride dissolved in sterile ultra-pure hydrochloric acid 0.1 mol/L. Germanium (68Ge) is irreversibly retained within the radionuclide generator and decays into its daughter nuclide gallium (68Ga), which is obtained from the generator as gallium (68Ga) chloride.
• Other components are: titanium dioxide (matrix), sterile ultra-pure hydrochloric acid 0.1 mol/L (elution solution)

A radionuclide generator is supplied with:

1. 1 PP container with eluent, 250 mL of sterile ultra-pure hydrochloric acid 0.1 mol/L (including a separate hook for PP vials; PP = polypropylene)
2. 1 vented spike (ABS = acrylonitrile-butadiene-styrene / PE = polyethylene)
3. 2 adapters 1/16" for male LUER (PEEK)
4. 2 tubes 60 cm (PEEK)
5. 1 tube 40 cm (PEEK)
6. 1 tube 20 cm (PEEK)
7. 3 manual tightening fittings 1/16" 10-32 (PEEK)
8. 1 manual tightening fitting 1/16" M6 (PEEK)
9. 1 connector with taps (TPX = polymethylpentene / HDPE = high-density polyethylene)
10. 1 male LUER connector (PP)

Description of the appearance of Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm and
contents of the pack
You do not need to obtain or handle this medicinal product.
Marketing Authorization Holder and Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

---

The following information is intended for healthcare professionals only:

The full SmPC of Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is provided as
a separate document in the product packaging, in order to supply healthcare professionals with additional
scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.

Patient Information Leaflet

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm 2.59 GBq radionuclide generator
gallium (Ga) chloride solution
Please read this leaflet carefully before you are given this medicine because 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 who will supervise 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 chloride (Ge)/Gallium chloride (Ga) GalliaPharm is and what it is used for
2. What you need to know before the gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is used
3. How the gallium chloride (Ga) solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is used
4. Possible side effects
5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
6. Contents of the pack and other information

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

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is a radionuclide generator of
germanium (Ge)/gallium (Ga), a device used to obtain a solution of gallium (Ga) chloride.
Gallium (Ga) chloride is a radioactive substance, handled by specialist physicians (nuclear medicine physicians) and pharmacists trained in working with radioactive materials. Gallium (Ga) chloride
is not intended to be used directly in patients, but is used for radiolabelling, a technique whereby a substance is labelled (radiolabelled) with a radioactive compound—in this case, Ga.
Only medicinal products specifically developed and approved for radiolabelling with Ga undergo the radiolabelling procedure with gallium (Ga) chloride. These radiolabelled medicinal products can recognise specific types of cells in the body, bind to them, and deliver the radioactive Ga to these cells. The small amount of radioactivity present in the Ga-radiolabelled medicinal product can be detected outside the body using special equipment. This may assist the physician in diagnosis. For further information, please refer to the package leaflet of the medicinal product to be radiolabelled with gallium (Ga) chloride.
The nuclear medicine specialist will provide you with more detailed information about the type of examination to be performed.
The use of a medicinal product labelled with Ga involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine specialist consider that the clinical benefit obtained from the procedure using the Ga-labelled medicinal product outweighs the risk associated with radiation exposure.

2. What you need to know before the gallium (Ga) chloride solution obtained from

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
The gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga)
GalliaPharm 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, please read the information on contraindications in the
package leaflet of the radiolabelled medicine.
Warnings and precautions
For information on special warnings and precautions for use of Ga-labelled medicines,
please consult the package leaflet of the radiolabelled medicine.
Children and adolescents
If you or your child is under 18 years of age, please consult a nuclear medicine specialist.
Other medicines and the gallium (Ga) chloride solution
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other
medicines, as they could interfere with image interpretation.
It is not known whether the gallium (Ga) chloride solution may interact with other medicines, as no
specific studies have been conducted. You will not receive an injection of gallium (Ga) chloride itself, but
another medicine radiolabelled with Ga.
For information on interactions associated with the use of Ga-labelled medicines, refer to the
package leaflet of the radiolabelled medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, please
consult a nuclear medicine specialist before receiving Ga-labelled medicines.
You must inform the nuclear medicine specialist before administration of Ga-labelled medicines if
pregnancy is possible, if your menstrual period is overdue, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist who will perform the procedure.
If you are pregnant
The nuclear medicine specialist will administer a Ga-labelled medicine during pregnancy only if the
expected benefit outweighs the potential risks.
If you are breastfeeding
You will be asked to interrupt breastfeeding. Ask the nuclear medicine specialist when you can resume
breastfeeding.
Driving and using machines
Effects on your ability to drive and use machines may occur due to the use of Ga-labelled medicines.
Please read the package leaflet of these medicines carefully.

