FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of the study showed no difference in efficacy between Resolor and placebo with response rates of 17% and 17.8% respectively (P=0.9002).
Danish: Resultaterne af studiet viste ingen forskel i effekten mellem Resolor og placebo med responsrater på henholdsvis 17 % og 17,8 % (p= 0,9002).
English: Paediatric population: Resolor should not be used in children and adolescents younger than 18 years (see section 5.1).
Danish: Pædiatrisk population: Resolor bør ikke anvendes til børn og unge under 18 år (se pkt.
English: Resolor is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Resolor anbefales ikke under graviditet eller til kvinder i den fødedygtige alder, der ikke anvender kontraception.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (including pregnancy, embryonal/foetal development, parturition or postnatal development) (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår forplantningstoksicitet (herunder graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling) (se pkt.
English: Prucalopride is a selective, high affinity serotonin (5-HT4) receptor agonist, which is likely to explain its prokinetic effects.
Danish: Prucaloprid er en selektiv, højaffinitets-serotonin (5-HT4)-receptoragonist, hvilket sandsynligvis forklarer stoffets prokinetiske virkning.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: In double-blind clinical studies, the incidence of QT-related adverse events and ventricular arrhythmias was low and comparable to placebo.
Danish: I dobbeltblindede kliniske studier var incidensen af QT-relaterede bivirkninger og ventrikulære arytmier lav og sammenlignelig med placebo.
English: What you need to know before you take Resolor
Danish: Det skal du vide, før du begynder at tage Resolor
English: Due to the specific mode of action of prucalopride (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy.
Danish: På grund af prucaloprids specifikke virkningsmekanisme (stimulering af den fremaddrivende motilitet) forventes en større daglig dosis end 2 mg ikke at øge virkningen.
English: Concomitant intake of food does not influence the oral bioavailability of prucalopride.
Danish: Samtidig indtagelse af føde påvirker ikke prucaloprids orale biotilgængelighed.
English: See the instructions in the patient leaflet of the contraceptive pill you are taking.
Danish: Se oplysningerne i indlægssedlen for den p-pille, som du bruger.
English: However, sometimes Resolor may cause dizziness and tiredness, especially on the first day of treatment, and this may have an effect on driving and use of machines.
Danish: Resolor kan dog forårsage svimmelhed og træthed, især på den første dag af behandlingen, og dette kan påvirke trafik- og arbejdssikkerheden.
English: - Renal impairment requiring dialysis.
Danish: - Nedsat nyrefunktion, der kræver dialyse.
English: If you have taken more Resolor than you should, it is possible that you will get diarrhoea, headache and/or nausea.
Danish: Hvis du har taget for mange Resolor-tabletter, er det muligt, at du får diarré, hovedpine og/eller kvalme.
English: In case of prolonged treatment, the benefit should be reassessed at regular intervals.
Danish: Ved længerevarende behandling bør fordelen vurderes regelmæssigt.
English: Caution should be exercised when prescribing Resolor to patients with severe hepatic impairment (Child-Pugh class C) due to limited data in patients with severe hepatic impairment (see section 4.2).
Danish: Der bør udvises forsigtighed, når Resolor ordineres til patienter med svært nedsat leverfunktion (Child-Pugh klasse C) på grund af begrænsede data hos patienter med svært nedsat leverfunktion (se pkt.
English: If you forget to take Resolor Do not take a double dose to make up for a forgotten tablet.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: An overdose may result in symptoms resulting from an exaggeration of prucalopride's known pharmacodynamic effects and include headache, nausea and diarrhoea.
Danish: Overdosering kan medføre symptomer, der opstår ved en forstærkelse af prucaloprids kendte farmakodynamiske virkning, og som omfatter hovedpine, kvalme og diarré.
English: Therapeutic doses of probenecid, cimetidine, erythromycin and paroxetine did not affect the pharmacokinetics of prucalopride.
Danish: Terapeutiske doser af probenecid, cimetidin, erytromycin og paroxetin påvirkede ikke prucaloprids farmakokinetik.
English: Resolor contains the active substance prucalopride.
Danish: Resolor indeholder det aktive stof prucaloprid.
English: In vitro, human liver metabolism is very slow and only minor amounts of metabolites are found.
Danish: In vitro-studier har vist, at den humane levermetabolisme er meget langsom, og der findes kun små mængder metabolitter.
English: Each pack contains 7 x 1, 14 x 1, 28 x 1 or 84 x 1 film-coated tablet.
