FrancophonIA/ELRC3.0 huggingface dataset:
English: Sanochemia Pharmazeutika Ag Cyclolux Multi
Danish: Cyclolux Multi
English: Sanochemia Pharmazeutika Ag Gadoteric Acid Gadotersäure
Danish: Gadotersäure Sanochemia
English: Solution for injection in cartridge | solution for injection in pre-filled syringe
Danish: Gadovist Pfs injektionsvæske, opløsning i cylinderampul | injektionsvæske, opløsning i fyldt injektionssprøjte
English: Ενεσιμο διαλυμα Intravenous use
Danish: intra-aintra-artikulær brug
English: Gadopentat
Danish: гадовист
English: Gadoteric Acid 0.0025mmol/Ml
Danish: Gadoteric Acid 0.0025mmol/Ml intraartikulær anvendelse
English: Bulgaria магневист
Danish: Bulgarien омнискен
English: Gadoteric Acid 0.5 Milli Molar / Ml Solution for injection Intravenous use
Danish: Gadoteric Acid 0.5mmol/Ml injektionsvæske, opløsning i fyldt injektionssprøjte
English: Conpharm Gmbh
Danish: Conpharm GmbH Gadopentat
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States for gadolinium containing medicinal products
Danish: Bilag IA - lægemidler indeholdende intravenøs gadobensyre, gadobutrol, gadoterinsyre, gadoteridol, gadoxinsyre og intra-artikulær gadopentdikesyre og intra-artikulær gadoterinsyre
English: Gadodiamide 14.35g/50 Ml
Danish: Gadodiamide 14.35g/50 Ml injektionsvæske, opløsning
English: Bayer Spa
Danish: Bayer S.p.A.
English: Gadoteric Acid 0.5mmol/Ml
Danish: Gadoteric Acid 0.5 Milli Molar / Ml
English: 90 (3 x 30) tablets (multipack)
Danish: 50 mg / 25 mg Filmovertrukket tablet Oral anvendelse Beholder (HDPE) 90 (3 x 30) tabletter (multipakning)
English: 30 tablets
Danish: 50 mg / 25 mg Filmovertrukket tablet Oral anvendelse Beholder (HDPE) 30 tabletter
English: The study designs were identical through the first 26 weeks.
Danish: Studiernes design var ens i de første 26 uger.
English: Date of first authorisation: 19 September 2016
Danish: Dato for første markedsføringstilladelse: 19 September 2016
English: There were no efficacy differences according to gender.
Danish: Der var ingen forskelle i effekt mellem kønnene.
English: Take the next dose at the next scheduled time and continue as normal.
Danish: Tag den næste dosis på det næste planlagte tidspunkt og fortsæt på normal vis.
English: Gender, age, ethnicity
Danish: Køn, alder, etnicitet
English: Component of a multipack, can't be sold separately
Danish: Del af en multipakning, sælges ikke separat.
English: Caution should therefore be exercised in patients receiving such medicinal products especially with high doses.
Danish: Der skal derfor udvises forsigtighed hos patienter, der får sådanne lægemidler, især i høje doser.
English: Study 2 (IBS 3002)
Danish: Studie 2 (IBS 3002)
English: All patients met Rome III criteria for IBS and were required to meet the following criteria:
Danish: Alle patienter opfyldte kriterierne for IBS ifølge Rome III og skulle derudover opfylde følgende kriterier:
English: You may feel pain on the right side of your belly or the upper area of the belly, right below the ribs.
Danish: Du kan have smerter i højre side af maven eller i det øverste område af maven, lige under ribbenene.
English: In principle, general dose recommendations also apply to patients aged 65 years and above.
Danish: I princippet gælder de generelle dosisanbefalinger også for patienter på 65 år og derover.
English: The tablets are packed in PCTFE/PVC/Al-blisters.
Danish: Tabletterne er pakket i PCTFE/PVC/Al-blister.
English: Take special care if you are 65 years of age or older, as there is a higher risk that you may have certain side effects (see section 4).
