FORTAZ ceftazidime injection powder lyophilized solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

CEFTAZIDIME SODIUM (UNII: CMC30V039K) (CEFTAZIDIME - UNII:9M416Z9QNR)

Dostopno od:

Cardinal Health

INN (mednarodno ime):

CEFTAZIDIME SODIUM

Sestava:

CEFTAZIDIME SODIUM 20 mg in 1 mL

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

New Drug Application

Lastnosti izdelka

FORTAZ- CEFTAZIDIME INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
CARDINAL HEALTH
----------
FORTAZ
(CEFTAZIDIME FOR INJECTION)
FORTAZ
(CEFTAZIDIME INJECTION)
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 or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic
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 empirical 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.
FORTAZ in sterile crystalline form is supplied in vials equivalent to
500 mg, 1 g, 2 g, or 6 g of
anhydrous ceftazidime and in ADD-Vantage
vials equivalent to 1 or 2 g of anhydrous ceftazidime.
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.
FORTAZ is available as a frozen, iso-osmotic, sterile, nonpyrogenic
solution with 1 or 2 g of
ceftazidime as ceftazidime sodium premixed with approximately 2.2 or
1.6 g, respectively, of Dextrose
Hydrous, USP. Dextrose has been added to adjust the osmolality. Sodium
hydroxide is used to adjust pH
and neutralize ceftazidime pentahydrate free acid to the sodium salt.
The pH may have been adjusted
with hydrochloric acid. Solutions of premixed FORTAZ range in color
from light yellow to amber.
The solution is intend