FrancophonIA/ELRC3.0 huggingface dataset:
English: Apply the sterile drape to the patient's arm. Anaesthetise the incision site and the subcutaneous space containing the implants (for example, by injecting 5 to 7 mL lidocaine 1% with adrenaline 1:100,000).
Danish: Det sterile klæde sættes på patientens arm. Indsnitstedet og det subkutane område med implantaterne bedøves (for eksempel ved at injicere 5 til 7 ml lidocain 1 % med adrenalin 1:100.000).
English: • #15 blade scalpel
Danish: • skalpel med #15-blad
English: In many cases the presence of pre-existing hepatic impairment (genetic disease, liver enzyme abnormalities, infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic medicines) and ongoing injecting drug use may have a causative or contributory role.
Danish: I mange tilfælde kan eksisterende nedsat leverfunktion (genetisk sygdom, leverenzymanomalier, infektion med hepatitis B- eller hepatitis C-virus, alkoholmisbrug, anoreksi, samtidig brug af andre potentielt hepatotoksiske lægemidler) og samtidigt intravenøst stofmisbrug spille en kausal eller medvirkende rolle.
English: Non-palpable implants must be located prior to attempted removal.
Danish: Implantater, som ikke kan palperes, skal lokaliseres før der gøres forsøg på at fjerne dem.
English: If the implant is encapsulated, or you see dimpling, use the scalpel to shave the adhering tissue to release the implant.
Danish: Hvis implantatet er indkapslet, eller du observerer en fordybning, anvendes skalpellen til at skære det væv væk, som har sat sig fast på implantatet, og frigøre det.
English: Patients who develop hepatic impairment while being treated with Sixmo should be monitored for signs and symptoms of toxicity or overdose.
Danish: Patienterne, som udvikler nedsat leverfunktion, mens de bliver behandlet med Sixmo, skal overvåges for tegn og symptomer på toksicitet eller overdosering.
English: In urine, most of the buprenorphine and norbuprenorphine was conjugated (buprenorphine: 1% free and 9.4% conjugated; norbuprenorphine: 2.7% free and 11% conjugated).
Danish: I urin var det meste buprenorphin og norbuprenorphin konjugeret (buprenorphin: 1 % frit og 9,4 % konjugeret; norbuprenorphin: 2,7 % frit og 11 % konjugeret).
English: Both buprenorphine and norbuprenorphine can further undergo glucuronidation by UDPglucuronosyltransferases.
Danish: Både buprenorphin og norbuprenorphin kan gennemgå glukuronidering af UDP-glukuronosyltransferaser.
English: Although some patients may require occasional supplemental dosing with buprenorphine, patients should not be provided with prescriptions for sublingual buprenorphine-containing products for asneeded use.
Danish: Selvom nogle patienter kan have behov for lejlighedsvise tilskud af buprenorphin-doser, må patienterne ikke få recepter på præparater, der indeholder sublingualt buprenorphin til behovsbehandling.
English: Anaesthetise the insertion area at the incision site and just under the skin, along the planned insertion channels, by injecting 5 mL lidocaine 1% with adrenaline 1:100,000.
Danish: Indsættelsesområdet bedøves på indsnitstedet og lige under huden, langs de planlagte indsættelseskanaler, ved at injicere 5 ml lidocain 1 % med adrenalin 1:100,000.
English: • have acute alcoholism or alcohol delirium caused by withdrawal from alcohol
Danish: • lider af akut alkoholisme eller alkohol-delirium forårsaget af alkoholabstinenser
English: • swelling, including tissue swelling in arms, legs or face caused by excess fluid
Danish: • hævelse, herunder hævelse af vævet i arme, ben eller ansigt forårsaget af overskydende væske
English: In both studies adult patients with opioid dependence who were new entrants to buprenorphine treatment were treated over 24 weeks with 4 Sixmo or 4 placebo implants.
