CEFOXITIN injection, powder, for solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Cefoxitin Sodium (UNII: Q68050H03T) (Cefoxitin - UNII:6OEV9DX57Y)

Dostopno od:

SAMSON MEDICAL TECHNOLOGIES LLC

INN (mednarodno ime):

Cefoxitin Sodium

Sestava:

Cefoxitin 100 g

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefoxitin and other antibacterial drugs, Cefoxitin for Injection, USP 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 antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefoxitin for Injection, USP is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. - Lower respiratory tract infections, including pneumonia and lung abscess, caused by Streptococcus pneumoniae , other streptococci (excluding enterococci, e.g., Enterococcus faecalis [formerly Streptococcus faecalis ]), Staphylococcus aureus (including penicillinase-producing strains), Escherichia

Povzetek izdelek:

Cefoxitin for Injection, USP is a dry white to off-white powder available in the following SmartPak® Pharmacy Bulk Package:    100 grams* (1 Pharmacy Bulk Package) Product No. 4100 NDC 66288-4100-1 sold in individual bags.    *Each 100 gram Pharmacy Bulk Package contains sterile cefoxitin sodium equivalent to 100 grams of cefoxitin. SmartPak® system components are not made with natural rubber latex. Special storage instructions Cefoxitin for Injection, USP in the dry state should be stored between 2-25°C (36-77°F). Avoid exposure to temperatures above 50°C. The dry material as well as solutions tend to darken, depending on storage conditions; product potency, however, is not adversely affected.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CEFOXITIN- CEFOXITIN INJECTION, POWDER, FOR SOLUTION
SAMSON MEDICAL TECHNOLOGIES LLC
----------
CEFOXITIN FOR INJECTION, USP
RX ONLY
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cefoxitin for
Injection, USP and other antibacterial drugs, Cefoxitin for Injection,
USP should be used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION:
CEFOXITIN FOR INJECTION, USP, PHARMACY BULK PACKAGE BAG SMARTPAK®
SHOULD BE USED ONLY IN
PATIENTS WHO REQUIRE A 1 GRAM DOSE AND NOT ANY FRACTION THEREOF.
CEFOXITIN FOR INJECTION USP,
PHARMACY BULK PACKAGE BAG SMARTPAK® SHOULD NOT BE USED IN PATIENTS
WHO REQUIRE LESS THAN THE
1 GRAM DOSE OF CEFOXITIN.
Cefoxitin for Injection, USP is a semi-synthetic, broad-spectrum cepha
antibiotic for intravenous
administration. It is derived from cephamycin C, which is produced by
_Streptomyces lactamdurans_. Its
chemical name is sodium
(_6R,7S_)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-thienyl)acetamido]-5-
thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate carbamate (ester).
The empirical formula is C
H N NaO S , and the structural formula is:
Cefoxitin for Injection contains approximately 53.8 mg (2.3 mEq) of
sodium per gram of cefoxitin.
Solutions of Cefoxitin for Injection, USP range from colorless to
light amber in color. The pH of
freshly constituted solutions usually ranges from 4.2 to 7.0.
BEFORE ADMINISTRATION, THIS PHARMACY BULK PACKAGE REQUIRES
RECONSTITUTION USING STERILE WATER FOR INJECTION, USP TO A
CONCENTRATION OF 100 MG PER ML AND FURTHER DILUTION IN 50 ML OF A
COMPATIBLE SOLUTION AND INFUSED INTRAVENOUSLY.
THIS PRODUCT IS NOT INTENDED TO BE USED IN PEDIATRIC AND RENALLY
IMPAIRED PATIENTS WHO REQUIRE LESS THAN A 1 GRAM DOSE.
Each SmartPak Pharmacy Bulk Package contains sterile Cefoxitin Sodium,
USP equivalent to 100
grams of cefoxitin and is intended for intravenous infusion only. A
Pharmacy Bulk Package is a
container of a sterile p