FrancophonIA/ELRC3.0 huggingface dataset:
English: There was no evidence of accumulation following two sequential injections of Xiapex administered 24 hours apart.
Danish: Der var ikke evidens for akkumulation efter to på hinanden følgende injektioner af Xiapex, administreret med 24 timers mellemrum.
English: • With one hand hold your penis.
Danish: • Hold om Deres penis med en hånd.
English: Within each frequency group, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet med faldende grad af alvorlighed.
English: The median age of the patients included was 60, ranging between 33 and 77 years.
Danish: Medianalderen for de inkluderede patienter var 60, i intervallet fra 33 til 77 år.
English: • You should only gently stretch your penis when you do not have an erection.
Danish: • De må kun strække Deres penis forsigtigt, når De ikke har erektion.
English: Standard two-year rodent bioassays have not been performed with Xiapex.
Danish: Standard bioanalyser over to år hos gnavere er ikke blevet udført med Xiapex.
English: This is called a corporal rupture or penile fracture.
Danish: Dette kaldes for en penisfraktur.
English: • After each injection of Xiapex, your penis may be wrapped with a bandage.
Danish: • Efter hver injektion af Xiapex kan De få lagt en bandage på Deres penis.
English: No formal medicinal product interaction studies with Xiapex have been performed.
Danish: Der ikke udført formelle interaktionsstudier med Xiapex.
English: Each injection was separated by approximately 4 weeks.
Danish: Hver injektion blev givet med ca. 4 ugers interval.
English: Caution should be exercised when Xiapex is administered to a breast-feeding woman.
Danish: Der skal udvises forsigtighed, når Xiapex administreres til ammende kvinder.
English: An open label phase 3 study, AUX-CC-806, evaluated the safety and efficacy of Xiapex.
Danish: Et åbent, fase 3-studie, AUX-CC-806, evaluerede sikkerheden og virkningen af Xiapex.
English: Xiapex was not associated with shortening of penile length in clinical trials in the treatment of Peyronie's disease.
Danish: Xiapex var ikke associeret med forkortelse af penislængde i kliniske studier af behandling af Peyronies sygdom.
English: The review of data presented in the PSUR for Xiapex, covering the period from 28 February 2018 to 27 February 2019, identified post-marketing and literature case reports of finger necrosis and/or amputation and of finger fractures in patients with Dupuytren's contracture treated with collagenase clostridium histolyticum.
Danish: Gennemgangen af data fremlagt i PSUR'en for Xiapex, der dækker den 28. februar 2018 til den 27. februar 2019, identificerede sagsrapporter efter marketing og fra litteraturen af fingernekrose og/eller amputation og af fingerfrakturer hos patienter med Dupuytrens kontraktur, der blev behandlet med collagenase clostridium histolyticum.
English: Different Fingers, Both MPs (n=244)
Danish: Forskellige fingre, Begge MP'er (n=244)
English: If your finger is still not able to straighten during a follow-up visit with your doctor, you may need additional treatments with Xiapex which may be administered approximately 4 weeks after the first treatment.
Danish: Hvis Deres finger stadigvæk ikke kan udstrækkes ved opfølgningsbesøget hos lægen, kan De have behov for yderligere behandling med Xiapex, som kan gives cirka 4 uger efter den første behandling.
English: Figure 1: Illustration of the injection technique.
Danish: Figur 1: Illustration af injektionsteknik
English: Anaphylactic reaction was reported in a patient previously treated with Xiapex (1 case).
Danish: Der blev rapporteret anafylaktisk reaktion hos en patient, der tidligere blev behandlet med Xiapex (1 tilfælde).
English: The majority of adverse events reported during the long-term follow-up period were non-serious, mild or moderate in intensity, and were not related to the local administration of Xiapex.
Danish: Hovedparten af rapporterede bivirkninger i løbet af den langvarige opfølgningsperiode var ikke alvorlige, lette eller moderate i intensitet, og de var ikke relateret til den lokale administration af Xiapex.
