FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients having disruptions to the blood-brain barrier (e.g., primary brain malignancies, central nervous system (CNS) metastases or other inflammatory conditions, active multiple sclerosis and advanced Alzheimer's disease) may be at increased risk of opioid withdrawal or reduced analgesia.
Danish: Patienter med forstyrrelser i blod-hjernebarrieren (f.eks. primære hjernemaligniteter, metastaser i centralnervesystemet (CNS) eller andre inflammatoriske tilstande, aktiv multipel sklerose og fremskreden Alzheimers sygdom) kan have en øget risiko for opioidabstinenssyndrom eller nedsat analgesi.
English: Additionally, naldemedine is a substrate of the P-glycoprotein (P-gp) efflux transporter, which may also be involved in reducing naldemedine penetration into the CNS.
Danish: Desuden er naldemedin et substrat for P-glykoprotein (P-gp)-efflukstransporteren, som også kan være involveret i at reducere penetreringen af naldemedin ind i CNS.
English: Following oral administration of radiolabelled naldemedine, 57.3% and 34.8% of the dose was excreted in urine and faeces for the [oxadiazole-14C]-naldemedine and 20.4% and 64.3% of the dose was excreted as the [carbonyl-14C]naldemedine in urine and faeces, respectively.
Danish: Efter oral administration af radioaktivt mærket naldemedin blev 57,3 % og 34,8 % af dosis udskilt i urin og fæces for [oxadiazol-14C]naldemedin, og hhv. 20,4 % og 64,3 % af dosis blev udskilt som [carbonyl-14C]-naldemedin i urin og fæces.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: No human data on the effect of naldemedine on fertility are available.
Danish: Der foreligger ingen data for virkningen af naldemedin på fertiliteten.
English: Following oral administration of [14C]-labelled naldemedine, the primary metabolite in plasma was nor-naldemedine, with a relative exposure compared to naldemedine of approximately 9 to 13%.
Danish: Efter oral administration af [14C]-mærket naldemedin var den primære metabolit i plasma nornaldemedin med en relativ eksponering på ca. 9 til 13 % sammenlignet med naldemedin.
English: Rizmoic contains sodium
Danish: Rizmoic indeholder natrium
English: Alteration of the analgesic dosing regimen prior to initiating Rizmoic is not required.
Danish: Det er ikke nødvendigt at ændre det analgetiske doseringsprogram, før Rizmoic påbegyndes.
English: Do not breast-feed during treatment with Rizmoic as it is not known if naldemedine passes into breast milk.
Danish: Du må ikke amme under behandlingen med Rizmoic, da det er ukendt, om naldemedin udskilles i modermælk.
English: Speak to your doctor immediately and stop taking Rizmoic.
Danish: Tal straks med lægen, og hold op med at tage Rizmoic.
English: See 'Other medicines and Rizmoic'.
Danish: Se 'Brug af anden medicin sammen med Rizmoic'.
English: Patients were allowed to receive rescue laxative(s) as needed regardless of being on a stable laxative regimen at baseline (apart from within 24 hours of the start of the Treatment Period).
Danish: Patienterne fik lov til at få behovsafføringsmiddel/-midler efter behov, selvom de var i et stabilt behandlingsprogram med afføringsmidler ved baseline (dog ikke inden for 24 timer før behandlingsperioden blev påbegyndt).
English: A single dose of naldemedine (0.01 mg to 3 mg) and multiple doses of 0.4 mg/day have been administered to patients with OIC in clinical studies.
Danish: En enkeltdosis af naldemedin (0,01 mg til 3 mg) og flere doser på 0,4 mg/dag blev administreret til patienter med OIC i kliniske studier.
English: Do not use this medicine after the expiry date which is stated on the carton and blisters after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og blisterne efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • You can take Rizmoic with or without laxatives.
Danish: • Du kan tage Rizmoic sammen med eller uden afføringsmidler.
English: No dose adjustment is required in patients older than 65 years of age (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter over 65 år (se pkt.
English: There are no data from the use of naldemedine in pregnant women.
Danish: Der er ingen data fra anvendelse af naldemedin til gravide kvinder.
English: The medicine is available in aluminium blisters, containing 7,10 or 14 tablets.
Danish: Lægemidlet fås i aluminiumblisterpakninger, der indeholder 7, 10 eller 14 tabletter.
English: Uncommon Rare
Danish: Ikke almindelig Sjælden
English: Opioid withdrawal syndrome aOne serious report of hypersensitivity reaction was observed in clinical studies with naldemedine.
Danish: Opioidabstinenss yndrom aEn alvorlig rapport om en overfølsomhedsreaktion blev observeret i kliniske studier med naldemedin.
