ORBACTIV Powder for solution for injection Ref.[10366] Active ingredients: Oritavancin

ORBACTIV (oritavancin) for injection contains oritavancin diphosphate, a semisynthetic lipoglycopeptide antibacterial drug.

The chemical name for oritavancin is [4"R]22O-N3''[(4'-chloro[1,1'-biphenyl]-4-yl)methyl] vancomycin phosphate [1:2] [salt]. The empirical formula of oritavancin diphosphate is C₈₆H₉₇N₁₀O₂₆Cl₃∙2H₃PO₄ and the molecular weight is 1989.09.

The chemical structure is represented below:

ORBACTIV is supplied as a sterile white to off-white lyophilized powder for intravenous infusion that contains oritavancin diphosphate, mannitol (an inactive ingredient) and phosphoric acid (to adjust pH 3.1 to 4.3). Each 50 ml capacity glass vial contains 400 mg of oritavancin (equivalent to 444 mg oritavancin diphosphate).

Each vial is reconstituted with sterile water for injection and further diluted with 5% Dextrose in sterile Water for intravenous infusion. Both the reconstituted solution and the diluted solution for infusion should be clear, colorless to pale yellow solution [see Dosage and Administration (2.2)].