CEFAZOLIN- cefazolin sodium powder, for solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Fresenius Kabi USA, LLC

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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, a

ملخص المنتج:

Cefazolin for Injection, USP supplied as follows: Cefazolin for Injection, USP, is supplied in 10 and 20 grams Pharmacy Bulk Package. Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 or 20 grams of cefazolin and is packaged 10 per carton. Preservative Free. 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]. The container closure is not made with natural rubber latex.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CEFAZOLIN - CEFAZOLIN SODIUM POWDER, FOR SOLUTION
FRESENIUS KABI USA, 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:
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
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 mcg/mL at 8 hours following a 1 gram