FrancophonIA/ELRC3.0 huggingface dataset:
English: Because budesonide is not excreted via the kidneys, patients with mild to moderate impairment may be treated with caution with the same doses as patients without renal impairment.
Danish: Da budesonid ikke udskilles via nyrerne, kan patienter med let til moderat nedsat nyrefunktion blive behandlet med de samme doser, som bruges til patienter uden nedsat nyrefunktion, men der skal udvises forsigtighed.
English: Metabolism of budesonide is decreased in EoE patients compared to healthy subjects resulting in increased plasma concentrations of budesonide.
Danish: Budesonids metabolisme er nedsat hos EoE-patienter sammenlignet med raske forsøgspersoner, og fører til øgede plasmakoncentrationer af budesonid.
English: Marketing Authorisation Holder and Manufacturer Dr. Falk Pharma GmbH
Danish: Indehaver af markedsføringstilladelsen og fremstiller Dr. Falk Pharma GmbH
English: There are no data on the effect of budesonide on human fertility.
Danish: Der foreligger ingen data for budesonids påvirkning af menneskets fertilitet.
English: In the clinical study BUL-1/EEA, a total of 10 out of 87 patients (11.5%) exposed to Jorveza (double-blind and open-label extension phase) experienced cases of suspected fungal infections associated with clinical symptoms, which were all of mild intensity, except in one patient for whom a moderate intensity was reported.
Danish: I det kliniske studie BUL-1/EEA oplevede i alt 10 ud af 87 (11,5 %) patienter eksponeret for Jorveza (dobbeltblindet forlænget behandlingsfase uden blinding) tilfælde af formodede svampeinfektioner forbundet med kliniske symptomer, der alle var lette i intensitet, undtagen hos én patient, hvor der blev rapporteret en moderat intensitet.
English: It is used in adults (older than 18 years of age) to treat eosinophilic oesophagitis, which is an inflammatory condition of the gullet (food pipe) that causes problems with swallowing food.
Danish: Det tages af voksne (over 18 år) til at behandle eosinofil øsofagitis, som er en betændelsestilstand i spiserøret, der giver problemer med at synke føde.
English: − cardiac glycosides such as digoxin (medicines used to treat heart conditions)
Danish: − hjerteglykosider, såsom digoxin (medicin til behandling af hjertelidelser)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Dr. Falk Pharma GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Dr. Falk Pharma GmbH
English: You should not drink grapefruit juice whilst you are taking this medicine as this can worsen its side effects.
Danish: Brug af Jorveza sammen med mad og drikke Du må ikke drikke grapefrugtjuice mens du tager denne medicin, da dette kan forværre bivirkningerne.
English: The action of glycoside can be potentiated by potassium deficiency which is a potential and known adverse reaction of glucocorticoids.
Danish: Virkningen af glykosider kan forstærkes ved kaliummangel, som er en potentiel og kendt bivirkning ved glukokortikosteroider.
English: In case your kidney problems are severe, you should not take Jorveza.
Danish: Hvis dine nyreproblemer er svære, bør du ikke tage Jorveza.
English: Budesonide undergoes extensive biotransformation by CYP3A4 in the mucosa of the small intestine and in the liver to metabolites of low glucocorticosteroid activity.
Danish: Budesonid gennemgår omfattende biotransformation af CYP3A4 i tyndtarmens slimhinde og i leveren til metabolitter med lav glukokortikosteroidaktivitet.
English: A slightly increased number of basophilic hepatic foci were observed in chronic rat studies with budesonide, and in carcinogenicity studies, an increased incidence of primary hepatocellular neoplasms, astrocytomas (in male rats) and mammary tumours (female rats) were observed.
Danish: Et lidt øget antal af basofile hepatiske foci blev observeret i kroniske rottestudier med budesonid, og i carcinogene studier blev en øget forekomst af primære hepatocellulære neoplasmer, astrocytomer (hos hanrotter) og mammatumorer (hunrotter) iagttaget.
