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

avera mckennan hospital - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir 100 mg

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

ferring pharmaceuticals ltd - budesonide - modified-release tablet - 9mg

Canada - English - Health Canada

tillotts pharma gmbh - budesonide - capsule (sustained-release) - 3mg - budesonide 3mg - adrenals

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ferring sdn. bhd. - budesonide -

Israel - English - Ministry of Health

ferring pharmaceuticals ltd - budesonide - tablets prolonged release - budesonide 9 mg - budesonide - for induction of remission in patients with mild to moderate active ulcerative colitis (uc).

Singapore - English - HSA (Health Sciences Authority)

ferring pharmaceuticals private limited - (tablet core) budesonide micronized - tablet, film coated, extended release - (tablet core) budesonide micronized 9.0 mg

Malta - English - Medicines Authority

ferring ireland limited united drug house, magna drive magna business park, citywest road dublin 24 , ireland - budesonide - prolonged-release tablet - budesonide 9 mg - antidiarrheals, intestinal antiinflammatory/antiinfective agents

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

calliditas therapeutics ab - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - tarpeyo is indicated to reduce the loss of kidney function in adults with primary immunoglobulin a nephropathy (igan) who are at risk for disease progression. tarpeyo is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of tarpeyo. serious hypersensitivity reactions, including anaphylaxis have occurred with other budesonide formulations. risk summary the available data from published case series, epidemiological studies and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with iga nephropathy. infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism (see clinical considerations) . in animal reproduction studies with pregnant rats and rabbits, administration of subcutaneous budesonide during organogenesis at doses approximately 0.3 times or 0.03 times, respectively, the maximum recommended human dose (mrhd), 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) . the estimated background risk of major birth defects and miscarriage of the indicated population is unknown. all pregnancies have a background risk 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 iga nephropathy in pregnancy is associated with adverse maternal outcomes, including increased rates of cesarean section, pregnancy-induced hypertension, pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including stillbirth and low birth weight. fetal/neonatal adverse reactions hypoadrenalism may occur in infants born to 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 embryo-lethal in rabbits and rats. in an embryo-fetal development study in pregnant rats dosed subcutaneously with budesonide during the period of organogenesis on gestation days 6 to 15 there were effects on fetal development and survival at subcutaneous doses up to approximately 500 mcg/kg in rats (approximately 0.3 times the maximum recommended human dose (mrhd) on a body surface area basis). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis on gestation days 6 to 18, there was an increase in maternal abortion, and effects on fetal development and reduction in litter weights at subcutaneous doses from approximately 25 mcg/kg (approximately 0.03 times the mrhd 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 0.006 times the maximum recommended human dose on a body surface area basis) and 500 mcg/kg in rats (approximately 0.3 times the maximum recommended human dose on a body surface area basis). in a peri- and post-natal development study, subcutaneous treatment of pregnant rats with budesonide during the period from day 15 post coitum to day 21 post partum, 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 at exposures ≥ 0.012 times the mrhd (on a mg/m2 basis at maternal subcutaneous doses of 20 mcg/kg/day and higher). these findings occurred in the presence of maternal toxicity. risk summary breastfeeding is not expected to result in significant exposure of the infant to tarpeyo. lactation studies have not been conducted with oral budesonide, including tarpeyo, and no information is available on the effects of the drug on the breastfed infant or the effects on the drug on milk production. one published study reports that budesonide is present in human milk following maternal inhalation of budesonide (see data). routine monitoring of linear growth in infants is recommended with chronic use of budesonide in the nursing mother. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tarpeyo and any potential adverse effects on the breastfed infant from tarpeyo, 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 to plasma ratio was approximately 0.5. budesonide was not detected in plasma, and no adverse events were noted in the breastfed infants following maternal use of inhaled budesonide. assuming a daily average milk intake of about 150 ml/kg/day and a milk to plasma ratio of 0.5, the estimated oral dose of budesonide for a 5 kg infant is expected to be less than 2 mcg/day for a maternal dose of 16 mg tarpeyo. assuming 100% bio-availability in the infant this is about 0.1% of the maternal dose and about 3% of the highest inhaled dose used clinically for asthma in infants. the safety and efficacy of tarpeyo in pediatric patients have not been established. clinical studies of tarpeyo did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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, 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 impairments (child-pugh class c). monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (child-pugh class b).

European Union - English - EMA (European Medicines Agency)

stada arzneimittel ag - budesonide, micronised - glomerulonephritis, iga - antidiarrheals, intestinal antiinflammatory / antiinfective agents - kinpeygo is indicated for the treatment of primary immunoglobulin a (iga) nephropathy (igan) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (upcr) ≥1.5 g/gram.

New Zealand - English - Medsafe (Medicines Safety Authority)

te arai biofarma limited - budesonide 3mg - modified release capsule - 3 mg - active: budesonide 3mg excipient: gelatin   ethylcellulose dispersion type b ink black 10a2 iron oxide black iron oxide red methacrylic acid copolymer polysorbate 80 purified talc sugar spheres titanium dioxide   triethyl citrate - indicated for the induction of remission in patients with mild to moderate crohn's disease affecting the ileum and/or the ascending colon.