Cefotaxime Sandoz

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

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Last ned Preparatomtale (SPC)
26-03-2013

Aktiv ingrediens:

Cefotaxime sodium 524.1mg equivalent to 500 mg cefotaxime;  

Tilgjengelig fra:

Sandoz New Zealand Limited

INN (International Name):

Cefotaxime sodium 524.1 mg (equivalent to 500 mg cefotaxime)

Dosering :

500 mg

Legemiddelform:

Powder for injection

Sammensetning:

Active: Cefotaxime sodium 524.1mg equivalent to 500 mg cefotaxime  

Enheter i pakken:

Vial, glass, 1 x 500mg, 500 mg

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Sandoz Industrial Products GmbH

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, glass, 500mg - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, 500mg - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, 500 mg - 10 dose units - 24 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

2000-08-16

Preparatomtale

                                CEFOTAXIME SANDOZ 
_CEFOTAXIME SODIUM PH EUR, POWDER FOR INJECTION, 500 MG, 1 G AND 2 G
(AS _
_CEFOTAXIME) _
PRESENTATION 
Cefotaxime Sandoz powder for injection is a white to slightly
yellowish powder aseptically filled into 
glass vials. 
Cefotaxime Sandoz 500 mg contains in a 15 ml vial, sterile Cefotaxime
Sodium Ph Eur equivalent to 
cefotaxime 500 mg. 
Cefotaxime Sandoz 1 g contains in a 20 ml vial, sterile
Cefotaxime Sodium Ph Eur equivalent to 
cefotaxime 1 g. 
Cefotaxime Sandoz 2 g contains in a 20 ml or 50 ml vial, sterile
Cefotaxime Sodium Ph Eur equivalent 
to cefotaxime 2 g. 
USES 
_ACTIONS _
PHARMACOTHERAPEUTIC GROUP 
J01DD01 - Third generation cephalosporins, cefotaxime. 
MECHANISM OF ACTION 
Beta-lactam antibiotic. 
PHARMACODYNAMIC EFFECTS 
Inhibition of bacterial cell wall synthesis. 
ONSET AND DURATION OF ACTION 
The duration of treatment depends on the patient's response and
therapy should be continued for at 
least three days after body temperature normalisation.  
ANTIBIOTIC CLASS 
Cefotaxime is a semisynthetic broad
spectrum bactericidal cephalosporin antibiotic for parenteral use. 
ANTIBIOTIC NATURE AND MODE OF ACTION 
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. 
Cefotaxime has been used with other beta-lactam antibiotics such
as carbenicillin in the treatment of 
neutropenic patients. 
Cefotaxime Sandoz may also be administered with metronidazole in the
treatment of mixed infections 
caused by anaerobic and aerobic organisms.  
SUSCEPTIBILITY DATA 
Dilution or diffusion techniques – either quantitative minimum
inhibitory concentrations (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 contr
                                
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