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

merck sharp & dohme corp. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate 100 ug - asmanex® hfa is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. important limitations of use - asmanex hfa is not indicated for the relief of acute bronchospasm. asmanex hfa is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. asmanex hfa is contraindicated in patients with known hypersensitivity to mometasone furoate or any of the ingredients in asmanex hfa [see warnings and precautions (5.8)] . risk summary there are no randomized clinical studies of asmanex hfa in pregnant women. there are clinical considerations with the use of asmanex hfa in pregnant women [see clinical considerations] . in animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommend

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

organon llc - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - asmanex® hfa is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. important limitations of use - asmanex hfa is not indicated for the relief of acute bronchospasm. asmanex hfa is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. asmanex hfa is contraindicated in patients with known hypersensitivity to mometasone furoate or any of the ingredients in asmanex hfa [see warnings and precautions (5.8)] . risk summary there are no randomized clinical studies of asmanex hfa in pregnant women. there are clinical considerations with the use of asmanex hfa in pregnant women [see clinical considerations] . in animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommend

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

merck sharp & dohme corp. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate 220 ug - asmanex® twisthaler® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. limitations of use asmanex twisthaler is not indicated for the relief of acute bronchospasm. asmanex twisthaler is not indicated in children less than 4 years of age. asmanex twisthaler is contraindicated: - status asthmaticus: in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - hypersensitivity: in patients with known hypersensitivity to milk proteins or any ingredients of asmanex twisthaler [see warnings and precautions (5.3) and description (11)]. risk summary there are no adequate and well-controlled studies of asmanex twisthaler in pregnant women. there are clinical considerations with the use of asmanex twisthaler in pregnant women [see clinical considerations] . in animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malfo

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

organon llc - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - asmanex® twisthaler® is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 4 years of age and older. limitations of use asmanex twisthaler is not indicated for the relief of acute bronchospasm. asmanex twisthaler is not indicated in children less than 4 years of age. asmanex twisthaler is contraindicated: - status asthmaticus: in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - hypersensitivity: in patients with known hypersensitivity to milk proteins or any ingredients of asmanex twisthaler [see warnings and precautions (5.3) and description (11)]. risk summary there are no adequate and well-controlled studies of asmanex twisthaler in pregnant women. there are clinical considerations with the use of asmanex twisthaler in pregnant women [see clinical considerations] . in animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malfo

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

physicians total care, inc. - mometasone furoate (unii: 04201gdn4r) (mometasone - unii:8hr4qj6dw8) - mometasone furoate 220 ug - asmanex® twisthaler® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. important limitations of use asmanex twisthaler is not indicated for the relief of acute bronchospasm. asmanex twisthaler is not indicated in children less than 4 years of age. asmanex twisthaler therapy is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. asmanex twisthaler is contraindicated in patients with known hypersensitivity to milk proteins or any ingredients of asmanex twisthaler. [see warnings and precautions (5.3) and description (11)]. pregnancy category c: there are no adequate and well-controlled studies of asmanex twisthaler use in pregnant women. animal reproduction studies in mice, rats, and rabbits revealed evidence of teratogenicity. asthma is a serious and potentially life-threatening condition. poorly controlled asthma during pregnancy is associated with adverse outc

Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - mometasone furoate - inhalation powder, capsule - 200 microgram(s) - glucocorticoids; mometasone

Ireland - English - HPRA (Health Products Regulatory Authority)

merck sharp & dohme ireland (human health) limited - mometasone furoate - inhalation powder, capsule - 400 microgram(s) - glucocorticoids; mometasone

Singapore - English - HSA (Health Sciences Authority)

organon singapore pte. ltd. - mometasone furoate - powder, metered - 200 mcg/inhalation - mometasone furoate 200 mcg/inhalation

Singapore - English - HSA (Health Sciences Authority)

organon singapore pte. ltd. - mometasone furoate - powder, metered - 400 mcg/inhalation - mometasone furoate 400 mcg/inhalation

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

organon pharma (uk) ltd - mometasone furoate - inhalation powder - 400microgram/1dose