FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used when laxatives have not provided acceptable relief of constipation.
Danish: Det anvendes, når afføringsmidler ikke har givet tilfredsstillende lindring af forstoppelse.
English: Moventig contains sodium
Danish: Moventig indeholder natrium
English: This is because large amounts can affect how much of the naloxegol medicine gets into the body.
Danish: Det skyldes, at store mængder heraf kan påvirke mængden af medicin (naloxegol), som du får ind i kroppen.
English: For patients who are unable to swallow the tablet whole, the tablet can be crushed to a powder and mixed in half a glass of water (120 ml) and drunk immediately.
Danish: Til patienter, der ikke er i stand til at synke tabletten hel, kan den knuses til pulver og blandes i et halvt glas vand (120 ml) og drikkes straks.
English: No data are available on the concomitant use of naloxegol with grapefruit juice.
Danish: Der foreligger ingen data vedrørende samtidig brug af naloxegol og grapefrugtjuice.
English: • Patients with underlying cancer who are at heightened risk of GI perforation, such as those with:
Danish: • Patienter med underliggende cancer, som har øget risiko for gastrointestinal perforation, såsom patienter med:
English: • if you have severe liver illness
Danish: • hvis du har en alvorlig leversygdom.
English: Patients taking methadone for treatment of opioid addiction were not included in the clinical development programme and use of naloxegol in these patients should be approached with caution.
Danish: Patienter, der tog methadon til behandling af opioidafhængighed blev ikke inkluderet i det kliniske udviklingsprogram, og der skal udvises forsigtighed ved brug af naloxegol hos sådanne patienter.
English: In male rats, a dose-related increase in Leydig cell adenomas and interstitial cell hyperplasia was observed at exposures considered sufficiently in excess of the maximum human exposure.
Danish: Hos hanrotterne blev der set en dosisrelateret stigning i Leydigcelleadenomer og interstitiel cellehyperplasi ved eksponeringer, der blev vurderet at være tilstrækkeligt højere end den maksimale humane eksponering.
English: Overall 393 and 317 patients had at least 6 and 12 months exposure to naloxegol 25 mg, respectively, in this study, which met the specified exposure requirements.
Danish: I dette studie blev i alt 393 og 317 patienter eksponeret for naloxegol 25 mg i hhv. 6 og 12 måneder, hvilket levede op til de specificerede eksponeringskrav.
English: A QTc study performed with naloxegol in healthy volunteers did not indicate any prolongation of the QT interval.
Danish: I et QTc-studie udført med naloxegol hos raske frivillige blev der ikke set tegn på forlængelse af QT-intervallet.
English: • if you currently have unusually severe, persistent or worsening stomach pain
Danish: • hvis du for nuværende har usædvanligt stærke, vedvarende eller forværrede mavesmerter.
English: Kyowa Kirin Holdings B.V. Bloemlaan 2
Danish: Kyowa Kirin Holdings B.V.
English: No dose adjustment is recommended for elderly patients.
Danish: Der anbefales ingen dosisjustering hos ældre patienter.
English: Plasma protein binding of naloxegol in humans was low and the fraction unbound ranged from 80% to
Danish: Plasmaproteinbindingen af naloxegol hos mennesker var lav, og den ubundne fraktion rangerede fra 80 % til 100 %.
English: Patients should be advised to discontinue therapy with naloxegol and promptly notify their physician if they develop unusually severe or persistent abdominal pain.
Danish: Patienter bør rådes til at seponere behandlingen med naloxegol og omgående underrette deres læge, hvis de udvikler usædvanligt svære eller vedvarende mavesmerter.