Danish: I begge studier blev voksne patienter med opioidafhængighed, som ikke havde fået behandling med buprenorphin før, behandlet i løbet af 24 uger med 4 Sixmo- eller 4 placeboimplantater.
English: • Liver damage, including liver failure, has been reported when using buprenorphine.
Danish: • Leverskade, herunder leversvigt, er blevet rapporteret under anvendelsen af buprenorphin.
English: Therefore, the potential to overdose with a full agonist exists, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining (see section 4.4).
Danish: Derfor eksisterer muligheden for en overdosering med en fuld agonist, især når der forsøges at afhjælpe de delvise opioidagonistvirkninger af buprenorphin, eller når plasmaniveauerne af buprenorphin falder (se pkt.
English: Counsel the patient on proper aseptic wound care.
Danish: Patienten skal rådgives om korrekt aseptisk sårbehandling.
English: • certain medicines to treat depression or Parkinson's disease, called monoamine oxidase inhibitors, such as phenelzine, isocarboxazid, iproniazid and tranylcypromine
Danish: • visse lægemidler til at behandle depression eller Parkinsons sygdom, som kaldes monoaminoxidasehæmmere, såsom phenelzin, isocarboxazid, iproniazid og tranylcypromin
English: Instruction for location of implants prior to removal
Danish: Anvisninger i at lokalisere implantaterne, før de fjernes
English: Do not blot or wipe away.
Danish: Må ikke duppes eller tørres af.
English: • slow heartbeat, abnormal heart rhythm that starts in the atrial chambers of the heart
Danish: • langsom puls, unormal hjerterytme, som begynder i hjertets forkamre
English: * Implant site adverse drug reaction (*) Observed as implant and non-implant site adverse drug reaction ** Reported with other approved buprenorphine only medicinal product *** Post-marketing data only
Danish: * Bivirkning på implantatstedet (*) Observeret som bivirkning på implantatstedet og ikke på implantatstedet ** Rapporteret med andre godkendte lægemidler kun med buprenorphin *** Kun data efter markedsføring
English: Also, scan or input the details of the implant procedure into the patient's medical records.
Danish: Detaljerne for implantatindgrebet scannes eller registreres i patientens medicinske journal.
English: Risk of serious complications of insertion and removal of implants Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants (see section 4.4).
Danish: Risiko for alvorlige komplikationer ved indsættelse og fjernelse af implantaterne Sjældne men alvorlige komplikationer, herunder nerveskade og migration, der fører til embolisme og død, kan være resultatet af en forkert indsættelse af lægemiddelimplantaterne (se pkt.
English: • signs of intoxication or overdose appear (miosis, lip cyanosis, sedation, bradycardia,
Danish: • der opstår tegn på forgiftning eller overdosering (miosis, læbecyanose, sedering, bradykardi,
English: Place a small adhesive bandage over the insertion site.
Danish: En lille selvklæbende bandage sættes over indsættelsesstedet.
English: • infection or any problems with wound healing
Danish: • infektion eller problemer med sårhelingen
English: • small bleeds beneath the skin
Danish: • små blødninger under huden
English: They are removed by the doctor at the end of the sixth month.
Danish: Lægen vil fjerne dem efter 6 måneder.
English: Talk to your doctor before using Sixmo if you have:
Danish: Kontakt lægen, før du bruger Sixmo, hvis du har:
English: In this double-blind and double-dummy study, patients maintained on doses of sublingual buprenorphine of 8 mg/day or less were transferred to 4 Sixmo implants (and daily sublingual placebo), or sublingual buprenorphine 8 mg/day or less (and 4 placebo implants).
Danish: I dette dobbeltblinde og dobbeltdummy-studie blev patienterne, der blev opretholdt på doser af sublingualt buprenorphin på 8 mg/dag eller mindre, overført til 4 Sixmo-implantater (og daglig sublingualt placebo), eller sublingualt buprenorphin
English: If continued treatment is desired at the end of the first six-month treatment cycle, a new set of 4 Sixmo implants may be administered following removal of the old implants for one additional treatment cycle of six months.
