FrancophonIA/ELRC3.0 huggingface dataset:
English: Low levels of Xiapex were quantifiable in the plasma of evaluable male patients for up to 30 minutes following administration of Xiapex into the penile plaque of patients with Peyronie's disease (see section 5.2).
Danish: Lave niveauer af Xiapex kunne kvantificeres i plasma hos evaluerbare mandlige patienter i op til 30 minutter efter administration af Xiapex i plaque på penis hos patienter med Peyronies sygdom (se pkt.
English: In contrast, the Class II collagenases (δ, ε, and ζ,) are products of colH gene, their initial cleavage sites are located within the interior of the collagen molecule and generate smaller collagen fragments.
Danish: I modsætning hertil er Klasse II kollagenaserne (δ, ε og ζ) produkter af colH genet, som har deres initiale spaltningssteder lokaliseret inden for det indre af kollagenmolekylet og som danner mindre kollagenfragmenter.
English: The flip-off plastic caps should be removed from both vials.
Danish: Fjern flip-off plastikhætterne fra begge hætteglas.
English: • increased/decreased sensitivity to stimuli to senses
Danish: • øget/nedsat følsomhed over for sansestimuleringer
English: N (%) of Recurrent Joints in Each Intervalb
Danish: N (%) af led med recidiv hvert intervalb
English: At study entry, patients in the clinical studies had: (1) a finger flexion contracture with a palpable cord of at least one finger (other than the thumb) of 20° to 100° in a MP joint or 20° to 80° in PIP joint and (2) a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Danish: Ved studiestart havde patienterne: (1) en palpabel streng på mindst en finger (bortset fra tommelfingeren) med en fingerbøjningskontraktur på 20° til 100° i et MP led eller 20° til 80° i et PIP led og (2) en positiv ”bordplade-test” defineret som manglende evne til samtidig at placere den (de) angrebne finger (fingre) og håndfladen fladt på en bordplade.
English: Your doctor will inject Xiapex into the plaque that is causing your penis to curve.
Danish: Deres læge vil injicere Xiapex i den plaque, der får Deres penis til at krumme.
English: In this condition, a cord forms in the tissue in the palm of the hand and causes one or more fingers to bend toward the palm so that they cannot be straightened.
Danish: I denne sygdom dannes der en streng i vævet i håndfladen, og det får en eller flere fingre til at bøje mod håndfladen, så de ikke kan rettes ud.
English: b A recurrent joint was a joint evaluated by the investigator as having a worsening Dupuytren's contracture due to a palpable cord.
Danish: b Et led med recidiv var et led, hvor investigatoren evaluerede, at det havde forværret Dupuytrens kontraktur på grund af en palpabel streng.
English: The improvement in curvature deformity was numerically similar among patients with baseline deformity from 30 to 60 degrees and those with curvature deformity from 61 to 90 degrees.
Danish: Forbedringen i krumningen var numerisk sammenlignelig blandt patienter med deformitet ved baseline på 30 til 60 grader, og patienter med en krumning på 61 til 90 grader.
English: • After a 30 second rest period, repeat the penile modelling technique for a total of 3 modelling attempts at 30 seconds for each attempt.
Danish: • Efter en hvileperiode på 30 sekunder gentages remodelleringsteknikken af penis i alt 3 gange med intervaller på 30 sekunder før hvert forsøg.
English: If a satisfactory response has not been achieved, the injection and finger extension procedures may be repeated after approximately 4 weeks.
Danish: Hvis der ikke er opnået et tilfredsstillende respons, kan injektionen i strengen og manipulationen af fingeren gentages efter cirka 4 uger.
English: Therefore, use of Xiapex in patients who have received tetracycline antibiotics (e.g., doxycycline) within 14 days prior to receiving an injection of Xiapex is not recommended.
