linical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests – 10th ed. Approved Standard, CLSI document M02-A10, CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898. January 2009.
Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria – 7th ed. Approved Standard, CLSI document M11-A7, CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898. January 2007.
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing – 19th Informational Supplement. Approved Standard, CLSI document M100-S19, CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898. January 2009.
16 HOW SUPPLIED/STORAGE AND HANDLING
TYGACIL (tigecycline) for injection is supplied in a single-dose 5 mL glass vial or 10 mL glass vial, each containing 50 mg tigecycline lyophilized powder for reconstitution.
Supplied:
5 mL - 10 vials/box. NDC 0008-4990-02
10 mL - 10 vials/box. NDC 0008-4990-20
Prior to reconstitution, TYGACIL should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Once reconstituted, TYGACIL may be stored at room temperature for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag). Alternatively, TYGACIL mixed with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP may be stored refrigerated at 2° to 8°C (36° to 46°F) for up to 48 hours following immediate transfer of the reconstituted solution into the intravenous bag. Reconstituted solution must be transferred and further diluted for intravenous infusion.
U.S. Patent Numbers: RE40086; RE40183; 5,284,963; 5,530,117; 5,675,030; and 7,365,087.
17 PATIENT COUNSELING INFORMATION
Patients should be counseled that antibacterial drugs including TYGACIL should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When TYGACIL 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 the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by TYGACIL or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1‑800‑934‑5556.
Wyeth®
Manufactured for:
Wyeth Pharmaceuticals Inc.
Philadelphia, PA 19101
By:
Wyeth Pharmaceuticals Inc.
Philadelphia, PA 19101
Or
Patheon Italia S. |
