FrancophonIA/ELRC3.0 huggingface dataset:
English: Take also special care if you have severe or prolonged diarrhoea and an additional disease, such as high blood pressure, previous disease of the heart and blood vessels (e.g. such as previous heart attacks) or diabetes.
Danish: Vær også ekstra forsigtig, hvis du har svær eller langvarig diarré og en yderligere sygdom, såsom højt blodtryk, tidligere hjertekarsygdom (f.eks. såsom tidligere hjertetilfælde) eller diabetes.
English: It is preferable to discuss stopping treatment with your doctor before actually doing so.
Danish: Det er bedst at tale med lægen om at stoppe behandlingen, før du stopper.
English: In those patients in whom diarrhoea led to discontinuation, it resolved after a few days of discontinuing treatment.
Danish: Hos de patienter, hvor diarré førte til seponering, ophørte diarréen nogle få dage efter, at behandlingen var afbrudt.
English: Concomitant treatment with proton pump inhibitors, laxatives or NSAIDs may increase the risk of diarrhoea.
Danish: Samtidig behandling med protonpumpehæmmere, afføringsmidler eller NSAID kan øge risikoen for diarré.
English: • lack of control over passing stools (faecal incontinence)
Danish: • Manglende kontrol over, hvornår du har afføring (fækal inkontinens)
English: Treatment with linaclotide also resulted in significant improvements in validated and disease-specific Quality of Life measure (IBS-QoL; p<0.0001), and EuroQoL (p = 0.001).
Danish: Behandling med linaclotid resulterede også i signifikante forbedringer i valideret og sygdomsspecifikt livskvalitetsmål (IBS-QoL; p<0,0001) og EuroQoL (p=0,001).
English: - Medicines that need careful and exact dosing, such as levothyroxine (a hormone to treat reduced function of the thyroid gland).
Danish: - Lægemidler, som kræver meget nøje og eksakt dosering, såsom lyvothyroxin (et hormon til behandling af nedsat skjoldbruskkirtelfunktion).
English: Effect of linaclotide on IBS-C symptoms during the first 12 weeks of treatment in the pooled phase 3 efficacy clinical studies (studies 1 and 2).
Danish: Virkningen af linaclotid på IBS-C-symptomer i de første 12 ugers behandling i de poolede kliniske fase 3-effektstudier (studie 1 og 2).
English: Linaclotide is a 14-amino acid synthetic peptide structurally related to the endogenous guanylin peptide family.
Danish: Linaclotid er et syntetisk peptid bestående af 14 aminosyrer, der er strukturelt relateret til den endogene guanylin peptidfamilie.
English: 2% of treated patients experienced severe diarrhoea and 5% of patients discontinued treatment due to diarrhoea in clinical studies.
Danish: 2 % af de behandlede patienter havde svær diarré, og 5 % af patienterne i kliniske studier afbrød behandlingen pga. diarré.
English: The European Medicines Agency has deferred the obligation to submit the results of clinical studies with Constella in one or more subsets of the paediatric population in functional constipation (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Constella i en eller flere undergrupper af den pædiatriske population med funktionel forstoppelse (se pkt.
English: It is used to treat the symptoms of moderate to severe irritable bowel syndrome (often just called “IBS”) with constipation in adult patients.
Danish: Det anvendes til at behandle symptomerne på moderat til svær irritabel tyktarm (ofte blot betegnet ”IBS”) med forstoppelse hos voksne patienter.
English: Caution should be exercised when prescribing medicinal products absorbed in the intestinal tract with a narrow therapeutic index such as levothyroxine as their efficacy may be reduced.
Danish: Der bør udvises forsigtighed ved udskrivelse af recepter på lægemidler, som absorberes i tarmen med et snævert behandlingsindeks som f.eks. levothyroxin, da deres virkning kan blive reduceret.
English: Clinical studies to determine the impact of age and gender on the clinical pharmacokinetics of linaclotide have not been conducted because it is rarely detectable in plasma.
