FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have cancer of the brain or central nervous system, multiple sclerosis, or Alzheimer's disease.
Danish: - hvis du har kræft i hjernen eller centralnervesystemet, multipel sklerose eller Alzheimers sygdom.
English: - if you have severe diarrhoea or stomach ache, tell your doctor, so that the doctor can monitor you and treat you with rehydration and appropriate medicines if needed.
Danish: - hvis du har svær diarré eller mavesmerter, skal du fortælle det til lægen, så lægen kan overvåge dig og behandle dig med rehydrering og om nødvendigt passende lægemidler.
English: The apparent terminal elimination half-life of naldemedine is approximately 11 hours, and the apparent total clearance (CL/F) of naldemedine is 8.4 L/h.
Danish: Den tilsyneladende terminale eliminationshalveringstid for naldemedin er ca. 11 timer, og den tilsyneladende totale clearance (CL/F) af naldemedin er 8,4 l/t.
English: A QTc study performed with naldemedine in healthy volunteers did not indicate any prolongation of the QT interval.
Danish: Et QTc-studie, der blev udført med naldemedin hos raske frivillige, indikerede ikke nogen forlængelse af QT-intervallet.
English: Patients with cardiovascular conditions
Danish: Patienter med kardiovaskulære sygdomme
English: Patients should be advised to report severe, persistent or worsening symptoms to their physician.
Danish: Patienterne skal rådes til at indberette svære, vedvarende eller forværrede symptomer til deres læge.
English: • Gastrointestinal perforation (a hole developing in the bowel wall)
Danish: • Mave-tarm-perforation (et hul, der udvikler sig i tarmvæggen)
English: Two of the nine cases have been classified as cases of interest by the MAH, one of which they consider ‘possibly related' and other ‘probably related'.
Danish: Indehaveren af markedsføringstilladelsen har klassificeret 2 af de 9 tilfælde som interessetilfælde, hvor de anser det ene af tilfældene som ‘muligvis relateret' og det andet som ‘sandsynligvis relateret'.
English: The MAH identified nine cases of gastrointestinal perforation in their global database.
Danish: Indehaveren af markedsføringstilladelsen har identificeret 9 tilfælde af mave-tarm-perforation i deres globale database.
English: Stop taking Rizmoic and contact your doctor if you get a combination of 3 or more of the following symptoms of opioid withdrawal on the same day:
Danish: Stop med at tage Rizmoic og kontakt lægen, hvis du får en kombination af 3 eller flere af de følgende symptomer på opioidabstinens på samme dag:
English: • The recommended dose is one 200 microgram tablet once daily.
Danish: • Den anbefalede dosis er én 200 mikrogram tablet én gang dagligt.
English: A responder was defined as a patient with ≥3 frequency of SBMs per week and an increase from baseline ≥1 SBM per week during the 2-week Treatment Period
Danish: En responder blev defineret som en patient med en hyppighed på ≥3 SBM'er pr. uge og en stigning fra baseline på ≥1 SBM pr. uge i løbet af den 2-ugers behandlingsperiode.
English: Naldemedine should not be used during pregnancy unless the clinical condition of the woman requires treatment with naldemedine.
Danish: Naldemedin bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med naldemedin.
English: If you stop taking your opioid medicine
Danish: Hvis du holder op med at tage dit opioide lægemiddel
English: Patients should be monitored for the development of severe, persistent or worsening abdominal pain.
Danish: Patienterne skal overvåges for udvikling af svære, vedvarende eller forværrede abdominalsmerter.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for naldemedine, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for naldemedin er CHMP nået frem til følgende videnskabelige konklusioner:
English: Opioid pain medicinal products
Danish: Smertelindrende opiode lægemidler
English: Using these medicines with Rizmoic may affect the way naldemedine works or increase its side effects.
Danish: Brug af disse lægemidler sammen med Rizmoic kan påvirke den måde, naldemedin virker på, eller øge dets bivirkninger.
English: Due to the limited therapeutic experience in patients 75 years old and older, naldemedine therapy should be initiated with caution in this age group.
Danish: På grund af den begrænsede terapeutiske erfaring hos patienter i alderen 75 år og ældre bør behandling med naldemedin påbegyndes med forsigtighed hos denne aldersgruppe.
English: A SBM was defined as a bowel movement (BM) without rescue laxative taken within the past 24 hours.
