DBL™ Cephazolin Sodium for Injection

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cefazolin sodium 1048mg equivalent to 1 g cephazolin

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Cefazolin sodium 1048 mg (equivalent to 1 g cephazolin)

Dosage:

1 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Cefazolin sodium 1048mg equivalent to 1 g cephazolin

Units in package:

Vial, glass, Type III 1g, 5 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

ACS Dobfar SpA

Therapeutic indications:

Respiratory Tract Infections Due to S. pneumoniae, Klebsiella sp, H. influenzae, Staph. aureus (including penicillinase-producing strains), and Group A ?-haemolytic streptococci. Injectable penicillin G benzathine is considered to be the medicine of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cephazolin in the subsequent prevention of rheumatic fever are not available at present.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type III 1g - 5 dose units - 36 months from date of manufacture stored at or below 25°C 36 hours reconstituted stored at or below 30°C 96 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 12 weeks reconstituted stored below -20°C (Deep freeze)

Authorization date:

1999-10-01

Summary of Product characteristics

              Data Sheet – New Zealand
Hosp 3.0
                 1
DBL™ CEPHAZOLIN SODIUM FOR INJECTION
500 MG AND 1 G VIALS
PRESENTATION
DBL™ Cephazolin Sodium for Injection 500 mg and 1 g vials contain a white to slightly yellow powder 
which reconstitutes with Sterile Water for Injection to give a colourless solution.
DBL™ Cephazolin Sodium for Injection 500 mg vial contains
cephazolin sodium equivalent to 500 mg of 
cephazolin.
DBL™ Cephazolin Sodium for Injection 1 g vial contains cephazolin sodium equivalent to 1 g of 
cephazolin.
USES
ACTIONS
DBL™ Cephazolin Sodium for Injection is a semisynthetic cephalosporin for intramuscular or intravenous 
administration. _In vitro_ tests demonstrate that the bactericidal action of cephalosporins results from 
inhibition of cell-wall synthesis.
DBL™ Cephazolin Sodium for Injection is active against the
following organisms _in vitro_ and in clinical 
infections:
_Staphylococcus aureus_ (including penicillinase-producing strains), _Staphylococcus epidermidis_. 
Group A β-haemolytic streptococci and other strains of streptococci (many strains of enterococci are 
resistant).
_Streptococcus pneumoniae_
_Escherichia coli_
_Klebsiella sp._
_Proteus mirabilis_
_Haemophilus influenzae_
_Enterobacter aerogenes_
Most strains of indole-positive _Proteus (Proteus vulgaris)_, _Enterobacter cloacae_, _Morganella morganii_, 
and _Providencia rettgeri_ are resistant.
Methicillin-resistant staphylococci, _Serratia_, _Pseudomonas_ and _Acinetobacter calcoaceticus_ (formerly 
_Mima_ and _Herellea sp_.) are almost uniformly resistant to cephazolin.
Disc Susceptibility Tests--Quantitative methods that require measurement of zone diameters give the 
most precise estimates of antibiotic susceptibility. One such
procedure has been recommended for use 
with discs for testing suscepti