English: Do not use any oral solutions, sprays or chewable tablets for at least 30 minutes before or after administration of the orodispersible tablet.
Danish: Brug ikke oral opløsninger, sprays eller tyggetabletter i mindst 30 minutter før og efter administration af smeltetabletten.
English: Other medicines and Jorveza
Danish: Brug af anden medicin sammen med Jorveza
English: − if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Jorveza: - hvis du er allergisk over for budesonid eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Chickenpox, herpes zoster and measles can have a more serious course in patients treated with glucocorticosteroids.
Danish: Skoldkopper, herpes zoster og mæslinger har et mere alvorligt forløb hos patienter i behandling med glukokortikosteroider.
English: Kidney and liver problems
Danish: Nyre- og leverproblemer
English: Co-treatment with potent CYP3A inhibitors such as ketoconazole, ritonavir, itraconazole, clarithromycin, cobicistat and grapefruit juice may cause a marked increase of the plasma concentration of budesonide and is expected to increase the risk of systemic adverse reactions.
Danish: Samtidig behandling med potente CYP3A-hæmmere, såsom ketoconazol, ritonavir, itraconazol, clarithromycin, cobicistat og grapefrugtsaft kan forårsage en markant stigning i plasmakoncentrationen af budesonid og forventes at øge risikoen for systemiske bivirkninger.
English: Therefore, concomitant use should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.
Danish: Samtidig anvendelse bør derfor undgås, medmindre fordelen opvejer den øgede risiko for systemiske kortikosteroid-bivirkninger.
English: Do not chew or swallow the undissolved orodispersible tablet.
Danish: Du må ikke tygge eller synke en uopløst smeltetablet.
English: 20 orodispersible tablets 30 orodispersible tablets 60 orodispersible tablets 90 orodispersible tablets 100 orodispersible tablets
Danish: 20 smeltetabletter 30 smeltetabletter 60 smeltetabletter 90 smeltetabletter 100 smeltetabletter
English: Preclinical data in acute, subchronic and chronic toxicological studies with budesonide showed atrophies of the thymus gland and adrenal cortex and a reduction especially of lymphocytes.
Danish: Prækliniske data i akutte, subkroniske og kroniske toksikologiske undersøgelser med budesonid har vist atrofi af thymuskirtlen og binyrebarken og en reduktion især af lymfocytter.
English: If you forget to take Jorveza
Danish: Hvis du har glemt at tage Jorveza
English: Jorveza is not recommended for use in patients with severe renal impairment.
Danish: Jorveza anbefales ikke til brug til patienter med svært nedsat nyrefunktion.
English: If you have any problem with your kidney or liver, talk to your doctor.
Danish: Hvis du har problemer med nyrerne eller leveren, skal du kontakte lægen.
English: Do not take this medicine if you are breast-feeding unless you have checked with your doctor.
Danish: Du må ikke tage dette lægemiddel under amning, medmindre du har rådført dig med din læge.
English: Clearance of budesonide is about 1315 L/hour/kg in healthy subjects and 6.54 ± 4.4 L/hour/kg in EoE patients.
Danish: Clearance for budesonid er ca. 13 -15 l/time/kg hos raske forsøgspersoner og 6,54 ± 4,4 l/time/kg hos EoE-patienter.
English: Fungal infections in the mouth, pharynx and the oesophagus were the most frequently observed adverse reactions in clinical studies with Jorveza.
Danish: Svampeinfektioner i munden, svælget og spiserøret var de hyppigst observerede bivirkninger i kliniske studier med Jorveza.
English: In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause foetal death and abnormalities of foetal development (smaller litter size, intrauterine growth retardation of foetuses and skeletal abnormalities).
Danish: Hos drægtige dyr har budesonid, ligesom andre glukokortikosteroider, vist sig at forårsage fosterdød og abnormiteter i den føtale udvikling (mindre kuldstørrelse, intrauterin væksthæmning af fostre og skeletabnormiteter).