Danish: Hvis en fortsat behandling ønskes efter den første 6-måneders behandlingscyklus, kan der administreres et nyt sæt af 4 Sixmo-implantater, efter de gamle implantater fjernes, i en ekstra behandlingscyklus på 6 måneder.
English: • fever, feeling cold, discomfort
Danish: • feber, kuldefølelse, ubehag
English: The implants should be positioned in a fan-shaped distribution at least 5 mm from the incision, and palpable after placement.
Danish: Implantaterne skal placeres i et vifteformet mønster mindst 5 mm fra indsnittet, og de skal palperes efter placeringen.
English: The manifestations of acute buprenorphine overdose include pinpoint pupils, sedation, hypotension, respiratory depression and death.
Danish: Manifestationerne af en akut overdosering med buprenorphin omfatter knappenålspupiller, sedering, hypotension, respirationsundertrykkelse og død.
English: Schedule an appointment for the sutures to be removed.
Danish: Der arrangeres et besøg for at fjerne suturerne.
English: Buprenorphine may cause drowsiness, particularly when taken together with alcohol or CNS depressants (such as tranquilisers, sedatives or hypnotics) (see section 4.5).
Danish: Buprenorphin kan medføre døsighed, især når det tages sammen med alkohol eller CNSundertrykkende midler (såsom beroligende midler, sedativa eller hypnotika) (se pkt.
English: Few cases of protrusion or expulsion of implants, mainly attributed to improper insertion technique, were reported in clinical studies with Sixmo (see section 4.4).
Danish: Der blev rapporteret få tilfælde af, at implantatet var fremsprunget eller blev udstødt, primært som følge af en forkert indsættelsesteknik, i kliniske studier med Sixmo (se pkt.
English: They are removed by the end of the sixth month.
Danish: De fjernes efter 6 måneder.
English: Due to the long half-life of buprenorphine, neonatal monitoring for several days should be considered at the end of pregnancy, to prevent the risk of respiratory depression or withdrawal syndrome in neonates.
Danish: På grund af buprenorphins lange halveringstid bør det sidst i graviditeten overvejes at overvåge fosteret i flere dage for at forebygge risikoen for respirationsundertrykkelse og abstinenssyndrom hos den nyfødte.
English: Do not force the implant beyond the end of the cannula with the obturator.
Danish: Implantatet må ikke trykkes længere end til enden af sprøjten med obturatoren.
English: Patients previously treated with sublingual buprenorphine or sublingual buprenorphine + naloxone, must be on stable doses between 2 to 8 mg/day for at least 30 days and deemed clinically stable by the treating healthcare professional.
Danish: Patienter, som tidligere blev behandlet med sublingualt buprenorphin eller sublingualt buprenorphin + naloxon skal være på stabile doser på 2 til 8 mg/dag i mindst 30 dage, og den behandlende læge eller sundhedspersonalet skal bedømme, at de er klinisk stabile.
English: The primary efficacy endpoint in both studies was the cumulative distribution function (CDF) of the percentage of urine samples that were negative for illicit opioids (as evaluated through thrice weekly urine toxicology and patient self-reported opioid use).
Danish: Det primære endepunkt for virkning i begge studier var den kumulative fordelingsfunktion (CDF) af procentdelen af urinprøver, som var negative for illegale opioider (evalueret via toksikologiske undersøgelser af urinen 3 gange ugentligt og patientens selvrapporterede opioidforbrug).
English: You may remove the pressure bandage after 24 hours and the adhesive bandage after five days.
Danish: Du kan fjerne trykbandagen efter 24 timer, og den selvklæbende bandage efter 5 dage.
English: Sixmo implants are intended to be in place for 6 months and provide a continuous delivery of buprenorphine.
Danish: Sixmo-implantater er beregnet til at blive på plads i 6 måneder, og kontinuerligt frigive buprenorphin.