Danish: Brug af Xiapex til patienter, som har fået tetracyklinantibiotika (f.eks. doxycyclin) inden for 14 dage før de skal have en injektion med Xiapex, anbefales derfor ikke.
English: • blood pressure increased
Danish: • forhøjet blodtryk
English: Proximal interphalangeal (PIP) joints: 0.7 mg.
Danish: Proksimale interfalangeal (PIP) led: 0,7 mg
English: If two cords of affected joints on the same hand are to be treated during a treatment visit, separate vials and syringes should be used for each reconstitution and injection.
Danish: Hvis to strenge med påvirkede led på den samme hånd skal behandles i løbet af et besøg under behandlingen, skal der anvendes separate hætteglas og sprøjter til hver rekonstitution og injektion.
English: • itching in the hand
Danish: • kløe i hånden
English: Your doctor may recommend you perform a series of finger flexion and extension exercises several times a day for several months.
Danish: Deres læge kan tilråde Dem at foretage en række fingerbøjnings- og udstrækningsøvelser mange gange daglig i flere måneder.
English: Xiapex contains sodium
Danish: Xiapex indeholder natrium
English: Taking into account the plausibility of the mechanism of collagenase clostridium histolyticum and the subsequent manipulation procedure in patients with Dupuytren's contracture, the PRAC considers that the product information for Xiapex should be updated to include a warning with regards to finger necrosis resulting in some cases in finger amputation and a warning with regards to finger fracture should be included in section 4.4 of the SmPC.
Danish: Under hensyntagen til den plausible mekanisme af collagenase clostridium histolyticum og den efterfølgende manipulationsprocedure hos patienter med Dupuytrens kontraktur, er PRAC af den mening, at produktinformationen for Xiapex bør opdateres, så der inkluderes en advarsel med hensyn til fingernekrose, hvilket i nogle tilfælde fører til amputation af fingeren, og en advarsel med hensyn til fingerfraktur bør inkluderes i pkt.
English: Administration of regional anaesthesia (penile block) or topical anaesthesia could be applied prior to Xiapex injection when desired.
Danish: Regionalanæstesi (anæstesi af penis) eller topikal anæstesi kan anvendes før Xiapex-injektionen, når det er nødvendigt.
English: The incidence of Xiapex-associated pruritus increased after more Xiapex injections in patients with Dupuytren's contracture.
Danish: Hyppigheden af Xiapex-associeret pruritus blev større efter flere Xiapex-injektioner hos patienter med Dupuytrens kontraktur.
English: **Based on the 95% CI of the mean not including zero, the mean change from baseline was considered statistically significant.
Danish: **Baseret på 95 % CI af gennemsnittet, der ikke inkluderer 0, blev den gennemsnitlige ændring fra baseline anset for at være statistisk signifikant.
English: Cumulative Nominal Recurrence Rate (%)c
Danish: Kumulativ nominelt recidiv pr. ledtype (%) Kumulativ nominel recidivrate (%)c
English: Therefore, the use of Xiapex is not recommended in pregnancy and treatment should be postponed until after pregnancy.
Danish: Xiapex bør derfor ikke anvendes under graviditet, og behandling bør udskydes til efter afsluttet graviditet.
English: Cases of skin laceration requiring skin graft after finger extension procedures have been reported postmarketing.
Danish: Tilfælde af rifter i huden, der kræver hudtransplantation efter manipulation af fingeren er blevet rapporteret efter markedsføring.
English: • With one hand, hold the tip of your penis with your fingers.
Danish: • Hold om spidsen af Deres penis med fingrene på den ene hånd.
English: When administering two injections in the same hand during a treatment visit, use a new syringe and separate vial of reconstituted solution (containing 0.58 mg of Xiapex) for the second injection.
Danish: Ved administration af to injektioner i den samme hånd i løbet af et besøg under behandlingen, skal der anvendes en ny sprøjte og et separat hætteglas med rekonstitueret opløsning (indeholdende 0,58 mg Xiapex) til den anden injektion.
