FrancophonIA/ELRC3.0 huggingface dataset:
English: CYP3A5 does not contribute significantly to the metabolism of budesonide.
Danish: CYP3A5 bidrager ikke væsentligt til metabolismen af budesonid.
English: Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Jorveza.
Danish: Indgivelse under graviditet skal undgås, medmindre der foreligger en tvingende grund til behandling med Jorveza.
English: Place the orodispersible tablet on the tip of your tongue and close your mouth.
Danish: Placer smeltetabletten på spidsen af tungen, og luk munden.
English: Take one orodispersible tablet in the morning and one orodispersible tablet in the evening.
Danish: Tag én smeltetablet om morgenen og én smeltetablet om aftenen.
English: Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity.
Danish: Undertrykkelse af inflammationsrespons og immunforsvar øger modtageligheden for infektioner og sværhedsgraden af disse.
English: Jorveza should not be used in children and adolescents under 18 years of age.
Danish: Jorveza bør ikke anvendes til børn og unge under 18 år.
English: − If you know that you are due to have an operation please tell your doctor that you are taking Jorveza.
Danish: - Hvis du ved, at du skal have en operation, skal du fortælle din læge, at du tager Jorveza.
English: The treatment with this medicinal product should be initiated by a physician experienced in the diagnosis and treatment of eosinophilic esophagitis.
Danish: Behandlingen med dette lægemiddel skal iværksættes af en læge med erfaring i diagnosticering og behandling af eosinofil øsofagitis (EoE).
English: These side effects depend on the duration of treatment, concomitant and previous glucocorticosteroid treatment and the individual sensitivity.
Danish: Disse bivirkninger afhænger af behandlingens varighed, samtidig eller tidligere behandling med glukokortikosteroider og den individuelle følsomhed.
English: No such effect has been observed with budesonide and concomitant intake of low-dose combination oral contraceptives.
Danish: Sådan en virkning er ikke set med budesonid og en samtidig indtagelse af lavdosis orale kombinationskontraceptiva.
English: Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).
Danish: Da den adrenale funktion kan være supprimeret ved behandling med budesonid, kan en ACTH-stimuleringstest for diagnosticering af hypofyseinsufficiens give falske resultater (lave værdier).
English: There are few data of pregnancy outcomes after oral administration of budesonide in humans.
Danish: Der foreligger begrænsede data af graviditeters udfald efter oral administration af budesonid til mennesker.
English: The glucocorticosteroid activity of the major metabolites, 6β-hydroxybudesonide and 16α-hydroxyprednisolone, is less than 1% of that of budesonide.
Danish: Glukokortikosteroidaktiviteten af hovedmetabolitterne, 6β-hydroxybudesonid og 16α-hydroxyprednisolon, er mindre end 1 % af budesonids.
English: Tell your doctors that you are taking Jorveza before you have any tests.
Danish: Fortæl lægerne, at du tager Jorveza, før du får foretaget nogen undersøgelser.
English: Do not eat, drink, brush your teeth or rinse your mouth for at least 30 minutes after you have taken the orodispersible tablet.
Danish: Du må ikke spise, drikke, børste tænder eller skylle munden i mindst 30 minutter, efter du har taget smeltetabletten.
English: Symptoms of fungal infection can be white spots in the mouth and throat and difficulty in swallowing.
Danish: Symptomerne på en svampeinfektion kan være hvide pletter i munden og halsen og synkebesvær.
English: MedDRA system organ class Very common
Danish: MedDRA-systemorganklasse Meget almindelig
English: Speak to your doctor if you want to interrupt or end your treatment early.
Danish: Kontakt din læge, hvis du ønsker at holde pause eller stoppe behandlingen tidligere.
English: The following side effects have been reported and are typical with medicines similar to Jorveza (corticosteroids), and can therefore also occur with this medicine.
Danish: Følgende bivirkninger er blevet rapporteret med og er typiske for lægemidler, der ligner Jorveza (kortikosteroider), og kan derfor også forekomme med dette lægemiddel.
English: Very common: may affect more than 1 in 10 people − fungal infections in the gullet (which can cause pain or discomfort when swallowing)
Danish: Meget almindelig: kan forekomme hos flere end 1 ud af 10 personer - svampeinfektioner i spiserøret (symptomer, som kan forårsage smerter eller ubehag ved synkning)
English: However, only minor effects on the breast-fed child are anticipated after oral use of Jorveza within the therapeutic range.