English: Your doctor will tell you when to remove the dressing.
Danish: Deres læge vil fortælle Dem, hvornår De kan fjerne bandagen.
English: Severe injury like e.g. finger necrosis or fracture could result in loss of finger or finger parts.
Danish: Svære skader som f.eks. fingernekrose eller -fraktur kan føre til, at du mister hele fingeren eller dele af fingrene.
English: In patients treated for these two indications, there was no apparent correlation of antibody frequency, antibody titers, or neutralizing status to clinical response or adverse reactions.
Danish: Hos patienter, der blev behandlet for disse to indikationer, var der ingen tydelig sammenhæng mellem antistoffrekvens, antistoftitre eller neutraliserende status og klinisk respons eller bivirkninger.
English: Whilst there is no clinical evidence of an interaction between tetracycline and anthracycline/anthraquinolone antibiotics and anthraquinone derivatives and Xiapex, such derivatives have been shown to inhibit matrix metalloproteinase-mediated collagen degradation at pharmacologically relevant concentrations in vitro.
Danish: Medens der ikke er nogen klinisk evidens for en interaktion mellem tetracyklin, antracyklin/antrakinolon antibiotika, antrakinonderivater og Xiapex, har sådanne derivater vist at hæmme matrix metalloproteinasemedieret kollagendegradering ved farmakologisk relevante koncentrationer in vitro.
English: If the first finger extension procedure does not result in disruption of the cord, a second and third attempt can be performed at 5- to 10-minute intervals.
Danish: Hvis den første manipulation af fingeren ikke fører til ruptur af strengen, kan der udføres et andet og tredje forsøg med 5-10 minutters intervaller.
English: Tell your doctor right away if you have trouble stretching or straightening your penis, or if you have pain or other concerns.
Danish: Fortæl det straks til lægen, hvis De har problemer med at strække Deres penis eller rette den ud, eller hvis De har smerter eller andre problemer.
English: The goal is to gradually create bending opposite to the patient's penile curvature, with stretching to the point of moderate resistance.
Danish: Målet er gradvist at bøje mod patientens peniskrumning, ved at strække til et punkt med moderat modstand.
English: A popping noise or popping sensation in the penis, sometimes described as “snapping” or “cracking” and sometimes accompanied by detumescence, haematoma and/or pain, were reported in 73/551 (13.2%) Xiapex-treated patients and 1/281 (0.3%) placebo-treated patients, in Studies 1 and 2 combined.
Danish: En poppende lyd eller poppende fornemmelse i penis, nogle gange beskrevet som et ”snap” eller et ”smæld” og til tider ledsaget af detumescens, hæmatom og/eller smerter, blev rapporteret hos 73/551 (13,2 %) af de Xiapex-behandlede patienter, og hos 1/281 (0,3 %) af de placebobehandlede patienter, når studie 1 og 2 kombineres.
English: Proper needle position is tested and confirmed by carefully noting resistance to minimal depression of the syringe plunger.
Danish: Den korrekte position af kanylen testes og bekræftes ved forsigtigt at føle modstand mod et minimalt tryk på injektionssprøjtens stempel.
English: Yes No Physician Rating of Severity at Baseline Mild Moderate Severe Missing1 Note: Includes all patients who received at least 1 injection of double-blind study medicinal product (Xiapex 0.58 mg or placebo).
Danish: Ja Nej Lægens vurdering af sværhedsgrad af sygdommen ved baseline Let Moderat Alvorlig Mangler1 Bemærk: Inkluderer alle patienter, som fik mindst 1 injektion af dobbeltblind studiemedicin (Xiapex 0,58 mg eller placebo).
English: • blood sugar increased
Danish: • forhøjet blodsukker
English: PDQ bother**
Danish: PDQ-besvær**
English: The penile pressure should be hold for 30 seconds, thereafter released with a resting period for 30 seconds before repeating the penile modelling technique for a total of 3 modelling attempts at 30 seconds for each attempt.
