FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean Percent Change from Baseline in Curvature Deformity at Week 36 (LOCF) (mITT* Population) - study AUX-CC-806
Danish: Gennemsnitlig procentvis ændring fra baseline i kurvaturdeformitet ved uge 36 (LOCF) (mITT*-population) - studie AUX-CC-806
English: Your doctor must not use Xiapex if the reconstituted solution is discoloured or contains particles.
Danish: Deres læge må ikke bruge Xiapex, hvis den tilberedte injektionsvæske er misfarvet eller indeholder partikler.
English: Severe penile haematoma including severe injection site haematoma were reported with the frequency very common.
Danish: Svært penilt hæmatom, herunder svært hæmatom ved injektionsstedet, blev rapporteret med hyppigheden meget almindelig.
English: In the retreatment study AUX-CC-862, 150 anti-AUX-I antibody positive samples and 149 anti-AUX-II antibody positive samples were assessed for potential cross-reactivity with human MMPs-1, -2, -3, -8, and -13.
Danish: I genbehandlingsstudiet AUX-CC-862 blev 150 anti-AUX-I-positive antistofprøver og 149 anti-AUX-II-positive antistofprøver vurderet for mulig krydsreaktivitet med humane MMP'er 1,2, -8 og -13.
English: The most frequently reported adverse drug reactions (≥25%) during the Xiapex controlled clinical studies were penile haematoma, penile swelling and penile pain.
Danish: De hyppigst rapporterede bivirkninger (≥25 %) i de kontrollerede kliniske studier med Xiapex var penilt hæmatom, hævelse af penis og penissmerter.
English: When injecting a cord affecting a PIP joint of the fifth finger, the needle insertion must not be more than 2 to 3 mm in depth and not more than 4 mm distal to the palmar digital crease.
Danish: Når der injiceres i en streng, som påvirker PIP led på den femte finger, må kanylen ikke indstikkes mere end 2 til 3 mm i dybden og ikke mere end 4 mm distalt for palmar digital bøjefuren.
English: Tell your doctor if you have previously received or are thinking about receiving Xiapex to treat a condition known as Peyronie's disease.
Danish: Fortæl det til lægen, hvis De tidligere har fået, eller hvis De overvejer at få Xiapex til behandling af en sygdom, der kaldes Peyronies sygdom.
English: Receiving an injection of Xiapex may cause damage to the tubes in your penis called the corpora.
Danish: Når De får en injektion med Xiapex, kan det beskadige de rør i penis, der kaldes corpora.
English: Injection of Xiapex into a Peyronie's plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque.
Danish: Injektion af Xiapex i en Peyronies plaque, som hovedsageligt består af kollagen, kan føre til en enzymatisk betinget ruptur af plaquen.
English: Primary efficacy endpoint was fixed flexion contracture in the treated joint pair subgroup.
Danish: De primære endepunkter for virkning var fikseret fleksionskontraktur i den behandlede undergruppe af ledpar.
English: Physician-rated change in contracture severity was reported as very much improved or much improved in 86% and 80% of the subjects in the Xiapex group compared to 3% and 5% of subjects in the placebo group for the CORD I and CORD II studies, respectively (p<0.001).
Danish: Lægens vurdering af ændring i sværhedsgrad af kontraktur blev rapporteret som virkelig meget bedre eller meget bedre hos 86 % og 80 % af studiepersonerne i Xiapexgruppen sammenlignet med 3 % og 5 % af studiepersonerne i placebogruppen for henholdsvis CORD I og CORD II studierne (p<0,001).
English: • shortness of breath, hyperventilation
Danish: • stakåndethed, hyperventilation
English: Parturition or postnatal development studies in animals were not conducted since human pharmacokinetic studies show that Xiapex levels are not quantifiable in the systemic circulation following injection into a Dupuytren's cord (see section 5.1).
Danish: Dyrestudier vedrørende fødsel og postnatal udvikling blev ikke udført, eftersom humane farmakokinetiske studier viser, at Xiapex-niveauer ikke er kvantificerbare i det systemiske kredsløb efter injektion i Dupuytrens streng (se pkt.
