FrancophonIA/ELRC3.0 huggingface dataset:
English: For PIP joints do not inject more than 4 mm distal to the palmar digital crease.
Danish: Injicer ikke mere end 4 mm distalt i forhold til palmar digital bøjefuren ved PIP led.
English: Open wound
Danish: • åbent sår
English: • groin pain and discomfort
Danish: • lyskensmerter og -besvær
English: Mean Change in Peyronie's Disease Bother Domain Score from Baseline to Week 52 - Studies 1 and 2
Danish: Tabel 10. Gennemsnitsændring i score i problem-domænet ved Peyronies sygdom fra baseline til uge 52 - studie 1 og 2
English: • thickening near ligament at base of penis
Danish: • fortykkelse nær ledbåndet ved roden af penis
English: 9 subjects received commercial Xiapex and 2 subjects had penile implant during the course of the non-treatment study (AUX-CC-810), and 18 subjects had prior surgical intervention for the treatment of Peyronie´s Disease.
Danish: 9 personer fik kommercielt Xiapex, og 2 forsøgspersoner fik et penilt implantat i løbet af studiet uden behandling (AUX-CC-810), og 18 personer havde tidligere gennemgået kirurgisk intervention med henblik på behandling af Peyronies sygdom.
English: Xiapex must be administered by a physician appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and management of Dupuytren's disease.
Danish: Xiapex skal administreres af en læge som er tilstrækkeligt trænet i korrekt administration af lægemidlet, samt har erfaring i diagnosticeringen og behandlingen af Dupuytrens sygdom.
English: • disease of the lymph vessels
Danish: • sygdom i lymfekarrene
English: • sore on the skin of the penis
Danish: • ømhed af huden på penis
English: For further information see “Instructions on how to gently stretch your penis” and “Instructions on how to gently straighten your penis” at the end of the Patient leaflet.
Danish: For yderligere oplysninger, se ”Anvisninger i forsigtigt at strække Deres penis”
English: Xiapex 0.9 mg powder and solvent for solution for injection
Danish: Xiapex 0,9 mg pulver og solvens til injektionsvæske, opløsning
English: Drug hypersensitivity Anaphylactic reaction*
Danish: Lægemiddeloverfølsomhed Anafylaktisk reaktion*
English: Blood blister Skin discolouration
Danish: Blodige blister Misfarvning af hud
English: If the cord has not disrupted after 3 attempts of extension per cord, a follow-up visit may be scheduled approximately 4 weeks after the injection.
Danish: Hvis ruptur af strengen ikke er opnået efter 3 forsøg på udstrækning pr. streng, aftales et opfølgningsbesøg ca. 4 uger efter injektionen.
English: Baseline, mean (SD) Day 31, mean (SD) Change, mean (SD) FFC = Fixed flexion contracture ROM = Range of motion
Danish: FFC = Fikseret fleksionskontraktur ROM = Ledbevægelighed
English: PIP Jointsb p-value
Danish: PIP ledb p-værdi
English: Package leaflet: Information for the user Xiapex 0.9 mg powder and solvent for solution for injection collagenase clostridium histolyticum
Danish: Indlægsseddel: Information til brugeren Xiapex 0,9 mg pulver og solvens til injektionsvæske, opløsning kollagenase clostridium histolyticum
English: Penile fracture (corporal rupture) or other serious injury to the penis
Danish: Penisfraktur eller anden alvorlig skade på penis
English: The rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the solvent for reconstitution should be swabbed with sterile alcohol (no other antiseptics must be used).
Danish: Gummiproppen og overfladerne af hætteglasset med Xiapex og hætteglasset med solvens til rekonstitution skal afsprittes (ingen andre antiseptika må anvendes).
English: • vomiting, diarrhoea, upper abdominal pain
Danish: • opkastning, diaré, smerter i øverste del af maven
English: If refrigerated, the reconstituted solution must be allowed to return to ambient room temperature (20ºC-25ºC) for approximately 15 minutes before use.