Danish: Trykket på penis skal holdes i 30 sekunder og dernæst fjernes med en hvileperiode på 30 sekunder, før remodelleringsteknikken af penis gentages i alt 3 gange med intervaller på 30 sekunder for hvert forsøg.
English: In Study AUX-CC-867, most (85%) subjects received local anaesthesia prior to the finger extension procedure.
Danish: I studie AUX-CC-867 fik de fleste (85 %) forsøgspersoner lokalanæstesi før manipulationerne af fingrene.
English: Injection site reactions were very common, occurring in the vast majority of patients, were mostly mild to moderate in severity and generally subsided within 1-2 weeks post injection.
Danish: Reaktioner på injektionsstedet var meget almindelige og forekom hos langt de fleste af patienterne, de var hovedsagelig milde til moderate og aftog almindeligvis inden for 1-2 uger efter injektion.
English: Same Finger, 1 MP, 1 PIP (n=350)
Danish: Samme finger, 1 MP, 1 PIP (n=350)
English: Xiapex may have a major influence on the ability to drive and use machines due to the swelling and pain which may impair the use of the treated hand in Dupuytren's disease.
Danish: Xiapex kan i væsentlig grad påvirke evnen til at føre motorkøretøj og betjene maskiner som følge af hævelse og smerter, som kan hæmme brugen af den behandlede hånd ved Dupuytrens sygdom.
English: Diagnostic imaging is recommended after manipulation if finger deformity, pain or increased swelling develops (see also section 4.8).
Danish: Diagnostisk billeddannelse anbefales efter manipulation, hvis der udvikles fingerdeformitet, smerter eller øget hævelse (se også pkt.
English: Within each finger, begin with the affected joint in the most proximal aspect of the finger and continue toward the distal aspect (eg, MP to PIP).
Danish: Der begyndes på hver finger med det mest proksimalt påvirkede led på fingeren, og fortsættes mod det distale led (f.eks. MP til PIP).
English: Different Fingers, 1 MP, 1 PIP (n=58)
Danish: Forskellige fingre, 1 MP, 1 PIP (n=58)
English: Xiapex must be used with caution in patients with coagulation disorders or those taking anticoagulants.
Danish: Anvendelse til patienter med koagulationssygdomme Xiapex skal anvendes med forsigtighed til patienter med koagulationssygdomme, eller dem som tager antikoagulantia.
English: Adverse reactions reported from the clinical programme are those that occurred in the Phase 3 double-blind placebo-controlled studies.
Danish: Bivirkninger, der blev rapporteret i det kliniske program, er dem, der forekom i de dobbeltblinde, placebokontrollerede fase 3-studier.
English: Xiapex is comprised of a mixture of Class I (AUX-I) and Class II (AUX-II) clostridial collagenases in a defined mass ratio.
Danish: Xiapex består af en blanding af klasse I (AUX-I) og klasse II (AUX-II) clostridiale kollagenaser i et defineret masseforhold.
English: Using a sterile syringe calibrated with 0.01 ml graduations, the appropriate amount of solvent supplied should be withdrawn in order to deliver as follows:
Danish: Ved anvendelse af en steril sprøjte, som er kalibreret med 0,01 ml gradueringer, skal en passende mængde af den tilhørende solvens trækkes op for at kunne give følgende:
English: (degrees)
Danish: (grader)
English: • swollen or enlarged glands near the elbow or under the arm
Danish: • hævede eller forstørrede kirtler nær albuen eller under armen
English: Swelling and pain may impair the use of the treated hand in Dupuytren's disease.
Danish: Hævelse og smerte kan hæmme brugen af den behandlede hånd ved Dupuytrens sygdom.
English: **Based on the 95% CI of the mean not including zero, the percent change from baseline was considered statistically significant.
Danish: **Baseret på 95 % CI af gennemsnittet, der ikke inkluderer 0, blev den procentvise ændring fra baseline anset for at være statistisk signifikant.
English: There were no adverse reactions on early embryonic development (indicating no evidence of teratogenicity) in rats.
