FrancophonIA/ELRC3.0 huggingface dataset:
English: For Dupuytren's contracture, the doctor injects the appropriate dose of Xiapex directly into a cord in the patient's palm.
Danish: Ved Dupuytrens kontraktur injicerer lægen den korrekte dosis Xiapex direkte i en streng i patientens håndflade.
English: Xiapex is used in patients with plaques that can be felt through the skin and in whom the abnormal curvature of the penis is at least 30 degrees at the start of therapy.
Danish: Xiapex anvendes hos patienter med plaks, der kan mærkes gennem huden, og hos hvem den abnorme krumning af penis er mindst 30 grader ved påbegyndelse af behandlingen.
English: Xiapex was compared with placebo (a dummy treatment) in two main studies involving a total of 374 adult patients with Dupuytren's contracture.
Danish: Xiapex blev sammenlignet med placebo (en virkningsløs behandling) i to hovedundersøgelser, der omfattede i alt 374 voksne patienter med Dupuytrens kontraktur.
English: For the full list of all side effects and restrictions with Xiapex, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Xiapex fremgår af indlægssedlen.
English: There was also a greater improvement with Xiapex than placebo in patient-reported scores of how bothersome the condition was after treatment.
Danish: Der var også større bedring med Xiapex end med placebo i patienternes beskrivelse af, hvor store gener de havde af sygdommen efter behandlingen.
English: What is the risk associated with Xiapex?
Danish: Hvilken risiko er der forbundet med Xiapex?
English: Xiapex is used to treat Dupuytren's contracture and Peyronie's disease in adults.
Danish: Xiapex anvendes til behandling af Dupuytrens kontraktur og Peyronies sygdom hos voksne.
English: The company that markets Xiapex must also ensure that all doctors expected to use the medicine are properly trained on the use of the medicine and experienced in diagnosing and managing Dupuytren's contracture or Peyronie's disease.
Danish: Virksomheden, der markedsfører Xiapex, skal desuden sikre, at alle læger, som forventes at bruge lægemidlet, er korrekt uddannet i lægemidlets brug og har erfaring med diagnosticering og behandling af Dupuytrens kontraktur eller Peyronies sygdom.
English: It contains the active substance collagenase clostridium histolyticum.
Danish: Det indeholder det aktive stof kollagenase clostridium histolyticum.
English: The main measure of effectiveness was the proportion of patients whose main affected joint could be straightened so that it was bent forwards by no more than 5 degrees.
Danish: Virkningen blev hovedsagelig bedømt på andelen af patienter, hvis primære berørte led kunne rettes ud, så deres indadgående krumning var på højst 5 grader.
English: A ‘penile modeling procedure' is then performed by the doctor after a further 1 to 3 days to gently stretch and bend the plaque in the opposite direction to the abnormal curvature.
Danish: Efter yderligere 1-3 dage foretager lægen en "modellering" af penis ved forsigtigt at strække og bøje plakken i modsat retning af den abnorme krumning.
English: Xiapex is a powder and solvent that are made up into a solution for injection.
Danish: Xiapex er et pulver og en solvens til injektionsvæske, opløsning.
English: What measures are being taken to ensure the safe and effective use of Xiapex?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Xiapex?
English: The collagenases in Xiapex are extracted from the bacterium Clostridium histolyticum.
Danish: Kollagenaserne i Xiapex udvindes af bakterien Clostridium histolyticum.
English: Peyronie's disease is a condition in which men develop plaques of fibrous, scar-like tissue in their penis, causing it to become abnormally curved, and sometimes leading to pain or difficulty in sexual intercourse.
Danish: Peyronies sygdom er en tilstand, hvor mænd får forhærdninger (plaks) af fibrøst, arlignende væv i penis, så den bliver abnormt krum, undertiden med smerter eller problemer ved samleje.
English: Why has Xiapex been approved?
Danish: Hvorfor blev Xiapex godkendt?
English: Xiapex is to be used in patients with cords in their palms that are thick enough to be felt through the skin.
Danish: Xiapex anvendes hos patienter, hvor strengene i håndfladen er så tykke, at de kan føles gennem huden.
English: Xiapex must be given by a doctor trained in the use of the medicine and experienced in diagnosing and managing Dupuytren's contracture or male genital problems.
