Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)
AURO PHARMA INC
J01XA01
VANCOMYCIN
1G
POWDER FOR SOLUTION
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 1G
INTRAVENOUS
10 VIALS
Prescription
GLYCOPEPTIDES
Active ingredient group (AIG) number: 0131315009; AHFS:
APPROVED
2018-06-22
Page 1 of 21 PRODUCT MONOGRAPH PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP Lyophilized Powder 500 mg, 1g and 5g vials STERILE Antibiotic AURO PHARMA INC . 3700 Steeles Avenue West, Suite 402 Date of Preparation: Woodbridge, Ontario, L4L 8K8, June 21, 2018 CANADA Submission Control No: 206963 Page 2 of 21 PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP Lyophilized Powder 500 mg, 1g and 5g vials THERAPEUTIC CLASSIFICATION 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. 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 adjuncts to appropriate surgical measures when staphylococcal infections are localized and purulent. Although no controlled clinical efficacy trials have been conducted, intravenous vancomycin has been suggested by the American Heart Association and the American Dental Association as prophylaxis against bacterial endocarditis in patients allergic to penicillin who have congenital and/or rheumatic or other acquired valvular heart disease when they undergo dental procedures or surgical procedures of the upper respiratory tract (Note: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint Perskaitykite visą dokumentą