CEFAZOLIN injection, powder, for solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

WG Critical Care, LLC

INN (Internationale Bezeichnung):

CEFAZOLIN SODIUM

Zusammensetzung:

CEFAZOLIN 10 g

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Cefazolin for Injection, USP is supplied in 10 gram or 20 gram Pharmacy Bulk Package bottles. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams or 20 grams of cefazolin and is supplied as follows: NDC 44567-708-10 10 gram Pharmacy Bulk Package (carton of 10) NDC 44567-709-10 20 gram Pharmacy Bulk Package (carton of 10) Also available: Cefazolin for Injection, USP equivalent to 500 mg or 1 gram cefazolin per vial is supplied as follows: NDC 44567-706-25 500 mg vial (carton of 25) NDC 44567-707-25 1 gram vial (carton of 25) As with other cephalosporins, cefazolin tends to darken depending on storage conditions, within the stated recommendations. However, product potency is not adversely affected. Before reconstitution protect from light and store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. CLINITEST is a registered trademark of Miles, Inc. CLINISTIX is a registered trademark of Bayer Corporation. Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Made in Italy Revised: March 2019

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
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CEFAZOLIN FOR INJECTION, USP
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. 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 or 20 grams Pharmacy
Bulk Packages. Each
Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams
or 20 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
14
13
8
4 3
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