Danish: Hvis den rekonstituerede injektionsvæske opbevares i køleskab skal den opnå stuetemperatur (20 °C - 25 °C) i cirka 15 minutter før brug.
English: After needle placement, if there is any concern that the needle is in the flexor tendon, apply a small amount of passive motion at the distal interphalangeal (DIP) joint.
Danish: Hvis der er nogen tvivl om, at kanylen er stukket ind i bøjesenen bevæges det distale interfalangeale (DIP) led lidt.
English: Only the supplied solvent must be used for reconstitution; it contains calcium which is required for the activity of Xiapex.
Danish: Solvensen indeholder calcium, som er nødvendigt for aktiviteten af Xiapex.
English: Using a new sterile, hubless syringe with 0.01 ml graduations and a permanently fixed, 26 or 27 gauge, 12 or 13 mm needle (not supplied), withdraw the adequate volume of reconstituted solution for a 0.58 mg dose of Xiapex required for injection to deliver:
Danish: Brug en ny steril injektionssprøjte uden hub med 0,01 ml gradueringer og en permanent fastgjort 26 eller 27 gauge, 12 eller 13 mm kanyle (medfølger ikke) og træk det korrekte volumen rekonstitueret injektionsvæske op, som er nødvendigt for at injicere en 0,58 mg dosis Xiapex:
English: Local anaesthesia may be applied before the modelling if desired.
Danish: Lokalanæstesi før remodelleringen kan anvendes, hvis det er nødvendigt.
English: MP PIP
Danish: PIP
English: • To return to see their physician approximately 24-72 hours after each injection for an examination of the injected hand and a possible finger extension procedure to disrupt the cord.
Danish: • at konsultere lægen ca. 24 - 72 timer efter hver injektion til en undersøgelse af den injicerede hånd og muligvis manipulation af fingeren for at opnå ruptur af strengen.
English: Xiapex 0.58 mg dose†
Danish: Injektionsvolumen for at give en Xiapex 0,58 mg dosis†
English: • drainage from a blister on the penis
Danish: • udsivning af væske fra en blister på penis
English: Study 1 or 2 b Each PDQ assessment required subjects to have had vaginal intercourse in the
Danish: a Forsøgspersonerne var fra ITT-populationen og fik mindst en dosis studielægemiddel i studie 1 eller b Hver vurdering af PDQ krævede, at forsøgspersonerne havde haft et vaginalt samleje i de sidste
English: MP Jointsa p-value
Danish: MP leda p-værdi
English: Secretion discharge Tenderness
Danish: Sekretudskillelse Ømhed
English: In the Dupuytren's contracture clinical trials at 30 days post the first injection, 92% of patients had circulating antibodies detected against AUX-I and 86% of patients against AUX-II.
Danish: I de kliniske studier af Dupuytrens kontraktur havde 92 % af patienterne udviklet cirkulerende antistoffer mod AUX-I 30 dage efter den første injektion, og 86 % af patienterne havde udviklet cirkulerende antistoffer mod AUX-II.
English: Xiapex 0.9 mg powder for injection collagenase clostridium histolyticum Intralesional use
Danish: Xiapex 0,9 mg pulver til injektionsvæske kollagenase clostridium histolyticum Intralæsional anvendelse
English: Pack of 1 vial of powder and 1 vial of solvent
Danish: Pakning med 1 hætteglas med pulver og 1 hætteglas med solvens.
English: If you receive more Xiapex than you should
Danish: Hvis De har fået for meget Xiapex
English: Discard the unused portion of the reconstituted solution and solvent after injection.
Danish: Kassér den ikke anvendte rekonstituerede injektionsvæske og solvens efter injektionen.
English: Table 2: Tabulated list of adverse reactions.
Danish: Tabel 2: Bivirkninger i tabelform.