English: The recommended dose is two orodispersible tablets (2 mg budesonide) per day.
Danish: Den anbefalede dosis er to smeltetabletter om dagen (2 mg budesonid).
English: For information about the observed adverse reactions, see section 4.8.
Danish: For information om de observerede bivirkninger, se pkt.
English: The orodispersible tablet should be taken after a meal.
Danish: Administration Smeltetabletten skal tages efter et måltid.
English: The mean peak plasma concentration (± standard deviation) was 0.44 ± 0.31 ng/mL, the area under the plasma-concentration-time curve (AUC0-12) was 1.44 ± 0.31 hr*ng/mL.
Danish: Den gennemsnitlige maksimale plasmakoncentration (± standardafvigelse) var 0,44 ± 0,31 ng/ml, arealet under kurven for plasmakoncentration som funktion af tiden (AUC0-12) var 1,44 ± 0,31 t*ng/ml.
English: Pharmacokinetic data following administration of single doses of 1 mg budesonide to fasted healthy subjects show a median lag time of 0.17 hours (range 0.00 - 0.33 hours) and a median time to peak plasma concentration of 1.00 hour (range 0.50 - 2.00 hours).
Danish: Farmakokinetiske data efter administration af enkeltdoser på 1 mg budesonid til fastende raske forsøgspersoner viser en median latenstid på 0,17 timer (interval 0,00 - 0,33 timer), og en median tid til maksimal plasmakoncentration på 1,00 time (interval 0,50 - 2,00 timer).
English: Jorveza contains sodium
Danish: Jorveza indeholder natrium
English: Swallow the dissolved material with saliva little by little, as the orodispersible tablet breaks up.
Danish: Synk det opløste materiale med spyttet lidt efter lidt, efterhånden som smeltetabletten smuldrer.
English: What Jorveza looks like and contents of the pack The orodispersible tablets are white, round, biplane tablets.
Danish: Udseende og pakningsstørrelser Smeltetabletterne er hvide, runde, biplane tabletter
English: Budesonide is eliminated only in marginal if any amounts by the kidney.
Danish: Budesonid elimineres kun i begrænset omfang og i så fald via nyrerne.
English: Following administration of Jorveza, budesonide is rapidly absorbed.
Danish: Budesonid absorberes hurtigt efter administration af Jorveza.
English: If you stop taking Jorveza
Danish: Hvis du holder op med at tage Jorveza
English: Anhydrous monosodium citrate Povidone K25
Danish: Mononatriumcitrat, vandfri Povidon K25
English: Glaucoma, cataract (including subcapsular cataract), blurred vision, central serous chorioretinopathy (CSCR) (see also section 4.4)
Danish: Glaukom, katarakt (herunder subkapsulær katarakt) sløret syn, central serøs korioretinopati (CSCR) (se også pkt.
English: Fertility was unaffected following budesonide treatment in animal studies (see section 5.3).
Danish: I dyrestudier var fertiliteten ikke påvirket under budesonid-behandling (se pkt.
English: In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of fetal development (see section 5.3).
Danish: Hos drægtige dyr har budesonid vist, ligesom andre glukokortikosteroider, at forårsage abnormiteter i den føtale udvikling (se pkt.
English: − decreased amount of the hormone cortisol in your blood.
Danish: Nedsat kortisol i blodet
English: Each orodispersible tablet contains 1 mg of budesonide.
Danish: Hver smeltetablet indeholder 1 mg budesonid.
English: Dyspepsia, duodenal or gastric ulcers, pancreatitis, constipation
Danish: Dyspepsi, ulcus gastroduodeni, pancreatitis, forstoppelse
English: The dissolved material should be swallowed with saliva little by little while the orodispersible tablet disintegrates.
Danish: Det opløste materiale skal synkes med spyttet lidt efter lidt, efterhånden som smeltetabletten smuldrer.
English: Concommitant use of glucocorticoids may result in enhanced potassium excretion and aggravated hypokalaemia.
