HOSPIRA CEFOXITIN SODIUM POWDER FOR INJECTION cefoxitin (as sodium) 1 g powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefoxitin sodium

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

cefoxitin sodium

Authorization status:

Registered

Patient Information leaflet

Hospira™
Cefoxitin Sodium for Injection CMI
Page 1
HOSPIRA™ CEFOXITIN SODIUM
POWDER FOR INJECTION
cefoxitin sodium _(ke-FOX-it-in) _
CONSUMER MEDICINE INFORMATION
_ _
_Date of Dispensing_
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address_
_ _
_ _
WHAT IS IN THIS LEAFLET
THIS LEAFLET ANSWERS SOME
COMMON QUESTIONS ABOUT
HOSPIRA™ CEFOXITIN SODIUM
POWDER FOR INJECTION.
It does not contain all the
available information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you being
given cefoxitin against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT HOSPIRA™
CEFOXITIN SODIUM
POWDER FOR INJECTION IS
USED FOR
Cefoxitin is an antibiotic that
belongs to a group of medicines
called cephalosporins. It is used
to treat many different types of
infections caused by bacteria. It
works by killing the bacteria
responsible for your infection. It
may be given with other
antibiotics.
It will not work against infections
caused by viruses such as colds
or the flu.
Your doctor may have prescribed
cefoxitin for another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
CEFOXITIN HAS BEEN PRESCRIBED
FOR YOU.
This medicine is available only
with a doctor’s prescription.
Cefoxitin is not addictive.
BEFORE YOU ARE GIVEN
HOSPIRA™ CEFOXITIN
SODIUM POWDER FOR
INJECTION
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
HOSPIRA™ CEFOXITIN SODIUM
POWDER FOR INJECTION IF YOU
HAVE AN ALLERGY TO CEFOXITIN OR
OTHER CEPHALOSPORIN
ANTIBIOTICS.
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing
or difficulty breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin.
YOU MUST NOT BE GIVEN
CEFOXITIN IF YOU HAVE HAD A
MAJOR ALLERGIC REACTION TO
PENICILLIN ANTIBIOTICS.

Summary of Product characteristics

Product Information – Australia
Version 1.0
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-
α
methoxy group in the
β
-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, _
Product Information – Australia
Version 1.0
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_Providencia rettgeri, Morgane