English: • reactions at the injection site like bleeding, pain, swelling, tenderness and bruising
Danish: • reaktioner på injektionsstedet såsom blødning, smerte, hævelse, ømhed og blå mærker
English: • burning sensation, partial loss of sensitivity, feeling of “pins and needles” or numbness
Danish: • en brændende fornemmelse, delvis tab af følsomhed, prikkende eller stikkende fornemmelse eller følelsesløshed
English: Mean Baseline (SD) Mean Final (SD) Mean increase (SD) 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: Gennemsnitlig stigning (SD) a Metacarpofalangeale led b Proksimal interfalangeale led c 2 primære led blev ekskluderet fra virkningsanalysen (1 led fra placebogruppen blev ikke evalueret og 1 led fra den Xiapexbehandlede gruppe havde en kontraktur ved baseline på 0 grader før behandling).
English: Inject the diluent slowly into the sides of the vial containing the lyophilized powder of Xiapex.
Danish: Injicer langsomt solvensen ind på siderne på hætteglasset med det frysetørrede Xiapex pulver.
English: Feeling hot Influenza like illness
Danish: Varmefølelse Influenzalignende sygdom
English: Pain in chest wall, groin, neck or shoulder
Danish: Smerte i thoraxvæg, lyske, nakke eller skulder
English: • chronic pain
Danish: • kronisk smerte
English: All Joints
Danish: Alle led
English: Penile Fracture (corporal rupture) or other serious injury to the penis has uncommonly occurred.
Danish: Penisfraktur eller anden alvorlig skade på penis er forekommet med en ikke almindelig hyppighed.
English: If the reconstituted Xiapex solution is refrigerated, allow this solution to return to room temperature for approximately 15 minutes before use.
Danish: Hvis den rekonstituerede Xiapex-injektionsvæske har været i køleskab, skal injektionsvæsken have lov til at opnå stuetemperatur igen i løbet af ca. 15 minutter før brug.
English: Instructions on how to gently stretch your penis
Danish: Anvisninger i forsigtigt at rette Deres penis ud
English: Dupuytren's contracture: The joint to be treated (MP or PIP) should be confirmed as the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection).
Danish: Dupuytrens kontraktur: Det led, som skal behandles (MP eller PIP), skal identificeres, eftersom det nødvendige volumen af solvens til rekonstitution bestemmes af ledtypen (PIP led har brug for et mindre volumen til injektion).
English: • formation of a blood clot inside the penile vein
Danish: • dannelse af en blodprop i venen i penis
English: Patients should be instructed to comply with the treatment instructions (see section 4.2) and to promptly contact the physician if there is trouble bending the finger after the swelling goes down (symptoms of tendon rupture).
Danish: 4.2) og om straks at kontakte lægen, hvis der er besvær med at bøje fingeren, efter hævelsen er forsvundet (symptomer på seneruptur).
English: Xiapex should be injected into the target plaque when the penis is in a flaccid state.
Danish: Xiapex skal injiceres på det markerede sted, mens penis er afslappet.
English: sudden loss of the ability to maintain an erection, pain in your penis, purple bruising and swelling of your penis, difficulty urinating or blood in the urine, a collection of blood under the skin at the injection site.
Danish: Kontakt straks lægen, hvis De oplever symptomer på penisfraktur eller anden alvorlig skade på penis, som er følgende: En poppende lyd eller fornemmelse i den erigerede penis, pludselig manglende evne til at opretholde en erektion, smerter i penis, blåsorte mærker og hævelse af penis, vandladningsbesvær eller blod i urinen, ansamling af blod under huden på injektionsstedet.
English: There is no quantifiable systemic exposure following a single injection of Xiapex in patients with Dupuytren's contracture and only minimal and short-lived systemic exposure of Xiapex in patients with Peyronie's disease.
Danish: Der er ingen kvantificerbar systemisk eksposition efter en enkelt injektion med Xiapex hos patienter med Dupuytrens kontraktur og kun minimal eller kortvarig systemisk eksposition med Xiapex hos patienter med Peyronies sygdom.
English: If the solution contains particulates, is cloudy, or is discoloured, do not inject the reconstituted solution.