English: • increased white blood cells
Danish: • forhøjet antal hvide blodlegemer
English: Injection of Xiapex into a Dupuytren's cord, which is comprised mostly of interstitial collagen types I and III, results in enzymatic disruption of the cord.
Danish: Injektion af Xiapex i en Dupuytrens streng, som hovedsagelig består af interstitielt kollagen type I og III, medfører en enzymatisk betinget ruptur af strengen.
English: The solution must be clear, colourless with no lumps or flakes or particles.
Danish: Injektionsvæsken skal være klar og farveløs uden klumper, flager eller partikler.
English: Dupuytren's contracture
Danish: Dupuytrens kontraktur
English: • 0.25 ml of reconstituted Xiapex for cords affecting a MP joint or • 0.20 ml of reconstituted Xiapex for cords affecting a PIP joint.
Danish: • 0,25 ml rekonstitueret Xiapex til strenge, som påvirker et MP-led eller • 0,20 ml rekonstitueret Xiapex til strenge, som påvirker et PIP-led.
English: • Not to flex or extend the fingers of the injected hand to reduce extravasation of Xiapex out of the cord until the finger extension procedure is completed.
Danish: • ikke at bøje eller strække fingrene på den hånd, der er blevet behandlet, for at reducere udsivning af Xiapex fra strengen indtil manipulation af fingeren er gennemført.
English: Only doctors that have been appropriately trained in the correct use of Xiapex and are experienced in the management of Dupuytren's or Peyronie's disease are allowed to give you treatment.
Danish: Kun læger med passende træning i den korrekte anvendelse af Xiapex, og som har erfaring med behandling af Duprytrens eller Peyronies sygdom har tilladelse til at give Dem behandlingen.
English: Most of the side effects that occurred in the clinical studies were mild or moderate in severity and were localised to the hand treated.
Danish: De fleste bivirkninger, som opstod i de kliniske studier, var milde til moderate og var lokaliseret til den behandlede hånd.
English: The most frequently reported adverse reactions during the Xiapex clinical studies (272 of 409 patients received up to three single injections of Xiapex and 775 patients received two concurrent injections in the same hand) were local injection site reactions such as oedema peripheral (local to the injection site), contusion (including ecchymosis), injection site haemorrhage and injection site pain.
Danish: De hyppigst rapporterede bivirkninger i de kliniske studier med Xiapex (272 ud af 409 patienter fik op til tre enkelte injektioner af Xiapex og 775 patienter fik samtidig to injektioner i den samme hånd) var reaktioner lokalt på injektionsstedet såsom perifere ødemer (lokalt på injektionsstedet), blå mærker (herunder blodudtrædninger), blødning på injektionsstedet og smerter på injektionsstedet.
English: Injection of Xiapex into collagen containing structures may result in damage to those structures, and possible permanent injury such as tendon rupture or ligament damage.
Danish: Injektion af Xiapex i strukturer, som indeholder kollagen, kan medføre skade på disse strukturer og muligvis permanent skade såsom seneruptur eller ligamentskade.
English: Gender, n (%) Male Female Family history of Dupuytren's disease, n
Danish: Familiær disposition af Dupuytrens sygdom, n (%)
English: b “skin laceration” includes “injection site laceration” and “laceration” c “oedema peripheral” includes “injection site oedema” and “oedema” d see also section 4.4
Danish: b ”rifter i huden” omfatter ”rifter på injektionsstedet” og ”rifter” c ”perifere ødemer” inkluderer ”ødemer på injektionsstedet” og ”ødemer” d se også pkt.
English: The primary endpoint of each study was to evaluate the proportion of patients who achieved a reduction in contracture of the selected primary joint (MP or PIP) to 5° or less of normal, approximately 4 weeks after the last injection of that joint.
Danish: Det primære endepunkt for hvert studie var at evaluere antallet af patienter, som opnåede en reduktion i kontraktur til ≤5° i det udvalgte primære led (MP eller PIP) ca. 4 uger efter den sidste injektion i leddet.
