Oritavancin package insert pdf

Orbactiv is a lipoglycopeptide antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused. Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparing the final intravenous solution. Indications and usage orbactiv is a lipoglycopeptide antibacterial. Orbactiv oritavancin for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections absssi caused or suspected to be caused by susceptible isolates of the following grampositive microorganisms. The crystallinity of the drug substance is not critical to the bioavailability of the drug product since the product is administered as an intravenous infusion following. Staphylococcus aureus including methicillin susceptible and methicillinresistant strains, streptococcus pyogenes, streptococcus agalactiae, streptococcus. Vibativ was studied in two phase 3 trials of patients with habpvabp 1,2. Oritavancin is a lipoglycopeptide antibacterial drug that inhibits of the. Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein. Pdf oritavancin, a semisynthetic derivative of the glycopeptide antibiotic.

Orbactiv oritavancin injection, powder, lyophilized, for solution the medicines company. Newer glycopeptide antibiotics for treatment of complicated skin and. Strictly confidential predecisional deliberation information oritavancin updated july 2014 draft updated version may be found at. Orbactiv oritavancin for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections absssi caused by susceptible isolates of the following grampositive microorganisms. Fetal risk women of childbearing potential should have a serum pregnancy test prior to administration of vibativ avoid use of vibativ during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus adverse developmental outcomes observed in 3 animal species at clinically. Reconstituted vials may be stored either refrigerated at 2 to 8 c 36 to 46 f, or at controlled room temperature 20 to 25 c 68 to 77 f.

Orbactiv oritavancin for injection, for intravenous use initial u. The long halflife of this drug enables a singledose administration. Staphylococcus aureus including methicillinsusceptible mssa and resistant mrsa isolates, streptococcus pyogenes, streptococcus. Aseptically transfer the required dose of reconstituted dalbavancin solution. Orbactiv oritavancin injection, powder, lyophilized, for solution if this spl contains inactivated ndcs listed by the fda initiated compliance action, they will be specified as such. Use of oritavancin in moderatetosevere absssi patients. Vibativ was studied in two phase 3 trials of patients with csssi 1. Diluted intravenous solution in an infusion bag should be used within 6 hours when stored at room temperature.

Staphylococcus aureus including methicillinsusceptible and methicillin. Pdf profile of oritavancin and its potential in the treatment of acute. The vancomycin dose could be adjusted based on an institutions guidelines and protocol. Comparison of the efficacy and safety of oritavancin front loaded dosing regimens to daily dosing. Highlights of prescribing information singleuse vials. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of c. The reconstituted vial contains 20 mgml dalbavancin as a clear, colorless to yellow solution. Consult the full prescribing information for dosage, preparation, and administration details. Model results indicate that adding oritavancin to a payer formu lary could. Orbactiv oritavancin for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections absssi caused by. Staphylococcus aureus including methicillinsusceptible mssa and resistant mrsa isolates, streptococcus pyogenes.