FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of naloxegol and quinidine did not antagonize the morphine-induced miosis effect, suggesting that P-gp inhibition does not meaningfully change the capacity of naloxegol to cross the blood-brain barrier at therapeutic doses.
Danish: Samtidig administration af naloxegol og quinidin antagoniserede ikke den morfininducerede miosis-effekt, hvilket tyder på, at P-gphæmning ikke har nogen betydelig indvirkning på naloxegols evne til at krydse blod-hjernebarrieren i terapeutiske doser.
English: OIC was confirmed through a two week run in period and defined as < 3 spontaneous bowel movements (SBMs) per week on average with constipation symptoms associated with at least 25% of bowel movements.
Danish: Opioidinduceret obstipation blev bekræftet via en to-ugers indkøringsperiode og defineret som <3 spontane afføringer (spontaneous bowel movements (SBM)) om ugen i gennemsnit og med obstipationssymptomer i forbindelse med mindst 25 % af afføringerne.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS Blister perforated unit dose
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER Perforeret enkeltdosisblister Ikke-perforeret blister
English: In a long-term safety study (Kodiac 8), the frequency of AE reports of back pain was 8.9% for naloxegol 25 mg versus 8.8% for usual care.
Danish: I et langsigtet sikkerhedsstudie (Kodiac 8) var hyppigheden af hændelsesrapporter om rygsmerter 8,9 % med naloxegol 25 mg kontra 8,8 % med sædvanlig behandling.
English: Safety and efficacy have not been established in patients with severe hepatic impairment (see section 5.2).
Danish: Sikkerhed og virkning er ikke fastlagt hos patienter med svær leverinsufficiens (se pkt.
English: A “symptom responder” was defined as meeting both the 12-week responder criteria and demonstrating improvement in pre-specified OIC symptoms and no deterioration in symptoms.
Danish: En ”symptomrespondent” var defineret som en patient, der levede op til det 12-ugers respondentkriterie, og som udviste forbedring i de præspecificerede symptomer på opioidinduceret obstipation, og som ikke havde nogen forværring i symptomer.
English: The use of naloxegol is not recommended in such patients.
Danish: Det frarådes at anvende naloxegol hos sådanne patienter.
English: Flatulence, nausea, vomiting
Danish: Flatulens, kvalme, opkastning
English: Naloxegol should be prescribed with caution in such patients taking into account their individual benefit-risk balance with observation for potential CNS effects, such as symptoms of opioid withdrawal and/or interference with opioid-mediated analgesia.
Danish: Naloxegol skal ordineres med forsigtighed til sådanne patienter under hensyntagen til deres individuelle benefit/risk-forhold, og de skal holdes under observation for potentielle CNS-virkninger, såsom symptomer på opioidabstinens og/eller forstyrrelser i opioidmedieret analgesi.
English: • if you have kidney problems
Danish: • hvis du har nyreproblemer.
English: Enterohepatic recirculation may be an explanation as extensive biliary excretion was seen in the rat.
Danish: Enterohepatisk recirkulation kan være forklaringen, idet der blev set omfattende udskillelse i galden hos rotter.
English: • stomach pain • diarrhoea (passing of frequent, watery stools)
Danish: • mavesmerter • diarré (hyppige, vandige afføring)
English: Potential for interference with opioid-mediated analgesia There were no clinically relevant differences between naloxegol 12.5 mg, 25 mg, and placebo in average pain intensity, daily opioid dose or in opioid withdrawal scores over the 12-week study.
Danish: Potentiale for forstyrrelser i opioidmedieret analgesi Der var ingen klinisk relevante forskelle mellem naloxegol 12,5 mg, 25 mg og placebo i de gennemsnitlige scorer for smerteintensitet, daglig opioiddosis eller opioidabstinens over det 12-ugers studie.
English: • underlying malignancies of gastrointestinal tract or peritoneum
Danish: • underliggende maligniteter i mave-tarm-kanalen eller peritoneum
English: In a few cases, symptoms suggestive of opioid withdrawal when taking naloxegol 25 mg were observed in patients taking methadone for their pain condition.
