VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP POWDER FOR SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Disponible des:

AURO PHARMA INC

Codi ATC:

J01XA01

Designació comuna internacional (DCI):

VANCOMYCIN

Dosis:

5G

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 5G

Vía de administración:

INTRAVENOUS

Unidades en paquete:

1 VIAL

tipo de receta:

Prescription

Área terapéutica:

GLYCOPEPTIDES

Resumen del producto:

Active ingredient group (AIG) number: 0131315007; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2018-06-22

Fitxa tècnica

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