- Approval Id
- ad5fe95a227c0230
- Drug Name
- ENDOLUCINBETA RADIOPHARMACEUTICAL PRECURSOR SOLUTION 40 GBQ/ML
- Product Name
- ENDOLUCINBETA RADIOPHARMACEUTICAL PRECURSOR SOLUTION 40 GBQ/ML
- Approval Number
- SIN15971P
- Approval Date
- 2020-07-03
- Registrant
- QT INSTRUMENTS (S) PTE LTD
- Licence Holder
- QT INSTRUMENTS (S) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong><br>
EndolucinBeta is only to be used by specialists experienced with <em>in vitro</em> radiolabelling.</p>
<p><u>Posology</u><br>
The quantity of EndolucinBeta required for radiolabelling and the quantity of Lutetium (<sup>177</sup>Lu)-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use. Refer to the Summary of Product Characteristics/Package Leaflet of the particular medicinal product to be radiolabelled.</p>
<p><u>Paediatric population</u><br>
For more information concerning paediatric use of Lutetium (<sup>177</sup>Lu)-labelled medicinal products refer to the Summary of Product Characteristics/Package Leaflet of the medicinal product to be radiolabelled.</p>
<p><u>Method of administration</u><br>
EndolucinBeta is intended for <em>in vitro</em> radiolabelling of medicinal products which are subsequently administered by the approved route.</p>
<p>EndolucinBeta should not be administered directly to the patient.</p>
<p>For instructions on preparation of the medicinal product before administration, see section 11 – <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>
EndolucinBeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (<sup>177</sup>Lu) chloride.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong><br>
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>Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6 – <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 Lutetium (<sup>177</sup>Lu)-labelled medicinal products prepared by radiolabelling with EndolucinBeta, refer to the Summary of Product Characteristics/Package Leaflet of the particular medicinal product to be radiolabelled.</p>
- Atc Code
- V10X
- Atc Item Name
- 其它治疗用放射性药物
- Pharma Manufacturer Name
- QT INSTRUMENTS (S) PTE LTD
