FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal elimination may be prolonged since 30% of the administered dose is eliminated by the renal route.
Danish: Nyreeliminationen kan være forlænget, da 30 % af den administrerede dosis elimineres via nyrerne.
English: If infected, it should be treated appropriately and be determined if remaining implants need to be removed.
Danish: Hvis det er inficeret, skal det behandles hensigtsmæssigt, og det skal besluttes, om de resterende implantater skal fjernes.
English: There is no experience of reimplantation beyond 12 months.
Danish: Der er ingen erfaring med gentagne implantationer over 12 måneder.
English: Number (%) of patients with broken implant(s) N=number of patients with data available.
Danish: Antal (%) patienter med knækket/knækkede implantat(er) N=antal patienter, hvor data er tilgængelige.
English: Step 11: Apply pressure to the incision site for approximately five minutes if necessary.
Danish: Trin 11: Der trykkes på indsnitstedet i ca. 5 minutter, hvis det er nødvendigt.
English: Primary opioid of abuse, n (%)
Danish: Primært opioid, der blev misbrugt, n (%)
English: It is used to treat opioid dependence in adults who are also receiving medical, social and psychological support.
Danish: Det anvendes til at behandle opioidafhængighed hos voksne, som også får medicinsk, social og psykologisk hjælp.
English: New implants will be inserted in the other arm.
Danish: Nye implantater vil blive indsat i den anden arm.
English: Uncommon, may affect up to 1 in 100 people
Danish: Ikke almindelig, kan forekomme hos op til 1 ud af 100 personer
English: If the treatment is continued, hepatic function should be monitored closely.
Danish: Hvis behandlingen fortsættes, skal leverfunktionen overvåges nøje.
English: CI=confidence interval, ITT=intent-to-treat, N=number of subjects, SE=standard error
Danish: CI=konfidensinterval, ITT=intent-to-treat, N=antal personer, SE=standardfejl
English: This risk increases when additionally using alcohol or other substances.
Danish: Denne risiko øges, hvis der også anvendes alkohol eller andre stoffer.
English: In this study, approximately 75% of patients reported prescription opioids as the primary opioid of abuse, and 21% of patients reported heroin as the primary opioid of abuse.
Danish: I dette studie rapporterede ca. 75 % af patienterne receptpligtige opioider som det primære misbrugsopioid, og 21 % af patienterne rapporterede heroin som det primære misbrugsopioid.
English: • 100×100 mm sterile gauze
Danish: • 100×100 mm sterilt gaze
English: It must be handled with adequate security and accountability for proper disposal in accordance with local requirements.
Danish: Det skal håndteres med passende sikkerhed og ansvarlighed, og det skal bortskaffes korrekt i henhold til lokale krav.
English: Do not use Sixmo if you:
Danish: Brug ikke Sixmo, hvis du:
English: You may fell dizzy, drowsy and less alert.
Danish: Du kan føle dig svimmel, døsig og ikke så opmærksom.
English: • Benzodiazepines: This combination may result in death due to respiratory depression of central origin.
Danish: • Benzodiazepiner: Denne kombination kan føre til dødsfald som følge af respirationsundertrykkelse af central oprindelse.
English: • Alcoholic drinks or medicines containing alcohol, as alcohol increases the sedative effect of buprenorphine.
Danish: • Alkoholiske drikkevarer eller lægemidler, der indeholder alkohol, da alkohol øger den sedative virkning af buprenorphin.
English: Name and address of the manufacturer of the active substance
Danish: Navn og adresse på fremstilleren af det aktive stof
English: If liver problems are suspected your doctor will carry out tests to decide if treatment should be stopped.
Danish: Hvis der er mistanke om leverproblemer, vil lægen udføre tests for at beslutte, om behandlingen skal stoppes.
English: • Misuse and abuse: If buprenorphine is abused it can lead to overdose and death.
Danish: • Forkert brug og misbrug: Hvis buprenorphin misbruges, kan det føre til en overdosering og døden.
