- 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 MEDICINES
- Dosage Form
- INJECTION, SOLUTION (RADIOPHARMACEUTICAL)
- Dosage
- <p><strong>4.2. Posology and method of administration</strong><br>
This pharmaceutical product is for use in designated nuclear medicine facilities only, and should only be handled by specialists experienced with <em>in vitro</em> radiolabelling.</p>
<p><u>Posology</u><br>
The quantity of the eluate gallium (<sup>68</sup>Ga) chloride solution required for radiolabelling and the quantity of <sup>68</sup>Ga-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.</p>
<p><em>Paediatric population</em><br>
Please refer to the package insert of the <sup>68</sup>Ga-labelled pharmaceutical product for more information concerning its paediatric use.</p>
<p><u>Method of administration</u><br>
The gallium (<sup>68</sup>Ga) chloride solution is not intended for direct use in patients but is used for <em>in vitro</em> radiolabelling of various carrier molecules. The route of administration of the final pharmaceutical product should be adhered to.</p>
<p>For instructions on extemporary preparation of the pharmaceutical product before administration, see section 10 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- OTHERS
- Indication Info
- <p><strong>4.1. Therapeutic indications</strong><br>
This pharmaceutical product is not intended for direct use in patients.</p>
<p>The eluate from the radionuclide generator (gallium (<sup>68</sup>Ga) chloride solution) is indicated for <em>in vitro</em> labelling of specific carrier molecules developed and approved for radiolabelling with such solution to be used for positron emission tomography (PET) imaging.</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong><br>
Do not administer gallium (<sup>68</sup>Ga) chloride solution directly to the patient.</p>
<p>The use of <sup>68</sup>Ga-labelled pharmaceutical products is contraindicated in case of hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>For information on contraindications to particular <sup>68</sup>Ga-labelled pharmaceutical products prepared by radiolabelling with gallium (<sup>68</sup>Ga) chloride solution, refer to the package insert of the particular pharmaceutical product to be radiolabelled.</p>
- 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/labgistics-asia-pte-ltd
