FrancophonIA/ELRC3.0 huggingface dataset:
English: The partial opioid agonist properties of buprenorphine may precipitate opioid withdrawal signs and symptoms in persons who are currently physically dependent on full opioid agonists - such as heroin, morphine, or methadone - before the effects of the full opioid agonist have subsided.
Danish: De partielle opioidagonistegenskaber ved buprenorphin kan fremkalde tegn og symptomer på opioide abstinenser hos personer, som aktuelt er fysisk afhængige af fulde opioidagonister - såsom heroin, morfin eller methadon - før virkningerne af den fulde opioidagonist har fortaget sig.
English: • the patient experiences lack of efficacy, as evidenced by lasting withdrawal symptoms that require repeated management with sublingual buprenorphine
Danish: • patienten oplever en manglende virkning, vist ved varige abstinenssymptomer, der kræver gentagne behandlinger med sublingualt buprenorphin
English: There are no or limited data on effects of buprenorphine on human fertility (see section 5.3).
Danish: Der er ingen eller utilstrækkelige data om virkningen af buprenorphin på human fertilitet (se pkt.
English: CI=confidence interval, ITT=intent-to-treat, N=number of subjects, SE=standard error In the analysis of the CDF (co-primary endpoint 1), a statistically significant difference between treatments (p<0.0001) was seen, which was in favour of Sixmo.
Danish: CI=konfidensinterval, ITT=intent-to-treat, N=antal personer, SE=standardfejl I analysen af CDF (co-primært endepunkt 1) blev der set en statistisk signifikant forskel mellem behandlingerne (p<0,0001), til Sixmos fordel.
English: Plasma buprenorphine concentrations after Sixmo are illustrated in figure 3.
Danish: Plasmakoncentrationerne af buprenorphin efter Sixmo er vist i figur 3.
English: • Please note that an ultrasound and MRI facilities need to be available to the clinical site at which the insertion and removal of Sixmo occurs.
Danish: • Bemærk, at der skal være apparatur til rådighed til ultralyds- og MR-scanninger på det kliniske center, hvor Sixmo indsættes og fjernes.
English: Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
Danish: Sixmo er indiceret til substitutionsbehandling for opioidafhængighed hos klinisk stabile voksne patienter, som har brug for ikke mere end 8 mg/dag sublingualt buprenorphin, i et medicinsk, socialt og psykologisk behandlingsregi.
English: • two X-plant clamps (vasectomy fixation clamps with 2.5 mm ring diameter)
Danish: • 2 X-plant-klemmer (fikseringsklemmer til vasektomi med 2,5 mm ringdiameter)
English: Cases of acute hepatic injury (including fatal cases) have been reported with the active substance buprenorphine in opioid-dependent addicts both in clinical trials and in post marketing adverse reaction reports.
Danish: Tilfælde af akut leverskade (herunder dødelige tilfælde) er blevet rapporteret med det aktive stof buprenorphin hos opioid-afhængige misbrugere, både i kliniske studier og i rapporter om bivirkninger efter markedsføring.
English: The insertion and removal of Sixmo should take place in a setting that allows for insertion under aseptic conditions, where the patient is able to lie on their back.
Danish: Indsættelsen og fjernelsen af Sixmo skal foretages på områder, hvor det er muligt at indsætte implantatet under aseptiske betingelser, hvor patienten kan ligge på ryggen.
English: • The holder of this card uses a buprenorphine only opioid dependence treatment called Sixmo.
Danish: • Indehaveren af dette kort bruger kun en opioidafhængighedsbehandling med buprenorphin , der hedder Sixmo.
English: Patients who may not be investigated using a magnetic resonance imaging (MRI) scan must not be allowed to receive Sixmo.
Danish: Patienter, som ikke kan undersøges med en magnetisk resonansscanning (MR-scanning) må ikke få Sixmo.
English: • migraine, tremor
Danish: • migræne, tremor
English: Subcutaneous insertion is essential to confirm proper placement by palpation.