Danish: Hvis injektionsvæsken indeholder partikler, er uigennemsigtig eller misfarvet, må den rekonstituerede opløsning ikke injiceres.
English: A treatment course consists of a maximum of 4 treatment cycles.
Danish: 4 behandlingscyklusser.
English: c Includes: injection site pain, penile pain, and injection site discomfort.
Danish: c Omfatter: smerter ved injektionsstedet, penissmerter og gener ved injektionsstedet.
English: Axillary pain Inflammation Injection site warmth, erythema, inflammation, vesicles or pruritus Swelling
Danish: Aksilsmerte Inflammation Varme, erytem, inflammation, blærer eller kløe ved injektionsstedet Hævelse
English: Haematoma Hypotension
Danish: Hæmatom Hypotension
English: The solution should slowly be swirled to ensure that all of the lyophilised powder has gone into solution.
Danish: Injektionsvæsken bør hvirvles langsomt rundt for at sikre, at alt det frysetørrede pulver er blevet opløst.
English: • fungal skin infection
Danish: • svampeinfektion på hud
English: Grounds for the variation to the terms of the Marketing Authorisation
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne
English: Injection of Xiapex into collagen-containing structures such as the corpora cavernosa of the penis may result in damage to those structures and possible injury such as corporal rupture (penile fracture).
Danish: Penisfraktur eller anden alvorlig skade på penis ved behandling af Peyronies sygdom Injektionen af Xiapex i kollagenholdige strukturer, såsom corpora cavernosa på penis, kan føre til beskadigelse af disse strukture og mulig skade, såsom penisfraktur.
English: Recurrence was assessed in successfully treated joints (i.e., subjects had a reduction in contracture to 5° or less at the Day 30 evaluation after the last injection of Xiapex in a previous study) and was defined as an increase in joint contracture by at least 20° in the presence of a palpable cord, or the joint underwent medical or surgical intervention primarily to correct a new or worsening Dupuytren's contracture in that joint.
Danish: Recidiv blev defineret som en gendannelse af kontraktur i led med mindst 20° med tilstedeværelse af en palpabel streng eller medicinsk eller kirurgisk intervention af leddet, primært for at korrigere en ny eller forværret Dupuytrens kontraktur i dette led.
English: Table 1: Tabulated list of adverse reactions.
Danish: Tabel 1: Bivirkninger i tabelform.
English: The single dose vial containing Xiapex and the single dose vial containing the solvent for solution for injection for reconstitution must be refrigerated.
Danish: Enkeltdosis hætteglasset med Xiapex og enkeltdosis hætteglasset med solvens til injektionsvæske, opløsning til rekonsitution skal opbevares i køleskab.
English: • superficial vein inflammation
Danish: • overfladisk venebetændelse
English: Musculoskeletal and connective tissue disorders
Danish: Ligamentsmerter Muskuloskeletale gener
English: Swelling face Skin disorders, like exfoliation, lesions, pain, tightness, discoloration or scab
Danish: Hævelse i ansigtet Hudsygdom som afskalning, læsioner, smerter, sammentrækning, misfarvning eller skorpedannelse
English: PIP Jointsb
Danish: PIP ledb
English: Prior to use, the vial containing Xiapex and the vial containing the solvent for solution for reconstitution must be removed from the refrigerator and allowed to stand at room temperature for at least 15 minutes and no longer than 60 minutes.
Danish: Før brug skal hætteglasset med Xiapex og hætteglasset med solvens til opløsning til rekonstitution tages ud af køleskabet og stå ved stuetemperatur i mindst 15 minutter, dog ikke længere end 1 time.
English: b) After removal of the flip-off cap from each vial, using aseptic technique swab the rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the diluent for reconstitution with sterile alcohol (no other antiseptics should be used).
Danish: b) Når flip-off-lågene er blevet taget af begge hætteglas, afsprittes gummiproppen og overfladerne af hætteglasset med Xiapex og hætteglasset med solvens til rekonstitution rundt om låget (ingen andre antiseptiske midler må anvendes).