3. How the gallium (Ga) chloride solution produced with germanium chloride is used

( Ge)/Gallium chloride ( Ga) GalliaPharm
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm is used only in areas under special control. The preparation of the gallium ( **Ga) chloride solution, the radiolabelling of a specific carrier medicinal product, as well as the administration of the radiolabelled medicinal product, will be managed by experienced and qualified personnel trained to handle it safely. These individuals will take great care in the safe use of this medicinal product and will inform you of their actions.
The amount of the Ga-radiolabelled medicinal product to be used in your case will be determined by the nuclear medicine specialist performing the procedure. This amount will be the lowest possible necessary to achieve the appropriate diagnostic result.
Administration of the gallium ( Ga) chloride solution and performance of the procedure
You will not receive the gallium ( **Ga) chloride solution directly, but another medicinal product that has been linked (radiolabelled) with the gallium ( **Ga) chloride solution.
Duration of the procedure
The nuclear medicine specialist will inform you about the usual duration of the procedure using the Ga-radiolabelled medicinal product. For further information, please read the package leaflet of the medicinal product to be radiolabelled.
After administration of the medicinal product radiolabelled with gallium ( Ga) chloride
The nuclear medicine specialist will inform you whether you need to take special precautions after receiving the Ga-radiolabelled medicinal product. If you have any doubts, consult the nuclear medicine specialist.
If you have received more Ga-radiolabelled medicinal product than you should, or if you have accidentally received a direct injection of gallium ( Ga) chloride
An overdose or accidental direct injection of gallium ( **Ga) chloride solution is unlikely, as you will receive the Ga-radiolabelled medicinal product only under the strict supervision of the nuclear medicine specialist responsible for the procedure. However, in the event of an overdose or accidental direct injection, you will receive appropriate treatment.
If you have any questions about the use of this medicinal product, please consult the nuclear medicine specialist performing the procedure.

4. Possible side effects

Like all medicines, this gallium-labelled medicine can cause side effects, although
not everybody will experience them.
After administration, the gallium-labelled medicine will produce small amounts of
ionising radiation, with a minimal risk of cancer and hereditary abnormalities.
For further information, please read the package leaflet of the radiolabelled medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult the nuclear medicine specialist. You may also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm

You will not be responsible for storing this medicinal product. It will be stored under the responsibility of a specialist in appropriate premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended exclusively for specialists.
The radionuclide generator must not be used after the expiry date stated on the container after "Exp.".
Do not dismantle the cassette.
The gallium (Ga) chloride solution obtained with Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm must be used immediately.

6. Contents of the pack and other information

What Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm contains

• The active substance consists of germanium (Ge) chloride and gallium (Ga) chloride dissolved in sterile ultra-pure hydrochloric acid 0.1 mol/L. Germanium (Ge) is irreversibly retained within the radionuclide generator and decays into the daughter radionuclide gallium (Ga), which is obtained from the generator as gallium (Ga) chloride.
• The other components are: titanium dioxide (matrix), sterile ultra-pure hydrochloric acid 0.1 mol/L (elution solution).

