FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro metabolism studies suggest that methylnaltrexone bromide does not inhibit the activity of CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 or CYP3A4, while it is a weak inhibitor of the metabolism of a model CYP2D6 substrate.
Danish: In vitro-undersøgelser af metabolismen viser, at methylnaltrexonbromid ikke inhiberer aktiviteten af CYP1A2, CYP2E1, CYP2B6, CYP2A6, CYP2C9, CYP2C19 og CYP3A4, hvorimod det svagt inhiberer metaboliseringen af et CYP2D6-modelsubstrat.
English: Consequently, no meaningful change in AUC of methylnaltrexone bromide, in addition to Cmax, was observed before and after multiple-dose administration of cimetidine.
Danish: Der blev således ikke observeret nogen relevant ændring af methylnaltrexonbromids AUC, foruden Cmax, før og efter flerdosisadministration af cimetidin.
English: The dose is given every 48 hours (every two days) as an injection under the skin.
Danish: Dosis gives hver 48. time (hver anden dag) som en injektion under huden.
English: If you forget a dose, talk to your doctor or pharmacist as soon as possible.
Danish: Hvis du har glemt at tage en dosis, så tal med din læge eller apoteket så hurtigt som muligt.
English: Methylnaltrexone bromide is eliminated primarily as the unchanged active substance.
Danish: Methylnaltrexonbromid udskilles primært som det uændrede, aktive stof.
English: In the second week, a patient's assigned dose could be increased to 0.30 mg/kg if the patient had 2 or fewer rescue-free laxations up to day 8.
Danish: I den anden uge kunne patientens tildelte dosis forøges til 0,30 mg/kg, hvis patienten havde 2 eller færre afføringer uden behovsmedicin op til dag 8.
English: Methylnaltrexone bromide is absorbed rapidly, with peak concentrations (Cmax) achieved at approximately 0.5 hours following subcutaneous administration.
Danish: Methylnaltrexonbromid absorberes hurtigt, og maksimal koncentration (Cmax) opnås ca. 0,5 time efter subkutan administration.
English: Patients should be monitored for severe, persistent, or worsening abdominal pain; methylnaltrexone bromide should be discontinued if this symptom occurs.
Danish: Patienter bør monitoreres for svære, vedvarende eller forværrede mavesmerter; methylnaltrexonbromid bør seponeres, hvis dette symptom indtræder.
English: Prior to screening, patients had opioid-induced constipation defined as either <3 bowel movements in the preceding week or no bowel movement for >2 days.
Danish: Før screening havde patienterne opioidinduceret obstipation defineret som enten <3 afføringer i den foregående uge eller ingen afføring i >2 dage).
English: The safety and efficacy of methylnaltrexone bromide in children less than 18 years has not been established.
Danish: Sikkerheden og virkningen ved methylnaltrexonbromid hos børn under 18 år er ikke blevet fastslået.
English: The adverse reactions are classified as: very common (≥1/10); common (≥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).
Danish: 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 (<1/10.000), og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Hold the syringe at eye level so that you can see the dosing marks and make sure the tip of the needle is in the fluid all of the time.
Danish: Hold sprøjten i øjenhøjde, så du kan se doseringsmærkerne, og sørg for, at nålespidsen hele tiden er i væsken.
English: The capped syringe or syringe and needle should NEVER be reused.
Danish: Den lukkede sprøjte eller sprøjten og kanylen må ALDRIG genbruges.
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperaturer under 30ºC.
English: The renal clearance of methylnaltrexone bromide was reduced following multiple-dose administration of cimetidine (from 31 L/h to 18 L/h).
Danish: Methylnaltrexonbromids renale clearance blev reduceret efter flerdosisadministration af cimetidin (fra 31 l/t til 18 l/t).
English: Patients were required to discontinue all previous laxative therapy.
Danish: Det var et krav, at patienterne afbrød al tidligere behandling med laksantia.
English: Do not use Relistor
Danish: Brug ikke Relistor
English: The effect on race could not be analysed because the study population was predominantly Caucasian (88 %).
Danish: En eventuel effekt af race kunne ikke analyseres, da forsøgspopulationen var overvejende kaukasisk (88 %).
English: The dose is normally given every 48 hours (every two days) as an injection under the skin.
Danish: Dosis gives normalt hver 48. time (hver anden dag) som en injektion under huden.
English: Relistor is given as a subcutaneous injection.
Danish: Relistor gives som en subkutan injektion.
English: Are you familiar with the technique of self injection or have you discussed this with your doctor (or nurse or pharmacist)?