Danish: Kliniske studier til at bestemme indvirkningen af alder og køn på linaclotids kliniske farmakokinetik er ikke blevet udført, fordi det kun sjældent kan detekteres i plasma.
English: The potential inhibitory activity of linaclotide and its active primary metabolite MM-419447 on the human efflux transporters BCRP, MRP2, MRP3, and MRP4 and the human uptake transporters OATP1B1, OATP1B3, OATP2B1, PEPT1 and OCTN1 was investigated in vitro.
Danish: Den potentielt hæmmende aktivitet, som linaclotid og dens aktive primære metabolit MM-419447 på de humane effluxtransportører BCRP, MRP2, MRP3 og MRP4 og de humane optagelsestransportører OATP1B1, OATP1B3, OATP2B1, PEPT1 og OCTN1 blev undersøgt in vitro.
English: Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted as required.
Danish: I tilfælde af overdosering skal patienten behandles symptomatisk og understøttende behandling indledes efter behov.
English: The most frequently reported adverse reaction associated with Constella therapy was diarrhoea, mainly mild to moderate in intensity, occurring in less than 20% of patients.
Danish: Den hyppigst rapporterede bivirkning i forbindelse med behandling med Constella var diarré, hovedsagelig af mild til moderat intensitet, som forekom hos mindre end 20 % af patienterne.
English: In general, linaclotide is minimally detectable in plasma following therapeutic oral doses and therefore standard pharmacokinetic parameters cannot be calculated.
Danish: Linaclotid er generelt minimalt detekterbart i plasma efter terapeutisk orale doser, og standard farmakokinetiske parametre kan derfor ikke beregnes.
English: Following single doses of up to 966 micrograms and multiple doses up to 290 micrograms of linaclotide, there were no detectable plasma levels of parent compound or the active metabolite (des-tyrosine).
Danish: Efter enkeltdoser på op til 966 mikrogram og flere doser op til 290 mikrogram linaclotid var der ingen detekterbare plasmaniveauer af modersubstansen eller den aktive metabolit (des-tyrosin).
English: • dehydration
Danish: • Dehydrering
English: In a study in healthy volunteers receiving a single dose of 2,897 micrograms (up to 10-fold the recommended therapeutic dose) the safety profile in these subjects was consistent with that in the overall population, with diarrhoea being the most commonly reported adverse event.
Danish: I et studie med raske frivillige, som modtog en enkelt dosis på 2897 mikrogram (op til 10 gange den anbefalede terapeutiske dosis), var sikkerhedsprofilen hos disse forsøgspersoner i overensstemmelse med profilen i den samlede population, som modtog behandling, idet diarré var den mest almindeligt rapporterede bivirkning.
English: As linaclotide is rarely detectable in plasma following therapeutic doses, standard distribution studies have not been conducted.
Danish: Da linaclotid sjældent detekteres i plasma efter terapeutiske doser, er der ikke udført standard distributionsstudier.
English: Pregnancy and breast-feeding Limited information is available on the effects of Constella in pregnant and breast-feeding women.
Danish: Graviditet og amning Der findes kun begrænset information om Constellas virkning på gravide og ammende kvinder.
English: Other signs and symptoms of IBS-C including bloating, complete spontaneous bowel movement (CSBM) frequency, straining, stool consistency, were improved in linaclotide treated patients vs. placebo (p<0.0001) as shown in the following table.
Danish: Andre tegn og symptomer på IBS-C, inklusiv oppustethed, hyppighed af spontane afføringer med komplet tømning af rectum (CSBM), pressen, afføringens konsistens, blev forbedret hos patienter behandlet med linaclotid vs. placebo (p<0,0001) som vist i følgende tabel.
English: Main secondary efficacy parameters
Danish: Betydningsful de sekundære effektparametre
English: Constella produces more frequent bowel movements and diarrhoea (looser stools) when it is taken with food than when it is taken on an empty stomach (see section 3).
