cefizox- Ceftizoxime sodium solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Ceftizoxime Sodium (UNII: 26337D5X88) (Ceftizoxime - UNII:C43C467DPE)

Mevcut itibaren:

Astellas Pharma US, Inc.

INN (International Adı):

Ceftizoxime sodium

Farmasötik formu:

SOLUTION

Kompozisyon:

1 g in 50 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Cefizox (ceftizoxime injection) is indicated in the treatment of infections due to susceptible strains of the microorganisms listed below. Lower Respiratory Tract Infections caused by Klebsiella spp.; Proteus mirabilis ; Escherichia coli; Haemophilus influenzae including ampicillin­resistant strains; Staphylococcus aureus (penicillinase­ and nonpenicillinase­producing); Serratia spp.; Enterobacter spp.; Bacteroides spp.; and Streptococcus spp. including S. pneumoniae , but excluding enterococci. Urinary Tract Infections caused by Staphylococcus aureus (penicillinase­ and nonpenicillinase­producing); Escherichia coli ; Pseudomonas spp. including P. aeruginosa ; Proteus mirabilis ; P. vulgaris ; Providencia rettgeri (formerly Proteus rettgeri ) and Morganella morganii (formerly Proteus morganii ); Klebsiella spp.; Serratia spp. including S. marcescens ; and Enterobacter spp. Gonorrhea including uncomplicated cervical and urethral gonorrhea caused by Neisseria gonorrhoeae . Pelvic Inflammatory Dise

Ürün özeti:

Cefizox® (ceftizoxime injection) is supplied as a frozen, iso-osmotic, sterile, nonpyrogenic solution in 50 mL single dose Galaxy® plastic containers (PL 2040) as follows: NDC 0469-7220-01                          Product No. 722001 1 g ceftizoxime/50 mL container NDC 0469-7221-02                          Product No. 722102 2 g ceftizoxime/50 mL container Store at or below -20°C/-4°F. Rx only See   DIRECTIONS FOR USE OF CEFIZOX®(ceftizoxime injection) IN Galaxy® PLASTIC CONTAINER (PL 2040) Galaxy® is registered trademark of Baxter International Inc. Ceftizoxime sodium is a product of Japan. Marketed by: Astellas Pharma US, Inc. Deerfield, IL 60015 Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015.

Ürün özellikleri

CEFIZOX- CEFTIZOXIME SODIUM SOLUTION
ASTELLAS PHARMA US, INC.
----------
CEFIZOX
(CEFTIZOXIME INJECTION)
IN GALAXY PLASTIC CONTAINER (PL2040)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefizox and
other antibacterial drugs, Cefizox should be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
FOR INTRAVENOUS USE
DES CRIPTION
Cefizox
(ceftizoxime injection) in the Galaxy
plastic container (PL 2040) contains ceftizoxime as
ceftizoxime sodium. It is a sterile, semisynthetic, broad spectrum,
cephalosporin antibiotic for
intravenous administration.
Chemically, it is the sodium (6_R_, 7_R_)7[2-(2imino4 thiazolin-4-yl)
glyoxylamido]8oxo5thia1-
azabicyclo[4.2.0.]oct2ene2carboxylate 7²-(_Z_)-(_O_-methyloxime). The
molecular formula is
C
H N NaO S and the molecular weight is 405.38. The structural formula
of ceftizoxime sodium
is as follows:
Cefizox (ceftizoxime injection) in the Galaxy
plastic container is a frozen iso-osmotic, sterile,
nonpyrogenic premixed 50 mL solution containing 1 g or 2 g of
ceftizoxime as ceftizoxime sodium.
Dextrose, USP has been added to these dosages to adjust osmolality
(approximately 1.9 g and 950 mg to
the 1 g and 2 g dosages as dextrose hydrous, respectively). Thawed
solutions range from very pale
yellow to yellow. The pH of thawed solutions range from 5.5 to 8.0.
After thawing to room
temperature, the solution is intended for intravenous use only.
The Galaxy
container is fabricated from a specially designed multilayer plastic
(PL 2040). Solutions
are in contact with the polyethylene layer of this container and can
leach out certain chemical
components of the plastic in very small amounts within the expiration
dating period. The suitability of
the plastic has been confirmed in tests in animals according to the
USP biological tests for plastic
containers, as well as by tissue culture toxicity studies.
CLINICAL PHARMACOLOGY
Following IV administration of 1, 2, and 3 gram doses of Cefizox to
normal