Danish: Vær særlig forsigtig, hvis du er 65 år eller derover, da der er øget risiko for, at du får bestemte bivirkninger (se afsnit 4).
English: • Alcoholism, alcohol abuse, alcohol addiction or chronic or acute excessive alcohol use.
Danish: • Alkoholisme, alkoholmisbrug, alkoholafhængighed eller kronisk eller akut overforbrug af alkohol.
English: Truberzi should not be given to children and adolescents less than 18 years old as there is no information about its use in this age group.
Danish: Truberzi må ikke gives til børn og unge under 18 år, da der ikke findes information om anvendelse af lægemidlet til denne aldersgruppe.
English: Serious allergic reactions have happened in some people after taking 1 or 2 doses of Truberzi.
Danish: Alvorlige allergiske reaktioner er forekommet hos nogle mennesker, efter de havde taget 1 eller 2 doser Truberzi.
English: If you are pregnant or breast-feeding or you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Do not drive or use machines while taking this medicine until you know how it affects you.
Danish: Lad være med at køre bil eller betjene maskiner, mens du tager dette lægemiddel, før du ved, hvordan det påvirker dig.
English: IBS is a common gut disorder.
Danish: IBS er en almindelig tarmlidelse.
English: In the event of acute overdose, the patient should be carefully observed and given standard supportive treatment as required.
Danish: I tilfælde af en akut overdosis skal patienten observeres nøje og have understøttende standardbehandling efter behov.
English: The pain may feel like it is moving through to your back or shoulder;
Danish: Det kan føles, som om smerterne breder sig til ryggen eller skulderen/skuldrene
English: Benefits and risks of the treatment should be periodically assessed in the context of patient symptoms severity.
Danish: Fordele og risici ved behandlingen skal vurderes jævnligt og ses i sammenhæng med sværhedsgraden af patientens symptomer.
English: Results for endpoints were based on electronic daily diary entries by patients.
Danish: Endepunkternes udfald var baseret på patienternes daglige registreringer i elektroniske dagbøger.
English: Do not stop taking Truberzi without first talking to your doctor as your symptoms may worsen.
Danish: Du må ikke holde op med at tage Truberzi uden først at tale med din læge om det, da dine symptomer kan forværres.
English: The safety and efficacy of eluxadoline in children aged 0 to18 years have not yet been established.
Danish: Eluxadolins sikkerhed og virkning hos børn i alderen 0 til 18 år er endnu ikke klarlagt.
English: Pharmacotherapeutic group: antipropulsives, ATC code: A07DA06 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Antipropulsiva, ATC-kode: A07DA06
English: • pain may begin soon after you start Truberzi.
Danish: • Smerterne kan komme hurtigt efter, at du er begyndt at tage Truberzi.
English: The efficacy results for ≥50% of responder days (primary composite endpoint) over 6 months are shown in Table 2.
Danish: Effektresultaterne for ≥ 50 % af respondentdagene (primære sammensatte endepunkt) i 6 måneder vises i tabel 2.
English: Table 2: Efficacy Results in Randomized Clinical Studies Study 1 (IBS 3001)
Danish: Tabel 2: Effektresultater i randomiserede kliniske studier Studie 1 (IBS 3001)
English: Responder rates P values
Danish: Respondentrater P-værdier
English: It is unlikely that Truberzi will affect your ability to drive or use tools or machines.
Danish: Det er ikke sandsynligt, at Truberzi vil påvirke din evne til at køre bil eller bruge værktøj eller maskiner.
English: Patients should be instructed if they miss a dose (delay of 4 hours) to take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose.
Danish: Patienterne skal informeres om, hvis de glemmer en dosis (mere end 4 timer efter det normale indtagelsestidspunkt), skal de tage den næste dosis på det sædvanlige tidspunkt og ikke tage to doser samtidigt som erstatning for den glemte dosis.
English: • Hepatic impairment (Child-Pugh Class A-C).
Danish: • Nedsat leverfunktion (Child-Pugh-klasse A-C).
