FrancophonIA/ELRC3.0 huggingface dataset:
English: Efficacy and durability of effect were measured in the primary end-point as response over the 12-week treatment period to naloxegol as defined by > 3 SBMs per week and a change from baseline of > 1 SBM per week for at least 9 out of the 12 study weeks and 3 out of the last 4 weeks.
Danish: Virkning hos den patientpopulation, som dette produktresumé henvender sig til Respons over 12 uger i gruppen med utilstrækkeligt respons på laksantia Effektiviteten og virkningsvarigheden blev målt i det primære endepunkt som respons på naloxegol over en 12-ugers behandlingsperiode, hvilket var defineret som ≥3 SBM om ugen og en ændring i forhold til baseline på ≥1 SBM om ugen i mindst 9 ud af de 12 studieuger og 3 ud af de sidste 4 uger.
English: Method of administration Oral use.
Danish: Administration Oral anvendelse
English: However, in 2 out of 8 patients (in both the moderate and severe renal impairment groups but not in the end stage renal failure group) up to 10-fold increases in the exposure of naloxegol were observed.
Danish: Der blev dog set op til 10-folds stigninger i eksponeringen for naloxegol hos 2 ud af 8 patienter (i grupperne med såvel moderat som svær nyreinsufficiens, men ikke i gruppen med nyreinsufficiens i slutstadiet).
English: If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.
Danish: Hvis noget af ovennævnte gælder for dig, eller du er i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Moventig.
English: Gastrointestinal perforation (see section 4.4)
Danish: Gastrointestinal perforation (se pkt.
English: Naloxegol was not studied in the clinical trial programme in patients who had a recent history of myocardial infarction within 6 months, symptomatic congestive heart failure, overt cardiovascular (CV) disease or patients with a QT interval of ≥ 500 msec. Moventig should be used with caution in these patients.
Danish: I det kliniske studieprogram blev naloxegol ikke undersøgt hos patienter med nyligt myokardieinfarkt (inden for 6 måneder), symptomatisk kongestivt hjertesvigt, åbenlys kardiovaskulær (CV) sygdom i anamnesen eller hos patienter med et QT-interval ≥ 500 msek.
English: In the 12-week studies (Kodiac 4 and 5), the frequency of back pain AEs was 4.3% for naloxegol 25 mg versus 2.0% for placebo, and the frequency of extremity pain AEs was 2.2% for naloxegol 25 mg, versus 0.7% for placebo.
Danish: I studierne af 12 ugers varighed (Kodiac 4 og 5) var hyppigheden af hændelser i form af rygsmerter 4,3 % med naloxegol 25 mg kontra 2,0 % med placebo, og hyppigheden af hændelser i form af ekstremitetssmerter var 2,2 % med naloxegol 25 mg kontra 0,7 % med placebo.
English: How to take Moventig
Danish: Sådan skal du tage Moventig
English: In the pooled data from Kodiac 4 and Kodiac 5, responder rates in the LIR subgroup were 30.1% for placebo, 42.5% for the 12.5 mg dose, and 47.7% for the 25 mg dose, with the relative risk (95% CI) for treatment effect versus placebo of 1.410(1.106, 1.797) and 1.584(1.253, 2.001) for the 12.5 mg and 25 mg groups, respectively.
Danish: I de samlede data fra Kodiac 4 og Kodiac 5 var respondentraterne i undergrupperne med utilstrækkeligt respons på laksantia 30,1 % med placebo, 42,5 % med 12,5 mg-dosen og 47,7 % med 25 mg-dosen, og den relative risiko (95 % CI) for behandlingens virkning kontra placebo var hhv. 1.410(1.106, 1.797) og 1.584(1.253, 2.001) i grupperne med 12,5 mg og 25 mg.
English: There was a higher incidence of discontinuations in patients taking the 25 mg dose compared to placebo due to diarrhoea (0.7% for placebo versus 3.1% for naloxegol 25 mg) and abdominal pain (0.2% versus 2.9%, respectively).
Danish: Hos de patienter, der tog 25 mgdosen, var der en højere forekomst af seponering på grund af diarré (0,7 % med placebo kontra 3,1 % med naloxegol 25 mg) og mavesmerter (hhv. 0,2 % kontra 2,9 %), end hos de patienter, der tog placebo.
English: Tell your doctor immediately, you may need a lower dose or to stop taking Moventig.
