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

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

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)].

Dosage Forms and Strengths

ORBACTIV is supplied as sterile, white to off-white lyophilized powder equivalent to 400 mg of oritavancin in a single-dose 50 mL clear glass vial.

How Supplied

ORBACTIV is supplied as single-dose 50 mL capacity glass vials containing sterile lyophilized powder equivalent to 400 mg of oritavancin (NDC 70842-140-01). Three vials are packaged in a carton to supply a single 1200 mg dose treatment (NDC 70842-140-03).

Drugs

Drug Countries
ORBACTIV Austria, Estonia, United States

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