Danish: En SBM blev defineret som en afføring (bowel movement, BM) uden indtagelse af behovsafføringsmidler i løbet af de forudgående 24 timer.
English: Therefore, treatment with naldemedine is not expected to alter the pharmacokinetics of co-administered medicines that are substrates of these enzymes and transporters.
Danish: Derfor forventes behandlingen med naldemedin ikke at ændre farmakokinetikken for samtidigt administrerede lægemidler, der er substrater for disse enzymer og transportere.
English: If you are being treated with an opioid medicine for cancer.
Danish: Hvis du bliver behandlet med et opioidt lægemiddel for kræft.
English: In juvenile toxicity studies in rats, at the same dose levels, exposure in juvenile animals (PND 10) was increased compared to adult animals (2.3 to 7.4-fold).
Danish: I toksicitetsstudier med unge rotter var eksponeringen ved de same dosisniveauer, hos unge dyr (PND 10) øget,sammenlignet med voksne dyr (2,3 til 7,4 gange).
English: Patients receiving a stable opioid morphine equivalent daily dose of ≥ 30 mg for at least 4 weeks before enrollment and self-reported OIC were eligible to participate.
Danish: Patienter, der fik en stabil morfinækvivalent daglig opioiddosis på ≥ 30 mg i mindst 4 uger, før de indgik, og selvrapporterede OIC, var egnede til at deltage.
English: For patients receiving laxative therapy at the Screening visit, it had to be continued at a stable dose until the end of the Treatment Period.
Danish: For patienter i behandling med afføringsmiddel ved screeningsbesøget skulle dette fortsætte med en stabil dosis, indtil behandlingsperioden var færdig.
English: Three-day earlier vaginal opening indicative of an early onset of sexual maturity was also observed, but only at high exposures considered sufficiently in excess of the maximum human exposure at an oral dose of 200 micrograms.
Danish: En vaginal åbning tre dage tidligere blev også observeret, indikativt for en tidlig seksuel modenhed, men kun ved høje eksponeringer, der anses for tilstrækkeligt over den maksimale humane eksponering ved en oral dosis på 200 mikrogram.
English: In vitro data also showed that naldemedine is not a direct inhibitor of OATP1B1, OATP1B3, OAT1 and OAT3 transporters.
Danish: In vitro-data viste også, at naldemedin ikke er en direkte hæmmer af OATP1B1-, OATP1B3-, OAT1og OAT3-transportere.
English: - if you are taking certain medicines such as itraconazole to treat fungal infections, or an antibiotic called rifampicin to treat tuberculosis and other infections.
Danish: - hvis du tager visse lægemidler, såsom itraconazol, til behandling af svampeinfektioner, såsom itraconazol, eller et antibiotikum, der kaldes rifampicin, til behandling af tuberkulose eller andre infektioner.
English: 7 film-coated tablets 10 film-coated tablets 28 film-coated tablets 30 film-coated tablets 84 film-coated tablets 100 film-coated tablets
Danish: 7 filmovertrukne tabletter 10 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 84 filmovertrukne tabletter 100 filmovertrukne tabletter
English: Your opioid pain medicine may cause the following symptoms: - reduction in how often you pass stools - hard stools - stomach ache - pain in the rectum when pushing hard stools out - a feeling that the bowel is still not empty after passing stools.
Danish: Dit smertelindrende opioide lægemiddel kan forårsage de følgende symptomer: - en reduktion i hyppigheden af dine afføringer - hård afføring - mavesmerter - smerter i endetarmen ved hård afføring - en følelse af, at tarmen stadig ikke er helt tømt efter afføring.
English: Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists, ATC code: A06AH05.
Danish: Farmakoterapeutisk klassifikation: Midler mod obstipatio, perifere opioid-receptor-antagonister, ATCkode: A06AH05.
English: In the run-in and treatment periods for all three studies, bisacodyl was used as rescue laxative if patients had not had a BM for 72 hours and were allowed one-time use of an enema if after 24 hours of taking bisacodyl, they still had not had a BM.
Danish: I indkørings- og behandlingsperioderne for alle tre studier blev bisacodyl anvendt som behovsafføringsmiddel, hvis patienterne ikke havde haft en BM i 72 timer, og éngangs-brug af et lavement var tilladt, hvis de stadig ikke havde haft en BM 24 timer efter, de tog bisacodyl.
