VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP POWDER FOR SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Saadav alates:

AURO PHARMA INC

ATC kood:

J01XA01

INN (Rahvusvaheline Nimetus):

VANCOMYCIN

Annus:

5G

Ravimvorm:

POWDER FOR SOLUTION

Koostis:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 5G

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

1 VIAL

Retsepti tüüp:

Prescription

Terapeutiline ala:

GLYCOPEPTIDES

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2018-06-22

Toote omadused

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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
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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
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