Ország: Kanada
Nyelv: angol
Forrás: Health Canada
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)
JAMP PHARMA CORPORATION
J01XA01
VANCOMYCIN
1G
POWDER FOR SOLUTION
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 1G
INTRAVENOUS
1G
Prescription
GLYCOPEPTIDES
Active ingredient group (AIG) number: 0131315009; AHFS:
CANCELLED POST MARKET
2022-11-16
1 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr JAMP-VANCOMYCIN 500mg/vial, 1000mg/vial, 5000mg/vial and 10,000mg/vial Vancomycin (as vancomycin hydrochloride) ANTIBIOTIC JAMP Pharma Corporation 1310 rue Nobel Boucherville, Québec J4B 5H3 Date of Revision: August 26, 2019 Submission Control No: 228660 2 PRODUCT MONOGRAPH Pr JAMP-VANCOMYCIN 500 mg/vial ,1000 mg/vial, 5000 mg/vial and 10,000 mg/vial Vancomycin 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 JAMP-VANCOMYCIN 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 JAMP-VANCOMYCIN and other antibacterial drugs, JAMP-VANCOMYCIN 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. 3 In other infections due to staphylococci, including osteomyelitis, pneumonia, septicemia and soft-tissue infections, vancomycin's effectiveness has been documented. Antibiotics are used as adjuncts to appropriate surgical measures when staphylococcal infections are localized and purulent. Although no controlled clinical Olvassa el a teljes dokumentumot