Danish: Hver pakning indeholder 7 x 1, 14 x 1, 28 x 1 eller 84 x 1 filmovertrukne tabletter.
English: In an oral dose study with radiolabelled prucalopride in man, small amounts of seven metabolites were recovered in urine and faeces.
Danish: I en undersøgelse med oral dosering af radioaktivt mærket prucaloprid hos mennesker blev der fundet små mængder af syv metabolitter i urin og fæces.
English: In an integrated analysis of 17 double-blind placebo-controlled studies, Resolor was given orally to approximately 3,300 patients with chronic constipation.
Danish: I en samlet analyse af 17 dobbeltblindede, placebokontrollede studier blev Resolor anvendt oralt hos ca. 3.300 patienter med kronisk obstipation.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på blisterkortet og æsken efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Prucalopride had no clinically relevant effects on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine or oral contraceptives.
Danish: Prucaloprid havde ingen klinisk relevant virkning på farmakokinetikken af warfarin, digoxin, alkohol, paroxetin eller orale kontraceptiva.
English: This study did not show significant differences between Resolor and placebo at either dose, based on mean QT measurements and outlier analysis.
Danish: Undersøgelsen viste ingen signifikante forskelle mellem Resolor og placebo for nogen af doserne på grundlag af gennemsnitlige QT-målinger og analyse af afvigende værdier.
English: Other metabolites identified and quantified in urine and faeces were R084536 (formed by N-dealkylation) accounting for 3% of the dose and products of hydroxylation (3% of the dose) and N-oxidation (2% of the dose).
Danish: Andre metabolitter, der blev identificeret og kvantificeret i urin og fæces, var R084536 (dannet ved N-dealkylering), der tegnede sig for 3 % af dosen, og hydroxylerings- (3 % af dosen) og N-oxidationsprodukter (2 % af dosen).
English: Resolor is not recommended for use during pregnancy.
Danish: Resolor bør ikke anvendes under graviditet.
English: Prucalopride did not inhibit specific CYP450 activities in in vitro studies in human liver microsomes at therapeutically relevant concentrations.
Danish: Prucaloprid hæmmede ikke specifikke CYP-aktiviteter i in vitro-studier med humane levermikrosomer ved terapeutisk relevante koncentrationer.
English: Take special care with Resolor and tell your doctor if you: - suffer from severe kidney disease, - suffer from severe liver disease, - are currently under supervision by a doctor for a serious medical problem such as lung or heart disease, nervous system or mental health problems, cancer, AIDS or a hormonal disorder.
Danish: Vær ekstra forsigtig med at bruge Resolor og fortæl det til lægen: - hvis du lider af svær nyresygdom - hvis du lider af svær leversygdom - hvis du i øjeblikket går til kontrol hos en læge på grund af en alvorlig sygdom såsom lunge eller hjertesygdom, problemer med nervesystemet eller psykiske problemer, kræft, aids eller hormonforstyrrelser.
English: If you have very bad diarrhoea, the contraceptive pill may not work properly and the use of an extra method of contraception is recommended.
Danish: Hvis du lider af meget slem diarré, virker dine p-piller muligvis ikke korrekt, og du anbefales derfor at bruge et ekstra præventionsmiddel.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Effects of other medicinal products on pharmacokinetics of prucalopride Ketoconazole (200 mg twice daily), a potent inhibitor of CYP3A4 and of P-gp, increased the systemic exposure to prucalopride by approximately 40%.
Danish: Andre lægemidlers virkning på prucaloprids farmakokinetik Ketoconazol (200 mg to gange dagligt), der er en potent hæmmer af CYP3A4 og P-gp, øgede den systemiske eksponering for prucaloprid med cirka 40 %.
English: The AUC0-24h exposure ratios at the NOAEL versus human children (dosed at approximately 0.04 mg/kg daily) ranged between 21 and 71 providing adequate safety margins for the clinical dose.
Danish: AUC0-24h eksponeringsratioerne ved NOAEL vs. menneskebørn (behandlet med cirka 0,04 mg/kg dagligt) var mellem 21 og 71, hvilket giver en tilstrækkelig sikkerhedsmargen for den kliniske dosis.
English: Frequencies are calculated based on the integrated analysis of 17 double-blind placebo-controlled clinical studies.
Danish: Hyppighederne er baseret på den samlede analyse af 17 dobbeltblindede, placebokontrollerede kliniske studier.
