FORTAZ- ceftazidime injection, powder, for solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

CEFTAZIDIME (UNII: 9M416Z9QNR) (CEFTAZIDIME ANHYDROUS - UNII:DZR1ENT301)

Mevcut itibaren:

Teligent Pharma, Inc.

INN (International Adı):

CEFTAZIDIME

Kompozisyon:

CEFTAZIDIME ANHYDROUS 200 mg in 1 mL

Uygulama yolu:

INTRAMUSCULAR

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

FORTAZ is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: FORTAZ 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. FORTAZ 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 FORTAZ and other antibacterial drugs, FORTAZ should be used only to treat infections that are proven or strongly suspected

Ürün özeti:

FORTAZ in the dry state should be stored between 15° and 30°C (59° and 86°F) and protected from light. FORTAZ is a dry, white to off-white powder supplied in vials as follows: * Equivalent to anhydrous ceftazidime.

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

FORTAZ - CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION
TELIGENT PHARMA, INC.
----------
FORTAZ
(CEFTAZIDIME FOR INJECTION)
PHARMACY BULK PACKAGE-
NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of FORTAZ and
other antibacterial drugs, FORTAZ 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.
FORTAZ 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. The Pharmacy Bulk Package vial contains 709 mg of sodium
carbonate. The sodium content is
approximately 54 mg (2.3mEq) per gram of ceftazidime.
FORTAZ in sterile crystalline form is supplied in Pharmacy Bulk
Packages equivalent to 6g of
anhydrous ceftazidime.
The 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 FORTAZ 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
8.
CLI