FrancophonIA/ELRC3.0 huggingface dataset:
English: The potential risk for humans on parturition and postnatal development is unknown.
Danish: Den potentielle risiko for mennesker ved fødsel og postnatal udvikling kendes ikke.
English: No systemic toxicity was observed in this study at any dose level.
Danish: Der blev ikke observeret nogen systemisk toksicitet i dette studie ved noget dosisniveau.
English: • Your doctor will also tell you when to come back if more treatment cycles are needed.
Danish: • Deres læge vil også fortælle Dem, hvornår De skal komme igen, hvis flere behandlingscyklusser er nødvendige.
English: Retreatment of recurrent contractures
Danish: Genbehandling af tilbagevendende kontrakturer
English: The majority of the skin lacerations occurred on the manipulation day.
Danish: Hovedparten af rifter i huden opstod på manipulationsdagen.
English: • Xiapex is given as part of a treatment cycle.
Danish: • Xiapex gives som en del af en behandlingscyklus.
English: Results showed no cross-reactivity with any of the five MMPs tested.
Danish: Resultaterne viste ingen krydsreaktivitet over for nogen af de fem testede MMP'er.
English: Patients should be instructed to consult a doctor immediately if they experience any of these signs or symptoms.
Danish: Patienterne skal informeres om straks at kontakte en læge, hvis de oplever nogle af disse tegn eller symptomer.
English: These data support the long-term safety profile of Xiapex confirming that no new safety risks were identified during the 5 year follow-up period.
Danish: Disse data støtter den langvarige sikkerhedsprofil for Xiapex og bekræfter, at der ikke blev identificeret nye sikkerhedsrisici i løbet af den 5-årige opfølgningsperiode.
English: Using an aseptic technique, the following procedure for reconstitution must be followed:
Danish: Ved at anvende aseptisk teknik skal følgende procedure til rekonstitution følges:
English: • sudden loss of the ability to maintain an erection
Danish: • pludselig manglende evne til at opretholde en erektion
English: Cases of finger necrosis have been reported, which in some cases led to amputation of finger parts.
Danish: Tilfælde af fingernekrose er blevet rapporteret, hvilket i nogle tilfælde førte til amputation af dele af fingrene.
English: The interval between treatment cycles is approximately six weeks.
Danish: Intervallet mellem behandlingscyklusserne er ca. 6 uger.
English: a A joint was considered in an interval if the duration of assessment falls in the interval.
Danish: a Et led blev anset for at være i et interval, hvis varigheden af vurderingen falder inden for intervallet.
English: Patients with penile curvature >90° were not included in the clinical studies.
Danish: Patienter med en peniskrumning >90° blev ikke inkluderet i de kliniske studier.
English: • The need to inform the patient about the signs and symptoms associated with the treatment and when to seek attention from the health care provider.
Danish: • Nødvendigheden af at informere patienterne om tegn og symptomer, som er forbundet med behandingen, og hvornår de skal søge behandling hos lægen
English: Emergency medication for treatment of potential allergic reactions should be available.
Danish: Der skal være relevante midler til rådighed til behandling af mulige allergiske reaktioner.
English: • unpleasant taste
Danish: • ubehagelig smag
English: You must limit motion of the treated finger for a day and it is not uncommon for the finger to straighten on its own for some patients.
Danish: De skal begrænse bevægelse af den behandlede finger i en dag, og det er ikke ualmindeligt at fingeren selv strækker sig ud hos nogle patienter.
English: Only stretch your penis if your penis is not hard (erect).
Danish: Stræk kun Deres penis, hvis Deres penis ikke er hård (erigeret).
English: Reduced peripheral circulation may be one contributing factor for finger necrosis.
Danish: Et nedsat perifert kredsløb kan være en bidragende faktor til fingernekrose.
English: This is particularly important for cords situated at the PIP joint of the fifth finger.
Danish: Dette er særligt vigtigt for strenge placeret ved PIP leddet på den femte finger.
English: The two classes of collagenases have similar but complementary substrate specificity.
Danish: De to klasser af kollagenaser har lignende men komplementær substratspecificitet.
English: The package leaflet is updated accordingly.
Danish: Indlægssedlen er blevet opdateret i henhold hertil.
English: At baseline, penile pain was either not present or was mild in most (98%) patients.
Danish: Ved baseline var penissmerter enten ikke til stede eller lette hos de fleste (98 %) patienter.
English: • Your doctor will tell you when you can resume sexual activity after each treatment cycle.
Danish: • Deres læge vil fortælle Dem, hvornår De kan genoptage seksuel aktivitet efter hver behandlingscyklus.