Danish: En subkutan indsættelse er afgørende for at bekræfte en korrekt placering ved palpation.
English: • painful period, erectile dysfunction
Danish: • smertefuld menstruation, erektil dysfunktion
English: Opioids may elevate cerebrospinal fluid pressure, which may cause seizures, so opioids should be used with caution in patients with head injury, intracranial lesions, other circumstances where cerebrospinal pressure may be increased, or history of seizure.
Danish: Opioider kan øge cerebrospinalvæsketrykket, hvilket kan fremkalde krampeanfald, så opioider skal anvendes med forsigtighed hos patienter med hovedlæsioner, intrakranielle læsioner, andre omstændigheder, hvor cerebrospinaltrykket kan være forhøjet, eller en anamnese med krampeanfald.
English: The primary endpoint was proportion of responders, defined as patients with no more than 2 of 6 months with evidence of illicit opioid use based on a composite of both urine and self-report results.
Danish: Det primære endepunkt var andelen af patienter, der responderede, defineret som patienter, der ikke havde mere end 2 ud af 6 måneder med evidens for illegal opioidanvendelse, baseret på en sammensætning af både urintests og selvrapporterede resultater.
English: Each dose consists of four implants, for subcutaneous insertion in the inner side of the upper arm.
Danish: Hver dosis består af fire implantater, til subkutan indsættelse på indersiden af overarmen.
English: After determining the anaesthesia is adequate and effective, make a 7 to 10 mm incision with a scalpel, parallel to the axis of the arm, between the second and third implants.
Danish: Efter det er besluttet at bedøvelsen er tilstrækkelig og effektiv, gøres et 7 til 10 mm indsnit med en skalpel, parallel med armens akse, mellem det andet og det tredje implantat.
English: Verify that patients have completed an appropriate induction period with sublingual buprenorphine or buprenorphine/naloxone, or are already clinically stable on buprenorphine or buprenorphine/naloxone before inserting Sixmo implants (see section 4.2).
Danish: Verificer, at patienterne har gennemført en relevant induktionsperiode med sublingualt buprenorphin eller buprenorphin/naloxon, eller at de allerede er klinisk stabile på buprenorphin eller buprenorphin/naloxon, før Sixmo-implantaterne indsættes (se pkt.
English: Patients may experience somnolence, especially in the first week following insertion of the implants and should be cautioned in this respect (see section 4.7).
Danish: Patienterne kan opleve somnolens, især i løbet af den første uge efter indsættelsen af implantaterne, og de skal advares om dette (se pkt.
English: Excessive palpation shortly after insertion of the implants may increase the chance of infection.
Danish: For kraftig palpation kort efter indsættelsen af implantaterne kan øge risikoen for infektion.
English: • verapamil, diltiazem, amiodarone: medicines to treat high blood pressure and heart disorders
Danish: • verapamil, diltiazem, amiodaron: lægemidler til at behandle højt blodtryk og hjertesygdomme
English: ITT=intent-to-treat, SL BPN = sublingual buprenorphine Buprenorphine was not included in urine toxicology assessments.
Danish: ITT=intent-to-treat, SL BPN = sublingualt buprenorphin Buprenorphin blev ikke inkluderet i toksikologiske vurderinger af urinen.
English: Do not drive or perform dangerous activities until you are certain Sixmo does not reduce your ability in such activities.
Danish: Du må ikke føre motorkøretøj eller udføre farlige aktiviteter, indtil du er sikker på, at Sixmo ikke hæmmer dine evner til at udføre sådanne aktiviteter.
English: Mean steady-state plasma buprenorphine concentrations were consistent across all clinical studies, at approximately 0.5 to 1 ng/mL (with the 4-implant dose), and were maintained for approximately 20 weeks (week 4 through week 24) in a 24-week treatment period.