English: Note: Do not push the obturator.
Danish: Bemærk: Der må ikke trykkes på obturatoren.
English: The same technique is employed for the removal of protruding or partially expelled implants.
Danish: Den samme teknik anvendes til at fjerne fremspringende eller delvis udstødte implantater.
English: The basis for successful use and subsequent removal of Sixmo is a correct and carefully performed subcutaneous insertion of the implants in accordance with the instructions.
Danish: Grundlaget for vellykket brug og efterfølgende fjernelse af Sixmo er en korrekt og nøje udført subkutan indsættelse af implantaterne i overensstemmelse med anvisningerne.
English: • consistency in compliance with clinic visit requirements
Danish: • vedvarende overholdelse af kravene til klinikbesøgene
English: In 3 patients treated in clinical studies, and in 1 patient treated during post-marketing, implants or fragments could not be located and were, therefore, not removed at the end of the treatment.
Danish: Hos 3 patienter, der blev behandlet i kliniske studier, og hos 1 patient, der blev behandlet efter markedsføring, kunne implantater eller fragmenter ikke lokaliseres, og de blev derfor ikke fjernet ved endt behandling.
English: Furthermore, after establishment of non-inferiority, superiority of Sixmo over sublingual buprenorphine was tested and established (p=0.034).
Danish: Efter non-inferioriteten blev fastlagt, blev superioriteten af Sixmo over sublingualt buprenorphin testet og fastlagt (p=0,034).
English: Each dose consists of 4 implants.
Danish: Hver dosis består af 4 implantater.
English: • dehydration, increased appetite
Danish: • dehydrering, øget appetit
English: NAME OF THE MARKETING AUTHORISATION HOLDER L. Molteni & C. dei F.lli Alitti
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN L. Molteni & C. dei F.lli Alitti
English: • period without episodes of hospitalisations (addiction or mental health issues), emergency room visits, or crisis interventions
Danish: • periode uden episoder med indlæggelse (afhængighed eller psykiske problemer), besøg på skadestuen eller kriseindgreb
English: Buprenorphine can influence the ability to drive and use machines and may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery.
Danish: Buprenorphin kan påvirke evnen til at føre motorkøretøj og betjene maskiner, og kan hæmme de psykiske eller fysiske evner, som er nødvendige for at udføre muligvis farlige opgaver, såsom at køre bil eller betjene maskiner.
English: The efficacy and safety of buprenorphine in elderly patients > 65 years has not been established.
Danish: Buprenorphins virkning og sikkerhed hos ældre patienter > 65 år er ikke klarlagt.
English: • Present this card to your doctor, dentist or surgeon before any medical treatment or surgery.
Danish: • Vis dette kort til lægen, tandlægen eller kirurgen), før nogen medicinsk behandling eller kirurgi.
English: The implants will be inserted through a small 2.5 to 3 mm subcutaneous incision.
Danish: Implantaterne vil blive indsat via et lille, 2,5 til 3 mm subkutant indsnit.
English: Buprenorphine should be used cautiously when co-administered with:
Danish: Buprenorphin bør anvendes med forsigtighed, når det administreres sammen med:
English: Nevertheless, it is possible to extract the buprenorphine from the Sixmo implant.
Danish: Det er imidlertid muligt at udvinde buprenorphin fra Sixmo-implantatet.
English: Step 12: Complete the Patient Alert Card and give it to the patient to keep.
Danish: Trin 12: Patientkortet udfyldes, og det gives til patienten.
English: • insertion site and date
Danish: • indsættelsesstedet og datoen
English: hypotension, respiratory depression);
Danish: hypotension, respirationsundertrykkelse),
English: Pups born tended to weigh less on postnatal day 1 compared with controls.
Danish: Afkommet blev født med en tendens til at veje mindre på den postnatale dag 1, sammenlignet med kontroller.
English: Sixmo implants are not radiopaque and cannot be seen by X-ray or CT scan.