Danish: Er du bekendt med, hvordan du injicerer dig selv, eller har du snakket med din læge (eller sygeplejerske eller apotekspersonalet) om det?
English: N-demethylation of methylnaltrexone bromide to produce naltrexone is not significant, accounting for 0.06 % of the administered dose.
Danish: Ndemethylering af methylnaltrexonbromid til naltrexon er ikke signifikant og udgør 0,06 % af den administrerede dosis.
English: Make sure not to touch the rubber stopper again.
Danish: Sørg for ikke at røre gummiproppen igen.
English: Patient weight in kg Fill syringe to mL level (dose) Less than 38 kg
Danish: Patientens vægt i kg Fyld injektionssprøjten til ml-niveau (dosis) Under 38 kg
English: Methylnaltrexone bromide does not affect the pharmacokinetics of medicinal products metabolised by cytochrome P450 (CYP) isozymes.
Danish: Methylnaltrexonbromid påvirker ikke farmakokinetikken af lægemidler, der metaboliseres af cytokrom P450 (CYP)-isozymer.
English: The following instructions explain how to inject Relistor.
Danish: Nedenstående instrukser forklarer, hvordan man skal indsprøjte Relistor.
English: Do you have a contact number for your community nurse or the health centre?
Danish: Har du et telefonnummer til din læge/sygeplejerske eller det lokale lægecenter?
English: Methylnaltrexone sulphate is an inactive metabolite and present in plasma at a level of approximately 25 % of drug related materials.
Danish: Methylnaltrexonsulfat er en aktiv metabolit og findes i plasma på et niveau på ca. 25 % af de lægemiddel-relaterede stoffer.
English: Following intravenous injection of methylnaltrexone bromide for 13 weeks, similar methylnaltrexone related toxicity was observed in both juvenile and adult dogs.
Danish: Efter intravenøs injektion af methylnaltrexonbromid i 13 uger blev der observeret samme methylnaltrexon-relateret toksicitet hos både unge og voksne hunde.
English: The mean steady-state Cmax and AUC for the elderly were 545 ng/mL and 412 ng•h/mL, approximately 8.1 % and 20 %, respectively, greater than those for young subjects.
Danish: Den gennemsnitlige steady state-Cmax og -AUC for ældre var 545 ng/ml og 412 ng•t/ml, henholdsvis ca. 8,1 % og 20 % større end for unge forsøgspersoner.
English: In adult and juvenile dogs given methylnaltrexone bromide at 20 mg/kg/day, clinical signs indicative of CNS toxicity and prolongation of QTc interval were observed.
Danish: Hos voksne og unge hunde, som fik en dosis på 20 mg/kg/dag, blev der observeret kliniske tegn, som tyder på CNS-toksicitet og forlængelse af QTc intervallet.
English: (See INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR at the end of this leaflet.)
Danish: (Se VEJLEDNING TIL FORBEREDELSE OG INJEKTION AF RELISTOR bagerst i denne indlægsseddel).
English: Do not insert it at an angle as the needle may bend or break.
Danish: Stik den ikke skævt ind, da det kan få kanylen til at bøje eller brække.
English: In vitro studies have shown methylnaltrexone bromide to be a mu-opioid receptor antagonist (inhibition constant [Ki] = 28 nM), with 8-fold less potency for kappa opioid receptors (Ki = 230 nM) and much reduced affinity for delta opioid receptors.
Danish: In vitro-forsøg har vist, at methylnaltrexonbromid er en my-opioidreceptorantagonist (inhibitionskonstant [Ki] = 28 nM) med 8-fold mindre effekt på kappa-opioidreceptorer (Ki = 230 nM) og stærkt reduceret affinitet til delta-opioidreceptorer.
English: Important notes:
Danish: Vigtigt:
English: Patients had a history of chronic non-cancer pain and were taking opioids with stable doses of at least 50 mg of oral morphine equivalents per day.
Danish: Patienterne havde en anamnese med kroniske ikke-cancer smerter og tog opioider i stabile doser svarende til mindst 50 mg oral morfin om dagen.
English: If severe or persistent diarrhoea occurs during treatment, patients should be advised not to continue therapy with methylnaltrexone bromide and consult their physician.
Danish: Opstår svær eller persisterende diarré under behandlingen, skal patienterne rådes til ikke at fortsætte behandling med methylnaltrexonbromid og kontakte deres læge.
English: It is recommended to rotate injection sites.
Danish: Det anbefales at bruge skiftende injektionssteder.
English: The three areas of the body recommended for injection of Relistor are upper legs, abdomen, and upper arms.