Danish: Xiapex skal gives af en læge, der er uddannet i lægemidlets brug og har erfaring med diagnosticering og behandling af Dupuytrens kontraktur eller problemer med de mandlige kønsorganer.
English: The main measures of effectiveness were the reduction in the abnormal curvature of the penis and the extent to which the condition was bothersome to the patient.
Danish: Virkningen blev hovedsagelig bedømt på reduktionen i den abnorme krumning af penis og på, hvilke gener patienten havde af sygdommen.
English: What is Xiapex?
Danish: Hvad er Xiapex?
English: How has Xiapex been studied?
Danish: Hvordan blev Xiapex undersøgt?
English: What is Xiapex used for?
Danish: Hvad anvendes Xiapex til?
English: What benefit has Xiapex shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Xiapex?
English: How is Xiapex used?
Danish: Hvordan anvendes Xiapex?
English: How does Xiapex work?
Danish: Hvordan virker Xiapex?
English: Date of first authorisation: 10 November 2017
Danish: Dato for første markedsføringstilladelse: 10. november 2017
English: Do this at a speed that is comfortable for you.
Danish: Tryk med en hastighed, der er behagelig for dig.
English: No specific studies have been conducted in elderly patients.
Danish: Der er ikke udført specifikke studier hos ældre patienter.
English: Wash your hands well with soap and warm water.
Danish: Vask dine hænder grundigt med sæbe og varmt vand.
English: Response over time
Danish: Respons over tid
English: The last dose was at week 44 for both treatment groups.
Danish: Den sidste dosis var i uge 44 i begge behandlingsgrupper.
English: No data are available on the response to live or inactive vaccines.
Danish: Der foreligger ingen data om respons på levende eller inaktive vacciner.
English: It is normal to see a drop of liquid.
Danish: Det er normalt at se en dråbe væske.
English: There may be a small amount of blood or liquid at the injection site.
Danish: Der kan være en lille smule blod eller væske på injektionsstedet.
English: Do not warm any other way.
Danish: Undlad at opvarme den på nogen anden måde.
English: The following side effects are all mild to moderate.
Danish: Nedenstående bivirkninger er alle lette til moderate.
English: If you stop treatment, symptoms of psoriasis may come back.
Danish: Hvis du stopper behandlingen, kan symptomerne på psoriasis vende tilbage.
English: • After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks.
Danish: • Efter den første dosis skal du have den næste dosis 4 uger senere og dernæst hver 8. uge.
English: Lift straight up
Danish: Løft lige opad
English: No dose recommendations can be made.
Danish: Der kan ikke gives anbefalinger vedrørende dosis.
English: • if you think you have an infection or have symptoms of an infection (see below under ‘Look out for infections and allergic reactions')
Danish: • hvis du tror, at du har en infektion, eller hvis du har symptomer på en infektion (se „Vær opmærksom på infektioner og allergiske reaktioner“ nedenfor)
English: Wash hands
Danish: Vask hænder
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal det administrerede produkts handelsnavn og batchnummer registreres tydeligt.
English: This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment.
Danish: Denne vejledning erstatter ikke det at tale med din læge om din medicinske tilstand eller din behandling.
English: • if you have tuberculosis or have been in close contact with someone with tuberculosis
Danish: • hvis du har tuberkulose eller har været i tæt kontakt med en, der har tuberkulose
English: Injection is complete when the handle is pushed all the way down, you hear a click, and the green body is no longer visible.
Danish: Injektionen er færdig, når håndtaget er trykket hele vejen ned, du hører et klik, og den grønne del ikke længere er synlig.
English: • if you have an infection that does not go away or that keeps coming back
Danish: • hvis du har en infektion, der ikke vil gå væk eller bliver ved med at vende tilbage
English: Patients were examined at four week intervals for a total of four visits.
Danish: Patienterne blev undersøgt hver 4. uge ved i alt fire besøg.
English: Baseline characteristics for randomised patients were similar to those observed in VOYAGE 1 and 2.
Danish: Baseline-karakteristika for randomiserede patienter var stort set de samme som dem, der blev observeret i VOYAGE 1 og 2.