English: • Pour the powder into half a glass of water (120 ml)
Danish: • Hæld pulveret i et halvt glas vand (120 ml)
English: • incomplete emptying of the rectum (after having a bowel movement, the feeling as if a stool is still in the rectum which needs to come out)
Danish: • ufuldstændig tømning af endetarmen (efter en afføring er der en følelse af, at der stadig er afføring i endetarmen, som skal ud)
English: In a thorough QT/QTc study, as defined by the ICH E14 Guideline, there were no clinically important changes in HR, RR, QT, PR or QRS intervals or T wave morphology observed.
Danish: I et grundigt QT-/QTc-studie, defineret i henhold til ICH E14-vejledningen, blev der ikke set nogen klinisk betydelige ændringer i HR-, RR-, QT-, PR- eller QRS-interval eller T-bølgemorfologi.
English: PEGylation reduces naloxegol's passive permeability and also renders the compound a substrate for the P-glycoprotein transporter.
Danish: PEGylering reducerer naloxegols passive permeabilitet og gør også stoffet til et substrat for transportproteinet P-gp.
English: As it is not known whether this medicone is excreted in human milk, do not use Moventig during breast-feeding.
Danish: Da det er ukendt, om dette lægemiddel udskilles i human mælk, må Moventig ikke bruges, hvis du ammer.
English: Across the range of doses evaluated peak plasma concentration and AUC increased in a doseproportional, or approximately dose proportional, manner.
Danish: På tværs af de vurderede dosisintervaller steg de maksimale plasmakoncentrationer og AUC på dosisproportionel eller næsten dosisproportionel vis.
English: In a separate pre- and post-natal development study in rats, body weights were lower for male pups following maternal administration at the high dose.
Danish: I et separat studie af den præ- og postnatale udvikling hos rotter var legemsvægten lavere hos hanungerne efter administration af den høje dosis til moderdyret.
English: Naloxegol use is therefore not recommended during pregnancy.
Danish: Det frarådes derfor at anvende naloxegol under graviditeten.
English: In a majority of subjects, a secondary plasma concentration peak of naloxegol was observed approximately 0.4 to 3 hours after the first peak.
Danish: Hos de fleste patienter blev der set endnu et peak i plasmakoncentrationen af naloxegol cirka 0,4 til 3 timer efter det første peak.
English: The glass should be rinsed with a further half glass of water (120 ml) and the contents drunk.
Danish: Glasset skal skylles med yderligere et halvt glas vand (120 ml), og indholdet skal drikkes.
English: Patients taking a minimum of 30 morphine equivalent units (meu) of opioids per day for at least 4 weeks before enrolment and self-reported OIC were eligible.
Danish: Patienter, der tog minimum 30 morfinækvivalente enheder (meu) af opioider om dagen i mindst 4 uger inden inklusion og havde selvrapporteret opioidinduceret obstipation, var egnede til deltagelse.
English: • medicines called ‘opioid antagonists' (such as naltrexone and naloxone) which are used to counteract the effects of opioids
Danish: • lægemidler, der kaldes ‘opioidantagonister' (såsom naltrexon og naloxon), som anvendes til at modvirke virkningen af opioider.
English: In some patients, however, a constellation of symptoms has been reported, which resembles the syndrome of central opioid withdrawal.
Danish: Hos visse patienter er der dog rapporteret om et symptomkompleks, der ligner central opioidabstinens.
English: Concomitant consumption of grapefruit juice while taking naloxegol should generally be avoided and considered only in consultation with a healthcare provider (see section 4.3).
Danish: Samtidig indtagelse af grapefrugtjuice under behandling med naloxegol bør generelt undgås og bør kun overvejes efter konsultation med en læge (se pkt.
English: • if you have kidney problems - your doctor may tell you to take a different dose (see section below “How to take Moventig”)
Danish: • hvis du har nyreproblemer - Din læge vil eventuelt ordinere en anden dosis (se afsnittet ”Sådan skal du tage Moventig” nedenfor).
English: • vascular endothelial growth factor (VEGF) inhibitor treatment.
Danish: • behandling med vaskulær endotelial vækstfaktor (VEGF)-hæmmer.