English: Store in the original blister package in order to protect from moisture.
Danish: Opbevares i det originale blisterpakning for at beskytte mod fugt.
English: Resolor is used for the treatment of chronic constipation in adults in whom laxatives do not work well enough.
Danish: Resolor anvendes til behandling af kronisk forstoppelse hos voksne, hvor afføringsmidler ikke virker godt nok.
English: The efficacy of prucalopride has been established in double-blind, placebo-controlled studies for up to 3 months.
Danish: Prucaloprids virkning er blevet klarlagt i dobbeltblindede, placebokontrollerede studier af en varighed på op til 3 måneder.
English: The safety profile of Resolor was consistent with that seen in female patients.
Danish: Resolors sikkerhedsprofil var den samme som hos kvindelige patienter.
English: 7 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 84 x 1 film-coated tablets
Danish: 7 x 1 filmovertrukne tabletter 14 x 1 filmovertrukne tabletter 28 x 1 filmovertrukne tabletter 84 x 1 filmovertrukne tabletter
English: This confirmed the results of two placebo controlled QT studies.
Danish: Resultaterne af to placebokontrollerede QT-studier blev dermed bekræftet.
English: Marketing authorisation holder Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 - 58 Baggot Street Lower Dublin 2
Danish: Indehaver af markedsføringstilladelsen Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza 50 - 58 Baggot Street Lower Dublin 2
English: Breast-feeding is not recommended during treatment with Resolor.
Danish: Amning anbefales ikke under behandling med Resolor.
English: TQT study
Danish: Grundigt QT-studie
English: A large fraction of the active substance is excreted unchanged (60-65% of the administered dose in urine and about 5% in faeces).
Danish: En stor del af det aktive stof udskilles uomdannet (60-65 % af den indgivne dosis i urin og cirka 5 % i fæces).
English: There is limited information on the safety and efficacy of Resolor for use in patients with severe and clinically unstable concomitant disease (e.g. cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders).
Danish: Der er begrænsede oplysninger om Resolors sikkerhed og virkning hos patienter med svær og klinisk ustabil sygdom (f.eks. hjerte-kar- eller lungesygdom, neurologiske eller psykiatriske lidelser, kræft eller aids og endokrine sygdomme).
English: In dogs, the effects observed in the gastrointestinal tract are sensitive to blockade with selective 5-HT4 receptor antagonists illustrating that the observed effects are exerted via selective action on 5-HT4 receptors.
Danish: I hunde var de observerede virkninger i mave-tarm-kanalen følsomme over for blokade med selektive 5-HT4-receptorantagonister, hvilket viser, at de observerede virkninger sker via selektiv virkning på 5-HT4-receptorerne.
English: The starting dose administered was 0.04 mg/kg/day titrated between 0.02 and 0.06 mg/kg/day (to a maximum of 2 mg daily) for children weighing ≤50 kg given as an oral solution of Resolor or matching placebo.
Danish: Den administrerede startdosis var 0,04 mg/kg/dag, der blev titreret til mellem 0,02 og 0,06 mg/kg/dag (til maksimalt 2 mg dagligt), til børn med en vægt på ≤ 50 kg og blev givet som en oral opløsning af Resolor eller tilsvarende placebo.
English: Response to the treatment was defined as having an average of ≥3 spontaneous bowel movements (SBMs) per week and an average number of faecal incontinence episodes of ≤1 per 2 weeks.
Danish: Behandlingsrespons blev defineret som gennemsnitligt ≥ 3 spontane afføringer (SBM) om ugen og et gennemsnitligt antal episoder med fækal inkontinens på ≤ 1 pr. 2 uger.
English: Resolor belongs to a group of gut motility enhancing medicines (gastrointestinal prokinetics).
Danish: Resolor tilhører en gruppe lægemidler, der øger tarmbevægelserne (gastrointestinale prokinetika).
English: The following adverse reactions were reported in controlled clinical studies at the recommended dose of 2 mg with frequencies corresponding to 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) and not known (cannot be estimated from the available data).
Danish: Følgende bivirkninger blev rapporteret i kontrollerede kliniske studier ved den anbefalede dosis på 2 mg med hyppigheder, som er defineret på følgende måde: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Lactose monohydrate (see section 2), microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, triacetin, titanium dioxide (E171), macrogol.
Danish: Lactosemonohydrat (se afsnit 2), mikrokrystallinsk cellulose, kolloid silica, magnesiumstearat, hypromellose, triacetin, titaniumdioxid (E 171) og macrogol.