Danish: Dog forventes kun mindre virkninger på det ammede barn efter oral anvendelse af Jorveza inden for det terapeutiske område.
English: Reduced liver function may affect the elimination of budesonide, causing higher systemic exposure.
Danish: En nedsat leverfunktion kan påvirke eliminationen af budesonid, og føre til en højere systemisk eksponering.
English: Systemic effects of glucocorticosteroids
Danish: Systemiske virkninger af glukokortikosteroider
English: If indicated, symptomatic candidiasis of the mouth and throat can be treated with topical or systemic anti-fungal therapy whilst still continuing treatment with Jorveza.
Danish: Hvor det er indiceret, kan symptomatisk candidiasis i mund og hals behandles med topikal eller systemisk antisvampebehandling, mens behandlingen med Jorveza stadig fortsættes.
English: Jorveza could affect the results of adrenal function tests (ACTH stimulation test) ordered by your doctor or in hospital.
Danish: Jorveza kan påvirke resultaterne af binyrefunktionsundersøgelser (ACTH-stimulationstest) hos lægen eller på hospitalet.
English: There are currently no data available for patients with renal impairment.
Danish: Der er aktuelt ingen tilgængelige data for patienter med nedsat nyrefunktion.
English: EU/1/17/1254/003 EU/1/17/1254/004 EU/1/17/1254/005
Danish: EU/1/17/1254/001 EU/1/17/1254/002 EU/1/17/1254/003 EU/1/17/1254/004 EU/1/17/1254/005
English: Although data on the use of inhaled budesonide in a large number of exposed pregnancies indicate no adverse effect, the maximal concentration of budesonide in plasma has to be expected to be higher in the treatment with Jorveza compared to inhaled budesonide.
Danish: Selvom data efter brug af inhaleret budesonid til et stort antal af gravide ikke indikerer nogen bivirkninger, bør den maksimale plasmakoncentration forventes at blive højere med Jorveza-behandling i forhold til inhaleret budesonid.
English: Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).
Danish: Jorveza er indiceret til behandlingen af eosinofil øsofagitis (EoE) hos voksne (over 18 år).
English: The risk of adverse reactions (systemic glucocorticosteroid effects) will be increased.
Danish: Risikoen for bivirkninger (systemiske glukokortikosteroide virkninger) vil være øget.
English: The following known adverse reactions of the therapeutic class (corticosteroids, budesonide) could also occur with Jorveza (frequency = not known).
Danish: De følgende kendte bivirkninger for den terapeutiske klasse (kortikosteroider, budesonid) kunne også forekomme med Jorveza (hyppighed = ikke kendt).
English: Further precautions during treatment with Jorveza − Contact your doctor if you get blurred vision or have other problems with your vision.
Danish: Yderligere forholdsregler under behandling med Jorveza: - Fortæl det til lægen, hvis du får sløret syn eller andre problemer med synet.
English: Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see section 4.5).
Danish: Samtidig behandling med ketoconazol eller andre CYP3A4-hæmmere bør undgås (se pkt.
English: The clinical relevance of these findings to man has not been established (see section 4.6).
Danish: Den kliniske relevans af disse observationer for mennesker er ikke klarlagt (se pkt.
English: − Tell your doctor if you have not yet had measles and/or if and when you have received your last vaccination for this disease.
Danish: - Fortæl det til lægen, hvis du ikke har haft mæslinger, og/eller om du har fået din sidste vaccine mod denne sygdom, og i så fald hvornår.
English: − ketoconazole or itraconazole (to treat fungal infections)
Danish: − ketoconazol eller itraconazol (til behandling af svampeinfektioner)
English: Esophageal candidiasis Oral and/or oropharyngeal candidiasis
Danish: Oral og/eller orofaryngeal candidiasis
English: No budesonide, but only budesonide metabolites were detected in urine.
Danish: Der blev ikke detekteret noget budesonid, men kun budesonidmetabolitter, i urinen.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister
English: − If you need to be vaccinated please speak to your doctor first.
Danish: - Hvis du skal vaccineres, så kontakt først din læge.
English: − liver disease.
Danish: - leversygdom.
English: These tumours are probably due to the specific steroid receptor action, increased metabolic burden and anabolic effects on the liver, effects which are also known from other glucocorticosteroids in rat studies and therefore represent a class effect in this species.