Danish: I nogle få tilfælde blev der set symptomer, der tydede på opioidabstinens ved indtagelse af naloxegol 25 mg hos patienter, der tog methadon for deres smertetilstand.
English: The effect of race on the pharmacokinetics of naloxegol is small (approximately 20% decrease in the AUC of naloxegol when other groups are compared to Caucasian) and, therefore, no dose adjustment is necessary.
Danish: Race har lille indvirkning på farmakokinetikken af naloxegol (AUC ca. 20 % lavere hos andre grupper end kaukasere), og derfor er det ikke nødvendigt at justere dosis.
English: When treatment with Moventig is started, all currently used laxatives should be stopped, until instructed by your doctor to restart.
Danish: Når du begynder på behandlingen med Moventig, skal du stoppe med at tage alle andre afføringsmidler, du bruger, indtil din læge fortæller dig, at du kan starte igen.
English: Therefore, use in breast-feeding mothers is not recommended.
Danish: Brug hos ammende mødre frarådes derfor.
English: Naloxegol as a crushed tablet mixed in water, given orally or administered through a nasogastric tube into the stomach, is bioequivalent to the whole tablet, with a median tmax of 0.75 and 1.50 hours (range 0.23 to 5.02 hours) for the crushed tablet given orally and the crushed tablet given via NG tube, respectively.
Danish: Naloxegol som knust tablet, blandet i vand, administreret oralt eller via nasogastrisk sonde ned i maven, er bioækvivalent med en hel tablet med en gennemsnitlig tmax på 0,75 og 1,50 time (interval 0,23 til 5,02 timer), når den knuste tablet administreres henholdsvis oralt og via nasogastrisk sonde.
English: • diltiazem or verapamil (for high blood pressure or angina).
Danish: • diltiazem eller verapamil (mod forhøjet blodtryk eller brystsmerter (angina)).
English: Other medicines and Moventig
Danish: Brug af anden medicin sammen med Moventig
English: A potentially treatmentrelated increased incidence of the skeletal variant bipartite vertebral centrum and a single foetus with anorchism was seen at the highest dose tested in the rat embryo-foetal development study.
Danish: Der blev set en potentielt behandlingsrelateret stigning i forekomsten af skeletvarianten todelt vertebralt centrum og et enkelt foster med anorchia ved den højeste afprøvede dosis i studiet af den embryoføtale udvikling hos rotter.
English: Posology The recommended dose of Moventig is 25 mg once daily.
Danish: Dosering Den anbefalede dosis af Moventig er 25 mg én gang dagligt.
English: Mechanism of action and pharmacodynamic effects Naloxegol is a PEGylated derivative of the mu-opioid receptor antagonist naloxone.
Danish: Virkningsmekanisme og farmakodynamisk virkning Naloxegol er et PEGyleret derivat af my-opioidreceptorantagonisten naloxon.
English: Studies in suckling rats have shown that naloxegol is excreted in the milk.
Danish: Studier af diende rotter har vist, at naloxegol udskilles i mælken.
English: The blood brain barrier integrity is important for minimizing naloxegol uptake into the CNS.
Danish: Det er vigtigt, at blod-hjernebarrieren er intakt for at minimere optagelsen af naloxegol i CNS.
English: Oval, 13x7 mm, mauve tablet.
Danish: Oval, 13 x 7 mm, lyserød tablet.
English: Symptom responder end-point
Danish: Endepunktet symptomrespondenter
English: Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
Danish: Moventig er indiceret til behandling af opioidinduceret obstipation hos voksne patienter, som har haft et utilstrækkeligt respons på laksantia.
English: Effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naloxegol was not evaluated.
Danish: Indvirkningen af svær leverinsufficiens (Child-Pughklasse C) på farmakokinetikken af naloxegol blev ikke vurderet.
English: The starting dose for patients taking moderate CYP3A4 inhibitors (e.g. diltiazem, verapamil) is 12.5 mg once daily.
