CEFOXITIN FOR INJECTION USP POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CEFOXITIN (CEFOXITIN SODIUM)

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

J01DC01

INN (International Name):

CEFOXITIN

Dosering :

2G

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

CEFOXITIN (CEFOXITIN SODIUM) 2G

Administreringsrute:

INTRAMUSCULAR

Enheter i pakken:

100ML

Resept typen:

Prescription

Terapeutisk område:

CEPHAMYCINS

Produkt oppsummering:

Active ingredient group (AIG) number: 0113134001; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2019-06-28

Preparatomtale

PRODUCT MONOGRAPH
PR
CEFOXITIN FOR INJECTION USP
1 g, 2 g cefoxitin per vial
Sterile Powder
Antibiotic
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision:
January 14, 2019
_Manufactured by:_
PFIZER HEALTHCARE INDIA PVT. LTD.
Irungattukottai - 602 105, India
_ _
_Distributed by: _
APOTEX INC.
150 Signet Drive
Toronto, ON, M9L 1T9
Control No: 220679
_Product Monograph – _
_Pr_
_Cefoxitin for Injection USP _
_ _
_Page 2 of 31 _
PRODUCT MONOGRAPH
PR
CEFOXITIN FOR INJECTION USP
1 g, 2 g cefoxitin per vial
Sterile Powder
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Cefoxitin is a cephamycin derived from cephamycin C. Evidence from
_in vitro _
studies suggests
that cefoxitin exerts its bactericidal action through the inhibition
of bacterial cell wall synthesis.
Studies have indicated that the resistance of cefoxitin to degradation
by bacterial beta-lactamases
is due to the methoxy group in the 7 α position.
After intravenous or intramuscular administration of a 1 g dose, high
serum concentrations are
attained which rapidly decline to about 2 mcg/mL at 3 hours in persons
with normal renal function.
The area under the plasma level-time curve is comparable after bolus
injection or intravenous
infusion over a period of 120 minutes.
INDICATIONS AND CLINICAL USE
TREATMENT
For the treatment of the following infections when due to susceptible
organisms:
1-
Intra-abdominal infections such as peritonitis and intra-abdominal
abscess
2-
Gynecological infections such as endometritis and pelvic cellulitis
3-
Septicemia
4-
Urinary tract infections (including those caused by
_Serratia marcescens_
and
_Serratia spp_
.)
5-
Lower respiratory tract infections
6-
Bone and joint infections caused by
_Staphylococcus aureus_
7-
Soft tissue infections such as cellulitis, abscesses and wound
infections
The
susceptibility
of
the
causative
organism(s)
to
Cefoxitin
for
Injection
USP
should
be
determined by conducting appropriate culture and susceptibility
studies. Therapy may be initiated
while awaiting these