English: Healthy volunteers
Danish: Raske frivillige
English: Change in the frequency of BMs per week from baseline to each visit (LS Mean) ITT population in study V9235
Danish: Ændring i hyppigheden af BM'er pr. uge fra baseline til hvert besøg (LS gennemsnit) ITT-population i studie V9235
English: Package leaflet: Information for the patient Rizmoic 200 micrograms film-coated tablets naldemedine This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Rizmoic 200 mikrogram filmovertrukne tabletter naldemedin Dette lægemiddel er underlagt supplerende overvågning.
English: Subjects were required to be treated with opioids for ≥14 days prior to Screening and had to be receiving a stable dose.
Danish: Det var et krav, at personerne blev behandlet med opioider i ≥14 dage før screening og med en stabil dosis.
English: - if your bowel is blocked or perforated, or if there is a high risk of your bowel becoming blocked, as a blockage may cause a hole to develop in the bowel wall.
Danish: - hvis dine tarme er tilstoppede eller perforerede, eller der er en stor risiko for, at dine tarme bliver tilstoppede, da en blokering kan føre til, at der udvikles et hul i tarmvæggen.
English: Gastrointestinal perforation is added a new adverse reaction with a frequency “Not known”.
Danish: Mave-tarm-perforation er blevet tilføjet som en ny bivirkning med hyppigheden “Ikke kendt”.
English: Hypromellose Talc
Danish: Filmovertræk Hypromellose Talcum
English: Rizmoic should be taken once daily, with or without food (see section 5.2).
Danish: Rizmoic skal tages én gang dagligt sammen med eller uden mad (se pkt.
English: There is limited experience in patients treated with opioid pain medicinal product(s) at daily doses of more than the equivalent of 400 mg of morphine.
Danish: Der er begrænset erfaring hos patienter, der behandles med smertelindrende opioidt/opiode lægemiddel/-midler ved daglige doser på over, hvad der svarer til 400 mg morfin.
English: There is no specific antidote for naldemedine.
Danish: Der findes ingen specifik antidot mod naldemedin.
English: Based on this, naldemedine is expected to exert its anti-constipating effects on opioids without reversing their CNS-mediated analgesic effects.
Danish: Baseret på dette forventes naldemedin at udøve dets anti-forstoppende virkning på opioider uden at revertere deres CNS-medierede analgetiske virkninger.
English: A single dose of naldemedine up to 100 mg and multiple doses of up to 30 mg/day for 10 days were administered to healthy volunteers in clinical studies.
Danish: En enkeltdosis af naldemedin på op til 100 mg og flere doser på op til 30 mg/dag i 10 dage blev administreret til raske frivillige i kliniske studier.
English: Based on these data, naldemedine can be taken with or without food (see section 4.2).
Danish: Baseret på disse data kan naldemedin tages sammen med eller uden mad (se pkt.
English: It is therefore considered that the presented cases are sufficient to support an update to the product information to both section 4.4 and 4.8.
Danish: De fremlagte tilfælde anses derfor for at være tilstrækkelige til at støtte en opdatering af produktinformationen i både pkt.
English: Naldemedine is an antagonist of opioid binding at the mu-, delta-, and kappa-opioid receptors.
Danish: Naldemedin er en antagonist for opioidbinding på mu-, delta- og kappa-opioidreceptorerne.
English: Rizmoic contains the active substance naldemedine.
Danish: Rizmoic indeholder det aktive stof naldemedin.
English: Additionally, patients who were not on laxatives within 30 days prior to Screening and only received rescue laxative at or after Screening were considered non-LIR.
Danish: Desuden blev patienter, der ikke fik afføringsmidler inden for 30 dage før screening og kun fik behovsafføringsmiddel ved eller efter screening, anset for at være ikke-LIR.
English: Aluminium/aluminium blister containing 7, 10 or 14 film-coated tablets.
Danish: Aluminium/aluminium-blister indeholdende 7, 10 eller 14 filmovertrukne tabletter.
English: There is no experience in patients treated for constipation induced by partial opioid mu-agonists (e.g. buprenorphine).
Danish: Der er ingen erfaring hos patienter, der behandles for forstoppelse induceret af partielle opioide µ-agonister (f.eks. buprenorphin).
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
English: - if you have severe liver disease such as alcoholic liver disease, viral liver infection or impaired liver function.
