VANCOMYCIN HYDROCHLORIDE FOR INJECTION USP POWDER FOR SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Pieejams no:

STERIMAX INC

ATĶ kods:

J01XA01

SNN (starptautisko nepatentēto nosaukumu):

VANCOMYCIN

Deva:

10G

Zāļu forma:

POWDER FOR SOLUTION

Kompozīcija:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 10G

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

100ML

Receptes veids:

Prescription

Ārstniecības joma:

GLYCOPEPTIDES

Produktu pārskats:

Active ingredient group (AIG) number: 0131315008; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2013-05-01

Produkta apraksts

_Product Monograph – _
_Pr_
_Vancomycin Hydrochloride for Injection USP _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VANCOMYCIN HYDROCHLORIDE FOR INJECTION USP
500 MG/VIAL, 1 G/VIAL, 5 G/VIAL AND 10 G/VIAL VANCOMYCIN
STERILE LYOPHILIZED POWDER FOR SOLUTION
Antibiotic
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4
CONTROL NO.: 220151
DATE OF REVISION:
November 5, 2018
_Product Monograph – _
_Pr_
_Vancomycin Hydrochloride for Injection USP _
_Page 2 of 31_
PRODUCT MONOGRAPH
PR
VANCOMYCIN HYDROCHLORIDE FOR INJECTION USP
500 MG/VIAL, 1 G/VIAL, 5 G/VIAL AND 10 G/VIAL VANCOMYCIN
STERILE LYOPHILIZED POWDER FOR SOLUTION
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTIONS AND CLINICAL PHARMACOLOGY
The bactericidal action of vancomycin against most gram-positive
bacteria results from the
inhibition of the biosynthesis of peptidoglycan polymers during the
second stage of cell wall
synthesis in dividing organisms. This effect occurs at a site
different from that of penicillins and
cephalosporins. The cytoplasmic membrane composition may also be
affected and membrane
permeability altered. There is also evidence that vancomycin
selectively inhibits RNA synthesis.
Vancomycin
is
a
tricyclic
glycopeptide
antibiotic
derived
from
_Amycolatopsis _
_orientalis_
(formerly
_Nocardia orientalis_
). It is primarily active against gram-positive organisms including
staphylococci and streptococci. It is active against
methicillin-resistant strains of
_Staphylococcus _
_aureus_
and
_Staphylococcus epidermidis. _
Vancomycin is poorly absorbed from the gastrointestinal tract. It is
given intravenously for
therapy of systemic infections.
Following
intravenous
administration,
vancomycin
is
widely
distributed
and
inhibitory
concentrations of vancomycin can be documented in the pericardial,
pleural, ascitic, and synovial
fluids. Low concentrations of the drug may appear in CSF if meninges
are inflamed. The volume
of distribution for vancomycin ranges from 0.43 to 1.25 L/kg. At a
concentration of 10 to 1