Danish: Sixmoimplantater er ikke radiologisk synlige, og kan ikke ses på røntgen- eller CT-scanninger.
English: • latest date on which the implant must be removed Keep this card in a safe place, since the information on the card may make it easier to carry out removal.
Danish: • den dato, hvor implantatet senest skal fjernes Opbevar dette kort på et sikkert sted, da oplysningerne på kortet kan gøre det nemmere at fjerne implantaterne.
English: Using aseptic technique, place the sterile equipment on the sterile field of the instrument stand.
Danish: Med en aseptisk teknik placeres det sterile udstyr i det sterile område af instrumentholderen.
English: It has a relatively wide therapeutic window as a consequence of its partial agonist/antagonist properties, which attenuates suppression of cardiovascular and respiratory function.
Danish: Det har et relativt bredt terapeutisk vindue som følge af dets partielle agonist/antagonist-egenskaber, der attenuerer undertrykkelsen af den kardiovaskulære og respiratoriske funktion.
English: • consistency in participation in recommended behavioural therapy/peer support programme
Danish: • vedvarende deltagelse i anbefalet adfærdsterapi/støtteprogram med ligestillede
English: Cardiac arrest or arrhythmias will require advanced life support techniques.
Danish: Ved hjertestop eller arytmi vil det være nødvendigt med avancerede livreddende teknikker.
English: • asthma or other breathing problems
Danish: • astma eller andre vejrtrækningsproblemer
English: • in case of patient's self-reported heroin use, other opioid use or craving and/ or urine samples positive for opioids
Danish: • i tilfælde af patientens selvrapporterede brug af heroin, andre opioider eller trang og/eller urinprøver, som er positive for opioider
English: When pregnant rats were exposed to buprenorphine through osmotic minipumps from gestation day 7 onwards, maternal food and water consumption was reduced on gestation days 7 to 20.
Danish: Når drægtige rotter blev eksponeret over for buprenorphin via osmotiske minipumper fra og med gestationsdag 7, var føde- og vandindtagelsen hos moderdyret nedsat fra gestationsdag 7 til 20.
English: • 1 implant applicator
Danish: • 1 implantatapplikator
English: • excessive sleepiness
Danish: • overdreven søvnighed
English: In the majority of patients, heroin was the primary opioid of use.
Danish: Hos de fleste patienter var heroin det primært anvendte opioid.
English: Risk of expulsion
Danish: Risiko for udstødning
English: If you cannot feel each of the four implants, or doubt their presence, use other methods to confirm the presence of the implant.
Danish: Hvis du ikke kan føle alle de 4 implantater, eller du er i tvivl om hvor de er, skal du tage andre metoder i brug til at bekræfte tilstedeværelsen af implantatet.
English: • The replacement implant(s) should be inserted in same arm either medially or laterally to in situ implants.
Danish: • Det/de implantat(er), der udskiftes med, skal indsættes i samme arm, enten medialt eller lateralt til in situ-implantaterne.
English: • thin adhesive strip around 6 mm wide (butterfly strip)
Danish: • tynd selvklæbende strip ca. 6 mm bred (butterfly-strip)
English: • If the patient returns the expelled implant, it should be measured to ensure that the entire implant was expelled (26.5 mm in length).
Danish: • Hvis patienten bringer det udstødte implantat tilbage, skal det måles for at sikre, at hele implantatet blev udstødt (26,5 mm langt).
English: Buprenorphine may reduce the ability to drive and use machines; especially during the first 24 to 48 hours up to one week following implant insertion.
Danish: Buprenorphin kan nedsætte evnen til at føre motorkøretøj og betjene maskiner, især i løbet af de første 24 til 48 timer og i op til en uge efter indsættelsen af implantatet.
English: If you feel the need for additional buprenorphine doses, contact your doctor straight away.
Danish: Hvis du mener, at du har behov for ekstra buprenorphindoser, skal du straks kontakte lægen.
