TAZICEF- ceftazidime injection, powder, for solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Hospira, Inc.

INN (Kansainvälinen yleisnimi):

CEFTAZIDIME

Koostumus:

CEFTAZIDIME ANHYDROUS 6 g

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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,

Tuoteyhteenveto:

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

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

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