avancin arm with methicillin-susceptible S. aureus at baselinewho did not receive treatment and were counted as non-responders/failures.
2 Early Responders are patients who had no increase from baseline in lesion area 48 to 72 hours after initiation of therapy, and had a temperature consistently at or below 37.6° C upon repeated measurement.
3 All patients in the clinical trials had blood cultures obtained at baseline. A total of 16 ABSSSI patients receiving dalbavancin had positive cultures at baseline for one of the above pathogens. Isolates included eleven S. aureus, three S. agalactiae, one S. pyogenes, and one S anginosus. Eleven of these patients (69%) were clinical responders at 48-72 hours and clinical successes at Day 26 to 30.
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15 REFERENCES
1.Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antibiotic Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard—Ninth Edition. CLSI document M07-A9. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
2.CLSI. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Third Informational Supplement. CLSI document M100-S23 Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013.
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16 HOW SUPPLIED/STORAGE AND HANDLING
DALVANCE (dalbavancin) for injection is supplied in the following packaging configuration:
500 mg/vial: package of 1 (NDC 57970-100-01)
Unreconstituted DALVANCE (dalbavancin) for injection should be stored at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) [see USP Controlled Room Temperature].
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17 PATIENT COUNSELING INFORMATION
Patients should be advised that allergic reactions, including serious allergic reactions, could occur, and that serious allergic reactions require immediate treatment. Patients should inform their healthcare provider about any previous hypersensitivity reactions to DALVANCE, or other glycopeptides.
Patients should be counseled that antibacterial drugs including DALVANCE should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When DALVANCE is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by DALVANCE and other antibacterial drugs in the future.
Patients should be advised that diarrhea is a common problem caused by antibacterial drugs and usually resolves when the drug is discontinued. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider.
Rx only
Manufactured for: Durata Therapeutics U.S. Limited
Chicag