English: Intralesional use.
Danish: Intralæsional anvendelse.
English: Patients must be instructed to avoid potentially hazardous tasks such as driving or using machines until it is safe to do so or as advised by the physician.
Danish: Patienterne skal instrueres om at undgå potentielt risikable opgaver såsom at føre motorkøretøj eller betjene maskiner, indtil det er sikkert at gøre det eller som tilrådet af lægen.
English: Preparation - Reconstitution procedure
Danish: Tilberedning - rekonstitutionsprocedure
English: Xiapex is indicated for:
Danish: Xiapex er indiceret til:
English: Patients should be instructed:
Danish: Patienterne skal instrueres i:
English: In addition, seropositivity for neutralizing anti-AUX-I and anti-AUX-II antibodies was maintained.
Danish: Desuden var seropositiviteten for neutraliserende anti-AUX-I- og anti-AUX-II-antistoffer opretholdt.
English: The reduction of the curve achieved will vary between individuals.
Danish: Den opnåede mindre krumning vil være forskellig fra person til person.
English: The injection procedure is detailed in the package leaflet and the physician training material and must be followed.
Danish: Injektionsproceduren er beskrevet i indlægssedlen og lægens træningsmateriale, og den skal følges.
English: IIEF erectile function**
Danish: IIEF erektil funktion **
English: Total FFC (°)
Danish: I alt FFC (°)
English: There were no changes in the international index of erectile function (IIEF) scores.
Danish: Der var ingen ændringer i scores for det internationale indeks for erektil funktion funktion (IIEF).
English: Greater patient satisfaction was correlated with improved range of motion (r=0.51, p<0.001).
Danish: Større patienttilfredshed var korreleret med forbedret ledbevægelighed (r=0,51, p<0,001).
English: Together, these collagenases work to provide broad hydrolytic activity towards collagen.
Danish: Disse kollagenaser arbejder tilsammen på at give en bred hydrolytisk aktivitet over for kollagen.
English: A total of 189 patients were enrolled and treated with Xiapex.
Danish: I alt 189 patienter blev inkluderet og behandlet med Xiapex.
English: Injection procedure
Danish: Injektionsprocedure
English: The figures 1 and 2 below are for illustrative purposes only and may not be representative of the precise location of anatomical structures in an individual patient.
Danish: Figur 1 og 2 neden for er kun til illustration og viser ikke nødvendigvis det præcise sted på anatomiske strukturer hos enkeltpatienter.
English: The maximal individual plasma concentrations of AUX-I and AUX-II were <29 ng/mL and <71 ng/mL, respectively.
Danish: De maksimale individuelle plasmakoncentrationer af AUX-I og AUX-II var hhv. <29 ng/ml og <71 ng/ml.
English: The duration of assessment ended at the last available measurement or at the day of medical intervention for joints that did not recur and the recurrence day for recurrent joints.
Danish: Varigheden af vurderingen ophørte ved den sidste tilgængelige måling, eller på dagen for medicinsk intervention for led, hvor der ikke var recidiv, og recidivdagen for led med recidiv.
English: Hold the penis in this more straightened position for 30 seconds, then let go.
Danish: Hold penis i denne mere udrettede position i 30 sekunder og giv så slip.
English: Repeat steps 1 through 8.
Danish: Gentag trin 1 til og med
English: TREATED PRIMARY JOINTS
Danish: BEHANDLEDE PRIMÆRE LED
English: The duration of assessment started at the day of success (visit after the last injection where the 0° to 5° measurement was first recorded).
Danish: Varigheden af vurderingen startede på dagen for succes (besøg efter den sidste injektion, hvor 0-5°-målingen først blev registreret).
English: • cold intolerance of the treated fingers
Danish: • kuldeintoleranse i de behandlede fingre
English: Total ROM (°)
Danish: I alt ROM (°)
English: • Let go of the tip of your penis and let your penis return to its normal length.
Danish: • Slip spidsen af penis og lad penis nå tilbage til sin normale længde.
English: All plasma levels were below the limits of quantification within 30 minutes following dosing.
Danish: Alle plasmaniveauer var under kvantificeringsgrænsen inden for 30 minutter efter administration.
English: Erectile dysfunction was reported in 52.9% of patients, and 27.5% reported previous trauma to penis.
Danish: Der blev indberettet erektil dysfunktion hos 52,9 % af patienterne, og 27,5 % indberettede tidligere traume på penis.
English: For each injection, follow steps 4-10.
Danish: For hver injektion gås gennem trin 4-10.
