Ceftriaxone (AFT)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ceftriaxone sodium 2158.6mg (Present as 2.386g ceftriaxone Na*3.5H2O. Eq 2.158g of ceftriaxone Na anhyd or 2g ceftriaxone anhyd)

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Ceftriaxone sodium 2158.6 mg (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 2158.6mg (Present as 2.386g ceftriaxone Na*3.5H2O. Eq 2.158g of ceftriaxone Na anhyd or 2g ceftriaxone anhyd)

Units in package:

Bottle, glass, 50mL capacity, 2 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Hanmi Fine Chemical Company Ltd

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 50mL capacity - 2 g - 24 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) - Vial, glass, multi-dose, 10mL capacity - 1 dose units - 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) - Vial, glass, multi-dose, 10mL capacity - 5 dose units - 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) - Vial, glass, multi-dose, 10mL capacity - 10 dose units - 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)

Authorization date:

1999-02-04

Summary of Product characteristics

CEFTRIAXONE-AFT
CEFTRIAXONE SODIUM EQUIVALENT TO CEFTRIAXONE 500 MG, 1 G AND 2 G
POWDER FOR
INJECTION
PRESENTATION
Ceftriaxone-AFT is a white to pale yellow powder packed in vials which
contain the
equivalent of 500 mg, 1 g or 2 g ceftriaxone.
USES
_ACTIONS _
Ceftriaxone is a long acting, broad-spectrum cephalosporin antibiotic
for parenteral use. The
bactericidal activity of ceftriaxone results from inhibition of cell
wall synthesis. Ceftriaxone
exerts
in
vitro
activity
against
a
wide
range
of
Gram-negative
and
Gram-positive
microorganisms. Ceftriaxone is highly stable to most beta-lactamases,
both penicillinases
and cephalosporinases, of Gram-positive and Gram-negative bacteria.
Ceftriaxone is usually active against the following microorganisms in
vitro and in clinical
infections (see Indications):
GRAM-POSITIVE AEROBES:
_Staphylococcus aureus _ (methicillin-sensitive)
_Staphylococci _coagulase-negative
Streptococcus pyogenes (

-hemolytic, group A)
Streptococcus agalactiae _(_

_-hemolytic, group B) _
_Streptococci _

-hemolytic (non-group A or B)
Streptococcus viridans
_Streptococcus pneumoniae _
NOTE:
Methicillin-resistant
_Staphylococcus _
spp.
are
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 (_including _C. amalonaticus) _
_Citrobacter freundii* _
_Escherichia coli _
_Enterobacter aerogenes* _
_Enterobacter cloacae* _
_Enterobacter _spp. (other)
_Haemophilus_ _ducreyi _
_Haemophilus influenzae _
_Haemophilus parainfluenzae _
_Hafnia alvei _
_Klebsiella oxytoca _
_Klebsiella pneumoniae** _
_Moraxella catarrhalis (_former_Branhamella catarrhalis) _
_Moraxella osloensis _
_Moraxella _spp. (other)
_Morganella morganii