Danish: Der var ingen skadelige effekter på den tidlige fosterudvikling hos rotter (tyder på ingen evidens for teratogenicitet).
English: The finger extension procedures were performed approximately 24 to 72 hours after injection.
Danish: Manipulationer af fingeren blev udført ca. 24 til 72 timer efter injektion.
English: At baseline, the mean (SD) Female PDQ score was 4.7 (3.61) and 2.7 (3.06) at week 36, i.e. a change from baseline of -2.0.
Danish: Ved baseline var gennemsnitlig (SD) kvindelig PDQ-score 4,7 (3,61) og 2,7 (3,06) ved uge 36, dvs. en ændring fra baseline på -2,0.
English: During clinical studies, blood samples from patients with Dupuytren's contracture and Peyronie's disease were tested at multiple time points for antibodies to the protein components of the medicinal product (AUX-I and AUX-II).
Danish: I de kliniske studier blev blodprøver fra patienter med Dupuytrens kontraktur og Peyronies sygdom undersøgt på forskellige tidspunkter for antistoffer overfor proteinkomponenterne i lægemidlet (AUX-I og AUX-II).
English: • To promptly contact their doctor if there is evidence of infection (e.g., fever, chills, increasing redness or oedema) or trouble bending the finger after the swelling goes down (symptoms of tendon rupture).
Danish: • straks at kontakte lægen hvis der er tegn på infektion (f.eks. feber, kuldegysninger, øget rødme eller hævelse) eller besvær med at bøje fingeren efter at hævelsen er faldet (symptom på seneruptur).
English: Body temperature increased
Danish: Øget legemstemperatur
English: For plaques that are only a few millimetres in width, the distance of withdrawal of the syringe may be very minimal.
Danish: Hvis plaquen kun er et par millimeter bred, kan kanylens bane, når den trækkes tilbage, være meget kort.
English: Tendon rupture or other serious injury to the injected finger/hand in the treatment of Dupuytren's contracture
Danish: Seneruptur eller anden alvorlig skade på den injicerede finger/hånd ved behandling af Dupuytrens kontraktur
English: There were no other clinically relevant differences between two concurrent injections of Xiapex in the same hand and up to three single injections of Xiapex in the types of adverse events reported (i.e., most adverse events were local to the treated extremity and of mild or moderate intensity).
Danish: Der var ingen andre klinisk relevante forskelle mellem to samtidige injektioner af Xiapex i den samme hånd og op til tre enkelte injektioner af Xiapex med hensyn til typen af rapporterede uønskede hændelser (dvs. de fleste uønskede hændelser var lokale i forhold til den behandlede ekstremitet, og lette til moderate i intensitet).
English: In other Xiapex-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or haematoma, sudden penile detumescence, and/or a penile “popping” sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded.
Danish: Hos andre Xiapex-behandlede patienter (9 ud af 1.044; 0,9 %) blev der rapporteret om en kombination af penil ekkymose eller penilt hæmatom, pludselig afslapning af penis og/eller en ”poppende” lyd eller fornemmelse i penis, og i disse tilfælde kan diagnosen penisruptur ikke udelukkes.
English: In each treatment cycle, two injections of Xiapex 0.58 mg or two injections of placebo were administered 1 to 3 days apart.
Danish: I hver behandlingscyklus blev to injektioner med Xiapex 0,58 mg eller to injektioner med placebo administreret med 1 til 3 dages mellemrum.
English: • collection of blood outside the blood vessels
Danish: • ansamling af blod uden for blodkarrene
English: A higher incidence of skin laceration may be attributable to more vigorous finger extension procedures in patients after receiving anaesthesia to the hand.
Danish: En større forekomst af rifter i huden kan tilskrives kraftigere manipulationer af fingrene hos patienter, efter de fik anæstesi i hånden.
English: g) With the tip of the needle placed within the plaque, initiate injection, maintaining steady pressure to slowly inject the drug into the plaque.
