FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Peyronie's disease clinical studies, at 6 weeks after the first treatment cycle of Xiapex, approximately 75% of patients had antibodies against AUX-I and approximately 55% of patients had antibodies against AUX-II.
Danish: I de kliniske studier af Peyronies sygdom havde ca. 75 % af patienterne antistoffer mod AUX-I 6 uger efter den første behandlingscyklus med Xiapex, og ca. 55 % af patienterne havde antistoffer mod AUX-II.
English: The efficacy of Xiapex was evaluated in two randomized, double-blind, placebo-controlled studies, Study 1 (AUX-CC-803) and Study 2 (AUX-CC-804), in adult males with Peyronie's disease.
Danish: Virkningen af Xiapex blev evalueret i to randomiserede, dobbeltblinde, placebokontrollerede studier, studie 1 (AUX-CC-803) og studie 2 (AUX-CC-804), hos voksne mænd med Peyronies sygdom.
English: Injections in up to two cords or two affected joints in the same hand can be administered according to the injection procedure during a treatment visit.
Danish: Injektioner i op til to strenge eller i to påvirkede led på den samme hånd kan administreres i henhold til injektionsproceduren i løbet af et besøg under behandlingen.
English: The treatment cycle was repeated at approximately six-week intervals for up to three additional times, for a maximum of 8 total injection procedures and 4 total modelling procedures.
Danish: Behandlingscyklussen blev gentaget med ca. 6-ugers intervaller op til yderligere 3 gange, til maks.
English: • painful erection, painful sex and erectile dysfunction.
Danish: • smertefuld erektion, smertefuldt samleje og rejsningsproblemer
English: b) Apply antiseptic at the site of the injection and allow the skin to dry.
Danish: b) Rens injektionsstedet med et antiseptisk middel og lad huden tørre.
English: Again keeping the needle under the skin at all times, withdraw the needle tip from the cord and reposition it a third time proximal to the initial injection (approximately 2-3 mm) and inject the final portion of the dose into the cord (see Figure 2).
Danish: 10. Kanylen holdes igen hele tiden under huden, hvorefter kanylespidsen trækkes op ad strengen og genplaceres denne tredje gang proksimalt i forhold til første injektion (ca. 2-3 mm) og den sidste del af dosen injiceres ind i strengen (se figur 2).
English: You should gently stretch your penis 3 times a day for 6 weeks after each treatment cycle.
Danish: De skal strække Deres penis forsigtigt 3 gange om dagen i 6 uger efter hver behandlingscyklus.
English: Calcium chloride dihydrate Sodium chloride Water for injections
Danish: Calciumchloriddihydrat Natriumchlorid Vand til injektionsvæsker
English: Xiapex must be administered by a physician appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and treatment of male urological diseases.
Danish: Xiapex skal administreres af en læge, som er tilstrækkeligt trænet i korrekt administration af lægemidlet og med erfaring i diagnosticering og behandling af urologiske sygdomme hos mænd.
English: N=43 N=225 N=180 Mean±SD 51.8±15.04 31.0±16.10 25.8±12.99 25.2±13.31 29.1±17.21 27.0±16.13 Median 50.0 Min, Max 30, 90
Danish: N=247 N=247 N=51 N=43 N=225 N=180 Gennemsnit±SD 51,8±15,04 31,0±16,10 25,8±12,99 25,2±13,31 29,1±17,21 27,0±16,13 Median 50,0 Min; max 30; 90 0; 81
English: Visually inspect the vial containing Xiapex.
Danish: Inspicer hætteglasset med Xiapex visuelt.
English: Curvature*
Danish: Krumning*
English: The administration of two concurrent Xiapex injections into Dupuytren's cords in the same hand was evaluated in clinical study AUX-CC-867, a historically-controlled, open-label multi-centre trial in 715 adult subjects (1450 Xiapex injections) with Dupuytren's contracture.