English: Effects of prucalopride on pharmacokinetics of other medicinal products A 30% increase in plasma concentrations of erythromycin was found during prucalopride co-administration.
Danish: Prucaloprids virkning på andre lægemidlers farmakokinetik Der blev fundet en 30 % forøgelse af plasmakoncentrationen af erythromycin ved samtidig administration med prucaloprid.
English: The side effects mostly occur at the start of treatment and usually disappear within a few days with continued treatment.
Danish: Bivirkningerne optræder især i starten af behandlingen og forsvinder typisk inden for nogle få dage ved fortsat behandling.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere information om Resolor på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: Resolor contains lactose
Danish: Resolor indeholder lactose
English: Children weighing >50 kg received 2 mg/day Resolor tablets or matching placebo.
Danish: Børn med en vægt på > 50 kg fik Resolor-tabletter 2 mg/dag eller tilsvarende placebo.
English: Women of childbearing potential have to use effective contraception during treatment with prucalopride
Danish: Kvinder i den fertile alder Kvinder i den fertile alder skal anvende sikker kontraception under behandlingen med prucaloprid.
English: The effect of Resolor on spontaneous bowel movements (SBM) also proved to be statistically superior to placebo for the portion of patients that had an increase of ≥1 SBM/week over the 12-week treatment period.
Danish: Det blev vist, at Resolors virkning på spontane afføringer (spontaneous bowel movements, SBM) også var statistisk superior i forhold til placebo hos den andel af patienterne, der havde en stigning på ≥1 SBM/uge over den 12-ugers behandlingsperiode.
English: In a small pharmacokinetic study, the Cmax and AUC of prucalopride were, on average, 10-20% higher in patients with moderate to severe hepatic impairment compared with healthy subjects (see sections 4.2 and 4.4).
Danish: I et lille farmakokinetisk studie var Cmax og AUC for prucaloprid i gennemsnit 10-20 % højere hos patienter med moderat til svært nedsat leverfunktion sammenlignet med raske personer (se pkt.
English: How to take Resolor
Danish: Sådan skal du tage Resolor
English: Compared with a constipation treatment working through osmotic action, prokinetic stimulation with prucalopride increased colonic motility as measured by the number of HAPCs during the first 12 hours after intake of the investigational product.
Danish: Sammenlignet med behandling med osmotisk virkende laksantia øgede prokinetisk stimulation med prucaloprid tarmmotiliteten målt ved antallet af HAPC'er i de første 12 timer efter indtagelse af studielægemidlet.
English: Efficacy beyond three months has not been demonstrated in placebo-controlled studies (see Section 5.1).
Danish: Effekt ud over tre måneder er ikke blevet påvist i placebokontrollerede studier (se pkt.
English: The quantitatively most important metabolite in excreta, R107504, accounted for 3.2% and 3.1% of the dose in urine and faeces, respectively.
Danish: Den kvantitativt vigtigste metabolit i ekskreterne, R107504, tegnede sig for 3,2 % og 3,1 % af dosen i henholdsvis urin og fæces.
English: Resolor may have a minor influence on the ability to drive and use machines, since dizziness and fatigue have been observed in clinical studies, particularly during the first day of treatment (see section 4.8).
Danish: Resolor kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner da der i kliniske studier er observeret svimmelhed og udmattelse, især på den første behandlingsdag (se pkt.
English: A human study has shown that prucalopride is excreted in breast milk.
Danish: Et humant studie har påvist, at prucaloprid udskilles i mælk.
English: These pharmacodynamic effects of prucalopride have been confirmed in human subjects with chronic constipation using manometry in an open-label, randomised, crossover, reader-blinded study investigating the effect of prucalopride 2 mg and an osmotic laxative on colon motility as determined by the number of colonic high-amplitude propagating contractions (HAPCs, also known as giant migrating contractions).
Danish: Disse farmakodynamiske virkninger af prucaloprid er bekræftet hos patienter med kronisk obstipation ved brug af manometri i et åbent, randomiseret, læserblindet overkrydsningsstudie, hvor man undersøgte effekten af 2 mg prucaloprid og et osmotisk afføringsmiddel på tarmmotiliteten, defineret som antallet af kraftige propagerende kontraktioner i colon (HAPC'er, også kaldet kraftige migrerende kontraktioner).
English: The primary efficacy endpoint was the proportion (%) of subjects that reached normalisation of bowel movements defined as an average of three or more spontaneous, complete bowel movements (SCBM) per week over the 12-week treatment period.