Danish: Constella medfører hyppigere afføring og diarré (løsere afføring), når det tages med mad, end når det tages på tom mave (se punkt 3).
English: All patients met Rome II criteria for IBS-C and were required to report a mean abdominal pain score of ≥ 3 on a 0-to-10-point numeric rating scale (criteria that correspond to a moderate to severe IBS population), < 3 complete spontaneous bowel movements and ≤ 5 SBMs per week during a 2-week baseline period.
Danish: Alle patienter opfyldte Rome II-kriterierne for IBS-C med en middel abdominal smertescore på ≥ 3 på en numerisk 0-10 punktsskala (kriterier, som svarer til en population med moderat til svær grad af IBS), < 3 spontane afføringer med komplet tømning af rectum og ≤ 5 SBM'er om ugen i en 2-ugers baseline-periode.
English: Linaclotide is a Guanylate Cyclase-C receptor agonist (GCCA) with visceral analgesic and secretory activities.
Danish: Linaclotid er en guanylatcyclase-C (GC-C) receptoragonist med viscerale analgetiske og sekretoriske aktiviteter.
English: Diarrhoea is the most common adverse reaction and is consistent with the pharmacological action of the active substance.
Danish: Diarré er den hyppigste bivirkning, og det stemmer overens med det aktive stofs farmakologiske virkning.
English: See the instructions in the patient leaflet of the contraceptive pill you are taking.
Danish: Se indlægssedlen til den p-pille, som du tager.
English: Special populations Patients with renal or hepatic impairment
Danish: Særlige populationer Patienter med nedsat nyre- eller leverfunktion
English: The recommended dose is one capsule (290 micrograms) once daily.
Danish: Den anbefalede dosis er en kapsel (290 mikrogram) en gang dagligt.
English: Extracellular cGMP decreases pain-fiber activity, resulting in reduced visceral pain in animal models.
Danish: Ekstracellulær cGMP sænker smerte-fiber-aktivitet, hvilket resulterer i reduceret visceral smerte i dyremodeller.
English: Results of this study showed that neither peptide is an inhibitor of the common efflux and uptake transporters studied at clinically relevant concentrations.
Danish: Resultater fra dette studie viste, at ingen af peptiderne er en hæmmer af de almindelige efflux- og optagelsestransportører, som er undersøgt ved klinisk relevante koncentrationer.
English: Talk to your doctor if you suffer from inflammatory diseases of the guts such as Crohn's disease or ulcerative colitis as Constella is not recommended in these patients.
Danish: Tal med din læge, hvis du har en betændelsessygdom i tarmen, såsom Crohns sygdom eller ulcerativ colitis, da Constella ikke er anbefalet til disse patienter.
English: Patients should be aware of the possible occurrence of diarrhoea and lower gastrointestinal bleeding during treatment.
Danish: Patienter skal være opmærksomme på mulig forekomst af diarré og blødning i den nedre del af mavetarm-kanalen under behandlingen.
English: Microcrystalline cellulose Hypromellose 4-6 mPa's - substitution type 2910 Calcium chloride dihydrate Leucine
Danish: Mikrokrystallinsk cellulose, Hypromellose 4-6 mPa - substitutionstype 2910 Calciumchloriddihydrat
English: It is expected that linaclotide is negligibly or not systemically distributed.
Danish: Det forventes, at der ikke forekommer nævneværdig eller systemisk distribution af linaclotid.
English: If you are breast-feeding, do not take Constella unless your doctor advises to do so.
Danish: Hvis du ammer, bør du kun tage Constella, hvis din læge råder dig til det.
English: • bleeding from the bowel or rectum including bleeding from piles/haemorrhoids
Danish: • Blødning fra tarmen eller endetarmen, inklusive blødning fra hæmorroider
English: Activation of GC-C results in an increase in concentrations of cyclic guanosine monophosphate (cGMP), both extracellularly and intracellularly.
Danish: Aktivering af GC-C resulterer i en stigning i koncentrationen af cyklisk guanosin monofosfat (cGMP), både ekstracellulært og intracellulært.
