FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians must warn patients that the sublingual route is the only effective and safe route of administration for this medicinal product (see section 4.4).
Danish: Læger skal rådgive deres patienter om, at sublingual indtagelse er den eneste effektive og sikre indgivelsesmåde for dette lægemiddel (se pkt.
English: For example, a patient stabilised to receive a daily dose of 8 mg buprenorphine may be given 16 mg buprenorphine on alternate days, with no dose on the intervening days.
Danish: For eksempel kan en patient, der er stabiliseret til at modtage en daglig dosis på 8 mg buprenorphin modtage 16 mg buprenorphin hver anden dag, uden nogen dosis på de mellemliggende dage.
English: Initial naloxone doses may range up to 2 mg and be repeated every 2-3 minutes until a satisfactory response is achieved, but should not exceed a 10 mg starting dose.
Danish: Initiale naloxon-doser kan være op til 2 mg og kan gentages hver 2-3 minutter, indtil et tilfredsstillende respons er opnået, men bør ikke overstige en startdosis på 10 mg. Hastigheden af kontinuerlig intravenøs infusion bør titreres efter patient-respons.
English: When initiating treatment with buprenorphine/naloxone, the physician must be aware of the partial agonist profile of buprenorphine and that it can precipitate withdrawal in opioid-dependent patients, particularly if administered less than 6 hours after the last use of heroin or other short-acting opioid, or if administered less than 24 hours after the last dose of methadone.
Danish: Når behandling med buprenorphin/naloxon indledes, skal lægen være opmærksom på buprenorphins partielle agonistprofil, og at det kan fremkalde abstinenssymptomer hos opioidafhængige patienter, særligt hvis det administreres mindre end 6 timer efter sidste brug af heroin eller andre korttidsvirkende opioider, eller hvis det administreres mindre end 24 timer efter den sidste dosis methadon.
English: These may be symptoms of liver damage.
Danish: Det kan være symptomer på leverskade.
English: The long half life of methadone should be considered when starting buprenorphine/naloxone.
Danish: Methadons lange halveringstid skal tages i betragtning, når behandlingen med buprenorphin/naloxon indledes.
English: PHARMACEUTICAL FORM AND CONTENTS 7 sublingual tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7 sublinguale resoribletter
English: Effect of hepatic impairment on pharmacokinetic parameters of buprenorphine and naloxone following SUBOXONE administration (change relative to healthy subjects)
Danish: Virkning af nedsat leverfunktion på de farmakokinetiske parametre for buprenorphin og naloxon efter administration af SUBOXONE (forskel i forhold til raske forsøgsdeltagere)
English: It is recommended that patients receiving buprenorphine/naloxone should be closely monitored if inducers (e.g. phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered.
Danish: Det anbefales, at patienter, der får buprenorphin/naloxon, overvåges nøje, hvis inducerende stoffer (for eksempel phenobarbital, carbamazepin, phenytoin, rifampicin) administreres samtidig.
English: Following treatment induction on day one, the patient should be stabilised to a maintenance dose during the next few days by progressively adjusting the dose according to the clinical effect of the individual patient.
Danish: Efter den indledende behandling på Dag 1 skal patienten stabiliseres til en vedligeholdelsesdosis over de næste par dage ved progressivt at justere dosen i henhold til den kliniske virkning hos hver enkelt patient.
English: Buprenorphine/naloxone has minor to moderate influence on the ability to drive and use machines when administered to opioid dependent patients.
Danish: Buprenorphin/naloxon påvirker i mindre til moderat grad evnen til at føre motorkøretøj eller betjene maskiner, når det administreres til opioidafhængige patienter.
English: barbiturates (used to cause sleep or sedation) such as Phenobarbital, secobarbital tranquilisers (used to cause sleep or sedation) such as chloral hydrate.
Danish: - barbiturater (som bruges til at inducere søvn eller sedering) for eksempel phenobarbital og secobarbital - beroligende midler (som bruges til at inducere søvn eller sedering) for eksempel chloralhydrat.
English: What Suboxone contains
Danish: Suboxone indeholder
English: • clonidine (used to treat high blood pressure) may extend the effects of this medicine.
Danish: • clonidin (som bruges til behandling af for højt blodtryk) kan forlænge virkningen af dette lægemiddel.
English: • Other medicines that may make you feel sleepy which are used to treat illnesses such as anxiety, sleeplessness, convulsions/seizures, pain.
Danish: • Andre lægemidler, der kan få dig til at føle dig søvnig, som bruges til behandling af lidelser så som angsttilstande, søvnløshed, kramper/krampeanfald og smerter.