English: Moventig contains the active substance naloxegol.
Danish: Moventig indeholder det aktive stof naloxegol.
English: The first of three multiplicity protected secondary endpoints was the 12-week responder rate in the LIR subgroup.
Danish: Det første af tre muliplicitetsbeskyttede sekundære endepunkter var respondentraten efter 12 uger i undergruppen med utilstrækkeligt respons på laksantia.
English: Patients with mean Numeric Rating Scale (NRS) pain scores equal to or higher than 7 were not studied due to the risk of confounding the efficacy result as a result of uncontrolled pain.
Danish: Patienter med en gennemsnitlig smertescore på Numeric Rating Scale (NRS) på 7 eller derover blev ikke undersøgt på grund af risikoen for at påvirke effektresultaterne som følge af ukontrolleret smerte.
English: Conditions in patients with cancer pain
Danish: Sygdomme hos patienter med cancersmerter
English: Response over 12 weeks in patients with an inadequate response to at least two classes of laxative Response to naloxegol over 12 weeks was tested in the sub-group of patients with inadequate response to at least two laxative classes, approximately 20% of the patients randomized.
Danish: Respons over 12 uger hos patienter med utilstrækkeligt respons på mindst to klasser af laksantia Responset på naloxegol over 12 uger blev afprøvet i undergruppen af patienter med utilstrækkeligt respons på mindst to klasser af laksantia, der udgjorde cirka 20 % af de randomiserede patienter.
English: Both studies were powered and stratified so that at least 50% of patients randomized to each treatment arm met baseline criteria to be categorized as a laxative inadequate responder (LIR).
Danish: Begge studier havde styrken til og var stratificeret således, at mindst 50 % af de patienter, der blev randomiseret til de enkelte behandlingsarme, levede op til baselinekriteriet om utilstrækkeligt respons på laksantia.
English: You may need to take a lower dose of Moventig
Danish: Det kan være, at du skal tage en lavere dosis af Moventig.
English: The starting dose for patients with moderate or severe renal insufficiency is 12.5 mg.
Danish: Startdosen til patienter med moderat eller svær nyreinsufficiens er 12,5 mg.
English: Use of naloxegol with another opioid antagonist (e.g. naltrexone, naloxone) should be avoided due to the potential for an additive effect of opioid receptor antagonism and an increased risk of opioid withdrawal.
Danish: Anvendelse af naloxegol sammen med en anden opioidantagonist (f.eks. naltrexon, naloxon) bør undgås på grund af risikoen for en additiv virkning af opioid-receptorantagonisme og en øget risiko for opioidabstinens.
English: Cases of opioid withdrawal syndrome have been reported in the naloxegol clinical programme (DSM5).
Danish: Der er rapporteret om tilfælde af opioidabstinenssyndrom i det kliniske program for naloxegol (DSM-5).
English: When naloxegol therapy is initiated, it is recommended that all currently used maintenance laxative therapy should be halted, until clinical effect of naloxegol is determined.
Danish: Ved påbegyndelse af behandling med naloxegol anbefales det, at alle samtidigt anvendte vedligeholdelsesbehandlinger med laksantia afbrydes, indtil den kliniske virkning af naloxegol er fastlagt.
English: Patients with clinically important disruptions to the blood-brain barrier (e.g. primary brain malignancies, CNS metastases or other inflammatory conditions, active multiple sclerosis, advanced Alzheimer's disease etc.) were not included in clinical studies and may be at risk for naloxegol entry into the CNS.
Danish: Patienter med klinisk betydelige beskadigelser af blod-hjernebarrieren (f.eks. primære hjernemaligniteter, CNS-metastaser eller andre inflammatoriske tilstande, aktiv multipel sklerose, fremskreden Alzheimers sygdom osv.) blev ikke inkluderet i de kliniske studier og kan have en risiko for, at naloxegol går ind i CNS.