Danish: Gennemsnitlige plasmakoncentrationer af buprenorphin var konsekvente i alle de kliniske studier, ved ca. 0,5 til 1 ng/ml (med 4-implantatdosen), og de blev opretholdt i ca. 20 uger (uge 4 til og med uge 24) i en 24-ugers behandlingsperiode.
English: CYP3A inhibitors
Danish: CYP3A-hæmmere
English: If opioid therapy is required as part of anaesthesia, patients should be continuously monitored in an anaesthesia care setting by persons not involved in the conduct of the surgical or diagnostic procedure.
Danish: Hvis opioidbehandlingen er nødvendig som følge af anæstesien, skal patienterne vedvarende overvåges på anæstesiologiske afdelinger af personer, som ikke er involveret i at udføre de kirurgiske eller diagnostiske procedurer.
English: • Similarly, inducers of CYP3A4 (e.g. phenobarbital, carbamazepine, phenytoin, rifampin) may have the potential to reduce buprenorphine plasma concentrations because of increased metabolism of buprenorphine to norbuprenorphine.
Danish: • På samme måde kan induktorer af CYP3A4 (f.eks. phenobarbital, carbamazepin, phenytoin, rifampin) have potentiale til at reducere plasmakoncentrationerne af buprenorphin som følge af den forhøjede metabolisme af buprenorphin til norbuprenorphin.
English: In a subset of patients, Sixmo implants broke during implant removal.
Danish: I en undergruppe af patienterne knækkede Sixmo-implantaterne, da implantaterne blev fjernet.
English: The reduced level of alertness can make driving and using machines hazardous (see section 4.7).
Danish: Det nedsatte opmærksomhedsniveau kan gøre det farligt at føre motorkøretøj og betjene maskiner (se pkt.
English: Medicines that inhibit the enzyme CYP3A4 may give rise to increased concentrations of buprenorphine.
Danish: Lægemidler, der hæmmer enzymet CYP3A4, kan medføre forhøjede koncentrationer af buprenorphin.
English: Each Sixmo implant is packaged individually into a PET/LDPE/Alu/LDPE-peelable foil laminate sachet.
Danish: Hvert Sixmo-implantat er individuelt pakket i et PET/LDPE/Alu/LDPE-brev med folielaminat, der kan trækkes af.
English: • aprepitant: a medicine to prevent nausea and vomiting
Danish: • aprepitant: et lægemiddel til at forhindre kvalme og opkastning
English: The opioid therapy must be provided by healthcare professionals trained in the use of anaesthetic medicinal products and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation.
Danish: Opioidbehandlingen skal administreres af læger og sundhedspersonale med træning i at anvende anæstetiske lægemidler og i at behandle de potente opioiders virkninger på vejrtrækningen, særlige oprettelsen og vedligeholdelsen af patente luftveje og assisteret ventilation.
English: Clinical studies of Sixmo did not include patients over 65 years and, therefore, the use of the product in this population is not recommended.
Danish: Kliniske studier af Sixmo omfattede ikke patienter over 65 år, og derfor bør præparatet ikke anvendes hos denne population.
English: The dissociation of buprenorphine from the µ-opioid receptors is expected to take up to several days after discontinuation of Sixmo treatment, which will prevent withdrawal symptoms immediately after removal of Sixmo.
Danish: Dissociationen af buprenorphin fra µ-opioidreceptorerne forventes at tage op til flere dage efter seponering af Sixmo-behandlingen, hvilket vil forhindre abstinenssymptomer umiddelbart efter, at Sixmo fjernes.
English: Patients in all groups were allowed to use supplemental sublingual buprenorphine to control potential withdrawal symptoms/cravings according to pre-specified criteria.
Danish: Det var tilladt for patienterne i alle grupperne at få tilskud af sublingualt buprenorphin til at kontrollere mulige abstinenssymptomer/trang i henhold til præspecificerede kriterier.
English: All patients receiving Sixmo should be monitored for conditions indicative of diversion, or progression of opioid dependence and addictive behaviours suggesting the need for more intensive and structured treatment for substance use.
