FrancophonIA/ELRC3.0 huggingface dataset:
English: • a small collection of blood under the skin at the injection site
Danish: • en lille ansamling af blod under huden på injektionsstedet
English: Incorrect injection into tendons, nerves or blood vessels may result in bleeding or damage and possible permanent injury to these structures.
Danish: Forkert injektion i sener, nerver eller blodkar kan føre til blødning eller skade og mulig permanent skade på disse strukturer.
English: Before finger manipulation procedure will be performed tell your doctor, if you have a condition affecting your bones, e.g. osteopenia or osteoporosis.
Danish: Før fingermanipulationen vil blive udført, skal du fortælle det til lægen, hvis du har en sygdom, der påvirker dine knogler, f.eks. osteopeni eller osteoporose.
English: If you are treated for Peyronie's disease
Danish: Hvis De behandles for Peyronies sygdom
English: Men with Peyronie's disease may have an erection that is curved or bent.
Danish: Mænd med Peyronies sygdom kan have en erektion, der er krummet eller bøjet.
English: Demographic and baseline characteristics Phase 3 Double-Blind, Placebo controlled studies (CORD I, CORD II)
Danish: Demografiske og baseline karakteristika Fase 3 dobbeltblinde, placebokontrollerede studier (CORD I, CORD II)
English: j) The second injection of each treatment cycle should be made approximately 2 to 3 mm apart from the first injection.
Danish: j) Den 2. injektion i hver behandlingscyklus bør foretages ca. 2 til 3 mm fra den første injektion.
English: The clinical efficacy in study AUX-CC-862 was similar to that reported in studies CORD I and CORD II.
Danish: Den kliniske virkning i studie AUX-CC-862 var sammenlignelig med, hvad der blev rapporteret i studie CORD I og CORD II.
English: 0.25 ml †Note that injection volume for delivery of a 0.58 mg dose is less than the total volume of solvent used for reconstitution.
Danish: 0,25 ml †Bemærk at injektionsvoluminet for at give en 0,58 mg dosis er mindre end det totale solvensvolumen, der blev anvendt til rekonstitution.
English: In these studies, patients were given up to 4 treatment cycles of Xiapex or placebo (weeks 0, 6, 12, 18), and were followed in a non-treatment follow-up period (weeks 24-52).
Danish: I disse studier fik patienterne op til 4 behandlingscyklusser med Xiapex eller placebo (uge 0, 6, 12, 18), og de blev fulgt i en opfølgningsperiode uden behandling (uge 24-52).
English: After the injection, your doctor will place a dressing on your hand.
Danish: Efter injektionen vil Deres læge sætte en forbinding på hånden.
English: The potential for a serious allergic reaction or the development of a musculoskeletal syndrome upon repeated use of Xiapex cannot be excluded.
Danish: Risikoen for en alvorlig allergisk reaktion eller udvikling af et syndrom i bevægeapparatet ved gentagen brug af Xiapex kan ikke udelukkes.
English: Whilst there is no clinical evidence from the current safety data of a musculoskeletal syndrome developing following the administration of Xiapex, the potential for it to occur cannot be excluded.
Danish: Mens der ikke er nogen klinisk evidens fra indeværende sikkerhedsdata for udvikling af et muskuloskeletalt syndrom efter administration af Xiapex, kan potentialet for at det forekommer, ikke udelukkes.
English: Improvement was observed regardless of joint type or finger involvement (range: 60.5% to 83.9%).
Danish: Der blev observeret forbedring uanset ledtype eller fingerinvolvering (interval: 60,5 % til 83,9 %).
English: This bending is called a contracture and is caused by the abnormal formation of a cord containing collagen under your skin.
Danish: Denne krumning kaldes en kontraktur og skyldes unormal dannelse af en streng, som indeholder kollagen, under huden.
English: The two polypeptides are purified by chromatographic steps customary for the separation and isolation of biotherapeutic proteins to yield a consistent, well characterized and controlled mixture of two collagenase enzymes.