English: Round, approximately 6.5 mm diameter, yellow tablet debossed with '222' and Shionogi logo on one side and '0.2' on the other side.
Danish: Rund, ca. 6,5 mm i diameter, gul tablet præget med '222' og Shionogi-logo på den ene side og med '0.2' på den anden side.
English: In the LIR subgroup, a greater proportion of responders was observed with naldemedine (46.4%) compared with placebo (30.2%) and the difference between groups (16.2%) was statistically significant (p<0.0001).
Danish: I LIR-undergruppen blev der observeret en større andel respondere med naldemedin (46,4 %) sammenlignet med placebo (30,2 %), og forskellen mellem grupperne (16,2 %) var statistisk signifikant (p<0,0001).
English: A population pharmacokinetic analysis from clinical studies with naldemedine did not identify a clinically meaningful effect of age, gender, body weight or race on the pharmacokinetics of naldemedine.
Danish: En populationsfarmakokinetisk analyse fra kliniske studier med naldemedin identificerede ingen klinisk relevant indvirkning af alder, køn, kropsvægt eller race på farmakokinetikken for naldemedin.
English: If you have taken more Rizmoic than you should, talk to your doctor or go to the hospital.
Danish: Hvis du har taget for meget Rizmoic, skal du kontakte lægen eller tage på hospitalet.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Abdominal adverse reactions (e.g. abdominal pain, vomiting and diarrhoea) have been reported with Rizmoic.
Danish: Abdominale bivirkninger (f.eks. abdominalsmerter, opkastning og diarré) er blevet rapporteret med Rizmoic.
English: In Study V9235, OIC was confirmed through a 2-week run-in period and was defined as no more than 4 SBMs total over 14 consecutive days and <3 SBMs in a given week.
Danish: I studie V9235 blev OIC bekræftet i løbet af en 2-ugers indkøringsperiode, og det blev defineret som ikke over 4 SBMer i alt i løbet af 14 på hinanden følgende dage og <3 SBMer i løbet af en uge.
English: From baseline to the last 2 weeks of treatment**
Danish: Fra baseline til de sidste 2 ugers behandling**
English: Due to the limited therapeutic experience, patients with severe renal impairment should be clinically monitored when initiating therapy with naldemedine.
Danish: På grund af den begrænsede terapeutiske erfaring, bør patienter med svært nedsat nyrefunktion overvåges klinisk, når de påbegynder behandling med naldemedin.
English: Novel histopathology findings were observed at all doses tested in female rats in ovaries (tertiary follicles/luteal cysts) in addition to irregular oestrous cycles, hyperplasia of mammary gland, and vaginal mucification already observed in adult animals (the lowest dose tested corresponded to an exposure margin of 6 or more, depending on the age of the pups).
Danish: Nye histopatologifund blev observeret ved alle de testede doser i ovarierne hos hunrotter (tertiære follikler/luteale cyster) i tillæg til uregelmæssige østruscyklusser, hyperplasi af brystkirtlen og vaginal mucification allerede observeret hos voksne dyr (den laveste testede dosis svarede til en eksponeringsmargin på 6 eller derover, afhængigt af afkommets alder).
English: It is a medicine used in adults to treat constipation caused by pain medicines, called opioids (e.g morphine, oxycodone, fentanyl, tramadol, codeine, hydromorphone, methadone).
Danish: Det er et lægemiddel, der anvendes til voksne til at behandle forstoppelse forårsaget af smertelindrende lægemidler, der kaldes opioider (f.eks. morfin, oxycodon, fentanyl, tramadol, kodein, hydromorphon, methadon).
English: In in vitro studies at clinically relevant concentrations, naldemedine did not inhibit the major CYP enzymes (including CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A, or CYP4A11 isozymes) and is not an inhibitor of OCT1, OCT2, BCRP, P-gp, MATE1, MATE2-K or BSEP transporters.
Danish: I in vitro-studier ved klinisk relevante koncentrationer hæmmede naldemedin ikke de vigtigste CYPenzymer (herunder CYP1A2-, CYP2A6-, CYP2B6-, CYP2C8-, CYP2C9-, CYP2C19-, CYP2D6-, CYP2E1-, CYP3A- eller CYP4A11-isozymer), og det er ikke en hæmmer af OCT1-, OCT2-, BCRP-, P-gp-, MATE1-, MATE2-K- eller BSEP-transportere.
English: Film coating: hypromellose , talc and yellow iron oxide (E172).
Danish: Filmovertræk: hypromellose, talcum og gul jernoxid (E172).
