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--- ema europa eu budesonide-list-nationally-authorised-medicinal-product pro medicin dk Medicin Praeparater 1488--- ema europa eu en documents kinpeygo-epar-medicine-overview_en pdf--- ema europa eu en medicines human EPAR kinpeygoOral administration Biotilgængelighed ca 10 % hos raske og ca 20 % ved aktiv Crohns sygdom Enterokapsler frigiver de aktive stof i terminale ileum og colon Kapsler med modificeret udløsnin g (polydepot) frigiver det aktive stof i ileum og den ascenderende del af colon --- tillotts com products entocort--- hpra ie homepage medicines medicines-information find-a-medicine item--- ncbi nlm nih gov pmc articles PMC4989907--- medicines org uk emc product 872 smpcBudesonide, the active ingredient of ENTOCORT® EC capsules, is a synthetic corticosteroid It is designated chemically as (RS)-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic Budesonide has a high topical glucocorticosteroid (GCS) activity and a substantial first pass elimination The formulation contains granules which The results of a comparison with budesonide (Entocort®) are shown below Treatment Cost per patient per day Cost per patient per 8 weeks Cost per patient per 6 months* Budesonide (Entocort®) £2 97 £166 32 £362 34 Budesonide (Budenofalk®) £2 25 £126 00 £275 50 Saving with Budenofalk® £0 72 £40 32 £86 84dailymed nlm nih gov dailymed drugInfo cfm--- scottishmedicines org uk budesonide_budenofalk_3mg_granules_final_dec 2 Overview of the market The estimated annual incidence of UC is 24 3 per 100,000 person-years in Europe and 19 2 per 100,000 person-years in North America 14 It affects approximately 500,000 individuals in USA 15 Until recently, therapeutic options for mild-moderate UC were limited to oral and rectal 5-aminosalisylates (5-ASA) preparations and rectal corticosteroids preparation Main Information Trade Name Entocort® CR 3 mg Gastro-resistant Capsule, Hard Active Substances Budesonide Dosage Form Gastro-resistant capsule, hard Licence Holder Tillotts Pharma GmbH Licence Number PA2018 003 001 Kinpeygo is a medicine used to treat adults with primary immunoglobulin A nephropathy (IgAN) whose disease is at risk rapidly getting worse IgAN is a disease where the kidneys gradually stop working and eventually fail, requiring patients to undergo dialysis or have a kidney transplant Kinpeygo is a ‘ hybrid medicine ’ Kinpeygo is a ‘hybrid medicine’ It is similar to a ‘reference medicine’ containing the same active substance, but is used for a different disease and is given in a different way The reference medicine for Kinpeygo is Entocort IgAN is rare, and Kinpeygo was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 In a study comparing the pharmacokinetics of Entocort CR Capsules in 8 children (range 9– 14 years) and 6 adults, Entocort CR Capules 9 mg for 7 days induced a systemic exposure (AUC) that was 17% higher in children than in adults, with maximum concentrations (C max) 50% higher in children than in adults (mean AUC ± SD: children 41 3 nmol L ± 21 2; adults 35 0 nmol L ± 19 8 Entocort 3 mg, gélules à libération modifiée not available BE227823 TILLOTTS PHARMA GMBH BE Entocort 3 mg, capsules met gereguleerde afgifte, hard not available BE227823 TILLOTTS PHARMA GMBH BE Budesonide EG 0,125 mg ml Suspension für einen Vernebler DE H 5287 001 BE532506 EUROGENERICS N V S A BEEntocort™ Entocort™ (budesonide) is a first-line anti-inflammatory agent and locally acting glucocorticosteroid indicated for the induction and maintenance of remission of mild to moderate ileocaecal Crohn’s disease (capsules) and ulcerative colitis (enemas) as well as for the remission of active microscopic colitis (capsules) Entocort
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