Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Cefuroxime sodium 789mg equivalent to to cefuroxime 750mg
Devatis Limited
750 mg
Powder for injection
Active: Cefuroxime sodium 789mg equivalent to to cefuroxime 750mg
Prescription
Cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most ?-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms. It is indicated for the treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria.
Package - Contents - Shelf Life: Vial, glass, Type III colourless 15 cc glass vial with rubber stopper and sealed with aluminium cap (1 vial) - 750 mg - 36 months from date of manufacture stored at or below 25°C protect from light 5 hours reconstituted (not refrigerated) stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type III colourless 15 cc glass vial with rubber stopper and sealed with aluminium cap (5 vials) - 3750 mg - 36 months from date of manufacture stored at or below 25°C protect from light 5 hours reconstituted (not refrigerated) stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type III colourless 15 cc glass vial with rubber stopper and sealed with aluminium cap (10 vials) - 7500 mg - 36 months from date of manufacture stored at or below 25°C protect from light 5 hours reconstituted (not refrigerated) stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2017-11-09
CEFUROXIME DEVATIS 250 mg, 750 mg & 1.5 g Powder for Injection/Infusion Module 1.3.1 New Zealand Data Sheet DEVATIS LIMITED Property-Strictly Confidential Version: NZ-V05 / March 2023 Page 1/10 NEW ZEALAND DATA SHEET 1. PRODUCT NAME CEFUROXIME DEVATIS 250 mg, 750 mg & 1.5 g Powder for Injection/Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each 250 mg vial contains cefuroxime sodium equivalent to 250 mg cefuroxime. Each 750 mg vial contains cefuroxime sodium equivalent to 750 mg cefuroxime. Each 1.5 g vial contains cefuroxime sodium equivalent to 1.5 g cefuroxime. Excipient with known effect: Each 250 mg vial contains 13.55 mg sodium. Each 750 mg vial contains 40.65 mg sodium. Each 1.5 g vial contains 81.38 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for injection/ infusion. Cefuroxime is a white to faintly yellow powder to which appropriate amounts of water are added to prepare an off-white suspension for intramuscular use or a yellow solution of intravenous administration. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Cefuroxime is a bactericidal cephalosporin antibiotic which is resistant to most ß-lactamases and is active against a wide range of Gram-positive and Gram-negative organisms. It is indicated for the treatment of infections before the infecting organism has been identified or when caused by sensitive bacteria. Susceptibility to cefuroxime sodium will vary with geography and time and local susceptibility data should be consulted where available (see section 5.1). Indications include Respiratory tract infections for example, acute and chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess and post-operative chest infections. Ear, nose and throat infections for example, sinusitis, tonsillitis, pharyngitis and otitis media. Urinary tract infections for example, acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria. Soft-tissue infections for example, cellulitis, erysi Prečítajte si celý dokument