Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)
FRESENIUS KABI CANADA LTD
J01XA01
VANCOMYCIN
500MG
POWDER FOR SOLUTION
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 500MG
INTRAVENOUS
10ML
Prescription
GLYCOPEPTIDES
Active ingredient group (AIG) number: 0131315003; AHFS:
APPROVED
2011-03-02
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP 500 mg, 1 g, 5 g and 10 g of vancomycin (as vancomycin hydrochloride) per vial Sterile lyophilized powder for solution ANTIBIOTIC FRESENIUS KABI CANADA LTD. Date of Revision: 165 Galaxy Blvd, Suite 100 February 27, 2018 Toronto, ON M9W 0C8 Control No.: 204448 2 Vancomycin Hydrochloride for Injection, USP – Product Monograph_ _Page 2 of 32_ _ PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP ANTIBIOTIC ACTIONS The inhibition of cell wall synthesis has been shown by _in vitro_ studies to be responsible for the bactericidal action of vancomycin against many gram-positive bacteria. There is also evidence that RNA synthesis is selectively inhibited and the permeability of the cell membrane is altered by vancomycin. INDICATIONS AND CLINICAL USE Vancomycin Hydrochloride for Injection, USP is indicated in the therapy of severe or life- threatening staphylococcal infections in patients who cannot receive or have failed to respond to the penicillins or cephalosporins, or who have infections with staphylococci resistant to other antibiotics, including methicillin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Hydrochloride for Injection, USP and other antibacterial drugs, Vancomycin Hydrochloride for Injection USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. In the treatment of staphylococcal endocarditis, vancomycin has been used successfully alone. In other infections due to staphylococci, including osteomyelitis, pneumonia, septicemia and soft-tissue infections, vancomycin's effectiveness has been documented. Antibiotics are used as Vancomy Aqra d-dokument sħiħ