FrancophonIA/ELRC3.0 huggingface dataset:
English: Instruct the patient that the pressure bandage can be removed after 24 hours and the adhesive bandage in three to five days.
Danish: Patienten informeres om, at trykbandagen kan fjernes efter 24 timer, og den selvklæbende bandage efter 3 til 5 dage.
English: Table 1: Adverse reactions reported in clinical studies and from post-marketing data with Sixmo and/or reported with other buprenorphine product System organ class
Danish: Tabel 1: Bivirkninger rapporteret i kliniske studier og fra data efter marketing med Sixmo,
English: Patients with mild to moderate hepatic impairment should be monitored for signs and symptoms of toxicity, or overdose caused by increased levels of buprenorphine (see section 4.2).
Danish: Patienter med let til moderat nedsat leverfunktion skal overvåges for tegn og symptomer på toksicitet, eller overdosering forårsaget af forhøjede niveauer af buprenorphin (se pkt.
English: Instruction for location of implants prior to removal Verify the location of the implants by palpation.
Danish: Anvisninger i at lokalisere implantaterne, før de fjernes Placeringen af implantaterne verificeres ved palpation.
English: Before administering Sixmo implants
Danish: Før du administrerer Sixmo-implantater
English: PHARMACEUTICAL FORM AND CONTENTS 4 implants
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 4 implantater
English: Step 1: The patient should lie on their back, with the intended arm flexed at the elbow and externally rotated, so that the hand is positioned next to the head.
Danish: Trin 1: Patienten skal ligge på ryggen, med den valgte arm bøjet ved albuen og roteret udad, så hånden befinder sig ved siden af hovedet.
English: Step 2: Clean the insertion site with an alcohol pad.
Danish: Trin 2: Indsættelsesstedet rengøres med en spritserviet.
English: Only a healthcare professional who is competent in minor surgery and is trained in the insertion of Sixmo should perform the procedure, using only the implant applicator, with the recommended local anaesthetic available.
Danish: Kun læger og sundhedspersonale med kompetence i mindre kirurgiske indgreb, og som er trænet i at indsætte Sixmo må udføre indgrebet, udelukkende ved at bruge implantatapplikatoren med anbefalede, tilgængelige lokalanæstetika.
English: Sixmo is contraindicated in patients with a history of keloid or hypertrophic scar formation at the site where Sixmo would be implanted, as difficulties in retrieving the implant are possible (see section
Danish: Sixmo er kontraindiceret hos patienter, som tidligere har dannede keloide eller hypertrofiske ar på implantatstedet for Sixmo, da det er muligt, at det kan være svært at tage implantatet ud igen (se pkt.
English: Clean the incision site.
Danish: Indsnitstedet rengøres.
English: Treatment discontinuation criteria
Danish: Kriterier for at seponere behandlingen
English: This should be stopped 12 to 24 hours before insertion of the next set of Sixmo implants.
Danish: Det skal stoppes 12 til 24 timer før det næste sæt Sixmo-implantater indsættes.
English: Only a healthcare professional who is trained in the insertion of Sixmo should perform the procedure, using only the implant applicator, with the recommended local anaesthetic available.
Danish: Kun læger og sundhedspersonale med træning i at indsætte Sixmo må udføre indgrebet, udelukkende ved at bruge implantatapplikatoren med anbefalede tilgængelige lokalanæstetika.
English: A number of cases of death due to respiratory depression have been reported while on buprenorphine, particularly when buprenorphine was used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information.
Danish: Et antal dødsfald som følge af respirationsundertrykkelse er blevet rapporteret, mens patienterne fik buprenorphin, især når buprenorphin blev anvendt i kombination med benzodiazepiner (se pkt.
English: • constipation, nausea, vomiting, diarrhoea
Danish: • forstoppelse, kvalme, opkastning, diarré
English: Step 8: While holding the obturator in place on the arm, retract the cannula along the obturator, leaving the implant in place (Figure 11).
Danish: Trin 8: Mens obturatoren holdes på plads på armen, trækkes sprøjten langs obturatoren, og implantatet sættes på plads (figur 11).
