FrancophonIA/ELRC3.0 huggingface dataset:
English: The location of the target treatment area in the Peyronie's plaque is identified at the point of maximum concavity (or focal point) in the erect penis state and marked with a surgical marker.
Danish: Behandlingsområdet i en Peyronies plaque identificeres som det punkt, hvor krumningen er maksimal (eller det fokale punkt) på den erigerede penis, og det markeres med en kirurgisk tusch.
English: c) Administer suitable local anaesthetic, if desired.
Danish: c) Hvis det ønskes, administreres egnet lokalanæstesi.
English: While the patient's wrist is in the flexed position, apply moderate stretching pressure to the injected cord by extending the finger for approximately 10 to 20 seconds.
Danish: Mens patientens håndled er i bøjet stilling, lægges et moderat tryk på den injicerede streng ved at strække fingeren ud i ca. 10 til 20 sekunder.
English: A phase 4, non-treatment, long-term follow-up study (AUX-CC-810) was undertaken to evaluate the efficacy and safety up to 5 years after the first injection of Xiapex in the pivotal 12-month doubleblind placebo-controlled phase 3 studies or in the 9-month open-label phase 3 studies.
Danish: Et fase 4, langvarigt opfølgningsstudie uden behandling (AUX-CC-810) blev iværksat for at evaluere virkning og sikkerhed i op til 5 år efter den første injektion af Xiapex i det pivotale 12-måneders, dobbeltblinde, placebokontrollerede fase 3-studie, eller i de 9-måneders åbne fase 3-studier.
English: Symptoms of penile fracture (corporal rupture) or other serious injury to your penis may include:
Danish: Symptomer på penisfraktur eller anden alvorlig skade på penis kan omfatte:
English: Paresthesia Hypoesthesia Burning sensation Dizziness Headache
Danish: Paræstesi Hypæstesi Brændende fornemmelse Svimmelhed Hovedpine
English: If your cord to be treated is attached to the skin, you are at higher risk of the skin splitting or tearing during the finger extension procedure following the injection of Xiapex.
Danish: Hvis den streng, der skal behandles, hæfter på huden, er der en større risiko for, at huden revner eller sprækker under manipulationen af fingeren efter injektionen af Xiapex.
English: Mean Change from Baseline in Peyronie's Disease Bother Score at Week 36 (LOCF) (mITT* Population) - study AUX-CC-806
Danish: Gennemsnitlig ændring fra baseline i score over besvær af Peyronies sygdom ved uge 36 (LOCF) (mITT*-Population) - studie AUX-CC-806
English: Cyst
Danish: Cyste
English: Powder: Contains sucrose, trometamol, hydrochloric acid Solvent: Contains calcium chloride dihydrate, sodium chloride, water for injection
Danish: Pulver: Indeholder saccharose, trometanol, saltsyre Solvens: Indeholder calciumchloriddihydrat, natriumchlorid, vand til injektionsvæsker
English: There is no relevant use of Xiapex in children and adolescents aged 0-18 years for the treatment of Dupuytren's contracture or Peyronie's disease.
Danish: Der er ikke relevant at bruge Xiapex til børn og unge i alderen 0-18 år til behandling af Dupuytrens kontraktur eller Peyronies sygdom.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: The site chosen for injection must be the area where the contracting cord is maximally separated from the underlying flexor tendons and where the skin is not intimately adhered to the cord.
Danish: Bekræft hvilken streng, der skal injiceres i. Det valgte sted for injektionen skal være et område, hvor den sammentrukne streng er maksimalt adskilt fra de underliggende bøjesener, og hvor huden ikke er tæt forbundet med strengen.
English: Two palpable cords affecting two joints may be injected or one palpable cord affecting two joints in the same finger may be injected at two locations during a treatment visit.
Danish: To palpable strenge, der påvirker to led kan injiceres, eller en palpabel streng, der påvirker to led på den samme finger kan injiceres på to steder i løbet af et besøg under behandlingen.
English: There has been no evidence of systemic toxicity to date in the clinical studies conducted with Xiapex administered through localized injection into the Dupuytren's cord or into the Peyronie's plaque.
Danish: Der har endnu ikke været evidens for systemisk toksicitet i de kliniske studier, som er udført med Xiapex administreret ved lokal injektion ind i en Dupuytrens streng eller i en Peyronies plaque.
English: Patients with Dupuytren's contractures that adhere to the skin may be at higher risk of skin lesions as a result of the pharmacological effect of Xiapex and the finger extension procedure on the skin overlying the targeted cord.