Danish: g) Med kanylespidsen placeret i plaquen påbegyndes injektionen med et konstant tryk for langsomt at injicere lægemidlet i plaquen.
English: Wrap the patient's treated hand with a soft, bulky, gauze dressing.
Danish: Forbind patientens hånd med et blødt stort stykke gaze.
English: In a single-dose phase or 61-day repeat-dose phase (3 times a week every 3 weeks for 3 cycles) study of intrapenile administration of collagenase clostridium histolyticum in dogs at exposures lower than or equal to the maximum recommended human dose on a mg/m2 basis, there was no evidence of systemic toxicity.
Danish: I et studie med en enkeltdosisfase eller med gentagne dosisfaser over 61 dage (3 gange om ugen hver 3. uge i 3 cyklusser) med intrapenil administration af kollagenase clostridium histolyticum hos hunde med eksponeringer lavere end eller lig med den maksimalt anbefalede humane dosis på en mg/m2 basis, var der intet tegn på systemisk toksicitet.
English: Because the collagen lysis process following Xiapex administration is localized and does not require or result in quantifiable systemic levels of AUX-I and AUX-II, the primary pharmacodynamic activity of Xiapex cannot be evaluated in subjects and therefore, such studies have not been undertaken.
Danish: Fordi den kollagene lyseringsproces, som følger efter en Xiapex administration, er lokal og fordi der efter administration af Xiapex ikke kan måles kvantificerbare systemiske niveauer af AUX-I og AUXII, kan den primære farmakodynamiske aktivitet af Xiapex ikke evalueres, og derfor er sådanne studier ikke blevet udført.
English: No new safety signals were identified among subjects who were retreated with Xiapex.
Danish: Ingen nye sikkerhedssignaler blev identificeret blandt forsøgspersoner, som blev genbehandlet med Xiapex.
English: Caution should be exercised when performing finger extension procedures in patients with bone fragility, which may predispose to digital phalangeal fracture (e.g. in patients with osteopenia/osteoporosis).
Danish: Der bør udvises forsigtighed, når der udføres manipulation med at strække fingrene hos patienter med skøre knogler, hvilket kan disponere patienten for digitale falangeale frakturer (f.eks. hos patienter med osteopeni/osteoporose).
English: In study AUX-CC-862, 64.5% of recurrent MP joints and 45.0% of recurrent PIP joints achieved clinical success after retreatment with up to three injections of Xiapex.
Danish: I studie AUX-CC-862 opnåede 64,5 % af tilbagevendende MP-led og 45,0 % af tilbagevendende PIP-led klinisk succes efter genbehandling med op til 3 injektioner af Xiapex.
English: See Figure 1 below for an illustration of the injection technique.
Danish: Se figur 1 med en illustration af injektionsteknik neden for.
English: *A formulation of two collagenase enzymes co-expressed and harvested from anaerobic fermentation of a phenotypically selected strain of Clostridium histolyticum bacterium.
Danish: *En formulering bestående af to kollagenaseenzymer høstet efter anaerob fermentering af en fænotypisk udvalgt stamme af Clostridium histolyticum bakterien.
English: Following Xiapex injection, severe allergic reaction could occur, and patients should be observed for 30 minutes before leaving the clinic in order to monitor for any signs or symptoms of a serious allergic reaction, e.g. wide spread redness or rash, swelling, tightness in the throat or difficulty breathing.
Danish: Efter injektion med Xiapex kan der opstå en svær allergisk reaktion, og patienterne skal observeres i 30 minutter, før de forlader klinikken, for at kunne overvåge for evt. tegn og symptomer på en alvorlig allergisk reaktion, f.eks. udbredt rødme eller udslæt, hævelse, indsnøring i halsen eller vejrtrækningsbesvær.
English: The cake of lyophilized powder should be intact and white in colour.
Danish: Klumpen af frysetørret pulver bør være intakt og have en hvid farve.
English: • Information on bleeding risk in patients with coagulation disorders including those on concurrent anti-coagulation therapy.
