Namibia - English - Namibia Medicines Regulatory Council

fresenius kabi manufacturing (sa) (pty) ltd - amikacin sulphate - injection - each 2ml vial contains:amikacin sulphate equivalent to amikacin 500mg

Kenya - English - Pharmacy and Poisons Board

ms pharma- jordan king abdullah (ii) bin al-hussein industrial - amikacine sulphate ep equivalent to amikacin - solution for injection - each 2ml vial contains amikacine sulphate ep… - amikacin

Israel - English - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - amikacin as sulfate - solution for injection - amikacin as sulfate 250 mg / 1 ml - amikacin - amikan is indicated in the short-term treatment of gram-negative organisms, including pseudomonas and some gram-positive organisms.sensitive gram-negative organisms include; pseudomonas aeruginosa, escherichia coli., indole-positive and indole-negative proteus spp., klebsiella, enterobacter and serratia spp., minea-herralae, citrobacter freundii, salmonella, shigella, acinetobacter and providencia spp.the principal gram-positive organism sensitive to amikacin is staphylococcus aureus, including some methicillin-resistant strains. amikan has some activity against other gram-positive organisms including certain strains of streptococcus pyogenes, enterococci and diplococcus pneumoniae.

Canada - English - Health Canada

bristol-myers squibb canada - amikacin (amikacin sulfate) - solution - 250mg - amikacin (amikacin sulfate) 250mg - aminoglycosides

United States - English - NLM (National Library of Medicine)

insmed incorporated - amikacin (unii: 84319sgc3c) (amikacin - unii:84319sgc3c) - limited population: arikayce® is indicated in adults, who have limited or no alternative treatment options, for the treatment of mycobacterium avium complex (mac) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. as only limited clinical safety and effectiveness data for arikayce are currently available, reserve arikayce for use in adults who have limited or no alternative treatment options. this drug is indicated for use in a limited and specific population of patients. this indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by month 6. clinical benefit has not yet been established [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. limitati

New Zealand - English - Medsafe (Medicines Safety Authority)

rex medical ltd - amikacin sulfate 333.775 mg/ml equivalent to amikacin 250mg - solution for injection - 500 mg/2ml - active: amikacin sulfate 333.775 mg/ml equivalent to amikacin 250mg excipient: sodium citrate dihydrate sodium metabisulfite sulfuric acid water for injection - amikacin injection is indicated in the short-term treatment of serious infections caused by susceptible strains of gram-negative bacteria, (see microbiology). 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.

Malta - English - Medicines Authority

norma hellas s.a. 54 menandrou str. gr-104 31 athens, greece - amikacin - solution for injection - amikacin 500 mg/2ml - antibacterials for systemic use

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

laboratorio sanderson s.a. - amikacina (sulfato) - amikacina (sulfato)....500 mg*

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

vitalis de panamÁ s.a. - amikacina (sulfato) - amikacina (sulfato)....500.00 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - amikacin sulfate 325 mg/ml equivalent to 250 mg/ml amikacin - solution for injection - 500 mg/2ml - 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