Danish: Patienter med Dupuytrens kontrakturer, der klæber til huden, kan have højere risiko for at få hudlæsioner på den hud, som ligger over den injicerede streng, som et resultat af den farmakologiske virkning af Xiapex og manipulation af fingeren.
English: Xiapex must only be injected into the Dupuytren's cord.
Danish: Xiapex må kun indsprøjtes i en Dupuytrens streng.
English: Total fixed flexion contracture and range of motion following administration of two concurrent injections of Xiapex 0.58 mg in the same hand, mITT population, study AUXCC-867 (first treatment cycle)
Danish: Total fikseret fleksionskontraktur og ledbevægelighed efter administration af to samtidige injektioner af Xiapex 0,58 mg i den samme hånd, mITT-population, studie AUX-CC-867 (første behandlingscyklus)
English: • abnormal sensation
Danish: • unormal fornemmelse
English: • small area of inflammation
Danish: • lille område med inflammation (betændelseslignende reaktion)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton containing 1 vial of powder and 1 vial of solvent
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton indeholder 1 hætteglas med pulver og 1 hætteglas med solvens
English: There is no experience in the use of Xiapex in pregnant women therefore the use of Xiapex is not recommended in pregnancy, and treatment should be postponed until after pregnancy.
Danish: Der er ingen erfaring fra anvendelsen af Xiapex til gravide kvinder, derfor bør Xiapex ikke anvendes under graviditeten, og behandling bør udsættes til efter graviditeten.
English: Each vial of Xiapex and sterile solvent for reconstitution should only be used for a single injection.
Danish: Hvert hætteglas med Xiapex og steril solvens til rekonstitution bør kun anvendes til en enkelt injektion.
English: Table 3 provides demographic and baseline characteristics for the study population and Tables 4-5 provide the results of the major efficacy endpoints measured in the 2 double-blind placebo-controlled studies CORD I (AUX-CC-857) and CORD II (AUX-CC-859).
Danish: Tabel 3 viser demografiske og baseline karakteristika for studiepopulationen og Tabellerne 4-5 viser resultaterne fra de vigtigste endepunkter for virkningen bestemt i de 2 dobbeltblinde placebokontrollerede studierCORD I (AUX-CC-857) og CORD II (AUX-CC-859).
English: Thrombocytopenia Lymphadenitis
Danish: Trombocytopeni Lymfadenitis
English: At five years after the initial injection of Xiapex the majority of subjects (>90%) were seropositive for anti-AUX-I and anti-AUX-II antibodies.
Danish: Fem år efter den første injektion af Xiapex var de fleste forsøgspersoner (>90 %) seropositive for anti-AUX-I- og anti-AUX-II-antistoffer.
English: Mean Penile Curvature Deformity (degrees) (Min-Max)
Danish: Gennemsnitlig peniskrumning (grader) (min.-maks.)
English: Xiapex treatment significantly improved penile curvature deformity in patients with Peyronie's disease compared with placebo (Table 9).
Danish: Xiapex-behandlingen forbedrede peniskrumningen signifikant hos patienter med Peyronies sygdom, sammenlignet med placebo (tabel 9).
English: Store in a refrigerator (2ºC-8ºC).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: At five years after the initial injection of Xiapex, 92.8% and 93.4% of subjects were seropositive for anti-AUX-I and anti-AUX-II respectively.
Danish: Fem år efter den første injektion af Xiapex var 92,8 % og 93,4 % af forsøgspersonerne seropositive for hhv. anti-AUX-I og anti-AUX-II.
English: Mean duration of PD (years) (Min-Max)
Danish: Gennemsnitsvarighed af PD (år) (min.-maks.)
English: Local swelling Pyrexia
Danish: Lokal hævelse Pyreksi
English: Following the finger extension procedure(s) and fitting patient with a splint (with treated joint in maximum extension), the patients should be instructed to:
Danish: Efter at finger manipulation er udført, og patienten er blevet udstyret med en skinne (hvor det behandlede led er maksimalt udstrakt), skal patienterne instrueres i:
English: This condition affects adult men, who have a ‘plaque' that can be felt and a curve to their erect penis.
Danish: Denne sygdom påvirker voksne mænd, som har en 'plaque', der kan føles, og en krumning af den erigerede penis.
English: At the follow-up visit approximately 24-72 hours after injection, it should be determined if the contracture has resolved.
Danish: Ved opfølgningsbesøget ca. 24 - 72 timer efter injektionen skal det bestemmes, om kontrakturen er bedret.
English: Injection site reaction or discolouration Pyrexia
Danish: Reaktioner ved injektionsstedet eller misfarvning Pyreksi
English: The recommended dose of Xiapex is 0.58 mg per injection into a palpable Dupuytren's cord.
