Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
CEFTAZIDIME (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301)
Hospira, Inc.
CEFTAZIDIME
CEFTAZIDIME ANHYDROUS 6 g
INTRAVENOUS
PRESCRIPTION DRUG
Tazicef (ceftazidime for injection, USP) is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Tazicef (ceftazidime for injection, USP) may be used alone in cases of confirmed or suspected sepsis. Ceftazidime has been used successfully in clinical trials as empiric therapy in cases where various concomitant therapies with other antibacterial drugs have been used. Tazicef may also be used concomitantly with other antibacterial drugs, such as aminoglycosides, vancomycin, and clindamycin; in severe and life-threatening infections; and in the immunocompromised patient. When such concomitant treatment is appropriate, prescribing information in the labeling for the other antibacterial drugs should be followed. The dose depends on the severity of the infection and the patient's condition. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tazicef (ceftazidime) and other antibacterial drugs,
Tazicef in the dry state should be stored at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] and protected from light. Tazicef (ceftazidime for injection, USP) is a dry, white to off-white powder supplied in pharmacy bulk vials as follows: NDC 0409-5086-11 10 multi-dose pharmacy bulk vials in a carton 6 g/vial
Abbreviated New Drug Application
TAZICEF- CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION HOSPIRA, INC. ---------- TAZICEF _BRAND OF _ _CEFTAZIDIME FOR INJECTION, USP_ PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tazicef (ceftazidime) and other antibacterial drugs, Tazicef (ceftazidime) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4- thiazolyl)[(1-carboxy-1-methylethoxy) imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1- azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structure: The molecular formula is C H N O S , representing a molecular weight of 636.6. Tazicef (ceftazidime for injection, USP) is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. Ceftazidime for Injection, USP in sterile crystalline form is supplied in 6-g Pharmacy Bulk ® 22 32 6 12 2 Packages equivalent to 6 g of anhydrous ceftazidime. The 6 grams Pharmacy Bulk Package bottle is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous use. THE PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION, FURTHER DILUTION IS REQUIRED BEFORE USE (see DOSAGE AND ADMINISTRATION-Directions for Proper Use of Pharmacy Bulk Package). Solutions of Tazicef range in color from light yellow to amber, depending on the diluent and volume used. The pH of freshly constituted solutions usually ranges from 5 to 7.5. CLIN read_full_document