Danish: Samtidig anvendelse af glukokortikosteroider kan forårsage, øget udskillelse af kalium og forværret hypokaliæmi.
English: Patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataract, family history of diabetes or family history of glaucoma may be at higher risk of experiencing systemic glucocorticosteroid adverse reactions (see below and section 4.8) and should therefore be monitored for the occurrence of such effects.
Danish: Patienter med tuberkulose, hypertension, diabetes mellitus, osteoporose, ulcus pepticum, glaukom, katarakt eller med familiær optræden af diabetes, eller familiær optræden af glaukom kan have en højere risiko for at opleve systemiske glukokortikosteroide bivirkninger (se nedenfor og i pkt.
English: Tel.: +49 (0)761 1514-0
Danish: Tlf: +49 (0)761 1514-0
English: Systemic effects of glucocorticosteroids (e.g., Cushing's syndrome, adrenal suppression, growth retardation, cataract, glaucoma, decreased bone mineral density and a wide range of psychiatric effects) may occur (see also section 4.8).
Danish: Systemiske virkninger af glukokortikosteroider (f.eks. Cushing's syndrom, binyrebarksuppression, væksthæmning, katarakt, glaukom, nedsat knoglemineraltæthed og forskellige psykiatriske virkninger) kan opstå (se også pkt.
English: What you need to know before you take Jorveza
Danish: Det skal du vide, før du begynder at tage Jorveza
English: Upper abdominal pain, gastroesophageal reflux disease, lip edema, nausea, oral paraesthesia
Danish: Smerter i øvre abdomen, gastroøsofageal reflukssygdom, læbeødem, kvalme, oral paræstesi
English: Allergic exanthema, petechiae, delayed wound healing, contact dermatitis, ecchymosis
Danish: Allergisk exanthem, petekkier, langsom sårheling, kontaktdermatitis, ekkymose
English: The orodispersible tablet should not be chewed or swallowed undissolved.
Danish: Smeltetabletten må ikke tygges eller synkes i uopløst tilstand.
English: − Cushing's syndrome, which is associated with too much corticosteroid and causes roundness of the face, weight gain, high blood sugar, build-up of fluid in the tissues (e.g. swollen legs),
Danish: Hyppigheden af disse hændelser er i øjeblikket ikke kendt: - øget infektionsrisiko - Cushings syndrom, som er forbundet med for meget kortikosteroid og forårsager opsvulmethed i ansigtet, vægtøgning, højt blodsukker, ophobning af væske i vævene (f.eks. hævede ben),
English: If you do come into contact with chickenpox or shingles, see your doctor straight away.
Danish: Hvis du kommer i kontakt med skoldkopper eller helvedesild, skal du straks kontakte din læge.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 1 mg budesonide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver smeltetablet indeholder 1 mg budesonid.
English: Do NOT take any liquid with the orodispersible tablet.
Danish: Du må IKKE tage smeltetabletten med væske.
English: reduced potassium level in the blood (hypokalaemia), irregular periods in women, unwanted body hair in women, impotence, stretch marks on the skin, acne.
Danish: uønsket kropsbehåring hos kvinder, impotens, strækmærker i huden, akne.
English: Jorveza 1 mg orodispersible tablets budesonide
Danish: Jorveza 1 mg smeltetabletter budesonid
English: Patients with hepatic impairment should not be treated (see sections 4.4 and 5.2).
Danish: Patienter med nedsat leverfunktion må ikke behandles (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Jorveza 1 mg orodispersible tablets budesonide
Danish: LÆGEMIDLETS NAVN Jorveza 1 mg smeltetabletter budesonid
English: NAME OF THE MEDICINAL PRODUCT Jorveza 1 mg orodispersible tablets
Danish: LÆGEMIDLETS NAVN Jorveza 1 mg smeltetabletter
English: Cardiac glycosides
Danish: Hypokaliæmi, hyperglykæmi
English: − Tell your doctor if you get fungal infections in the mouth, throat and gullet or if you think you have any infection during treatment with this medicine.