English: White/Off-white to pale yellow, rod-shaped implant, 26.5 mm long and 2.4 mm in diameter.
Danish: Hvidt/off-white til lysegult, stavformet implantat, 26,5 mm langt og 2,4 mm i diameter.
English: Prior to entry into acute studies PRO-805, PRO-806, PRO-810 and TTP-400-02-01, patients were treatment naïve adults, with moderate to severe opioid dependency.
Danish: Før patienterne indgik i de akutte studier PRO-805, PRO-806, PRO-810 og TTP-400-02-01 var patienterne behandlingsnaive voksne med moderat til svær opioidafhængighed.
English: Study PRO-806 had two co-primary endpoints, which were the CDF of the percentage of urine samples that were negative for illicit opioids for Weeks 1 to 24 in the Sixmo and placebo groups (coprimary 1), and the CDF of the percentage of urine samples that were negative for illicit opioids for Weeks 1 to 24 in the Sixmo and placebo groups, with imputation based on illicit drug self-report data (co-primary 2).
Danish: Studie PRO-806 har 2 co-primære endepunkter, som var CDF af procentdelen af urinprøver, som var negative for illegale opioider for uge 1 til 24 i grupperne med Sixmo og placebo (co-primær 1) og CDF for procentdelen af urinprøver, der var negative for illegale opioider for uge 1 til 24 i grupperne med Sixmo og placebo, hvor imputationen var baseret på selvrapporterede data om illegale drugs (co-primær 2).
English: • Other CNS depressants: Other opioid derivatives (e.g. methadone, analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these combinations increase CNS depression.
Danish: • Andre CNS-undertrykkende midler: Andre opioidderivater (f.eks. methadon, analgetika og antitussiva), visse antidepressiva, sedative H1-receptorantagonister, barbiturater, andre anxiolytika end benzodiazepiner, neuroleptika, clonidin og beslægtede stoffer: disse kombinationer forstærker CNS-undertrykkelsen.
English: A key secondary endpoint in Study PRO-806 was the difference in proportions of urine samples that were negative for opioids over 24 weeks for Sixmo versus sublingual buprenorphine.
Danish: Et afgørende sekundært endepunkt i studie PRO-806 var forskellen i andelen af urinprøver, der var negative for opioider i løbet af 24 uger for Sixmo versus sublingualt buprenorphin.
English: Apply an ice pack on the arm for 40 minutes every two hours for the first 24 hours, then as needed.
Danish: Sæt en ispose på armen i 40 minutter hver 2. time i de første 24 timer, og dernæst efter behov.
English: Reproductive system and breast disorders uncommon dysmenorrhoea, erectile dysfunction
Danish: Det reproduktive system og mammae ikke almindelig dysmenorré, erektil dysfunktion
English: • sleep disorder, disinterest
Danish: • søvnforstyrrelse, manglende interesse
English: The mortality index was significantly increased in the buprenorphine groups.
Danish: Mortalitetsindekset var signifikant forhøjet i buprenorphingrupperne.
English: • Monoamine oxidase inhibitors (MAOI): Possible exacerbation of the effects of opioids, based on experience with morphine.
Danish: • Monoaminoxidasehæmmere (MAO-hæmmere): En muligt forstærket virkning af opioider, baseret på erfaring med morfin.
English: When the first 6-month treatment period is up, a new set of Sixmo implants may be given after removal of the old implants, preferably on the same day.
Danish: Når den første 6-måneders behandlingsperiode er færdig, kan der gives et nyt sæt Sixmo-implantater efter de gamle implantater er fjernet, helst på samme dag.
English: • reactions at the implant site infection, including wound infection rash, scaring reduced healing swollen area containing pus
Danish: • reaktioner på implantatstedet infektion, herunder sårinfektion udslæt, ardannelse nedsat heling hævet område, der indeholder pus
English: Buprenorphine undergoes N-dealkylation to its major pharmacologically active metabolite norbuprenorphine and subsequent glucuronidation.