English: Both collagenases effectively cleave interstitial collagen but at different sites on the molecule; additionally, they prefer different conformations (triple helical versus denatured or cleaved).
Danish: Begge kollagenaser spalter effektivt interstitielt kollagen men forskellige steder på molekylet.
English: Xiapex has not been studied in children and adolescents aged 0-18 years and hence no pharmacokinetic data are available.
Danish: Der foreligger ingen farmakokinetiske data, eftersom Xiapex er ikke undersøgt hos børn og unge i alderen 0 - 18 år.
English: a) Before use, remove the vial containing the lyophilized powder of Xiapex and the vial containing the diluent for reconstitution from the refrigerator and allow the two vials to stand at room temperature for at least 15 minutes and no longer than 60 minutes.
Danish: a) Før brug skal hætteglasset med det frysetørrede pulver med Xiapex og hætteglasset med solvens til rekonstitution tages ud af køleskabet, og de to hætteskal skal stå ved stuetemperatur i mindst 15 minutter og ikke længere and 1 time.
English: • reactions at the injection site like pain, warmth, swelling, presence of a blister, redness of skin and/or skin rash
Danish: • reaktioner på injektionsstedet såsom smerte, varme, hævelse, blærer, rødme i huden og/eller udslæt
English: The joint to be treated (metacarpophalangeal [MP] or proximal interphalangeal [PIP]) should be confirmed and the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection).
Danish: Det led, der skal behandles (metacarpofalangeal [MP] eller proksimal interfalangeal [PIP]), skal bekræftes, og det nødvendige solvensvolumen til rekonstitutionen bestemmes af ledtypen (PIP-led kræver et mindre injektionsvolumen).
English: g) Discard the syringe and needle used for reconstitution and the diluent vial.
Danish: g) Injektionssprøjten og kanylen, der er anvendt til rekonstitution, samt hætteglasset med solvens bortskaffes.
English: • scar tissue in penis
Danish: • arvæv i penis
English: Slowly swirl the solution to ensure that all of the lyophilized powder has gone into solution.
Danish: Injektionsvæsken hvirvles langsomt rundt for at sikre, at alt det frysetørrede pulver er blevet opløst.
English: • muscle spasm, muscle weakness, musculoskeletal stiffness or discomfort
Danish: • muskelkrampe, muskelsvaghed, stivhed eller ubehag i knogler, led og muskler
English: Solvent: 3 ml solution supplied in a clear glass vial (5 ml, type I glass) with rubber stopper, aluminium seal and flip-off cap (polypropylene).
Danish: Solvens: 3 ml opløsning leveres i et klart hætteglas (5 ml, type I glas) med gummiprop, aluminiumforsegling og flip-off plastikhætte af polypropylen.
English: The reconstituted solution of Xiapex must be clear.
Danish: Den rekonstituerede injektionsvæske af Xiapex skal være klar.
English: The following information is intended for Peyronie's disease patients only:
Danish: Følgende oplysninger er kun beregnet til patienter med Peyronies sygdom: Anvisninger i forsigtigt at strække Deres penis
English: A finger extension procedure was performed if needed, approximately 24 hours after injection to facilitate disruption of the cord.
Danish: Fingeren blev cirka et døgn efter injektionen manipuleret, efter behov for at lette ruptur af strengen.
English: For cords affecting the PIP joint, perform the finger extension procedure when the MP joint is in the flexed position.
Danish: For strenge, der påvirker PIP-leddet, udføres finger manipulationen med MP-leddet i bøjet stilling.
English: • feeling of pain in the groin, shoulder, chest wall, or neck
Danish: • smerter i lysken, skulder, brystkasse eller nakke
English: Musculoskeletal discomfort or stiffness, joint stiffness or crepitation Limb discomfort Tendonitis Muscle spasms or weakness
Danish: Muskuloskeletale gener eller stivhed, stivhed eller krepitation i led Ubehag i lemmerne Tendonitis
English: d Includes: contusion, ecchymosis, penile haemorrhage, and injection site haemorrhage.