Danish: Disse tumorer skyldes sandsynligvis den specifikke steroidreceptorvirkning, øget metabolisk belastning og anabolske virkninger på leveren, dvs. virkninger, som også er kendt fra andre glukokortikosteroider i rottestudier og derfor repræsenterer en klassevirkning i denne dyreart.
English: The systemic exposure of budesonide is considerably increased in patients with severely impaired hepatic function.
Danish: Den systemiske eksponering af budesonid er væsentligt øget hos patienter med svært nedsat leverfunktion.
English: Patients with hepatic impairment should therefore not be treated.
Danish: Patienter med nedsat leverfunktion må derfor ikke behandles.
English: This medicine contains 52 mg sodium (main component of cooking/table salt) per daily dose.
Danish: Dette lægemiddel indeholder 52 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. daglig dosis.
English: Openlabel extension of the treatment with 1 mg budesonide orodispersible tablet twice daily for further 6 weeks in patients without remission in the double-blind phase increased the rate of patients with clinico-pathologic remission to 84.7%.
Danish: Forlængelse af behandlingen uden blinding med 1 mg budesonid smeltetablet to gange dagligt i yderligere 6 uger hos patienter uden remission i den dobbeltblindede fase øgede raten af patienter med klinisk-patologisk remission til 84,7 %.
English: 79108 Freiburg Germany
Danish: 79108 Freiburg Tyskland
English: Disodium hydrogen citrate Docusate sodium Macrogol 6000
Danish: Dinatriumhydrogencitrat Docusatnatrium Macrogol 6000
English: The orodispersible tablet should not be taken with liquid or food.
Danish: Smeltetabletten må ikke tages med væske eller mad.
English: Do not take this medicine during pregnancy without checking with your doctor first.
Danish: Du må ikke tage dette lægemiddel under graviditeten, uden at spørge din læge til råds først.
English: Jorveza has no or negligible influence on the ability to drive and use machines.
Danish: Jorveza påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Jorveza comes in blisters in packs with 20, 30, 60, 90 or 100 orodispersible tablets.
Danish: Jorveza leveres i blistre i pakninger med 20, 30, 60, 90 eller 100 smeltetabletter.
English: These measures ensure optimal exposure of the esophageal mucosa to the active substance.
Danish: Disse forsigtighedsregler sikrer, at den øsofageale slimhinde eksponeres optimalt for det aktive stof.
English: Pack sizes: 20, 30, 60, 90 or 100 orodispersible tablets.
Danish: Pakningsstørrelser: 20, 30, 60, 90 eller 100 smeltetabletter.
English: This medicinal product contains 52 mg of sodium per daily dose equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 52 mg natrium pr. daglig dosis, svarende til 2,6 % af den af WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: When patients are subject to surgery or other stresses, supplementary systemic glucocorticosteroid treatment is therefore recommended.
Danish: I de tilfælde, hvor patienter skal opereres eller udsættes for andre stresssituationer, anbefales derfor supplerende systemisk glukokortikosteroidbehandling.
English: Method of administration Take the orodispersible tablet after a meal.
Danish: Administrationsmetode Tag smeltetabletten efter et måltid.
English: Adverse reactions observed in clinical studies with Jorveza are listed in the table below, by MedDRA system organ class and frequency.
Danish: Bivirkninger, der blev observeret i kliniske studier med Jorveza angives i tabellen nedenfor, i henhold til MedDRA-systemorganklasse og hyppighed.
English: However, no systematic study investigating different levels of hepatic impairment is available.
Danish: Imidlertid foreligger der intet systematisk studie, som undersøger de forskellige grader af nedsat leverfunktion.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med budesonid seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: - The other ingredients are disodium hydrogen citrate, docusate sodium, macrogol 6000, magnesium stearate, mannitol, anhydrous monosodium citrate, povidone K25, sodium hydrogen carbonate and sucralose (see also section 2, ”Jorveza contains sodium”).
Danish: - Øvrige indholdsstoffer: Dinatriumhydrogencitrat, docusatnatrium, macrogol 6000, magnesiumstearat, mannitol, vandfri mononatriumcitrat, povidon K25, natriumhydrogencarbonat og sucralose (se også punkt 2, ”Jorveza indeholder natrium”).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Do not chew or swallow.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Må ikke tygges eller synkes uopløst.
English: MedDRA system organ class
Danish: MedDRA-systemorganklasse
English: Some glucocorticoids have been reported to produce cleft palate in animals.