Danish: Startdosen til patienter, der tager moderate CYP3A4-hæmmere (f.eks. diltiazem, verapamil) er 12,5 mg én gang dagligt.
English: Caution with regards to the use of naloxegol should be exercised in patients with any condition which might result in impaired integrity of the gastrointestinal tract wall (e.g. severe peptic ulcer disease, Crohn's Disease, active or recurrent diverticulitis, infiltrative gastrointestinal tract malignancies or peritoneal metastases).
Danish: Der skal udvises forsigtighed med hensyn til brug af naloxegol hos patienter med en hvilken som helst tilstand, der kan resultere i nedsat integritet af mave-tarm-kanalens væg (f.eks. svær ulcus pepticum, Crohns sygdom, aktiv eller tilbagevendende diverticulitis, infiltrerende maligniteter i mave-tarmkanalen eller peritonealmetastaser).
English: Therefore, caution should be used when prescribing naloxegol to such patients (see section 4.3).
Danish: Der skal derfor udvises forsigtighed ved ordination af naloxegol til sådanne patienter (se pkt.
English: Exposure of naloxegol in end-stage renal disease (ESRD) patients on haemodialysis was similar to healthy volunteers with normal renal function.
Danish: Eksponeringen for naloxegol hos patienter med nyresygdom i slutstadiet i hæmodialyse var ensartet med eksponeringen hos raske frivillige med normal nyrefunktion.
English: Therefore, a dose adjustment of naloxegol is recommended when co-administered with diltiazem and other moderate CYP3A4 inhibitors (see section 4.2).
Danish: Det anbefales derfor at justere dosis af naloxegol ved samtidig administration af diltiazem og andre moderate CYP3A4-hæmmere (se pkt.
English: To qualify as LIR, in the two weeks prior to first study visit patients had to have reported concurrent OIC symptoms of at least moderate severity while taking at least one laxative class for a minimum of four days during the pre study period.
Danish: For at blive kvalificeret som havende utilstrækkeligt respons på laksantia skulle patienterne i de to uger inden det første studiebesøg have rapporteret om symptomer på opioidinduceret obstipation af mindst moderat sværhedsgrad, selvom de tog mindst en klasse af laksantia i mindst fire dage inden studieperioden.
English: Clinically important disruptions of the blood-brain barrier Naloxegol is a peripherally acting mu-opioid receptor antagonist with restricted access to the central nervous system (CNS).
Danish: Klinisk betydelige beskadigelser af blod-hjernebarrieren Naloxegol er en perifert virkende my-opioidreceptorantagonist med begrænset adgang til centralnervesystemet (CNS).
English: There is limited clinical experience with the use of naloxegol in OIC patients with cancer-related pain.
Danish: Der er begrænset klinisk erfaring med brug af naloxegol hos patienter med opioidinduceret obstipation og cancerrelaterede smerter.
English: In a pooled analysis of Kodiac 4 and Kodiac 5 (90, 88 and 99 patients in the placebo, 12.5 mg and 25 mg groups respectively), higher response rates in this population was observed for the 25 mg dose group compared with placebo (p=0.040).
Danish: I den samlede analyse af Kodiac 4 og Kodiac 5 (90, 88 og 99 patienter i hhv. placebo-, 12,5 mg- og 25 mggrupperne) blev der set højere responsrater i denne population med 25 mg-dosen i forhold til placebo (p=0,040).
English: Long-term exposure to naloxegol 25 mg, up to 52 weeks, was generally safe and well tolerated in the treatment of OIC patients with non-cancer-related pain.
Danish: Langvarig eksponering for naloxegol 25 mg (op til 52 uger) var generelt sikker og veltolereret ved behandling af patienter med opioidinduceret obstipation og ikke-cancerrelaterede smerter.
English: Doses of naloxegol up to 1,000 mg were administered in healthy volunteers in clinical studies.
Danish: I kliniske studier blev der administreret naloxegol-doser på op til 1.000 mg hos raske forsøgspersoner.
