Basic Information
GALLIAPHARM RADIONUCLIDE GENERATOR 0.74 – 1.85 GBQ
INJECTION, SOLUTION (RADIOPHARMACEUTICAL)
Regulatory Information
SIN16844P
August 23, 2023
Prescription Only
Therapeutic
OTHERS
January 24, 2024
June 4, 2025
XV09X
Company Information
Active Ingredients
Strength: 0.74 – 1.85 GBq
Strength: > 60 % of the loaded activity
Detailed Information
Contraindications
**4.3. Contraindications** Do not administer gallium (68Ga) chloride solution directly to the patient. The use of 68Ga-labelled pharmaceutical products is contraindicated in case of hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. For information on contraindications to particular 68Ga-labelled pharmaceutical products prepared by radiolabelling with gallium (68Ga) chloride solution, refer to the package insert of the particular pharmaceutical product to be radiolabelled.
Indication Information
**4.1. Therapeutic indications** This pharmaceutical product is not intended for direct use in patients. The eluate from the radionuclide generator (gallium (68Ga) chloride solution) is indicated for _in vitro_ labelling of specific carrier molecules developed and approved for radiolabelling with such solution to be used for positron emission tomography (PET) imaging.