CEFAZOLIN injection, powder, for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

General Injectables and Vaccines, Inc.

INN (International Name):

CEFAZOLIN SODIUM

Sammensætning:

CEFAZOLIN 500 mg in 2.2 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske 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

Produkt oversigt:

Cefazolin for Injection, USP, containing cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin, is supplied as follows: Cefazolin for Injection, USP is also available in a 10 gram Pharmacy Bulk Package. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams of cefazolin and is supplied 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. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Italy ©2018 Sagent Pharmaceuticals, Inc. Revised: September 2018 SAGENT Pharmaceuticals®

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
----------
CEFAZOLIN FOR INJECTION, USP
RX ONLY
SAGENT®
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.
Cefazolin for Injection, USP is a sterile white to cream powder
supplied in vials. Each vial contains,
cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin.
The sodium content is approximately 24 mg (1 mEq)/500 mg of cefazolin
sodium or approximately 48
mg (2.1 mEq)/1 gram of cefazolin sodium.
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 to be administered by intramuscular or
intravenous routes.
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 following a 1-gram dose.
Studies have shown that following intravenous administration of
Cefazolin for Injection 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 for Injection is approximately 1.8
hours following IV administration
and approximately 2 hours following IM 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.