English: Transaminases increased
Danish: Øgede transaminaser
English: Patients requiring a titrated daily dose> 8 mg buprenorphine/day may not find this regimen adequate.
Danish: Patienter, der kræver en titreret daglig dosis > 8 mg buprenorphin/dag, finder muligvis ikke denne dosering tilstrækkelig.
English: To avoid precipitating withdrawal, induction with buprenorphine/naloxone or buprenorphine only should be undertaken when objective and clear signs of withdrawal are evident (demonstrated e.g. by a score indicating mild to moderate withdrawal on the validated Clinical Opioid Withdrawal Scale, COWS).
Danish: For at undgå udvikling af abstinenser bør buprenorphin/naloxon eller buprenorphin først administreres, når der optræder tydelige og objektive tegn på abstinenser (påvises f.eks. ved en score, der indikerer lette til moderate abstinenser på den validerede COWS (Clinical Opioid Withdrawal Scale).
English: The lowest dose studied represented exposure multiples of 1x for buprenorphine and 5x for naloxone at the maximum human therapeutic dose calculated on a mg/m² basis.
Danish: Den laveste, undersøgte dosis repræsenterede eksponering for buprenorphin 1x og 5x for naloxon ved den maksimale humane terapeutiske dosis udregnet på basis af mg/m2.
English: Naloxone can be cleared more rapidly than buprenorphine, allowing for a return of previously controlled buprenorphine overdose symptoms, so a continuing infusion may be necessary.
Danish: Naloxon kan elimineres hurtigere end buprenorphin, hvilket giver risiko for tilbagevenden af tidligere kontrollerede symptomer på buprenorphinoverdosering.
English: For subjects randomized to either active treatment, dosing began with 8 mg of buprenorphine on Day 1, followed by 16 mg (two 8 mg) of buprenorphine on Day 2.
Danish: Hos forsøgspersoner, der var randomiseret til en af de aktive behandlinger, startede doseringen med 8 mg buprenorphin på Dag 1, efterfulgt af 16 mg (to 8 mg) buprenorphin på Dag 2.
English: A reduction of the buprenorphine/naloxone dose may be needed.
Danish: Det kan være nødvendigt at nedsætte dosis af buprenorphin/naloxon.
English: Sub-optimal treatment with buprenorphine/naloxone may prompt medicine misuse by the patient, leading to overdose or treatment dropout.
Danish: Sub-optimal behandling med buprenorphin/naloxon kan forårsage stofmisbrug hos patienten, hvilket kan føre til overdosering eller behandlingsophør.
English: Keep the tablet under your tongue until it dissolves.
Danish: Hold resoribletten under tungen til den er opløst.
English: Patients receiving Suboxone should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir or azole antifungals such as ketoconazole or itraconazole, macrolide antibiotics).
Danish: Patienter, der behandles med Suboxone skal monitoreres nøje, og en dosisreduktion kan være nødvendig ved samtidig behandling med potente CYP3A4-hæmmere (for eksempel proteasehæmmere som ritonavir, nelfinavir eller indinavir eller azol-svampemidler som ketoconazol eller itraconazol, makrolidantibiotika).
English: Buprenorphine is a partial agonist at the µ (mu)-opiate receptor and chronic administration produces dependence of the opioid type.
Danish: Buprenorphin er en partiel agonist på µ (my)-opioidreceptoren, og kronisk administration fremkalder opioidafhængighed.
English: A peri-postnatal study has not been conducted with buprenorphine/naloxone; however, maternal oral administration of buprenorphine at high doses during gestation and lactation resulted in difficult parturition (possible as a result of the sedative effect of buprenorphine), high neonatal mortality and a slight delay in the development of some neurological functions (surface righting reflex and startle response) in neonatal rats.
Danish: Der er ikke gennemført noget peri-postnatalt studie med buprenorphin/naloxon, men maternel oral administration af høje doser buprenorphin under drægtighed og diegivning resulterede i svær fødsel (muligvis på grund af buprenorphins sedative virkning), høj neonatal dødelighed og en mindre forsinkelse i udviklingen af visse neurologiske funktioner (opretterefleks (“surface righting reflex”) og overreaktion på forskrækkelse (“startle response”) hos nyfødte rotter.
English: Table 3 summarizes the results from a clinical trial in which the exposure after single-dose administration of Suboxone 2.0/0.5mg (buprenorphine/naloxone) sublingual tablet was determined in healthy subjects, and in subjects with hepatic impairment.
Danish: Tabel 3 opsummerer resultaterne fra et klinisk studie, hvor eksponeringen efter administration af en enkeltdosis af Suboxone 2,0/0,5 mg (buprenorphin/naloxon) sublinguale resoribletter blev fastlagt hos raske forsøgsdeltagere og hos forsøgsdeltagere med nedsat leverfunktion.