English: The effect of naloxegol on fertility in humans has not been studied.
Danish: Naloxegols indvirkning på fertiliteten hos mennesker er ikke blevet undersøgt.
English: The responder rates in this population were placebo 30.0%, 12.5 mg 44.3% and 25 mg 44.4%.
Danish: Respondentraterne i denne population var 30 % med placebo, 44,3 % med 12,5 mg og 44,4 % med 25 mg.
English: Opioid withdrawal syndrome
Danish: Opioidabstinens -syndrom
English: Naloxegol acts by binding to mu-opioid receptors in the GI tract targeting the underlying causes of OIC (i.e. reduced GI motility, hypertonicity and increased fluid absorption resulting from long-term opioid treatment).
Danish: Naloxegol virker ved binding til my-opioidreceptorerne i mave-tarm-kanalen og modvirker de underliggende årsager til opioidinduceret obstipation (dvs. reduceret gastrointestinal motilitet, hypertonicitet og øget væskeabsorption som følge af langvarig opioidbehandling).
English: No dosage adjustment is required for patients taking weak CYP3A4 inhibitors.
Danish: Det er ikke nødvendigt at justere dosen hos patienter, der tager svage CYP3A4-hæmmere.
English: There is a theoretical possibility that naloxegol could provoke opioid withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist.
Danish: Der er en teoretisk mulighed for, at naloxegol kan fremprovokere opioidabstinens hos et ammet spædbarn, hvis moder tager en opioidreceptoragonist.
English: For extremity pain, the rate for naloxegol 25 mg was 3.5% versus 3.3% for usual care.
Danish: Hvad angår ekstremitetssmerter, var hyppigheden med naloxegol 25 mg 3,5 % kontra 3,3 % med sædvanlig behandling.
English: Patients with known or suspected gastrointestinal (GI) obstruction or in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation (see section 4.4).
Danish: Patienter med kendt eller mistænkt gastrointestinal (GI) obstruktion eller patienter med øget risiko for tilbagevendende obstruktion på grund af muligheden for gastrointestinal perforation (se pkt.
English: Kodiac 8 was a Phase III, 52-week, multi-center, open-label, randomized, parallel group, safety and tolerability study of naloxegol versus usual care in the treatment of OIC in patients with non-cancer-related pain.
Danish: Kodiac 8 var et 52-ugers randomiseret parallelgruppe- og multicenterstudie i fase III med åben behandling til vurdering af sikkerheden og tolerancen af naloxegol kontra sædvanlig behandling af opioidinduceret obstipation hos patienter med ikke-cancerrelaterede smerter.
English: Eligible patients were randomized in a 2:1 ratio to receive either naloxegol 25 mg daily (qd) or usual care treatment for OIC for 52 weeks.
Danish: Egnede patienter blev randomiseret i forholdet 2:1 til at modtage enten naloxegol 25 mg dagligt eller sædvanlig behandling for opioidinduceret obstipation i 52 uger.
English: • if you have stomach ulcers, Crohn's Disease (an illness where your gut is inflamed), diverticulitis (another illness where your gut is inflamed), cancer in your gut or ‘peritoneum' (the lining of your stomach area), or any conditon that might damage the wall of your bowel
Danish: • hvis du har mavesår, Crohns sygdom (en sygdom med betændelse i tarmen), diverticulitis (en anden sygdom med betændelse i tarmen), kræft i tarmen eller 'bughinden' (hinden i maveregionen) eller en anden sygdom, som eventuelt kan beskadige tarmvæggen.
English: In this study, naloxegol at doses of 12.5 mg and 25 mg was generally safe and well tolerated as compared with placebo in the treatment of OIC patients with non-cancer-related pain.
Danish: I dette studie var naloxegol i doser på 12,5 mg og 25 mg generelt sikre og veltolererede sammenlignet med placebo ved behandling af patienter med opioidinduceret obstipation og ikkecancerrelaterede smerter.
English: A possible treatment-related foetal skeletal malformation of fused arches was noted at highest dose tested in the rabbit embryo-foetal development study, in the absence of maternal toxicity.
