CEFTAZIDIME injection, powder, for solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

WG Critical Care, LLC

INN (mednarodno ime):

CEFTAZIDIME

Sestava:

CEFTAZIDIME ANHYDROUS 6 g in 100 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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: 1. Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp.; Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin-susceptible strains). 2. Skin and Skin-Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus; Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin-susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci). 3. Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.

Povzetek izdelek:

Ceftazidime for injection, USP in the dry state should be stored at 20ºC to 25°C (68ºF to 77°F) [See USP controlled room temperature] and protected from light. Ceftazidime for injection, USP is a white to cream-colored crystalline powder supplied in Pharmacy Bulk Package Bottles as follows: NDC 44567-237-06 6 g* Pharmacy Bulk Package bottle (Carton of 6) *Equivalent to anhydrous ceftazidime.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CEFTAZIDIME- CEFTAZIDIME INJECTION, POWDER, FOR SOLUTION
WG CRITICAL CARE, LLC
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CEFTAZIDIME FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
For Intravenous Use
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
ceftazidime for injection and other antibacterial drugs, ceftazidime
for injection 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 structural formula:
The molecular formula is C
H
N O S ●5H O, representing a molecular weight of
636.65.
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 is a white to cream-colored crystalline
powder. Solutions
of ceftazidime for injection, USP 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.
Ceftazidime for injecton, USP in sterile crystalline form is supplied
in 6 gram Pharmacy
Bulk Package bottles equivalent to 6 grams of anhydrous ceftazidime.
22
22
6
7 2
2
The Pharmacy Bulk Package bottle contains 708 mg of sodium carbonate.
The sodium
content is approximately 54 mg (2.3 mEq) per gram of ceftazidime.
The 6 g 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