English: The efficacy and safety of naloxegol was established in two replicate double-blind, placebo-controlled studies in patients with OIC and non-cancer related pain (Kodiac 4 and Kodiac 5).
Danish: Virkningen og sikkerheden af naloxegol blev fastlagt i to dobbeltblindede, placebokontrollerede replikationsstudier med patienter med opioidinduceret obstipation og ikke-cancerrelaterede smerter (Kodiac 4 og Kodiac 5).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Moventig in one or more subsets of the paediatric population in opioid induced constipation (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Moventig i en eller flere undergrupper af den pædiatriske population ved opioidinduceret obstipation (se pkt.
English: Contents of the pack and other information What Moventig contains
Danish: Pakningsstørrelser og yderligere oplysninger Moventig indeholder:
English: No dose adjustment is recommended based on age (see section 5.2).
Danish: Det anbefales ikke at justere dosis på baggrund af alder (se pkt.
English: Patients were prohibited from using laxatives other than bisacodyl rescue laxative if they had not had a bowel movement for 72 hours.
Danish: Det var ikke tilladt for patienterne at anvende laksantia bortset fra bisacodyl som nødlaksativ, hvis de ikke havde haft afføring i 72 timer.
English: • other medicines for constipation (any laxatives)
Danish: • andre lægemidler mod forstoppelse (et hvilket som helst afføringsmiddel)
English: • The active substance is naloxegol.
Danish: • Aktivt stof: naloxegol.
English: • if you are taking methadone (see section below “Other medicines and Moventig”)
Danish: • hvis du tager methadon (se afsnittet nedenfor ”Brug af anden medicin sammen med Moventig”).
English: Conditions with increased potential for gastrointestinal perforation Cases of gastrointestinal perforation have been reported in the post-marketing setting, including fatal cases when naloxegol was used in patients who were at an increased risk of gastrointestinal (GI) perforation.
Danish: Tilstande med øget risiko for gastrointestinal perforation Efter markedsføringen er der rapporteret om tilfælde af gastrointestinal perforation, herunder dødelige tilfælde, hvor naloxegol blev anvendt til patienter med en øget risiko for gastrointestinal perforation.
English: Stop taking the medicine and tell your doctor straight away if you develop opioid withdrawal symptoms (if you have a combination of three or more of these symptoms: feeling depressed, nausea, vomiting, muscle aches, increased tearing, runny nose, dilation of the pupils, goosebumps, excess sweating, diarrhoea, yawning, fever or insomnia) which would usually occur within the first few days after starting naloxegol.
Danish: Stop med at tage lægemidlet, og fortæl det straks til lægen, hvis du udvikler opioidabstinens symptomer (hvis du har en kombination af tre eller flere af følgende symptomer: nedtrykthed, kvalme, opkastning, muskelsmerter, øget tåresekretion, næseflåd, udvidede pupiller, gåsehud, udtalt svedtendens, diarré, gaben, feber eller søvnløshed), hvilket normalt vil indtræde i løbet af de første dage efter opstart af naloxegol.
English: It is recommended that Moventig is taken in the morning, for patient convenience to avoid bowel movements in the middle of the night.
Danish: For patientens velværes skyld anbefales det, at Moventig tages om morgenen for at undgå afføring midt om natten.
English: Interaction with other opioid antagonists
Danish: Interaktion med andre opioidantagonister
English: The recommended dose is 1 tablet of 25 mg each day.
Danish: Den anbefalede dosis er én 25 mg-tablet om dagen.
English: In vitro studies demonstrate that naloxegol is a full neutral antagonist at the mu-opioid receptor.
Danish: In vitro-studier har vist, at naloxegol er en komplet neutral antagonist ved my-opioidreceptoren.
English: It is a medicine used in adults to treat constipation specifically caused by pain medicines, called opioids, (e.g. morphine, oxycodone, fentanyl, tramadol, codeine) taken on a regular basis.
