VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP POWDER FOR SOLUTION

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

थमां उपलब्ध:

EUGIA PHARMA INC.

ए.टी.सी कोड:

J01XA01

INN (इंटरनेशनल नाम):

VANCOMYCIN

डोज़:

1G

फार्मास्यूटिकल फॉर्म:

POWDER FOR SOLUTION

रचना:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 1G

प्रशासन का मार्ग:

INTRAVENOUS

पैकेज में यूनिट:

100

प्रिस्क्रिप्शन प्रकार:

Prescription

उत्पाद समीक्षा:

Active ingredient group (AIG) number: 0131315001; AHFS:

प्राधिकरण का दर्जा:

APPROVED

प्राधिकरण की तारीख:

2022-11-25

उत्पाद विशेषताएं

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