CEFAZOLIN- cefazolin sodium injection, solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

CEFAZOLIN SODIUM (UNII: P380M0454Z) (CEFAZOLIN - UNII:IHS69L0Y4T)

Boleh didapati daripada:

Baxter Healthcare Corporation

INN (Nama Antarabangsa):

CEFAZOLIN SODIUM

Komposisi:

CEFAZOLIN 1 g in 50 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Cefazolin Injection, USP is indicated in the treatment of the following infections due to susceptible organisms: Due to S. pneumoniae, Klebsiella  species, H. influenzae, S. aureus  (penicillin sensitive and penicillin resistant), and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available. Due to E. coli, P. mirabilis, Klebsiella  species, and some strains of enterobacter and enterococci. Due to S. aureus  (penicillin sensitive and penicillin-resistant), group A beta-hemolytic streptococci, and other strains of streptococci. Due to E. coli, various strains of streptococci, P. mirabilis, Klebsiella  species, and S. aureus . Due to S. aureus . (i.e. , prostati

Ringkasan produk:

As with other cephalosporins, cefazolin tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected. Cefazolin Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL single dose GALAXY plastic containers as follows: 2G3503 NDC 0338-3503-41 1 g cefazolin in 50 mL Supplied 24/case Store at or below -20°C/-4°F. [See DIRECTIONS FOR USE OF CEFAZOLIN INJECTION, USP IN GALAXY CONTAINER (PL 2040 PLASTIC). ] Handle frozen product containers with care. Product containers may be fragile in the frozen state. Rx Only

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CEFAZOLIN- CEFAZOLIN SODIUM INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
CEFAZOLIN INJECTION, USP
IN GALAXY CONTAINER
(PL 2040 PLASTIC)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Cefazolin Injection, USP and other antibacterial drugs, Cefazolin
Injection, USP should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
DESCRIPTION
Cefazolin Injection, USP is a semi-synthetic cephalosporin for
parenteral administration.
It is the sodium salt of
(6_R_,7_R_)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-
[2-(1_H_-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic
acid.
Structural Formula:
The sodium content is 46 mg per gram of cefazolin.
Dextrose Hydrous, USP structural (molecular) formula:
The molecular weight of Dextrose Hydrous, USP is 198.17.
The chemical name is D-Glucose, Monohydrate.
Cefazolin Injection, USP is a frozen, premixed, iso-osmotic, sterile,
nonpyrogenic 50 mL
solution containing cefazolin sodium equivalent to 1 g of Cefazolin,
USP. Dextrose, USP
has been added to adjust osmolality (2 g as dextrose hydrous).
The pH of Cefazolin Injection, USP has been adjusted with sodium
bicarbonate. The
solution is intended for intravenous use after thawing to room
temperature.
This GALAXY container (PL 2040 Plastic) 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 period. However, 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
Studies have shown that following intravenous administration of
cefazolin to normal
volunteers, mean serum concentrations peaked at approximately 185
mcg/mL and were
approximately 4 mcg/mL at 8 hour