English: p < 0.001 for superiority p < 0.001 for non-inferiority, p=0.062 for superiority formal statistical testing was not performed
Danish: p < 0,001 for superioritet p < 0,001 for non-inferioritet, p = 0,062 for superioritet der blev ikke udført formel statistisk afprøvning
English: • if you have an active infection, including active tuberculosis
Danish: • hvis du har en aktiv infektion, herunder aktiv tuberkulose.
English: The key efficacy results for the primary and major secondary study endpoints are shown in Table 2 below.
Danish: De vigtigste resultater for virkning for de primære og sekundære endepunkter fremgår af tabel 2 nedenfor.
English: • if you are being treated for an infection
Danish: • hvis du får behandling for en infektion
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
Danish: Det bør overvejes at seponere behandlingen hos patienter, som ikke har udvist respons efter 16 ugers behandling.
English: There is limited information in subjects aged ≥ 65 years.
Danish: Der foreligger begrænsede data om patienter i alderen ≥ 65 år.
English: Tremfya may increase the risk of infection.
Danish: Tremfya kan øge risikoen for infektion.
English: Select from the following areas for your injection:
Danish: Vælg mellem følgende områder til din injektion:
English: Your injection is now complete!
Danish: Injektionen er nu færdig!
English: You should not stop using Tremfya without speaking to your doctor first.
Danish: Du må ikke holde op med at bruge Tremfya uden først at tale med lægen.
English: Tremfya has not been studied in these patient populations.
Danish: Tremfya er ikke undersøgt hos disse patientpopulationer.
English: Do not remove until you are ready to inject Tremfya (See Step 2).
Danish: Undlad at fjerne det, før du er klar til at injicere Tremfya (se trin 2).
English: The yellow band indicates that the needle guard is locked.
Danish: Det gule bånd angiver, at kanylebeskyttelsen er låst.
English: Pre-treatment evaluation for tuberculosis
Danish: Undersøgelse for tuberkulose inden behandling
English: Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse.
Danish: Læs også indlægssedlen omhyggeligt inden du begynder din injektion, og diskutér eventuelle spørgsmål, du måtte have med din læge eller sundhedspersonalet.
English: Do not use the 5-centimetre area around your belly-button.
Danish: Undlad at bruge området 5 centimeter omkring navlen.
English: Regional disease
Danish: Regional sygdom
English: It is important to pinch enough skin to inject under the skin and not into the muscle.
Danish: Det er vigtigt at klemme om nok hud til at injicere under huden og ikke ind i musklen.
English: • Tremfya should not be used in pregnancy as the effects of this medicine in pregnant women are not known.
Danish: • Tremfya bør ikke anvendes under graviditeten, da denne medicins virkning på gravide ikke kendes.
English: • if you are allergic to guselkumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for guselkumab eller et af de øvrige indholdsstoffer i Tremfya (angivet i punkt 6).
English: Do not touch needle or let it touch any surface.
Danish: Undlad at røre ved kanylen eller lade den røre ved nogen overflade.
English: If possible, areas of the skin that show psoriasis should be avoided as injection sites.
Danish: Hvis det er muligt, skal hudområder med aktiv psoriasis undgås som injektionssteder.
English: Herpes simplex infections
Danish: Herpes simplex-infektioner
English: (subcutaneous injection).
Danish: (subkutan injektion).
English: Do not touch, fan or blow on the injection site after you have cleaned it.
Danish: Undlad at berøre, vifte henover eller puste på injektionsstedet, efter at du har renset det.
English: Serious hypersensitivity reactions have been reported in the post-marketing setting.
Danish: Alvorlige overfølsomhedsreaktioner er blevet rapporteret efter markedsføringen.
English: Name and address of the manufacturers of the biological active substance Biogen Inc. (BIIB)
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof Biogen Inc. (BIIB)
English: The adverse reactions are classified by MedDRA System Organ Class and frequency, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er klassificeret efter MedDRA-systemorganklasse og hyppighed med følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Wipe your chosen injection site with an alcohol swab and allow it to dry.
Danish: Aftør det valgte injektionssted med en spritserviet, og lad det tørre.
English: Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Danish: Tal med din læge, hvis du er gravid, har mistanke om, at du er gravid eller planlægger at blive gravid.
English: The safety and efficacy of Tremfya in children and adolescents below the age of 18 years have not yet been established.
