VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Sẵn có từ:

JAMP PHARMA CORPORATION

Mã ATC:

J01XA01

INN (Tên quốc tế):

VANCOMYCIN

Liều dùng:

10G

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 10G

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

250ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

GLYCOPEPTIDES

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2022-11-02

Đặc tính sản phẩm

_Vancomycin Hydrochloride for Injection, USP (Product Monograph) Page
1 of 27 _
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 of vancomycin
(as vancomycin hydrochloride)
Sterile lyophilized
powder for solution
ANTIBIOTIC
JAMP Pharma Corporation
1310 rue Nobel,
Boucherville,
Quebec
J4B 5H3, Canada
Date of Revision:
October 25, 2022
Control No.: 250896
_Vancomycin Hydrochloride for Injection, USP (Product Monograph) Page
2 of 27 _
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-
tiss