CEFAZOLIN- cefazolin sodium injection, powder, for solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Sagent Pharmaceuticals

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

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. Storage Conditions 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. PREMIER ProRx® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Italy ©2018 Sagent Pharmaceuticals, Inc. PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Revised: September 2018

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

CEFAZOLIN- CEFAZOLIN SODIUM INJECTION, POWDER, FOR SOLUTION
SAGENT PHARMACEUTICALS
----------
CEFAZOLIN FOR INJECTION, USP
PHARMACY BULK PACKAGE -
NOT FOR DIRECT INFUSION
PREMIERProRx
Rx only
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. 476.5
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.)
®
14 13 8
4 3
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