देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)
EUGIA PHARMA INC.
J01XA01
VANCOMYCIN
500MG
POWDER FOR SOLUTION
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 500MG
INTRAVENOUS
100
Prescription
Active ingredient group (AIG) number: 0131315003; AHFS:
APPROVED
2022-11-25
Page 1 of 26 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP 500 mg, 1 g and 5 g of vancomycin (as vancomycin hydrochloride) per vial Sterile lyophilized powder for solution ANTIBIOTIC EUGIA PHARMA INC. Date of Preparation: 3700 Steeles Avenue West, Suite 402 NOV 22, 2022 Woodbridge, Ontario L4L 8K8 CANADA Submission Control No.: 268611 Page 2 of 26 PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP 500 mg, 1 g and 5 g of vancomycin (as vancomycin hydrochloride) per vial Sterile lyophilized powder for solution 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, vancomy पूरा दस्तावेज़ पढ़ें