Danish: Alle patienter, der får Sixmo, skal overvåges for tilstande, der kunne tyde på diversion, eller progression af opioidafhængighed og vanedannende adfærd, der tyder på et behov for mere intensiv og struktureret behandling mod stofmisbrug.
English: The removed implant contains a significant amount of residual buprenorphine.
Danish: Det fjernede implantat indeholder en signifikant restmængde af buprenorphin.
English: Your doctor will examine the insertion site one week following implant insertion and at a minimum once-monthly thereafter for signs of:
Danish: Lægen vil undersøge indsættelsesstedet en uge efter indsættelsen af implantatet, og derefter mindst én gang månedligt for tegn på:
English: Severe respiratory insufficiency
Danish: Svær respirationsinsufficiens
English: Step 6: While lifting, gently advance the applicator subcutaneously along the channel marking on the skin.
Danish: Trin 6: Mens der løftes fremføres applikatoren forsigtigt subkutant langs den markerede kanal på huden.
English: When used during pregnancy, particularly late pregnancy, buprenorphine may cause withdrawal symptoms, including breathing problems, in the newborn baby.
Danish: Når det anvendes under graviditeten, især i den sene graviditet, kan buprenorphin forårsage abstinenssymptomer, herunder vejrtrækningsproblemer, hos det nyfødte barn.
English: sublingual buprenorphine N=119
Danish: Sublingualt buprenorphin N = 119
English: Naloxone may be of value for the management of buprenorphine overdose.
Danish: Naloxon kan være nyttigt til at behandle en overdosering med buprenorphin.
English: • The active substance is buprenorphine.
Danish: • Aktivt stof: buprenorphin.
English: Buprenorphine is a partial agonist at the µ (mu)-opioid receptor and chronic administration produces dependence of the opioid type.
Danish: Buprenorphin er en partiel agonist ved µ (mu)-opioidreceptoren, og kronisk administration danner afhængighed af opioidtypen.
English: Alternatively, replacement implant(s) may be inserted in the contralateral arm.
Danish: Ellers kan det(de) implantat(er), der udskiftes med, indsættes i den modsatte arm.
English: Especially, inform your doctor during Sixmo treatment before using:
Danish: Du skal især fortælle det til lægen under din behandling med Sixmo, før du bruger:
English: Sixmo was shown to be noninferior to sublingual buprenorphine, the proportion of responders being 87.6% in the sublingual buprenorphine and 96.4% in the Sixmo group.
Danish: Sixmo viste sig at være non-inferiort til sublingualt buprenorphin, hvor andelen af patienter, der responderede var 87,6 % i gruppen med sublingualt buprenorphin, og 96,4 % i Sixmo-gruppen.
English: Patients should be warned that it is extremely dangerous to selfadminister non-prescribed benzodiazepines while taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their healthcare professional (see section 4.4).
Danish: Patienterne skal advares om, at det er ekstremt farligt at selvadministrere ikke ordinerede benzodiazepiner, mens de tager dette præparat, og de skal også rådes til kun at bruge benzodiazepiner samtidigt med dette præparat efter lægens eller sundhedspersonalets anvisninger (se pkt.
English: Serious complications from insertion and removal of Sixmo implants
Danish: Alvorlige komplikationer fra indsættelsen og fjernelsen af Sixmo-implantater
English: • decreased sexual desire, decreased orgasmic sensation
Danish: • nedsat sexlyst, nedsat orgasmefølelse
English: Follow steps 6 through 9 for the insertion of the three remaining implants through the same incision.
Danish: Trin 6 til og med trin 9 følges for at indsætte de 3 resterende implantater via det samme indsnit.
English: If you stop Sixmo treatment your doctor will monitor you for withdrawal symptoms.
Danish: Hvis du stopper behandlingen med Sixmo, vil lægen overvåge dig for abstinenssymptomer.