English: Six weeks after the eighth injection (fourth treatment cycle) of Xiapex >99% of Xiapex-treated patients developed high titers of antibodies to both AUX-I and AUX-II.
Danish: Seks uger efter den 8. injektion (4. behandlingscyklus) med Xiapex udviklede > 99 % af de Xiapex-behandlede patienter høje antistoftitre mod både AUX-I og AUX-II.
English: • Induce a penile erection
Danish: • Inducer erektion af penis
English: The study inclusion and exclusion criteria as well as the treatment schedule and the co-primary efficacy endpoints were the same as in the pivotal AUX-CC-803 and AUX-CC-804 studies.
Danish: Studiets inklusions- og eksklusionskriterier, samt behandlingsskemaet og de to primære endepunkter for virkning var de samme som i de pivotale AUX-CC-803- og AUX-CC-804-studier.
English: Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.
Danish: Injektioner i strengen og manipulationen af fingeren kan foretages op til 3 gange pr. streng med cirka 4 ugers interval.
English: Long Term Recurrence Rates for Joints Treated Successfully with XIAPEX
Danish: Langtids-recidivrater for led, der blev behandlet med XIAPEX med et vellykket resultat
English: The overall safety profile was similar in the two Phase 3 double-blind placebo-controlled studies (832 male patients, 551 patients received Xiapex) and in an open-label Phase 3 study (189 male patients) of patients who had previously received placebo in the controlled studies.
Danish: Den samlede sikkerhedsprofil var sammenlignelig i de to dobbeltblinde, placebokontrollerede fase 3-studier (832 mandlige patienter, 551 patienter fik Xiapex) og i et åbent fase 3-studie (189 mandlige patienter) med patienter, der tidligere havde fået placebo i de kontrollerede studier.
English: The recommended dose of Xiapex is 0.58 mg per injection administered into a Peyronie's plaque.
Danish: Den anbefalede dosis Xiapex er 0,58 mg pr. injektion, administreret i en Peyronies plaque.
English: • The active substance is collagenase clostridium histolyticum.
Danish: • Aktivt stof: kollagenase clostridium histolyticum.
English: Peyronie's disease occurs exclusively in adult male patients and hence there is no relevant use of Xiapex in the paediatric population aged 0-18 years for the treatment of Peyronie's disease.
Danish: Peyronies sygdom forekommer udelukkende hos voksne mænd, og det er derfor ikke relevant at anvende Xiapex hos børn og unge i alderen 0-18 år til behandling af Peyronies sygdom.
English: The active substance in Xiapex is collagenase clostridium histolyticum, and this collagenase is produced using the microorganism Clostridium histolyticum.
Danish: Det aktive stof i Xiapex er kollagenase clostridium histolyticum, og denne kollagenase dannes naturligt ved hjælp af mikroorganismen Clostridium histolyticum.
English: The double-blind study population comprised 832 male patients of whom 551 patients received Xiapex and 281 received placebo.
Danish: Den dobbeltblinde studiepopulation bestod af 832 mandlige patienter, hvoraf 551 fik Xiapex, og 281 fik placebo.
English: • For cords affecting PIP joints, each dose is administered in an injection volume of 0.20 ml.
Danish: • Til strenge, som påvirker PIP-led, administreres hver dosis i et injektionsvolumen på 0,20 ml.
English: Your doctor will ask you to return approximately 24-72 hours after your injection to attempt to extend your finger to straighten it.
Danish: Lægen vil bede Dem om at komme igen ca. 24 - 72 timer efter injektionen for at prøve at få udstrakt Deres finger.
English: Absorption Following administration of either a single dose of 0.58 mg of Xiapex to 16 patients with Dupuytren's contracture, or two concurrent injections of 0.58 mg of Xiapex in the same hand in 12 patients with Dupuytren's contracture, no quantifiable levels of Xiapex were detected in plasma from 5 minutes to 30 days post injection.
