Ceftazidime Sandoz

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftazidime pentahydrate 582.4mg equivalent to 500 mg ceftazidime

Available from:

Sandoz New Zealand Limited

INN (International Name):

Ceftazidime pentahydrate 582.4 mg (equivalent to 500 mg ceftazidime)

Dosage:

500 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Ceftazidime pentahydrate 582.4mg equivalent to 500 mg ceftazidime Excipient: Nitrogen Sodium carbonate

Units in package:

Vial, glass, single dose, 15 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sandoz GmbH

Therapeutic indications:

Ceftazidime Sandoz is indicated for the treatment of single or multiple infections caused by susceptible organisms. May be used alone as first choice medicine before the results of sensitivity tests are available. May be used in combination with an aminoglycoside or most other beta-lactam antibiotics. May be used with an antibiotic against anaerobes when the presence of Bacteroides fragilis is suspected. Indications include: severe infections e.g. septicaemia, bacteraemia, peritonitis, meningitis; infections in immunosuppressed patients; infections in patients in intensive care, e.g. infected burns; respiratory tract infections including lung infections in cystic fibrosis; ear, nose and throat infections; urinary tract infections; skin and soft tissue infections; gastrointestinal, biliary and abdominal infections; bone and joint infections; infections associated with haemo-and peritoneal dialysis and with continuous ambulatory peritoneal dialysis (CAPD).

Product summary:

Package - Contents - Shelf Life: Vial, glass, single dose, - 15 mL - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2002-03-07

Summary of Product characteristics

CEFTAZIDIME SANDOZ 
_CEFTAZIDIME PH EUR, POWDER FOR INJECTION, 250 MG, 500 MG, 1 G AND 2 G
(AS _
_CEFTAZIDIME) _
PRESENTATION 
Ceftazidime Sandoz powder for injection is a white to cream
coloured powder aseptically filled into 
single dose glass vials. 
Ceftazidime Sandoz 250 mg contains in a 15 ml vial, sterile
ceftazidime pentahydrate equivalent to 
ceftazidime 250 mg. 
Ceftazidime Sandoz 500 mg contains in a 15 ml vial, sterile
ceftazidime pentahydrate equivalent to 
ceftazidime 500 mg. 
Ceftazidime Sandoz 1 g contains in 20 ml or 50 ml vials, sterile
ceftazidime pentahydrate equivalent 
to ceftazidime 1 g. 
Ceftazidime Sandoz 2 g contains in 50 ml or 100 ml vials,
sterile ceftazidime pentahydrate equivalent 
to ceftazidime 2 g. 
USES 
_ACTIONS _
PHARMACOTHERAPEUTIC GROUP 
J01DD02 – Third generation cephalosporins, ceftazidime. 
MECHANISM OF ACTION 
Beta-lactam antibiotic. 
PHARMACODYNAMIC EFFECTS 
Inhibition of bacterial cell wall synthesis. 
ANTIBIOTIC CLASS 
Third generation cephalosporin. 
ANTIBIOTIC NATURE AND MODE OF ACTION 
Ceftazidime is bactericidal in action, exerting its effect on
target cell wall proteins and causing 
inhibition of cell wall synthesis. A wide range of pathogenic
strains and isolates are susceptible _in vitro_ 
including strains resistant to gentamicin and other
aminoglycosides. Ceftazidime is stable to most 
beta-lactamases produced by Gram-positive and Gram-negative
organisms and consequently is 
active against many ampicillin and cephalothin resistant strains (but
not methicillin resistant strains). 
_In vitro_, the activities of ceftazidime and aminoglycoside
antibiotics in combination have been shown 
to be at least additive; there is evidence of synergy
in some strains tested. This property may be 
important in the treatment of febrile neutropenic patients. 
SUSCEPTIBILITY DATA 
Dilution or diffusion techniques – either quantitative (MIC) or
breakpoint, should be used following a 
regul