Danish: • Information om blødningsrisiko hos patienter med koagulationssygdomme herunder patienter i samtidig antikoagulationsbehandling.
English: • Wear the splint at bedtime for up to 4 months.
Danish: • At have en skinne på ved sengetid i op til 4 måneder.
English: • 0.39 ml of solvent for cords affecting a MP joint in Dupuytren's contracture • 0.31 ml of solvent for cords affecting a PIP joint in Dupuytren's contracture
Danish: • 0,39 ml solvens til strenge, der påvirker et MP-led ved Dupuytrens kontraktur • 0,31 ml solvens til strenge, der påvirker et PIP-led ved Dupuytrens kontraktur
English: On the basis of the scientific conclusions for collagenase clostridium histolyticum the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing collagenase clostridium histolyticum is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for collagenase clostridium histolyticum er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder collagenase clostridium histolyticum, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: a Baseline was defined as the last observation prior to the first injection of Xiapex in the previous phase 3 study (i.e AUX-CC-802, AUX-CC-803, AUX-CC-804 or AUX-CC-806) b Reference was defined as the last post-baseline non-missing observed value from the previous phase 3 study (i.e AUX-CC-802, AUX-CC-803, AUX-CC-804 or AUX-CC-806) * Note: 29 subjects were excluded from this analysis.
Danish: a Baseline blev defineret som den sidste observation før den første injection af Xiapex i det tidligere fase 3-studie (dvs. AUX-CC-802, AUX-CC-803, AUX-CC-804 eller AUX-CC-806) b Reference blev defineret som den sidste ikke-manglende observerede værdi efter baseline fra det tidligere fase 3-studie (dvs. AUX-CC-802, AUX-CC-803, AUX-CC-804 eller AUX-CC-806) * Bemærk: 29 forsøgspersoner blev ekskluderet fra denne analyse.
English: The mITT population was defined as all randomized subjects who had both a penile curvature deformity measurement and a PDQ assessment at baseline and at one or more subsequent time points.
Danish: mITT-populationen var defineret som alle randomiserede forsøgspersoner, som både havde en måling af peniskrumning og en PDQ-vurdering ved baseline, og ved et eller flere efterfølgende tidspunkter.
English: Collagenase clostridium histolyticum was not mutagenic in Salmonella typhimurium (AMES test) and was not clastogenic in both an in vivo mouse micronucleus assay and an in vitro chromosomal aberration assay in human lymphocytes.
Danish: Kollagenase clostridium histolyticum var ikke mutagent i Salmonella typhimurium (AMES-test), og det var ikke klastogent hverken i en in vivo mikronukleusanalyse med mus eller i en in vitro kromosomafvigelsesanalyse med humane lymfocytter.
English: • ringing in the ear
Danish: • ringen for ørerne
English: For Peyronie's disease, Xiapex breaks down the collagen in the plaque that is causing your erect penis to curve, which may help the previously bent erection to become straighter and enable you to feel less bothered by your disease.
Danish: Ved Peyronies sygdom nedbryder Xiapex kollagen i den plaque, der får Deres erigerede penis til at krumme, hvilket kan hjælpe den tidligere bøjede erektion med at blive en mere lige erektion og gøre Dem mindre besværet af Deres sygdom.
English: • One to three days after the second injection of Xiapex in a treatment cycle, you will need to return to your doctor for a manual procedure that will help stretch and help straighten your penis.
Danish: • En til tre dage efter den anden injektion af Xiapex i en behandlingscyklus skal De igen møde hos lægen til en manuel procedure, der vil hjælpe med at strække Deres penis og rette den ud.
English: Dyspnoea Hyperventilation
Danish: Dyspnø Hyperventilering
English: The double-blind study population comprised 409 patients of whom 272 received Xiapex 0.58 mg and 137 received placebo.
Danish: Den dobbeltblinde studiepopulation bestod af 409 patienter, hvoraf 272 fik Xiapex 0,58 mg, og 137 fik placebo.