English: The MAH shall ensure that in each MS where SIXMO is marketed, all physicians expected to insert / remove SIXMO subcutaneous (SC) implant are provided with an educational programme, aiming at preventing / minimising the important identified risk of implant protrusion / (spontaneous) expulsion, the important potential risks of damage to nerves or blood vessels during insertion / removal procedure, (dislocation and) migration / missing (partial) implant.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle lægerne, der forventes at indsætte/fjerne SIXMO subkutane (s.c.) implantater, i alle de medlemslande, hvor SIXMO markedsføres, får et uddannelsesprogram udleveret for at forhindre/minimere de vigtige identificerede risici for, at implantatet fremspringer/udstødes (spontant), de vigtige mulige risici for at beskadige nerver eller blodkar under indgrebet, hvor implantatet indsættes/fjernes, ved (flytning og) migration/manglende (delvise) implantater.
English: Do not drink alcohol during Sixmo treatment, as it increases the sedative effect.
Danish: Du må ikke drikke alkohol i løbet af behandlingen med Sixmo, da det forstærker den sløvende virkning.
English: Study PRO-806
Danish: Studie PRO-806
English: Prior to initiating Sixmo therapy, the patient's medical and treatment history, including use of nonopioid psychoactive substances, needs to be reviewed, in order to ensure that Sixmo treatment can be safely initiated.
Danish: Før behandlingen med Sixmo påbegyndes, skal patientens medicinske anamnese og tidligere behandlinger gennemgås, herunder brugen af ikke-opioide psykoaktive stoffer, for at sørge for, at det er sikkert at påbegynde behandlingen med Sixmo.
English: Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
Danish: Der er også blevet rapporteret dødsfald i forbindelse med samtidig administration af buprenorphin og andre midler med undertrykkende egenskaber, såsom alkohol eller andre opioider.
English: When a hepatic event is suspected, liver function evaluation is required, including consideration whether to discontinue treatment with Sixmo.
Danish: Hvis der er mistanke om en leverhændelse, er en evaluering af leverfunktionen nødvendig, herunder en overvejelse af, om behandlingen med Sixmo skal seponeres.
English: One applicator is used to insert all four implants.
Danish: Der anvendes en applikator til at indsætte alle fire implantater.
English: Implant kit: 4 Sixmo implants with 1 applicator
Danish: Implantatsæt: 4 Sixmo-implantater med 1 applikator
English: • If the expelled implant is not intact, the healthcare professional should palpate the insertion location to identify the location of any remaining partial implant.
Danish: • Hvis det udstødte implantat ikke er intakt, skal lægen eller sundhedspersonalet palpere indsætningsstedet for at identificere, hvor evt. resterende delvise implantater befinder sig.
English: • phenobarbital, carbamazepine, phenytoin: medicines to treat epilepsy and other illnesses
Danish: • phenobarbital, carbamazepin, phenytoin: lægemidler til at behandle epilepsi og andre sygdomme
English: Criteria for the use of supplemental sublingual buprenorphine It is possible that a subset of patients may require occasional supplemental sublingual buprenorphine support to achieve full control of opioid withdrawal symptoms and cravings, e.g. at times of personal stress or crisis.
Danish: Kriterier for anvendelsen af tilskud af sublingualt buprenorphin Det er muligt, at en undergruppe af patienter kan have behov for lejlighedsvise tilskud af sublingualt buprenorphin for at opnå fuld kontrol over opioide-abstinenssymptomer og trang, f.eks. i perioder med personligt stress eller kriser.
English: Buprenorphine has a mean elimination half-life from plasma ranging from 24 to 48 hours.
Danish: Buprenorphin har en gennemsnitlig eliminationshalveringstid fra plasma fra 24 til 48 timer.
English: • Substances like buprenorphine may cause a sudden drop in blood pressure, causing dizziness when getting up quickly.
Danish: • Stoffer som buprenorphin kan forårsage et pludseligt blodtryksfald, og forårsage svimmelhed, hvis du rejser dig op for hurtigt.