English: For elderly patients, although no dose adjustment is required, the treatment should be carefully monitored and periodically re-assessed (see section 4.4).
Danish: Selvom det ikke er nødvendigt at foretage dosisjustering for ældre patienter, skal behandlingen nøje overvåges og regelmæssigt revurderes (se pkt.
English: • infrequent, hard, small or pellet-like stools (faeces).
Danish: • mindre hyppig, hård eller kugleformet afføring (fæces) i små stykker
English: If you stop taking Constella
Danish: Hvis du holder op med at tage Constella
English: The effect of linaclotide and its metabolites to inhibit the common intestinal enzymes (CYP2C9 and CYP3A4) and liver enzymes (CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4) or to induce liver enzymes (CYP1A2, 2B6, and 3A4/5) was investigated in vitro.
Danish: Den virkning, som linaclotid og dets metabolitter foranledigede mht. at hæmme de almindelige tarmenzymer (CYP2C9 og CYP3A4) og leverenzymer (CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4) eller til at inducere leverenzymer (CYP1A2, 2B6, og 3A4/5) blev undersøgt in vitro.
English: Keep the bottle tightly closed in order to protect from moisture.
Danish: Hold beholderen tæt tillukket for at beskytte mod fugt.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Constella 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 eller behandling med Constella skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Results of these studies showed that linaclotide and des-tyrosine metabolite are not inhibitors or inducers of the cytochrome P450 enzyme system.
Danish: Resultaterne af disse studier viste, at linaclotid og des-tyrosin-metabolit ikke er hæmmere eller induktorer af cytokrom P450-enzymsystemet.
English: White to off-white-orange opaque capsule (18 mm x 6.35 mm) marked “290” with grey ink.
Danish: Hvid til off white-orange uigennemsigtig kapsel (18 mm x 6,35 mm) mærket ”290” med gråt blæk.
English: Should prolonged (e.g. more than 1 week) or severe diarrhoea occur, medical advice should be sought and temporary discontinuation of linaclotide until diarrhoea episode is resolved may be considered.
Danish: Hvis der forekommer svær eller langvarig diarré (f.eks. over 1 uge), bør der søges lægehjælp, og det bør overvejes midlertidigt at afbryde behandlingen med linaclotid, indtil problemet med diarré er løst.
English: If you experience severe or prolonged diarrhoea (passing of frequent watery stools for 7 days or more), stop taking Constella and contact your doctor (see section 4).
Danish: Hvis du oplever svær eller langvarig diarré (hyppig vandig afføring i 7 dage eller derover), skal du venligst holde op med at tage Constella og kontakte din læge (se punkt 4).
English: If you forget to take Constella
Danish: Hvis du har glemt at tage Constella
English: Constella contains the active substance linaclotide.
Danish: Constella indeholder det aktive stof linaclotid.
English: What you need to know before you take Constella 3.
Danish: Det skal du vide, før du begynder at tage Constella
English: Constella should be used after organic diseases have been ruled out and a diagnosis of moderate to severe IBS-C (see section 5.1) is established.
Danish: Constella bør kun bruges efter organiske sygdomme er blevet udelukket og en diagnose af moderat til svær IBS-C (se pkt.
English: Both linaclotide and its active metabolite bind to the GC-C receptor, on the luminal surface of the intestinal epithelium.
Danish: Både linaclotid og dets aktive metabolit binder til GC-C-receptoren på den luminale overflade af tarmepitelet.
English: The co-primary endpoints in both clinical studies were 12-week IBS degree of relief responder rate and 12 week abdominal pain/discomfort responder rate.
Danish: De co-primære endepunkter i begge kliniske studier var respondentraten efter 12 uger med hensyn til IBS-lindring og abdominal(t) smerte/ubehag.
English: Constella has no or negligible influence on the ability to drive and use machines.
Danish: Constella påvirker ikke eller kun minimalt evnen til at føre motorkøretøj eller betjene maskiner.
