CEFAZOLIN injection powder for solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

APP Pharmaceuticals, LLC

INN (International Nazwa):

CEFAZOLIN SODIUM

Skład:

CEFAZOLIN 20 g in 100 mL

Typ recepty:

PRESCRIPTION DRUG

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
APP PHARMACEUTICALS, LLC
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CEFAZOLIN FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefazolin for
Injection, USP and other antibacterial drugs, Cefazolin for Injection,
USP should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Cefazolin for 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:
C
H N NAO S M.W. 476.49
The pH of the constituted solution is between 4 and 6.
Each pharmacy bulk package bottle contains 48 mg of sodium/1 gram of
cefazolin sodium.
Cefazolin for Injection, USP is supplied in 20 g bottles and is
intended for intravenous infusion only.
Each Pharmacy Bulk bottle contains cefazolin sodium equivalent to 20 g
of cefazolin.
A pharmacy bulk package is a container of a sterile preparation for
intravenous use that contains many
single doses. The contents are intended for use in a pharmacy
admixture service and are restricted to the
preparation of admixtures for intravenous infusion. FURTHER DILUTION
IS REQUIRED BEFORE
USE.
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 hours
for a 1 gram dose.
The serum half-life for cefazolin is approximately 1.8 hours following
IV administration.
In a study (using normal volunteers) of constant intravenous infusion
with dosages of 3.5 mg/kg for 1
hour (approximately 250 mg) and 1.5 mg/kg the next 2 hours
(approximately 100 mg), cefazolin
produced a steady serum level at the third hour of approximately 28
mcg/mL.
Studies in patients hosp