CEFAZOLIN- cefazolin sodium injection, powder, for solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

cefazolin sodium (UNII: P380M0454Z) (cefazolin - UNII:IHS69L0Y4T)

Tillgänglig från:

Sagent Pharmaceuticals

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Cefazolin for Injection, USP is indicated for the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections: 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 the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin for Injection, USP is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for Injection, USP in the subsequent prevention of rheumatic fever are not available at present. Urinary Tract Infections: Due to E. coli, P. mirabilis, Klebsiella species, and some strains of enterobacter and enterococci. Skin and Skin Structure Infections: Due to S. aureus (penicillin-sensitive and penicillin-resistant), group A beta-hemolytic streptococci, and other strains of

Produktsammanfattning:

Cefazolin for Injection, USP Pharmacy Bulk Package, containing cefazolin sodium equivalent to 10 grams of cefazolin, is supplied as follows: Cefazolin for Injection, USP, containing cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin, is also available as follows: As with other cephalosporins, Cefazolin for Injection, USP tends to darken depending on storage conditions, within the stated recommendations, however, product potency is not adversely affected. Before reconstitution, store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Brands listed are the trademarks of their respective owners. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Italy ©2018 Sagent Pharmaceuticals, Inc. Revised: September 2018 SAGENT Pharmaceuticals®

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CEFAZOLIN- CEFAZOLIN SODIUM INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
CEFAZOLIN FOR INJECTION, USP
SAGENT
Rx only
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
3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-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. 4 76.5
The pH of the reconstituted solution is between 4 and 6.
Cefazolin for Injection, USP is a white to cream sterile powder. The
color of Cefazolin for Injection,
USP solutions may range from pale yellow to yellow without a change in
potency.
Cefazolin for Injection, USP is supplied in 10 gram Pharmacy Bulk
Packages. Each Pharmacy Bulk
Package contains cefazolin sodium equivalent to 10 grams of cefazolin.
The sodium content is
approximately 48 mg (2.1 mEq) per gram of cefazolin sodium.
It is to be administered by intravenous route.
A Pharmacy Bulk Package is a container of a sterile preparation for
parenteral use that contains many
single doses. The contents of this pharmacy bulk package are intended
for use by a pharmacy admixture
service for addition to suitable parenteral fluids in the preparation
of admixtures for intravenous
infusion (see DOSAGE AND ADMINISTRATION, DIRECTIONS FOR PROPER USE OF
PHARMACY BULK
PACKAGE.) FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.
CLINICAL PHARMACOLOGY
After intramuscular administration of Cefazolin for Injection to
normal volunteers, the mean serum
concentrations were 37 mcg/mL at 1 hour and 3 mcg/mL at 8 hours
following a 500-mg dose, and 64
mcg/mL at 1 hour and 7 mcg/mL at 8 hours fol