Danish: Nogle glukokortikosteroider er rapporteret at forårsage ganespalte hos dyr.
English: When ketoconazole was administered approximately 12 hours after budesonide, the plasma concentration of budesonide increased approximately 3-fold.
Danish: Når ketoconazol blev givet ca. 12 timer efter budesonid, steg plasmakoncentrationen af budesonid ca. 3 gange.
English: Depression, irritability, euphoria, psychomotor hyperactivity, anxiety, aggression
Danish: Depression, irritabilitet, eufori, psykomotorisk hyperaktivitet, angst, aggression
English: Jorveza contains the active substance budesonide, a corticosteroid medicine that reduces inflammation.
Danish: Jorveza indeholder det aktive stof budesonid, et kortikosteroid-lægemiddel, der reducerer inflammation (betændelse).
English: In clinical studies conducted with Jorveza oral, oropharyngeal and esophageal candida infections have been observed with a high frequency (see section 4.8).
Danish: I kliniske studier udført med Jorveza er orale, orofaryngeale og øsofageale svampeinfektioner blevet observeret med stor hyppighed (se pkt 4.8).
English: − ritonavir and cobicistat (to treat HIV infections)
Danish: − ritonavir og cobistat (til behandling af hiv-infektion)
English: − oestrogens (used for hormone replacement therapy or contraception)
Danish: − østrogener (anvendes som hormonbehandling eller prævention)
English: Your doctor will decide on the appropriate measures and if it is still all right for you to take this medicine.
Danish: Din læge vil beslutte den rette behandling, og om denne medicin stadig er den rette for dig.
English: Budesonide is a non-halogenated glucocorticosteroid, which acts primarily anti-inflammatory via binding to the glucocorticoid receptor.
Danish: Budesonid er et non-halogeneret glukokortikosteroid, hvis virkning primært er antiinflammatorisk via binding til glukokortikoid-receptoren.
English: Budesonide had no effect on fertility in rats.
Danish: Budenosid har ingen effekt på fertiliteten hos rotter.
English: Glucocorticosteroids may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis and reduce the stress response.
Danish: Glukokortikosteroider kan forårsage undertrykkelse af hypothalamus-hypofyse-binyreaksen (HPA) og reducere stressresponset.
English: Any oral solutions, sprays or chewable tablets should be used at least 30 minutes before or after administration of Jorveza.
Danish: Ved enhver brug af oral opløsning, spray eller tyggetabletter skal der gå mindst 30 minutter før og efter administration af Jorveza.
English: A relevant proportion of budesonide is metabolised in the liver by CYP3A4.
Danish: En betydelig del af budesonid metaboliseres i leveren af CYP3A4.
English: For patients who are not appropriately responding during 6 weeks the treatment can be extended to up to 12 weeks.
Danish: Behandlingen kan forlænges op til 12 uger for patienter, der ikke responderer tilfredsstillende i løbet af 6 uger.
English: Your doctor will help you decide whether you should continue treatment and not breast-feed or if you should stop treatment over the period your baby is being breast-fed.
Danish: Din læge vil hjælpe dig med beslutte, om du bør fortsætte behandlingen og undgå at amme, eller om du bør standse behandlingen i den periode, hvor du ammer dit barn.
English: In the treatment of EoE with Jorveza, budesonide inhibits antigen-stimulated secretion of many pro-inflammatory signal molecules such as thymic stromal lymphopoeitin, interleukin-13 and eotaxin-3 in the esophageal epithelium, which results in a significant reduction of the esophageal eosinophilic inflammatory infiltrate.
Danish: I behandlingen af EoE med Jorveza hæmmer budesonid antigenstimuleret sekretion af mange proinflammatoriske signalmolekyler, såsom thymisk, stromal lymfopoeitin, interleukin-13 og eotaxin-3 i det øsofageale epitel, hvilket fører til en signifikant reduktion af det øsefageale inflammatoriske infiltrat.