English: The overall benefit-risk of naldemedine should be considered in these patients with close monitoring for symptoms of opioid withdrawal.
Danish: Det samlede benefit/risk-forhold for naldemedin skal overvejes hos disse patienter med nøje overvågning for symptomer på opioidabstinenssyndrom.
English: Naldemedine functions as a peripherally-acting mu-opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids without reversing the central nervous system (CNS)-mediated opioid effects.
Danish: Naldemedin fungerer som en perifert virkende mu-opioidreceptorantagonist i væv såsom mave-tarmkanalen og reducerer derved de forstoppende virkninger af opioider uden at revertere opioidvirkningerne medieret af centralnervesystemet (CNS).
English: Rizmoic with drink
Danish: Brug af Rizmoic sammen med drikke
English: Rizmoic can be used in patients using an opioid medicine for cancer pain or long term non-cancer pain after they have previously been treated with a laxative.
Danish: Rizmoic kan anvendes til patienter, der bruger et opioidt lægemiddel mod kræftsmerter eller langvarige smerter, der ikke stammer fra kræft, efter tidligere behandling med et afføringsmiddel.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer):
English: Diarrhoea Abdominal painb Nausea
Danish: Diarré Abdominalsmert erb
English: Talk to your doctor or pharmacist immediately whilst taking Rizmoic: - if you develop severe, lasting or worsening stomach pain as this could be a symptom of developing a hole in your bowel wall and can be life-threatening.
Danish: Kontakt straks lægen eller apotekspersonalet, mens du tager Rizmoic: - hvis du udvikler svære, vedvarende eller forværrede mavesmerter, da det kan være tegn på, at du er ved at udvikle et hul i tarmvæggen, hvilket kan være livstruende.
English: No dose adjustment is required in patients with mild or moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
English: In cases of severe diarrhoea or abdominal pain, the patient should be monitored and treated for dehydration using rehydration and appropriate treatment as needed (see section 4.8).
Danish: I tilfælde af svær diarré eller svære mavesmerter skal patienten overvåges og behandles for dehydrering med rehydrering og passende behandling efter behov (se pkt.
English: Naldemedine is absorbed with a time to achieve peak plasma concentration of approximately 0.75 hours in the fasted state.
Danish: Naldemedin absorberes med en tid til at opnå maksimal plasmakoncentration på ca. 0,75 timer i fastende tilstand.
English: Naldemedine was not studied in the clinical trial programme in patients who had a recent history of myocardial infarction, stroke or transient ischaemic attack within 3 months of screening.
Danish: Naldemedin er ikke blevet undersøgt i det kliniske studieprogram hos patienter med en nylig anamnese på myokardieinfarkt, apopleksi eller transitorisk iskæmisk anfald inden for de sidste 3 måneder før screeningen.
English: Clinical outcomes for studies V9231 and V9232
Danish: Kliniske udfald for studie V9231 og V9232
English: Caution should be exercised with regards to opioid withdrawal.
Danish: Der bør udvises forsigtighed, når opioider seponeres.
English: Naldemedine 200 micrograms or placebo was administered for 2 weeks to cancer patients with OIC.
Danish: Naldemedin 200 mikrogram eller placebo blev administreret i 2 uger til patienter med cancer og OIC.
English: The efficacy and safety were also assessed in the laxative inadequate responders (LIR) and non-LIR subgroups.
Danish: Virkning og sikkerhed blev også vurderet i undergrupper med patienter, der responderede i utilstrækkelig grad på afføringsmiddel (laxative inadequate responders, LIR), og ikke-LIR-patienter.
English: The patient recovered following discontinuation from the study bMedDRA Preferred Terms: abdominal pain, abdominal pain upper, abdominal pain lower and abdominal discomfort
Danish: Patienten blev symptomfri efter ophør i studiet bMedDRA foretrukne termer: abdominalsmerter, øvre abdominalsmerter, nedre abdominalsmerter og abdominalt ubehag
English: Tablet core: Mannitol, croscarmellose sodium (see section 2 under ‘Rizmoic contains sodium') and magnesium stearate.
Danish: Tabletkerne: Mannitol (E421), croscarmellosenatrium (se punkt 2 under 'Rizmoic indeholder natrium') og magnesiumstearat.
English: Rizmoic is a round, approximately 6.5 mm diameter, yellow film-coated tablet debossed with '222' and the Shionogi logo on one side and '0.2' on the other side.
Danish: Rizmoic er en rund, ca. 6,5 mm i diameter, gul filmovertrukket tablet præget med '222' og Shionogilogo på den ene side og med '0.2' på den anden side.
English: Dose-dependent increases in gastrointestinal-related adverse reactions, including abdominal pain, diarrhoea, and nausea, were observed.