Danish: Efter administration af enten en enkelt dosis på 0,58 mg Xiapex til 16 patienter med Dupuytrens kontraktur eller to samtidige injektioner med 0,58 mg Xiapex i den samme hånd hos 12 patienter med Dupuytrens kontraktur blev der ikke målt kvantificerbare niveauer af Xiapex i plasma fra 5 minutter til 30 dage efter injektion.
English: Clinical study experience with Xiapex is currently limited to four treatment cycles in which a total of 8 injections may be administered into the plaque causing the curvature.
Danish: Erfaringer fra kliniske studier med Xiapex er aktuelt begrænset til fire behandlingscyklusser, hvor i alt 8 injektioner kan administreres i den plaque, der forårsager krumningen.
English: Because Xiapex is not a substrate for cytochrome P450 or other medicinal product metabolizing enzyme pathways, and because no active metabolites are expected, no metabolism studies have been performed.
Danish: Der er ikke udført metaboliske studier, eftersom Xiapex ikke er et substrat for cytokrom P450 eller andre lægemiddelmetaboliserende enzymsystemer, og eftersom ingen aktive metabolitter er forventet.
English: Therefore, Xiapex must be injected only into the Peyronie's plaque and care should be taken to avoid injecting into the urethra, nerves, blood vessels, corpora cavernosa or other collagen-containing structures of the penis.
Danish: Derfor må Xiapex kun injiceres i Peyronies plaquen, og der skal udvises forsigtighed, så det undgås at injicere det i ureter, nerver, blodkar, corpora cavernosa eller andre kollagenholdige strukturer i penis.
English: The incidence of Xiapex-associated pruritus was similar after each injection regardless of the number of injections administered.
Danish: Forekomsten af Xiapex-associeret pruritus efter hver injektion var den samme uanset antallet af administrerede injektioner.
English: A significant mean improvement (74.4%) from baseline to Day 31 was observed overall in fixed flexion contracture following administration of two concurrent injections of Xiapex 0.58 mg (one injection per joint) in the same hand, see Table 6.
Danish: En signifikant gennemsnitlig forbedring (74,4 %) fra baseline til dag 31 blev observeret samlet ved fikseret fleksionskontraktur efter administration af to samtidige injektioner af Xiapex 0,58 mg (en injektion pr. led) i den samme hånd, se tabel 6.
English: Tables 11-12 provide the results of the co-primary efficacy endpoints measured in the open label phase 3 study AUX-CC-806.
Danish: Tabel 11-12 viser resultaterne af de to primære endepunkter for virkning målt i det åbne fase 3-studie AUX-CC-806.
English: Corporal rupture was reported as a serious adverse reaction after Xiapex injection in 5 out of 1044 patients (0.5%) in the controlled and uncontrolled clinical trials in Peyronie's disease.
Danish: Penisruptur blev rapporteret som en alvorlig bivirkning efter Xiapex-injektion hos 5 ud af 1.044 patienter (0,5 %) i de kontrollerede og ikke-kontrollerede kliniske studier af Peyronies sygdom.
English: When administering two injections in the same hand during a treatment visit, begin with the affected finger in the most ulnar aspect of the hand and continue toward the radial aspect (eg, fifth finger to index finger).
Danish: Når der administreres to injektioner i den samme hånd under et besøg under behandlingen, skal der begyndes med den yderste finger på hånden og fortsættes mod den inderste finger (f.eks. fra lillefingeren mod pegefingeren).
English: A penile modelling procedure is performed 1 to 3 days after the second injection of each treatment cycle.
Danish: Remodellering af penis udføres 1 til 3 dage efter den anden injektion i hver behandlingscyklus.
English: VARIABLE
Danish: VARIABEL
English: Figure 2: Three step injection of Xiapex into the cord.