Danish: Der blev noteret en potentielt behandlingsrelateret føtal skeletal misdannelse i form af arcusfusion med den højeste afprøvede dosis i studiet af den embryoføtale udvikling hos kaniner uden maternel toksicitet.
English: • rifampin (an antibiotic), carbmazepine (for epilepsy) or the herbal medicine St. John's wort (for depression).
Danish: • rifampicin (et antibiotikum), carbamazepin (mod epilepsi) eller naturlægemidlet perikon (mod depression).
English: You may need to stop taking Moventig
Danish: Det kan være, at du skal stoppe med at tage Moventig.
English: Co-administration of the P-gp inhibitor quinidine resulted in a 1.4 fold increase in the AUC (90% CI: 1.3-1.5) and a 2.4 fold increase in the Cmax (90% CI: 2.2-2.8) of naloxegol.
Danish: Samtidig administration af Pgp-hæmmeren quinidin resulterede i en 1,4-folds stigning i AUC (90 % CI: 1,3-1,5) og i en 2,4-folds stigning i Cmax (90 % CI: 2,2-2,8) af naloxegol.
English: Tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager et eller flere af følgende lægemidler:
English: • if you have cancer in your gut or ‘peritoneum' (the lining of your stomach area), advanced or recurrent ovarian cancer or if you are taking medicines used to treat cancer such as “VEGF inhibitors” (e.g. bevacizumab).
Danish: • hvis du har kræft i tarmen eller 'bughinden' (en hinde i maveregionen) eller fremskreden eller tilbagevendende kræft i æggestokkene, eller hvis du tager lægemidler, der anvendes til behandling af kræft, såsom ”VEGF-hæmmere” (f.eks. bevacizumab).
English: Oval, 10.5x5.5 mm, mauve tablet.
Danish: Oval, 10,5 x 5,5 mm, lyserød tablet.
English: There is a theoretical potential for provoking opioid withdrawal in the foetus with use of an opioid receptor antagonist in the mother, who is being treated with a concurrent opioid.
Danish: Der er en teoretisk mulighed for at fremprovokere opioidabstinens hos fostret, hvis der anvendes en opioidreceptorantagonist til en moder, der samtidig er i behandling med et opioid.
English: Concomitant use with strong CYP3A4 inhibitors (e.g. clarithromycin, ketoconazole, itraconazole or telithromycin; protease inhibitors such as ritonavir, indinavir or saquinavir; grapefruit juice when consumed in large quantities), see section 4.5.
Danish: Samtidig brug af stærke CYP3A4-hæmmere (f.eks. clarithromycin, ketoconazol, itraconazol eller telithromycin; proteasehæmmere såsom ritonavir, indinavir eller saquinavir; grapefrugtjuice i store mængder) se pkt.
English: Interaction with P-gp inhibitors
Danish: Interaktion med P-gp-hæmmere
English: • if the natural protective barrier between the blood vessels in the head and in the brain is damaged, for example if you have cancer in the brain or the central nervous system, or if you have a disease of the central nervous system like multiple sclerosis or Alzheimer's diseasecontact your doctor immediately if you experience lack of pain relief from your opioid medicine or symptoms of opioid withdrawal syndrome (see section 4).
Danish: • hvis den naturlige beskyttelsesbarriere mellem blodkarrene i hovedet og i hjernen (den såkaldte blod-hjerne-barriere) er beskadiget, for eksempel hvis du har kræft i hjernen eller centralnervesystemet, eller hvis du har en sygdom i centralnervesystemet, såsom multipel sklerose eller Alzheimers sygdom.
English: Moventig 25 mg: a mauve coloured, oval, dimensions 13 x 7 mm, film-coated tablet, marked “nGL” on one side and “25” on the other side.
Danish: Moventig 25 mg: en lyserød oval, filmovertrukken tablet, der måler 13 x 7 mm og er mærket ”nGL” på den ene side og ”25” på den anden side.