Danish: Der blev observeret dosisafhængige stigninger i gastrointestinale bivirkninger, herunder abdominalsmerter, diarré og kvalme.
English: In Studies V9231 and V9232, patients who, based on concomitant medication records, were on laxative therapy prior to entering the study and who stopped its use within 30 days prior to Screening, and had self-reported OIC, were considered to be a LIR.
Danish: I studie V9231 og V9232 blev patienter, som, ifølge data om samtidige lægemidler, fik afføringsmidler før indtræden i studiet, , og som stoppede med disse inden for 30 dage før screening og havde selvrapporteret OIC, anset for at være LIR.
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjælden (kan forekomme hos op til 1 ud af 1.000 personer):
English: From baseline to the last 2 weeks of treatment***
Danish: Fra baseline til de sidste 2 ugers behandling***
English: The primary endpoint for Studies V9231 and V9232 was the proportion of SBM responders, defined as: ≥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: Det primære endepunkt for studie V9231 og V9232 var andelen af SBM-respondere defineret som: ≥3 SBMer pr. uge og en ændring fra baseline på ≥1 SBM pr. uge i mindst 9 ud af de 12 studieuger og i 3 ud af de sidste 4 uger.
English: Naldemedine 3-G was a minor metabolite in plasma, with a relative exposure to naldemedine of less than 3%.
Danish: Naldemedin 3-G var en mindre væsentlig metabolit i plasma med en relativ eksponering for naldemedin på under
English: What you need to know before you take Rizmoic Do not take Rizmoic:
Danish: Det skal du vide, før du begynder at tage Rizmoic Tag ikke Rizmoic:
English: A patient who took a single dose of naldemedine 1 mg experienced severe drug withdrawal syndrome, including nausea and stomach cramping and was given esomeprazole and ondansetron for nausea and midazolam hydrochloride for stomach cramping.
Danish: En patient, der tog en enkeltdosis naldemedin på 1 mg, oplevede svært lægemiddelabstinenssyndrom, herunder kvalme og mavekramper, og fik esomeprazol og ondansetron for kvalme og midazolamhydrochlorid for mavekramper.
English: The pharmacokinetics of naldemedine in the paediatric population has not been studied (see section 4.2).
Danish: Farmakokinetikken for naldemedin i den pædiatriske population er ikke blevet undersøgt (se pkt.
English: You should stop taking Rizmoic when you stop taking your opioid pain medicine.
Danish: Du skal holde op med at tage Rizmoic, når du holder op med at tage dit opioide smertelægemiddel.
English: Itraconazole, a strong CYP3A inhibitor, increased exposure to naldemedine 2.9 fold that may result in an increased risk of adverse reactions.
Danish: Itraconazol, en potent CYP3A-hæmmer, øgede eksponeringen for naldemedin med 2,9 gange, hvilket kan medføre en øget risiko for bivirkninger.
English: In studies V9222 and V9236, the mean age of the subjects was 64.3 years; 51.8% were 65 years of age or older; 39.4% were women and 97.1% were Japanese.
Danish: I studie V9222 og V9236 var gennemsnitsalderen for forsøgspersonerne 64,3 år; 51,8 % var 65 år eller ældre, 39,4 % var kvinder, og 97,1 % var japanere.
English: Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea or vomiting, muscle aches, lacrimation or rhinorrhea, pupillary dilation or piloerection or sweating, diarrhoea, yawning, fever or insomnia.
Danish: Opioidabstinenssyndrom er en gruppe af tre eller flere af de følgende tegn eller symptomer: dysfori, kvalme eller opkastning, muskelsmerter, lakrimation eller rhinorré, pupildilatation eller piloerektion eller svedtendens, diarré, gaben, feber eller insomni.
English: For Study V9235, long term efficacy data defined as the change in frequency of BMs at week 52 from baseline, assessed as a secondary endpoint, showed that subjects in the naldemedine group had improvements in the frequency of BMs compared with subjects in the placebo group in both LIR (3.10 vs 1.90, p=0.0210) and non-LIR (4.26 vs 3.39, p=0.1349) subgroups.
Danish: I studie V9235 viste langvarige virkningsdata, defineret som ændringen i hyppigheden af BM'er ved uge 52 efter baseline, vurderet som et sekundært endepunkt, at forsøgspersonerne i naldemedingruppen så forbedringer i hyppigheden af BM'er, sammenlignet med forsøgspersonerne i placebogruppen i både LIR (3,10 vs. 1,90, p=0,0210) og ikke-LIR- (4,26 vs. 3,39, p=0,1349) undergrupperne.