Danish: Det primære effektmål var andelen (%) af studiepersoner, der nåede normalisering af afføringen defineret som gennemsnitligt mindst tre spontane, fuldstændige afføringer (SCBM) pr. uge over den 12-ugers behandlingsperiode.
English: The efficacy of Resolor was established in three multicentre, randomised, double-blind, 12-week placebo-controlled studies in subjects with chronic constipation (n=1,279 on Resolor, 1,124 females, 155 males).
Danish: Resolors virkning blev påvist i tre randomiserede, dobbeltblindede, placebokontrollerede multicenterstudier af 12 ugers varighed hos studiepersoner med kronisk obstipation (n = 1.279 på Resolor; 1.124 kvinder og 155 mænd).
English: The incidence of subjects with at least 1 treatment-emergent adverse event (TEAE) was similar between the Resolor treatment group (69.8%) and the placebo treatment group (60.7%).
Danish: Forekomsten af patienter med mindst 1 bivirkning, der var opstået som følge af behandlingen (treatment-emergent adverse event, TEAE), var ens i Resolor-gruppen (69,8 %) og placebogruppen (60,7 %).
English: Compared to subjects with normal renal function, plasma concentrations of prucalopride after a single 2 mg dose were on average 25% and 51% higher in subjects with mild (ClCR 50-79 ml/min) and moderate (ClCR 25-49 ml/min) renal impairment, respectively.
Danish: Sammenlignet med studiepersoner med normal nyrefunktion var plasmakoncentrationerne af prucaloprid efter en enkelt 2 mg-dosis i gennemsnit henholdsvis 25 % og 51 % højere hos studiepersoner med let nedsat (ClCR 50-79 ml/min) og moderat nedsat (ClCR 25-49 ml/min) nyrefunktion.
English: What Resolor contains
Danish: Resolor indeholder:
English: In dogs, prucalopride alters colonic motility patterns via serotonin 5-HT4 receptor stimulation: it stimulates proximal colonic motility, enhances gastroduodenal motility and accelerates delayed gastric emptying.
Danish: Hos hunde ændrer prucaloprid tarmmotilitetsmønstrene via stimulering af 5-HT4-receptoren: Det stimulerer proksimal tarmmotilitet, forstærker gastroduodenal motilitet og accelererer forsinket gastrisk tømning.
English: - if you are on renal dialysis, - if you suffer from perforation or obstruction of the gut wall, severe inflammation of the intestinal tract, such as Crohn's disease, ulcerative colitis or toxic megacolon/megarectum.
Danish: - hvis du er i dialyse - hvis du lider af perforation eller tillukning af tarmvæggen eller svær betændelse i tarmkanalen såsom Crohns sygdom, ulcerøs colitis (sårdannelse og betændelse i tyktarmen) eller toksisk megakolon/megarektum (kraftig udvidelse af tyktarmen/endetarmen).
English: Patients with renal impairment: The dose for patients with severe renal impairment (GFR <30 ml/min/1.73 m2) is 1 mg once daily (see sections 4.3 and 5.2).
Danish: Patienter med nedsat nyrefunktion: Til patienter med svært nedsat nyrefunktion (GFR < 30 ml/min/1,73 m2) er dosis 1 mg én gang dagligt (se pkt.
English: If you are older than 65 years or have severe liver disease, the starting dose is one 1 mg tablet once a day, which your doctor may increase to 2 mg once a day if needed.
Danish: Hvis du er over 65 år, eller hvis du har en alvorlig leversygdom, er startdosis én 1 mg-tablet én gang dagligt.
English: After the first day of treatment, the most common adverse reactions were reported in similar frequencies (incidence no more than 1% different between prucalopride and placebo) during Resolor therapy as during placebo, with the exception of nausea and diarrhoea that still occurred more frequently during Resolor therapy, but less pronounced (differences in incidence between Resolor and placebo of 1.3% and 3.4%, respectively).
Danish: Efter første behandlingsdag blev de hyppigste bivirkninger rapporteret med samme hyppighed for både Resolor og placebo (højst 1 % forskel mellem prucaloprid og placebo i incidens), bortset fra kvalme og diarré, der stadig optrådte hyppigere under Resolor-behandling, men mindre udtalt (forskellene i incidens mellem Resolor og placebo var på henholdsvis 1,3 % (kvalme) og 3,4 % diarré)).