Danish: Tag de følgende forholdsregler under behandlingen med Jorveza, da dit immunsystem kan være svækket: - Fortæl det til lægen, hvis du får svampeinfektioner i munden, halsen og spiserøret, eller hvis du tror, du har en infektion under behandling med denne medicin.
English: Cushing's syndrome, adrenal suppression, growth retardation in children Metabolism and nutrition disorders Hypokalaemia, hyperglycaemia Psychiatric disorders
Danish: Cushings syndrom, binyresuppression, væksthæmning hos børn
English: Muscle and joint pain, muscle weakness and twitching, osteoporosis, osteonecrosis
Danish: Knogler, led, muskler og bindevæv Muskel- og ledsmerter, muskelsvaghed og muskeltrækninger, osteoporose, osteonekrose
English: What Jorveza contains - The active substance is budesonide.
Danish: - Aktivt stof: Budesonid.
English: How to take Jorveza
Danish: Sådan skal du tage Jorveza
English: Single dose pharmacokinetic data in fasted patients with EoE are available with 4 mg budesonide: Median lag-time was 0.00 hours (range 0.00 - 0.17), median time to peak plasma concentration was 1.00 hour (range 0.67 - 2.00 hours); peak plasma concentration was 2.56 ± 1.36 ng/mL, and AUC0-12 was 8.96 ± 4.21 hr*ng/mL.
Danish: Farmakokinetiske data for administration af enkeltdoser til fastende patienter med EoE er tilgængelige for 4 mg budesonid: Den mediane latenstid var 0,00 timer (interval 0,00 - 0,17), mediantiden til den maksimale plasmakoncentration var 1,00 time (interval 0,67 - 2,00 timer).
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen apotekspersonalet.
English: LIST OF EXCIPIENTS Contains sodium, see leaflet for further information.
Danish: Se indlægssedlen for yderligere oplysninger.
English: Each orodispersible tablet contains 26 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver smeltetablet indeholder 26 mg natrium.
English: If you take more Jorveza than you should
Danish: Hvis du har taget for meget Jorveza
English: − tiredness
Danish: Diuretika
English: What you need to know before you take Jorveza 3.
Danish: Det skal du vide, før du begynder at tage Jorveza Sådan skal du tage Jorveza Bivirkninger
English: − increased pressure in your eye (which can cause glaucoma) or eye problems such as clouding of the lens (cataracts) or if somebody in your family has glaucoma
Danish: Kontakt lægen eller apotekspersonalet, før du begynder at tage Jorveza, hvis du har: - tuberkulose - højt blodtryk - diabetes, eller hvis nogen i din familie har diabetes - knogleskørhed (osteoporose) - sår i maven eller i første del af tyndtarmen (mavesår) - øget tryk i øjet (som kan forårsage glaukom) eller øjenproblemer, såsom uklarhed af linsen (grå stær) eller hvis nogen i din familie har glaukom.
English: Orodispersible tablet
Danish: Nedsat nyrefunktion
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medicalprescription .
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: − increased pressure in the brain, possibly with increased pressure in the eye (swelling of the optic disk) in adolescents
Danish: - langsom vækst hos børn - humørsvingninger, såsom depression, irritabilitet eller eufori (opstemthed) - rastløshed med øget fysisk aktivitet, angst, aggression - øget tryk i hjernen, eventuelt med øget tryk i øjet (hævelse af den optiske disk) hos unge - sløret syn - øget risiko for blodpropper, betændelse i blodkarrene (som kan opstå i forbindelse med ophør af medicinen efter lang tids brug).
English: Adverse reactions
Danish: Utilpashed
English: - if you have cancer.
Danish: - Hvis du har kræft.
English: All cases were mild or moderate in severity and none was serious.
Danish: Alle tilfælde var milde eller moderate i sværhedsgrad og ingen var alvorlige
English: In this case INCRELEX cannot help you grow and should not be used.
