Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.25 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. limitations of use: - budesonide inhalation suspension is not indicated for the relief of acute bronchospasm. the use of budesonide inhalation suspension is contraindicated in the following conditions: - primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see warnings and precautions (5.3), description (11) , adverse reactions (6.2) ]. risk summary there are no adequate well-controlled studies of budesonide inhalation suspension in pregnant women. however, there are published studies on the use of budesonide, the active ingredient in budesonide inhalation suspension, in pregnant women. in animal reproduction studies, budesonide, administered by the subcutaneous route, caused structural abnormalities, wa

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

dispensing solutions, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.5 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. important limitations of use: - budesonide inhalation suspension is not indicated for the relief of acute bronchospasm. the use of budesonide inhalation suspension is contraindicated in the following conditions: - primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see warnings and precautions (5.3), description (11) and adverse reactions, post-marketing experience (6.2) ]. studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. the results from a large population-based prospective cohort epidemiological study reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995-1997 (ie, sw

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.25 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. important limitations of use: the use of budesonide inhalation suspension is contraindicated in the following conditions: studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. the results from a large population-based prospective cohort epidemiological study reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995 to 1997 (ie, swedish medical birth registry; registry of congenital malformations; child cardiology registry) indicate no increased risk for congenital malformations from the use of inhaled budesonide during early pregnancy. congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10 to 12 weeks after the last menstrual period), th

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

physicians total care, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.25 mg in 2 ml - budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. important limitations of use: - budesonide inhalation suspension is not indicated for the relief of acute bronchospasm. the use of budesonide inhalation suspension is contraindicated in the following conditions: - primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see warnings and precautions (5.3), description (11) and adverse reactions, post-marketing experience (6.2) ]. studies of pregnant women, have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. the results from a large population-based prospective cohort epidemiological study reviewing data from three swedish registries covering approximately 99% of the pregnancies from 1995-1997 (ie, sw

Belgija - anglų - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ferring sa-nv - budesonide, micronised 9 mg - prolonged-release tablet - 9 mg - budesonide 9 mg - budesonide

Izraelis - anglų - Ministry of Health

abic marketing ltd, israel - budesonide - suspension for inhalation - budesonide 0.25 mg / 1 ml - budesonide - budesonide - bronchial asthma especially in cases where other therapy is insufficient or insuitable.

Izraelis - anglų - Ministry of Health

abic marketing ltd, israel - budesonide - suspension for inhalation - budesonide 0.5 mg / 1 ml - budesonide - budesonide - bronchial asthma especially in cases where other therapy is insufficient of unsuitable.

Europos Sąjunga - anglų - EMA (European Medicines Agency)

teva pharma b.v.  - budesonide, formoterol fumarate dihydrate - asthma; pulmonary disease, chronic obstructive - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with copd with forced expiratory volume in 1 second (fev1) 

Europos Sąjunga - anglų - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol fumarate dihydrate - pulmonary disease, chronic obstructive; asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.copdsymptomatic treatment of patients with severe copd (fev1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Europos Sąjunga - anglų - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.