English: The mean doses per week in Sixmo subjects in PRO-805 and PRO-806 studies were 5.16 mg and 3.16 mg, with relatively low mean days of use per week of 0.45 and 0.31, respectively.
Danish: De gennemsnitlige doser pr. uge hos personerne, der fik Sixmo i PRO-805- og PRO-806-studierne var 5,16 mg og 3,16 mg, med relativt lave gennemsnitlige dage med forbrug pr. uge på hhv. 0,45 og 0,31.
English: L. Molteni & C. dei Fratelli Alitti Societa di Esercizio S.p.A. Strada Statale 67
Danish: L. Molteni & C. dei Fratelli Alitti Societa di Esercizio S.p.A.
English: • vulvovaginal fungal infection
Danish: • vulvovaginal svampeinfektion
English: In faeces, almost all of the buprenorphine and norbuprenorphine were free (buprenorphine: 33% free and 5% conjugated; norbuprenorphine: 21% free and 2% conjugated).
Danish: I fæces var næsten alt buprenorphin og norbuprenorphin frit (buprenorphin: 33 % frit og 5 % konjugeret; norbuprenorphin: 21 % frit og 2 % konjugeret).
English: Prior to the launch of SIXMO in each Member State (MS), the Marketing Authorisation Holder (MAH) must agree the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Danish: Før SIXMO markedsføres i hvert medlemsland skal indehaveren af markedsføringstilladelsen nå til enighed med den nationale kompetente myndighed om indholdet og formatet af uddannelsesmaterialet, herunder kommunikationsmedier, udleveringskanaler samt alle andre aspekter af programmet.
English: Stop immediately once the proximal marking on the cannula has disappeared into the incision (Figures 7 and 8).
Danish: Der skal straks stoppes når den proksimale markering på sprøjten ikke længere kan ses i indsnittet (figur 7 og 8).
English: Vascular disorders common hot flush, vasodilatation**, hypertension**
Danish: Vaskulære sygdomme almindelig hedetur, vasodilatation**, hypertension**
English: • Patients who have contraindications for MRI should be not allowed to receive the implant.
Danish: • Patienter, som har kontraindikationer mod MR-scanninger bør ikke få implantatet.
English: Table 2: Patient characteristics in the studies PRO-805 and PRO-806 Study PRO-805
Danish: Tabel 2: Patientkarakteristikken i studie PRO-805 og PRO-806 Studie PRO-805
English: The incision should be made parallel to the axis of the arm, between the second and third implants, to access the subcutaneous space (Figure 15).
Danish: Indsnittet skal laves parallelt med armens akse, mellem det andet og tredje implantat, for at få subkutan adgang (figur 15).
English: • If an implant comes out after insertion, take the following steps: Schedule an appointment with the inserting doctor as soon as possible.
Danish: • Hvis et implantat falder ud efter indsættelsen, skal du gøre følgende: Snarest muligt aftale et besøg hos lægen, som indsatte implantatet.
English: Step 15: Pick up the skin edge with Adson single toothed tissue forceps and separate the tissues above and below the visible implant, using an iris scissors or a curved mosquito forceps (Figure 16).
Danish: Trin 15: Huden løftes med Adson-vævstangen med en enkelt tand og vævet separeres over og under det synlige implantat, ved at bruge en iris-saks eller en buet moskito-tang (figur 16).
English: After one subcutaneous insertion in each arm (for a total of two treatments cycles), most patients should be transitioned back to their previous sublingual buprenorphine dose (i.e. the dose from which they were transferred to Sixmo treatment) for continued treatment.
Danish: Efter en subkutan indsættelse i hver arm (i alt 2 behandlingscyklusser) bør de fleste patienter vende tilbage til deres tidligere sublinguale buprenorphin-dosis (dvs. den dosis de fik før de startede behandlingen med Sixmo) med henblik på fortsat behandling.