Cefotaxime Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefotaxime sodium 1048.2mg Equivalent to 1000 mg cefotaxime;  

Available from:

Sandoz New Zealand Limited

INN (International Name):

Cefotaxime sodium 1048.2 mg (Equivalent to 1000 mg cefotaxime)

Dosage:

1000 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Cefotaxime sodium 1048.2mg Equivalent to 1000 mg cefotaxime  

Units in package:

Vial, glass, 1000 mg, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sandoz Industrial Products GmbH

Product summary:

Package - Contents - Shelf Life: Vial, glass, 1000 mg - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, 1000 mg - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, 1000 mg - 10 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2000-08-16

Summary of Product characteristics

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