Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Meropenem trihydrate 1140mg equivalent to Meropenem 1000mg;
AFT Pharmaceuticals Ltd
Meropenem trihydrate 1140 mg (Equivalent to Meropenem 1000 mg )
1000 mg
Powder for injection
Active: Meropenem trihydrate 1140mg equivalent to Meropenem 1000mg Excipient: Sodium carbonate
Prescription
Shenzhen Haibin Pharmaceutical Co Ltd
Meropenem-AFT is indicated for treatment, in adults and children, of the following infections caused by multiple susceptible bacteria and as empiric therapy prior to the identification of the causative organisms: · Lower respiratory tract infections · Urinary tract infections, including complicated infections · Intra-abdominal infections · Gynaecological infections, including postpartum infections · Skin and skin structure infections · Meningitis · Septicaemia · Empiric treatment, including initial monotherapy, for presumed bacterial infections in host-compromised, neutropenic patients Because of its broad spectrum of bactericidal activity against gram positive and gram-negative aerobic and anaerobic bacteria, meropenem is effective for the treatment of polymicrobial infections.
Package - Contents - Shelf Life: Vial, glass, Type 1, 38 mL - 10 dose units - 3 years from date of manufacture stored at or below 30°C protect from light - Vial, glass, Type 1, 30 mL - 10 dose units - 3 years from date of manufacture stored at or below 30°C protect from light
2013-07-19
Page 1 of 12 DATA SHEET 1 MEROPENEM-AFT (MEROPENEM TRIHYDRATE POWDER FOR INJECTION OR INFUSION) (Meropenem-AFT) Meropenem trihydrate powder for injection or infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Meropenem-AFT 500mg Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous meropenem. Meropenem-AFT 1g Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem. Excipients: Each 500 mg vial contains 104 mg sodium carbonate. Each 1 g vial contains 208 mg sodium carbonate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion. A white to light yellow powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Meropenem-AFT is indicated for the treatment, in adults and children, of the following infections caused by single or multiple susceptible bacteria and as empiric therapy prior to the identification of the causative organisms (see sections 4.4 and 5.1): • Lower Respiratory Tract Infections • Urinary Tract Infections, including complicated infections • Intra-abdominal Infections • Gynecological Infections, including postpartum infections • Skin and Skin Structure Infections • Meningitis • Septicaemia • Empiric treatment, including initial monotherapy, for presumed bacterial infections in host- compromised, neutropenic patients Because of its broad spectrum of bactericidal activity against Gram-positive and Gram-negative aerobic and anaerobic bacteria, meropenem is effective for the treatment of polymicrobial infections. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS AND ADOLESCENTS Page 2 of 12 Dosage range is 1.5 g – 6 g daily in three divided doses. Usual dose 500 mg to 1 g by intravenous administration every 8 hours depending on type and severity of infection, the known or expected susceptibility of the pathogen(s) and the condition of the patient. Exceptions 1. Febrile episodes in neutropenic patients – the dose should be 1 g every 8 hours. 2. Meningitis – the dose should be 2 g every Đọc toàn bộ tài liệu