English: Priorities are the re-establishment of a patient and protected airway and institution of assisted ventilation, if needed.
Danish: Prioriteterne er at genetablere patienten og beskyttede luftveje og påbegynde assisteret ventilation, hvis det er nødvendigt.
English: • local anaesthetic, such as 1% lidocaine with adrenaline 1:100,000
Danish: • lokalanæstetikum, såsom 1 % lidocain med adrenalin 1:100,000
English: The formation of norbuprenorphine was initially found to be performed by CYP3A4; subsequent studies also demonstrated the involvement of CYP2C8.
Danish: Først fandt man, at dannelsen af norbuprenorphin blev udført af CYP3A4, men efterfølgende studier viste, at CYP2C8 også var involveret.
English: This risk is increased with the concomitant abuse of buprenorphine and alcohol and other substances, especially benzodiazepines.
Danish: Denne risiko øges ved samtidig misbrug af buprenorphin og alkohol og andre stoffer, især benzodiazepiner.
English: Step 14: Put on sterile gloves.
Danish: Trin 14: Der påføres sterile handsker.
English: At steady state, a small decrease in buprenorphine concentrations was also recorded between week 4 and week 24.
Danish: Ved steady-state blev der også registreret en lille reduktion i buprenorphinkoncentrationen mellem uge 4 og uge 24.
English: • reduced consciousness
Danish: • nedsat bevidsthed
English: • evidence of implant coming out of the skin
Danish: • bevis forom implantatet stikker ud af huden
English: Buprenorphine can cause fatal breathing problems in non-dependent people or children.
Danish: Buprenorphin kan forårsage dødelige vejrtrækningsproblemer hos ikke-afhængige personer eller børn.
English: If the implants are inserted deeply, it is possible that neurovascular injury may occur.
Danish: Hvis implantaterne er indsat dybt, er det muligt, at der kan opstå neurovaskulær skade.
English: • an examination table for the patient to lie on
Danish: • en undersøgelsesbriks, som patienten kan ligge på
English: Sixmo contains the active substance buprenorphine, which is a type of opioid medicine.
Danish: Sixmo indeholder det aktive stof buprenorphin, som er en type opioid-lægemiddel.
English: • depression, euphoria
Danish: • depression, eufori
English: These are very common or common adverse reactions with buprenorphine.
Danish: Disse er meget almindelige eller almindelige bivirkninger med buprenorphin.
English: Study PRO-805 (ITT)
Danish: PRO-805 (ITT)
English: Implant site related adverse reactions with the current (and commercially used) insertion and removal techniques were reported in 25.9% and 14.1% of patients in the double-blind and extension studies, respectively.
Danish: Bivirkninger relateret til implantatstedet med de aktuelle (og kommercielt anvendte) teknikker til indsættelse og fjernelse, blev rapporteret hos 25,9 % og 14,1 % af patienterne i hhv. dobbeltblinde studier og forlængelsesstudier.
English: Buprenorphine and its metabolites are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely.
Danish: Buprenorphin og dets metabolitter udskilles i human mælk i så stor en mængde, at en påvirkning af ammede nyfødte/spædbørn er sandsynlig.
English: Sixmo should be used only in patients who are opioid tolerant.
Danish: Sixmo må kun anvendes til patienter, som er opioid-tolerante.
English: Study PRO-806 included an open-label comparator arm with sublingual buprenorphine (12 to 16 mg/day).
Danish: Studie PRO-806 inkluderede en åben komparatorarm med sublingualt buprenorphin (12 til 16 mg/dag).
English: Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist, e.g. morphine.
Danish: Dyreforsøg og klinisk erfaring har vist, at buprenorphin kan være vanedannende, men på et lavere niveau end en fuld agonist, f.eks. morfin.
English: • increased level of a liver enzyme, alanine aminotransferase, in blood tests
Danish: • forhøjet niveau af et leverenzym, alaninaminotransferase, i blodprøver
English: • Avoid moving implants around under the skin or gain a lot of weight after insertion of Sixmo as this may make it difficult to locate implants.