Danish: Den anbefalede dosis af Xiapex er 0,58 mg pr. injektion i en palpabel Dupuytrens streng.
English: -11.4% b a Mean percent change, treatment difference, 95% CI, and p-value were based on an ANOVA model with factors for treatment, stratum of baseline penile curvature, and their interaction and using last observation carried forward (LOCF) in the modified intent-to-treat (mITT) population.
Danish: -11,4 % b a Gennemsnitlig procentvis ændring, behandlingsforskel, 95 % CI og p-værdi var baseret på en ANOVA-model med faktorer for behandling, stratum af peniskrumning ved baseline og deres interaktion, og brug af sidste observation ekstrapoleret (last observation carried forward, LOCF) i den modificerede intention-to-treat (mITT)-population.
English: e) The penis should be in a flaccid state before Xiapex is injected.
Danish: e) Penis skal være afslappet før Xiapex injiceres.
English: • swelling in the hand or arm
Danish: • hævelse i hånden eller armen
English: With your dominant hand, place the needle into the cord, using caution to keep the needle within the cord.
Danish: Med den dominante hånd stikkes kanylen ind i strengen, hvor den med forsigtighed holdes inde i strengen.
English: In the two double-blind, placebo-controlled phase 3 studies in Peyronie's disease, 65.5% of Xiapex-treated patients developed penile haematoma and 14.5% developed penile ecchymosis.
Danish: I de to dobbeltblinde, placebokontrollerede fase 3-studier af Peyronies sygdom udviklede 65,5 % af de Xiapex-behandlede patienter penilt hæmatom, og 14,5 % udviklede penil ekkymose.
English: • Wearing gloves, grasp the plaque or indurated portion of the flaccid penis about 1 cm proximal and distal to the injection site.
Danish: • Med handsker tages fat i plaquen eller den indurerede del af den afslappede penis, ca. 1 cm proksimalt og distalt fra injektionsstedet.
English: If cords of two affected joints in one finger were treated, perform the finger extension procedure on the cord affecting the MP joint before performing the procedure on the cord affecting the PIP joint.
Danish: Hvis der blev behandlet strenge fra to påvirkede led i en finger, skal der udføres manipulation af fingeren på den streng, der påvirker MP-leddet, før proceduren udføres på strengen, der påvirker PIP-leddet.
English: Reconstitute with appropriate volume before use.
Danish: Kun til intralæsional anvendelse Rekonstitueres med passende volumen før brug Læs indlægssedlen inden brug.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial for use with Xiapex label
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglas med solvens til brug med Xiapex
English: Apply a dressing as necessary.
Danish: Læg en bandage, hvis det er nødvendigt.
English: i) Discard the unused portion of the reconstituted solution and diluent after each injection.
Danish: i) Bortskaf den ubrugte portion af den rekonstituerede injektionsvæske samt solvensen efter hver injektion.
English: A long-term, non-treatment, Year 2 to Year 5 follow-up study (AUX-CC-860) was undertaken to evaluate recurrence of contracture and long-term safety in subjects who received up to 8 single injections of Xiapex 0.58 mg in a previous Phase 3 open-label or double-blind with open-label extension study.
Danish: Et langvarigt opfølgende studie uden behandling, år 2 til år 5, (AUX-CC-860) blev udført for at evaluere recidiv af kontraktur og langvarig sikkerhed hos forsøgspersoner, der fik op til 8 enkelte injektioner af Xiapex 0,58 mg i et tidligere fase 3 åbent studie eller et dobbeltblindet studie med åben forlængelse.
English: The disease can cause a change in the shape of the erect penis due to the abnormal build-up of scar tissue, known as a plaque, within the stretchy fibres of the penis.
Danish: Sygdommen kan forårsage, at formen på en erigeret penis ændres som følge af en unormal ophobning af arvæv i de elastiske fibre i penis, hvilket kaldes en plaque.
English: Peyronie's disease
Danish: Peyronies sygdom
English: Xiapex demonstrated a clinically significant benefit compared to placebo in the proportion of patients achieving the primary endpoint of a reduction in the contracture of all joints treated to 5° or less, approximately 4 weeks after the last injection (MP plus PIP, MP only, PIP only).
Danish: Xiapex viste en klinisk signifikant fordel sammenlignet med placebo mht. andelen af patienterne, som opnåede det primære endepunkt, nemlig reduktion i kontraktur til ≤5° af alle behandlede led (MP plus PIP, MP alene, PIP alene) ca. 4 uger efter den sidste injektion.
