Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
cefazolin sodium (UNII: P380M0454Z) (cefazolin - UNII:IHS69L0Y4T)
Sagent Pharmaceuticals
INTRAVENOUS
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
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 Olvassa el a teljes dokumentumot