English: Identification of treatment area a) Prior to each treatment cycle, identify the treatment area as follows:
Danish: Identifikation af behandlingsområdet a) Før hver behandlingscyklus skal behandlingsområdet identificeres på følgende måde:
English: This is a disease that causes your finger(s) to bend inward.
Danish: Dette er en sygdom, som får Deres finger(re) til at krumme indad.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, or embryonal/foetal development, (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår fertilitet, graviditet eller embryonisk/føtal udvikling (se pkt.
English: Treatment of two concurrent injections
Danish: Behandling af to samtidige injektioner
English: For patients with an increased risk of fracture, e.g. patients with osteopenia/osteoporosis, special caution is needed during the manipulation procedure.
Danish: For patienter med en øget risiko for fraktur, f.eks. patienter med osteopeni/osteoporose, er det nødvendigt at udvise særlig forsigtighed i løbet af manipulationsindgrebet.
English: If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if the physician determines that further treatment is not clinically indicated, then the subsequent treatment cycles should not be administered.
Danish: Hvis krumningen er under 15 grader efter den første, anden eller tredje behandlingscyklus, eller hvis lægen vurderer, at yderligere behandling ikke er klinisk indiceret, skal de efterfølgende behandlingscyklusser ikke administreres.
English: The total volume of the injection depends on the joint being treated.
Danish: Det totale volumen af injektionen afhænger af det led, som skal behandles.
English: c The nominal rate of recurrence was the total number of recurrences occurring prior to the last day of the interval divided by the total number of joints (×100).
Danish: c Den nominelle recidivrate var det totale antal recidiv, der opstod før den sidste dag i intervallet, divideret med det totale antal led (×100).
English: It is recommended to avoid strenuous activities of your finger until instructed further by your doctor.
Danish: Det tilrådes at undgå anstrengende aktiviteter med Deres finger indtil De er yderligere vejledt af Deres læge.
English: Patients develop ADAs after repeated administration, the cross-reactivity of which versus endogenous MMPs involved in pregnancy and labour cannot be excluded.
Danish: Patienter udvikler ADA efter gentagen administration, krydsreaktiviteten af den versus endogent MMPs involveret i graviditet og fødsel kan ikke udelukkes.
English: Be sure to ask your doctor when you can resume normal activities after treatment with Xiapex.
Danish: Sørg endelig for at spørge Deres læge om, hvornår De kan begynde normale aktiviteter igen efter behandling med Xiapex.
English: • if you have had an allergic reaction to a previous Xiapex injection.
Danish: • hvis De tidligere har haft en allergisk reaktion på en Xiapex-injektion.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De får dette lægemiddel.
English: The following side effects have been seen with Xiapex:
Danish: Følgende bivirkninger er blevet observeret med Xiapex:
English: b p-value < 0.05.
Danish: b p-værdi <0,05.
English: For many people, a contracture causes significant difficulties with performing everyday tasks like driving, shaking hands, playing sports, opening jars, typing or holding objects.
Danish: For mange mennesker medfører en kontraktur betydelige vanskeligheder med at udføre daglige opgaver som at køre, give hånd, udføre sport, åbne glas/dåser, skrive på tastatur eller holde på genstande.
English: Age category (years), n (%)
Danish: Alderskategori (år), n (%)
English: If more than one plaque is present, only the plaque causing the curvature deformity should be injected.
Danish: Hvis der findes mere end én plaque, skal kun den plaque, der forårsager deformiteten, injiceres.
English: The mean age was 63 years (range 33 to 89 years) and 80% of patients were male.
Danish: Gennemsnitsalderen var 63 år (interval fra 33 til 89 år), og 80 % af patienterne var mænd.
English: These differences account for the ability of the two classes of enzymes to digest collagen in a complementary manner.
Danish: Disse forskellige egenskaber forklarer de to enzymklassers evne til at spalte kollagen på en komplementær måde.
English: The goal is always to deposit the full dose entirely within the plaque.
Danish: Målet er altid at afsætte hele dosis i plaquen.
English: Solvent required for reconstitution
Danish: Solvens nødvendig til rekonstitution
English: Volumes needed for administration
Danish: Voluminer nødvendige til administration Behandlingsområde
English: Your doctor will perform all injections of Xiapex.
Danish: Deres læge vil give alle injektionerne af Xiapex.
English: Call your doctor right away if you have any of these symptoms of an allergic reaction after an injection of Xiapex:
Danish: Kontakt straks Deres læge, hvis De får nogle af disse symptomer på en allergisk reaktion efter injektion af Xiapex:
English: The median duration of disease was 4.9 years (range 2.0 to 27.9 years).