English: The Sixmo PK was assessed in opioid-dependent patients treated with Sixmo in studies TTP-400-0201, PRO-810, PRO-805, PRO-806, PRO-807 and PRO-811.
Danish: Farmakokinetikken af Sixmo blev vurderet hos opioidafhængige patienter i behandling med Sixmo i studie TTP-400-02-01, PRO-810, PRO-805, PRO-806, PRO-807 and PRO-811.
English: The healthcare professional should review the patient's treatment history for concomitant use of CYP3A4 inhibitors prior to initiating Sixmo treatment to determine suitability (see section 4.5).
Danish: Læger og sundhedspersonale skal gennemgå patientens behandlingsanamnese for samtidig anvendelse af CYP3A4-hæmmere, før behandlingen med Sixmo påbegyndes, for at bestemme egnetheden (se pkt.
English: Sixmo is not recommended during pregnancy, nor in women of childbearing age not using contraception.
Danish: Sixmo bør ikke anvendes under graviditeten eller til kvinder i den fertile alder, som ikke anvender prævention.
English: • pain, such as abdominal pain, bone pain, muscle pain, chest pain, headache
Danish: • smerter, såsom mavesmerter, knoglesmerter, muskelsmerter, brystsmerter, hovedpine
English: • cellulitis, skin infection, boil
Danish: • cellulitis, hudinfektion, byld
English: Modification of the Sixmo dose is not required in patients with renal impairment.
Danish: Det er ikke påkrævet at modificere Sixmo-dosis hos patienter med nedsat nyrefunktion.
English: Instruct the patient to apply an ice pack to the arm for 40 minutes every two hours for first 24 hours, then as needed.
Danish: Patienten skal instrueres i at sætte en ispose på armen i 40 minutter hver 2. time i de første 24 timer, og dernæst efter behov.
English: Precipitation of opioid withdrawal syndrome
Danish: Fremkaldelse af opioidt abstinenssyndrom
English: Step 7: While holding the cannula in place, unlock the obturator and remove the obturator.
Danish: Trin 7: Mens sprøjten holdes på plads låses obturatoren op, og den fjernes.
English: • 4 Sixmo implants
Danish: • 4 Sixmo-implantater
English: Improper insertions or infections may lead to protrusion or expulsion.
Danish: Forkerte indsættelser eller infektioner kan føre til, at implantatet er fremspringende eller udstødes.
English: • The other ingredient is ethylene vinyl acetate copolymer.
Danish: • Øvrige indholdsstoffer: ethylenvinylacetat-copolymer.
English: If Sixmo implants are not immediately replaced upon removal, patients should be maintained on sublingual buprenorphine (2 to 8 mg/day), as clinically indicated, until Sixmo treatment is resumed.
Danish: Hvis Sixmo-implantaterne ikke straks udskiftes efter de fjernes, skal patienten vedligeholdes med sublingualt buprenorphin (2 til 8 mg/dag) efter klinisk indikation, indtil behandlingen med Sixmo genoptages.
English: • enlarged prostate or narrowed urethra
Danish: • forstørret blærehalskirtel eller forsnævret urinrør
English: Place an adhesive bandage over the incision.
Danish: En selvklæbende bandage placeres over indsnittet.
English: Metabolites of buprenorphine accumulate in patients with renal failure.
Danish: Buprenorphins metabolitter akkumulerer hos patienter med nyresvigt.
English: Mark the insertion site with the surgical marker.
Danish: Indsættelsesstedet markeres med en kirurgisk tusch.
English: Withdraw the cannula until the hub is flush with the obturator, then twist the obturator clockwise to lock onto the cannula (Figure 12).
Danish: Sprøjten trækkes tilbage, indtil porten er på linje med obturatoren, og derefter drejes obturatoren med uret, så den låses på sprøjten (figur 12).