English: Warner Chilcott Deutschland GmbH Dr.-Otto-Roehm-Strasse 2-4, 64331 Weiterstadt, Germany
Danish: Warner Chilcott Deutschland GmbH Dr.-Otto-Roehm-Strasse 2-4, 64331 Weiterstadt, Tyskland
English: Mean plasma elimination half-life is 5 hours with high inter-subject variability.
Danish: Den gennemsnitlige plasmahalveringstid er 5 timer med stor inter-individuel variation.
English: Global Symptom Response
Danish: Respons, globale symptomer
English: Other side effects can include
Danish: Andre bivirkninger kan omfatte
English: However, such an increase is unlikely to be of clinical significance (see section 5.2).
Danish: Det er dog ikke sandsynligt, at en sådan forhøjelse vil være af klinisk betydning (se pkt.
English: Drug dependence and potential for abuse
Danish: Medicinafhængighed og misbrugspotentiale
English: Severe constipation that can lead to hospitalization has happened after taking Truberzi.
Danish: Svær forstoppelse, som kan medføre hospitalsindlæggelse, er forekommet efter indtagelse af Truberzi.
English: • an average of worst abdominal pain (WAP) scores in the past 24 hours of >3.0 on a 0 to 10 scale over the week prior to randomization.
Danish: • En gennemsnitsscore for ‘Worst Abdominal Pain' (WAP) i de forudgående 24 timer på > 3,0 på en skala fra 0 til 10 i ugen inden randomisering.
English: Please report to your doctor: - how much alcohol you drink (e.g. daily number of drinks); - if you experience any effects, such as dizziness and sleepiness.
Danish: Fortæl din læge: - hvor meget alkohol, du drikker (fx antal genstande om dagen); - hvis du får bivirkninger såsom svimmelhed og søvnighed.
English: All patients should be instructed not to use alcohol while on treatment with eluxadoline.
Danish: Alle patienter skal instrueres i ikke at indtage alkohol under behandling med eluxadolin.
English: • an average global symptom score >2.0 on a 0-4 scale (0 corresponds to no symptoms, 1 corresponds to mild symptoms, 2 corresponds to moderate symptoms, 3 corresponds to severe symptoms and 4 corresponds to very severe symptoms) over the week prior to randomization
Danish: • En gennemsnitsscore for globale symptomer på > 2,0 på en skala fra 0 til 4 (0 står for ingen symptomer, 1 står for lette symptomer, 2 står for moderate symptomer, 3 står for kraftige symptomer, og 4 står for meget kraftige symptomer) i ugen inden randomisering.
English: The occurrence of such events in patients with an intact biliary tract cannot be excluded.
Danish: Forekomst af sådanne bivirkninger hos patienter med intakte galdeveje kan ikke udelukkes.
English: Medicinal products that cause constipation
Danish: Lægemidler, der forårsager obstipation
English: The absolute bioavailability of eluxadoline has not been determined but is estimated to be low due to limited absorption and first pass effects.
Danish: Eluxadolins absolutte biotilgængelighed er ikke fastlagt, men skønnes at være lav på grund af den begrænsede absorption og first pass-effekten.
English: PCTFE/PVC/Al-blister containing 14 film-coated tablets.
Danish: PCTFE/PVC/Al-blister med 14 filmovertrukne tabletter.
English: Eluxadoline This medicine is subject to additional monitoring.
Danish: Eluxadolin Dette lægemiddel er underlagt supplerende overvågning.
English: Gastric lavage or charcoal administration should be considered.
Danish: Gastrisk lavage eller indgift af kul bør overvejes.
English: The treatment should be initiated and supervised by a physician experienced in diagnosis and management of gastrointestinal disorders.
Danish: Behandlingen skal initieres og overvåges af en læge med erfaring i diagnostik og behandling af mavetarm-sygdomme.
English: Assessment of drug interactions
Danish: Undersøgelse af lægemiddelinteraktioner
English: BSS <5 Response
Danish: Respons, BSS på < 5
English: Abdominal distention Gastroesophageal reflux disease4
Danish: Abdominal distention Gastroøsofageal refluks4
English: However, you may experience side effects such as sleepiness or dizziness while taking Truberzi which might affect your ability to drive or use machines.
