cefazolin- Cefazolin injection, powder, for solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Cefazolin sodium (UNII: P380M0454Z) (Cefazolin - UNII:IHS69L0Y4T)

Mevcut itibaren:

ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND PHARMACEUTICALS LTD.)

INN (International Adı):

Cefazolin

Farmasötik formu:

INJECTION, POWDER, FOR SOLUTION

Kompozisyon:

10 g

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Cefazolin for injection 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 is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin for injection 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 streptococci.

Ürün özeti:

Cefazolin for injection, USP Each Pharmacy Bulk Package contains cefazolin sodium equivalent to 10 grams of cefazolin. Cefazolin for injection is available as follows: 10 vials 10 grams/100 mL vials per carton (NDC 63304-941-10). As with other cephalosporins, Cefazolin for injection tends to darken depending on storage conditions; within the stated recommendations, however, product potency is not adversely affected. Store dry powder at 20° to 25° C (68° to 77°F) [See USP Controlled Room Temperature]. Before reconstitution PROTECT FROM LIGHT.

Ürün özellikleri

CEFAZOLIN- CEFAZOLIN INJECTION, POWDER, FOR SOLUTION
ORCHID HEALTHCARE (A DIVISION OF ORCHID CHEMICALS AND
PHARMACEUTICALS LTD.)
----------
CEFAZOLIN FOR INJECTION USP
"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 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:
Each vial contains 48 mg (2 mEq) of sodium/1 gram of cefazolin sodium.
Cefazolin for injection, USP is
white to off-white crystalline powder.
Cefazolin for injection, USP is supplied in 10 grams Pharmacy Bulk
Packages. Each Pharmacy Bulk
Package contains, cefazolin sodium equivalent to 10 grams of
cefazolin.
A Pharmacy Bulk Package is sterile dosage form for parenteral use that
contains many single doses.
The contents are restricted for use in a pharmacy admixture service
and are intended for the preparation
of admixtures for intravenous use. NOT FOR DIRECT INJECTION. 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 a 1 gram dose.
The serum half-life for Cefazolin for injection is approximately 1.8
hours following IV 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 produced a steady serum level at the third hour of
approximately 28 mcg/