Danish: • Undgå at flytte implantatet rundt under huden eller at tage meget på i vægt efter indsættelsen af Sixmo, da det kan gøre det besværligt at lokalisere implantaterne.
English: • The patient should be instructed to place the implant in a glass jar with a lid, store it safely away from others, especially children, and bring it to the healthcare professional to determine whether the full implant has been expelled.
Danish: • Patienten skal anvises i at placere implantatet i et glas med et låg, opbevare det sikkert væk fra andre, især børn, og bringe det til lægen eller sundhedspersonalet for at bestemme, om hele implantatet er blevet udstødt.
English: Particularly, this occurs when additionally using alcohol, other opioids or certain medicines which calm, induce sleep or relax muscles.
Danish: Dette sker især, når der også bruges alkohol, andre opioider eller visse lægemidler, som virker beroligende, søvndyssende eller muskelafslappende.
English: Its activity in opioid maintenance treatment is attributed to its slowly reversible properties at the µ receptors which, over a prolonged period, minimises the need for use of other opioids.
Danish: Dets aktivitet i forbindelse med opioidvedligeholdelsesbehandling tilskrives dets langsomme, reversible egenskaber ved µ receptorerne, som over en længere periode minimerer behovet for at bruge andre opioider.
English: Generally, concentrations were comparable to the trough buprenorphine concentration of 8 mg per day sublingual buprenorphine.
Danish: Generelt var koncentrationerne sammenlignelige til den laveste buprenorphinkoncentration på 8 mg dagligt sublingualt buprenorphin.
English: The safety of Sixmo was evaluated in five Phase 3 studies (3 double-blind and placebo and/or activecontrolled studies, and two open-label extension studies).
Danish: Sixmos sikkerhed blev evalueret i 5 fase 3-studier (3 dobbeltblinde og placebokontrollerede og/eller aktivt kontrollerede studier, og 2 åbne forlængelsesstudier).
English: If pregnancy occurs during treatment with Sixmo the benefit to the patient should be weighed against the risk to the foetus.
Danish: Hvis der opstår graviditet under behandlingen med Sixmo, skal fordelen for patienten opvejes mod risikoen for fosteret.
English: Median age (range), years
Danish: Medianalder (interval), år
English: The safety and efficacy of Sixmo was investigated in 3 double-blind Phase 3 clinical studies in which a total of 309 patients were treated with Sixmo for up to 6 months (1 implant cycle).
Danish: Sixmos sikkerhed og virkning blev undersøgt i 3 dobbeltblinde fase 3 kliniske studier, hvor i alt 309 patienter blev behandlet i op til 6 måneder (1 implantatcyklus) med Sixmo.
English: For patients returning for subsequent treatment with Sixmo, preparations should be made to perform both the removal and insertion of Sixmo at the same visit.
Danish: For patienter, der kommer tilbage til efterfølgende behandling med Sixmo, skal der forberedes på både at udføre fjernelsen og indsættelsen af Sixmo ved det samme besøg.
English: • the patient experiences severe or intolerable side effects (including severe precipitated withdrawal);
Danish: • patienten oplever svære eller intolerable bivirkninger (herunder svære fremkaldte abstinenser),
English: In particular, patients may experience somnolence for up to one week after subcutaneous insertion; therefore, they should be cautioned about driving or operating hazardous machinery especially during this time period.
Danish: Især kan patienterne opleve somnolens i op til en uge efter den subkutane indsættelse, og derfor skal de advares mod at føre motorkøretøj eller betjene farlige maskiner, især i løbet af denne periode.
English: The patient alert card should mention:
Danish: Patientkortet skal nævne:
English: • 5 mL syringe with 25G×1.5" needle (0.5×38 mm)
Danish: • 5 ml sprøjte med 25G×1,5" kanyle (0,5×38 mm)
English: In the post-marketing setting, 2 cases were reported where Sixmo implants had locally migrated from the insertion site.