Danish: Du skal måske have en lavere dosis eller stoppe med at tage Moventig.
English: Therefore, Moventig is not recommended in patients who are taking strong CYP3A4 inducers (see section 4.4).
Danish: Derfor er Moventig frarådet hos patienter, der tager stærke CYP3A4-induktorer (se pkt.
English: Naloxegol has not been studied in patients with severe hepatic impairment.
Danish: Naloxegol er ikke undersøgt hos patienter med svær leverinsufficiens.
English: Therefore, naloxegol has not been studied in OIC patients with moderate or severe hepatic impairment.
Danish: Naloxegol er derfor ikke undersøgt hos patienter med opioidinduceret obstipation og moderat eller svær leverinsufficiens.
English: Naloxegol was found to have no effect on fertility of male and female rats at oral doses up to 1,000 mg/kg per day (greater than 1,000 times the human therapeutic exposure (AUC) at the recommended human dose of 25 mg/day).
Danish: 1.000 mg/kg pr. dag (over 1.000 gange højere end den humane terapeutiske eksponering (AUC) ved brug af den anbefalede humane dosis på 25 mg/dag).
English: No dosage adjustment is required for patients with mild renal impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med mild nyreinsufficiens.
English: Clinical studies of naloxegol did not include sufficient numbers of patients aged 75 years or over to determine whether they respond differently than younger patients, however, based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in this age group.
Danish: De kliniske studier af naloxegol omfattede ikke et tilstrækkeligt antal patienter over 75 år til at afgøre, hvorvidt de responderer anderledes end yngre patienter.
English: EU/1/14/962/001 30 film-coated tablets EU/1/14/962/002 90 film-coated tablets EU/1/14/962/008 30 x 1 film-coated tablets (unit dose) EU/1/14/962/003 90 x 1 film-coated tablets (unit dose)
Danish: EU/1/14/962/001 30 filmovertrukne tabletter EU/1/14/962/002 90 filmovertrukne tabletter EU/1/14/962/008 30 x 1 filmovertrukne tabletter (enkeltdosis) EU/1/14/962/003 90 x 1 filmovertrukne tabletter (enkeltdosis)
English: Naloxegol is not recommended in patients who are taking strong CYP3A4 inducers (e.g. carbamazepine, rifampin, St. John's Wort) (see section 4.5).
Danish: Naloxegol er frarådet til patienter, der tager stærke CYP3A4-induktorer (f.eks. carbamazepin, rifampicin, hypericum perforatum) (se pkt.
English: As renal clearance is a minor route of elimination for naloxegol, regardless of severity (i.e. moderate, severe and end stage renal failure), the impact of renal impairment on the pharmacokinetics of naloxegol was minimal in most subjects.
Danish: Da den renale clearance udgør en ubetydelig eliminationsvej for naloxegol, var indvirkningen af nyreinsufficiens på farmakokinetikken af naloxegol minimal hos de fleste patienter, uanset sværhedsgrad (dvs. nyreinsufficiens af moderat og svær grad og i slutstadiet).
English: Abdominal paina, diarrhoea
Danish: Mavesmertera, diarré
English: Moventig 25 mg tablets are available in aluminium blisters in pack sizes of 10, 30 or 90 film--coated tablets in non-perforated blisters and 10x1, 30x1, 90x1 or 100x1 film-coated tablets in perforated unit dose blisters.
Danish: Moventig 25 mg tabletter fås i aluminiumblistre i pakningsstørrelserne 10, 30 eller 90 filmovertrukne tabletter i blistre uden perforering og 10x1, 30x1, 90x1 eller 100x1 tabletter i perforerede enkeltdosisblistre.
English: Tablet core mannitol (E421) cellulose microcrystalline (E460) croscarmellose sodium (E468) magnesium stearate (E470b) propyl gallate (E310)
Danish: Tabletkerne mannitol (E421) cellulose, mikrokrystallinsk (E460) croscarmellosenatrium (E468) magnesiumstearat (E470b) propylgallat (E310)
English: Paediatric population The pharmacokinetics of naloxegol in the paediatric population has not been studied.
Danish: Pædiatrisk population Farmakokinetikken af naloxegol i den pædiatriske population er ikke blevet undersøgt.
