Ceftazidime Kabi

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftazidime pentahydrate 1.1648 g equivalent to ceftazidime 1 g (sterile);  

Available from:

Fresenius Kabi New Zealand Limited

Dosage:

1 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Ceftazidime pentahydrate 1.1648 g equivalent to ceftazidime 1 g (sterile)   Excipient: Sodium carbonate

Prescription type:

Prescription

Therapeutic indications:

Indicated for the treatment of adults and children including neonates with 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. Susceptibility to ceftazidime will vary with geography and time and local susceptibility data should be consulted where available (see section 5.1 Pharmacodynamic properties). 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, Type II clear with with halobutyl rubber stopper and flip-off cap - 1 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, Type II clear with with halobutyl rubber stopper and flip-off cap - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, Type II clear with with halobutyl rubber stopper and flip-off cap - 10 dose units - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2018-05-10

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
CEFTAZIDIME KABI ceftazidime (as pentahydrate) 1 g or 2 g powder for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CEFTAZIDIME KABI powder for injection contains either 1 g or 2 g of
ceftazidime (as
pentahydrate).
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection.
Supplied as a white to pale yellow powder. On the addition of Water
for Injections,
Ceftazidime Kabi dissolves with effervescence to produce a solution
for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CEFTAZIDIME KABI is indicated for the treatment of adults and children
including
neonates with 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.
Susceptibility to ceftazidime will vary with geography and time and
local susceptibility data
should be consulted where available (see section 5.1 Pharmacodynamic
properties).
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.
2
-
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).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
Dosage depends upon the severity, sensitivity, site and type of
infection and upon the age
and renal function of the patient.
ADULTS:
1-6 g/day in 2 or 3 divided doses by intravenous (i.v.) or
in