Danish: Efter markedsføring blev der rapporteret 2 tilfælde, hvor Sixmo-implantaterne havde migreret lokalt fra indsættelsesstedet.
English: Physicians should also be informed about risks and complications of this procedure (i.e. implant migration, protrusion, expulsion, and nerve damage).
Danish: Lægerne skal også informeres om risici og komplikationer ved dette indgreb (dvs. implantatmigration, fremspring, udstødning og nerveskade).
English: In rare cases, implants or partial implants could not be localized and were, therefore, not removed (see section 4.2).
Danish: I sjældne tilfælde kunne implantaterne eller de partielle implantater ikke lokaliseres, og de blev derfor ikke fjernet (se pkt.
English: If spontaneous expulsion of the implant occurs after insertion, the following steps should be taken:
Danish: Hvis der opstår en spontan udstødning af implantatet efter indsættelsen, skal der udføres de følgende trin:
English: If buprenorphine is administered to some non-opioid dependent individuals, who are not tolerant to the effects of opioids, potentially fatal respiratory depression may occur.
Danish: Hvis buprenorphin administreres til nogle personer uden opioidafhængighed, som ikke er tolerante over for virkningerne af opioider, kan der opstå potentielt dødelig respirationsundertrykkelse.
English: • rifampicin: a medicine to treat tuberculosis or certain other infections
Danish: • rifampicin: et lægemiddel til at behandle tuberkulose eller visse andre infektioner
English: • The safety concerns associated with SIXMO therapy (i.e. potential life-threatening interactions with other, concomitant therapies)
Danish: • Sikkerhedsproblematik i forbindelse med SIXMO-behandlingen (dvs. mulige livstruende interaktioner med andre behandlinger, der gives samtidigt)
English: Sixmo is formulated as a diversion and abuse deterrent formulation.
Danish: Sixmo er formuleret til at virke afskrækkende for diversion og misbrug.
English: Step 18: Disposal of Sixmo implants should be in accordance with local requirements as it contains buprenorphine.
Danish: Trin 18: Sixmo-implantaterne skal bortskaffes i henhold til lokale krav, da de indeholder buprenorphin.
English: The syndrome may be milder and more protracted than that from short acting full μ-opioid agonists.
Danish: Syndromet kan være lettere og mere forlænget end syndromet fra korttidsvirkende fulde μ-opioidagonister.
English: No published information is available regarding a potential effect of buprenorphine on male and female fertility.
Danish: Der er ingen tilgængelig publiceret information om en mulig virkning af buprenorphin på fertiliteten hos kvinder og mænd.
English: • reduced adrenal gland function, such as Addison's disease
Danish: • nedsat binyrebarkfunktion, såsom Addisons sygdom
English: Supportive measures (including oxygen, vasopressors) should be employed in the management of circulatory shock and pulmonary oedema as indicated.
Danish: Støtteforanstaltninger (herunder oxygen, vasopressorer) skal iværksættes ved behandling af kredsløbsshock og lungeødem, som indiceret.
English: Respiratory and central nervous system (CNS) depression
Danish: Undertrykkelse af respirationen og centralnervesystemet (CNS)
English: There are no prospective data with Sixmo beyond two treatment cycles, and there is no experience with inserting Sixmo implants into other sites of the arm, sites other than the upper arm or re-insertion into previously-used sites.
Danish: Der er ingen prospektive data med flere end 2 behandlingscyklusser med Sixmo, og der er ingen erfaring med at indsætte Sixmo-implantater på andre steder end i overarmen, eller med at indsætte dem igen på tidligere anvendte steder.
English: These underlying factors including confirmation of viral hepatitis status must be taken into consideration before prescribing Sixmo and during treatment.
Danish: Disse underliggende faktorer, herunder bekræftelse af viral hepatitis-status, skal tages i betragtning, inden ordination af Sixmo og under behandlingen.