English: 10 film-coated tablets 30 film-coated tablets 90 film-coated tablets 10 x 1 film-coated tablets 30 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
Danish: 10 filmovertrukne tabletter 30 filmovertrukne tabletter 90 filmovertrukne tabletter 10 x 1 filmovertrukne tabletter 30 x 1 filmovertrukne tabletter 90 x 1 filmovertrukne tabletter 100 x 1 filmovertrukne tabletter
English: Naloxegol 25 mg dose, compared with placebo, also resulted in greater improvement (change from baseline) of week 12 PAC-SYM rectal domain scores in both studies (p=0.004 and p<0.001, Kodiac 4 and 5, respectively) and for the stool domain scores in Kodiac 4 (p=0.031) and Kodiac 5 (p<0.001).
Danish: Sammenlignet med placebo gav naloxegol 25 mg-dosen også større forbedring (ændring i forhold til baseline) efter uge 12 på PAC-SYM, hvad angik rektaldomænescorer i begge studier (p=0,004 og p<0,001 i hhv. Kodiac 4 og 5) og afføringsdomænescorer i Kodiac 4 (p=0,031) og Kodiac 5 (p<0,001).
English: − tablet core: mannitol (E421), cellulose microcrystalline (E460), croscarmellose sodium (E468) - see section 2 under ‘Moventig contains sodium', magnesium stearate (E470b), propyl gallate (E310)
Danish: • Øvrige indholdsstoffer: tabletkerne: mannitol (E421), mikrokrystallinsk cellulose (E460), croscarmellosenatrium (E468) - se afsnit 2 under 'Moventig indeholder natrium', magnesiumstearat (E470b), propylgallat (E310).
English: Therefore, concomitant use with strong CYP3A4 inhibitors is contraindicated (see section 4.3).
Danish: Derfor er samtidig brug af stærke CYP3A4-hæmmere kontraindiceret (se pkt.
English: − film-coating: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), iron oxide red (E172) and iron oxide black (E172).
Danish: filmovertræk: hypromellose (E464), titandioxid (E171), macrogol (E1521), rød jernoxid (E172) og sort jernoxid (E172).
English: Pack sizes of 10 x 1, 30 x 1, 90 x 1 and 100 x 1 film-coated tablets in perforated unit dose blisters.
Danish: Pakningsstørrelser med 10 x 1, 30 x 1, 90 x 1 og 100 x 1 filmovertrukne tabletter i perforerede enkeltdosisblistre.
English: Tell your doctor, you may need to stop taking Moventig.
Danish: Kontakt lægen, det kan være nødvendigt at stoppe behandlingen med Moventig.
English: In Kodiac 4, response rates in the placebo, 12.5 mg and 25 mg groups in the LIR subgroup were 28.8%, 42.6% and 48.7%, while in Kodiac 5, the corresponding response rates were 31.4, 42.4% and 46.8%.
Danish: I Kodiac 4 var responsraterne i placebo-, 12,5 mg- og 25 mg-grupperne i undergruppen med utilstrækkeligt respons på laksantia hhv. 28,8 %, 42,6 % og 48,7 %, mens de tilsvarende responsrater i Kodiac 5 var på hhv.31,4 %, 42,4 % og 46,8 %.
English: Talk to your doctor, pharmacist or nurse whilst taking Moventig:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, mens du tager Moventig:
English: Package leaflet: Information for the patient Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets naloxegol
Danish: Indlægsseddel: Information til patienten Moventig 12,5 mg filmovertrukne tabletter Moventig 25 mg filmovertrukne tabletter naloxegol
English: Patients taking methadone as primary therapy for their pain condition were observed in clinical trials to have a higher frequency of gastrointestinal adverse reactions (such as abdominal pain and diarrhoea) than patients not receiving methadone.
Danish: I kliniske studier var der en højere forekomst af gastrointestinale bivirkninger (såsom mavesmerter og diarré) hos de patienter, der tog methadon som primær behandling for deres smertetilstand, end hos de patienter, der ikke fik methadon.
English: No dose adjustment is required for patients with mild to moderate hepatic impairment.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med mild til moderat leverinsufficiens.
English: In an open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, single-dose, crossover study to evaluate the effect of multiple doses of rifampin on the single dose PK of naloxegol, coadministration of rifampin and naloxegol resulted in a 89% (90% CI: 88%-90%) decrease in naloxegol AUC and a 76% decrease in naloxegol Cmax (90% CI: 69%-80%), compared to when naloxegol was administered alone.