Danish: Det er et lægemiddel, der anvendes til voksne til behandling af forstoppelse, der er specifikt forårsaget af regelmæssig brug af smertestillende lægemidler, der kaldes opioider (f.eks. morfin, oxycodon, fentanyl, tramadol og kodein).
English: No antidote is known for naloxegol and dialysis was noted to be ineffective as a means of elimination in a clinical study in patients with renal failure.
Danish: Der er ingen kendt antidot mod naloxegol, og dialyse var ikke effektivt til elimination i et klinisk studie af patienter med nyresvigt.
English: If a patient on opioid therapy receives an overdose of naloxegol, the patient should be monitored closely for potential evidence of opioid withdrawal symptoms or reversal of central analgesic effect.
Danish: Hvis en patient i opioidbehandling får en overdosis af naloxegol, skal patienten overvåges nøje for potentielle tegn på opioidabstinens eller reversering af centralanalgetisk virkning.
English: Table 1 Adverse reactions by System Organ Class (SOC) and frequency System Organ Classification
Danish: Tabel 1 Bivirkninger i henhold til systemorganklasse og hyppighed Systemorganklasse
English: Results from a QWBA (Quantitative Whole Body Autoradiography) study in the rat and the lack of antagonism of CNS opiate effects in humans at naloxegol doses less than 250 mg, indicate minimal distribution of naloxegol into the CNS.
Danish: Resultaterne fra et QWBA-studie (Quantitative Whole Body Autoradiography Study) hos rotter og den manglende antagonisme af opiatvirkninger på CNS hos mennesker ved brug af naloxegoldoser under 250 mg tyder på minimal fordeling af naloxegol til CNS.
English: Piramal Pharma Solutions (Dutch) B.V. Bargelaan 200 u 715
Danish: Piramal Pharma Solutions (Dutch) B.V.
English: • if you develop severe, persistent or worsening stomach pain.
Danish: • hvis du får stærke, vedvarende eller forværrede mavesmerter.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tager dette lægemiddel.
English: Tabulated list of adverse reactions Adverse reactions are classified according to frequency and System Organ Class.
Danish: Tabeloversigt over bivirkninger Bivirkningerne er klassificeret i henhold til hyppighed og systemorganklasse.
English: Naloxegol at therapeutic doses has minimal uptake across the blood brain barrier.
Danish: Naloxegol i terapeutiske doser optages minimalt på tværs af blod-hjernebarrieren.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: Carcinogenicity studies of naloxegol were conducted in rats and mice.
Danish: Der blev udført karcinogenicitetsstudier af naloxegol hos rotter og mus.
English: • ketoconazole or itraconazole - to treat fungal infections
Danish: • ketoconazol eller itraconazol - til behandling af svampeinfektioner
English: • if you are taking certain other medicines such as ketoconazole or itraconazole (to treat fungal infections), clarithromycin or telithromycin (antibiotics) or ritonavir, indinavir or saquinavir (to treat HIV).
Danish: • hvis du tager visse andre lægemidler, såsom ketoconazol eller itraconazol (til behandling af svampeinfektioner), clarithromycin eller telithromycin (antibiotika) eller ritonavir, indinavir eller saquinavir (til behandling af hiv).
English: In these patients renal impairment may adversely affect other clearance pathways (hepatic/gut drug metabolism, etc.) resulting in higher exposure.
Danish: Hos sådanne patienter kan nyreinsufficiens have negativ indvirkning på andre udskillelsesveje (lægemiddelmetabolisering i leveren/tarmen etc.) og resultere i højere eksponering.
English: As the effects of P-gp inhibitors on the PK of naloxegol were small relative to the effects CYP3A4 inhibitors, the dosing recommendations for Moventig when co-administered with medicinal products causing both P-gp and CYP3A4 inhibition should be based on CYP3A4 inhibitor status - strong, moderate or weak (see sections 4.2, 4.3 and 4.5).