Danish: De to polypeptider er oprenset ved kromatografiske trinvise forløb, som er almindelige ved separation og isolering af bioterapeutiske proteiner for at give en konsistent, veldefineret og kontrolleret blanding af de to kollagenaseenzymer.
English: Clinically meaningful improvement in hand function as determined by the URAM (Unite´ Rhumatologique des Affections de la Main) score was observed at Day 31 (-11.3) and Day 61 (-12.3).
Danish: Klinisk meningsfyldt forbedring af håndfunktionen, bestemt via URAM-score (Unité Rhumatologique des Affections de la Main) blev observeret ved dag 31 (-11.3) og dag 61 (-12.3).
English: The section 4.8 of the SmPC is updated to include the adverse reactions “digital necrosis” and “digital fracture” with a frequency “not known”.
Danish: 4.8 i produktresuméet er blevet opdateret, så bivirkningerne “digital nekrose” og ”digital fraktur” er blevet inkluderet med hyppigheden ”ikke kendt”.
English: Table 13: Long Term Efficacy variables - study AUX-CC-810 Baselinea
Danish: Tabel 13: Langvarige virkningsvariable - studie AUX-CC-810
English: Long-term efficacy and safety
Danish: Langvarig virkning og sikkerhed
English: The powder is a white lyophilised powder.
Danish: Pulveret er et hvidt frysetørret pulver.
English: • Information on the potential risk of matrix metalloproteinases (MMP) cross reactivity including the development of musculoskeletal syndrome and exacerbation/initiation of autoimmune disorders.
Danish: • Information vedrørende den potentielle risiko for matriks-metalloproteinase (MMP) krydsreaktion herunder udvikling af muskuloskeletalt syndrom og forværring/initiering af autoimmune sygdomme.
English: Routine supportive care and symptomatic treatment must be provided in the case of overdose.
Danish: I tilfælde af overdosering gives rutinemæssig understøttende pleje og symptomatisk behandling.
English: • if you have a history of problems with the normal clotting of your blood or if you are taking any medicines to help control the normal clotting of your blood (known as anticoagulation medicines).
Danish: • hvis De tidligere har haft problemer med normal størkning af blodet, eller hvis De tager nogen medicin, som hjælper med at kontrollere den normale størkning af blodet (kendt som blodfortyndende medicin).
English: If you experience dizziness, numbness or altered sensation, and headache immediately after an injection of Xiapex you must avoid potentially hazardous tasks such as driving or using machines until these effects have passed or until advised by your doctor.
Danish: Hvis De oplever svimmelhed, følelsesløshed eller ændret følesans og hovedpine umiddelbart efter en injektion med Xiapex, skal De undgå potentielt risikable opgaver såsom at føre motorkøretøj eller betjene maskiner, indtil disse virkninger er gået væk, eller indtil det er tilrådet af Deres læge.
English: Hydrochloric acid 2.4% w/w (for pH adjustment)
Danish: Saltsyre 2,4 % w/w (til pH justering)
English: Blood blistera Blister
Danish: Blodige blistera Blister
English: At study entry, patients must have had penile curvature deformity of at least 30 degrees in the stable phase of Peyronie's disease.
Danish: Ved studieinklusion skulle patienterne have en krumning på mindst 30 grader i den stabile fase af Peyronies sygdom.
English: With your non-dominant hand, secure the patient's hand to be treated while simultaneously applying tension to the cord.
Danish: Med Deres ikke-dominante hånd sikres den hånd, som patienten skal have behandlet, samtidig med at der føles på strengen.
English: An improvement from baseline was also seen in range of motion at Day 31 for all the treated joint pair subgroups, see Table 6.
Danish: Der blev også observeret en forbedring fra baseline i ledbevægelighed ved dag 31 for alle de behandlede undergrupper af ledpar, se tabel 6.
English: Most patients experiencing tendon/ligament rupture or injury have gone on to have successful surgical repair.
