Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres

TheraSphere Yttrium-90 Glass Microspheres 13.0 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 12.5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 12.0 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 11.5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 11.0 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 10.5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 9.5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 9.0 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 8.5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 8.0 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 7.5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 6.5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 6.0 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 5.5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 4.5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 4.0 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 3.5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 20 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 15 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 10 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 7 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 5 GBq Dose

TheraSphere Yttrium-90 Glass Microspheres 3 GBq Dose

For use with a TheraSphere Administration Set to administer TheraSphere Y90 Glass Microspheres

SIR-Y001 (3Gbq/5ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.

SIR-Y002 (1.8Gbq/3ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 1.8 GBq of Y90 ± 10% (at the time of calibration) in a total of 3 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.