Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Cefepime dihydrochloride monohydrate 1.189 g equivalent to cefepime 1 g
AFT Pharmaceuticals Ltd
Cefepime dihydrochloride monohydrate 1.189 g (= cefepime 1 g)
1 g
Powder for injection
Active: Cefepime dihydrochloride monohydrate 1.189 g equivalent to cefepime 1 g Excipient: Arginine
Prescription
Qilu Antibiotics Pharmaceutical Co Ltd
Adults: Cefepime-AFT is indicated for the treatment of the indications 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 · Septicaemia · Empiric treatment in febrile neutropenic patients.
Package - Contents - Shelf Life: Vial, glass, Type 1 glass with rubber stopper - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, Type II glass with film-coated rubber stopper - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, Type II glass with film-coated rubber stopper - 5 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, Type 1 glass with rubber stopper - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Vial, glass, Type II glass with film-coated rubber stopper - 10 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, Type 1 glass with rubber stopper - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light
2013-08-09
Page 1 of 15 NEW ZEALAND DATA SHEET 1. CEFEPIME-AFT POWDER FOR INJECTION Cefepime-AFT 500 mg powder for injection. Cefepime-AFT 1 g powder for injection. Cefepime-AFT 2 g powder for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cefepime-AFT 500 mg: each vial contains 500 mg cefepime (as dihydrochloride monohydrate). Cefepime-AFT 1 g: each vial contains 1 g cefepime (as dihydrochloride monohydrate). Cefepime-AFT 2g: each vial contains 2 g cefepime (as dihydrochloride monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for injection. White to pale yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults Cefepime-AFT 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. • Septicaemia • Empiric treatment in febrile neutropenic patients (see section 4.4). Culture and susceptibility studies should be performed when appropriate to determine susceptibility of the causative organism(s) to cefepime. Empiric therapy with Cefepime-AFT 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-AFT can be used appropriately as monotherapy prior to identification of the causative Page 2 of 15 organisms(s). In the treatment of febrile neutropenia, consideration should be given to the need for other antibiotics in combination with Cefepime-AFT. In patients who are at risk of mixed aerobic-anaerobic infection, including infections in which _Bacterioides fragilis _ may be present, concurrent init Прочитайте повний документ