English: Solvent for Xiapex
Danish: Solvens til Xiapex
English: • sexual dysfunction
Danish: • forstyrret seksuel funktion
English: Figure 3: Illustration how to stretch your penis
Danish: Figur 3: Illustration af, hvordan De skal strække Deres penis
English: Class I cleaves insoluble triple helical collagen with higher affinity than Class II collagenase.
Danish: Klasse I spalter uopløseligt triple spiralformet kollagen med højere affinitet end Klasse II kollagenase.
English: • penis size reduced
Danish: • reduceret penisstørrelse
English: There are no known interactions with concomitant use of medicines for erectile dysfunction and Xiapex treatment.
Danish: Der er ingen kendte påvirkninger ved samtidig brug af lægemidler til erektil dysfunktion og behandling med Xiapex.
English: The overall safety profile was similar regardless of the timing of the post-injection finger extension procedure (i.e., 24 hours, 48 hours, and ≥72 hours after injection) among patients who received two concurrent injections of Xiapex in Study AUX-CC-867.
Danish: Den samlede sikkerhedsprofil var sammenlignelig uanset timingen af manipulationen af fingrene efter injektionen (dvs. 24 timer, 48 timer og ≥ 72 timer efter injektionen) blandt patienter, der fik to samtidige injektioner af Xiapex i studie AUX-CC-867.
English: Disorientation Agitation Insomnia Irritability Restlessness
Danish: Desorientering Agitation Søvnløshed Irritabilitet Rastløshed
English: Physicians should advise the patient to wait for at least 4 weeks after the second injection of a treatment cycle before resuming sexual activity taking care to ensure that any pain and swelling has ceased and to be cautious when resuming sexual activity.
Danish: Lægerne skal råde patienterne til at vente mindst 4 uger efter den anden injektion i en behandlingscyklus, før der genoptages seksuel aktivitet, og sikre, at smerter og hævelser er væk og være forsigtig, når de genoptager seksuel aktivitet.
English: • skin disorder/irritation
Danish: • hudsygdom/irritation
English: • The other ingredients are sucrose, trometamol and hydrochloric acid 2.4% w/w (for pH
Danish: • Øvrige indholdsstoffer: saccharose, trometamol og saltsyre 2,4 % w/w (til justering af pH).
English: • Locate the plaque at the point of maximum concavity (or focal point) in the bend of the penis
Danish: • Lokaliser plaquen på stedet med maksimal krumning (eller det fokale punkt) på den bøjede penis
English: For Dupuytren's disease, Xiapex breaks down the collagen forming the cord and thereby releasing the contracture completely or partly and enabling your finger(s) to be straighter.
Danish: Ved Dupuytrens sygdom nedbryder Xiapex den kollagendannende streng, og frigører derved kontrakturen fuldstændigt eller delvist, og gør det muligt for Dem at rette Deres finger/ fingre mere ud.
English: Table 1 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), and uncommon (≥1/1,000 to <1/100), and not known: cannot be estimated from the available data.
Danish: Tabel 2 viser bivirkninger efter systemorganklasse og hyppighedskategori under anvendelse af følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100) og ikke kendt: kan ikke estimeres ud fra forhåndenværende data.
English: Peyronie's plaque
Danish: Peyronies plaque
English: Xiapex must be reconstituted with the solvent provided and to the appropriate volume prior to intralesional injection (see section 6.6).
Danish: Xiapex skal rekonstitueres med det medfølgende solvens og til det passende volumen forud for den intralæsionale injektion (se pkt.
English: Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie's disease are reduced.
Danish: Efter ruptur af plaquen er peniskrumningen og patientbesværet fra Peyronies sygdom reduceret.
English: The reduction in the Bother domain score was numerically similar between patient groups stratified by degree of baseline curvature deformity (30 to 60 degrees and 61 to 90 degrees).