Danish: Administration af to samtidige Xiapex-injektioner i Dupuytrens strenge på samme hånd blev evalueret i det kliniske studie AUX-CC-867, et historisk kontrolleret åbent multicenterstudie hos 715 voksne forsøgspersoner (1450 Xiapex-injektioner) med Dupuytrens kontraktur.
English: -1.1 b a Mean change, treatment difference, 95% CI, and p-value all 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: -1,1 b a Gennemsnitsændring, 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 ført fremad (last observation carried forward, LOCF) i den modificerede intention-to-treat (mITT)-population.
English: Adverse reactions reported from the clinical programme are those that occurred in the Phase 3 double blind placebo-controlled studies for the treatment of Dupuytren's contracture in adult patients with a palpable cord (AUX-CC-857, AUX-CC-859) and the post-marketing clinical studies (AUX-CC-864, AUX-CC-867) for two concurrent injections in the same hand.
Danish: De bivirkninger, som er rapporteret fra det kliniske program er dem, som forekom i de placebokontrollerede fase 3dobbeltblinde studier til behandling af Dupuytrens kontraktur hos voksne patienter med en palpabel streng (AUX-CC-857, AUX-CC-859) og kliniske studier efter markedsføring (AUX-CC-864, AUX-CC-867), til to samtidige injektioner i den samme hånd.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Xiapex powder vial label
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Xiapex-pulver, etiket til hætteglas
English: In addition to the in-office penile modelling procedure, patients should be provided instructions on the appropriate technique to self-perform penile modelling activities at home each day for the 6-week period following the physician penile plaque modelling visit of each treatment cycle, according to the detailed instructions provided in the package leaflet.
Danish: Ud over den ambulante procedure til remodellering af penis skal patienten have udleveret instruktioner i den passende teknik til hjemme dagligt at udføre remodellering af penis i en 6-ugers periode efter lægebesøget med remodellering af penis i hver behandlingscyklus, i henhold til de detaljerede anvisninger, der gives i indlægssedlen.
English: Administration of a local anaesthetic medicinal product prior to injection of Xiapex is not recommended, as it may interfere with proper placement of the injection.
Danish: Indgivelse af lokalbedøvelse før injektion af Xiapex kan ikke anbefales, da det kan forstyrre korrekt placering af injektionen.
English: Penile modelling procedure
Danish: Procedure for remodellering af penis
English: If insertion of the needle into a tendon is suspected or paresthesia is noted by the patient, withdraw the needle and reposition it into the cord.
Danish: Hvis der er mistanke om, at kanylen er stukket ind i en sene, eller patienten oplever paræstesi, skal kanylen trækkes tilbage og stikkes ind i strengen igen.
English: In the two Phase 3 double-blind placebo-controlled studies, most adverse reactions were local events of the penis and groin and the majority of these events were of mild or moderate severity, and most (79%) resolved within 14 days of the injection.
Danish: I de to fase 3 dobbeltblinde, placebokontrollerede studier var de fleste bivirkninger lokale i penis og lysken, størstedelen af bivirkningerne var af let til moderat sværhedsgrad, og de fleste (79 %) gik væk i løbet af 14 dage efter injektionen.
English: Clinical study experience with Xiapex is currently limited to up to 3 injections per cord and up to a total of 8 injections in the hands.
Danish: Erfaring fra kliniske studier med Xiapex er aktuelt begrænset til op til 3 injektioner pr. streng og op til i alt 8 injektioner i hænderne.
English: In the three double-blind, placebo-controlled phase 3 studies in Dupuytren's contracture, 73% of Xiapex-treated patients reported an ecchymosis or a contusion and 38% reported a haemorrhage at the injection site.
Danish: I tre dobbeltblinde, placebokontrollerede fase 3-studier af Dupuytrens kontraktur rapporterede 73 % af de Xiapex-behandlede patienter om en ekkymose eller et blåt mærke, og 38 % rapporterede en blødning på injektionsstedet.
