Patient leaflet - Galliapharm 1.11 - 3.70 GBq Radionuclide Generator
1. What GalliaPharm is and what it is used for
GalliaPharm is a germanium (68Ge)/gallium (68Ga) radionuclide generator, a device used to obtain a solution of gallium (68Ga) chloride. Gallium (68Ga) chloride is a radioactive substance that is handled by specialised doctors (nuclear medicine doctors) and pharmacists trained to work with radioactive materials. Gallium (68Ga) chloride is not intended for direct use in patients, but is used for radiolabelling, a technique in which a substance is tagged (radiolabelled) with a radioactive compound, here 68Ga.
Only medicines that have been specifically developed and approved for radiolabelling with 68Ga undergo the radiolabelling procedure with gallium (68Ga) chloride. These radiolabelled medicines can recognise and attach to particular types of cells in the body and take the radioactive 68Ga to these cells in your body. The low amount of radioactivity present in the 68Ga-labelled medicine can be detected from outside of the body by special cameras. This may help your doctor with the diagnosis. Please refer to the Package Leaflet of the medicine that is to be radiolabelled with gallium (68Ga) chloride for more information.
The nuclear medicine doctor will explain to you in more detail what type of examination will be performed.
The use of a 68Ga-labelled medicine does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the 68Ga-labelled medicine overcomes the risk due to radiation.
1. What you need to know before the gallium (68Ga) chloride solution obtained with GalliaPharm is used
The gallium (68Ga) chloride solution obtained with GalliaPharm must not be used
- if you are allergic to gallium (68Ga) chloride or any of the other ingredients of this medicine (listed in section 6).
If you are using a 68Ga-labelled medicine, you should read information on contraindications in the Package Leaflet of the medicine to be radiolabelled.
Warnings and precautions
For information concerning special warnings and special precautions for use of 68Ga-labelled medicines please refer to the Package Leaflet of the medicine to be radiolabelled.
Children and adolescents
Please speak to your nuclear medicine doctor if you or your child are under 18 years old.
Other medicines and gallium (68Ga) chloride solution
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the interpretation of the images by your doctor.
It is not known whether gallium (68Ga) chloride solution may interact with other medicines as specified studies have not been carried out. You will not receive an injection of gallium (68Ga) chloride, but a medicine radiolabelled with 68Ga.
For information concerning other medicines in combination with the use of 68Ga-labelled medicines, please read the Package Leaflet of the radiolabelled medicine.
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 doctor for advice before you are given 68Ga-labelled medicines.
You must inform the nuclear medicine doctor before the administration of 68Ga-labelled medicines if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
If you are pregnant
The nuclear medicine doctor will only administer a 68Ga-labelled medicine during pregnancy if a benefit is expected which would outweigh the risks.
If you are breast-feeding
You will be asked to stop breast-feeding. Please ask your nuclear medicine doctor when you can resume breast-feeding.
Driving and using machines
There could be effects on your ability to drive and to use machines due to the use of 68Ga-labelled medicines. Please read the Package Leaflets of these medicines carefully.
2. How gallium (68Ga) chloride solution produced with GalliaPharm is used
There are strict laws on the use, handling, and disposal of radiopharmaceutical products. GalliaPharm will only be used in special controlled areas. The production of gallium (68Ga) chloride solution, radiolabelling of a specific carrier medicine, as well as administration of 68Ga-labelled medicine to you, will only be handled by people who are trained and qualified to use it safely. They will take special care for the safe use of this medicine and will keep you informed of their actions.
The nuclear medicine doctor supervising the procedure will decide on the amount of medicine radiolabelled with 68Ga to be used in your case. It will be the smallest quantity necessary to achieve the appropriate outcome.
Administration of gallium (68Ga) chloride solution and conduct of the procedure
You will not be given the gallium (68Ga) chloride solution, but another medicine which has been combined (radiolabelled) with gallium (68Ga) chloride solution.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure with a 68Ga-labelled medicine. For more information, please read the Package Leaflet of the radiolabelled medicine.
After the medicine radiolabelled with gallium (68Ga) chloride solution has been given
The nuclear medicine doctor will inform you if you need to take any special precautions after receiving the 68Ga-labelled medicine. Contact your nuclear medicine doctor if you have any questions.
If you have been given more medicine radiolabelled with gallium (68Ga) chloride solution than you should, or have received direct injection of gallium (68Ga) chloride solution inadvertently
An overdose, or inadvertent direct injection of gallium (68Ga) chloride solution is unlikely, because you will only receive the 68Ga-labelled medicine precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of an overdose, or inadvertent direct injection you will receive the appropriate care.
Should you have any further questions on the use of this medicine, please ask the nuclear medicine doctor who supervises the procedure.
4. Possible side effects
Like all medicines, the 68Ga-labelled medicine can cause side effects, although not everybody gets them.
After the 68Ga-labelled medicine is administered, it will deliver low amounts of ionising radiation with the least risk of cancer and hereditary abnormalities.
For more information about possible side effects, please read the Package Leaflet of the radiolabelled medicine.
Reporting of side effects
If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How GalliaPharm is stored
You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulation on radioactive materials.
The following information is intended for the specialist only.
The radionuclide generator must not be used after the expiry date stated on the container after “EXP”.
Do not dismantle the case.
The gallium (68Ga) chloride solution obtained with GalliaPharm must be used immediately.
6. Contents of the pack and other information
What GalliaPharm contains
- The active substance consists of germanium (68Ge) chloride and gallium (68Ga) chloride dissolved in sterile ultrapure 0.1 mol/l hydrochloric acid. Germanium (68Ge) is irreversibly trapped inside the radionuclide generator decaying to its daughter nuclide (68Ga), which is obtained from the generator as gallium (68Ga) chloride.
The other ingredients are: Titanium dioxide (matrix)
Sterile ultrapure 0.1 mol/l hydrochloric acid (solution for elution)
One radionuclide generator is supplied with:
- 1. 1 x PP – container with the eluent, 250 ml sterile ultrapure 0.1 mol/l hydrochloric acid (including a separate hanger for PP-bottles; PP = Polypropylene)
- 2. 1 x Vented spike (ABS = Acrylonitrile Butadiene Styrene/PE = Polyethylene)
- 3. 2 x Adapter 1/16" to male LUER (PEEK)
- 4. 2 x Tubing 60 cm (PEEK)
- 5. 1 x Tubing 40 cm (PEEK)
- 6. 1 x Tubing 20 cm (PEEK)
- 7. 3 x Fingertight fitting 1/16" 10-32 (PEEK)
- 8. 1 x Fingertight fitting 1/16" M6 (PEEK)
- 9. 1 x Stopcock manifold (TPX = Polymethylpentene/HDPE = High Density Polyethylene)
- 10. 1 x Male LUER union (PP)
What GalliaPharm looks like and contents of the pack
You will not need to obtain or handle this medicine.
Marketing Authorisation Holder
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany
Manufacturer
Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10
13125 Berlin
Germany