English: Do not take Suboxone
Danish: Tag ikke Suboxone
English: Clinical data confirm that CYP3A4 is responsible for the Ndealkylation of buprenorphine.
Danish: Kliniske data bekræfter, at CYP3A4 er ansvarlig for N-dealkyleringen af buprenorphin.
English: • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing, severe hives/nettle rash.
Danish: • hævelse af ansigt, læber, tunge eller svælg, hvilket kan gøre det svært at synke eller trække vejret, alvorlig nældefeber/udslæt.
English: In some patients, after a satisfactory stabilisation has been achieved, the frequency of dosing may be decreased to 3 times a week (for example on Monday, Wednesday and Friday).
Danish: Hos nogle patienter, kan doseringshyppigheden nedsættes til 3 gange om ugen (for eksempel mandag, onsdag og fredag), når der er opnået tilfredsstillende stabilisering.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHOLDEREN AF MARKEDSFØRINGSTILLADELSEN
English: Cases of acute hepatic injury have been reported in opioid-dependent addicts both in clinical trials and in post marketing adverse reaction reports.
Danish: Der er modtaget indberetning om akut leverskade hos opioidafhængige stofmisbrugere, både i kliniske studier og i bivirkningsrapporter efter markedsføring.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: The dose of buprenorphine or the CYP3A4 inducer may need to be adjusted accordingly.
Danish: Dosis af buprenorphin eller det CYP3A4inducerende stof skal muligvis justeres herefter.
English: In a double-blind, double-dummy, parallel-group study comparing buprenorphine ethanolic solution to a full agonist active control, 162 subjects were randomized to receive the ethanolic sublingual solution of buprenorphine at 8 mg/day (a dose which is roughly comparable to a dose of 12 mg/day of buprenorphine/naloxone), or two relatively low doses of active control, one of which was low enough to serve as an alternative to placebo, during a 3 to10 day induction phase, a 16-week maintenance phase and a 7-week detoxification phase.
Danish: I et dobbeltblindt, dobbel-dummy, parallel-gruppestudie til sammenligning af buprenorphinethanolopløsning med en ren agonist som aktiv kontrol blev 162 forsøgspersoner randomiseret til at få den sublinguale ethanolopløsning af buprenorphin ved 8 mg/dag (en dosis, som stort set svarer til en dosis buprenorphin/naloxon på 12 mg/dag), eller to relativt lave doser af den aktive kontrol, hvoraf den ene var lav nok til at tjene som et alternativ til placebo, i en indledende fase på 3 til 10 dage, en 16-ugers vedligeholdelsesfase og en 7-ugers afvænningsfase.
English: • Keep the tablets in place under the tongue until they have completely dissolved.
Danish: • Hold resoribletterne på plads under tungen, indtil de er helt opløst.
English: • if you are taking naltrexone or nalmefene for the treatment of alcohol or opioid dependence.
Danish: • hvis du tager naltrexon eller nalmefen til behandling af alkohol- eller opioidafhængighed.
English: A dietary dose of 100 ppm (estimated exposure approximately 2.4x for buprenorphine at a human dose of 24 mg buprenorphine/naloxone based on AUC, plasma levels of naloxone were below the limit of detection in rats) had no adverse effect on fertility in females.
Danish: Tilskud på100 ppm (beregnet eksponering ca. 2,4x for buprenorphin ved en human dosis på 24 mg buprenorphin/naloxon baseret på AUC, plasmaniveauer for naloxon var under detektionsgrænsen hos rotter) havde ingen utilsigtet virkning på fertiliteten hos hunner.
English: This medicine may cause severe, possibly fatal, respiratory depression (reduced ability to breathe) in children and non-dependent people who accidentally or deliberately take it.
Danish: Dette lægemiddel kan forårsage alvorlig og muligvis dødelig hæmning af vejrtrækningen (nedsat vejrtrækningsevne) hos børn og ikke-afhængige personer, som tager lægemidlet ved en fejltagelse eller med overlæg.
English: Clear signs of withdrawal should be evident before taking your first dose of Suboxone.
Danish: Der skal være tydelige tegn på abstinenser, inden du tager den første dosis Suboxone.
English: (see section 4.3 and 5.2).
Danish: 4.3 og 5.2).
English: As buprenorphine/naloxone pharmacokinetics may be altered in patients with hepatic impairment, lower initial doses and careful dose titration in patients with mild to moderate hepatic impairment are recommended.
