- Approval Id
- fa115961c184ff24
- Drug Name
- GALLIAPHARM RADIONUCLIDE GENERATOR 0.74 – 1.85 GBQ
- Product Name
- GALLIAPHARM RADIONUCLIDE GENERATOR 0.74 – 1.85 GBQ
- Approval Number
- SIN16844P
- Approval Date
- 2023-08-23
- Registrant
- LABGISTICS ASIA PTE LTD
- Licence Holder
- LABGISTICS ASIA PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION (RADIOPHARMACEUTICAL)
- Dosage
- **4.2. Posology and method of administration**
This pharmaceutical product is for use in designated nuclear medicine facilities only, and should only be handled by specialists experienced with _in vitro_ radiolabelling.
Posology
The quantity of the eluate gallium (68Ga) chloride solution required for radiolabelling and the quantity of 68Ga-labelled pharmaceutical product that is subsequently administered will depend on the pharmaceutical product that is radiolabelled and its intended use. Refer to the package insert of the particular pharmaceutical product to be radiolabelled.
_Paediatric population_
Please refer to the package insert of the 68Ga-labelled pharmaceutical product for more information concerning its paediatric use.
Method of administration
The gallium (68Ga) chloride solution is not intended for direct use in patients but is used for _in vitro_ radiolabelling of various carrier molecules. The route of administration of the final pharmaceutical product should be adhered to.
For instructions on extemporary preparation of the pharmaceutical product before administration, see section 10 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Route Of Administration
- OTHERS
- Indication Info
- **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.
- 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.
- Atc Code
- V09X
- Atc Item Name
- 其它诊断用放射性药物
- Pharma Manufacturer Name
- LABGISTICS ASIA PTE. LTD.
- Company Detail Path
- /organization/2eede45900f22ba8/labgistics-asia-pte-ltd
