PMS-VANCOMYCIN 500 MG POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Available from:

PHARMASCIENCE INC

ATC code:

J01XA01

INN (International Name):

VANCOMYCIN

Dosage:

500MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 500MG

Administration route:

INTRAVENOUS

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

GLYCOPEPTIDES

Product summary:

Active ingredient group (AIG) number: 0131315003; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-03-14

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-VANCOMYCIN
Vancomycin Hydrochloride for Injection USP
0.5g and 1g Vancomycin per Vial Sterile Lyophilized
Powder for Injection
ANTIBIOTIC
PHARMASCIENCE INC.
Date of Revision:
6111 Royalmount Ave, Suite #100
March 8, 2018
Montréal, Québec
H4P 2T4
www.pharmascience.com
Control No. 213062
_pms-VANCOMYCIN Product Monograph _
_Page 2 of 30_
PRODUCT MONOGRAPH
NAME OF DRUG
PR
PMS-VANCOMYCIN
Vancomycin Hydrochloride for Injection USP
0.5g and 1g 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
pms-VANCOMYCIN 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 pms-
VANCOMYCIN and other antibacterial drugs, pms-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.
In other infections due to staphylococci, including osteomyelitis,
pneumonia, septicemia, and soft-
tissue infections, vancomycin's effectiveness
has been documented. Antibiotics
are us