The fixed combination of meropenem-vaborbactam is available as a powder in single-dose (preservative-free) vials containing 2 g (meropenem 1 g [as the trihydrate] plus vaborbactam 1 g) and sodium carbonate 0.575 g.3379
The contents of each 2-g vial should be reconstituted with 20 mL of sodium chloride 0.9% (withdrawn from an infusion bag) and mixed gently to dissolve the powder.3379 The reconstituted solution will have approximate meropenem and vaborbactam concentrations of 50 mg/mL each.3379 The reconstituted solution is not suitable for direct injection.3379
The reconstituted solution must be diluted immediately in the infusion bag containing sodium chloride 0.9% from which the volume used for reconstitution of the appropriate dose was withdrawn.3379 The manufacturer’s instructions for preparing various doses of meropenem-vaborbactam from the reconstituted solution are as follows:3379
For 4 g (meropenem 2 g plus vaborbactam 2 g), withdraw the entire contents (i.e., approximately 21 mL each) of 2 vials and add to an infusion bag containing 250, 500, or 1000 mL of sodium chloride 0.9% (less the 40 mL used for reconstitution).
For 2 g (meropenem 1 g plus vaborbactam 1 g), withdraw the entire contents (i.e., approximately 21 mL) of 1 vial and add to an infusion bag containing 125, 250, or 500 mL of sodium chloride 0.9% (less the 20 mL used for reconstitution).
For 1 g (meropenem 0.5 g plus vaborbactam 0.5 g), withdraw 10.5 mL and add to an infusion bag containing 70, 125, or 250 mL of sodium chloride 0.9% (less the 20 mL used for reconstitution).
Sodium Content
Each 2-g vial of this fixed combination contains 0.25 g (10.9 mEq) of sodium.3379
Trade Name(s)
Vabomere
The diluted solution of meropenem-vaborbactam for infusion is administered intravenously over 3 hours.3379 The reconstituted solution is not suitable for direct injection.3379
Meropenem-vaborbactam is a white to light yellow powder that forms a colorless to light yellow solution upon both reconstitution and dilution.3379 Intact vials of meropenem-vaborbactam should be stored at controlled room temperature.3379
Diluted solutions of meropenem-vaborbactam for infusion should be visually inspected for particulate matter and discoloration prior to administration.3379 Administration of the diluted solution for infusion must be completed within 4 hours if stored at room temperature or 22 hours if stored at 2 to 8°C.3379 Any unused portions should be discarded.3379
Meropenem-vaborbactam reconstituted and diluted for infusion demonstrated less than 10% loss of either drug when stored for up to 10 hours at room temperature and for up to 26 hours under refrigeration (5°C); however, a degradation product formation assessment revealed that the solution did not consistently meet impurity limits during this period.3381
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