English: Figure 3: Plasma buprenorphine concentrations after insertion of Sixmo (concentrations up to day 28 are based on study PRO-810, while concentrations after day 28 are based on studies PRO-805, PRO-806, PRO-807 and PRO-811)
Danish: Figur 3: Plasmakoncentrationer af buprenorphin efter indsættelse af Sixmo (koncentrationerne op til dag 28 er baseret på studie PRO-810, mens koncentrationerne efter dag 28 er baseret på studie PRO-805, PRO-806, PRO-807 og PRO-811)
English: 4.5 Interaction with other medicinal products and other forms of interaction Buprenorphine should not be administered together with:
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Figure 1: Cumulative Distribution Function of the Percentage of Urine Samples Negative for Opioids in Weeks 1-16, Study PRO-805 (ITT)
Danish: Figur 1: Kumulativ fordelingsfunktion for procentdelen af urinprøver, der var negative for opioider i uge 1-16, studie PRO-805 (ITT)
English: • Implant insertion and six-month removal date(s)
Danish: • Datoen/datoerne for indsættelse og fjernelse efter 6 måneder
English: • the patient experiences withdrawal symptoms, e.g. sweating, lacrimation, yawning, nausea,
Danish: • patienten oplever abstinenssymptomer, f.eks. øget svedtendens, tåreflåd, gaben, kvalme,
English: Injury, poisoning and procedural complications common procedural pain*, procedural site reaction* uncommon post procedural complication (*), contusion (*), wound dehiscence*, migration of implanted drug***, device breakage***
Danish: Traumer, forgiftninger og behandlingskomplikationer almindelig smerter fra indgrebet*, reaktion på indgrebsstedet* ikke almindelig komplikation efter indgrebet (*), kontusion (*), sårdehiscens*, migration af implanteret lægemiddel***, knækket anordning***
English: Step 13: The patient should lie on their back, with the implant arm flexed at the elbow and externally rotated, so that the hand is positioned next to the head.
Danish: Trin 13: Patienten skal ligge på ryggen, med armen med implantatet bøjet ved albuen og roteret udad, så hånden befinder sig ved siden af hovedet.
English: In the worst case, it can result in breathing stopping, heart failure and death.
Danish: • vejrtrækningsbesvær, langsom vejrtrækning I det værste tilfælde kan det føre til, at vejrtrækningen holder op, hjertesvigt og døden.
English: After insertion of the implants, the doctor will apply a sterile gauze with a pressure bandage to minimize bruising.
Danish: Efter implantaterne indsættes, vil lægen lægge en steril gaze med en trykbandage for at minimere blå mærker.
English: Opioids should be used with caution in patients with myxoedema, hypothyroidism or adrenal cortical insufficiency (e.g. Addison's disease).
Danish: Opioider skal anvendes med forsigtighed hos patienter med myksødem, hypotyreoidisme eller binyrebarkinsufficiens (f.eks. Addisons sygdom).
English: • latex, talc-free sterile gloves
Danish: • sterile handsker uden latex og talcum
English: • abnormal sensation such as prickling, “pins and needles”, tingling and itchiness
Danish: • unormal følelse, såsom stikkende fornemmelse, ”prikken og stikken”, prikkende fornemmelse og kløe
English: Exploratory surgery without knowledge of the exact location of all implants is strongly discouraged.
Danish: Det frarådes på det kraftigste at udføre eksplorativ kirurgi uden at kende til alle implantaternes præcise placering.
English: Mean plasma buprenorphine concentrations up to day 28 are based on data from the relative bioavailability study PRO-810 (which had intensive PK sampling), while concentrations after day 28 are based on pooled data from studies PRO-805, PRO-806, PRO-807 and PRO-811.
Danish: De gennemsnitlige plasmakoncentrationer af buprenorphin op til dag 28 er baseret på data fra studiet af relativ biotilgængelighed, PRO-810 (som havde en intensiv farmakokinetisk prøvetagning), mens koncentrationerne efter dag 28 er baseret på puljede data fra studierne PRO-805, PRO-806, PRO-807 og PRO-811.
English: • stability of living environment
Danish: • stabile bopælsforhold
English: • a history of connective tissue disease such as scleroderma • a history of recurrent methicillin-resistant Staphylococcus aureus infections (MRSA)
Danish: • tilbagevendende methicillin-resistent Staphylococcus aureus-infektioner (MRSA) i sygehistorien
English: Exploratory surgery without knowledge of the exact location of all implants is strongly discouraged (see section 4.4).