Danish: I et ikke-randomiseret overkrydsningsstudie med åben behandling, faste sekvenser, 3 perioder, 3 behandlinger og enkeltdosis til evaluering af virkningen af flere doser af rifampicin på farmakokinetikken af enkeltdosis-naloxegol, resulterede samtidig administration af rifampicin og naloxegol i en reduktion på 89 % (90 % CI: 88 %-90 %) i AUC af naloxegol og i en reduktion på 76 % i Cmax af naloxegol (90 % CI: 69 %-80 %), sammenlignet med administration af naloxegol alene.
English: No dose adjustment is required for patients taking weak CYP3A4 inhibitors (e.g. alprazolam, atorvastatin (see section 4.5).
Danish: Det er ikke nødvendigt at justere dosis hos patienter, der tager svage CYP3A4-hæmmere (f.eks. alprazolam, atorvastatin) (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSER)
English: The LIR subgroup symptom responder rates in Kodiac 4 for placebo, 12.5 mg and 25 mg arms were 24.6%, 36.5% and 45.3% and the symptom responder rates in Kodiac 5 were 25.6%, 33.6% and 42.7%.
Danish: Symptomresponsraten i undergruppen med utilstrækkeligt respons på laksantia i Kodiac 4 var 24,6 % med placebo, 36,5 % med 12,5 mg og 45,3 % med 25 mg, og symptomresponsraterne i Kodiac 5 var hhv. 25,6 %, 33,6 % og 42,7 %.
English: EU/1/14/962/004 10 film-coated tablets EU/1/14/962/005 30 film-coated tablets EU/1/14/962/006 90 film-coated tablets EU/1/14/962/009 10 x 1 film coated tablets (unit dose) EU/1/14/962/010 30 x 1 film-coated tablets (unit dose) EU/1/14/962/007 90 x 1 film-coated tablets (unit dose) EU/1/14/962/011 100 x 1 film-coated tablets (unit dose)
Danish: EU/1/14/962/004 10 filmovertrukne tabletter EU/1/14/962/005 30 filmovertrukne tabletter EU/1/14/962/006 90 filmovertrukne tabletter EU/1/14/962/009 10 x 1 filmovertrukne tabletter (enkeltdosis) EU/1/14/962/010 30 x 1 filmovertrukne tabletter (enkeltdosis) EU/1/14/962/007 90 x 1 filmovertrukne tabletter (enkeltdosis) EU/1/14/962/011 100 x 1 filmovertrukne tabletter (enkeltdosis)
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or any other opioid antagonist.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne angivet i pkt.
English: Moventig 12.5 mg tablets are available in aluminium blisters in pack sizes of 30 or 90 film-coated tablets in non-perforated blisters and 30x 1 or 90x1 film-coated tablets in perforated unit dose blisters.
Danish: Moventig 12,5 mg tabletter fås i aluminiumblistre i pakningsstørrelserne 30 eller 90 filmovertrukne tabletter i blistre uden perforering og 30x1 eller 90x1 tabletter i perforerede enkeltdosisblistre.
English: Talk to your doctor, pharmacist or nurse before taking Moventig:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Moventig:
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Moventig.
Danish: Hvis du er i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Moventig.
English: 30 film-coated tablets 90 film-coated tablets 30 x 1 film-coated tablets 90 x 1 film-coated tablets
Danish: 30 filmovertrukne tabletter 90 filmovertrukne tabletter 30 x 1 filmovertrukne tabletter 90 x 1 filmovertrukne tabletter
English: Concurrent methadone use
Danish: Samtidig brug af methadon
English: Under multiplicity testing procedure, statistical significance for the 12.5 mg treatment group versus placebo in the LIR subgroup was observed in Kodiac 4 (p=0.028) but not in Kodiac 5 (p=0.074).
Danish: Under multiplicitetsafprøvningsproceduren blev der set statistisk signifikans i forhold til placebo i den behandlingsgruppe, der fik 12,5 mg, i undergruppen med utilstrækkeligt respons på laksantia i Kodiac 4 (p=0,028) men ikke i Kodiac 5 (p=0,074).
English: Naloxegol exposure was found to increase with increased weight, however, the differences in exposure were not considered clinically relevant.
Danish: Forskellene i eksponeringen blev dog ikke anset for at være klinisk relevante.