English: In the controlled and uncontrolled clinical studies of Xiapex in Peyronie's disease corporal rupture and other serious penile injury were reported uncommonly (see section 4.4)
Danish: I kontrollerede og ikke-kontrollerede kliniske studier med Xiapex ved Peyronies sygdom blev der rapporteret om penisfraktur samt andre alvorlige penisskader med hyppigheden ikke almindelig (se pkt.
English: • blister or redness/discolouration of the penis
Danish: • blister eller rødme/misfarvning af penis
English: If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart, as determined by your doctor.
Danish: Hvis sygdommen har medført flere kontrakturer, kan yderligere strenge blive behandlet ved andre besøg under behandlingen med ca. 4 ugers mellemrum, som fastlægges af Deres læge.
English: After reconstitution, immediate use of the medicine is recommended.
Danish: Det anbefales, at medicinen anvendes straks efter tilberedning.
English: Bending your penis should not cause any pain or discomfort.
Danish: Der bør ikke opstå smerter eller ubehag ved at bøje Deres penis.
English: Please consult a doctor immediately if you experience 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: Tal straks med lægen, hvis De oplever nogle tegn eller symptomer på en alvorlig overfølsomhedsreaktion, f.eks. omfattende rødme, udslæt, hævelse, tæthed i halsen eller vejrtrækningsbesvær.
English: • The treatment of Dupuytren's contracture in adult patients with a palpable cord.
Danish: • Voksne patienter til behandling af Dupuytrens kontraktur med en palpabel streng.
English: Erythema Hyperhidrosis
Danish: Hyperhidrose
English: The incidence of skin laceration (29.1%) was higher for subjects treated with two concurrent injections of Xiapex in historically-controlled clinical study AUX-CC-867 compared with subjects treated with up to three single injections in the Phase 3 placebo-controlled pivotal studies in Dupuytren's contracture (CORD I and CORD II) (8.8%).
Danish: Forekomsten af rifter i huden (29,1 %) var større for forsøgspersoner i behandling med to samtidige injektioner af Xiapex i det historisk kontrollerede kliniske studie AUX-CC-867, sammenlignet med forsøgspersoner i behandling med op til tre enkelte injektioner i fase III placebokontrollerede pivotale studier af Dupuytrens kontraktur (CORD I og CORD II) (8,8 %).
English: There is no relevant use of Xiapex in the paediatric population aged 0-18 years for the treatment of Dupuytren's contracture.
Danish: Det er ikke relevant at anvende Xiapex den pædiatriske population og unge i alderen 0-18 år til behandling af Dupuytrens kontraktur.
English: If a cord contracture remains, a passive finger extension procedure will be performed in an attempt to disrupt the cord.
Danish: Hvis der stadig er kontraktur af strengen, skal der udføres en passiv manipulation af fingeren for at forsøge at rumpere strengen.
English: Baseline disease characteristics of patientsa with Peyronie's Disease (PD)
Danish: Sygdomskarakteristika ved baseline hos patientera med Peyronies sygdom (PD) Studie 1
English: Approximately 24-72 hours after injection, a finger extension procedure may be performed, as necessary, to facilitate cord disruption.
Danish: Omkring 24 - 72 timer efter injektion kan den behandlede finger, om nødvendigt, manipuleres for at lette ruptur af strengen.
English: a Metacarpophalangeal joint; b Proximal interphalangeal joint; c 2 primary joints were excluded from the efficacy analysis (1 joint from the placebo group was not evaluated and 1 joint from the Xiapex treated group had a baseline contracture of 0 degrees before treatment).
Danish: a Metacarpofalangeale led; bProksimale interfalangeale led; c 2 primære led blev udelukket fra virkningsanalysen (1 led fra placebogruppen blev ikke vurderet og 1 led fra den Xiapexbehandlede gruppe havde en baseline kontraktur på 0 grader før behandling).
English: These collagenases, referred to as AUX-I and AUX-II, are representative of the two major collagenase classes (Class I and
Danish: Disse kollagenaser, refereret til som AUX-I og AUX-II, er repræsentative for de to største kollagenaseklasser (Klasse I og Klasse II), som dannes af Clostridium histolyticum.
English: The solution should visually be inspected for particulate matter and discoloration prior to administration.
Danish: Injektionsvæsken bør inspiceres visuelt for partikler og misfarvning før administration.
English: If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart.
Danish: Hvis sygdommen har ført til flere kontrakturer, kan yderligere strenge blive behandlet ved andre besøg under behandlingen, ca. med 4 ugers mellemrum.
English: Xiapex also demonstrated a clinically significant benefit compared to placebo in decreasing the degree of contracture and increasing both the range of motion from baseline for all joints treated (MP plus PIP, MP only, PIP only) and the subject global assessment of treatment satisfaction.
