STERILE VANCOMYCIN HYDROCHLORIDE, USP POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Compra

Scheda tecnica Scheda tecnica (SPC)
12-02-2008

Principio attivo:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)

Commercializzato da:

PHARMACEUTICAL PARTNERS OF CANADA INC

Codice ATC:

J01XA01

INN (Nome Internazionale):

VANCOMYCIN

Dosaggio:

1G

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 1G

Via di somministrazione:

INTRAVENOUS

Confezione:

1GM

Tipo di ricetta:

Prescription

Area terapeutica:

GLYCOPEPTIDES

Dettagli prodotto:

Active ingredient group (AIG) number: 0131315001; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2008-02-15

Scheda tecnica

                                PRODUCT MONOGRAPH
Pr
Sterile Vancomycin Hydrochloride, USP
Pr
Vancomycin Hydrochloride for Injection, USP
Antibiotic
Pharmaceutical Partners of Canada Inc.
Date of Preparation:
45 Vogell Road, Suite 200
January 17, 2008
Richmond Hill, ON
L4B 3P6
Control No.: 119199
1
NAME OF DRUG
Sterile Vancomycin Hydrochloride, USP
Vancomycin Hydrochloride for Injection, USP
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTION
_In vitro_ studies indicate that the bactericidal action of vancomycin
hydrochloride against
many gram-positive bacteria results from the inhibition of cell-wall
synthesis. There is
also evidence that vancomycin alters the permeability of the cell
membrane and
selectively inhibits RNA synthesis.
INDICATIONS AND CLINICAL USES
VANCOMYCIN HYDROCHLORIDE IV may be 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
and
cephalosporins
or
who
have
infections
with
staphylococci resistant to other antibiotics, including methicillin.
VANCOMYCIN
HYDROCHLORIDE
IV
has
been
used
successfully
alone
in
the
treatment of staphylococcal endocarditis.
VANCOMYCIN HYDROCHLORIDE IV has been reported to be effective alone or
in
combination with an aminoglycoside for endocarditis caused by
_Streptococcus viridans_
or _S. bovis._ For endocarditis caused by enterococci (e.g. _E.
faecalis_), VANCOMYCIN
HYDROCHLORIDE IV has been reported to be effective only in combination
with an
aminoglycoside.
VANCOMYCIN
HYDROCHLORIDE
IV
has
been
reported
to
be
effective
for
the
treatment of diphtheroid endocarditis. VANCOMYCIN HYDROCHLORIDE IV has
been
used successfully in combination with either rifampin, an
aminoglycoside, or both in
early-onset prosthetic valve endocarditis caused by _S. epidermidis_
or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order to
isolate and identify
causative
organisms
and
to
determine
their
susceptibilities
to
VANCOMYCIN
HYDROCHLORIDE IV.
2
Its
effectiveness
has
been
documented
in
other

                                
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