Danish: Du vil dog kunne få bivirkninger såsom søvnighed eller svimmelhed, mens du tager Truberzi, og det kan påvirke din evne til at køre bil eller betjene maskiner.
English: Avoid frequent use of loperamide (a medicine used to treat diarrhoea) if you are taking Truberzi as this may increase the risk of constipation.
Danish: Undgå hyppig anvendelse af loperamid (et lægemiddel til behandling af diaré), hvis du tager Truberzi, da det kan øge risikoen for forstoppelse.
English: Based on the physical-chemical and biopharmaceutical properties (very low oral bioavailability), eluxadoline is expected to have minimal abuse or dependence liability.
Danish: På baggrund af de fysisk-kemiske og biofarmaceutiske egenskaber (meget lav oral biotilgængelighed) forventes eluxadolin at have minimal tendens til at medføre misbrug eller afhængighed.
English: The tablets should be taken orally with food in the morning and in the evening.
Danish: Tabletterne skal tages oralt (gennem munden) morgen og aften sammen med mad.
English: The active substance has linear pharmacokinetics with no accumulation upon repeated twice daily dosing.
Danish: Det aktive stof har lineær farmakokinetik uden akkumulering efter gentagen dosering to gange dagligt.
English: Unchanged eluxadoline recovered in urine was 0.01% and 0.05% of dose in ESRD and healthy participants, respectively.
Danish: Mængden af uforandret eluxadolin, der blev genfundet i urinen, var 0,01 % og 0,05 % af dosis hos henholdsvis deltagere med ESRD og raske deltagere.
English: Truberzi is a medicine that contains the active substance eluxadoline.
Danish: Truberzi er et lægemiddel, der indeholder det aktive stof eluxadolin.
English: Talk to your doctor or pharmacist if you are unsure if any of the above apply to you.
Danish: Tal med lægen eller apotekspersonalet, hvis du er usikker på, om noget af ovenstående gælder for dig.
English: Following a 1,000 mg oral dose in healthy male volunteers, M11 was detected in urine but not in systemic circulation.
Danish: Efter en oral dosis på 1.000 mg til raske frivillige mænd blev M11 påvist i urin, men ikke i det systemiske kredsløb.
English: A relevant proportion of patients diagnosed with IBS-D may be affected by bile-acid malabsorption as a potential reason for IBS-D symptoms.
Danish: En betydelig andel af patienter med diagnosen IBS-D kan være påvirket af galdesyremalabsorption som en mulig årsag til IBS-D-symptomerne.
English: It is unknown whether eluxadoline is excreted in human milk.
Danish: Det er ukendt, om eluxadolin udskilles i human mælk.
English: All events resolved upon discontinuation of Truberzi, with symptoms typically improved by the following day.
Danish: Alle tilfælde forsvandt efter seponering af Truberzi, og symptomerne var typisk bedret den efterfølgende dag.
English: The efficacy and safety of eluxadoline in IBS-D patients was established in two randomized, multicenter, multi-national, double-blind, placebo-controlled studies (Studies 1 & 2).
Danish: Eluxadolins virkning og sikkerhed hos IBS-D-patienter blev fastlagt i to randomiserede, multinationale, dobbeltblinde, placebokontrollerede multicenterstudier (studie 1 og 2).
English: There is limited amount of data from the use of eluxadoline in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af eluxadolin til gravide kvinder.
English: There was an overall increased frequency of adverse events in the older population compared to patients <65 years which was comparable across all treatment groups, including placebo.
Danish: Generelt var der en øget hyppighed af bivirkninger i den ældre population sammenlignet med patienter < 65 år, hvilket var konsistent på tværs af alle behandlingsgrupper, herunder placebogruppen.
English: Risk of constipation with eluxadoline in patients with other IBS sub-types is unknown, but may be increased.
Danish: Risikoen for obstipation ved eluxadolin hos patienter med andre IBS-undertyper er ukendt, men kan være øget.
