Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Amikacin sulfate 325 mg/mL equivalent to 250 mg/mL Amikacin
Pfizer New Zealand Limited
Amikacin sulfate 325 mg/mL (Equiv to 250 mg/mL Amikacin)
500 mg/2mL
Solution for injection
Active: Amikacin sulfate 325 mg/mL equivalent to 250 mg/mL Amikacin Excipient: Sodium citrate dihydrate Sodium hydroxide Sodium metabisulfite Sulfuric acid Water for injection
Vial, 5 x 2mL, 10 mL
Prescription
Prescription
Qilu Tianhe Pharmaceutical Co Ltd
Package - Contents - Shelf Life: Vial, 2mL - 5 dose units - 24 months from date of manufacture stored at or below 25°C
1992-02-11
Version: pfdamiki10923 Supersedes pfdamiki10522 Page 1 of 17 NEW ZEALAND DATA SHEET 1. PRODUCT NAME DBL™ Amikacin 500 mg/2 mL solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin. The injection consists of the sulfate salt. Each 2 mL vial contains amikacin sulfate equivalent to amikacin activity 500 mg (500,000 I.U.). EXCIPIENT(S) WITH KNOWN EFFECT • Sodium metabisulfite For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DBL Amikacin Injection is a sterile clear, colourless to pale yellow solution, free from specks, lint, or other visible evidence of contamination. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Amikacin Injection is indicated in the short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria (see section 5.1). _ _ _Staphylococcus aureus,_ including methicillin-resistant strains is the principal Gram-positive organism sensitive to amikacin. The use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy, and should be confined to patients suffering from severe infections caused by susceptible strains of stapylococcus who have failed to respond or are allergic to other available antibiotics. DBL Amikacin Injection is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used. In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci. If concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately and at different sites because _in-_ _vitro _ mixing of the two drugs causes inactivation of amikacin. Version: pfdamiki10923 Supersedes pfdamiki10522 Page 2 of 17 Clinical studies have shown amikacin to be effective in Izlasiet visu dokumentu