Danish: Tremfyas sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: Talk to your doctor or nurse if you have any questions about giving yourself an injection.
Danish: Tal med din læge eller sundhedspersonalet, hvis du har spørgsmål i forbindelse med at give dig selv en injektion.
English: There are no data from the use of guselkumab in pregnant women.
Danish: Der er ingen data fra anvendelse af guselkumab til gravide kvinder.
English: • if you have recently had a vaccination or if you are due to have a vaccination during treatment with Tremfya.
Danish: • hvis du er blevet vaccineret for nylig eller skal have en vaccination, mens du bliver behandlet med Tremfya.
English: Population pharmacokinetic analyses indicated there were no apparent changes in CL/F estimate in patients ≥ 65 years of age compared to patients < 65 years of age, suggesting no dose adjustment is needed for elderly patients.
Danish: Farmakokinetiske populationsanalyser indikerede, at der ikke var nogen tilsyneladende ændringer i estimater af Cl/F hos patienter ≥ 65 år sammenlignet med patienter < 65 år, hvilket tyder på, at det ikke er nødvendigt at justere dosis til ældre patienter.
English: Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Danish: Sørg for at bortskaffe beholderen som anvist af din læge eller sundhedspersonalet, når beholderen er fyldt.
English: In humans, selective blockade of IL-23 was shown to normalize production of these cytokines.
Danish: Hos mennesker viste selektiv blokade af IL-23 at normalisere produktionen af disse cytokiner.
English: Some cases occurred several days after treatment with guselkumab, including cases with urticaria and dyspnoea.
Danish: Nogle tilfælde forekom adskillige dage efter behandling med guselkumab, herunder tilfælde af urticaria og dyspnø.
English: sucrose and water for injections.
Danish: saccharose og vand til injektionsvæsker.
English: After proper training in subcutaneous injection technique, patients may inject Tremfya if a physician determines that this is appropriate.
Danish: Efter passende træning i subkutan injektionsteknik, kan patienterne selv injicere Tremfya, hvis en læge beslutter, at det er hensigtsmæssigt.
English: Do not lift the pre-filled pen during the injection.
Danish: Undlad at løfte den fyldte pen under injektionen.
English: Safety guard activates
Danish: Sikkerhedsanordningen aktiveres
English: The safety guard will cover the needle and lock into place, removing the needle from your skin.
Danish: Sikkerhedsanordningen dækker kanylen og låses på plads og fjerner kanylen fra din hud.
English: The effect of guselkumab on human fertility has not been evaluated.
Danish: Virkningen af guselkumab på human fertilitet er ikke blevet vurderet.
English: However, the physician should ensure appropriate medical follow-up of patients.
Danish: Lægen skal dog sikre sig, at der sker den nødvendige medicinske opfølgning.
English: Antidrug antibodies were not associated with lower efficacy or development of injection-site reactions.
Danish: Antistoffer mod lægemidlet var ikke forbundet med ringere virkning eller udvikling af reaktioner på injektionsstedet.
English: Tremfya is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.
Danish: Børn og unge Tremfya frarådes til børn og unge under 18 år, da det ikke er undersøgt hos denne aldersgruppe.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC16.
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, interleukinhæmmere, ATC-kode: L04AC16.
English: Prepare for your injection
Danish: Gør dig klar til injektionen
English: How much Tremfya is given and for how long Your doctor will decide for how long you need to use Tremfya.
Danish: Så meget Tremfya vil du få og i så lang tid Din læge vil beslutte, hvor længe du skal bruge Tremfya.
English: This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with psoriasis.
Danish: Denne medicin virker ved at blokere aktiviteten af et protein, der hedder IL-23, som findes i forhøjede mængder hos patienter med psoriasis.
English: Major Secondary Endpoints PASI 75 response at both Week 12 and Week 48
Danish: Vigtigste sekundære endepunkter PASI 75-respons i både uge 12 og uge 48
English: There were no preneoplastic changes observed in histopathology evaluations of animals treated up to 24-weeks, or following the 12-week recovery period during which drug was detectable in the serum.
Danish: Der blev ikke observeret nogen præ-neoplastiske ændringer i histopatologiske vurderinger af dyr, som blev behandlet i op til 24 uger, eller efter en restitutionsperiode på 12 uger, hvorunder lægemidlet kunne påvises i serum.