Danish: Da buprenorphin/naloxons farmakokinetiske egenskaber kan være ændret hos patienter med nedsat leverfunktion, anbefales en lavere initialdosis og omhyggelig dosistitrering hos patienter med let til moderat nedsat leverfunktion.
English: Misusing this medicine by injecting it can cause withdrawal symptoms, infections, other skin reactions and potentially serious liver problems (see Warnings and precautions).
Danish: Misbrug af dette lægemiddel ved injektion kan forårsage abstinenssymptomer, infektioner, andre hudreaktioner og leverproblemer, der kan være alvorlige (se “Advarsler og forsigtighedsregler”).
English: o naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine.
Danish: o naltrexon og nalmefen er opioidantagonister, der kan blokere de farmakologiske virkninger af buprenorphin.
English: Patients should be monitored for signs and symptoms of precipitated opioid withdrawal, toxicity or overdose caused by increased levels of naloxone and/or buprenorphine.
Danish: Patienterne bør monitoreres for tegn og symptomer på opioidabstinenser, -toksicitet eller -overdosering som følge af øgede niveauer af naloxon og/eller buprenorphin.
English: Patients should be clearly monitored during the switching period from buprenorphine or methadone to buprenorphine/naloxone since withdrawal symptoms have been reported.
Danish: Patienterne skal monitoreres nøje i omstillingsperioden fra buprenorphin eller methadon til buprenorphin/naloxon, idet der er modtaget indberetning om abstinenssymptomer.
English: A doctor's assessment of your readiness for treatment will guide the timing of your first Suboxone dose.
Danish: Lægen vil vurdere, om du er klar til at indlede behandlingen og hjælpe dig med at finde det rette tidspunkt for din første dosis Suboxone.
English: However, when administered intravenously to opioid-dependent persons, the presence of naloxone in Suboxone produces marked opioid antagonist effects and opioid withdrawal, thereby deterring intravenous abuse.
Danish: Administreres det derimod intravenøst til opioidafhængige personer, fremkalder indholdet af naloxon i Suboxone en udtalt opioid-antagonistvirkning og opioidabstinenser, hvilket modvirker intravenøst misbrug.
English: Both active substances of Suboxone, buprenorphine and naloxone, are extensively metabolized in the liver, and the plasma levels were found to be higher for both buprenorphine and naloxone in patients with moderate and severe hepatic impairment.
Danish: De 2 aktive stoffer i Suboxone, buprenorphin og naloxon, metaboliseres begge i udbredt grad i leveren, og der blev fundet højere plasmaniveauer af både buprenorphin og naloxon hos patienter med moderat eller alvorligt nedsat leverfunktion.
English: Orthostatic hypotension
Danish: Hypotension Ortostatisk hypotension
English: 3 - Starting from the edge where the seal is lifted, pull back the foil on the back to remove the tablet.
Danish: 3 - Tag fat i det hjørne, hvor forseglingen ikke klæber til folien, og træk folien på bagsiden tilbage for at tage resoribletten ud.
English: Asthma Dyspnoea
Danish: Astma Dyspnø Gaben
English: NAME OF THE MARKETING AUTHORISATION HOLDER Indivior Europe Limited
Danish: Indehaver af markedsføringstilladelsen Indivior Europe Limited
English: The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
Danish: Spektret af anomalier rækker fra forbigående asymptomatisk forhøjede levertransaminaser til rapporter om leversvigt, levernekrose, hepatorenalt syndrom, hepatisk encefalopati og død.
English: This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines with the ability to harm your liver (see section 4).
Danish: Dette kan også skyldes virusinfektioner (kronisk hepatitis C), alkoholmisbrug, appetitmangel eller brug af anden medicin, der kan skade leveren (se punkt 4).
English: o For patients receiving methadone, the dose of methadone should be reduced to a maximum of 30 mg/day before beginning buprenorphine/naloxone therapy.
Danish: o Hos patienter i methadonbehandling skal methadondosis reduceres til maksimalt 30 mg/dag, inden behandling med buprenorphin/naloxon indledes.
English: Dose titration in steps of 2-8 mg buprenorphine is guided by reassessment of the clinical and psychological status of the patient, and should not exceed a maximum single daily dose of 24 mg buprenorphine.
Danish: Dosistitrering i trin på 2-8 mg buprenorphin sker i henhold til revurderingen af patientens kliniske og psykologiske status og en maksimal daglig dosis på 24 mg buprenorphin som enkeltdosis bør ikke overskrides.
English: A patient who is under-dosed with buprenorphine/naloxone may continue responding to uncontrolled withdrawal symptoms by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines.