English: The 12.5 mg dose in the LIR subgroup also resulted in greater improvement in total PAC SYM at week 12 compared with placebo in both studies (p= 0.020 and p=0.001 respectively).
Danish: I undergruppen med utilstrækkeligt respons på laksantia resulterede 12,5 mg-dosen også i en større forbedring end placebo i total PAC SYM efter 12 uger i begge studier (hhv. p=0,020 og p=0,001).
English: piloerection, sweating, diarrhoea, yawning, fever or insomnia.
Danish: mavesmerter, diarré, kvalme, hovedpine og flatulens.
English: • rectal straining (having to push very hard to move the stool out of the rectum, which can also cause pain in the anus during pushing)
Danish: • anstrengelse ved afføring (du skal presse meget hårdt for at få afføringen ud af endetarmen,
English: There is no gender effect on the PK of naloxegol.
Danish: Køn har ingen indvirkning på farmakokinetikken af naloxegol.
English: Stool consistency in the LIR subgroup as measured by the Bristol stool scale improved in Kodiac 5 versus placebo (p<0.001) but not in Kodiac 4 (p=0.156).
Danish: Afføringskonsistensen målt på Bristol afføringsskala (Bristol Stool Scale) blev forbedret i undergruppen med utilstrækkeligt respons på laksantia i Kodiac 5 kontra placebo (p<0,001) men ikke i Kodiac 4 (p=0,156).
English: Mean number of days per week with at least one SBM There was an increase in the mean number of days per week with at least one SBM in the LIR subgroup for the 25 mg dose in Kodiak 4 and Kodiac 5 (p<0.001 in both studies) and also for the 12.5 mg dose (p=0.006 in both studies).
Danish: Gennemsnitligt antal dage om ugen med mindst en spontan afføring Der var en stigning i det gennemsnitlige antal dage om ugen med mindst en spontan afføring i undergruppen med utilstrækkeligt respons på laksantia med 25 mg-dosen i Kodiac 4 og Kodiac 5 (p<0,001 i begge studier) og også med 12,5 mg-dosen (p=0,006 i begge studier).
English: Moventig 25 mg film-coated tablet (tablet).
Danish: Moventig 25 mg filmovertrukken tablet (tablet).
English: Reports of severe abdominal pain and diarrhoea have been observed in clinical trials with the 25 mg dose, typically occurring shortly after initiation of treatment.
Danish: Der er rapporteret om svære mavesmerter og diarré i kliniske studier med 25 mg-dosen.
English: Patients with CV conditions
Danish: Patienter med kardiovaskulære sygdomme
English: There was a statistically significant difference for the 25 mg dose versus placebo for the LIR subgroup responder rate in Kodiac 4 (p=0.002) and Kodiac 5 (p=0.014).
Danish: Der var en statistisk signifikant forskel med 25 mg-dosen kontra placebo i respondentraten i undergruppen med utilstrækkeligt respons på laksantia i Kodiac 4 (p=0,002) og Kodiac 5 (p=0,014).
English: Tablet coat hypromellose (E464) titanium dioxide (E171) macrogol (E1521) iron oxide red (E172) iron oxide black (E172)
Danish: Tabletovertræk hypromellose (E464) titandioxid (E171) macrogol (E1521) jernoxid, rød (E172) jernoxid, sort (E172)
English: In Kodiac 4, placebo, 12.5 mg and 25 mg dose had median time to first post dose SBM of 43.4, 20.6, and 5.4 hours, respectively.
Danish: I Kodiac 4 var den gennemsnitlige tid til første spontane afføring efter dosering af placebo, 12,5 mg og 25 mg hhv. 43,4 timer, 20,6 timer og 5,4 timer.
English: Moventig 12.5 mg film-coated tablet (tablet).
Danish: Moventig 12,5 mg filmovertrukken tablet (tablet).
English: In an open-label, non-randomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect of multiple doses of ketoconazole on the single dose PK of naloxegol, co-administration of ketoconazole and naloxegol resulted in a 12.9 fold (90% CI: 11.3-14.6) increase in naloxegol AUC and a 9.6-fold increase in naloxegol Cmax (90% CI: 8.1-11.3), compared to when naloxegol was administered alone.