Danish: Buprenorphin gennemgår N-dealkylering til den primære, farmakologisk aktive metabolit, norbuprenorphin, og efterfølgende glukuronidering.
English: In study PRO-805, the primary endpoint was the CDF of the percentage of urine samples that were negative for illicit opioids over weeks 1 to 16, while the CDF over weeks 17 to 24 was evaluated as secondary endpoint.
Danish: I studie PRO-805 var det primære endepunkt CDF af procentdelen af urinprøver, der var negative for illegale opioider i løbet af uge 1 til 16, mens CDF i løbet af uge 17 til 24 blev evalueret som sekundært endepunkt.
English: Patients with a history of keloid or hypertrophic scar formation should not undergo subcutaneous insertion, as difficulties in retrieving the implant are possible.
Danish: Patienter med en anamnese med keloid eller hypertrofisk ardannelse må ikke gennemgå en subkutan indsættelse, da det er muligt, at det kan være svært at få implantatet ud igen.
English: Sixmo is a white/off-white to pale yellow rod-shaped implant, 26.5 mm long and 2.4 mm in diameter.
Danish: Sixmo er et hvidt/off-white til lysegult, stavformet implantat, 26,5 mm langt og 2,4 mm i diameter.
English: In a pharmacokinetic study with sublingual buprenorphine, buprenorphine plasma levels were found to be higher and the half-life was found to be longer in patients with moderate and severe hepatic impairment, but not in patients with mild hepatic impairment (see section 5.2).
Danish: I et farmakokinetisk studie med sublingualt buprenorphin blev der fundet, at plasmaniveauerne var højere og halveringstiden længere hos patienter med moderat til svært nedsat leverfunktion, men ikke hos patienter med let nedsat leverfunktion (se pkt.
English: Due to the inflexibility with regard to dose increases and to the increased dose requirements during pregnancy, Sixmo is not considered to be an optimal treatment choice for pregnant women, therefore treatment with Sixmo should not be started in pregnant women.
Danish: Som følge af, at Sixmo ikke er fleksibelt hvad angår dosisstigninger, og da dosiskravene er forhøjede under graviditeten, anses Sixmo ikke for at være et optimalt behandlingsvalg for gravide kvinder.
English: Co-administration during buprenorphine 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 i løbet af behandlingen med buprenorphin er kontraindiceret som følge af mulige farlige interaktioner, der kan fremkalde pludseligt indsættende og intense opioid-abstinenssymptomer (se pkt.
English: Place the implant in a glass jar with a lid. Store it safely away from others, especially children.
Danish: Opbevar det på et sikkert sted, væk fra andre, især børn.
English: • reduced sense of touch or sensation
Danish: • nedsat berøringssans eller følelse
English: • Opioid antagonists: naltrexone and nalmefene can block the pharmacological effects of buprenorphine.
Danish: • Opioidantagonister: naltrexon og nalmefen kan blokere de farmakologiske virkninger af buprenorphin.
English: • high blood pressure, feeling heartbeat
Danish: • højt blodtryk, hjertebanken
English: In some cases, the dose delivered by the implants might be more than the one you need.
Danish: I nogle tilfælde kan den dosis, som frigives af implantaterne, være for stor.
English: Expulsion of the implant
Danish: Udstødning af implantatet
English: Adverse drug reactions were categorized as implant or non-implant adverse reactions.
Danish: Bivirkninger blev kategoriseret som implantat- eller ikke-implantat-bivirkninger.
English: Table 5: Implant breakage in Sixmo double-blind Phase 3 studies Current technique and training PRO-806
Danish: Tabel 5: Knækket implantat i dobbeltblindede, fase 3-studier med Sixmo Aktuel teknik og træning
English: • Implants are located under the skin, at the inner side of the upper arm.
Danish: • Implantaterne befinder sig under huden, på indersiden af overarmen.
English: The safety and efficacy of Sixmo in children under 18 years have not yet been established.