Danish: Det frarådes på det kraftigste at udføre eksplorativ kirurgi uden at kende til alle implantaternes præcise placering (se pkt.
English: • urinary hesitation, urge to urinate, urinating more frequently with little urinary output
Danish: • vandladningsretention, vandladningstrang, hyppigere vandladning med lille mængde urin
English: Investigations common alanine aminotransferase increased uncommon aspartate aminotransferase increased, weight decreased, blood lactate dehydrogenase increased, gamma-glutamyl-transferase increased, weight increased, blood alkaline phosphatase decreased, amylase increased, blood bicarbonate increased, blood bilirubin increased, blood cholesterol decreased, blood glucose increased, haematocrit decreased, haemoglobin decreased, lipase increased, lymphocyte count decreased, mean cell haemoglobin increased, mean cell volume abnormal, monocyte count increased, neutrophil count increased, platelet count decreased, red blood cell count decreased
Danish: Undersøgelser almindelig forhøjet alaninaminotransferase ikke almindelig forhøjet aspartataminotransferase, vægttab, forhøjet lactatdehydrogenase i blodet, forhøjet gamma-glutamyltransferase, vægtøgning, nedsat basisk fosfatase i blodet, forhøjet amylase, forhøjet bicarbonat i blodet, forhøjet bilirubin i blodet, nedsat kolesterol i blodet', forhøjet glucose i blodet, nedsat hæmatokrit, nedsat hæmoglobin, forhøjet lipase', nedsat lymfocyttal, forhøjet gennemsnitligt hæmoglobin i cellerne, unormalt gennemsnitligt cellevolumen forhøjet monocyttal, forhøjet neutrofiltal, nedsat trombocyttal, nedsat antal røde blodlegemer
English: Instructions for removal of Sixmo
Danish: Anvisninger i at fjerne Sixmo
English: • If it is not possible to palpate the remaining implant, an ultrasound or MRI should be performed per techniques described in section 4.2 under “Instructions for removal of Sixmo”.
Danish: • Hvis det ikke er muligt at palpere det resterende implantat, skal der udføres en ultralyds- eller MR-scanning med de teknikker, som beskrives i pkt.
English: • other stomach and bowel disorders, tooth disorder
Danish: • andre mave-tarmsygdomme, tandsygdom
English: Table 3: Percentage of Opioid-Negative Urine Samples for Weeks 1 to 16 and Weeks 17 to 24,
Danish: Tabel 3: Procentdel af urinprøver negative for opioider for uge 1 til 16 og uge 17 til 24, studie
English: Buprenorphine given under the tongue will be stopped 12 to 24 hours before insertion of Sixmo implants.
Danish: Buprenorphin, der gives under tungen, vil blive stoppet 12 til 24 timer før Sixmo-implantaterne indsættes.
English: Eye disorders common mydriasis** uncommon eye discharge, lacrimal disorder, vision blurred
Danish: Øjne almindelig mydriasis** ikke almindelig øjenudflåd, lakrimale forstyrrelser, sløret syn
English: After removal of the implant, the doctor will apply a sterile gauze with a pressure bandage to minimize bruising.
Danish: Efter implantaterne er fjernet, vil lægen lægge en steril gaze med en trykbandage for at minimere blå mærker.
English: How to use Sixmo
Danish: Sådan skal du bruge Sixmo
English: In case toxicity or overdose symptoms develop, the removal of the implants and transition to a medicinal product that allows dose adjustment are required.
Danish: I tilfælde af, at der udvikles symptomer på toksicitet eller overdosering, er det nødvendigt at fjerne implantaterne og overgå til et lægemiddel, som gør det muligt at dosisjustere.
English: • An appointment for the patient should be scheduled to return to the inserting healthcare professional as soon as possible.
Danish: • Patienten skal snarest muligt aftale et besøg hos den læge eller sundhedspersonalet, som indsatte implantatet.