English: EU/1/17/1254/001 (20 orodispersible tablets) EU/1/17/1254/002 (30 orodispersible tablets) EU/1/17/1254/003 (60 orodispersible tablets) EU/1/17/1254/004 (90 orodispersible tablets) EU/1/17/1254/005 (100 orodispersible tablets)
Danish: EU/1/17/1254/001 (20 smeltetabletter) EU/1/17/1254/002 (30 smeltetabletter) EU/1/17/1254/003 (60 smeltetabletter) EU/1/17/1254/004 (90 smeltetabletter) EU/1/17/1254/005 (100 smeltetabletter)
English: Driving and using machines Jorveza is not expected to affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Jorveza forventes ikke at påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg Germany
Danish: Dr. Falk Pharma GmbH Leinenweberstrasse 5 79108 Freiburg Tyskland
English: INFORMATION IN BRAILLE Jorveza 1mg
Danish: INFORMATION I BRAILLESKRIFT Jorveza 1 mg
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Danish: (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000
English: During treatment of patients with hepatic impairment with other budesonide containing products, budesonide levels were increased.
Danish: Under behandling af patienter med nedsat leverfunktion med andre budesonidholdige produkter var budesonidniveauerne øgede.
English: No studies have been conducted with Jorveza in patients with impaired liver function.
Danish: Der er ikke udført studier med Jorveza hos patienter med nedsat leverfunktion.
English: Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported in women also receiving oestrogens or oral contraceptives.
Danish: Forhøjede plasmakoncentrationer og øget virkning af glukokortikosteroider er beskrevet hos kvinder, som tager østrogener eller orale kontraceptiva.
English: Do not take this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Tag ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteren efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: If you have any liver disease, you should not take Jorveza.
Danish: Hvis du har en leversygdom, må du ikke tage Jorveza.
English: Ketoconazole 200 mg once daily orally increased the plasma concentration of budesonide (3 mg single dose) approximately 6-fold during concomitant administration.
Danish: Ketoconazol 200 mg 1 gang dagligt oralt øgede plasmakoncentrationen af budesonid (3 mg enkeltdosis) ca. 6 gange ved samtidig administration.
English: The median elimination half-life is 2 - 3 hours in healthy subjects (receiving 1 mg budesonide) and 4 - 5 hours in EoE patients (receiving 4 mg budesonide).
Danish: Den mediane eliminationshalveringstid er 2 - 3 timer hos raske forsøgspersoner (der modtog 1 mg budesonid) og 4 - 5 timer hos EoE-patienter (der modtog 4 mg budesonid).
English: Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, corticosteroids acting locally, ATC code: A07EA06
Danish: Farmakoterapeutisk klassifikation: Midler mod diarré og tarminflammation/-infektion, corticosteroider med lokal virkning, ATC-kode: A07EA06.
English: The volume of distribution following administration of 1 mg budesonide to healthy subjects was 35.52 ± 14.94 L/kg and 42.46 ± 23.90 L/kg following administration of 4 mg budesonide to patients with EoE.
Danish: Fordelingsvolumen efter administration af 1 mg budesonid til raske personer var 35,52 ± 14,94 l/kg og 42,46 ± 23,90 l/kg efter administration af 4 mg budesonid til patienter med EoE.
English: Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)
Danish: Øget risiko for trombose, vaskulitis (abstinenssyndrom efter langtidsterapi).
English: The safety and efficacy of Jorveza in children and adolescents under the age of 18 years have not been established.
Danish: Jorvezas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: The recommended daily dose is 2 mg budesonide as one 1-mg-tablet in the morning and one in the evening.
Danish: Dosering Den anbefalede daglige dosis er 2 mg budesonid som én 1 mg tablet om morgenen og én om aftenen.
English: Use as directed by the physician.
Danish: Anvendes efter lægens anvisninger.
English: In a randomised, placebo-controlled, double-blind phase III clinical study including 88 adult patients with active EoE (randomisation rate: 2:1), 1 mg budesonide given twice daily as an orodispersible tablet for 6 weeks induced clinico-pathologic remission (defined as both peak of < 16 eosinophils/mm2 high power field in esophageal biopsies and no or only minimal symptoms of dysphagia or pain during swallowing) in 34 out of 59 patients (57.6%) versus 0/29 patients (0%) in the placebo-group.
Danish: I et randomiseret, placebokontrolleret, dobbeltblindet klinisk fase III-studie, der inkluderede 88 voksne patienter med aktiv EoE (randomiseringsrate: 2:1), inducerede 1 mg budesonid indgivet to gange dagligt som en smeltetablet i 6 uger klinisk-patologisk remission (defineret som både maksimalt < 16 eosinofiler/mm2 high power field (lysmikroskopi) i øsofageale biopsier, og ingen eller kun minimale symptomer på dysfagi eller smerter under synkning) hos 34 ud af 59 patienter (57,6 %) versus 0/29 patienter (0 %) i placebogruppen.