CEFAZOLIN FOR INJECTION POWDER FOR SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

CEFAZOLIN (CEFAZOLIN SODIUM)

Saadav alates:

FRESENIUS KABI CANADA LTD

ATC kood:

J01DB04

INN (Rahvusvaheline Nimetus):

CEFAZOLIN

Annus:

10G

Ravimvorm:

POWDER FOR SOLUTION

Koostis:

CEFAZOLIN (CEFAZOLIN SODIUM) 10G

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

100ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

FIRST GENERATION CEPHALOSPORINS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0109442006; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2016-03-04

Toote omadused

PRODUCT MONOGRAPH
PR CEFAZOLIN FOR INJECTION
Manufacturer’s Standard
10 GRAMS OF CEFAZOLIN (AS CEFAZOLIN SODIUM) PER VIAL
STERILE POWDER FOR SOLUTION
ANTIBIOTIC
FRESENIUS KABI CANADA LTD.
45 Vogell Rd, Suite 200
Date of Preparation:
March 3, 2016
Richmond Hill, ON L4B 3P6
Control No.:
191717
Cefazolin-PM-ENG-v1.0-non-annotated
Page 2 of 17
PRODUCT MONOGRAPH
PR CEFAZOLIN FOR INJECTION
10 GRAMS OF CEFAZOLIN (AS CEFAZOLIN SODIUM) PER VIAL
STERILE POWDER FOR SOLUTION
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTION AND CLINICAL PHARMACOLOGY
Cefazolin for Injection is a cephalosporin antibiotic for parenteral
administration. Cefazolin exerts its
bactericidal effect by inhibiting bacterial cell wall synthesis.
Cefazolin is about 85% bound to serum
protein. The peak level in serum is approximately 32-42 mg/mL after an
intramuscular (i.m.)
injection of
500 mg. Over 80% of injected cefazolin is excreted in the urine during
the first 24 hours
after i.m.
injection; most is excreted during the first 4-6 hours.
INDICATIONS AND CLINICAL USE
Cefazolin for Injection is indicated in the treatment of the following
infections when
caused by
susceptible strains of the listed organisms:
RESPIRATORY TRACT INFECTIONS caused by _Streptococcus pneumoniae,
Klebsiella_
_pneumoniae, Hemophilus influenzae, Staphylococcus aureus
_(penicillin-sensitive and penicillin
resistant)
and group A _beta-haemolytic streptococci_.
URINARY TRACT INFECTIONS caused by _Escherichia coli, Proteus
mirabilis, Klebsiella_
_ _
_pneumoniae _and some strains of enterobacter, and enterococci. See
NOTE below.
SKIN AND SOFT TISSUE INFECTIONS caused by _Staphylococcus aureus
_(penicillin sensitive
and
penicillin- resistant), group A beta-haemolytic streptococci and other
strains of streptococci.
BONE AND JOINT INFECTIONS caused by _Staphylococcus aureus_.
SEPTICEMIA caused by _Streptococcus pneumoniae, Staphylococcus aureus
_(penicillin-sensitive
and
penicillin resistant), _Proteus Mirabilis, Escherichia coli _and
_Klebsiella pneumoniae_. See
NOTE
below.
ENDOCARDITIS ca