Danish: De tre områder på kroppen, der anbefales til injektion af Relistor, er lår, mave og overarme.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with methylnaltrexone bromide should be made, taking into account the benefit of breast-feeding to the child and the benefit of methylnaltrexone bromide therapy to the woman.
Danish: En beslutning om, hvorvidt amning skal forsættes/stoppes eller behandling med methylnaltrexonbromid skal fortsættes/seponeres, skal træffes under hensyntagen til barnets fordel ved amning og kvindens fordel ved behandling med methylnaltrexonbromid.
English: If you receive only the vial, you will need to obtain alcohol swabs and an injection syringe.
Danish: Hvis du kun får hætteglasset, skal du selv anskaffe spritservietter og en injektionssprøjte.
English: In these studies, the median age was 68 years (range 21-100); 51 % were females.
Danish: I disse forsøg var den gennemsnitlige alder 68 år (fra 21 til -100), hvoraf 51 % var kvinder.
English: The efficacy and safety of methylnaltrexone bromide were also demonstrated in open-label treatment administered from Day 2 through Week 4 in Study 301, and in two open-label extension studies (301EXT and 302EXT) in which methylnaltrexone bromide was given as needed for up to 4 months (only 8 patients up to this point).
Danish: Virkningen og sikkerheden af methylnaltrexonbromid blev også påvist i en ublindet behandling, der blev administreret fra dag 2 til og med uge 4 i forsøg 301, og i to ublindede forlængelsesforsøg (301EXT og 302EXT), hvor methylnaltrexonbromid blev givet efter behov i op til 4 måneder (kun 8 patienter indtil nu).
English: During the first week (days 1, 3, 5, 7), patients received either methylnaltrexone bromide 0.15 mg/kg or placebo.
Danish: I løbet af den første uge (dag 1, 3, 5, 7) fik patienterne enten 0,15 mg/kg methylnaltrexonbromid eller placebo.
English: There are no adequate data with the use of methylnaltrexone bromide in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af methylnaltrexonbromid hos gravide kvinder.
English: Women using this medicine should not breast-feed, since it is not known if methylnaltrexone bromide passes into human breast milk.
Danish: Kvinder, der bruger dette lægemiddel, bør ikke amme, da det ikke vides, om methylnaltrexonbromid udskilles i modermælken.
English: The most common adverse reactions in all patients exposed to methylnaltrexone bromide during all phases of placebo-controlled studies were abdominal pain, nausea, diarrhoea and flatulence.
Danish: De mest almindelige bivirkninger hos alle de patienter, der har fået methylnaltrexonbromid i alle faser af placebokontrollerede forsøg, var abdominalsmerter, kvalme, diarré og flatulens.
English: If you weigh less than 38 kg or more than 114 kg you should use Relistor vials because the correct dose cannot be accurately delivered with these pre-filled syringes.
Danish: Hvis du vejer mindre end 38 kg eller mere end 114 kg, bør du anvende Relistor i hætteglas, da den korrekte dosis ikke kan indgives nøjagtigt med disse fyldte injektionssprøjter.
English: Allow the injection site to air-dry before injecting.
Danish: Lad injektionsstedet lufttørre, før du injicerer.
English: In this study, the median patient age was 49 years (range 23-83); 60% were females.
Danish: I dette forsøg var gennemsnitsalderen 49 år (fra 23 til 83), og 60 % var kvinder.
English: Each of the methyl-6-naltrexol isomers has somewhat less antagonist activity than parent compound, and a low exposure in plasma of approximately 8 % of the drug-related materials.
Danish: Hver af methyl-6-naltrexol-isomererne har noget mindre antagonistaktivitet end moderstoffet, og de lægemiddelrelaterede stoffers eksponering i plasma er noget lavere, ca 8 %.
English: Patients had opioid-induced constipation (< 3 rescue medication-free bowel movements per week during the screening period).
Danish: Patienterne havde opioidinduceret obstipation (<3 afføringer om ugen uden behovsmedicin i screeningsperioden).
English: • If you or your doctor know that your bowels were or are obstructed or your bowels are in a state where there is an immediate need for surgical intervention (which has to be diagnosed by your doctor).
Danish: • hvis du eller din læge ved, at din tarm har været eller er forstoppet eller din tarm er i en tilstand, hvor der er umiddelbart behov for operation (hvilket skal diagnosticeres af din læge).
English: Talk to your doctor or pharmacist before using Relistor.
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Relistor
English: Quickly pull the needle out of the skin, being careful to keep it at the same angle as it was inserted.
Danish: Træk kanylen hurtigt ud af huden, idet den holdes i den samme vinkel, som da den blev ført ind.
