Lemoxol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftazidime pentahydrate 1160mg equivalent to ceftazidime 1000 mg

Available from:

Multichem NZ Limited

INN (International Name):

Ceftazidime pentahydrate 1160 mg (equivalent to ceftazidime 1000 mg)

Dosage:

1 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Ceftazidime pentahydrate 1160mg equivalent to ceftazidime 1000 mg Excipient: Sodium carbonate

Units in package:

Vial, glass, 15mL type III glass vial, type I rubber closure, aluminium flip-top cap, 1 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Orchid Chemicals and Pharmaceuticals Limited

Product summary:

Package - Contents - Shelf Life: Vial, glass, 15mL type III glass vial, type I rubber closure, aluminium flip-top cap - 1 g - 36 months from date of manufacture stored at or below 25°C protect from light. Shelf life of 36 months is assigned from date of manufacture of API not date of packing 24 hours reconstituted stored at or below 25°C protect from light. When reconstituted in water for injection 7 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. When reconstituted in water for injection 6 hours reconstituted stored at or below 25°C protect from light. When reconstituted in intravenous solutions listed in the data sheet 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. When reconstituted in intravenous solutions listed in the data sheet

Authorization date:

2002-08-28

Summary of Product characteristics

NEW ZEALAND DATA SHEET 
LEMOXOL 
Ceftazidime, powder for injection, 1g and 2g 

Please refer to the Medsafe website (www.medsafe.govt.nz) for the
most recent 
version of this prescribing information. 
Page 1 of 14 

PRESENTATION 
Lemoxol 1g is a white to almost white powder containing
1160mg ceftazidime 
pentahydrate (equivalent to ceftazidime 1g) and
118mg sodium carbonate. 

Lemoxol 2g is a white to almost white powder containing
2320mg ceftazidime 
pentahydrate (equivalent to ceftazidime 2g) and
236mg sodium carbonate. 

On the addition of Water for injection, Lemoxol dissolves with
effervescence to 
produce a clear solution for injection or infusion. 
_ _
PHARMACOLOGY 
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 regularly updated, recognised and standardised method
(e.g. 
NCCLS)