A radionuclide generator is supplied with:

1. 1 PP container with eluent, 250 mL of sterile ultra-pure hydrochloric acid 0.1 mol/L (including a separate hook for PP vials; PP = polypropylene)
2. 1 vented piercing device (ABS = acrylonitrile-butadiene-styrene / PE = polyethylene)
3. 2 adapters 1/16" for LUER male (PEEK)
4. 2 tubes, 60 cm (PEEK)
5. 1 tube, 40 cm (PEEK)
6. 1 tube, 20 cm (PEEK)
7. 3 manual tightening connectors 1/16" 10-32 (PEEK)
8. 1 manual tightening connector 1/16" M6 (PEEK)
9. 1 connector with valves (TPX = polymethylpentene / HDPE = high-density polyethylene)
10. 1 LUER male connector (PP)

Description of the appearance of Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm and
contents of the pack
You will not have to obtain or handle this medicine yourself.

Marketing Authorization Holder and Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

---

The following information is intended for healthcare professionals only:

The full SmPC of Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is provided as a
separate document in the product packaging, in order to supply healthcare professionals with additional
scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.

Package leaflet: Information for the patient

Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm 2.96 GBq radionuclide generator
gallium ( Ga) chloride solution
Please read this leaflet carefully before you are administered this medicine because
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 who will supervise the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet

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

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

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is a radionuclide generator of
germanium (Ge)/gallium (Ga), a device used to obtain a solution of gallium (Ga) chloride.
Gallium (Ga) chloride is a radioactive substance, handled by specialist physicians (nuclear medicine physicians) and pharmacists trained in working with radioactive materials. Gallium (Ga) chloride
is not intended to be used directly in patients, but is used for radiolabelling, a technique whereby a substance is labelled (radiolabelled) with a radioactive compound, in this case Ga.
Only medicinal products specifically developed and approved for radiolabelling with Ga undergo the radiolabelling procedure using gallium (Ga) chloride. These radiolabelled medicinal products can recognize specific types of cells in the body to which they bind, delivering the radioactive Ga to these cells within the body. The small amount of radioactivity present in the Ga-radiolabelled medicinal product can be detected outside the body using special equipment. This may assist the physician in diagnosis. For further information, please refer to the package leaflet of the medicinal product to be radiolabelled with gallium (Ga) chloride.
The nuclear medicine specialist will provide you with more detailed information about the type of examination to be performed.
The use of a Ga-labelled medicinal product involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine specialist consider that the clinical benefit obtained from the procedure using the Ga-labelled medicinal product outweighs the risk associated with radiation exposure.

2. What you need to know before the gallium (Ga) chloride solution obtained from

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
The gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga)
GalliaPharm 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, please read the information on contraindications in the
package leaflet of the radiolabelled medicine.
Warnings and precautions
For information on special warnings and precautions for use of Ga-labelled medicines,
please consult the package leaflet of the radiolabelled medicine.
Children and adolescents
If you or your child is under 18 years of age, please consult a nuclear medicine specialist.
Other medicines and the gallium (Ga) chloride solution
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other
medicines, as they could interfere with the interpretation of images.
It is not known whether the gallium (Ga) chloride solution may interact with other medicines, as no
specific studies have been conducted. You will not receive an injection of gallium (Ga) chloride itself, but
a different medicine radiolabelled with Ga.
For information on interactions associated with the use of Ga-labelled medicines, please refer to the
package leaflet of the radiolabelled medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding with
breast milk, please consult a nuclear medicine specialist before receiving Ga-labelled medicines.
You must inform the nuclear medicine specialist before administration of Ga-labelled medicines if
there is any possibility of pregnancy, if menstruation has not occurred, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist who will perform the procedure.
If you are pregnant
The nuclear medicine specialist will administer a Ga-labelled medicine during pregnancy only if the
expected benefit outweighs the potential risks.
If you are breastfeeding
You will be asked to interrupt breastfeeding. Ask the nuclear medicine specialist when it will be safe to
resume breastfeeding.
Driving and using machines
Effects on your ability to drive and use machines may occur due to the use of Ga-labelled medicines.
Please read the package leaflet of these medicines carefully.