English: Clinical study experience with Xiapex is currently limited to up to 3 injections per cord and up to 8 injections in total.
Danish: Erfaringen fra kliniske studier med Xiapex er for tiden begrænset med op til 3 injektioner pr. streng og op til 8 injektioner totalt.
English: Some patients with Dupuytren's contracture developed IgE-anti-drug antibodies in greater proportions and higher titers with successive Xiapex injections.
Danish: Dupuytrens kontraktur udviklede IgE-antistoffer mod lægemidlet i en større grad og højere titre ved efterfølgende Xiapex-injektioner.
English: In the double-blind portion of the three phase 3 placebo-controlled clinical studies in Dupuytren's contracture, 17% of Xiapex-treated patients had mild reactions (i.e. pruritus) after up to 3 injections.
Danish: I den dobbeltblinde del af tre fase 3-placebokontrollerede kliniske studier med Dupuytrens kontraktur havde 17 % af de Xiapex-behandlede patienter lette reaktioner (dvs. pruritus) efter op til 3 injektioner.
English: Withdraw the needle slowly so as to deposit the full dose along the needle track within the plaque.
Danish: Kanylen trækkes langsomt tilbage, så hele dosis afsættes langs kanylens bane i plaquen.
English: Your doctor will take care to avoid injecting into tendons, nerves or blood vessels.
Danish: Lægen vil sørge for, at der ikke injiceres i sener, nerver elle blodkar.
English: • Using the target plaque as a fulcrum point, use both hands to apply firm, steady pressure to elongate and stretch the plaque.
Danish: • Den plaque, der skal behandles, anvendes som et støttepunkt med begge hænder, så der med en fast hånd påføres et konstant tryk for at forlænge og strække plaquen.
English: The patient should then be instructed to self-perform penile modelling activities at home each day for the 6-week period following the physician penile plaque modelling visit of each treatment cycle, according to the detailed instructions provided in the package leaflet.
Danish: Patienten skal dernæst anvises i selv at udføre remodellering af penis hjemme hver dag i den 6-ugers periode efter lægebesøget med remodellering af penis i hver behandlingscyklus, i henhold til de detaljerede anvisninger, der gives i indlægssedlen.
English: Peyronie's disease Penile Fracture (corporal rupture) or other serious injury to the penis
Danish: Peyronies sygdom Penisfraktur eller anden alvorlig skade på penis
English: With your other hand, gently bend your penis in the opposite direction of the curve (see Figure 4).
Danish: Bøj forsigtig penis mod krumningen med den anden hånd (se figur 4).
English: Place the needle tip on the side of the target plaque in alignment with the point of maximal concavity.
Danish: Placer kanylespidsen ved siden af målplaquen, så den er på linje med punktet, hvor krumningen er størst.
English: Wearing gloves the physician should grasp the plaque or indurated portion of the flaccid penis about 1 cm proximal and distal to the injection site.
Danish: Lægen skal med handsker tage fat i den plaque eller den indurerede del af den afslappede penis, ca. 1 cm proksimalt og distalt fra injektionsstedet.
English: Xiapex is a powder and solvent for solution for injection.
Danish: Xiapex er et pulver og en solvens til injektionsvæske, opløsning.
English: Penis injury a Includes: injection site haematoma and penile haematoma were reported with the verbatim term of penile bruising or injection site bruising in 87% of patients.
Danish: Hæmatom i skrotum Ledskader Penisskader a Omfatter: hæmatom ved injektionsstedet og penilt hæmatom, blev rapporteret med beskrivelsen blå mærker på penis eller injektionsstedet hos 87 % af patienterne.
English: Xiapex is injected by your doctor into the cord in your finger/hand or plaque in your penis and works by breaking down the collagen in the cord or plaque.
Danish: Lægen injicerer Xiapex i strengen i Deres finger/hånd eller i plaquen på Deres penis.