Danish: En patient, der er underdoseret med buprenorphin/naloxon, kan fortsætte med at reagere på ukontrollerede abstinenssymptomer med selvmedicinering med opioider, alkohol eller sedativa-hypnotika som for eksempel benzodiazepiner.
English: Hypersensitivity Anaphylactic shock
Danish: Overfølsomhed Anafylaktisk shock
English: No dose modification based on renal function is required but caution is recommended when dosing subjects with severe renal impairment (see Section 4.3).
Danish: Det er ikke nødvendigt at foretage dosisjustering baseret på nyrefunktionen, men forsigtighed anbefales ved dosering til personer med alvorligt nedsat nyrefunktion (se pkt.
English: Keep out of the sight and reach of children and other household members.
Danish: Opbevar lægemidlet utilgængeligt for børn og andre medlemmer i husstanden.
English: If you have been taking methadone or a long acting opioid, the dose of methadone should ideally be reduced to below 30 mg/day before beginning Suboxone therapy.
Danish: Hvis du tager methadon eller et langtidsvirkende opioid, bør din methadondosis ideelt set reduceres til under 30 mg/dag, inden du påbegynder behandling med Suboxone.
English: Alopecia Dermatitis exfoliative Dry skin Skin mass
Danish: Alopeci Eksfoliativ dermatitis Tør hud Knuder
English: o CYP3A4 inducers: Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine.
Danish: o CYP3A4-inducerende stoffer: Samtidig brug af CYP3A4-inducerende stoffer med buprenorphin kan nedsætte plasma-buprenorphin, hvilket potentielt kan resultere i sub-optimal behandling af opioidafhængighed.
English: Buprenorphine/naloxone should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
Danish: Desuden bør brugen af buprenorphin / naloxon under graviditeten vurderes af lægen, og behandlingen bør kun fortsættes, hvis den potentielle fordel opvejer den potentielle risiko for fosteret.
English: - The other ingredients are lactose monohydrate, mannitol, maize starch, povidone K30, citric acid anhydrous, sodium citrate, magnesium stearate, acesulfame potassium and natural lemon and lime flavour.
Danish: - Øvrige indholdsstoffer: lactosemonohydrat, mannitol, majsstivelse, povidon K30, vandfri citronsyre, natriumcitrat, magnesiumstearat, acesulfamkalium og naturlig citron- og limearoma.
English: Sudden withdrawal syndrome caused by taking Suboxone too soon after use of illicit opioids, drug withdrawal syndrome in newborn.
Danish: Pludseligt opstående abstinenssyndrom forårsaget af for tidlig indtagelse af Suboxone efter brugen af ulovlige opioider, abstinenssyndrom hos nyfødte.
English: Other medicines and Suboxone Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Suboxone Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Taking the wrong dose of benzodiazepines may cause death due to respiratory failure (inability to breathe).
Danish: Hvis du tager den forkerte dosis af benzodiazepiner, kan det medføre døden på grund af vejrtrækningsstop.
English: Co-administration during buprenorphine/naloxone treatment is contraindicated due to the potentially dangerous interaction that may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms (see section 4.3).
Danish: Samtidig administration under buprenorphin/naloxon-behandling er kontraindiceret på grund af den potentielt farlige interaktion, der kan udløse pludseligt indsættende langvarige og intense opioidabstinenser (se pkt.
English: • adrenocortical disorder (e.g. Addison's disease)
Danish: • forstyrrelser i binyrebarkfunktionen (f.eks. Addisons sygdom)
English: N-dealkylbuprenorphine is a -opioid agonist with weak intrinsicactivity.
Danish: N-dealkylbuprenorphin er en -opioidagonist med svag intrinsic activity.
English: - The active substances are buprenorphine and naloxone.
Danish: • Aktive stoffer: buprenorphin og naloxon.
English: The most commonly reported treatment related adverse reactions reported during the pivotal clinical trials were constipation and symptoms commonly associated with drug withdrawal (i.e. insomnia, headache, nausea, hyperhidrosis and pain).
Danish: De hyppigst rapporterede behandlingsrelaterede bivirkninger, der blev indberettet i de pivotale kliniske studier, var obstipation og symptomer, der almindeligvis forbindes med opioidafvænning (dvs. søvnløshed, hovedpine, kvalme, hyperhidrosis og smerter).
English: After a time of successful treatment, you may agree with your doctor to reduce the dose gradually to a lower maintenance dose.
Danish: Når behandlingen har været vellykket i et stykke tid, kan det i samråd med lægen besluttes at reducere dosis gradvist til en lavere vedligeholdelsesdosis.
English: Mouth ulceration Tongue discolouration
Danish: Orale ulcerea Misfarvning af tungen