English: Figure 2: Cumulative Distribution Function of the Percentage of Urine Samples Negative for Opioids in Weeks 1-24 (co-primary endpoint 1), Study PRO-806 (ITT Population)
Danish: Figur 2: Kumulativ fordelingsfunktion af procentdelen af urinprøver, der var negative for opioider i uge 1-24 (co-primært endepunkt 1), studie PRO-806 (ITT-population)
English: • abnormal mean cell volume
Danish: • unormalt gennemsnitligt cellevolumen
English: What Sixmo contains
Danish: Sixmo indeholder:
English: • drug withdrawal syndrome, such as sweating, feeling hot and cold
Danish: • lægemiddelabstinenssyndrom, såsom svedtendens, varme- eller kuldefølelse
English: Reconfirm the location of the implants by palpation.
Danish: Placeringen af implantaterne genbekræftes ved palpation.
English: Ask your doctor or pharmacist for advice in these cases.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: Nervous system disorders common headache, dizziness, somnolence, hypertonia**, syncope** uncommon hypoaesthesia, migraine, depressed level of consciousness, hypersomnia, paraesthesia, tremor
Danish: Nervesystemet almindelig hovedpine, svimmelhed, somnolens, hypertoni**, synkope** ikke almindelig hypoæstesi, migræne, nedsat bevidsthedsniveau, hypersomni, paræstesi, tremor
English: Sixmo 74.2 mg implant buprenorphine
Danish: Sixmo 74,2 mg implantat buprenorphin
English: Psychiatric disorders common insomnia, anxiety, hostility**, nervousness**, paranoia** uncommon depression, libido decreased, sleep disorder, apathy, euphoric mood, orgasmic sensation decreased, restlessness, irritability, drug dependence***, agitation***, thinking abnormal***
Danish: Psykiske forstyrrelser almindelig insomni, angst, fjendtlighed**, nervøsitet**, paranoia** ikke almindelig depression, nedsat libido, søvnforstyrrelser, apati, eufori, nedsat orgasmefølelse, rastløshed, irritabilitet, lægemiddelafhængighed***, agitation***, unormale tanker***
English: The remaining partial implant should be removed using the techniques described in section 4.2 under “Instructions for removal of Sixmo”.
Danish: Det resterende delvise implantat skal fjernes ved hjælp af teknikkerne, som beskrives i pkt.
English: If implants for repeat treatment are not inserted on the same day as removal of previous implants, individuals should be maintained on a fixed dose of 2 to 8 mg/day of sublingual buprenorphine, as clinically indicated, until repeat treatment occurs.
Danish: Hvis implantaterne til gentagen behandling ikke indsættes på den samme dag, som de gamle implantater fjernes, skal patienten opretholdes på en fast dosis på 2 til 8 mg/dag sublingualt buprenorphin, efter klinisk indikation, indtil den gentagne behandling påbegyndes.
English: • surgical marker
Danish: • kirurgisk tusch
English: Verify the location of the implants by palpation.
Danish: Placeringen af implantaterne verificeres ved palpation.
English: In case toxicity or overdose symptoms are observed, the removal of the implants and transition to a medicinal product that allows dose adjustment are required.
Danish: I tilfælde af, at der observeres toksicitet eller symptomer på overdosering, er det nødvendigt at fjerne implantaterne og overgå til et lægemiddel, som gør det muligt at dosisjustere.
English: Removal of Sixmo implants
Danish: Fjernelse af Sixmo-implantater
English: Clean removal site with alcohol pad prior to marking the skin.
Danish: Stedet, hvor implantaterne skal fjernes, rengøres med en spritserviet, før huden markeres.
English: Apply a pressure bandage with sterile gauze to minimize bruising.
Danish: En trykbandage med sterilt gaze påføres for at minimere blå mærker.
English: • CYP3A4 inhibitors and inducers: Buprenorphine is metabolized to norbuprenorphine primarily by CYP3A4; therefore, potential interactions may occur when Sixmo is given concurrently with medicinal products that affect CYP3A4 activity.
Danish: • CYP3A4-hæmmere og -inducere: Buprenorphin metaboliseres til norbuprenorphin primært af CYP3A4.
English: Table 4: Percentage of Opioid-Negative Urine Samples for Weeks 1 to 24, Study PRO-806
Danish: Tabel 4: Procentdel af urinprøver negative for opioider for uge 1 til 24, studie PRO-806
English: Other medicines and Sixmo
Danish: Brug af anden medicin sammen med Sixmo
English: Step 4: Lift the edge of the incision opening with the toothed forceps.