English: The majority of reported cases of diarrhoea were mild (43%) to moderate (47%); 2% of treated patients experienced severe diarrhoea.
Danish: Størstedelen af de rapporterede tilfælde af diarré var lette (43 %) til moderate (47 %).
English: Intracellular cGMP causes secretion of chloride and bicarbonate into the intestinal lumen, through activation of the cystic fibrosis transmembrane conductance regulator (CFTR), which results in increased intestinal fluid and accelerated transit.
Danish: Intracellulær cGMP forårsager udskillelse af chlorid og bicarbonat i tarmlumen gennem aktivering af cystisk fibrose transmembran konduktans regulator (CFTR), der resulterer i øget tarmvæske og accelereret transittid.
English: They should be instructed to inform their physician if severe or prolonged diarrhoea or lower gastrointestinal bleeding occurs (see section 4.8).
Danish: De skal instrueres i at informere deres læge, hvis der forekommer svær eller langvarig diarré eller blødning i den nedre del af mave-tarm-kanalen (se pkt.
English: Linaclotide is rarely detectable in plasma following administration of the recommended clinical doses and in vitro studies have shown that linaclotide is neither a substrate nor an inhibitor/inducer of the cytochrome P450 enzyme system and does not interact with a series of common efflux and uptake transporters (see section 5.2).
Danish: Linaclotid kan sjældent detekteres i plasma efter administration af de anbefalede kliniske doser, og in vitro-studier har vist, at linaclotid hverken er et substrat eller en hæmmer/induktor af cytochrom P450-enzymsystemet og ikke interagerer med en række almindelige efflux- og optagelsestransportører (se pkt.
English: In both studies, these improvements were seen by week 1 and sustained over the entire treatment periods (Figures 1 and 2).
Danish: I begge studier konstateredes disse forbedringer i uge 1, og de blev opretholdt i hele behandlingsperioden.
English: Clinically meaningful response in overall IBS-QoL (> 14 points difference) was achieved in 54% of linaclotide treated patients vs. 39% in placebo treated patients.
Danish: Klinisk relevant respons i samlet IBS-QoL (> 14-punkts forskel) blev opnået hos 54 % af de patienter, som blev behandlet med linaclotid, vs. 39 % hos patienter, som blev behandlet med placebo.
English: Taking Constella immediately after a high fat breakfast resulted in more frequent and looser stools, as well as more gastrointestinal adverse events, compared with taking it in the fasted state.
Danish: Når Constella blev indtaget umiddelbart efter et morgenmåltid med højt fedtindhold, opstod der hyppigere og tyndere afføring samt flere gastrointestinale bivirkninger sammenlignet med indtagelse i fastende tilstand.
English: Do not take this medicine if you are pregnant, think you may be pregnant or are planning to have a baby, unless your doctor advises you to do so.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, må du kun bruge denne medicin efter aftale med lægen.
English: During the 2-weeks pre-treatment baseline period, patients had a mean abdominal pain score of 5.6 (0-10 scale) with 2.2% of abdominal pain-free days, a mean bloating score of 6.6 (0-10 scale), and an average of 1.8 spontaneous bowel movements (SBM)/week.
Danish: I den 2-ugers baseline-periode før start af behandling, havde patienterne en middel abdominal smertescore på 5,6 (skala på 0-10) med 2,2 % smertefrie dage, en middel oppustethedsscore på 6,6 (skala på 0-10) og et gennemsnit på 1,8 spontane afføringer (SBM)/uge.
English: In the two pivotal phase 3 studies in which patients were dosed with 290 micrograms of linaclotide once daily, linaclotide was only detected in 2 out of 162 patients approximately 2 h following the initial linaclotide dose (concentrations were 0.241 ng/ml to 0.239 ng/ml) and in none of the 162 patients after 4 weeks of treatment.