English: What Xiapex is and what it is used for What you need to know before you are given Xiapex How Xiapex is used
Danish: Virkning og anvendelse Det skal De vide, før De får Xiapex Sådan får De Xiapex
English: At a follow-up visit 1 to 3 days after the second injection of each treatment cycle, perform a penile modelling procedure (as described below) on the flaccid penis to stretch and elongate the plaque that Xiapex has disrupted:
Danish: Ved et opfølgende besøg 1 til 3 dage efter den anden injektion i hver behandlingscyklus skal der udføres en remodellering af penis (som beskrives nedenfor) på den afslappede penis for at strække og forlænge den behandlede plaque, som Xiapex har sprunget.
English: Local anaesthesia may be used, if needed, during the finger extension procedure.
Danish: Om nødvendigt kan anvendes lokalanæstesi under manipulation af fingeren.
English: Xiapex is supplied in a pack containing 1 vial of Xiapex powder and 1 vial of solvent.
Danish: Xiapex fås som en pakning, der indeholder 1 hætteglas med Xiapex og 1 hætteglas med solvens.
English: • a popping sound or sensation in an erect penis
Danish: • en poppende lyd eller fornemmelse i den erigerede penis
English: For Xiapex no clinical data on exposed pregnancies are available.
Danish: Der er ingen kliniske data fra anvendelse af Xiapex til gravide kvinder.
English: N=31 N=167 N=134 Mean±SD 23.2±6.47 24.9±6.12 22.9±7.70 22.9±8.13 23.3±7.54 23.6±7.48 Median 26.0 Min, Max 2, 30
Danish: N=181 N=183 N=37 N=31 N=167 N=134 Gennemsnit± SD 23,2±6,47 24,9±6,12 22,9±7,70 22,9±8,13 23,3±7,54 23,6±7,48 Median 26,0 Min; max 2; 30
English: The solvent should slowly be injected into the sides of the vial containing the lyophilised powder of Xiapex.
Danish: Solvensen bør injiceres langsomt ind på siderne af hætteglasset med det frysetørrede Xiapex pulver.
English: If the cord has not disrupted after 3 attempts of extension, a follow-up visit may be scheduled approximately 4 weeks after the injection.
Danish: Hvis strengen ikke er sprængt efter 3 forsøg med manipulation, kan der planlægges et opfølgende besøg ca. 4 uger efter injektionen.
English: Use of Xiapex in patients who have received anticoagulants (with the exception of up to 150 mg acetylsalicylic acid daily) within 7 days prior to receiving an injection of Xiapex is not recommended.
Danish: Det kan ikke anbefales at behandle patienter, som har fået antikoagulantia (med undtagelse af acetylsalicylsyre op til 150 mg daglig) inden for de seneste 7 dage før de skal have en Xiapex injektion.
English: You should gently straighten your penis 1 time a day for 6 weeks after each treatment cycle.
Danish: De skal rette Deres penis forsigtigt ud 1 gang om dagen i 6 uger efter hver behandlingscyklus.
English: If, at that subsequent visit the contracted cord persists, an additional injection and finger extension procedure may be performed.
Danish: Hvis den kontraherede streng stadig er til stede ved det efterfølgende besøg, kan der udføres en yderligere injektion og manipulation af fingeren.
English: The MAH shall ensure that all physicians who are expected to prescribe/use Xiapex are appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and management of Dupuytren's contracture and Peyronie's disease.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som forventes at ordinere/ anvende Xiapex, er tilstrækkeligt trænet i korrekt administration af lægemidlet og har erfaring i diagnosticeringen og behandlingen af Dupuytrens kontraktur og Peyronies sygdom.
English: Table 8 provides the baseline disease characteristics for the study population and Tables 9 -10 provide the results of the co-primary efficacy endpoints measured in the 2 double-blind placebo-controlled studies AUX-CC-803 and AUX-CC-804.