3. How the gallium (Ga) chloride solution produced with germanium chloride is used

( Ge)/Gallium chloride ( Ga) GalliaPharm
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Germanium chloride
( Ge)/Gallium chloride ( Ga) GalliaPharm is used only in areas under special control. The
production of the gallium ( Ga) chloride solution, the radiolabelling of a specific carrier medicinal product,
as well as the administration of the radiolabelled medicinal product with Ga, will be managed by experienced and qualified personnel trained to handle it safely.
These individuals will take great care in the safe use of this medicinal product and will inform you about their actions.
The amount of Ga-radiolabelled medicinal product to be used in your case will be determined by the nuclear medicine specialist performing the procedure. This amount will be the lowest possible necessary to achieve the appropriate diagnostic result.
Administration of the gallium ( Ga) chloride solution and performance of the procedure
You will not receive the gallium ( Ga) chloride solution directly, but another medicinal product that has been linked (radiolabelled) to the gallium ( Ga) chloride solution.
Duration of the procedure
The nuclear medicine specialist will inform you about the usual duration of the procedure using the Ga-radiolabelled medicinal product. For further information, please read the package leaflet of the medicinal product to be radiolabelled.
After administration of the medicinal product radiolabelled with the gallium ( Ga) chloride solution
The nuclear medicine specialist will inform you whether you need to take any special precautions after receiving the Ga-radiolabelled medicinal product. If you have any doubts, consult the nuclear medicine specialist.
If you have received more Ga-radiolabelled medicinal product than intended, or if you have accidentally received a direct injection of gallium ( Ga) chloride
An overdose or accidental direct injection of gallium ( Ga) chloride solution is unlikely, as you will receive the Ga-radiolabelled medicinal product only under the strict supervision of the nuclear medicine specialist responsible for the procedure. However, in the event of an overdose or accidental direct injection, you will receive appropriate treatment.
If you have any questions about the use of this medicinal product, consult the nuclear medicine specialist performing the procedure.

4. Possible side effects

Like all medicines, this Ga-labelled medicine can cause side effects, although not everybody gets them.
After administration, the Ga-labelled medicine will produce small amounts of ionising radiation, with a minimal risk of cancer and hereditary abnormalities.
For further information, please read the package leaflet of the radiolabelled medicinal product.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult the nuclear medicine specialist. You may also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm

You will not be responsible for storing this medicinal product. It will be stored under the supervision of a specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended exclusively for the specialist.

The radionuclide generator must not be used after the expiry date stated on the container after "Exp.".

Do not dismantle the cassette.

The gallium (Ga) chloride solution obtained with Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm must be used immediately.

6. Package contents and other information

What Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm contains

• The active substance consists of germanium (68Ge) chloride and gallium (68Ga) chloride dissolved in sterile ultra-pure hydrochloric acid 0.1 mol/L. Germanium (68Ge) is irreversibly retained within the radionuclide generator and decays into the daughter radionuclide gallium (68Ga), which is obtained from the generator as gallium (68Ga) chloride.
• The other components are: titanium dioxide (matrix), sterile ultra-pure hydrochloric acid 0.1 mol/L (solution for elution)

One radionuclide generator is supplied with:

1. 1 PP container with eluent, 250 mL of sterile ultra-pure hydrochloric acid 0.1 mol/L (including a separate hook for PP vials; PP = polypropylene)
2. 1 vented puncture device (ABS = acrylonitrile-butadiene-styrene / PE = polyethylene)
3. 2 adapters 1/16" for male LUER (PEEK)
4. 2 tubes 60 cm (PEEK)
5. 1 tube 40 cm (PEEK)
6. 1 tube 20 cm (PEEK)
7. 3 manual tightening fittings 1/16" 10-32 (PEEK)
8. 1 manual tightening fitting 1/16" M6 (PEEK)
9. 1 connector with stopcocks (TPX = polymethylpentene / HDPE = high-density polyethylene)
10. 1 male LUER connector (PP)

Description of the appearance of Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm and
contents of the pack
You are not required to obtain or handle this medicinal product.
Marketing Authorisation Holder and Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

---

The following information is intended for healthcare professionals only:

The full SmPC of Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is provided as a
separate document in the product package, in order to supply healthcare professionals with additional
scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.