Danish: I de to centrale fase 3-studier, hvori patienter fik en dosis på 290 mikrogram linaclotid en gang dagligt, blev linaclotid kun detekteret hos 2 ud af 162 patienter cirka 2 timer efter den oprindelige linaclotid-dosis (koncentrationer var 0,241 ng/ml til 0,239 ng/ml) og i ingen af de 162 patienter efter 4 ugers behandling.
English: A food interaction clinical study in healthy subjects showed that linaclotide was not detectable in plasma either in fed or in fasted conditions at the therapeutic doses.
Danish: Et klinisk studie af fødevareinteraktion hos raske forsøgspersoner viste, at linaclotid ikke kunne detekteres i plasma, hverken i fastende tilstand eller efter indtagelse af føde ved de terapeutiske doser.
English: Capsule content: microcrystalline cellulose, hypromellose, calcium chloride dihydrate and leucine.
Danish: Kapselindehold: mikrokrystallinsk cellulose, hypromellose, calciumchloriddihydrat og leucin.
English: Driving and using machines Constella will not affect your ability to drive or use machines
Danish: Trafik- og arbejdssikkerhed Constella vil ikke påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Both linaclotide and des-tyrosine active metabolite are reduced and enzymatically proteolyzed within the gastrointestinal tract to smaller peptides and naturally occurring amino acids.
Danish: Både linaclotid og den aktive des-tyrosin- metabolit reduceres og nedbrydes enzymatisk i mave-tarmkanalen til mindre peptider og naturligt forekommende aminosyrer.
English: Following a single oral dose of 2,897 micrograms linaclotide on day 8, after a 7-day course of 290 micrograms/day in 18 healthy volunteers, approximately 3 to 5% of the dose was recovered in the faeces, virtually all of it as the des-tyrosine active metabolite.
Danish: Efter enkeltdoser af 2897 mikrogram linaclotid på dag 8, efter et 7-dages forløb med 290 mikrogram/dag hos 18 raske frivillige blev cirka 3 - 5 % af dosis genfundet i afføringen, stort set alt sammen som den aktive des-tyrosin-metabolit.
English: When 2,897 micrograms was administered on day 8, following a 7-day course of 290 micrograms/day, linaclotide was detectable in only 2 of 18 subjects at concentrations just above the lower limit of quantification of 0.2 ng/ml (concentrations ranged from 0.212 to 0.735 ng/ml).
Danish: Når der blev administreret 2897 mikrogram på dag 8 efter et 7-dages forløb med 290 mikrogram/dag, var linaclotid kun detekterbart hos 2 ud af 18 forsøgspersoner med koncentrationer lige over den nedre kvantificeringsgrænse på 0,2 ng/ml (koncentrationer lå på mellem 0,212 og 0,735 ng/ml).
English: Warning: The bottle contains one or more sealed canisters containing silica gel to keep the capsules dry.
Danish: Advarsel: Beholderen indeholder en eller flere forseglede tørrekapsler med silicagel for at holde kapslerne tørre.
English: This medicinal product should not be used in children and adolescents (see sections 4.4 and 5.1).
Danish: Dette lægemiddel bør ikke anvendes til børn og unge (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON CONTAINING 4 x 28 CAPSULE BOTTLES (MULTIPACK) WITH BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE, DER INDEHOLDER BEHOLDERE MED 4 X 28 KAPSLER (MULTIPAKNING) MED BLUE BOX
English: Through its action at GC-C, linaclotide has been shown to reduce visceral pain and increase GI transit in animal models and increase colonic transit in humans.
Danish: Linaclotid har gennem sin virkning på GC-C vist sig at reducere visceral smerte og forkorte transittiden i mave-tarmkanalen i dyremodeller og forkorte transittiden i colon hos mennesker.
English: In a cross-over food interaction study, 18 healthy subjects were administered Constella 290 micrograms for 7 days both in the fasting and fed state.
Danish: I et cross-over-interaktionsstudie med blev Constella, 290 mikrogram, givet til 18 raske forsøgspersoner i 7 dage i både fastende og ikke-fastende tilstand.