CEFAZOLIN injection, powder, for solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Civica, Inc.

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Cefazolin for Injection, USP is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections:  due to S. penumoniae, Klebsiella species, H. Influenzae, S. aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci. Injectable benzathine penicillin is considered to be 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. 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

Ապրանքի ամփոփագիր:

Cefazolin for Injection, USP, is supplied in 10 gram Pharmacy Bulk Package vials. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams of cefazolin, as follows: Cefazolin for Injection, USP Vial Size Packaged NDC No. 10 grams 100 mL Carton of 10 vials 72572-056 -10  Also available as: Cefazolin for Injection, USP Vial Size Packaged NDC No. 1 gram 10 mL Carton of 25 vials 72572-055 -25  Preservative Free. 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, protect from light and store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. This container closure is not made with natural rubber latex. CLINITEST is a registered trademark of Miles, Inc. CLINISTIX is a registered trademark of Bayer Corporation. Distributed by: Civica, Inc. Lehi, UT 84043 Manufactured by: Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, Portugal Revised: August 2021 PIN604-CIV/1

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
CIVICA, INC.
----------
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 and other antibacterial drugs, Cefazolin for
Injection 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 (6R,
7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-
yl)]thio]methyl]-8-oxo-7-[2(1H-tetrazol-1-yl)acetoamido]-5-thia-1-azabicyclo[4.2.0]oct-2-
ene-2-carboxylic acid.
The structural formula is as follows:
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.
The pH ranges from 4.0 and 6.0 for a solution containing 100 mg of
cefazolin per mL.
Cefazolin for Injection, USP is supplied in 10 gram Pharmacy Bulk
Packages. Each
Pharmacy Bulk Package contains Cefazolin Sodium, USP 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
intravenous use that
contains many single doses. The contents are intended for use in a
pharmacy admixture
service and are restricted to the preparation of admixtures for
intravenous infusion.
FURTHER DILUTION IS REQUIRED BEFORE USE.
CLINICAL PHARMACOLOGY
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 1 gram dose.
The serum half-life for Cefazolin for Injection is approximately 1.8
hours following
intravenous administration.
In a study (using normal volunteers) of cons