Danish: De fleste patienter, der oplevede sene/ligamentruptur eller skade, har efterfølgende gennemgået vellykket kirurgi.
English: • Not perform strenuous activity with the injected hand until advised to do so.
Danish: • Ikke at udføre anstrengende aktiviteter med den injicerede hånd, indtil det tilrådes.
English: The recurrence day was the visit where the recurrence was reported or the day of intervention if a joint was treated for a worsening Dupuytren's contracture.
Danish: Recidivdagen var det besøg, hvor recidivet blev rapporteret, eller interventionsdagen, hvis et led blev behandlet for forværret Dupuytrens kontraktur.
English: One exception is the use of up to 150 mg daily dose of acetylsalicylic acid (a substance present in many medicines used to prevent blood clotting) which can be taken.
Danish: En undtagelse er brugen af acetylsalicylsyre op til 150 mg daglig (et stof, som er i meget medicin, som bruges til at forebygge blodpropper), som kan anvendes.
English: Severe allergic reactions can happen in patients who receive Xiapex, because it contains proteins foreign to the human body.
Danish: Der kan opstå svære allergiske reaktioner hos patienter, der får Xiapex, da det indeholder proteiner, som menneskekroppen ser som fremmedlegemer.
English: This includes medicines to help control the normal clotting of your blood (known as anticoagulation medicines), anthraquinone derivatives, some antibiotics (tetracyclines and anthracyclines/anthraquinolones) used to treat infections.
Danish: Dette omfatter medicin som hjælper med at kontrollere den normale størkning af Deres blod (kendt som blodfortyndende medicin), antrakinonderivater, nogle typer antibiotika (tetracykliner og antracykliner/antrakinolon) anvendes til behandling af infektioner.
English: Both classes of collagenases readily hydrolyze gelatin (denatured collagen) and small collagen peptides, whereas Class II has higher affinity for small collagen fragments.
Danish: Begge klasser af kollagenaser hydrolyserer hurtigt gelatine (denatureret kollagen) og små kollagenpeptider, hvorimod Klasse II har højere affinitet for små kollagenfragmenter.
English: Contact your doctor right away if you are concerned by increasing pain or symptoms in the fingers after the treatment.
Danish: Kontakt straks lægen, hvis du er bekymret over flere smerter eller symptomer i fingrene efter behandlingen.
English: If you are treated for Dupuytren's contracture
Danish: Hvis De behandles for Dupuytrens kontraktur
English: • painful/increased urination
Danish: • smertefuld/øget vandladning
English: N (%) of Joints in Each Intervala
Danish: N (%) led i hvert intervala
English: Mean increase in range of motion from baseline (Last injection)
Danish: Gennemsnitlig stigning af ledbevægelighed fra baseline (Sidste injektion)
English: Patients were excluded if they had a ventral curvature deformity, an isolated hourglass deformity or a calcified plaque that could have interfered with the injection technique.
Danish: Patienterne blev ekskluderet, hvis de havde en ventral krumning, en isoleret timeglasdeformitet eller en forkalket plaque, der kunne have påvirket injektionsteknikken.
English: Administration of Xiapex at greater than recommended doses is expected to be associated with increased local reactions at the site of injection.
Danish: Administration af Xiapex i doser højere end de anbefalede forventes at være forbundet med øgede lokalreaktioner på injektionsstedet.
English: For joints reported as recurring in a previous study, the day of recurrence was the first visit with a fixed flexion contracture measurement of 20° or greater following the report of recurrence.
Danish: For led, der blev rapporteret som at have recidiv i et tidligere studie, var dagen for recidiv det første besøg med en fikseret fleksionskontrakturmåling på 20° eller derover efter rapportering af recidiv.
English: Almost all patients had positive titers for anti-AUX-I antibodies (97.9%) and anti-AUX-II antibodies (97.5%) 60 days post two concurrent injections.
Danish: Næsten alle patienter havde positive titre mod anti-AUX-I-antistoffer (97,9 %) og anti-AUX-II-antistoffer (97,5 %) 60 dage efter to på hinanden følgende injektioner.
