natgillin/translations-raw huggingface dataset:
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).
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).
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.
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.
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.
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'.
• 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.
• To make sure there is no medicine left, rinse the empty glass with another half a glass of water (120 ml), and drink it
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.
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.
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.
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.
• 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.
• if your bowels are, or may be, blocked (obstructed) or you have been warned that your bowels are at risk of becoming blocked.
Der var ingen relevant indvirkning på mavesymptomer i nogen af studierne (p=0,256 og p=0,916 i hhv. Kodiac 4 og 5).
There was no relevant impact on abdominal symptoms in either study (p=0.256 and p=0.916, Kodiac 4 and 5, respectively).
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.
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.
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.
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.
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.
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.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER Perforeret enkeltdosisblister Ikke-perforeret blister
MINIMUM PARTICULARS TO APPEAR ON BLISTERS Blister perforated unit dose
I et langsigtet sikkerhedsstudie (Kodiac 8) var hyppigheden af hændelsesrapporter om rygsmerter 8,9 % med naloxegol 25 mg kontra 8,8 % med sædvanlig behandling.
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.
Sikkerhed og virkning er ikke fastlagt hos patienter med svær leverinsufficiens (se pkt.
Safety and efficacy have not been established in patients with severe hepatic impairment (see section 5.2).
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.
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.
Det frarådes at anvende naloxegol hos sådanne patienter.
The use of naloxegol is not recommended in such patients.
Flatulens, kvalme, opkastning
Flatulence, nausea, vomiting
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.
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.
• hvis du har nyreproblemer.
• if you have kidney problems
Enterohepatisk recirkulation kan være forklaringen, idet der blev set omfattende udskillelse i galden hos rotter.
Enterohepatic recirculation may be an explanation as extensive biliary excretion was seen in the rat.
• mavesmerter • diarré (hyppige, vandige afføring)
• stomach pain • diarrhoea (passing of frequent, watery stools)
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.
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.
• underliggende maligniteter i mave-tarm-kanalen eller peritoneum
• underlying malignancies of gastrointestinal tract or peritoneum
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.
In a few cases, symptoms suggestive of opioid withdrawal when taking naloxegol 25 mg were observed in patients taking methadone for their pain condition.
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.
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.
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.
When treatment with Moventig is started, all currently used laxatives should be stopped, until instructed by your doctor to restart.
Brug hos ammende mødre frarådes derfor.
Therefore, use in breast-feeding mothers is not recommended.
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.
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.
• diltiazem eller verapamil (mod forhøjet blodtryk eller brystsmerter (angina)).
• diltiazem or verapamil (for high blood pressure or angina).
Brug af anden medicin sammen med Moventig
Other medicines and Moventig
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.
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.
Dosering Den anbefalede dosis af Moventig er 25 mg én gang dagligt.
Posology The recommended dose of Moventig is 25 mg once daily.
Virkningsmekanisme og farmakodynamisk virkning Naloxegol er et PEGyleret derivat af my-opioidreceptorantagonisten naloxon.
Mechanism of action and pharmacodynamic effects Naloxegol is a PEGylated derivative of the mu-opioid receptor antagonist naloxone.
Studier af diende rotter har vist, at naloxegol udskilles i mælken.
Studies in suckling rats have shown that naloxegol is excreted in the milk.
Det er vigtigt, at blod-hjernebarrieren er intakt for at minimere optagelsen af naloxegol i CNS.
The blood brain barrier integrity is important for minimizing naloxegol uptake into the CNS.
Oval, 13 x 7 mm, lyserød tablet.
Oval, 13x7 mm, mauve tablet.
Endepunktet symptomrespondenter
Symptom responder end-point
Moventig er indiceret til behandling af opioidinduceret obstipation hos voksne patienter, som har haft et utilstrækkeligt respons på laksantia.
Moventig is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
Indvirkningen af svær leverinsufficiens (Child-Pughklasse C) på farmakokinetikken af naloxegol blev ikke vurderet.
Effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naloxegol was not evaluated.
Startdosen til patienter, der tager moderate CYP3A4-hæmmere (f.eks. diltiazem, verapamil) er 12,5 mg én gang dagligt.
The starting dose for patients taking moderate CYP3A4 inhibitors (e.g. diltiazem, verapamil) is 12.5 mg once daily.
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).
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).
Der skal derfor udvises forsigtighed ved ordination af naloxegol til sådanne patienter (se pkt.