English: If evidence for opioid-mediated interference with analgesia or opioid withdrawal syndrome occurs, patients should be instructed to discontinue Moventig and contact their physician.
Danish: Hvis der opstår tegn på opioidmedierede forstyrrelser i analgesi eller opioidabstinens, skal patienten instrueres i at seponere Moventig og kontakte lægen.
English: Use in patients with severe hepatic impairment is not recommended.
Danish: Brug hos patienter med svær leverinsufficiens er frarådet.
English: (≥ 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: Hyppighedskategorierne er defineret i henhold til følgende konventioner: 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
English: The starting dose for patients taking moderate CYP3A4 inhibitors is 12.5 mg once daily and the dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.2).
Danish: Startdosen til patienter, der tager moderate CYP3A4-hæmmere, er 12,5 mg én gang dagligt, og dosen kan øges til 25 mg, hvis 12,5 mg er veltolereret af patienten (se pt. 4.2).
English: If opioid withdrawal syndrome is suspected the patient should discontinue Moventig and contact their physician.
Danish: Hvis der er mistanke om opioidabstinenssyndrom, skal patienten seponere Moventig og kontakte sin læge.
English: Naloxegol functions as a peripherally-acting mu-opioid receptor antagonist in the gastrointestinal tract, thereby decreasing the constipating effects of opioids without impacting opioid-mediated analgesic effects on the central nervous system.
Danish: Naloxegol er en perifert virkende my-opioidreceptorantagonist i mave-tarm-kanalen og reducerer dermed de obstiperende virkninger af opioider uden at påvirke de opioidforårsagede analgetiske virkninger på centralnervesystemet.
English: Moventig 12.5 mg: a mauve coloured, oval, dimensions 10.5 x 5.5 mm film-coated tablet, marked “nGL” on one side and “12.5” on the other side.
Danish: Moventig 12,5 mg: en lyserød, oval, filmovertrukken tablet, der måler 10,5 x 5,5 mm og er mærket ”nGL” på den ene side og ”12.5” på den anden side.
English: Paediatric population The use of naloxegol in the paediatric population has not been studied.
Danish: Pædiatrisk population Brug af naloxegol i den pædiatriske population er ikke blevet undersøgt.
English: Patients with cancer-related pain No dose adjustment is required for patients with cancer-related pain (see sections 4.3 and 4.4).
Danish: Patienter med cancerrelaterede smerter Det er ikke nødvendigt at justere dosis hos patienter med cancerrelaterede smerter (se pkt.
English: Naloxegol must not be used in patients with known or suspected gastrointestinal obstruction or in patients at increased risk of recurrent obstruction, or in patients with underlying cancer who are at heightened risk of GI perforation (see section 4.3).
Danish: Naloxegol må ikke anvendes til patienter med kendt eller mistanke om gastrointestinal obstruktion eller til patienter med en øget risiko for tilbagevendende obstruktion eller til patienter med en underliggende cancer, som har en øget risiko for gastrointestinal perforation (se pkt.
English: Available toxicological data in rats have shown naloxegol excreted in milk (see section 5.3).
Danish: Tilgængelige toksikologiske data fra rotter har vist, at naloxegol udskilles i mælken (se pkt.
English: Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea, vomiting, muscle aches, lacrimation, rhinorrhoea, pupillary dilation,
Danish: Opioidabstinenssyndrom er et symptomkompleks med tre eller flere af følgende tegn eller symptomer: dysfori, kvalme eller opkastning, muskelsmerter, tåresekretion eller rinorré, pupiludvidelse eller piloarrektion eller svedtendens, diarré, gaben, feber eller insomni.
English: In Kodiac 5 the corresponding times to first post dose SBM were 38.2, 12.8, and 18.1 hours, respectively.
Danish: I Kodiac 5 var de tilsvarende tider til første spontane afføring efter dosering hhv. 38,2 timer, 12,8 timer og 18,1 timer.
English: • nasopharyngitis (runny or stuffy nose)
Danish: • nasofaryngitis (snue med løbende eller tilstoppet næse)