Страна: Канада
Язык: английский
Источник: Health Canada
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)
STRIDES PHARMA CANADA INC
J01XA01
VANCOMYCIN
1G
POWDER FOR SOLUTION
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 1G
INTRAVENOUS
100
Prescription
GLYCOPEPTIDES
Active ingredient group (AIG) number: 0131315009; AHFS:
APPROVED
2021-08-06
1 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP Vancomycin Hydrochloride for Injection, USP 500 mg, 1 g, 5 g and 10 g per vial Vancomycin (as vancomycin hydrochloride) Sterile Lyophilized Powder for Injection ANTIBIOTIC MARCAN PHARMACEUTICALS INC. DATE OF PREPARATION: 2 GURDWARA RD, # 112 JUN 14, 2023 OTTAWA, ONTARIO K2E 1A2, CANADA www.marcanpharma.com Submission Control No.: 275787 _ _ _ _ _ _ _ _ 2 _ _ _ _ _ _ _ _ _ _ PRODUCT MONOGRAPH PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP Vancomycin Hydrochloride for Injection, USP 500 mg, 1 g, 5 g and 10 g Vancomycin per vial Sterile Lyophilized Powder for Injection THERAPEUTIC CLASSIFICATION Antibiotic ACTION 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 who 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. 3 In the treatment of staphylococcal endocarditis, vancomycin has been used suc Прочитать полный документ