VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP POWDER FOR SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Доступна з:

STRIDES PHARMA CANADA INC

Код атс:

J01XA01

ІПН (Міжнародна Ім'я):

VANCOMYCIN

Дозування:

5G

Фармацевтична форма:

POWDER FOR SOLUTION

Склад:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 5G

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

GLYCOPEPTIDES

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2021-08-06

Характеристики продукта

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
Vancomycin Hydrochloride for Injection, USP
500 mg, 1 g, 5 g and 10 g per vial
Vancomycin (as vancomycin hydrochloride)
Sterile Lyophilized Powder for Injection
ANTIBIOTIC
MARCAN PHARMACEUTICALS INC.
DATE OF PREPARATION:
2 GURDWARA RD, # 112
JUN 14, 2023
OTTAWA, ONTARIO
K2E 1A2, CANADA
www.marcanpharma.com
Submission Control No.: 275787
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2
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PRODUCT MONOGRAPH
PR
VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
Vancomycin Hydrochloride for Injection, USP
500 mg, 1 g, 5 g and 10 g Vancomycin per vial
Sterile Lyophilized Powder for Injection
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION
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 who 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.
3
In the treatment of staphylococcal endocarditis, vancomycin has been
used suc