English: You will be given Xiapex as an injection directly into the area that is causing your finger/penis to bend (intralesional injection).
Danish: De vil få Xiapex som en injektion direkte i det område, der får Deres finger/penis til at bøje sig (intralæsional injektion).
English: • difficulty urinating or blood in the urine
Danish: • vandladningsbesvær eller blod i urinen
English: Talk to your doctor or pharmacist before you are given Xiapex.
Danish: Kontakt lægen eller apotekspersonalet, før De får Xiapex.
English: As an exploratory analysis, female sexual partners completed two questionnaires at both the screening visit and week 36: the PDQ for Female Sexual Partners (an adaptation of Peyronie's disease bother and psychological symptom domains of the PDQ for men, scoring from 0-12) and the Female Sexual Function Index (FSFI, scale from 2-36, where a higher score represents better sexual functioning).
Danish: Som en eksploratorisk analyse udfyldte de kvindelige seksualpartnere to spørgeskemaer, både ved screeningsbesøget og ved uge 36: PDQ for kvindelige seksualpartnere (en adaptering af domænerne for besvær og psykologiske symptomer af PDQ for mænd, med en scoring fra 0-12 for Peyronies sygdom) og indekset over kvindelig seksualfunktion (Female Sexual Function Index, FSFI, skala fra 2-36, hvor en højere score repræsenterer en bedre seksualfunktion).
English: Each injection contains a 0.58 mg dose.
Danish: Hver injektion indeholder en 0,58 mg dosis.
English: This medicine must only be injected into the collagen cord in your hand by your doctor.
Danish: Dette lægemiddel må kun injiceres i kollagenstrengen i Deres hånd af lægen.
English: The median age was 58 years (range 23 to 84 years).
Danish: Medianalderen var 58 år (interval fra 23 til 84 år).
English: Each treatment cycle consists of two Xiapex injections and one penile modelling procedure.
Danish: Hver behandlingscyklus består af to Xiapex-injektioner og en procedure for remodellering af penis.
English: Improvement of the total fixed flexion contracture was also observed irrespectively of the time of finger extension, 24, 48 or 72 hours after injection, with a mean improvement at Day 31 of 75.2% 74.8% and 72.4% respectively.
Danish: Forbedringen af den totale fikserede fleksionskontraktur blev også observeret uanset tidspunktet for fingermanipuleringen, 24, 48 eller 72 timer efter injektionen, med en gennemsnitlig forbedring ved dag 31 på hhv. 75,2 % 74,8 % og 72,4 %.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: Pre-existing reduced peripheral circulation, e.g. Raynaud syndrome, and the use of epinephrine combined with local anaesthetics in these patients may contribute to this (see also section 4.8).
Danish: Præeksisterende nedsat perifert kredsløb, f.eks. Raynauds syndrome, og anvendelsen af adrenalin kombineret med lokalanæstetika hos disse patienter kan bidrage til dette (se også pkt.
English: Early diagnosis and prompt evaluation and treatment are important because tendon rupture/ligament injury may potentially affect overall hand function.
Danish: Tidlig diagnose og prompte evaluering og behandling er vigtigt, da seneruptur/ligamentskade kan påvirke håndens overordnede funktion.
English: The second Xiapex injection is administered 1 to 3 days after the first injection.
Danish: Den anden Xiapex-injektion skal administreres 1 til 3 dage efter den første injektion.
English: • if you are currently taking any anticoagulation medicines, you must not receive Xiapex within 7 days of last dose of your anticoagulation medicine.
Danish: • hvis De samtidig tager blodfortyndende medicin, må De ikke få Xiapex inden for 7 dage efter sidste dosis af Deres blodfortyndende medicin.
English: • If you are allergic to collagenase clostridium histolyticum or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for kollagenase clostridium histolyticum eller et af de øvrige indholdsstoffer i Xiapex (angivet i afsnit 6).