English: Truberzi is contraindicated in patients without a gallbladder.
Danish: Truberzi er kontraindiceret hos patienter uden galdeblære.
English: Eluxadoline exists predominantly as the (S,S)-diastereomer (>99%) and undergoes little or no chiral conversion in vivo.
Danish: Eluxadolin findes fortrinsvis som (S,S)-diastereomeren (> 99 %) og gennemgår kun ringe eller slet ingen chiral omdannelse in vivo.
English: Approximately 50% of constipation events occurred within the first 2 weeks of treatment.
Danish: Cirka 50 % af tilfældene af obstipation opstod inden for de første 2 behandlingsuger.
English: The effect on other statins which are more sensitive OATP1B1 substrates (e.g. simvastatin and atorvastatin), however, may be more pronounced.
Danish: Virkningen på andre statiner, der er mere følsomme OATP1B1-substrater (fx simvastatin og atorvastatin) kan imidlertid være mere udtalt.
English: An overdose of eluxadoline may result in symptoms resulting from an exaggeration of the known pharmacodynamic effects of the medicinal product.
Danish: En overdosis af eluxadolin kan give symptomer, der skyldes, at lægemidlets kendte farmakodynamiske virkninger øges.
English: Serious cases resulting in hospitalization and death, primarily in patients without a gallbladder have been reported.
Danish: Der er blevet indberettet alvorlige tilfælde, der resulterede i hospitalsindlæggelse og død, især hos patienter uden galdeblære.
English: 80% (8/10) of sphincter of Oddi spasm events presented within the first week of treatment.
Danish: 80 % (8/10) af tilfældene af spasmer i sphincter Oddi forekom inden for den første behandlingsuge.
English: Do not use this medicine after the expiry date which is stated on blister and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteret og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The use of eluxadoline with other medicinal products that may cause constipation (for example anticholinergics, opioids etc) should also be avoided.
Danish: Anvendelse af eluxadolin sammen med andre lægemidler, der kan forårsage obstipation (for eksempel antikolinergika, opioider osv.), skal også undgås.
English: The safety and efficacy of eluxadoline in this subgroup of IBS-D patients has not been established.
Danish: Eluxadolins sikkerhed og virkning i denne undergruppe af IBS-D-patienter er ikke klarlagt.
English: Eluxadoline also reverses hyperalgesic responses in an animal model of acute colitis-induced visceral pain.
Danish: Eluxadolin reverserer desuden det hyperalgesiske respons i en dyremodel af akutte colitis-inducerede viscerale smerter.
English: Study1 (IBS-3001) continued double-blinded for an additional 26 weeks for long-term safety (total of 52 weeks of treatment), followed by a 2-week follow-up.
Danish: Studie 1 (IBS-3001) fortsatte dobbeltblindet i yderligere 26 uger for at undersøge den langsigtede sikkerhed (i alt 52 ugers behandling) efterfulgt af 2 ugers opfølgning.
English: The administration of eluxadoline with a high fat meal significantly decreased both Cmax (50%) and AUC (60%) without any effect on Tmax.
Danish: Indgift af eluxadolin i forbindelse med et fedtholdigt måltid reducerede både Cmax (50 %) og AUC (60 %) signifikant uden nogen virkning på Tmax.
English: Therefore, the 75 mg dose twice daily can be considered for this population, but its benefit risk ratio should be periodically assessed in the context of their symptoms severity (see section 4.2).
Danish: En dosis på 75 mg to gange dagligt kan derfor overvejes til denne population, men benefit-risk-forholdet skal vurderes jævnligt og ses i sammenhæng med sværhedsgraden af patientens symptomer (se pkt.
English: These patients may be at risk for severe complications of bowel obstruction.
Danish: Disse patienter kan have risiko for alvorlige komplikationer af tarmobstruktion.
English: In rat, eluxadoline was excreted into milk in an approximately dose proportional manner with maximal concentrations less than plasma concentrations.
Danish: Hos rotter blev eluxadolin udskilt i mælk på en tilnærmelsesvis dosisproportionel måde med en maksimal koncentration, der var lavere end plasmakoncentrationen.
