CEFAZOLIN injection, powder, for solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Henry Schein, Inc.

Spôsob podávania:

INTRAMUSCULAR

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Cefazolin for Injection, USP is indicated in 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 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 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

Prehľad produktov:

Each vial of Cefazolin for Injection, USP contains cefazolin sodium equivalent to 1 gram or 2 grams cefazolin. NDC 60505-6142-5, 1 gram, carton of 25 vials NDC 60505-6231-5, 2 grams, carton of 25 vials 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. 1 gram Manufactured by: Qilu Pharmaceutical Co., Ltd. High Tech Zone Jinan, 250101, China Manufactured for: Apotex Corp. Weston, Florida, USA 33326 Code number: 34040001011F Rev 01/22

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
HENRY SCHEIN, INC.
----------
CEFAZOLIN FOR INJECTION, USP
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:
The sodium content is 48 mg (2 mEq sodium ion) per 1 gram of
cefazolin.
Cefazolin for Injection, USP is a sterile white or off-white powder or
crystalline powder
containing Cefazolin Sodium USP supplied in vials equivalent to 1 gram
or 2 grams of
cefazolin.
CLINICAL PHARMACOLOGY
After intramuscular administration of Cefazolin for Injection, USP 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,
USP 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, USP is approximately
1.8 hours following
IV administration and approximately 2.0 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 1.5 mg/kg the next 2
hours
(approximately 100 mg), Cefazolin for Injection, USP produced a steady
serum level at
the third hour of approximately 28 mcg/mL.
Studies in patients hospitalized with infections indicate that
Cefazolin for Injection, USP
produces mean