Malta - engelsk - Medicines Authority

teva pharma b.v. swensweg 5, 2031 ga haarlem, netherlands - budesonide - nebuliser suspension - budesonide 0.25 mg - drugs for obstructive airway diseases

Malta - engelsk - Medicines Authority

teva pharma b.v. swensweg 5, 2031 ga haarlem, netherlands - budesonide - nebuliser suspension - budesonide 0.5 mg - drugs for obstructive airway diseases

Malta - engelsk - Medicines Authority

teva pharma b.v. swensweg 5, 2031 ga haarlem, netherlands - budesonide - nebuliser suspension - budesonide 1 mg - drugs for obstructive airway diseases

USA - engelsk - NLM (National Library of Medicine)

carilion materials management - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide capsules (enteric coated) are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon. budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn’s disease involving the ileum and/or the ascending colon for up to 3 months. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). anaphylactic reactions have occurred [ ]. see adverse reactions (6.2) budesonide was teratogenic and embryocidal in rabbits and rats. budesonide produced fetal loss, decreased pup weights, and skeletal abnormalities at subcutaneous doses of 25 mcg/kg in rabbits (approximately 0.05 times the maximum recommended human dose on a body surface area basis) and 500 mcg/kg in rats (approximately 0.5 times the maximum recommended human dose

Irland - engelsk - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - budesonide - nebuliser suspension - 1 mg/2ml - glucocorticoids; budesonide

Irland - engelsk - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - budesonide - nebuliser suspension - 0.5 mg/2ml - glucocorticoids; budesonide

USA - engelsk - NLM (National Library of Medicine)

