VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Dostopno od:

SANDOZ CANADA INCORPORATED

Koda artikla:

J01XA01

INN (mednarodno ime):

VANCOMYCIN

Odmerek:

1G

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 1G

Pot uporabe:

INTRAVENOUS

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

GLYCOPEPTIDE ANTIBACTERIALS

Povzetek izdelek:

Active ingredient group (AIG) number: 0131315009; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2012-10-22

Lastnosti izdelka

_ _
_Vancomycin hydrochloride for Injection _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VANCOMYCIN HYDROCHLORIDE FOR INJECTION
500 mg, 1 g and 5 g of vancomycin (as vancomycin hydrochloride)
per vial
Sterile lyophilized
powder for solution
Manufacturer’s Standard
ANTIBIOTIC
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville,
QC
J4B 1E6
Date of Revision:
June 10, 2021
Submission
Control No: 245821
_ _
_Vancomycin hydrochloride for Injection _
_Page 2 of 28_
_ _
PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION
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 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 and other antibacterial drugs, Vancomycin
Hydrochloride for Injection 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.