English: Percentage of patients who achieved reduction in contracture to 5° or less (Last injection)
Danish: Procentdel af patienter, som fik kontrakturen reduceret til ≤5° (Sidste injektion)
English: In each treatment cycle, you will receive one injection of Xiapex, followed by a second injection on a separate day (1 to 3 days later).
Danish: I hver behandlingscyklus vil De få en injektion med Xiapex efterfulgt af endnu en injektion på en anden dag (1 til 3 dage senere).
English: It is not known whether collagenase clostridium histolyticum is excreted in human milk.
Danish: Det er ukendt, om kollagenase clostridium histolyticum udskilles i human mælk.
English: After confirming that the needle is correctly placed in the cord, inject approximately one-third of the dose.
Danish: Efter at have bekræftet at kanylen er korrekt placeret ind i strengen injiceres ca. en tredjedel af dosen.
English: b p-value < 0.01
Danish: b p-værdi <0,01
English: Blood glucose increased Blood pressure systolic increased
Danish: Forhøjet glucose i blodet Forhøjet systolisk blodtryk Forhøjet legemstemperatur
English: The adverse reaction profile was similar after each injection, regardless of the number of injections administered.
Danish: Bivirkningsprofilen var den samme efter hver injektion uanset antallet af administrerede injektioner.
English: Peyronie's disease: The treatment area should be identified and marked with a surgical marker on the erected penis.
Danish: Peyronies sygdom: Behandlingsområdet skal identificeres og markeres med en kirurgisk tusch på den erigerede penis.
English: Sodium injected per plaque in the treatment of Peyronie's disease: 0.9 mg.
Danish: Natrium injiceret pr. plaque ved behandling af Peyronies sygdom: 0,9 mg.
English: • fractured finger • loss of finger or finger parts
Danish: • brækket finger • mistede dele af eller hele fingeren
English: • For Peyronie's disease if the treatment of your plaque involves the tube (called the urethra) that your urine passes through.
Danish: • ved Peyronies sygdom, hvis behandlingen af Deres plaque omfatter urinrøret (kaldet ureter, det rør, som urinen passerer igennem).
English: Through the 5 year follow up period (Table 13), subjects demonstrated an improvement in penile curvature and in PDQ bother compared with the last observed value from the previous phase 3 studies.
Danish: Til og med de 5 års opfølgningsperiode (tabel 13) viste forsøgspersonerne en forbedring i peniskrumning og i PDQ-besvær, sammenlignet med den sidste observerede værdi fra de tidligere fase 3-studier.
English: • Proper amount of volumes for both reconstitution and injection differences in the metocarpophalangeal (MP) and proximal interphalangeal (PIP) joints for Dupuytren's contracture and for the Peyronie's disease plaque.
Danish: • Korrekt volumen til både rekonstitution og injektion og forskelle for metocarpofalangeale (MP) og proksimale interfalangeale (PIP) led for Dupuytrens kontraktur og for plaques for Peyronies sygdom.
English: Treatment of Peyronie's plaques that involve the penile urethra due to potential risk to this structure.
Danish: Behandling af Peyronies plaques, der omfatter penisureter, på grund af en mulig risiko for denne struktur.
English: Identification of treatment area
Danish: Identifikation af behandlingsområdet
English: Pregnancy and fertility
Danish: Graviditet og fertilitet
English: The recommended dose of your prescribed medicine is 0.58 mg.
Danish: Den anbefalede dosis af Deres ordinerede medicin er 0,58 mg.
English: Neutralizing antibodies to AUX-I or AUX-II, were detected in 60% and 51.8%, respectively, of patients tested.
Danish: Neutraliserende antistoffer mod AUX-I eller AUX-II blev detekteret hos hhv. 60 % og 51,8 % af de testede patienter.
English: Since the enzymes in Xiapex have some sequence homology with human matrix metalloproteinases (MMPs), anti-drug antibodies (ADA) could theoretically interfere with human MMPs.