Danish: I dette tilfælde kan INCRELEX ikke hjælpe dig med at vokse og det bør derfor ikke bruges.
English: Severe Primary IGFD is defined by:
Danish: Svær primær IGFD defineres ved:
English: Upon re-administration, symptoms did not re-occur in all patients.
Danish: Ved re-administration, opstod symptomerne ikke igen hos alle patienter.
English: Some patients required hospitalization.
Danish: Nogle patienter krævede hospitalsindlæggelse.
English: This medicinal product should not be used during pregnancy unless clearly necessary.
Danish: Dette lægemiddel bør ikke anvendes under graviditet, med mindre det er klart nødvendigt.
English: There was no death during the studies.
Danish: Der var ingen dødsfald under studierne.
English: Systemic/local hypersensitivity
Danish: Systemisk/lokal hypersensitivitet
English: Use alcohol or soap and water to clean the skin where you are going to inject you.
Danish: Brug alkohol eller sæbe og vand til at rense huden, der hvor du vil sprøjte dig selv.
English: That parents and caregivers should always ensure that the child has a source of sugar.
Danish: Forældre og plejepersonale skal altid sikre, at barnet har en sukkerkilde til rådighed.
English: Therefore there is insufficient medical information to determine whether there are significant risks to a foetus.
Danish: Derfor er der ikke tilstrækkelig medicinsk information til at afgøre om der er signifikant risiko for et foster.
English: These studies did not indicate direct or indirect harmful effects with respect to fertility and pregnancy, but due to the different route of application the relevance of these findings is unclear.
Danish: Disse studier indikerer ikke nogen direkte eller indirekte skadelige virkninger med hensyn til fertilitet og graviditet, men på grund af den anderledes indgivelsesvej er relevansen af disse resultater uklar.
English: Store in a refrigerator (2C - 8°C).
Danish: Opbevares i køleskab (2C - 8°C).
English: Carcinogenic potential
Danish: Karcinogent potentiale
English: Post-marketing reports
Danish: Post-marketing rapporter
English: It is important that you have a well-balanced diet including protein and fat such as meat and cheese in addition to sugarcontaining foods.
Danish: Det er vigtigt, at du får en velafbalanceret kost med protein og fedt, herunder kød og ost, udover sukkerholdig mad.
English: • basal IGF-1 levels below the 2.5th percentile for age and gender and
Danish: • basale IGF-1-niveauer under 2,5 percentilen for alder og køn og
English: In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test.
Danish: I nogle tilfælde, når det skønnes nødvendigt, kan lægen beslutte at bekræfte diagnosen ved at udføre en IGF-I-generationstest.
English: If the recommended dose is not tolerated by the patient, treatment with a lower dose can be considered.
Danish: Hvis den anbefalede dosis ikke tolereres af patienten, kan behandling med en lavere dosis overvejes.
English: You are now ready to inject (see Figure 7).
Danish: Du er nu klar til at indsprøjte (se figur 7).
English: • height standard deviation score  -3.0 and
Danish: • højde standardafvigelse score  -3,0 og
English: All 4 subjects recovered from the event without sequelae.
Danish: Alle 4 patienter kom sig uden sequelae.
English: Race No information is available.
Danish: Race Ingen tilgængelige oplysninger.
English: Wash your hands before getting INCRELEX ready for your injection.
Danish: Vask hænderne, inden du gør INCRELEX klar til din indsprøjtning.
English: You should have examinations periodically.
Danish: De skal undersøges med regelmæssige mellemrum.
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (not known).
Danish: Eftersom disse reaktioner er rapporteret af frivillige fra en befolkningsgruppe af ukendt størrelse er det umuligt med sikkerhed at estimere reaktionernes hyppighed (ikke kendt).
English: 28100 Dreux
Danish: 28100 Dreux Frankrig
English: - in premature babies or neonates because it contains benzyl alcohol.
Danish: - Til præmature spædbørn eller nyfødte, da det indeholder benzylalkohol.