Danish: Pædiatrisk population Sixmos sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Buprenorphine is extensively metabolized in the liver.
Danish: Buprenorphin metaboliseres i omfattende grad i leveren.
English: Insertion and removal of the Sixmo implants must be performed by a physician who is competent in minor surgery and has been trained to conduct the insertion and removal procedure.
Danish: Sixmo-implantaterne skal indsættes og fjernes af en læge, som har kompetence til at udføre mindre kirurgiske indgreb, og som er trænet i at indsætte og fjerne implantatet.
English: Grasp the centre of the implant with the X-plant clamp(s) (Figure 17) and apply gentle traction.
Danish: Der gribes fat i midten af implantatet med X-plant-klemmen/klemmerne (figur 17) og der trækkes forsigtigt.
English: Patients who discontinue treatment with Sixmo should be switched back to their previous dose of sublingual buprenorphine within 12 to 24 hours following removal of the Sixmo implants (i.e. the dose from which they were transferred prior to starting Sixmo treatment).
Danish: Patienter, som seponerer behandlingen med Sixmo, skal have deres dosis ændret til den tidligere dosis af sublingualt buprenorphin inden for 12 til 24 timer efter Sixmo-implantaterne fjernes (dvs. den dosis de fik før de startede behandlingen med Sixmo).
English: • fatigue, chills, weakness, increased muscle tone
Danish: • træthed, kulderystelser, svaghed, øget muskeltonus
English: • pain and dysfunction of chewing muscles and joints called temporomandibular joint syndrome
Danish: • smerter og dysfunktion i tyggemusklerne og leddene, hvilket kaldes temporomandibulært ledsyndrom
English: Apply liquid adhesive to the skin margins and allow to dry before closing the incision with the thin adhesive strip around 6 mm wide (butterfly strip).
Danish: Det flydende klæbemiddel påføres ved hudkanterne, og det skal tørre, før indsnittet lukkes med den tynde klæbestrip, som er ca. 6 mm bred (butterfly-strip).
English: If implant(s) or implant fragment(s) are not removed during a removal attempt, the patient should undergo imaging for localisation as soon as is feasible with the subsequent removal attempt performed on the same day as localisation.
Danish: Hvis implantatet/implantaterne eller fragment(er) fra implantatet ikke fjernes under et forsøg på at fjerne det/dem, skal der foretages en visualiseringsprocedure med henblik på lokalisering så snart det er muligt, og det næste forsøg på at fjerne implantatet skal finde sted på samme dag som lokaliseringen.
English: Long-term administration of buprenorphine during the last three months of pregnancy may cause a withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions).
Danish: Langvarig administration af buprenorphin i løbet af det sidste trimester i graviditeten kan forårsage abstinenssymptomer hos den nyfødte (f.eks. hypertoni, neonatal tremor, neonatal agitation, myoklonus eller krampeanfald).
English: Retention in treatment was high in the Sixmo groups, with 65.7% and 64.0% of patients completing studies PRO-805 and PRO-806, respectively.
Danish: Behandlingsretention var høj i Sixmo-grupperne, hvor 65,7 % og 64,0 % af patienterne gennemførte hhv. PRO-805- og PRO-806-studierne.
English: Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence
Danish: Samtidig administration af opioidantagonister (naltrexon, nalmefen) til behandling af alkohol- eller opioidafhængighed
English: Renal elimination plays a relatively small role (approximately 30%) in the overall clearance of buprenorphine and buprenorphine plasma concentrations were not increased in patients with renal impairment.
Danish: Nyreelimination spiller en relativt lille rolle (ca. 30 %) i den samlede clearance af buprenorphin, og plasmakoncentrationen af buprenorphin var ikke forhøjet hos patienter med nedsat nyrefunktion.
English: Before inserting Sixmo, your doctor will give you a local anaesthetic to numb the area.
Danish: Før Sixmo indsættes, vil lægen give dig lokalbedøvelse, så du bliver følelsesløs i området.