Danish: Reduktionen i score i problem-domænet var numerisk sammenlignelig mellem patientgrupperne, stratificeret efter krumningsgraden ved baseline (30 til 60 grader og 61 til 90 grader).
English: Only straighten your penis if you have an erection that happens without any sexual activity (spontaneous erection).
Danish: Ret kun Deres penis forsigtigt ud, hvis De har en erektion, der opstår uden seksuel aktivitet (spontan erektion).
English: • the change from baseline to Week 52 in the Bother domain of the Peyronie's Disease
Danish: • ændringen fra baseline til uge 52 i problem-domænet af Spørgeskemaet of Peyronies sygdom
English: Your doctor must not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Danish: Deres læge må ikke bruge lægemidlet efter den udløbsdato, der står på kartonen og etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • 0.39 ml of solvent for the penile plaque in Peyronie's disease e) Inject the diluent slowly into the sides of the vial containing the lyophilized powder of Xiapex.
Danish: • 0,39 ml solvens til plaque på penis ved Peyronies sygdom e) Injicer langsomt solvensen ind på siderne på hætteglasset med det frysetørrede Xiapex pulver.
English: Most adverse events were non-serious, mild or moderate in intensity, and related to the local administration of Xiapex or to the finger extension procedure to facilitate cord disruption.
Danish: De fleste bivirkninger var ikke-alvorlige, lette til moderate i intensitet og relateret til den lokale administration af Xiapex eller til manipulationen af fingeren for at lette ruptur af strengen.
English: This is a condition where adult men have a ‘plaque' that can be felt and a curve to their penis.
Danish: Dette er en sygdom, hvor voksne mænd har en 'plaque', der kan føles, og en krumning af deres penis.
English: There were no clinically meaningful differences in the incidence of adverse events following treatment with Xiapex based on the severity of baseline erectile dysfunction or concomitant phosphodiesterase type 5 (PDE5) inhibitor use.
Danish: Der var ingen klinisk meningsfyldte forskelle i forekomsten af bivirkninger efter behandling med Xiapex, baseret på sværhedsgraden af erektil dysfunktion ved baseline eller samtidig anvendelse af phosphodiesterase type 5 (PDE 5)-hæmmer.
English: Call your doctor right away if you experience any of the symptoms of penile fracture or serious injury to your penis listed above, as this may require surgical intervention.
Danish: Kontakt straks lægen, hvis De oplever nogle af de symptomer på penisfraktur eller alvorlig skade på Deres penis, som er anført ovenfor, da det kan kræve et kirurgisk indgreb.
English: Store in a refrigerator at 2ºC-8ºC.
Danish: Opbevares i køleskab ved 2 ºC-8 ºC.
English: The cord affecting a selected primary joint received up to 3 injections of 0.58 mg of Xiapex or placebo.
Danish: Strengen, som angreb det udvalgte primære led, fik op til 3 injektioner med 0,58 mg Xiapex eller placebo.
English: Figure 4: Illustration how to straighten your penis
Danish: Figur 4: Illustration af, hvordan De skal rette Deres penis ud
English: A study AUX-CC-862 was conducted in patients with Dupuytren's contracture who had recurrence of contracture in a joint that was effectively treated with Xiapex in a previous clinical study.
Danish: Et studie AUX-CC-862 blev udført hos patienter med Dupuytrens kontraktur, som havde en tilbagevendende kontraktur i et led, der med effekt blev behandlet med Xiapex i et tidligere klinisk studie.
English: Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with Xiapex and after any pain and swelling has ceased and be cautious when resuming sexual activity.
Danish: De må ikke have samleje eller nogen anden seksuel aktivitet i mindst 4 uger efter den anden injektion i en behandlingscyklus med Xiapex, og efter smerterne og hævelsen er væk, og vær forsigtig, når du genoptager seksuel aktivitet.
English: A penile modelling procedure was performed on patients at the study site 1 to 3 days after the second injection of the cycle.