Danish: Den mediane sygdomsvarighed var 4,9 år (i intervallet fra 2,0 til 27,9 år).
English: Your doctor will take care of storing, handling and disposing of Xiapex.
Danish: Deres læge vil sørge for opbevaring, håndtering og bortskaffelse ad Xiapex.
English: Your doctor will carefully select an area where the collagen cord is best accessible and will proceed with the injection into the cord.
Danish: Deres læge vil omhyggeligt udvælge et område, hvor kollagenstrengen er lettest tilgængelig og vil give injektionen ind i strengen.
English: Pharmacotherapeutic group: Other Drugs For Disorders of the Musculo-Skeletal System-Enzymes, ATC code: M09AB02
Danish: Farmakoterapeutisk klassifikation: Andre lægemidler mod sygdomme i det muskuloskeletale system enzymer, ATC-kode: M09AB02
English: Peyronie's disease occurs exclusively in adult male patients and hence there is no relevant information for use in females.
Danish: Peyronies sygdom forekommer udelukkende hos voksne mænd, og der er derfor ingen relevant information om brugen hos kvinder.
English: • Reminder of the need to report adverse events, including medication errors.
Danish: • Påmindelse om kravet om rapportering af bivirkninger herunder medicineringsfejl.
English: • Your doctor will show you how to gently stretch and straighten your penis the right way.
Danish: • Deres læge vil vise Dem, hvordan De forsigtigt strækker Deres penis og retter den ud på den korrekte måde.
English: f) Insert and advance the needle transversely through the width of the plaque, towards the opposite side of the plaque without passing completely through it.
Danish: f) Indsæt og før kanylen tværs gennem plaquens bredde mod den modsatte side af plaquen, uden at stikke helt igennem den.
English: • Mark the point with a surgical marker.
Danish: • Marker punktet med en kirurgisk tusch.
English: After treatment with Xiapex, one of these tubes may break during an erection.
Danish: Efter behandling med Xiapex kan et af disse rør gå i stykker under en erektion.
English: For patients who achieved a contracture of the selected joint to 5° or less, the mean number of injections required to achieve this was 1.5 in the 2 studies.
Danish: Hos de patienter, som opnåede en kontraktur på ≤5° i det udvalgte led, var det gennemsnitlige antal nødvendige injektioner for at opnå dette 1,5 i de 2 studier.
English: The plaque may interfere with the ability to get a straight erection because the plaque will not stretch as much as the rest of the penis.
Danish: Plaquen kan påvirke evnen til at opnå en lige rejsning, da plaquen ikke vil strække sig så meget som resten af penis.
English: No patients had quantifiable plasma levels 15 minutes after modelling of plaque on Day 3 (i.e., 24 hours after Injection 2 on Day 2).
Danish: Ingen patienter havde kvantificerbare plasmaniveauer 15 minutter efter remodellering af plaque på dag 3 (dvs. 24 timer efter injektion 2 på dag 2).
English: The solvent is a clear colourless solution.
Danish: Solvens er en klar farveløs opløsning.
English: Injection procedure a) The reconstituted Xiapex solution should be clear.
Danish: Injektionsprocedure a) Den rekonstituerede Xiapex-injektionsvæske skal være klar.
English: All patients had participated in and completed the studies AUX-CC-803 or AUX-CC-804, in which they had received placebo.
Danish: Alle patienterne havde deltaget i og gennemført studie AUX-CC-803 eller AUX-CC-804, hvor de havde fået placebo.
English: The CHMP recommends that the terms of the Marketing Authorisation should be varied.
Danish: CHMP anbefaler, at betingelserne for markedsføringstilladelsen/-tilladelserne ændres.
English: The signs and symptoms of Peyronie's disease are caused by a collagen plaque.
Danish: Tegn og symptomer på Peyronies sygdom forårsages af en kollagenplaque.
English: No dose adjustment is necessary in any special patient groups e.g., Elderly, Renally or Hepatically Impaired, by Gender or Race.
Danish: Dosisjustering er ikke nødvendig hos nogen særlige patientgrupper f.eks. ældre, ved nedsat nyre- eller leverfunktion, efter køn eller race.
English: Severe allergic reaction has been reported uncommonly (1 case).
Danish: Der er ikke almindeligt (1 tilfælde) blevet rapporteret en alvorlig allergisk reaktion.
English: Data on the long-term recurrence rates following successful treatment with Xiapex are provided in Table 7.
Danish: Data for langtidsrecidivrater efter vellykket behandling med XIAPEX gives i tabel 7.
English: In the unlikely event that your doctor administers a higher dose than recommended, you may experience an increase in the severity of possible side effects listed in section 4 “Possible Side Effects”.