Danish: Tabel 8 viser sygdomskarakteristika ved baseline for studiepopulationen, og tabel 9-10 viser resultaterne af de to primære endepunkter for virkning, målt i de 2 dobbeltblinde, placebokontrollerede studier AUX-CC-803 og AUX-CC-804.
English: • collection of blood outside of a blood vessel on scrotum
Danish: • ansamling af blod uden for et blodkar på pungen
English: Powder and solvent for solution for injection 1 vial of powder
Danish: Pulver og solvens til injektionsvæske, opløsning 1 hætteglas pulver
English: Injections in up to two cords or two affected joints in the same hand can be administered during a treatment visit.
Danish: Injektioner i op til to strenge eller i to påvirkede led på den samme hånd kan administreres i løbet af et besøg under behandlingen.
English: • skin wound, blood blister
Danish: • sår i huden, blodig vabel
English: The efficacy of Xiapex 0.58 mg was evaluated in two pivotal randomized, double-blind, placebo-controlled studies, CORD I (AUX-CC-857) and CORD II (AUX-CC-859), in adult patients with Dupuytren's contracture.
Danish: Virkningen af Xiapex 0,58 mg blev evalueret i to pivotale randomiserede, dobbeltblinde, placebokontrollerede studier CORD I (AUX-CC-857) og CORD II (AUX-CC-859) hos voksne patienter med Dupuytrens kontraktur.
English: The volume of solvent required and the volume of reconstituted Xiapex to be administered into the Dupuytren's cord differs depending on the type of joint being treated (for the reconstitution instructions, see section 6.6, Table 14).
Danish: Volumen af nødvendigt solvens og volumen af rekonstitueret Xiapex, som skal administreres i Dupuytrens streng, varierer alt afhængig af den type led, som skal behandles (se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xiapex in all subsets of the paediatric population in the treatment of Dupuytren's contracture (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Xiapex i alle undergrupper af den pædiatriske population ved behandlingen af Dupuytrens kontraktur (se pkt.
English: • reactions at the injection site such as presence of a blister, swelling, itching or a solid raised area under the skin
Danish: • reaktioner på injektionsstedet såsom blister, hævelse, kløe eller et fast, hævet område under huden
English: Based on the Patient Global Assessment of Treatment Satisfaction, more than 85% of subjects in the CORD I and CORD II studies reported either being quite satisfied or very satisfied with their treatment with Xiapex versus approximately 30% treated with placebo (p<0.001).
Danish: Mere end 85 % af studiepersonerne i CORD I og CORD II studierne var enten temmelig tilfredse eller meget tilfredse med deres behandling med Xiapex versus ca. 30 % af de placebobehandlede (p<0,001), baseret på ”Patient Global Assessment of Treatment Satisfaction” spørgeskemaet.
English: The following information is intended for healthcare professionals only: Instructions for use and handling
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Instruktioner for anvendelse og håndtering Peyronies sygdom
English: Other medicines and Xiapex
Danish: Brug af anden medicin sammen med Xiapex
English: Hold pressure for 30 seconds then release.
Danish: Trykket på penis skal holdes i 30 sekunder, og dernæst fjernes.
English: • Not to attempt to disrupt the injected cord by self-manipulation at any time.
Danish: • ikke at forsøge at sprænge den injicerede streng ved selvmanipulationpå noget tidspunkt
English: Most of the side effects that occurred in the clinical studies were mild or moderate in severity and most resolved within 2 weeks of the injection.
Danish: De fleste bivirkninger, der opstod i de kliniske studier, var lette to moderate af sværhedsgrad, og de fleste gik væk i løbet af 2 uger efter injektionen.