Danish: Da virkningerne af P-gp-hæmmere på naloxegols farmakokinetik var små i forhold til virkningerne af CYP3A4-hæmmere, bør doseringsanbefalingerne for Moventig ved samtidig administration af lægemidler, der forårsager både P-gp- og CYP3A4-hæmning, baseres på CYP3A4-hæmmerens status - stærk, moderat eller svag (se pkt.
English: Cancer-related pain
Danish: Cancerrelaterede smerter
English: Safety and tolerability over an extended 12-week period Kodiac 7 was a 12-week safety extension that allowed for patients from Kodiac 4 to continue the same blinded treatment from Kodiac 4 for an additional 12 weeks (placebo, naloxegol 12.5 mg or 25 mg daily).
Danish: Sikkerhed og tolerance over en 12-ugers forlængelsesperiode Kodiac 7 var en 12-ugers sikkerhedsforlængelse, der tillod patienter fra Kodiac 4 at fortsætte med den samme blindede behandling som i Kodiac 4 i yderligere 12 uger (placebo, naloxegol 12,5 mg eller 25 mg dagligt).
English: During the 52-week treatment period there were no important unexpected differences in the safety and tolerability findings between the naloxegol 25 mg treatment group and the usual care treatment group.
Danish: I løbet af den 52-ugers behandlingsperiode var der ingen vigtige uventede forskelle i sikkerheden og tolerancen mellem de grupper, der fik hhv. naloxegol 25 mg og sædvanlig behandling.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 12.5 mg / 25 mg tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. 12,5 mg / 25 mg tablet, dvs. det er i det væsentlige natrium-frit.
English: • To make sure there is no medicine left, rinse the empty glass with another half a glass of water (120 ml), and drink it
Danish: • For at sikre, at der ikke er noget medicin tilbage, skal du skylle det tomme glas med endnu et halvt glas vand (120 ml) og drikke det.
English: Patients assigned to usual care followed a laxative treatment regimen for OIC determined by the investigator according to best clinical judgment, excluding peripheral mu-opioid receptor antagonists.
Danish: De patienter, der fik tildelt sædvanlig behandling, fulgte et laksansbehandlingsregimen for opioidinduceret obstipation, der blev fastlagt af investigatoren på baggrund af dennes bedste kliniske vurdering, eksklusive perifere my-opioidreceptorantagonister.
English: A double-blind, randomized, 2-part, crossover, single centre study was conducted to evaluate the effect of quinidine on the pharmacokinetics of naloxegol and the effect of the co-administration of naloxegol and quinidine on morphine-induced miosis in healthy volunteers.
Danish: Der blev udført et dobbeltblindet, randomiseret overkrydsningsstudie i 2 dele på et enkelt center for at evaluere virkningen af quinidin på farmakokinetikken af naloxegol og virkningen af samtidig administration af naloxegol og quinidin på morfininduceret miosis hos raske frivillige.
English: • if your bowels are, or may be, blocked (obstructed) or you have been warned that your bowels are at risk of becoming blocked.
Danish: • hvis dine tarme er, eller der er mistanke om, at de er blokerede, eller hvis du har fået at vide, at du har risiko for, at dine tarme bliver blokeret.
English: There was no relevant impact on abdominal symptoms in either study (p=0.256 and p=0.916, Kodiac 4 and 5, respectively).
Danish: Der var ingen relevant indvirkning på mavesymptomer i nogen af studierne (p=0,256 og p=0,916 i hhv. Kodiac 4 og 5).
English: Due to poorer permeability and increased efflux of naloxegol across the blood-brain barrier, related to P-gp substrate properties, the CNS penetration of naloxegol is minimal.
Danish: På grund af den ringere permeabilitet og øgede effluks af naloxegol på tværs af blod-hjernebarrieren, der er relateret til P-gp-substratets egenskaber, er naloxegols indtrængen i CNS minimal.