English: Carefully pull back the plunger on the syringe to either the 0.4 mL mark for 8 mg of Relistor or the 0.6 mL mark for 12 mg Relistor.
Danish: Træk forsigtigt stemplet tilbage i sprøjten til enten 0,4 ml-mærket for 8 mg Relistor, eller til 0,6 ml-mærket for 12 mg Relistor.
English: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: Use of methylnaltrexone bromide in patients with colostomy, peritoneal catheter, active diverticular disease or fecal impaction has not been studied.
Danish: Anvendelse af methylnaltrexonbromid til patienter med kolostomi, peritonealkateter, aktiv divertikelsygdom eller fækulit er ikke undersøgt.
English: A study of healthy volunteers noted orthostatic hypotension associated with a dose of 0.64 mg/kg administered as an intravenous bolus.
Danish: I et studie med raske forsøgspersoner blev der konstateret ortostatisk hypotension forbundet med en dosis på 0,64 mg/kg, der blev administreret som en intravenøs bolus.
English: In these patients, the treatment with usual laxatives should be stopped when commencing treatment with Relistor (see section 5.1).
Danish: Hos disse patienter bør behandling med sædvanlige laksantia stoppes, når behandlingen med Relistor påbegyndes (se pkt.
English: Methylnaltrexone bromide
Danish: Methylnaltrexonbromid
English: Stool consistency was not meaningfully improved in patients who had soft stool at baseline.
Danish: Afføringskonsistensen blev ikke forbedret væsentligt hos de patienter, der ved baseline havde blød afføring.
English: If you forget to use Relistor
Danish: Hvis du har glemt at bruge Relistor
English: The effect of mild and moderate hepatic impairment on the systemic exposure to methylnaltrexone bromide has been studied in 8 subjects each, with Child-Pugh Class A and B, compared to healthy subjects.
Danish: Virkningen af mild og moderat nedsat leverfunktion på den systemiske eksponering af methylnaltrexonbromid er blevet undersøgt særskilt hos 8 forsøgspersoner med en Child-Pugh-score, klasse A eller B, sammenlignet med raske personer.
English: It is used for patients when other medicines for constipation, called laxatives, have not worked well enough.
Danish: Det anvendes til patienter, hvor anden medicin mod forstoppelse (afføringsmidler), ikke har virket godt nok.
English: Cardiac effects were observed in some non-clinical studies in canines (prolongation of action potentials in Purkinje fibers or prolongation of the QTc interval).
Danish: I nogle prækliniske forsøg blev der observeret hjertepåvirkninger hos hunde (forlængelse af aktionspotentialet i Purkinje fibre eller forlængelse af QTc-intervallet).
English: Pack sizes of 4, 7, 8 and 10 pre-filled syringes.
Danish: Pakningsstørrelser på 4, 7, 8 og 10 fyldte injektionssprøjter.
English: Clear solution, colourless to pale-yellow, essentially free from visible particulates.
Danish: Klar opløsning, farveløs til svagt gul, stort set fri for synlige partikler.
English: Use of methylnaltrexone bromide in patients with known or suspected mechanical gastrointestinal obstruction, patients at increased risk for recurrent obstruction or in patients with acute surgical abdomen is contraindicated due to the potential for gastrointestinal perforation.
Danish: Brug af methylnaltrexonbromid til patienter med kendt eller mistænkt mekanisk, gastrointestinal obstruktion, patienter med øget risiko for recidiverende obstruktion eller til patienter med akut abdomen er kontraindiceret som følge af muligheden for gastrointestinal perforation.
English: This allows methylnaltrexone bromide to function as a peripherally acting mu-opioid antagonist in tissues such as the gastrointestinal tract, without impacting opioid-mediated analgesic effects on the central nervous system.
Danish: Det gør det muligt for methylnaltrexonbromid at fungere som en perifert virkende myopioidantagonist i væv såsom mave-tarmkanalen uden at hæmme de opioid-medierede analgetiske effekter på det centrale nervesystem.
English: • Please talk to your doctor if you experience stomach ache which continues, nausea (feeling sick) or vomiting (being sick) that is new or becomes worse.
Danish: • Tal med din læge, hvis du oplever mavesmerter, der bliver ved, kvalme (du føler dig syg) eller opkastning (du er syg), der er nye eller bliver værre.
English: It is recommended to move to a different site each time an injection is given.
Danish: Det anbefales at vælge et nyt sted for hver ny injektion.
English: Methylnaltrexone bromide is a selective antagonist of opioid binding at the mu-receptor.
Danish: Methylnaltrexonbromid er en selektiv antagonist for opioidbinding til my-receptoren.