Danish: Skulle det usandsynlige ske, at Deres læge indgiver en højere dosis end anbefalet, kan De opleve, en øget hyppighed af bivirkningerne anført i afsnit 4 ”Bivirkninger”.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE sight and REACH OF CHILDREN
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Peyronie's disease This condition does not occur in females.
Danish: Peyronies sygdom Denne sygdom forekommer ikke hos kvinder.
English: • worsening of Peyronie's disease
Danish: • forværring af Peyronies sygdom
English: AUX-I and AUX-II are single polypeptide chains consisting of approximately 1000 amino acids of known sequence with a molecular weight of 114 kDa and 113 kDa respectively as determined by mass spectrometry.
Danish: AUX-I og AUX-II er enkeltstrengede polypeptidkæder, som består af ca. 1000 aminosyrer med defineret sekvens med en molekylevægt på henholdsvis 114 kDa og 113 kDa bestemt ved massespektrofotometri.
English: • Gently pull your penis away from your body to its full length and hold the stretch for
Danish: • Træk forsigtigt Deres penis væk fra kroppen, til den når sin fulde længde, og hold strækket i
English: As with any non-human protein medicinal product, patients may develop antibodies to the therapeutic protein.
Danish: Ved behandling med alle lægemidler bestående af et fremmed protein kan patienterne udvikle antistoffer mod det terapeutiske protein.
English: You must not be given Xiapex if you know that you have had a serious allergic reaction to collagenase or any of the other ingredients.
Danish: De må ikke få en injektion med Xiapex, hvis De ved, at De har haft en alvorlig overfølsomhedsreaktion over for kollagenase eller nogen af de andre indholdsstoffer.
English: No safety concerns related to the inhibition of endogenous MMPs have been observed, in particular no adverse events indicating the development or exacerbation of autoimmune diseases or the development of a musculoskeletal syndrome (MSS).
Danish: Ingen sikkerhedsmæssige problemer relateret til hæmningen af endogent MMPs er blevet observeret, i særdeleshed ingen bivirkninger som indikerer udvikling eller forværring af autoimmune sygdomme eller udvikling af et muskuloskeletalt syndrom (MSS).
English: 1 Not used to calculate physician rating of severity at baseline percentage-actual denominator of N=247 used.
Danish: 1 Ikke anvendt til at beregne lægens vurdering af sværhedsgrad af sygdommen ved baseline i procent-aktuel fællesnævner på N=247 er anvendt.
English: This indicates the target area in the plaque for Xiapex deposition
Danish: Dette indikerer målområdet i plaquen for Xiapexinjektionen
English: For each subject in whom a Week 12 sample was selected, the corresponding Week 6, 18, 24, and 52 samples were assayed if they were also binding antibody positive.
Danish: For hver forsøgsperson, hvor der blev udtaget en uge 12-prøve, blev de tilsvarende prøver for uge 6, 18, 24 og 52 undersøgt, om de også var positive for bindende antistof.
English: Your doctor will tell you when to come back for this.
Danish: Deres læge vil fortælle Dem, hvornår De skal møde til det.
English: All p-values < 0.001 for all comparisons between Xiapex and placebo, except for PIP joints in Study CORD II which was not eligible for statistical testing due to a hierarchical testing procedure.
Danish: Alle p-værdier <0,001 for alle sammenligninger mellem Xiapex og placebo, med undtagelse af PIP led i CORD II studiet som ikke var brugbare til statistisk analyse som følge af en rangordnet testprocedure.
English: If the needle is in the proper location, there will be some resistance noted during the injection procedure.
Danish: Hvis kanylen er korrekt placeret, kan man mærke en vis modstand under injektionsproceduren.
English: The solvent that is used to dissolve the powder is a clear colourless liquid.
Danish: Den solvens, som skal bruges til at opløse pulveret, er en klar, farveløs væske.
English: No new safety signals were identified among subjects who were followed for 5 years after their initial injection of Xiapex in a previous clinical study.
Danish: Der blev ikke identificeret nogen nye sikkerhedssignaler blandt forsøgspersoner, der blev fulgt i 5 år efter deres første injektion af Xiapex i et tidligere klinisk studie.
English: Collagenases are proteinases that hydrolyze collagen under physiological conditions.
Danish: Kollagenaser er proteinaser, som hydrolyserer kollagen under fysiologiske forhold.
English: Cases of digital phalangeal fractures have been reported after finger manipulation procedure.
Danish: Tilfælde af digitale falangeale frakturer er blevet rapporteret efter manipulationen.