cefotan- cefotetan disodium injection, solution cefotan- cefotetan disodium injection, powder, for solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

现在购买

下载 产品特点 (SPC)
19-09-2006

有效成分:

cefotetan disodium (UNII: 0GXP746VXB) (cefotetan - UNII:48SPP0PA9Q)

可用日期:

AstraZeneca Pharmaceuticals, LP

INN(国际名称):

cefotetan disodium

药物剂型:

INJECTION, SOLUTION

组成:

1 g in 50 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CEFOTAN and other antibacterial drugs, CEFOTAN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. CEFOTAN is indicated for the therapeutic treatment of the following infections when caused by susceptible strains of the designated organisms: Cefotetan, like other cephalosporins, has no activity against Chlamydia trachomatis . Therefore, when cephalosporins are used in the treatment of pelvic inflammatory disease, and C. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added. *Efficacy for this organism in this organ system was studied in fewer tha

產品總結:

CEFOTAN (cefotetan disodium for injection) is a dry, white to pale yellow powder supplied in vials containing cefotetan disodium equivalent to 1 g and 2 g cefotetan activity for intravenous and intramuscular administration. The vials should not be stored at temperatures above 22°C (72°F) and should be protected from light. 1 g ADD-Vantage Vial (NDC 0310-0376-31) 2 g ADD-Vantage Vial (NDC 0310-0377-32) 1 g Vial (NDC 0310-0376-10) 2 g Vial (NDC 0310-0377-20) 1 g Piggyback Vial (NDC 0310-0376-11) 2 g Piggyback Vial (NDC 0310-0377-21) CEFOTAN is also available as a 10 g pharmacy bulk package. 10 g in 100 mL Vial (NDC 0310-0375-10) CEFOTAN (cefotetan injection) is supplied as a frozen, iso-osmotic, premixed solution in single dose Galaxy® plastic containers (PL 2040) as follows: 1 g in 50 mL plastic container (NDC 0310-0378-51) 2 g in 50 mL plastic container (NDC 0310-0379-51) Store containers at or below -20°C/-4°F. [See DIRECTIONS FOR USE OF CEFOTAN (cefotetan injection) IN GALAXY® PLASTIC CONTAINER (PL 2040)].

产品特点

                                CEFOTAN- CEFOTETAN DISODIUM INJECTION, SOLUTION
CEFOTAN- CEFOTETAN DISODIUM INJECTION, POWDER, FOR SOLUTION
ASTRAZENECA PHARMACEUTICALS, LP
----------
CEFOTAN®
CEFOTETAN DISODIUM FOR INJECTION
FOR INTRAVENOUS OR INTRAMUSCULAR USE
CEFOTAN®
CEFOTETAN INJECTION
FOR INTRAVENOUS USE ONLY
IN GALAXY® PLASTIC CONTAINER (PL 2040)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of CEFOTAN and
other antibacterial drugs, CEFOTAN should be used only to treat or
prevent infections that are proven
or strongly suspected to be caused by bacteria.
DESCRIPTION
CEFOTAN (cefotetan disodium for injection) and CEFOTAN (cefotetan
injection) in Galaxy
* plastic
container (PL 2040) as cefotetan disodium are sterile, semisynthetic,
broad-spectrum, beta-lactamase
resistant, cephalosporin (cephamycin) antibiotics for parenteral
administration. It is the disodium salt of
[6R-(6α,7α)]-7-[[[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl]amino]-7-
methoxy-3-[[(1-methyl-1_H_-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-
carboxylic acid. Its molecular formula is
C
H N Na O S with a molecular weight of 619.57.
STRUCTURAL FORMULA
CEFOTAN (cefotetan disodium for injection) is supplied in vials
containing 80 mg (3.5 mEq) of sodium
per gram of cefotetan activity. It is a white to pale yellow powder
which is very soluble in water.
Reconstituted solutions of CEFOTAN (cefotetan disodium for injection)
are intended for intravenous
and intramuscular administration. The solution varies from colorless
to yellow depending on the
concentration. The pH of freshly reconstituted solutions is usually
between 4.5 to 6.5.
CEFOTAN in the ADD-Vantage Vial† is intended for intravenous use
only after dilution with the
appropriate volume of ADD-Vantage diluent solution.
CEFOTAN is available in two vial strengths. Each CEFOTAN 1 g vial
contains cefotetan disodium
equivalent to 1 g cefotetan activity. Each CEFOTAN 2 g vial contains
cefotetan disodium equivalent to
2 g cefotetan activity.
                                
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