English: Treatment with eluxadoline also resulted in significant improvements in patients whose IBS-D symptoms were not adequately controlled with use of loperamide prior to enrolment.
Danish: Behandling med eluxadolin medførte desuden signifikante forbedringer hos de patienter, hvis IBS-Dsymptomer ikke blev kontrolleret i tilstrækkelig grad af loperamid inden inklusion i studiet.
English: Following a single oral dose of 300 mg [14C] eluxadoline in healthy male subjects, 82.2% of the total [14C] eluxadoline was recovered in faeces in 336 hours and less than 1% was recovered in urine in 192 hours.
Danish: Efter en enkelt oral dosis på 300 mg [14C] eluxadolin til raske mænd blev 82,2 % af det samlede [14C] eluxadolin påvist i fæces inden for 336 timer, og mindre end 1 % blev påvist i urin inden for 192 timer.
English: A total of 1,282 patients in Study 1 (IBS-3001) and 1,146 patients in Study 2 (IBS-3002) were enrolled and received treatment with Truberzi 75 mg, Truberzi 100 mg or placebo twice daily.
Danish: Der deltog i alt 1.282 patienter i studie 1 (IBS-3001) og 1.146 patienter i studie 2 (IBS-3002), som fik Truberzi 75 mg, Truberzi 100 mg eller placebo to gange dagligt.
English: Your doctor may prescribe you a lower dose of one 75 mg tablet twice a day if you: - are 65 years of age or older; - are unable to tolerate the 100 mg dose;
Danish: Din læge vil muligvis ordinere en lavere dosis på én 75 mg tablet to gange dagligt, hvis du: - er 65 år eller derover - ikke kan tåle dosen på 100 mg
English: The European Medicines Agency has deferred the obligation to submit the results of clinical studies with Truberzi in one or more subsets of the paediatric population in IBS-D (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Truberzi i en eller flere undergrupper af den pædiatriske population med IBS-D (se pkt.
English: For the daily composite response, eluxadoline began to separate from placebo shortly after initiating treatment with a maximal effect seen at 4-6 weeks that was maintained throughout the course of treatment.
Danish: Hvad angår det daglige kombinerede respons begyndte eluxadolin at adskille sig fra placebo kort tid efter behandlingsstart, og der blev observeret en maksimal virkning efter 4-6 uger, som blev opretholdt under hele behandlingsforløbet.
English: Pharmacokinetic data for healthy volunteers pooled across Phase 1 studies (using the 100 mg single oral dose) and analyzed for potential differences based on sex, age, race, and BMI demonstrated no significant differences.
Danish: Farmakokinetiske data fra raske frivillige, der blev puljet på tværs af fase 1-studier (med anvendelse af en enkelt oral dosis på 100 mg) og analyseret for potentielle forskelle baseret på køn, alder, etnicitet og BMI, viste ingen signifikante forskelle.
English: Improvements in global symptoms of IBS were assessed based on an adequate relief response endpoint defined as achieving adequate relief of IBS symptoms on at least 50% of weeks and on a global symptom response endpoint defined by a daily rating of global symptoms of none or mild on at least 50% of days.
Danish: Forbedringer i globale symptomer på IBS blev vurderet på baggrund af et responsendepunkt for tilstrækkelig lindring, defineret som tilstrækkelig lindring af IBS-symptomer mindst 50 % af ugerne, og et responsendepunkt for globale symptomer, defineret som en daglig klassificering af globale symptomer som ingen eller lette mindst 50 % af dagene.
English: What you need to know before you take Truberzi 3.
Danish: Det skal du vide, før du begynder at tage Truberzi 3.
English: Although no direct drug-drug interactions have been demonstrated, chronic use of loperamide with eluxadoline should be avoided as this may increase the risk of constipation.
Danish: Selvom der ikke er påvist direkte interaktioner med andre lægemidler, skal kronisk anvendelse af loperamid sammen med eluxadolin undgås, da det kan øge risikoen for obstipation.