Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Pluvicto 1 000 MBq/mL solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection/infusion. Clear, colourless to slightly yellow solution, pH: 4.5 to 7.0. |
One mL of solution contains 1 000 MBq of lutetium (177Lu) vipivotide tetraxetan at the date and time of calibration.
The total amount of radioactivity per single-dose vial is 7 400 MBq ± 10% at the date and time of administration. Given the fixed volumetric activity of 1 000 MBq/mL at the date and time of calibration, the volume of the solution in the vial can range from 7.5 mL to 12.5 mL in order to provide the required amount of radioactivity at the date and time of administration.
Physical characteristics: Lutetium-177 decays to a stable hafnium-177 with a physical half-life of 6.647 days by emitting beta-minus radiation with a maximum energy of 0.498 MeV (79%) and photon radiation (γ) of 0.208 MeV (11%) and 0.113 MeV (6.4%).
Excipient with known effect: Each mL of solution contains up to 0.312 mmol (7.1 mg) of sodium. Each vial contains up to 88.75 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lutetium ¹⁷⁷Lu vipivotide tetraxetan |
|
| List of Excipients |
|---|
|
Acetic acid |
Clear, colourless type I glass vial, closed with a bromobutyl rubber stopper and aluminium seal.
Each vial contains a volume of solution that can range from 7.5 mL to 12.5 mL corresponding to a radioactivity of 7 400 MBq ± 10% at the date and time of administration.
The vial is enclosed within a lead container for protective shielding.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/22/1703/001
| Drug | Countries | |
|---|---|---|
| PLUVICTO | Austria, Canada, France, Croatia, Ireland, Israel, Italy, Lithuania, Romania, United Kingdom, United States |
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