JAMP-VANCOMYCIN POWDER FOR SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

متاح من:

JAMP PHARMA CORPORATION

ATC رمز:

J01XA01

INN (الاسم الدولي):

VANCOMYCIN

جرعة:

1G

الشكل الصيدلاني:

POWDER FOR SOLUTION

تركيب:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 1G

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

1G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

GLYCOPEPTIDES

ملخص المنتج:

Active ingredient group (AIG) number: 0131315009; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2022-11-16

خصائص المنتج

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
JAMP-VANCOMYCIN
500mg/vial, 1000mg/vial, 5000mg/vial and 10,000mg/vial
Vancomycin (as vancomycin hydrochloride)
ANTIBIOTIC
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Date of Revision:
August 26, 2019
Submission Control No:
228660
2
PRODUCT MONOGRAPH
Pr
JAMP-VANCOMYCIN
500 mg/vial ,1000 mg/vial, 5000 mg/vial and 10,000 mg/vial Vancomycin
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
JAMP-VANCOMYCIN 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
JAMP-VANCOMYCIN and other
antibacterial drugs, JAMP-VANCOMYCIN 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.
3
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