Danish: - hvis du har en svær leversygdom, såsom alkoholisk leversygdom, viral leverinfektion eller nedsat leverfunktion.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and embryo-fetal development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet og embryoføtal udvikling.
English: Very Common Common
Danish: Meget almindelig
English: • an enlarged colon due to a condition known as Ogilvie's syndrome;
Danish: • forstørret tyktarm på grund af en sygdom, der kaldes Ogilvies syndrom,
English: At therapeutic doses, most opioids (e.g morphine, meperidine, methadone) are excreted into breast milk in minimal amounts.
Danish: Ved terapeutiske doser udskilles de fleste opioider (f.eks. morfin, meperidin, methadon) i brystmælken i minimale mængder.
English: Rizmoic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients who have previously been treated with a laxative.
Danish: Rizmoic er indiceret til behandling af opioid-induceret forstoppelse (opioid-induced constipation, OIC) hos voksne patienter, som tidligere er blevet behandlet med et afføringsmiddel.
English: • a disease causing severe inflammation of the digestive tract such as Crohn's disease .
Danish: • sygdom, der foråsager en svær betændelse i fordøjelseskanalen, såsom Crohns sygdom.
English: The peak plasma concentration was reduced by 35% and time to achieve peak plasma concentration was delayed from 0.75 hours in the fasted state to 2.5 hours in the fed state, whereas no significant difference was observed in the area under the plasma concentration-time curve by food intake.
Danish: Den maksimale plasmakoncentration var reduceret med 35 %, og tiden til at opnå maksimal plasmakoncentration var forsinket fra 0,75 timer i fastende tilstand til 2,5 timer i ikke-fastende tilstand, hvorimod der ikke blev observeret nogen signifikant forskel i arealet under kurven for plasmakoncentration som funktion af tiden ved fødevareindtagelse.
English: If any of the above apply to you, or you are not sure, talk to your doctor or pharmacist before taking Rizmoic.
Danish: Hvis noget af det ovenstående gælder for dig, eller du er i tvivl, skal du tale med din læge eller apotekspersonalet, før du tager Rizmoic.
English: Pack sizes of 7, 10, 28, 30, 84 or 100 tablets.
Danish: Pakningsstørrelser på 7, 10, 28, 30, 84 eller 100 tabletter.
English: - if you are allergic to naldemedine or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for naldemedin eller et af de øvrige indholdsstoffer i Rizmoic (angivet i punkt 6).
English: Naldemedine is highly bound to serum proteins, predominantly to human serum albumin and to a lesser extent to α1-acid-glycoprotein and γ-globulin, with a mean protein binding ratio in humans of 93.2%.
Danish: Naldemedin er i høj grad bundet til serumproteiner hovedsageligt til humant serumalbulin og i mindre grad til α1-syre-glykoprotein og γ-globulin med en gennemsnitlig proteinbindingsandel hos mennesker på 93,2 %.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naldemedine was not evaluated.
Danish: Virkningen af svært nedsat leverfunktion (Child-Pugh klasse C) på farmakokinetikken for naldemedin blev ikke evalueret.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppering er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Proportion of SBM responders in patients with cancer and OIC during the 2-week treatment period (Studies V9222 and V9236)
Danish: Andel af SBM-respondere hos patienter med cancer og OIC i løbet af den 2-ugers behandlingsperiode (studie V9222 og V9236)
English: Two serious cases of diarrhoea were reported in patients with cancer and OIC.
Danish: To alvorlige tilfælde med diarré blev rapporteret hos patienter med cancer og OIC.
English: The absolute bioavailability of naldemedine has not been established.
Danish: Den absolutte biotilgængelighed af naldemedin er ikke klarlagt.
English: In clinical studies, patients with OIC who were administered 0.4 mg/day (twice the recommended dose) over 4 weeks had an increased incidence of GI-related adverse drug reactions including diarrhoea and abdominal pain frequently within 1-2 days after initial dosing.
Danish: I kliniske studier havde patienter med OIC, som fik administreret 0,4 mg/dag (to gange den anbefalede dosis) i løbet af 4 uger, en øget forekomst af gastrointestinale bivirkninger, herunder diarré og abdominalsmerter hyppigt i løbet af 1-2 dage efter den indledende dosering.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Rizmoic in one or more subsets of the paediatric population in the treatment of 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 Rizmoic i en eller flere undergrupper af den pædiatriske population ved behandling af opioidinduceret forstoppelse (se pkt.