Danish: Sammenlignet med placebo viste behandlingen med Xiapex også klinisk signifikant fordel mht. reduktion af graden af kontraktur og stigning i bevægeligheden af alle behandlede led (MP plus PIP, MP alene, PIP alene) fra baseline samt studiepersonens generelle vurdering af tilfredshed med behandlingen.
English: Tell your doctor if you are thinking about receiving or have previously received Xiapex to treat a condition known as Dupuytren's contracture.
Danish: Fortæl det til lægen, hvis De tidligere har fået, eller hvis De overvejer at få Xiapex til behandling af en sygdom, der kaldes Dupuytrens kontraktur.
English: Next, keeping the needle under the skin at all times, withdraw the needle tip from the cord and reposition it in a slightly more distal location (approximately 2-3 mm) to the initial injection in the cord and inject another one-third of the dose.
Danish: Herefter trækkes kanylespidsen op ad strengen, mens kanylen hele tiden holdes under huden, og genplaceres distalt (ca. 2-3 mm) i forhold til den initiale injektion i strengen, og der injiceres endnu en tredjedel af dosen.
English: Inspect the solution visually for particulate matter and discolouration prior to administration.
Danish: Inspicer injektionsvæsken visuelt for partikler og misfarvning før administration.
English: c) Use only the supplied diluent for reconstitution.
Danish: c) Brug kun den leverede solvens til rekonstitution.
English: • skin wound at the site of injection
Danish: • sår i huden på injektionsstedet
English: The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to ensure proper injection placement to minimize occurrence of injection-related adverse events and to inform on expected and potential risks associated with the treatment.
Danish: Indehaveren af markedsføringstilladelsen skal efter aftale med myndighederne i medlemslandende og inden markedsføring implementere et træningsprogram for læger for at sikre korrekt placering af injektionen for at minimere tilfælde af injektionsrelaterede bivirkninger.
English: Apply antiseptic at the site of the injection and allow the skin to dry.
Danish: Rens injektionsstedet med et antiseptisk middel og lad huden tørre.
English: Penile modelling helps relieve curvature deformity and straighten the penile shaft.
Danish: Remodellering af penis afhjælper krumningen og retter penisskaftet ud.
English: Administration of a local anaesthetic medicinal product prior to injection of Xiapex into a Dupuytren's cord is not recommended, as it may interfere with proper placement of the injection.
Danish: Administration af lokalanæstetikum før injektion af Xiapex i en Dupuytrens streng anbefales ikke, da det kan påvirke den korrekte placering af injektionen.
English: Do not store, pool, or use any vials containing unused reconstituted solution or solvent.
Danish: De må ikke gemme, blande eller bruge hætteglas, der indeholder ikke anvendt rekonstitueret injektionsvæske eller solvens.
English: All Joints p-value
Danish: Alle led p-værdi
English: At the follow-up visit 1 to 3 days after the second injection of each treatment cycle, the trained physician should perform a penile modelling procedure on the flaccid penis to stretch and elongate the treated plaque that Xiapex has disrupted.
Danish: Ved det opfølgende besøg 1 til 3 dage efter den anden injektion i hver behandlingscyklus skal den trænede læge udføre en remodellering af penis på den afslappede penis for at strække og forlænge den behandlede plaque, som Xiapex har sprunget.
English: Other minor influences on the ability to drive and use machines include dizziness, paresthesia, hypoesthesia, and headache that have also been reported following injection of Xiapex.
Danish: Andre faktorer, som i mindre grad påvirker evnen til at føre motorkøretøj eller betjene maskiner og som ligeledes er rapporteret efter injektion af Xiapex omfatter svimmelhed, paræstesi, hypæstesi og hovedpine.
English: In the double-blind portion of the two phase 3 placebo-controlled clinical trials in Peyronie's disease, a greater proportion of Xiapex-treated patients (4%) compared to placebo-treated patients (1%) had localized pruritus after up to 4 treatment cycles (involving up to 8 Xiapex injections).
Danish: I den dobbeltblinde del af to fase 3-placebokontrollerede kliniske studier af Peyronies sygdom havde en større andel af de Xiapex-behandlede patienter (4 %), sammenlignet med placebobehandlede patienter (1 %), lokaliseret pruritus efter op til 4 behandlingscyklusser (med op til 8 Xiapex-injektioner).
English: Xiapex significantly reduced patient-reported bother associated with Peyronie's disease compared with placebo (Table 10).
Danish: Xiapex forbedrede det patientrapporterede besvær forbundet med Peyronies sygdom, sammenlignet med placebo (tabel 10).