Therefore, caution should be used when prescribing naloxegol to such patients (see section 4.3).
Eksponeringen for naloxegol hos patienter med nyresygdom i slutstadiet i hæmodialyse var ensartet med eksponeringen hos raske frivillige med normal nyrefunktion.
Exposure of naloxegol in end-stage renal disease (ESRD) patients on haemodialysis was similar to healthy volunteers with normal renal function.
Det anbefales derfor at justere dosis af naloxegol ved samtidig administration af diltiazem og andre moderate CYP3A4-hæmmere (se pkt.
Therefore, a dose adjustment of naloxegol is recommended when co-administered with diltiazem and other moderate CYP3A4 inhibitors (see section 4.2).
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.
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.
Klinisk betydelige beskadigelser af blod-hjernebarrieren Naloxegol er en perifert virkende my-opioidreceptorantagonist med begrænset adgang til centralnervesystemet (CNS).
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).
Der er begrænset klinisk erfaring med brug af naloxegol hos patienter med opioidinduceret obstipation og cancerrelaterede smerter.
There is limited clinical experience with the use of naloxegol in OIC patients with cancer-related pain.
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).
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).
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.
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.
I kliniske studier blev der administreret naloxegol-doser på op til 1.000 mg hos raske forsøgspersoner.
Doses of naloxegol up to 1,000 mg were administered in healthy volunteers in clinical studies.
Naloxegols indvirkning på fertiliteten hos mennesker er ikke blevet undersøgt.
The effect of naloxegol on fertility in humans has not been studied.
Respondentraterne i denne population var 30 % med placebo, 44,3 % med 12,5 mg og 44,4 % med 25 mg.
The responder rates in this population were placebo 30.0%, 12.5 mg 44.3% and 25 mg 44.4%.
Opioidabstinens -syndrom
Opioid withdrawal syndrome
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).
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).
Det er ikke nødvendigt at justere dosen hos patienter, der tager svage CYP3A4-hæmmere.
No dosage adjustment is required for patients taking weak CYP3A4 inhibitors.
Der er en teoretisk mulighed for, at naloxegol kan fremprovokere opioidabstinens hos et ammet spædbarn, hvis moder tager en opioidreceptoragonist.
There is a theoretical possibility that naloxegol could provoke opioid withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist.
Hvad angår ekstremitetssmerter, var hyppigheden med naloxegol 25 mg 3,5 % kontra 3,3 % med sædvanlig behandling.
For extremity pain, the rate for naloxegol 25 mg was 3.5% versus 3.3% for usual care.
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.
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).
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.
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.
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.
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.
• 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.
• 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
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.
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.
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.
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.
• rifampicin (et antibiotikum), carbamazepin (mod epilepsi) eller naturlægemidlet perikon (mod depression).
• rifampin (an antibiotic), carbmazepine (for epilepsy) or the herbal medicine St. John's wort (for depression).
Det kan være, at du skal stoppe med at tage Moventig.
You may need to stop taking Moventig
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.
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.
Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager et eller flere af følgende lægemidler:
Tell your doctor, pharmacist or nurse if you are taking any of the following medicines:
• 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).
• 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).
Oval, 10,5 x 5,5 mm, lyserød tablet.
Oval, 10.5x5.5 mm, mauve tablet.
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.
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.
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.
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.
Interaktion med P-gp-hæmmere
Interaction with P-gp inhibitors
• 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.
• 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).
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.
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.
Hvis der opstår tegn på opioidmedierede forstyrrelser i analgesi eller opioidabstinens, skal patienten instrueres i at seponere Moventig og kontakte lægen.
If evidence for opioid-mediated interference with analgesia or opioid withdrawal syndrome occurs, patients should be instructed to discontinue Moventig and contact their physician.
Brug hos patienter med svær leverinsufficiens er frarådet.
Use in patients with severe hepatic impairment is not recommended.
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
(≥ 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).
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).
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).
Hvis der er mistanke om opioidabstinenssyndrom, skal patienten seponere Moventig og kontakte sin læge.
If opioid withdrawal syndrome is suspected the patient should discontinue Moventig and contact their physician.
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.
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.
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.
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.
Pædiatrisk population Brug af naloxegol i den pædiatriske population er ikke blevet undersøgt.
Paediatric population The use of naloxegol in the paediatric population has not been studied.