Danish: Trin 4: Løft kanterne på indsnittet med en pincet med tænder.
English: Mean (SE)
Danish: Gennemsnit (SE)
English: Sixmo is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Sixmo bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: • While using Sixmo, situations may arise where you need acute pain treatment or anaesthesia.
Danish: • Når du bruger Sixmo, kan der opstå situationer, hvor du får behov for akut smertebehandling eller bedøvelse Spørg din læge eller apotekspersonalet til råds i disse tilfælde.
English: hypercapnia, pre-existing respiratory depression or kyphoscoliosis [curvature of spine leading to potential shortness of breath]).
Danish: kronisk obstruktiv lungesygdom, cor pulmonale, nedsat respiratorisk reserve, hypoxi, hyperkapni, eksisterende respirationsundertrykkelse eller kyfoskoliose [krumning af rygsøjlen, der potentielt kan medføre stakåndethed]).
English: Treatment with Sixmo implants
Danish: Behandling med Sixmo-implantater
English: Side effects can occur with the following frequencies: Common, may affect up to 1 in 10 people
Danish: Almindelige, kan forekomme hos op til 1 ud af 10 personer
English: No Sixmo dose adjustment is therefore considered necessary for patients with renal impairment.
Danish: En dosisjustering anses ikke for at være nødvendig hos patienter med nedsat nyrefunktion.
English: • lymph node disease
Danish: • lymfeknudesygdom
English: Equipment for removal of Sixmo
Danish: Udstyr til at fjerne Sixmo
English: Equipment for subcutaneous insertion of Sixmo
Danish: Udstyr til subkutan indsættelse af Sixmo
English: Figure 12
Danish: Figur 12
English: Step 3: Put on sterile gloves and check the function of the implant applicator by removing the obturator from the cannula and relocking it. Clean the insertion site with an antiseptic solution, such as chlorhexidine.
Danish: Trin 3: Sterile handsker skal anvendes, og funktionen af implantatapplikatoren kontrolleres ved at fjerne obturatoren fra sprøjten og låse den igen.
English: Infection may occur at the site of the insertion or removal.
Danish: Der kan forekomme infektion på stedet, hvor implantatet er indsat eller fjernet fra.
English: Most frequent implant adverse reactions were implant site pain, implant site pruritus, implant site haematoma, implant site haemorrhage, implant site erythema and implant site rash.
Danish: De hyppigste implantat-bivirkninger var smerter på implantatstedet, pruritus på implantatstedet, hæmatom på implantatstedet, blødning på implantatstedet, erytem på implantatstedet og udslæt på implantatstedet.
English: If you have more Sixmo than you need
Danish: Hvis du får for meget Sixmo
English: • eye discharge, blurred vision, lacrimal disorder
Danish: • øjenudflåd, sløret syn, unormal tåreflåd
English: Mark the channel tracks where each implant will be inserted by drawing 4 lines - with each line 40 mm long.
Danish: Kanalerne, hvor hvert implantat vil blive indsat, markeres ved at tegne 4 linjer - hver linje på 40 mm. Implantaterne vil blive indsat i et tæt, vifteformet mønster, med 4 til 6 mm mellemrum, hvor viften åbner mod skulderen (figur 3).
English: Ethylene vinyl acetate copolymer
Danish: Ethylenvinylacetat-copolymer
English: The MAH shall also ensure that in each MS where SIXMO is marketed, each patient being prescribed this SC implant receives from the treating physician the Patient Information Leaflet (PIL) and a (wallet-sized) patient alert card, to be carried out at all times while on SIXMO treatment, and presented to other health care professionals (HCP) before any medical treatment / intervention is carried out.
Danish: Indehaveren af markedsføringstilladelsen skal også sikre, at alle patienter, der får ordineret dette subkutane implantat, i hvert medlemsland, hvor SIXMO markedsføres, får udleveret indlægssedlen af den behandlende læge og et patientkort (på størrelse med et kreditkort).
English: Figure 17
Danish: Figur 17