Ceftdime

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftazidime pentahydrate 1.164 g equivalent to 1 g Ceftazidime;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Ceftazidime pentahydrate 1.164 g (equivalent to 1 g Ceftazidime)

Dosage:

1 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Ceftazidime pentahydrate 1.164 g equivalent to 1 g Ceftazidime   Excipient: Sodium carbonate

Units in package:

Vial, glass, Type III 10 mL colourless vial with bromobutyl rubber stopper and aluminium flip-off cap. 1 vial, 1 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Hanmi Fine Chemical Company Ltd

Therapeutic indications:

Ceftazidime for Injection is indicated for the treatment of single and mixed infections caused by susceptible aerobic organisms with suspected or documented resistance to other antimicrobials, but not to ceftazidime, and as an alternative to aminoglycosides in pseudomonal infection in patients in whom aminoglycoside toxicity is a cause for concern and other pseudomonal antibiotics cannot be used. Indications include: · Severe infections in general: for example septicaemia, including neonatal sepsis, bacteraemia, and in patients in intensive care units with specific problems, e.g., infected burns.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type III 10 mL colourless vial with bromobutyl rubber stopper and aluminium flip-off cap. 1 vial - 1 g - 36 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) protect from light

Authorization date:

2006-05-01

Summary of Product characteristics

Data Sheet – New Zealand 

Hosp 1.0  
               1 

DBL
®
 CEFTAZIDIME FOR INJECTION  

NAME OF MEDICINE 
Ceftazidime pentahydrate 

PRESENTATION 
DBL
®
 Ceftazidime for Injection is a cephalosporin antibiotic for use by
injection only.  It is supplied as a 
white to faintly yellow powder in
vials containing 1 g and 2 g ceftazidime (as
pentahydrate) with sodium 
carbonate anhydrous (115 mg per gram of ceftazidime).  On
the addition of Water for Injections, DBL
®

Ceftazidime for Injection dissolves with effervescence to produce a
clear, colourless solution for injection.  
DBL
®
 Ceftazidime for Injection contains approximately
50 mg (2.17 mEq) of sodium per gram of 
ceftazidime.  116 mg ceftazidime pentahydrate is equivalent
to 100 mg ceftazidime anhydrous. For 
laboratory tests associated with ceftazidime administration,
ceftazidime pentahydrate should be used.  

USES  
_ACTIONS _
MICROBIOLOGY 
Ceftazidime is bactericidal in action, exerting its effect on
target cell wall proteins and causing inhibition of 
cell wall synthesis.  It 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).   Ceftazidime has been shown to
have _in vitro _activity against the following 
organisms:  
_GRAM-NEGATIVE:  _
_Pseudomonas aeruginosa_  
Pseudomonas species (other) 
_Klebsiella pneumoniae_ 
Klebsiella species (other) 
_Proteus mirabilis_ 
_Proteus vulgaris_ 
_Morganella morganii_ (formerly _Proteus morganii_) 
_Proteus rettgeri_ 
Providencia species 
_Escherichia coli_ 
Enterobacter species 
Citrobacter species 
Serratia species 
Acinetobacter species 
_Neisseria gonorrhoeae_ 
_Neisseria meningitidis_ 
Haemophilus influenzae (including ampicillin-resistan