English: If a serious hypersensitivity reaction occurs, administration of Tremfya should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en alvorlig overfølsomhedsreaktion, skal administration af Tremfya seponeres med det samme og passende behandling iværksættes.
English: The immunogenicity of Tremfya was evaluated using a sensitive and drug-tolerant immunoassay.
Danish: Immunogeniciteten af Tremfya blev vurderet med en sensitiv og lægemiddeltolerant immunanalyse.
English: Position syringe at about a 45 degree angle to the skin.
Danish: Placer injektionssprøjten i en vinkel på ca. 45 grader i forhold til huden.
English: Table 1 provides a list of adverse reactions from psoriasis clinical studies as well as from post-marketing experience.
Danish: Tabel 1 viser en liste over bivirkninger fra kliniske studier med psoriasis samt erfaring efter markedsføringen.
English: You must look out for signs of these conditions while you are taking Tremfya.
Danish: Du skal være opmærksom på tegn på disse tilstande, mens du bruger Tremfya.
English: Prescribers should consult the Summary of Product Characteristics of the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.
Danish: Den ordinerende læge skal læse produktresuméet for den specifikke vaccine for at få yderligere oplysninger om og vejledning i samtidig brug af immunsupprimerende midler efter vaccination.
English: Of the patients who developed antidrug antibodies, approximately 7% had antibodies that were classified as neutralizing, which equates to 0.4% of all patients treated with Tremfya.
Danish: Af de patienter, som udviklede antistoffer mod lægemidlet, havde ca. 7 % antistoffer, som blev klassificeret som neutraliserende, hvilket svarer til 0,4 % af alle patienter, der blev behandlet med Tremfya.
English: Before live viral or live bacterial vaccination, treatment with Tremfya should be withheld for at least 12 weeks after the last dose and can be resumed at least 2 weeks after vaccination.
Danish: Inden vaccination med levende vira eller levende bakterier skal behandling med Tremfya afbrydes i mindst 12 uger efter den sidste dosis og behandlingen kan genoptages mindst 2 uger efter vaccinationen.
English: Medication injects as you push.
Danish: Medicinen injiceres, mens du trykker.
English: Patients should be instructed to inject the full amount of Tremfya according to the ‘Instructions for use' provided in the carton.
Danish: Patienterne skal have besked på at injicere den fulde mængde af Tremfya i henhold til „Brugsanvisning“, som medfølger i kartonen.
English: Serious side effects Tell your doctor or seek medical help immediately if you get any of the following side effects:
Danish: Alvorlige bivirkninger Fortæl det straks til lægen eller søg akut lægehjælp, hvis du får en eller flere af følgende bivirkninger:
English: Human IgGs are known to be excreted in breast milk during the first few days after birth, and decrease to low concentrations soon afterwards; consequently, a risk to the breast-fed infant during this period cannot be excluded.
Danish: Det vides, at humane IgG'er udskilles i brystmælk i løbet af de første få dage efter fødslen, for kort tid derefter at falde til lave koncentationer.
English: Use your other hand to pinch skin at the injection site.
Danish: Brug din anden hånd til at klemme huden sammen på injektionsstedet.
English: If a patient develops a clinically important or serious infection or is not responding to standard therapy, the patient should be monitored closely and Tremfya should be discontinued until the infection resolves.
Danish: Hvis patienten udvikler en klinisk betydningsfuld eller alvorlig infektion, eller ikke responderer på standardbehandling, skal patienten overvåges nøje, og Tremfya skal seponeres, indtil infektionen har fortaget sig.
English: Patients receiving Tremfya should be monitored for signs and symptoms of active TB during and after treatment.
Danish: Patienter, der får Tremfya, skal overvåges nøje for tegn og symptomer på aktiv tuberkulose under og efter behandlingen.
English: Week 156
Danish: Uge 156
English: Do not inject into areas with scars or stretch marks.
Danish: Undlad at injicere i områder med ar eller strækmærker.
English: Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as scaling, shedding, flaking, itching, pain and burning.
Danish: Tremfya kan forbedre hudens tilstand og neglenes udseende og reducere symptomer som for eksempel skæl, flagedannelse, kløe, smerter og brændende fornemmelse.