English: Patients should be advised to discontinue naldemedine and to contact their physician if opioid withdrawal occurs.
Danish: Patienter skal rådes til at seponere naldemedin og kontakte lægen, hvis der opstår opioid abstinenssyndrom.
English: Available data in rats have shown excretion of naldemedine in milk (see section 5.3).
Danish: Tilgængelige data fra rotter har vist udskillelse af naldemedin i mælken (se pkt.
English: In Studies V9231 and V9232, patients had to either not be using laxatives or be willing to discontinue laxative use at the time of Screening and be willing to use only the provided rescue laxatives during the Screening and Treatment Periods.
Danish: I studie V9231 og V9232 skulle patienterne enten ikke bruge afføringsmidler eller indvillige i at seponere afføringsmidler på screeningstidspunktet og indvillige i kun at bruge de udleverede behovsafføringsmidler i løbet af screenings- og behandlingsperioderne.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natriumfrit.
English: There was a statistically significant difference for naldemedine treatment group versus placebo for the primary endpoint in Studies V9231 and V9232 (see Table 3).
Danish: Der var en statistisk signifikant forskel i behandlingsgruppen med naldemedin versus placebo for det primære endepunkt i studie V9231 og V9232 (se tabel 3).
English: Contents of the pack and other information What Rizmoic contains
Danish: Pakningsstørrelser og yderligere oplysninger Rizmoic indeholder:
English: The most commonly reported adverse reactions in patients with cancer and OIC were diarrhoea (24.5%) and abdominal pain (3.9%).
Danish: De mest almindeligt rapporterede bivirkninger hos patienter med cancer og OIC var diarré (24,5 %) og abdominalsmerter (3,9 %).
English: Naldemedine has not been studied in patients with severe hepatic impairment.
Danish: Naldemedin er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion.
English: Stopping Rizmoic while continuing to take your opioid medicine may cause the constipation to return.
Danish: Hvis du stopper med at tage Rizmoic, mens du fortsætter med at tage dit opioide lægemiddel, kan det få din forstoppelse til at vende tilbage.
English: Talk to your doctor or pharmacist if you are taking any of the following medicines: - Rifampicin, clarithromycin or telithromycin (antibiotic medicines) - Itraconazole or ketoconazole (medicines to treat fungal infections) - Ritonavir, indinavir or saquinavir (medicines for HIV infection) - Phenytoin, carbamazepine, phenobarbital (medicines to treat epilepsy) - St John's wort (Hypericum perforatum), a herbal medicine used for depression
Danish: Kontakt lægen eller apotekspersonalet, hvis du tager et eller flere af de følgende lægemidler: - Rifampicin, clarithromycin eller telithromycin (antibiotika) - Itraconazol eller ketoconazol (lægemidler til behandling af svampeinfektioner) - Ritonavir, indinavir eller saquinavir (lægemidler mod hiv-infektion) - Phenytoin, carbamazepin, phenobarbital (lægemidler til behandling af epilepsi) - Prikbladet perikon (Hypericum perforatum), et naturlægemiddel, der bruges mod depression
English: If obstruction or perforation are suspected, naldemedine must be discontinued (see section 4.3).
Danish: Hvis der er formodning om obstruktion eller perforation, skal naldemedin seponeres (se pkt.
English: The adverse reactions with naldemedine 200 microgram tablets in patients with chronic non-cancer pain and OIC and in patients with cancer and OIC reported in clinical studies are presented in the tables according to the MedDRA system organ classification.
Danish: Bivirkningerne med naldemedin 200 mikrogram tabletter hos patienter med non-maligne kroniske smerter og OIC og hos patienter med cancer og OIC rapporteret i kliniske studier er vist i tabellerne i henhold til MedDRAs systemorganklassifikation.
English: Patients with cardiovascular disease risk factors were not excluded from the naldemedine clinical trial programme, with BMI ≥ 30 kg/m2, and a medical history of hypertension and/or dyslipidaemia being the most commonly reported risk factors.
Danish: Patienter med risikofaktorer for kardiovaskulær sygdom blev ikke ekskluderet fra det kliniske studieprogram med naldemedin, hvor de mest almindeligt rapporterede risikofaktorer var et BMI ≥ 30 kg/m2, en medicinsk anamnese med hypertension og/eller dyslipidæmi.
English: There is a theoretical possibility that naldemedine provokes opioid withdrawal in a breast-fed neonate whose mother is taking an opioid receptor agonist.
Danish: Der er en teoretisk mulighed for, at naldemedin udløser opioidabstinenser hos ammede nyfødte, hvis moderen tager en opioid-receptoragonist.