The concentrate for solution for infusion (sterile concentrate) is a clear to slightly opalescent, colourless to slightly yellowish solution.
The solution has a pH of approximately 6.5 and an osmolality of approximately 270 to 330 mOsm/kg.
Each ml of concentrate for solution for infusion contains 10 mg tislelizumab.
Each 10 ml vial contains 100 mg tislelizumab (100 mg/10 ml).
Tislelizumab is an Fc-engineered humanised immunoglobulin G4 (IgG4) variant monoclonal antibody produced in recombinant Chinese hamster ovary cells.
Excipient with known effect: Each ml of concentrate for solution for infusion contains 0.069 mmol (or 1.6 mg) sodium.
Excipients/Inactive Ingredients: Sodium citrate dihydrate, Citric acid monohydrate, L-histidine hydrochloride monohydrate, L-histidine, Trehalose dihydrate, Polysorbate 20, Water for injection.