golden state medical supply, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide capsules (enteric coated) are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred [see adverse reactions (6.2)] . risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. there are clinical considerations [see clinical considerations ]. in animal reproduction studies with pregnant rats and rabbits, administration of subcutaneous budesonide during organogenesis at doses approximately 0.5 times or 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. maternal toxicity was observed in both rats and rabbits at these dose levels [see data]. based on animal data, advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage of the indicated population is unknown. all pregnancies have a background of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk some published epidemiological studies show an association of adverse pregnancy outcomes in women with crohn's disease, including preterm birth and low birth weight infants, during periods of increased disease activity (including increased stool frequency and abdominal pain). pregnant women with crohn's disease should be counseled regarding the importance of controlling disease. fetal/neonatal adverse reactions hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. infants should be carefully observed for signs of hypoadrenalism, such as poor feeding, irritability, weakness, and vomiting, and managed accordingly [see warnings and precautions (5.1)]. data animal data budesonide was teratogenic and embryolethal in rabbits and rats. in an embryo-fetal development study in pregnant rats dosed subcutaneously with budesonide during the period of organogenesis from gestation days 6-15 there were effects on fetal development and survival at subcutaneous doses up to approximately 500 mcg/kg in rats (approximately 0.5 times the maximum recommended human dose on a body surface area basis). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6-18, there was an increase in maternal abortion, and effects on fetal development and reduction in litter weights at subcutaneous doses up to approximately 25 mcg/kg in rabbits (approximately 0.05 times the maximum recommended human dose on a body surface area basis). maternal toxicity, including reduction in body weight gain, was observed at subcutaneous doses of 5 mcg/kg in rabbits (approximately 0.01 times the maximum recommended human dose on a body surface area basis) and 500 mcg/kg in rats (approximately 0.5 times the maximum recommended human dose on a body surface area basis). in a peri-and post-natal development study, rats dosed subcutaneously with budesonide during the period of day 15 post coitum to day 21 postpartum, budesonide had no effects on delivery but did have an effect on growth and development of offspring. in addition, offspring survival was reduced and surviving offspring had decreased mean body weights at birth and during lactation along with delayed sexual maturation at exposures 0.2 times the mrhd (on a mg/m 2 basis at maternal subcutaneous doses of 20 mcg/kg/day and higher). these findings occurred in the presence of maternal toxicity. risk summary lactation studies have not been conducted with oral budesonide, including budesonide capsules (enteric coated), and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. one published study reports that budesonide is present in human milk following maternal inhalation of budesonide [ see data ]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for budesonide capsules (enteric coated) and any potential adverse effects on the breastfed infant from budesonide capsules (enteric coated), or from the underlying maternal condition. data one published study reports that budesonide is present in human milk following maternal inhalation of budesonide which resulted in infant doses approximately 0.3% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.4 and 0.5. budesonide plasma concentrations were not detected and no adverse events were noted in the breastfed infants following maternal use of inhaled budesonide. the recommended daily dose of budesonide capsules (enteric coated) is higher (up to 9 mg daily) compared with inhaled budesonide (up to 800 mcg daily) given to mothers in the above described study. the maximum budesonide plasma concentration following a 9 mg daily dose (in both single-and repeated-dose pharmacokinetic studies) of oral budesonide is approximately 5 to 10nmol/l which is up to 10 times higher than the1 to 2 nmol/l for a 800 mcg daily dose of inhaled budesonide at steady state in the above inhalation study. assuming the coefficient of extrapolation between the inhaled and oral doses is constant across all dose levels, at therapeutic doses of budesonide capsules (enteric coated), budesonide exposure to the nursing child may be up to 10 times higher than that by budesonide inhalation. the safety and effectiveness of budesonide capsules (enteric coated) have been established in pediatric patients 8 to 17 years of age who weigh more than 25 kg for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon. use of budesonide capsules (enteric coated) in this age group is supported by evidence from adequate and well controlled studies of budesonide capsules (enteric coated) in adults, with additional data from 2 clinical studies in 149 pediatric patients treated up to 8 weeks and one pharmacokinetic study in 8 pediatric patients [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)] . the observed safety profile of budesonide capsules (enteric coated) in pediatric patients is consistent with its known safety profile in adults and no new safety concerns were identified [see adverse reactions (6.1)] . systemic corticosteroids, including budesonide capsules (enteric coated), may cause a reduction of growth velocity in pediatric patients. pediatric patients with crohn's disease have a 17% higher mean systemic exposure and cortisol suppression than adults with crohn's disease [see warning and precautions (5.1) and clinical pharmacology (12.2)] . the safety and effectiveness of budesonide capsules (enteric coated) have not been established in pediatric patients less than 8 years of age for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon. the safety and effectiveness of budesonide capsules (enteric coated) have not been established in pediatric patients for the maintenance of clinical remission of mild to moderate crohn's disease. an open-label study to evaluate the safety and tolerability of budesonide capsules (enteric coated) as maintenance treatment in pediatric patients aged 5 to 17 years was conducted, and did not establish the safety and efficacy of maintenance of clinical remission. clinical studies of budesonide capsules (enteric coated) did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. of the 651 patients treated with budesonide capsules (enteric coated) in clinical studies, 17 (3%) were greater than or equal to 65 years of age and none were greater than 74 years of age. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. patients with moderate to severe hepatic impairment (child-pugh class b and c, respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to budesonide [see warnings and precautions (5.1) and clinical pharmacology (12.3)] . avoid use in patients with severe hepatic impairment (child-pugh class c). monitor for increased signs and/or symptoms of hypercorticism and consider dosage reduction in patients with moderate hepatic impairment (child-pugh class b) [see dosage and administration (2.4)] . no dosage adjustment is needed in patients with mild hepatic impairment (child-pugh class a).

Malta - engelsk - Medicines Authority

kleva s.a. 189 parnithos avenue, 13671 acharnai, attiki, greece - budesonide - nasal spray, suspension - budesonide 100 µg - nasal preparations

Malta - engelsk - Medicines Authority

teva pharma b.v. (utrecht) swensweg 5, 2031 ga haarlem, netherlands - budesonide - nebuliser suspension - budesonide 0.25 mg/ml - drugs for obstructive airway diseases

Irland - engelsk - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - budesonide - nebuliser suspension - 0.25 mg/2ml - glucocorticoids