VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Disponibil de la:

FRESENIUS KABI CANADA LTD

Codul ATC:

J01XA01

INN (nume internaţional):

VANCOMYCIN

Dozare:

5G

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 5G

Calea de administrare:

INTRAVENOUS

Unități în pachet:

100ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

GLYCOPEPTIDES

Rezumat produs:

Active ingredient group (AIG) number: 0131315005; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2011-03-02

Caracteristicilor produsului

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
500 mg, 1 g, 5 g and 10 g of vancomycin (as vancomycin hydrochloride)
per vial
Sterile lyophilized powder for solution
ANTIBIOTIC
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite 100 February 27, 2018
Toronto, ON M9W 0C8
Control No.: 204448
2
Vancomycin Hydrochloride for Injection, USP
–
Product Monograph_ _Page 2 of 32_ _
PR
VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
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, vancomycin's effectiveness has been
documented. Antibiotics are used as
Vancomy