Danish: Eftersom nogle sekvenser i Xiapex enzymerne er de samme som for dem der ses ved human matrix metalloproteinaser (MMPs), kunne antidrug antistoffer (ADA) teoretisk interferere med human MMP.
English: Following extension of your finger, your doctor will fit you with a splint to wear at bedtime for up to 4 months.
Danish: Efter udstrækning af Deres finger vil lægen give Dem en skinne, som skal tages på ved sengetid i op til 4 måneder.
English: Neutralizing antibodies were assayed for a subset of 70 samples selected to be representative of high and low titer binding antibody responses at week 12 of treatment.
Danish: Neutraliserende antistoffer blev undersøgt i en undergruppe med 70 prøver, der blev udvalgt som repræsentative for høj- og lavtiter bindende antistofrespons ved 12. behandlingsuge.
English: After treatment with Xiapex, blood vessels in your penis may also break, causing blood to collect under the skin (which is called a haematoma).
Danish: Efter behandlingen med Xiapex kan blodkarrene i Deres penis også gå i stykker og forårsage en ansamling af blod under huden (hvilket kaldes en hæmatom).
English: The mean (SD) FSFI score was 20.56 (10.08) at baseline and 26.72 (7.73) at week 36, a change from baseline of 7.54.
Danish: Den gennemsnitlige (SD) FSFI-score var 20,56 (10,08) ved baseline og 26,72 (7,73) ved uge 36, en ændring fra baseline på 7,54.
English: Complex regional pain syndrome Monoplegia Syncope vasovagal Tremor
Danish: Komplekst regionalt smertesyndrom Monoplegi Vasovagal synkope Tremor
English: Taking into account the PRAC Assessment Report on the PSUR(s) for collagenase clostridium histolyticum, the scientific conclusions of the CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for collagenase clostridium histolyticum er CHMP nået frem til følgende videnskabelige konklusioner:
English: Signs or symptoms that may reflect serious injury to the treated finger/hand after injection or manipulation should be promptly evaluated because surgical intervention may be required.
Danish: Tegn eller symptomer, der kan afspejle alvorlig skade på den behandlede finger/hånd efter injektionen eller manipulationen bør evalueres prompte, da det kan være nødvendigt med et kirurgisk indgreb.
English: The safety of more than one treatment course of Xiapex for Peyronie's disease is not known.
Danish: Sikkerheden efter mere end ét behandlingsforløb med Xiapex for Peyronies sygdom er ukendt.
English: Orient the needle so that it enters the plaque from the side, NOT downwards or perpendicularly towards the corpora cavernosum.
Danish: Orienter kanylen, så den stikkes ind i plaquen fra siden, IKKE nedad eller vinkelret mod corpora cavernosum.
English: Time of finger extension after injection had no impact on the rate of clinical success for either MP or PIP joints.
Danish: Tidspunktet for fingermanipulationen efter injektionen påvirkede ikke hyppigheden af klinisk succes for hverken MPeller PIP-led.
English: The Bother domain score is a composite of the following patient-reported items: concern about erection pain, erection appearance, and the impact of Peyronie's disease on intercourse and on frequency of intercourse.
Danish: Score i problem-domænet er sammensat af følgende patientrapporterede dele: bekymringer om erektionssmerter, erektionens udseende og påvirkningen af Peyronies sygdom ved samleje og hyppigheden af samleje.
English: Other endpoints included ≥50% reduction from baseline in degree of contracture, percent change from baseline in degree of contracture, change from baseline in range of motion, subject global assessment of treatment satisfaction and physician global assessment of severity.
Danish: Andre endepunkter omfattede ≥50 % reduktion fra baseline i kontrakturgrad, procentvis ændring fra baseline i kontrakturgrad, ændring fra baseline i bevægeligheden, studiepersonens generelle vurdering af tilfredshed med behandling og lægens generelle vurdering af sværhedsgrad.
English: Abnormal dreams Depression Sexual inhibition
Danish: Unormale drømme Depression Seksuel hæmning