Danish: Figur 2: Tretrins injektion af Xiapex i strengen
English: • avoidance of sex
Danish: • undgåelse af samleje
English: Tabulated list of adverse reactions Table 2 presents adverse reactions listed by system organ class and frequency categories, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to
Danish: Liste over bivirkninger i tabelform Tabel 1 indeholder bivirkninger opstillet efter organklassificering og frekvens ved brug af følgende konvention: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til
English: The target plaque is used as a fulcrum point with both hands, to firmly apply a steady pressure to elongate and stretch the plaque.
Danish: Den plaque, der skal behandles, anvendes som et støttepunkt for begge hænder, så der med en fast hånd påføres et konstant tryk for at forlænge og strække plaquen.
English: The syringe and needle used for reconstitution are thereafter removed and discarded.
Danish: Injektionssprøjten og kanylen, som er anvendt til rekonstitution, fjernes derefter og bortskaffes.
English: Gently stretch your penis 3 times a day.
Danish: Stræk forsigtigt Deres penis 3 gange om dagen.
English: 1 vial of solvent
Danish: 1 hætteglas solvens
English: • swollen face
Danish: • hævelse i ansigt
English: Contents of the pack and other information What Xiapex contains
Danish: Pakningsstørrelser og yderligere oplysninger Xiapex indeholder:
English: System organ class Very common Common Uncommon
Danish: Meget almindelig Almindelig Ikke almindelig
English: h) Upon complete withdrawal of the needle, apply gentle pressure at the injection site.
Danish: h) Når kanylen er helt trukket tilbage, trykkes der forsigtigt på injektionsstedet.
English: • agitation, disorientation, irritability, restlessness, difficulty sleeping
Danish: • ophidselse, desorientering, irritabilitet, rastløshed, søvnbesvær
English: No more than 3 attempts per affected joint are recommended to disrupt a cord.
Danish: Det anbefales ikke at udføre mere end 3 forsøg pr. påvirket led på at få strengen til at briste.
English: • The solvent contains calcium chloride dihydrate, sodium chloride and water for injections.
Danish: • Solvensen indeholder kalciumchloriddihydrat, natriumchlorid og vand til injektionsvæsker.
English: Mean percent change in penile curvature deformity from baseline to week 52 - Studies 1 and 2
Danish: Gennemsnitlig procentvis ændring i peniskrumning fra baseline til uge 52 - studie 1 og 2
English: Because Xiapex lyses collagen, care must be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand.
Danish: Eftersom Xiapex lyserer kollagen, skal der udvises forsigtighed for at undgå injektion i sener, nerver, blodkar eller andre strukturer i hånden, som indeholder kollagen.
English: • dizziness, headache, nausea
Danish: • svimmelhed, hovedpine, kvalme
English: Following each of two intralesional administrations, separated by 24 hours, of Xiapex 0.58 mg into the penile plaque of 19 patients with Peyronie's disease, plasma levels of AUX-I and AUX-II in patients with quantifiable levels (82% and 40% for AUX-I and AUX-II, respectively) were minimal and shortlived.
Danish: Efter hver af de to intralæsionale doser af Xiapex 0,58 mg (administreret med 24 timers mellemrum) i plaquen på penis hos 19 patienter med Peyronies sygdom var plasmaniveauerne af AUX-I og AUX-II hos patienter med kvantificerbare niveauer (82 % og 40 % for hhv. AUX-I og AUX-II) minimale og af kort tids varighed.
English: Peyronie's Disease Questionnaire (PDQ)b,Mean Patient-Reported PD Bother Domain Score (range: 0-16) c
Danish: Spørgeskema om Peyronies sygdom (Peyronie's Disease Questionnaire, PDQ)b,gennemsnitlig patientrapporteret PD-score i problem-domænet (interval: 0-16) c
English: • To elevate the injected hand as much as possible until the day after the finger extension procedure.
Danish: • at holde den injicerede hånd løftet op så meget som muligt indtil dagen efter fingermanipulationen.
English: • tremor/shaking, increased sensitivity to stimuli
Danish: • rysten, øget følsomhed ved stimulering
English: Severe penile haematoma was also reported as an adverse reaction in 39 of 1044 patients (3.7%) in the controlled and uncontrolled clinical studies in Peyronie's disease.