Package leaflet: Information for the patient

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm 3.33 GBq radionuclide generator
gallium (Ga) chloride solution
Please read this leaflet carefully before you are given this medicine because 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 who will supervise 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 chloride (Ge)/Gallium chloride (Ga) GalliaPharm is and what it is used for
2. What you need to know before the gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is used
3. How the gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is used
4. Possible side effects
5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
6. Contents of the pack and other information

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

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is a radionuclide generator of
germanium (Ge)/gallium (Ga), a device used to obtain a solution of gallium (Ga) chloride.
Gallium (Ga) chloride is a radioactive substance, handled by specialist physicians (nuclear medicine physicians) and pharmacists trained in working with radioactive materials. Gallium (Ga) chloride
is not intended to be used directly in patients, but is used for radiolabelling, a technique whereby a substance is labelled (radiolabelled) with a radioactive compound, in this case Ga.
Only medicinal products specifically developed and approved for radiolabelling with Ga undergo the radiolabelling procedure with gallium (Ga) chloride. These radiolabelled medicinal products can recognize specific types of cells in the body, bind to them, and deliver the radioactive Ga to these cells. The small amount of radioactivity present in the Ga-radiolabelled medicinal product can be detected outside the body using special equipment. This may assist the physician in diagnosis. For further information, please refer to the package leaflet of the medicinal product to be radiolabelled with gallium (Ga) chloride.
The nuclear medicine specialist will provide you with more detailed information about the type of examination to be performed.
The use of a Ga-labelled medicinal product involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine specialist consider that the clinical benefit obtained from the procedure using the Ga-labelled medicinal product outweighs the risk associated with radiation exposure.

2. What you need to know before the gallium (Ga) chloride solution obtained from

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
The gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga)
GalliaPharm must not be used

• if you are allergic to gallium (Ga) chloride or to any of the other ingredients of this medicinal product (listed in section 6).

If you are using a radiolabelled Ga-containing medicine, please read the information regarding contraindications in the package leaflet of the radiolabelled medicine.
Warnings and precautions
For information on special warnings and precautions for use of Ga-labelled medicines, consult the package leaflet of the radiolabelled medicine.
Children and adolescents
If you or your child is under 18 years of age, please consult a nuclear medicine specialist.
Other medicines and the gallium (Ga) chloride solution
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other medicines, as they could interfere with image interpretation.
It is not known whether the gallium (Ga) chloride solution may interact with other medicines, as specific studies have not been conducted. You will not receive an injection of gallium (Ga) chloride itself, but rather another medicine radiolabelled with Ga.
For information on interactions related to the use of Ga-labelled medicines, refer to the package leaflet of the radiolabelled medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, please consult a nuclear medicine specialist before receiving Ga-labelled medicines.
You must inform the nuclear medicine specialist before administration of Ga-labelled medicines if there is any possibility of pregnancy, if your menstrual period is overdue, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist who will perform the procedure.
If you are pregnant
The nuclear medicine specialist will administer a Ga-labelled medicine during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding
You will be asked to stop breastfeeding. Ask the nuclear medicine specialist when you can safely resume breastfeeding.
Driving and using machines
Effects on your ability to drive and use machines may occur due to the use of Ga-labelled medicines. Please read the package leaflet of these medicines carefully.

3. How the gallium (⁶⁸Ga) chloride solution produced with germanium chloride (⁶⁸Ge) is used

(⁶⁸Ge)/Gallium chloride (⁶⁸Ga) GalliaPharm
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Germanium chloride (⁶⁸Ge)/Gallium chloride (⁶⁸Ga) GalliaPharm is used only in areas under special control. The preparation of the gallium (⁶⁸Ga) chloride solution, the radiolabelling of a specific carrier medicinal product, as well as the administration of the radiolabelled medicinal product, will be carried out by experienced and qualified personnel trained to handle it safely. These individuals will take great care in the safe use of this medicinal product and will inform you of their actions.
The amount of the ⁶⁸Ga-radiolabelled medicinal product to be used in your case will be determined by the nuclear medicine specialist performing the procedure. This amount will be the lowest possible necessary to achieve the appropriate diagnostic result.