English: For Study V9235, the efficacy of naldemedine vs. placebo was assessed as secondary endpoints by the frequency of BMs as presented in Table 4.
Danish: For studie V9235 blev virkningen af naldemedin vs. placebo vurderet som sekundære endepunkter ved hyppigheden af BM'er som vist i tabel 4.
English: Talk to your doctor or pharmacist before taking Rizmoic: - if you suffer from a disease which may affect your bowel wall such as:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Rizmoic: - hvis du lider af en sygdom, som kan påvirke tarmvæggen, såsom:
English: Two of the nine cases were excluded by the MAH because they were not considered valid, and in the remaining five cases the MAH excluded a causal relationship in addition to the reporter.
Danish: Indehaveren af markedsføringstilladelsen udelukkede 2 af de 9 tilfælde, da de ikke blev anset for valide, og for de resterende 5 tilfælde udelukkede indehaveren af markedsføringstilladelsen samt rapportøren en kausal sammenhæng.
English: Rizmoic has no influence on your ability to drive or to use machines.
Danish: Rizmoic påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: The primary endpoint for Study V9236 and the secondary endpoint, without multiplicity adjustment, for Study V9222 were the proportion of SBM responders during the 2-week Treatment Period.
Danish: Det primære endepunkt for studie V9236 og det sekundære endepunkt uden justering for multiplicitet for studie V9222 var andelen af SBM-respondere i løbet af den 2-ugers behandlingsperiode.
English: Store in the original package in order to protect the tablets from light and moisture.
Danish: Opbevares i den originale yderpakning for at beskytte tabletterne mod lys og fugt.
English: On the basis of the scientific conclusions for naldemedine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing naldemedine is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for naldemedin er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder naldemedin, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Store in the original package in order to protect from light and moisture.
Danish: Opbevares i den originale yderpakning for at beskytte mod lys og fugt.
English: EU/1/18/1291/001 7 film-coated tablets EU/1/18/1291/002 28 film-coated tablets EU/1/18/1291/003 84 film-coated tablets EU/1/18/1291/004 10 film-coated tablets EU/1/18/1291/005 30 film-coated tablets EU/1/18/1291/006 100 film-coated tablets
Danish: EU/1/18/1291/001 7 filmovertrukne tabletter EU/1/18/1291/002 28 filmovertrukne tabletter EU/1/18/1291/003 84 filmovertrukne tabletter EU/1/18/1291/004 10 filmovertrukne tabletter EU/1/18/1291/005 30 filmovertrukne tabletter EU/1/18/1291/006 100 filmovertrukne tabletter
English: Nevertheless, given the times to onset and the mechanism of action of Naldemedine which leads to an increase in the propulsive contractions of the intestinal muscle it is considered that Naldemedine could plausibly have contributed to perforation events in these patients who were already at increased risk due to the presence of additional risk factors including underlying disease and concomitant treatments.
Danish: På grund af det tidsmæssige forhold og naldemedins virkningsmekanisme, som medfører en forøgelse af de propulsive kontraktioner i tarmmuskulaturen, anses det ikke desto mindre for plausibelt, at naldemedin kunne have bidraget til hændelser med perforation hos disse patienter, som allerede havde en øget risiko som følge af tilstedeværende yderligere risikofaktorer, herunder underliggende sygdom og samtidige behandlinger.
English: NL-8465 RX Oudehaske
Danish: NL-8465 RX Oudehaske 8465 RX Oudehaske
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Danish: Bilag IV Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne
English: The primary efficacy endpoint for Study V9235 was the change in the frequency of BMs per week from baseline to Weeks 12, 24, 36 and 52.
Danish: Det primære endepunkt for virkning for studie V9235 var ændringen i hyppigheden af BMer pr. uge fra baseline til uge 12, 24, 36 og 52.
English: Interaction with strong P-gp inhibitors
Danish: Interaktion med potente P-gp-hæmmere
English: Patients with evidence of significant structural abnormalities of the gastrointestinal tract were not enrolled in these studies.
Danish: Patienter med evidens for signifikante strukturelle anomalier i mave-tarm-kanalen indgik ikke i disse studier.
English: Naldemedine did not cause significant induction of CYP1A2, CYP2B6 or CYP3A4 isozymes.
Danish: Naldemedin forårsagede ikke signifikant induktion af CYP1A2-, CYP2B6- eller CYP3A4-isozymer.