Ireland - English - HPRA (Health Products Regulatory Authority)

alpharma aps - miconazole - dental solution - 50 milligram

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

astrazeneca pharmaceuticals lp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.25 mg in 2 ml - pulmicort respules is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. limitations of use : the use of pulmicort respules is contraindicated in the following conditions: risk summary there are no adequate well-controlled studies of pulmicort respules in pregnant women. however, there are published studies on the use of budesonide, the active ingredient in pulmicort respules, in pregnant women. in animal reproduction studies, budesonide, administered by the subcutaneous route, caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at less than the maximum recommended human daily inhalation dose (mrhdid), but these effects were not seen in rats that received inhaled doses approximately 2 times the mrhdid (see data ). studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. experience with oral corticosteroids suggests that

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

astrazeneca pharmaceuticals lp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 180 ug - pulmicort flexhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. limitations of use: the use of pulmicort flexhaler is contraindicated in the following conditions: risk summary there are no adequate well-controlled studies of pulmicort flexhaler in pregnant women. however, there are published studies on the use of budesonide, the active ingredient in pulmicort flexhaler, in pregnant women. in animal reproduction studies, budesonide, administered by the subcutaneous route, caused structural abnormalities, was embryocidal, and reduced fetal weights in rats and rabbits at less than the maximum recommended human daily inhalation dose (mrhdid), but these effects were not seen in rats that received inhaled doses approximately 2 times the mrhdid (see data ). studies of pregnant women have not shown that inhaled budesonide increases the risk of abnormalities when administered during pregnancy. experience with oral corticosteroids suggests that rod

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

physicians total care, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 180 ug - pulmicort flexhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. important limitations of use: - pulmicort flexhaler is not indicated for the relief of acute bronchospasm. pulmicort flexhaler is not indicated for the relief of acute bronchospasm. the use of pulmicort flexhaler is contraindicated in the following conditions: - primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. - severe hypersensitivity to milk proteins or any ingredients of pulmicort flexhaler [seewarnings and precautions (5.3), description (11) ]. severe hypersensitivity to milk proteins or any ingredients of pulmicort flexhaler [seewarnings and precautions (5.3), description (11) ]. teratogenic effects: pregnancy category b studies of pregnant women, have not shown that inhaled budesonide incre

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

physicians total care, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 0.25 mg in 2 ml - pulmicort respules 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: • pulmicort respules is not indicated for the relief of acute bronchospasm. the use of pulmicort respules 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 pulmicort respules [see warnings and precautions (5.3),description (11) and adverse reactions, post-marketing experience (6.2) ]. teratogenic effects: pregnancy category b – 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, swedish medic

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

rebel distributors corp - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 90 ug - pulmicort flexhaler is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older. important limitations of use: the use of pulmicort flexhaler is contraindicated in the following conditions: teratogenic effects: pregnancy category b 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 (i.e., 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 10-12 weeks after the last menstrual perio

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

astrazeneca pty ltd - budesonide, quantity: 0.25 mg/ml - inhalation, conventional - excipient ingredients: disodium edetate; sodium chloride; polysorbate 80; citric acid; sodium citrate dihydrate; water for injections - treatment of bronchial asthma. indications as approved 15 july 1997: treatment of bronchial asthma. pulmicort may also be used when replacement or reduction in oral steroid therapy is desirable. treatment of acute laryngotracheobronchitis (croup) in infants and children.

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

astrazeneca pty ltd - budesonide, quantity: 0.5 mg/ml - inhalation, conventional - excipient ingredients: disodium edetate; sodium chloride; polysorbate 80; citric acid; sodium citrate dihydrate; water for injections - treatment of bronchial asthma and long term prophylaxis. indications as approved 15 july 1997: treatment of bronchial asthma. pulmicort may also be used when replacement or reduction in oral steroid therapy is desirable. treatment of acute laryngotracheobronchitis (croup) in infants and children.

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

astrazeneca pty ltd - budesonide, quantity: 100 microgram/actuation - insufflation - excipient ingredients: - treatment of bronchial asthma. indications as at 3 june 1994: treatment of bronchial asthma. may also be used when replacement or reduction in oral steroid therapy is desired.

Israel - English - Ministry of Health

dexcel ltd, israel - betamethasone as valerate; fusidic acid - cream - fusidic acid 2 %; betamethasone as valerate 0.1 % - betamethasone and antibiotics - betamethasone and antibiotics - treatment of eczematous dermatoses when secondary bacterial infection is confirmed.