Danish: Svært hæmatom på penis blev også rapporteret som en bivirkning hos 39 ud af 1.044 patienter (3,7 %) i de kontrollerede og ikke-kontrollerede kliniske studier af Peyronies sygdom.
English: Digital necrosisd Digital fractured a reported with a higher incidence (very common) in patients who received two concurrent injections of Xiapex in the same hand compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren's contracture.
Danish: Digital nekrosed Digital frakturd a rapporteret med en større forekomst (meget almindelig) hos patienter, der fik to samtidige injektioner af Xiapex i den samme hånd, sammenlignet med forsøgspersoner i behandling med op til tre enkelte injektioner i fase III placebokontrollerede pivotale studier ved Dupuytrens kontraktur.
English: A higher rate for skin laceration has been shown following two concurrent injections in the same hand in a controlled post-marketing trial (see also Section 4.8).
Danish: En større forekomst af rifter i huden er blevet vist efter to samtidige injektioner i den samme hånd i et kontrolleret studie efter markedsføring (se også pkt.
English: Special penile conditions/diseases not studied in clinical trials Xiapex treatment in patients having a calcified plaque that could have interfered with the injection technique, chordee in the presence or absence of hypospadias, thrombosis of the dorsal penile artery and/or vein, infiltration by a benign or malignant mass resulting in penile curvature, infiltration by an infectious agent, such as in lymphogranuloma venereum, ventral curvature from any cause and isolated hourglass deformity of the penis has not been studied and treatment in these patients should be avoided.
Danish: Xiapex-behandling er ikke blevet undersøgt hos patienter med en forkalket plaque, der kunne have påvirket injektionsteknikken, chordee med eller uden hypospadi, trombosering af den dorsale penisarterie og/eller -vene, infiltration af en benign eller malign masse, der fører til krumning af penis, infiltration af en infektiøs agens, såsom ved lymphogranuloma venereum, ventral krumning uanset årsag og isoleret timeglasdeformitet af penis.
English: • For cords affecting MP joints each dose is administered in an injection volume of 0.25 ml.
Danish: • Til strenge, som påvirker MP-led, administreres hver dosis i et injektionsvolumen på 0,25 ml.
English: Baseline Mean Mean Change a Treatment Difference (95% CI)
Danish: Gennemsnitsændring a Behandlingsforskel (95 % CI)
English: Signs or symptoms that may reflect serious injury to the penis should be promptly evaluated in order to assess for corporal rupture or severe penile haematoma, which may require surgical intervention.
Danish: Tegn og symptomer, der kan afspejle alvorlig skade på penis, skal straks evalueres for at vurdere, om det drejer sig om penisfraktur eller svært penilt hæmatom, hvilket kan kræve et kirurgisk indgreb.
English: An anaphylactic reaction was reported in a post-marketing clinical study in a patient who had previous exposure to Xiapex for the treatment of Dupuytren's contracture, demonstrating that severe reactions including anaphylaxis can occur following Xiapex injections.
Danish: I et klinisk studie efter markedsføring blev der rapporteret om en anafylaktisk reaktion hos en patient, der tidligere var blevet eksponeret for Xiapex ved behandling af Dupuytrens kontraktur, hvilket viser, at svære reaktioner, herunder anafylaksi, kan opstå efter Xiapex-injektioner.
English: At the follow-up visit approximately 24-72 hours after injection, determine if the contracture has resolved.
Danish: Ved opfølgningsbesøget ca. 24 - 72 timer efter injektionen afgøres det, om kontrakturen er opløst.
English: If injecting into a cord affecting the PIP joint of the fifth (little) finger, care must be taken to inject as close to the palmar digital crease as possible and not to insert more than 2 mm to 3 mm in depth.
Danish: Ved injektion ind i en streng, som påvirker PIP leddet på den femte finger (lillefingeren), skal der injiceres så tæt på den palmare digitale bøjning som muligt og ikke mere end 2 -3 mm i dybden.