Patient leaflet - Galliad 0.74 -1.85 GBq Radionuclide Generator
1. What GalliAd is and what it is used for
This medicine is a radiopharmaceutical product not intended for direct use in patients.
GalliAd is a germanium (68Ge) / gallium (68Ga) radionuclide generator, a device used to obtain a solution of gallium (68Ga) chloride.
The obtained gallium (68Ga) chloride solution is used for radiolabelling, a technique in which a substance is tagged (radiolabelled) with a radioactive compound, here 68Ga.
GalliAd is used to label certain medicines that have been specially developed and approved for the use with the active substance gallium (68Ga) chloride. These medicines act as carriers to take the radioactive 68Ga to where it is needed. These may be substances that have been designed to recognise a particular type of cell in the body, including tumour cells (cancer). The low amount of radioactivity administered can be detected outside of the body by special cameras.
Please refer to the package leaflet of the medicine that is to be radiolabelled with gallium (68Ga) chloride. The nuclear medicine doctor will explain to you what type of examination will be performed with thisproduct.
The use of a 68Ga-labelled medicinal product 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 radiopharmaceutical overcomes the risk due to radiation.
2. What you need to know before the Gallium (68Ga) chloride solution obtained with GalliAd is used
The Gallium (68Ga) chloride solution obtained with GalliAd 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 medicinal product, you should read information on contraindications in the package leaflet of the product to be radiolabelled.
Warnings and precautions
For information concerning special warnings and special precautions for use of 68Ga labelled medicinal products please refer to the Package Leaflet of the medicinal product 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.
It is not known whether gallium (68Ga) chloride may interact with other medicines as specified studies have not been carried out.
For information concerning interactions associated with the use of 68Ga labelled medicinal products refer to the Package Leaflet of the medicinal product to be radiolabelled.
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 medicines radiolabelled with GalliAd.
You must inform the nuclear medicine doctor before the administration of medicines radiolabelled with GalliAd 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 this product 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 medicine used in combination with GalliAd. Please read the package leaflet of that medicine carefully.
3. How Gallium (68Ga) chloride solution obtained with GalliAd is used
There are strict laws on the use, handling and disposal of radiopharmaceutical products. GalliAd will only be used in special controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this product and will keep you informed of their actions.
The nuclear medicine doctor supervising the procedure will decide on the quantity of medicine radiolabelled with GalliAd to be used in your case. It will be the smallest quantity necessary to achieve the appropriate outcome, depending on the medicine to be labelled and its intended use. Please read the package leaflet of the medicine that is to be radiolabelled for more information.
Administration of Gallium (68Ga) chloride solution obtained with GalliAd and conduct of the procedure You will not get the Gallium (68Ga) chloride solution, but another product radiolabelled with GalliAd. Gallium (68Ga) chloride solution must be used only in combination with another medicine which has been
specifically developed for being combined (radiolabelled) with GalliAd. You will only be given the final radiolabelled product.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure after the administration of the medicine radiolabelled with GalliAd.
After administration of the medicine radiolabelled with GalliAd has been performed The nuclear medicine doctor will inform you if you need to take any special precautions after receiving the medicine radiolabelled with GalliAd. Contact your nuclear medicine doctor if you have any questions.
If you have been given more medicine radiolabelled with GalliAd than you should An overdose is unlikely, because you will only receive the medicine radiolabelled with GalliAd precisely controlled by the nuclear medicine doctor supervising the procedure. However, in the case of an overdose, you will receive the appropriate treatment.
Should you have any further question on the use of this product, please ask the nuclear medicine doctor who supervises the procedure.
4. Possible side effects
Like all medicines, the medicine radiolabelled with GalliAd can cause side effects, although not everybody gets them.
After the medicine radiolabelled with GalliAd is administered, it will deliver low amounts of ionising radiation with the least risk of cancer and hereditary abnormalities.
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 the leaflet. You can also report side effects directly via 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 GalliAd 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 plastic case. Do not store above 25°C.
The gallium (68Ga) chloride solution obtained with GalliAd must be used immediately.
6. Contents of the pack and other information
What GalliAd contains
The active substances is Gallium (68Ga) chloride solution
The other ingredients are: Titanium dioxide (matrix) Sterile 0.1 N hydrochloric acid (solution for elution)
What GalliAd looks like and contents of the pack You will not need to obtain or handle this medicine.
Marketing Authorisation Holder and Manufacturer IRE-Elit
Avenue de l’Espérance
B-6220 Fleurus
Belgium
This medicinal product is authorised in the Member States of the EEA under the following names:
| Country | Product name |
| Austria | GalliAd 0.74 – 1.85 GBq, Radionuklidgenerator |
| Belgium | GalliAd 0.74 – 1.85 GBq, radionuclidegenerator / générateur radiopharmaceutique / Radionuklidgenerator/ |
| Denmark | GalliAd 0.74 – 1.85 GBq, radionuklidgenerator |
| Finland | Galliad 0.74 – 1.85 GBq, radionuklidgeneraattori / radionuklidgenerator |
| France | Galliad 0.74 – 1.85 GBq, générateur radiopharmaceutique |
| Germany | GalliAd 0.74 – 1.85 GBq, Radionuklidgenerator |
| Italy | Germanio cloruro (68Ge)/Gallio cloruro (68Ga) IRE-ELiT |
| Netherlands | GalliAd 0,74 – 1,85 GBq, radionuclidegenerator |
| Norway | Galliad |
| Luxemburg | GalliAd 0.74 – 1.85 GBq, générateur radiopharmaceutique |
| Spain | GalliAd 0.74 – 1.85 GBq, generador de radionùclido |
| Sweden | Galliad 0.74 – 1.85 GBq, radionuklidgenerator |
| United Kingdom | GalliAd 0.74 – 1.85 GBq, radionuclide generator |
This leaflet was last revised on May 2018
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The following information is intended for medical or healthcare professionals only:
The complete SmPC of GalliAd 0.74 – 1.85 GBq, radionuclide generator is provided as a separate document in the product package, with the objective to provide healthcare professionals with other additional scientific and practical information about the administration and use of this radiopharmaceutical.
Please refer to the SmPC.