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.

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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires delbert s.a.s. - amikacin sulfate - eq. amikacin 250 mg/ml - solution for injection - 500 mg/2 ml - amikacin sulfate - amikacin

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires delbert s.a.s. - amikacin sulfate - eq. amikacin 250 mg/ml - solution for injection - 1 g/4 ml - amikacin sulfate - amikacin

Namibia - English - Namibia Medicines Regulatory Council

fresenius kabi manufacturing (sa) (pty) ltd - amikacin sulphate - injection - each 4ml of solution contains:amikacin sulphate equivalent to amikacin 1g

Namibia - English - Namibia Medicines Regulatory Council

fresenius kabi manufacturing (sa) (pty) ltd - amikacin sulphate - injection - each 2ml of vial contains:amikacin sulphate equivalent to amikacin 100 mg

Namibia - English - Namibia Medicines Regulatory Council

fresenius kabi manufacturing (sa) (pty) ltd - amikacin sulphate - injection - each 2ml vial contains:amikacin sulphate equivalent to amikacin 250mg

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

Bahrain - English - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

jaffar pharmacy - amikacin sulphate - injection - 100