Administration of the gallium (⁶⁸Ga) chloride solution and performance of the procedure
You will not receive the gallium (⁶⁸Ga) chloride solution directly, but rather another medicinal product that has been linked (radiolabelled) with the gallium (⁶⁸Ga) chloride solution.

Duration of the procedure
The nuclear medicine specialist will inform you about the usual duration of the procedure using the ⁶⁸Ga-labelled medicinal product. For further information, please read the package leaflet of the medicinal product to be radiolabelled.

After administration of the medicinal product radiolabelled with gallium (⁶⁸Ga) chloride solution
The nuclear medicine specialist will inform you whether you need to take any special precautions after receiving the ⁶⁸Ga-labelled medicinal product. If you have any doubts, please consult the nuclear medicine specialist.

If you have received more of the medicinal product radiolabelled with gallium (⁶⁸Ga) chloride solution than you should,
or if you have accidentally received a direct injection of gallium (⁶⁸Ga) chloride
An overdose or accidental direct injection of the gallium (⁶⁸Ga) chloride solution is unlikely, as you will receive the ⁶⁸Ga-labelled medicinal product only under the strict supervision of the nuclear medicine specialist responsible for the procedure. However, in the event of an overdose or accidental direct injection, appropriate treatment will be provided.

If you have any doubts about the use of this medicinal product, please consult the nuclear medicine specialist performing the procedure.

4. Possible side effects

Like all medicines, this Ga-labelled medicine can cause side effects, although
not everybody will experience them.
After administration, the Ga-labelled medicine will produce small amounts of
ionising radiation, with a minimal risk of cancer and hereditary abnormalities.
For further information, please read the package leaflet of the radiolabelled medicine.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. You may also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm

You will not be responsible for storing this medicinal product. It will be stored under the responsibility of the specialist, in suitable premises. Storage of radiopharmaceuticals will comply with national regulations concerning radioactive products.
The following information is intended exclusively for the specialist.
The radionuclide generator must not be used after the expiry date stated on the container after "Exp.".
Do not dismantle the box.
The solution of gallium (Ga) chloride obtained with Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm must be used immediately.

6. Package contents and other information

What Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm contains

• The active substance consists of germanium (Ge) chloride and gallium (Ga) chloride dissolved in sterile ultra-pure hydrochloric acid 0.1 mol/L. Germanium (Ge) is irreversibly retained within the radionuclide generator and decays into its daughter nuclide gallium (Ga), which is obtained from the generator as gallium (Ga) chloride.
• The other components are: titanium dioxide (matrix), sterile ultra-pure hydrochloric acid 0.1 mol/L (elution solution).

A radionuclide generator is supplied with:

1. 1 PP container with eluent, 250 mL of sterile ultra-pure hydrochloric acid 0.1 mol/L (including a separate hook for PP vials; PP = polypropylene)
2. 1 air inlet spike (ABS = acrylonitrile-butadiene-styrene / PE = polyethylene)
3. 2 adapters 1/16" for LUER male (PEEK)
4. 2 tubes, 60 cm (PEEK)
5. 1 tube, 40 cm (PEEK)
6. 1 tube, 20 cm (PEEK)
7. 3 manual clamp connectors 1/16" 10-32 (PEEK)
8. 1 manual clamp connector 1/16" M6 (PEEK)
9. 1 connector with valves (TPX = polymethylpentene / HDPE = high-density polyethylene)
10. 1 LUER male connector (PP)

Description of the appearance of Germanium chloride ( Ge)/Gallium chloride ( Ga) GalliaPharm and
package contents
You do not need to obtain or handle this medicine yourself.

Marketing Authorization Holder and Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

---

The following information is intended for healthcare professionals only:

The full SmPC of Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is provided as a
separate document in the product packaging, in order to offer healthcare professionals additional
scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.

