New Zealand - English - Medsafe (Medicines Safety Authority)

chiesi new zealand limited t/a emerge health - ciclesonide 80ug (ex actuator, (100µg /dose delivered ex valve)) - aerosol inhaler, metered dose - 80 mcg/dose - active: ciclesonide 80ug (ex actuator, (100µg /dose delivered ex valve)) excipient: ethanol norflurane

Australia - English - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - ciclesonide, quantity: 100 microgram - inhalation, pressurised - excipient ingredients: norflurane; ethanol - alvesco is indicated as prophylactic treatment of asthma in adults, adolescents and in children 6 years of age and older.

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

sunovion pharmaceuticals inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 80 ug - alvesco is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. important limitations of use: alvesco is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. alvesco is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of alvesco. rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported. teratogenic effects : pregnancy category c oral administration of ciclesonide in rats up to 900 mcg/kg/day (approximately 10 times the maximum human daily inhalation dose based on mcg/m2 /day) produced no teratogenicity or other fetal effects. however, subcutaneous administration of ciclesonide in rabbits at 5 mcg/kg/day (less than the maximum human daily inhalation dose based on mcg/m2 /day) or greater produced fetal toxicity. th

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

prasco laboratories - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide inhalation aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. important limitations of use: ciclesonide inhalation aerosol is not indicated for the relief of acute bronchospasm. ciclesonide inhalation aerosol is not indicated for children under 12 years of age. ciclesonide inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ciclesonide inhalation aerosol is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of ciclesonide inhalation aerosol. rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported. teratogenic effects : pregnancy category c oral administration of ciclesonide in rats up to 900 mcg/kg/day (approximately 10 times the maximum human daily inhalation dose

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

sunovion pharmaceuticals inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 37 ug - zetonna® (ciclesonide) nasal aerosol is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. zetonna is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of zetonna [see warnings and precautions (5.3) ]. teratogenic effects : pregnancy category c. there are no adequate and well-controlled trials in pregnant women. zetonna should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. oral administration of ciclesonide in rats at approximately 120 times the maximum recommended human daily intranasal dose (mrhdid) in adults (on a mcg/m2 basis at a maternal dose of 900 mcg/kg/day) produced no teratogenicity or other fetal

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

sunovion pharmaceuticals inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 50 ug - omnaris nasal spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. omnaris nasal spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older. omnaris nasal spray is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of omnaris nasal spray [see warnings and precautions (5.3)] . teratogenic effects : pregnancy category c. there are no adequate and well-controlled studies in pregnant women. omnaris nasal spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. in addition, because there is a natural increase in corticosteroid p

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

physicians total care, inc. - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 80 ug - alvesco is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. alvesco is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. alvesco is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of alvesco. rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported. teratogenic effects : pregnancy category c oral administration of ciclesonide in rats up to 900 mcg/kg/day (approximately 10 times the maximum human daily inhalation dose based on mcg/m2 /day) produced no teratogenicity or other fetal effects. however, subcutaneous administration of ciclesonide in rabbits at 5 mcg/kg/day (less than the maximum human daily inhalation dose based on mcg/m2 /day) or greater produced fetal toxicity. this included fetal loss, reduc

Canada - English - Health Canada

takeda canada inc - ciclesonide - aerosol, metered dose - 50mcg - ciclesonide 50mcg - corticosteroids

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

covis pharma us, inc - ciclesonide (unii: s59502j185) (ciclesonide - unii:s59502j185) - ciclesonide 80 ug - alvesco is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. limitations of use : alvesco is not indicated for the relief of acute bronchospasm. alvesco is not indicated for children under 12 years of age. alvesco is contraindicated in: there are no available data on alvesco use in pregnant women to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there is low systemic exposure following alvesco oral inhalation administration at the recommended dose [see clinical pharmacology (12.3)] . in animal reproduction studies, ciclesonide administered by the oral route to pregnant rats during the period of organogenesis did not cause any evidence of fetal harm at doses up to 15 times the maximum recommended human daily oral inhalation dose (mrhdoid) of 640 mcg/day. teratogenicity, characteristic of corticosteroids, decreased body weight and/or skeletal variations were observed in

Australia - English - Department of Health (Therapeutic Goods Administration)

chiesi australia pty ltd - ciclesonide, quantity: 200 microgram - inhalation, pressurised - excipient ingredients: ethanol; norflurane - alvesco is indicated as prophylactic treatment of asthma in adults, adolescents and in children 6 years of age and older.