Ceftriaxone Actavis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftriaxone sodium 2.386 g (Present as 2.386g ceftriaxone Na*3.5H2O. Eq 2.158g of ceftriaxone Na anhyd or 2g ceftriaxone anhyd);  ;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Ceftriaxone sodium 2.386 g (Present as 2.386g ceftriaxone Na*3.5H2O. Eq 2.158g of ceftriaxone Na anhyd or 2g ceftriaxone anhyd)

Dosage:

2 g

Pharmaceutical form:

Powder for injection

Composition:

Active: Ceftriaxone sodium 2.386 g (Present as 2.386g ceftriaxone Na*3.5H2O. Eq 2.158g of ceftriaxone Na anhyd or 2g ceftriaxone anhyd)    

Units in package:

Vial, glass, 1 x 2g, 2 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Fresenius Kabi Anti-Infectives S.r.l.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 2g - 1 dose units - 36 months from date of manufacture stored at or below 25°C 6 hours reconstituted stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2002-02-21

Summary of Product characteristics

Data Sheet – New Zealand 

Hosp 4.0 
                 1 

DBL
® 
CEFTRIAXONE SODIUM FOR INJECTION 

250 MG, 500 MG, 1 G, 2 G VIALS 

PRESENTATION 
Active ingredient: ceftriaxone in the form of the
disodium salt. 
DBL
® 
Ceftriaxone Sodium for Injection contains approximately 83
mg (3.6 mEq) of sodium per gram of 
ceftriaxone. 
Appearance: Vials are colourless and contain dry
substance which is a white or yellowish crystalline 
powder equivalent to 250 mg, 500 mg, 1g or 2g ceftriaxone. 
USES 
ACTIONS 
The bactericidal activity of ceftriaxone results from inhibition
of bacterial cell wall synthesis. Ceftriaxone 
exerts in-vitro activity against a wide
range of gram-negative and gram-positive micro-organisms. 
Ceftriaxone is highly stable to most β-lactamases, both
penicillinases and cephalosporinases, of gram-
positive and gram-negative bacteria.  
Ceftriaxone is usually active against the following
micro-organisms in vitro and in clinical infections (see 
Indications and usage): 
GRAM-POSITIVE AEROBES 
_Staphylococcus aureus_
 (methicillin-sensitive),
Staphylococci coagulase-negative, _Streptococcus _
_pyogenes_
 (β -hemolytic, group
A), _Streptococcus agalactiae_ (β -hemolytic, group
B), β -hemolytic 
Streptococci (non-group A or B), _Streptococcus
viridans, Streptococcus pneumoniae._  
_Note_
:
Methicillin-resistant _Staphylococcus _spp. is resistant to cephalosporins,
including ceftriaxone. In 
general, _Enterococcus faecalis_, _Enterococcus
faecium _and _Listeria monocytogenes _are resistant. 
GRAM-NEGATIVE AEROBES 
_Acinetobacter lwoffi, Acinetobacter anitratus_
 (mostly _A. baumanii_ )*, _Aeromonas hydrophila, Alcaligenes _
_faecalis, Alcaligenes odorans_
, _Alcaligenes _-like bacteria, _Borrelia burgdorferi,
Capnocytophaga _spp., 
_Citrobacter diversus_
 (