Danish: Der blev udført en remodellering af penis på patienterne på studiecenteret 1 til 3 dage efter den anden injektion i cyklussen.
English: • popping sound/sensation indicating penile fracture
Danish: • poppende lyd/fornemmelse, der kan tyde på penisfraktur
English: • the percent change from baseline to Week 52 in penile curvature deformity and
Danish: • den procentvise ændring fra baseline til uge 52 i peniskrumning, og
English: • You should only gently straighten your penis if you have an erection that happens without any sexual activity (spontaneous erection).
Danish: • De må kun rette Deres penis forsigtigt ud, hvis De har en erektion, der opstår uden seksuel aktivitet (spontan erektion).
English: What you need to know before you are given Xiapex You must not be given Xiapex:
Danish: Det skal De vide, før De får Xiapex De må ikke få Xiapex
English: With the other hand, hold the base of your penis with the fingers (see Figure 3).
Danish: Med den anden hånd holder De om roden på Deres penis (se figur 3).
English: The efficacy and safety of Xiapex in patients receiving anticoagulant medicinal products other than up to 150 mg acetylsalicylic acid per day prior to Xiapex administration is not known.
Danish: Virkningen og sikkerheden af Xiapex kendes ikke hos de patienter, som får andre antikoagulantia end acetylsalicylsyre op til 150 mg daglig førend administration af Xiapex.
English: Direct pressure on the injection site should be avoided.
Danish: Det bør undgås at trykke direkte på injektionsstedet.
English: Avoid having the needle tip pass completely through the cord to help minimise the potential for injection of Xiapex into tissues other than the cord.
Danish: Undgå at kanylespidsen går helt igennem strengen for dermed at minimere risikoen for injektion af Xiapex i andet væv end strengen.
English: Serious adverse reactions of tendon rupture (6 cases), tendonitis (1 case), other ligament injury (2 cases) and complex regional pain syndrome (1 case) related to the medicinal product were reported.
Danish: Alvorlige bivirkninger som seneruptur (6 tilfælde), betændelse i sene (1 tilfælde), anden ligamentskade (2 tilfælde) og komplekst regionalt smertesyndrom (1 tilfælde) relateret til lægemidlet blev også rapporteret.
English: This medicine must only be injected into the plaque in your penis by your doctor.
Danish: Dette lægemiddel må kun injiceres i plaquen på penis af lægen.
English: • feeling of pain in the hand, wrist or arm
Danish: • en følelse af smerte i hånden, håndleddet eller armen
English: In the pivotal clinical studies about 30% of the patients received penile block before injection.
Danish: I de pivotale kliniske studier fik ca. 30 % af patienter anæstesi af penis før injektion.
English: Post-treatment surgery The impact of treatment with Xiapex on subsequent surgery, if needed, is not known.
Danish: Operation efter behandling Indvirkningen af Xiapexbehandling på eventuelle efterfølgende nødvendige operationer kendes ikke.
English: Care should be taken when injecting Xiapex into cords contracting the PIP joints as clinical studies indicate an increased risk of tendon rupture and ligament injury associated with treatment of PIP contractures with Xiapex.
Danish: Der bør udvises forsigtighed, når Xiapex injiceres i strenge, der kontraherer PIP leddene, da kliniske studier indikerer en øget risiko for seneruptur og ligamentskade forbundet med behandling af PIP kontrakturer med Xiapex.
English: Clinical success (a reduction of contracture to ≤5° within 30 days) after two concurrent injections of Xiapex (one per joint) in the same hand was achieved for the majority of MP joints (64.6%) compared with 28.6% of PIP joints following a single injection per affected joint.
Danish: Klinisk succes (en reduktion af kontrakturen til ≤ 5° inden for 30 dage) efter to samtidige injektioner af Xiapex (en pr. led) i den samme hånd blev opnået for hovedparten af MP-led (64,6 %), sammenlignet med 28,6 % af PIP-led efter en enkelt injektion pr. påvirket led.
