Regulatory Information
QT INSTRUMENTS (S) PTE LTD
QT INSTRUMENTS (S) PTE LTD
Therapeutic
Prescription Only
Formulation Information
SOLUTION
**4.2 Posology and method of administration** EndolucinBeta is only to be used by specialists experienced with _in vitro_ radiolabelling. Posology The quantity of EndolucinBeta required for radiolabelling and the quantity of Lutetium (177Lu)-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. Paediatric population For more information concerning paediatric use of Lutetium (177Lu)-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled. Method of administration EndolucinBeta is intended for _in vitro_ radiolabelling of medicinal products which are subsequently administered by the approved route. EndolucinBeta should not be administered directly to the patient. For instructions on preparation of the medicinal product before administration, see section 12 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
OTHERS
Medical Information
**4.1 Therapeutic indications** 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 (177Lu) chloride.
**4.3 Contraindications** 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_. Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). For information on contraindications to particular Lutetium (177Lu)-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.
V10X
其它治疗用放射性药物
Manufacturer Information
QT INSTRUMENTS (S) PTE LTD
ITM Medical Isotopes GmbH
Active Ingredients
Documents
Package Inserts
PM_GBA_ELB_SmPC_SG_09_proposed.pdf
Approved: February 24, 2021