METRONIDAZOLE solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)

から入手可能:

B. Braun Medical Inc.

INN（国際名）:

METRONIDAZOLE

構図:

METRONIDAZOLE 500 mg in 100 mL

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Metronidazole Injection USP and other antibacterial drugs, Metronidazole 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. Metronidazole Injection USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Metronidazole Injection USP therapy. In a mixed aerobic and anaerobic infection, antibiotics appropriate for the treatment of the aerobic infection should be used in addition to Metronidazole Injection USP. Metronidazole Injection USP is effective in Bacteroides fragil

製品概要:

Metronidazole Injection USP, sterile, is supplied in 100 mL fill PAB® containers, each containing an isotonic, buffered solution of 500 mg metronidazole; packaged 24 per case. Metronidazole injection is sterile premixed solution intended for single use only. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Protect from light until use.

認証ステータス:

New Drug Application

製品の特徴

METRONIDAZOLE- METRONIDAZOLE SOLUTION
B. BRAUN MEDICAL INC.
----------
METRONIDAZOLE INJECTION USP
METRONIDAZOLE
500 MG/ 100 ML (5 MG/ML)
STERILE
FOR INTRAVENOUS INFUSION ONLY.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Metronidazole Injection USP and other antibacterial drugs,
Metronidazole Injection USP
should be used only to treat or prevent infections that are proven or
strongly suspected
to be caused by bacteria.
WARNING
Metronidazole has been shown to be carcinogenic in mice and rats (see
PRECAUTIONS). Its use, therefore, should be reserved for the
conditions
described in the INDICATIONS AND USAGE section below.
DESCRIPTION
Metronidazole Injection USP is a sterile, parenteral dosage form of
metronidazole in
water.
Each 100 mL of Metronidazole Injection USP contains a sterile,
nonpyrogenic, isotonic,
buffered solution of Metronidazole USP 500 mg, Sodium Chloride USP 740
mg, Dibasic
Sodium Phosphate•7H O USP 112 mg, and Citric Acid Anhydrous USP 40
mg in Water
for Injection USP. Metronidazole Injection USP has a calculated
osmolarity of 297
mOsmol/liter and a pH of 5.8 (4.5–7.0). Sodium content: 13.5
mEq/container.
Metronidazole is classified as a nitroimidazole antimicrobial and is
administered by the
intravenous route.
Metronidazole USP is chemically designated
2-methyl-5-nitroimidazole-1-ethanol
(C H N O ):
2
6
9
3
3
Not made with natural rubber latex, PVC, or DEHP.
The plastic container is a copolymer of ethylene and propylene
formulated and
developed for parenteral drugs. The copolymer contains no
plasticizers. The safety of
the plastic container has been confirmed by biological evaluation
procedures.
The material passes Class VI testing as specified in the U.S.
Pharmacopeia for Biological
Tests – Plastic Containers. The container/solution unit is a closed
system and is not
dependent upon entry of external air during administration. No vapor
barrier is
necessary.
CLINICAL PHARMACOLOGY
Metronidazole is a synthetic antibacterial compound. Disposition of
met