English: Xiapex is a lyophilized product for parenteral administration containing collagenase clostridium histolyticum which is comprised of two collagenases in a defined mass ratio.
Danish: Xiapex er et frysetørret middel til parenteral administration, der indeholder kollagenase clostridium histolyticum, som består af to kollagenaser i et defineret masseforhold.
English: Total (n=724)
Danish: I alt (n=724)
English: • pain at the injection site and above the penis
Danish: • smerter på injektionsstedet og området over penis
English: If this syndrome were to develop, it would occur progressively and is characterized by one or more of the following signs and symptoms: arthralgia, myalgia, joint stiffness, stiffness of the shoulders, hand oedema, palmar fibrosis and thickening or nodules forming in the tendons.
Danish: Hvis dette syndrom skulle udvikles, ville det forekomme progressivt og er karakteriseret ved et eller flere af følgende tegn og symptomer: artralgi, myalgi, ledstivhed, stivhed af skuldrene, håndødemer, håndfladefibrose og fortykkelse eller knudedannelse i senerne.
English: Penile blister Pruritus genital Painful erection Erectile dysfunction Dyspareunia Penile erythema
Danish: Blister på penis Genital kløe Smertefuld erektion Erektil dysfunktion Dyspareuni Penilt erytem
English: • The treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy (see sections 4.2 and 4.4).
Danish: • Voksne mænd til behandling af Peyronies sygdom med en palpabel plaque og krumning på mindst 30 grader ved begyndelsen af behandlingen (se pkt.
English: • inflammation of the lymph nodes (lymphadenitis), inflammation of lymphatic channels (lymphangitis) leading to reddened skin with elevated borders, tender and warm, usually accompanied by a red streak, enlarged lymph nodes
Danish: • betændelse i lymfeknuder (lymfadenitis), betændelse i lymfekar (lymfangitis), der viser sig ved rød, varm og øm hud med afgrænset hævelse og sædvanligvis med en rød stribe og hævede lymfeknuder
English: • Perform a series of finger flexion and extension exercises several times a day for several months.
Danish: • at uddføre en række fingerbøjnings- og udstrækningsøvelser flere gange om dagen i adskillige måneder.
English: The diluent contains calcium which is required for the activity of Xiapex.
Danish: Den indeholder calcium, som er nødvendigt for aktiviteten af Xiapex.
English: Nominal Change in Recurrence Rate vs Previous Year (%)
Danish: Nominel ændring i recidivrate vs. året før
English: When Xiapex was given intravenously every other day to male and female rats before cohabitation and through mating and implantation, no effects on the oestrus cycle, tubal transport, implantation and pre-implantation development and/or on libido or epididymal sperm maturation were noted with intravenous doses up to 0.13 mg/dose (approximately 11 times the human dose on a mg/m2 basis).
Danish: Ved intravenøs administration af Xiapex hver anden dag til han- og hunrotter før samliv, ved parring og ved implantation, blev der ikke observeret nogen virkninger på brunstcyklus, tubaltransport, implantation og præimplantation udvikling og/eller på libido eller epididymal modning af sæd ved intravenøse doser op til 0,13 mg/dosis (ca. 11 gange den humane dosis på en mg/m2 basis).
English: The following side effects have been seen with Xiapex administered in up to two cords or joints per treatment visit:
Danish: Der er set følgende bivirkninger ved Xiapex, når det blev administreret i op til to strenge eller led pr. besøg under behandlingen:
English: • painful glands near the elbows or under the arm
Danish: • smertefulde kirtler nær albuen eller under armen
English: In addition, patients were instructed to perform penile modelling at home for six weeks after each treatment cycle.
Danish: Desuden blev patienterne instrueret i at udføre remodellering af penis hjemme i 6 uger efter hver behandlingscyklus.