AURO CEFEPIME 1 g; cefepime (as hydrochloride) 1 g powder for injection vial

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
23-11-2017

有効成分:

cefepime, Quantity: 1000 mg

から入手可能:

Strides Pharma Science Pty Ltd

INN(国際名):

Cefepime

医薬品形態:

Injection, powder for

構図:

Excipient Ingredients: arginine

投与経路:

Intravenous, Intramuscular

パッケージ内のユニット:

5 vials, 1 vial

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Adults: Cefepime is indicated in the treatment of the infections listed below when caused by susceptible bacteria.. - Lower respiratory tract infections, including pneumonia and bronchitis. - Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. - Skin and skin structure infections. Intra-abdominal infections, including peritonitis and biliary tract infections. - Gynaecological infections. Septicaemia. - Empirical treatment in febrile neutropenic patients (see Precautions). Cefepime is also indicated for surgical prophylaxis in patients undergoing intra-abdominal surgery. In this indication it is essential that metronidazole also be administered. Paediatrics: Cefepime is indicated in paediatric patients over 2 months of age for the treatment of the infections listed below when caused by susceptible bacteria. Pneumonia. - Urinary tract infections, both complicated, including pyelonephritis, and uncomplicated infections. - Skin and skin structure infections. - Septicaemia. - Empirical treatment in febrile neutropenic patients (see Precautions). Culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. Empirical therapy with Cefepime may be instituted before results of susceptibility studies are known; however, once these results become available, the antibiotic treatment should be adjusted accordingly. Because of its broad spectrum of bactericidal activity against Gram positive and Gram negative bacteria, Cefepime can be used appropriately as monotherapy prior to identification of the causative organisms(s). In the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with Cefepime. In patients who are at risk of mixed aerobic/ anaerobic infection, including infections in which Bacterioides fragilis may be present, concurrent initial therapy with an antianaerobic agent is recommended before the causative organism(s) is known.

製品概要:

Visual Identification: White to pale yellow powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Licence status A

承認日:

2010-08-26