English: This medicine is given by an injection under the skin (by subcutaneous injection) in either (1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (if not self-injecting).
Danish: Dette lægemiddel gives som en injektion under huden (subkutan injektion) i enten (1) låret, (2) maven eller (3) overarmen (hvis du ikke selv giver injektionen).
English: Not known: Gastrointestinal perforation (see section 4.4)
Danish: Ikke kendt: Gastrointestinal perforation (se pkt.
English: For patients with long-term pain (except patients receiving supportive care for advanced illness), fill the syringe to the 0.6 mL mark for 12 mg of Relistor.
Danish: Til patienter med længerevarende smerter (med undtagelse af patienter, der får understøttende behandling for fremskreden sygdom) fyldes sprøjten til 0,6 ml mærket for 12 mg Relistor.
English: Do not attempt to administer an injection until you are sure that you understand how to prepare and give an injection.
Danish: Forsøg ikke at give en injektion, før du er sikker på, at du ved, hvordan injektionen skal forberedes og gives.
English: The effects of methylnaltrexone bromide in pregnant women are not known.
Danish: Virkningen af methylnaltrexonbromid hos gravide kvinder er ikke kendt.
English: Due to light sensitivity, the solution for injection should be used within 24 hours.
Danish: Efter optrækning i injektionssprøjten: På grund af lysfølsomhed bør injektionsopløsningen anvendes inden for 24 timer.
English: Step 5: Disposing of supplies
Danish: Trin 5: Bortskaffelse af udstyr
English: An integrated analysis of pharmacokinetic data from healthy subjects indicated that methylnaltrexone bromide mg/kg dose-adjusted exposure increased as body weight increased.
Danish: En samlet analyse af farmakokinetiske data fra raske forsøgspersoner viste stigende methylnaltrexonbromideksponering med dosisjustering i mg/kg ved stigende kropsvægt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodiumfree.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per dosis, dvs. at det stort set er natriumfrit.
English: Methylnaltrexone bromide has minor influence on the ability to drive and use machines.
Danish: Methylnaltrexonbromid påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: • Please also talk to your doctor if you have a colostomy, a tube in your abdomen (peritoneal catheter), or suffer from diverticular disease or faecal impaction as this medicine should be used carefully in these circumstances.
Danish: • Du bedes også tale med din læge, hvis du har kolostomi, kateter gennem bugvæggen (peritonealkateter) eller lider af betændelse i tyktarmen (diverticulosis coli) eller kronisk forstoppelse (koprolit), da dette lægemiddel bør anvendes med forsigtighed under disse omstændigheder.
English: Patients weighing less than 38 kg or greater than 114 kg should use Relistor vials because the recommended mg/kg dose cannot be accurately delivered with the pre-filled syringe.
Danish: Patienter, der vejer mindre end 38 kg eller mere end 114 kg, bør bruge Relistor i hætteglas, da den anbefalede mg/kg dosis ikke kan gives nøjagtigt med den fyldte sprøjte.
English: If you get a stomach ache that is either severe or will not go away, stop taking this medicine and call your doctor straight away.
Danish: Hvis du får mavesmerter, der enten er kraftige eller ikke vil forsvinde, så hold op med at tage dette lægemiddel og kontakt straks din læge.
English: Animal studies have shown excretion of methylnaltrexone bromide in breast milk.
Danish: Dyreforsøg har påvist udskillelse af methylnaltrexonbromid i modermælk.
English: Do not attempt to administer an injection until you are sure that you understand how to give the injection.
Danish: Forsøg ikke at give en injektion, før du er sikker på, at du ved, hvordan injektionen skal gives.
English: Slowly push the plunger up until all air bubbles are removed.
Danish: Skub langsomt stemplet op, indtil alle luftboblerne er væk.
English: These patients should use Relistor vials and not the pre-filled syringe.
Danish: Disse patienter bør bruge Relistor i hætteglas og ikke den fyldte sprøjte.
English: Dispose of the capped syringe or needle and syringe in a closable puncture-resistant container as instructed by your doctor, nurse or pharmacist.
Danish: Bortskaf den lukkede sprøjte eller kanylen og sprøjten i en punktursikker beholder, der kan lukkes, som anvist af din læge, sygeplejerske eller apoteket.
English: Subcutaneous injections of Relistor at 150 mg/kg/day decreased fertility in rats.
Danish: Subkutane injektioner med Relistor på 150 mg/kg/dag nedsatte fertiliteten hos rotter.
English: You can press a cotton ball or gauze over the injection site.
Danish: Pres et stykke vat eller gaze over injektionsstedet.