Finished product reference
Germanium (68 Ge) / Gallium (68 Ga)
Solution · Intravenous · 100 mCi · 3 mL
- List code
- 53044
- Pharmacologic class
- Radionuclide generator; germanium-68/gallium-68 generator (radiopharmaceutical precursor)
What it is and how it works
The generator contains germanium-68 (half-life about 271 days) adsorbed on a column; it decays to gallium-68 (half-life about 68 minutes), which is eluted as gallium (68Ga) chloride solution in dilute hydrochloric acid. The eluate is not administered directly but is used to radiolabel carrier molecules (kits) for PET imaging.
Indications
Supply of gallium-68 chloride for in vitro radiolabelling of carrier molecules (e.g. DOTATATE, DOTATOC, PSMA-11) that have been specifically developed and authorised for labelling with this radionuclide, to prepare PET radiopharmaceuticals.
Dosage and administration (summary)
Not for direct administration to patients; the eluate is used in radiopharmacy according to the instructions of the kit used, and dosing of the final radiopharmaceutical is individualised according to protocol.
Contraindications
The eluate must not be administered directly to patients; contraindications are those of the radiolabelled medicinal product prepared from it.
Warnings and precautions
Handling must follow radiation protection and aseptic radiopharmacy procedures; germanium-68 breakthrough and metal impurities should be tested before labelling as specified. Quality control of the radiolabelled product (radiochemical purity) is required before administration.
Storage and supply
Store the generator at room temperature (below 25 °C) in its original lead shielding in accordance with national regulations on radioactive materials.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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