Cefotaxime (Pacific)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefotaxime sodium 1048mg equivalent to 1 g cefotaxime

Available from:

Viatris Limited

INN (International Name):

Cefotaxime sodium 1048 mg (equivalent to 1 g cefotaxime)

Dosage:

1 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Cefotaxime sodium 1048mg equivalent to 1 g cefotaxime Excipient: Nitrogen

Units in package:

Vial, glass, Type II clear tubular vials with chlorobutyl rubber stoppers and aluminium overseals 10 per pack, 10 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Fresenius Kabi Anti-Infectives S.r.l.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type II clear tubular vials with chlorobutyl rubber stoppers and aluminium overseals 10 per pack - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 3 hours reconstituted, use immediately

Authorization date:

2006-04-19

Summary of Product characteristics

CEFOTAXIME
CEFOTAXIME SODIUM, POWDER FOR INJECTION, EQUIVALENT TO CEFOTAXIME 500
MG, 1 G
AND 2 G
PRESENTATION
Cefotaxime is a white to slightly yellowish powder, which, when
dissolved in Water for
Injections B.P., forms a straw coloured solution given by intravenous
or intramuscular
administration.
Each Cefotaxime 500 mg vial contains sterile cefotaxime sodium
equivalent to cefotaxime
500 mg.
Each Cefotaxime 1 g vial contains sterile cefotaxime sodium equivalent
to cefotaxime 1 g.
Each Cefotaxime 2 g vial contains sterile cefotaxime sodium equivalent
to cefotaxime 2 g.
Variations in the intensity of colour of the freshly prepared solution
do not indicate change in
potency or safety.
USES
_ACTIONS _
Cefotaxime is a semi-synthetic broad-spectrum bactericidal
cephalosporin antibiotic. It is a
other β-lactam antibiotic whose mode of action is inhibition of
bacterial cell wall synthesis.
Cefotaxime is exceptionally active _ in vitro_ against Gram-negative
organisms sensitive or
resistant to first or second generation cephalosporins. It is similar
to other cephalosporins in
activity against Gram-positive bacteria.
SUSCEPTIBILITY DATA
Dilution or diffusion techniques – either quantitative minimum
inhibitory concentration (MIC)
or breakpoint, should be used following a regularly updated,
recognised and standardised
method
e.g.
NCCLS.
Standardised
susceptibility
test
procedures
require
the
use
of
laboratory
control
micro-organisms
to
control
the
technical
aspects
of
the
laboratory
procedures.
A report of “Susceptible” indicates that the pathogen is likely to
be inhibited if the microbial
compound in the blood reaches the concentrations usually achievable.
Some strains of
_Pseudomonas aeruginosa_ (approximately 25%) and _Bacteroides_
(approximately 43%) have
_in vitro_ MIC <16 mg/L.A report of “Intermediate” indicates that
the results should be
considered equivocal, and if the micro-organism is not fully
susceptible to alternative,
clinically feasible drugs, the test should be repeated. This category
implies pos