Ceftriaxone Mylan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

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

Available from:

Viatris Limited

INN (International Name):

Ceftriaxone sodium 2.158 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 infusion

Composition:

Active: Ceftriaxone sodium 2.158 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, Type I; pack of 1 vial, 2 g

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Fresenius Kabi Anti-Infectives S.r.l.

Therapeutic indications:

Infections caused by pathogens sensitive to ceftriaxone e.g.: - sepsis; - meningitis; - abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts); - infections of the bones, joints, soft tissue, skin and of wounds; - infections in patients with impaired defence mechanisms; - renal and urinary tract infections; - respiratory tract infections, particularly pneumonia, and ear, nose and throat infections; - genital infections, including gonorrhoea. - Perioperative prophylaxis of infections.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I; pack of 1 vial - 2 g - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, Type I; pack of 5 vials - 10 g - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2009-06-03

Summary of Product characteristics

Page 1 of 12
NEW ZEALAND DATA SHEET
_CEFTRIAXONE MYLAN _
_CEFTRIAXONE SODIUM 1 G, POWDER FOR INJECTION AND _
_2 G, POWDER FOR INFUSION _
PRESENTATION
1g injection; 2g infusion
Vials are colourless and contain an almost white or yellowish powder
equivalent to 1 g or 2 g
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 _(
β
-hemolytic, group A)
_Streptococcus agalactiae _(
β
-hemolytic, group B)
_Streptococci _
β
_-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_ _
_Capnocytophaga _spp._ _
_Citrobacter diversus (_including _C. amalonaticus) _
_Citrobacter freundii* _
_Escherichia coli _
_Enterobacter aerogenes* _
_Enterobacter cloacae* _
_Enterobacter _spp. (other)_ _
_Haemophilus ducreyi _
_Haemophilus influenzae _
Page 2 of 12
_Haemophilus parainfluenzae _
_Hafnia alvei _
_Klebsiella oxytoca _
_Klebsiella pneumoniae** _
_Moraxella catarrhalis (_former _Branhamella catarrhalis) _
_Moraxella osloensis _
_Moraxella _spp. (other)_ _
_Morg