Hospira™ Cefoxitin Sodium

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Cefoxitin sodium 1.051 g equivalent to cefoxitin 1 g

Tilgængelig fra:

Pfizer New Zealand Limited

INN (International Name):

Cefoxitin sodium 1.051 g (= cefoxitin 1 g)

Dosering:

1 g

Lægemiddelform:

Powder for injection

Sammensætning:

Active: Cefoxitin sodium 1.051 g equivalent to cefoxitin 1 g

Enheder i pakken:

Vial, glass, single dose, molded, Type I, clear, 20 mL, with a grey closure, Al seal & PP plastic button; 5x1g vials, 5 g

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Orchid Chemicals and Pharmaceuticals Limited

Terapeutiske indikationer:

Hospira™ Cefoxitin Sodium Powder for Injection is indicated for the treatment of the following infections when due to susceptible organisms (see Microbiology) peritonitis and other intraabdominal and intra-pelvic infections, female genital tract infections, septicaemia, endocarditis, urinary tract infections, respiratory tract infections, bone and joint infections, skin and skin structure infections. Hospira™ Cefoxitin Sodium Powder for Injection has a high degree of stability against betalactamase and is therefore effective against beta-lactamase producing organisms resistant to penicillins or cephalosporins. It can also be used in mixed infections provided that the organisms are sensitive to it. Hospira™ Cefoxitin Sodium Powder for Injection can be used as adjunctive therapy in the surgical treatment of infections including abscesses, infection complicating hollow viscous perforations, cutaneous infections and infections of serous surfaces whether caused by aerobes, mixed aerobes and anaerobes, or anaerobes.

Produkt oversigt:

Package - Contents - Shelf Life: Vial, glass, single dose, molded, Type I, clear, 20 mL, with a grey closure, Al seal & PP plastic button; 5x1g vials - 5 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) protect from light

Autorisation dato:

2011-11-21

Produktets egenskaber

Datasheet – New Zealand
Version 2.0
Page 1
HOSPIRA™ CEFOXITIN SODIUM POWDER FOR INJECTION
NAME OF THE MEDICINE
Non proprietary name: cefoxitin sodium
Chemical name: Sodium
(6R,7S)-3-[(carbamoyloxy)methyl]-7-methoxy-8-oxo-7-[[(thiophen-2-
yl)acetyl]amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate.
Molecular formula: C
16
H
16
N
3
NaO
7
S
2
Molecular weight: 449.4
Chemical Abstracts Service (CAS) registry number: 33564-30-6
DESCRIPTION
Hospira™ Cefoxitin Sodium Powder for Injection is a white to off
white sterile powder of cefoxitin
sodium for intravenous and intramuscular administration following
reconstitution. Each vial contains
cefoxitin sodium equivalent to 1 g of Cefoxitin.
Each gram of cefoxitin sodium contains approximately 51.2 mg (2.2 mEq)
of sodium. The pH of
10% w/v cefoxitin sodium in Water for Injections is 4.2 to 7.0.
PHARMACOLOGY
Cefoxitin is a bactericidal antibiotic which acts by inhibiting
bacterial cell wall synthesis. Due to the
presence of a 7-

methoxy group in the

-lactam ring, it exhibits a high degree of stability in the
presence of beta-lactamases.
MICROBIOLOGY
Cefoxitin is active against the following microorganisms _in vitro_:
Aerobic bacteria
1.
Gram-positive cocci including _Staphylococci_ (including
coagulase-positive, coagulase-
negative and penicillinase producing strains), Group A beta-haemolytic
streptococci
(_Streptococcus pyogenes_), Group B beta-haemolytic streptococci
(_Streptococcus agalactiae_)
and Streptococcus pneumoniae (_Diplococcus pneumoniae_). Other
streptococci (most strains
of enterococci, e.g. _Streptococcus faecalis_) are resistant.
2.
Gram-negative cocci including _Neisseria gonorrhoeae_ (including
penicillinase-producing
strains) and _Neisseria meningitidis_.
3.
Gram-negative rods (facultative anaerobes) including _Escherichia
coli, Klebsiella _
_pneumoniae, Klebsiella_ spp, _Proteus mirabilis, Proteus
_(indole-positive), _Proteus vulgaris, _
_Providencia rettgeri, Morganella morganii, Serratia marcescens ,
Providencia_ spp,
_Salmonella_ an