English: N=29 N=154 N=123 Mean±SD 6.5±3.47 3.4±3.30 3.2±3.30 2.7±2.84 2.5±3.01 2.4±2.89 Median 6.0 Min, Max 0, 15
Danish: N=183 N=183 N=34 N=29 N=154 N=123 Gennemsnit± SD 6,5±3,47 3,4±3,30 3,2±3,30 2,7±2,84 2,5±3,01 2,4±2,89 Median 6,0 Min; max 0; 15
English: 9 subjects received commercial Xiapex and 1 subject had penile implant during the course of the non-treatment study (AUX-CC-810), and 12 subjects had prior surgical intervention for the treatment of Peyronie´s Disease.
Danish: 9 personer fik kommercielt Xiapex og 1 forsøgsperson fik et penilt implantat i løbet af studiet uden behandling (AUX-CC-810), og 12 personer havde tidligere gennemgået kirurgisk intervention med henblik på behandling af Peyronies sygdom.
English: • pain in your penis
Danish: • smerter i penis
English: Manufacturer Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Danish: Fremstiller Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sverige
English: • bruising or swelling of the penis and pain in the penis
Danish: • blå mærker eller hævelse af penis og smerter i penis
English: There is no experience in the use of Xiapex in breast-feeding women therefore the use of Xiapex is not recommended during breast-feeding.
Danish: Der er ingen erfaring med anvendelse af Xiapex til ammende kvinder, og derfor bør Xiapex ikke anvendes under amning.
English: • fever, general pain, discomfort, tiredness, feeling hot, malaise, flu-like illness
Danish: • feber, generel smerte, ubehag, træthed, varmefølelse, utilpashed, influenzalignende sygdom
English: Fungal skin infection Infection
Danish: Svampeinfektion på hud Infektion
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xiapex in all subsets of the paediatric population in the treatment of Peyronie's disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Xiapex i alle undergrupper af den pædiatriske population ved behandling af Peyronies sygdom (se pkt.
English: • Administer suitable local anaesthetic, if desired.
Danish: • Hvis det ønskes, administreres egnet lokalanæstesi.
English: • stiffness, creaking of the joints
Danish: • stivhed, skuren i leddene
English: Injection site cellulitis Lymphangitis
Danish: Cellulitis ved injektionsstedet Lymfangitis
English: • fast heart rate
Danish: • hurtig puls
English: Mean Baseline (SD) Mean Final (SD) Mean increase (SD)
Danish: Gennemsnit baseline (SD) Gennemsnit slut (SD) Gennemsnitlig stigning (SD)
English: d) Using a new hubless syringe containing 0.01 ml graduations with a permanently fixed 27-gauge
Danish: d) Med en ny injektionssprøjte uden hub, der har 0,01 ml gradueringer med en permanent fastgjort
English: The volume of reconstituted Xiapex to be administered into the plaque is 0.25 ml (for reconstitution instructions, see section 6.6, Table 14).
Danish: Det volumen af rekonstitueret Xiapex, der skal administreres i en plaque, er 0,25 ml (se pkt.
English: Lymphangiopathy Thrombophlebitis superficial
Danish: Lymfangiopati Superficiel tromboflebitis
English: Marketing Authorisation Holder Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden
Danish: Indehaver af markedsføringstilladelsen Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sverige
English: If the solution contains particles, is cloudy or discoloured, it should not be injected.
Danish: Hvis injektionsvæsken indeholder partikler, er uklar eller misfarvet, bør den ikke injiceres.
English: Mean age (years) (Min-Max)
Danish: Gennemsnitsalder (år) (min.-maks.)
English: • To return to see their physician approximately 24-72 hours after injection for an examination of the injected hand and a finger extension procedure to disrupt the cord.
Danish: • At komme tilbage til deres læge ca. 24 - 72 timer efter injektionen til undersøgelse af den injicerede hånd og for en manipulation af fingeren for at opnå ruptur af strengen.
English: Class I collagenases (α, β, γ, and η) are the products of the colG gene, they initiate collagen hydrolysis near the amino and carboxy termini of triple helical domains and generate large proteolytic fragments.
Danish: De initierer kollagenhydrolyse tæt ved amino- og carboxyender af triple helix domæner og danner store proteolytiske fragmenter.