Danish: I et ikke-randomiseret overkrydsningsstudie med åben behandling, faste sekvenser, 3 perioder og 3 behandlinger til evaluering af virkningen af flere doser af ketoconazol på farmakokinetikken af enkeltdosis-naloxegol, resulterede samtidig administration af ketoconazol og naloxegol i en 12,9-folds (90 % CI: 11,3-14,6) stigning i AUC af naloxegol og i en 9,6-folds stigning i Cmax af naloxegol (90 % CI: 8,1-11,3), sammenlignet med administration af naloxegol alene.
English: Pack sizes of 10, 30 and 90 film-coated tablets in non-perforated blisters.
Danish: Pakningsstørrelser med 10, 30 og 90 filmovertrukne tabletter i ikke-perforerede blistre.
English: Pack sizes of 30 and 90 film-coated tablets in non-perforated blisters.
Danish: Pakningsstørrelser med 30 og 90 filmovertrukne tabletter i ikke-perforerede blistre.
English: In an open-label, nonrandomized, fixed-sequence, 3-period, 3-treatment, crossover study to evaluate the effect of multiple doses of diltiazem on the single dose PK of naloxegol, co-administration of diltiazem and naloxegol resulted in a 3.4-fold (90% CI: 3.2-3.7) increase in naloxegol AUC and a 2.9fold increase in naloxegol Cmax (90% CI: 2.6-3.1), compared to when naloxegol was administered alone.
Danish: I et ikke-randomiseret overkrydsningsstudie med åben behandling, faste sekvenser, 3 perioder og 3 behandlinger til evaluering af virkningen af flere doser af diltiazem på farmakokinetikken af enkeltdosis-naloxegol, resulterede samtidig administration af diltiazem og naloxegol i en 3,4-folds (90 % CI: 3,2-3,7) stigning i AUC af naloxegol og i en 2,9-folds stigning i Cmax af naloxegol (90 % CI: 2,6-3,1), sammenlignet med administration af naloxegol alene.
English: Patients who had a QTcF >500 msec at screening, had a recent history of myocardial infarction within 6 months before randomization, had symptomatic congestive heart failure, or had any other overt CV disease were excluded from the clinical studies.
Danish: ved screeningen, nyligt myokardieinfarkt (inden for 6 måneder inden randomisering) i anamnesen, symptomatisk kongestivt hjertesvigt eller andre åbenlyse CV-sygdomme, blev udelukket fra de kliniske studier.
English: The dose can be increased to 25 mg if 12.5 mg is well tolerated by the patient (see section 4.2).
Danish: Dosen kan øges til 25 mg, hvis 12,5 mg er veltolereret af patienten (se pt.
English: In the LIR subgroup, the 25 mg dose increased the symptom responder rates in both studies as compared to placebo (Kodiac 4 p=0.001, Kodiac 5 p=0.005).
Danish: I undergruppen med utilstrækkeligt respons på laksantia øgede 25 mg-dosen symptomresponsraten i begge studier i forhold til placebo (Kodiac 4 p=0,001, Kodiac 5 p=0,005).
English: Note: Selection of ADRs and their frequencies based on the 25 mg dose a Reflects MedDRA Preferred Terms of: “abdominal pain”, “abdominal pain upper”, “abdominal pain lower” and “gastrointestinal pain”.
Danish: a Afspejler den foretrukne MedDRA-term for: "mavesmerter”, ”øvre mavesmerter”, ”nedre mavesmerter” og ”gastrointestinale smerter”.
English: In patients taking opioids with constipation, who have tried at least one laxative and had incomplete relief of constipation, Moventig has been shown in clinical trials to increase the number of bowel movements and improve symptoms of constipation caused by opioids.
Danish: Det er påvist i kliniske forsøg; at Moventig øger antallet af afføringer og forbedrer opioidforårsagede forstoppelsessymptomer hos patienter, der tager opioider, der forårsager forstoppelse, og som har prøvet mindst et afføringsmiddel uden at opnå komplet lindring af forstoppelse.
English: Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets
Danish: Moventig 12,5 mg filmovertrukne tabletter Moventig 25 mg filmovertrukne tabletter
English: Interaction with strong CYP3A4 inducers
Danish: Interaktion med stærke CYP3A4-induktorer
English: If you take more Moventig than you should
Danish: Hvis du har taget for meget Moventig
English: Each film-coated tablet contains 25 mg naloxegol (as naloxegol oxalate).
Danish: Hver filmovertrukken tablet indeholder 25 mg naloxegol (som naloxegoloxalat).