Patient Information Leaflet

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm 3.70 GBq radionuclide generator
gallium (Ga) chloride solution
Please read this leaflet carefully before you are given this medicine, because 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 who will supervise your 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 chloride (Ge)/Gallium chloride (Ga) GalliaPharm is and what it is used for
2. What you need to know before the gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is used
3. How the gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is used
4. Possible side effects
5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
6. Package contents and other information

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

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is a radionuclide generator of
germanium (Ge)/gallium (Ga), a device used to obtain a solution of gallium (Ga) chloride.
Gallium (Ga) chloride is a radioactive substance, handled by specialist physicians (nuclear medicine physicians) and pharmacists trained in working with radioactive materials. Gallium (Ga) chloride
is not intended to be used directly in patients, but is used for radiolabelling, a technique in which a substance is labelled (radiolabelled) with a radioactive compound, in this case Ga.
Only medicinal products specifically developed and approved for radiolabelling with Ga undergo the radiolabelling procedure with gallium (Ga) chloride. These radiolabelled medicinal products can recognise specific types of cells in the body, bind to them, and deliver the radioactive Ga to these cells. The small amount of radioactivity present in the radiolabelled medicinal product with Ga can be detected outside the body using special equipment. This may assist the physician in diagnosis. For further information, please refer to the package leaflet of the medicinal product to be radiolabelled with gallium (Ga) chloride.
The nuclear medicine specialist will provide you with more detailed information about the type of examination to be performed.
The use of a medicinal product labelled with Ga involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine specialist consider that the clinical benefit obtained from the procedure using the Ga-labelled medicinal product outweighs the risk associated with radiation exposure.

2. What you need to know before the gallium (Ga) chloride solution obtained from

Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm
The gallium (Ga) chloride solution obtained from Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm must not be used

• if you are allergic to gallium (Ga) chloride or to any of the other ingredients of this medicinal product (listed in section 6).

If you are using a radiolabelled medicine containing Ga, please read the contraindications information in the package leaflet of the radiolabelled medicine.
Warnings and precautions
For information on special warnings and precautions for use of Ga-labelled medicines, consult the package leaflet of the radiolabelled medicine.
Children and adolescents
If you or your child is under 18 years of age, please consult a nuclear medicine specialist.
Other medicines and the gallium (Ga) chloride solution
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other medicines, as they could interfere with image interpretation.
It is not known whether the gallium (Ga) chloride solution may interact with other medicines, as specific studies have not been conducted. You will not receive an injection of gallium (Ga) chloride itself, but rather another medicine radiolabelled with Ga.
For information on interactions related to the use of Ga-labelled medicines, please refer to the package leaflet of the radiolabelled medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, please consult a nuclear medicine specialist before receiving Ga-labelled medicines.
You must inform the nuclear medicine specialist before administration of Ga-labelled medicines if there is any possibility of pregnancy, if you have missed menstrual periods, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist who will perform the procedure.
If you are pregnant
The nuclear medicine specialist will administer a Ga-labelled medicine during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding
You will be asked to stop breastfeeding. Ask the nuclear medicine specialist when you can resume breastfeeding.
Driving and using machines
Effects on your ability to drive and use machinery may occur due to the use of Ga-labelled medicines. Please read the package leaflet of these medicines carefully.

3. How the gallium (⁶⁸Ga) chloride solution produced with germanium chloride (⁶⁸Ge) is used

(⁶⁸Ge)/Gallium chloride (⁶⁸Ga) GalliaPharm
Strict rules apply for the use, handling, and disposal of radiopharmaceuticals. Germanium chloride (⁶⁸Ge)/Gallium chloride (⁶⁸Ga) GalliaPharm is used only in areas under special control. The preparation of the gallium (⁶⁸Ga) chloride solution, the radiolabelling of a specific carrier medicinal product, as well as the administration of the radiolabelled medicinal product, will be carried out by experienced and qualified personnel trained to handle it safely. These individuals will take great care in the safe use of this medicinal product and will inform you about their actions.
The amount of the radiolabelled medicinal product containing ⁶⁸Ga to be used in your case will be determined by the nuclear medicine specialist performing the procedure. This amount will be as low as reasonably possible while still achieving the appropriate diagnostic result.