Danish: d Omfatter: kontusion, ekkymose, penil hæmoragi og blødning ved injektionsstedet.
English: Confirm the joint to be treated (metacarpophalangeal [MP] or proximal interphalangeal [PIP]) as the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection).
Danish: Identificer det led, som skal behandles (metacarpofalangeal [MP] eller proksimal interfalangeal [PIP]), eftersom det nødvendige volumen af solvens til rekonstitution bestemmes af ledtypen (PIP-led kræver et mindre volumen til injektion).
English: Baselinea
Danish: Gennemsnit ved baseline
English: • upper respiratory infection
Danish: • infektion af de øvre luftveje
English: • discomfort, injury, paralysis of the limb
Danish: • ubehag, skade, lammelse i arm eller ben
English: In addition, based on the review of post marketing case reports of penile fracture in patients with Peyronie's disease, the PRAC considers that the product information for Xiapex should be updated to include a new wording for section 4.4 of the SmPC and section 2 of the PIL to increase the minimum time span between injection and resumption of sexual activity to at least 4 weeks and to be cautious when resuming sexual activity.
Danish: Desuden, på basis af gennemgangen af sagsrapporter efter marketing om penisfraktur hos patienter med Peyronies sygdom, anser PRAC det for nødvendigt at opdatere produktinformationen for Xiapex, så der inkluderes en ny ordlyd i pkt.
English: Xiapex powder is supplied in a clear glass vial (3 ml, type I glass) with rubber stopper, aluminium seal and flip-off cap (polypropylene).
Danish: Xiapex-pulver leveres i et klart hætteglas (3 ml, type I glas) med gummiprop, aluminiumforsegling og flip-off plastikhætte af polypropylen.
English: Lymph node pain Eosinophilia Lymphadenopathy
Danish: Smerte i lymfeknuder Eosinofili
English: Use only the supplied diluent for reconstitution.
Danish: Kun den leverede solvens må bruges til rekonstitution.
English: Injection site vesicles or pruritus Localised oedema Nodule
Danish: Blærer eller kløe ved injektionsstedet Lokaliseret ødem Knude
English: Penile size reduced Penile vein thrombosis Scrotal oedema Scrotal pain
Danish: Reduceret penisstørrelse Trombose i penil vene Ødem i skrotum
English: d) Using a 1 ml syringe with 0.01 ml graduations with a 27-gauge 12-13 mm needle (not supplied), withdraw the correct volume of the diluent supplied:
Danish: d) Med en 1 ml injektionssprøjte med 0,01 ml gradueringer og en 27 gauge 12-13 mm kanyle (medfølger ikke), trækkes det korrekte volumen af tilhørende solvens op:
English: The reconstituted Xiapex solution should be clear.
Danish: Den rekonstituerede Xiapex-injektionsvæske skal være klar.
English: Diarrhoea Vomiting Abdominal pain upper
Danish: Mavesmerter i øvre del af abdomen
English: Xiapex 0.9 mg powder and solvent for solution for injection collagenase clostridium histolyticum
Danish: Xiapex 0,9 mg pulver og solvens til injektionsvæske, opløsning kollagenase clostridium histolyticum
English: Upper respiratory infection
Danish: Infektion af de øvre luftveje
English: After removal of the flip-off cap from each vial, using aseptic technique swab the rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the diluent for reconstitution with sterile alcohol (no other antiseptics should be used).
Danish: Når flip-off-lågene er blevet taget af begge hætteglas, afsprittes gummiproppen og omliggende overflader af hætteglasset med Xiapex og hætteglasset med solvens til rekonstitution (ingen andre antiseptiske midler må anvendes).
English: Penile ulceration Rash erythematous Night sweats
Danish: Sårdannelse på penis Erytematøst udslæt Nattesved