Administration of the gallium (⁶⁸Ga) chloride solution and performance of the procedure
You will not receive the gallium (⁶⁸Ga) chloride solution directly, but rather another medicinal product that has been linked (radiolabelled) with the gallium (⁶⁸Ga) chloride solution.

Duration of the procedure
The nuclear medicine specialist will inform you about the usual duration of the procedure using the ⁶⁸Ga-radiolabelled medicinal product. For further information, please read the package leaflet of the medicinal product to be radiolabelled.

After administration of the radiolabelled medicinal product containing gallium (⁶⁸Ga) chloride solution
The nuclear medicine specialist will inform you whether you need to take any special precautions after receiving the ⁶⁸Ga-radiolabelled medicinal product. If you have any doubts, please consult the nuclear medicine specialist.

If you have received more of the radiolabelled medicinal product containing gallium (⁶⁸Ga) chloride solution than you should, or if you accidentally received a direct injection of gallium (⁶⁸Ga) chloride
An overdose or accidental direct injection of the gallium (⁶⁸Ga) chloride solution is unlikely, as you will receive the ⁶⁸Ga-radiolabelled medicinal product only under the strict supervision of the nuclear medicine specialist responsible for the procedure. However, in the event of an overdose or accidental direct injection, appropriate treatment will be provided.

If you have any questions about the use of this medicinal product, please consult the nuclear medicine specialist performing the procedure.

4. Possible side effects

Like all medicines, this gallium-labelled medicine can cause side effects, although
not everybody gets them.
After administration, the gallium-labelled medicine will produce small amounts of
ionising radiation, with a minimal risk of cancer and hereditary abnormalities.
For further information, please read the package leaflet of the radiolabelled medicine.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. You may also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm

You will not be responsible for storing this medicinal product. It will be stored under the responsibility of the specialist, in appropriate premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive products.
The following information is intended exclusively for the specialist.
The radionuclide generator must not be used after the expiry date indicated on the container following "Exp.".
Do not dismantle the shielded container.
The solution of gallium (Ga) chloride obtained with Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm must be used immediately.

6. Package contents and other information

What Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm contains

• The active substance consists of germanium (68Ge) chloride and gallium (68Ga) chloride dissolved in 0.1 mol/L sterile ultra-pure hydrochloric acid. Germanium (68Ge) is irreversibly retained within the radionuclide generator and decays into its daughter radionuclide gallium (68Ga), which is obtained from the generator as gallium (68Ga) chloride.
• The other components are: titanium dioxide (matrix), 0.1 mol/L sterile ultra-pure hydrochloric acid (elution solution).

One radionuclide generator is supplied with:

1. 1 PP container with eluent, 250 mL of 0.1 mol/L sterile ultra-pure hydrochloric acid (including a separate hook for PP vials; PP = polypropylene)
2. 1 vented puncture device (ABS = acrylonitrile-butadiene-styrene / PE = polyethylene)
3. 2 adapters 1/16" for male LUER (PEEK)
4. 2 tubes 60 cm (PEEK)
5. 1 tube 40 cm (PEEK)
6. 1 tube 20 cm (PEEK)
7. 3 manual tightening connectors 1/16" 10-32 (PEEK)
8. 1 manual tightening connector 1/16" M6 (PEEK)
9. 1 connector with stopcocks (TPX = polymethylpentene / HDPE = high-density polyethylene)
10. 1 male LUER connector (PP)

Description of the appearance of Germanium chloride (68Ge)/Gallium chloride (68Ga) GalliaPharm and
contents of the pack
You do not need to obtain or handle this medicinal product yourself.

Marketing Authorization Holder and Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

The following information is intended for healthcare professionals only:

The full SmPC (Summary of Product Characteristics) for Germanium chloride (Ge)/Gallium chloride (Ga) GalliaPharm is provided as a separate document in the product packaging, in order to supply healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical. Refer to the SmPC.