FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have mild heart failure and you are being treated with Kromeya, your heart failure status must be closely monitored by your doctor.
Danish: Hvis du har lettere hjerteinsufficiens og bliver behandlet med Kromeya, skal status for din hjerteinsufficiens følges nøje af din læge.
English: Patients were then re-treated with adalimumab 0.8 mg/kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9% (15 of 19 subjects) and PGA clear or minimal of 52.6% (10 of 19 subjects).
Danish: Patienterne blev herefter genbehandlet med adalimumab 0,8 mg/kg hver anden uge i yderligere 16 uger, og responsraterne, som blev observeret under genbehandlingen, var sammenlignelige med responsraterne i den tidligere dobbeltblinde periode: PASI 75-respons på 78,9% (15 ud af 19 forsøgspersoner) og PGA clear eller minimal på 52,6% (10 ud af 19 forsøgspersoner).
English: If your child has mild heart failure and is being treated with Kromeya, his/her heart failure status must be closely monitored by your doctor.
Danish: Hvis dit barn har lettere hjerteinsufficiens og bliver behandlet med Kromeya, skal status for hans/hendes hjerteinsufficiens følges nøje af din læge.
English: Among patients who were not in response at week 4, 43% of adalimumab maintenance patients responded by week 12 compared to 30% of placebo maintenance patients.
Danish: Blandt de patienter, som ikke havde respons i uge 4, responderede 43 % af patienterne i adalimumab vedligeholdelsesbehandling ved uge 12 sammenlignet med 30 % af patienter i placebogruppen.
English: When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient years.
Danish: Når kontrollerede dele af disse studier og igangværende og afsluttede åbne opfølgningsstudier med en gennemsnitlig varighed på omkring 3,3, inkluderende 6.427 patienter og med over 26.439 patientårs behandling kombineres, er den observerede hyppighed af maligniteter, fraset lymfomer og ikkemelanom hudkræft, cirka 8,5 pr. 1.000 patient-år.
English: Table 15 Efficacy response in placebo-controlled period for study nr-axSpA II
Danish: Tabel 15 Effekt respons i den placebokontrollerede periode af Studie nr-axSpA II
English: • a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;
Danish: • sæklignende udposning på væggen af en større pulsåre (aneurisme), betændelse og blodprop i en blodåre, tilstopning af et blodkar
English: Rates of discontinuation of corticosteroids or immunomodulators are presented in Table 19.
Danish: Rater for seponering af kortikosteroider eller immunmodulerende lægemidler er vist i tabel 19.
English: • lung diseases causing shortness of breath (including inflammation);
Danish: • lungesygdom som forårsager kortåndethed (inklusive inflammation)
English: After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75% relative to baseline), entered period B and received open-label 40 mg adalimumab every other week.
Danish: Efter 16 ugers behandling gik de patienter, der mindst havde opnået et PASI 75-respons (forbedring i PASI-score på mindst 75% i forhold til baseline), over i periode B og fik åben-label 40 mg adalimumab hver anden uge.
English: • Your child might get infections more easily while receiving Kromeya treatment.
Danish: • Dit barn kan lettere få infektioner under behandling med Kromeya.
English: Method and route of administration
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration
Danish: Hypokaliæmi, forhøjet urinsyre, unormal blod-natrium, hypokalcæmi hyperglykæmi, hypofosfatæmi, dehydrering
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Danish: Det primære endepunkt var den procentvise ændring i antallet af led med aktiv artrit (hævelse, som ikke skyldes deformitet, eller led med tab af bevægelse plus smerte og/eller ømhed) fra baseline til uge 12, som blev opnået med et mediant fald på -62,6 % (median procentvise ændring -88,9 %) hos patienter i adalimumab-gruppen sammenlignet med et fald på -11,6 % (median procentvise ændring -50,0 %) hos patienter i placebo-gruppen.
English: • Tell your doctor if your child has lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
Danish: • Fortæl din læge, hvis dit barn har haft fast bopæl eller rejst i områder, hvor svampeinfektioner som histoplasmose, kokcidioidomyse eller blastomykose er almindelige.
English: Record injection and dispose components
Danish: Registrer injektionen og bortskaf alle dele
English: In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Danish: I fase 3-studiet med adalimumab hos patienter med pædiatrisk Crohns sygdom, der evaluerede effekten og sikkerheden af to vedligeholdelsesdosisregimer tilpasset legemsvægt (efter induktionsbehandling tilpasset legemsvægt) i op til 52 ugers behandling, forekom ALAT-stigninger ≥ 3 x ULN hos 2,6% (5/192) af patienterne, hvoraf 4 havde fået samtidig behandling med immunsuppressiva ved baseline.
English: RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
Danish: RA-studie III evaluerede 619 patienter, der var  18 år, med moderat til alvorlig aktiv reumatoid artrit, som havde haft et ikke-effektivt respons på methotrexat i doser på 12,5 til 25 mg eller som var intolerante over for 10 mg methotrexat hver uge.
English: Kromeya is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Danish: Kromeya kan anvendes til behandling af Crohns sygdom hos børn i alderen 6 til 17 år.
English: Kromeya can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Danish: Kromeya kan også anvendes til behandling af alvorlig aktiv og progressiv reumatoid artrit, der ikke tidligere er behandlet med methotrexat.
English: Always take the outer carton of the medicine with you, even if it is empty.
Danish: Tag altid medicinens ydre karton med, også selvom den er tom.
English: Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18% vs. 9% respectively, p=0.031) and study UC-II (17% vs. 9% respectively, p=0.019).
Danish: I forhold til placebo opnåede en statistisk signifikant større procentdel af de patienter, der blev induceret med 160/80 mg adalimumab, klinisk remission i uge 8 (studie UC-I: henholdsvis 18 % og 9%, p=0,031; studie UC-II: henholdsvis 17 % og 9%, p=0,019).
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 16).
Danish: Vurdering af neglepsoriasis inkluderede the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) og the Nail Psoriasis Severity Index (NAPSI) (se tabel 16).
English: Table 27 Time to treatment failure in studies UV I and UV II
Danish: Tabel 27 Tid til behandlingssvigt i studie UV I og UV II
English: Table 22 Time to treatment failure in studies UV I and UV II
Danish: Tabel 22 Tid til behandlingssvigt i studie UV I og UV II
English: Patients treated with Kromeya should be given the patient reminder card.
Danish: Patienter i Kromeya-behandling bør få udleveret et særligt patientkort.
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7%) in the adalimumab-treated women with RA and 5/74 (6.8%) in the untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52) and 16/152 (10.5%) in the adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16).
Danish: Hyppigheden af graviditeter, som blev afsluttet med mindst et levende født spædbarn med en større misdannelse var 6/69 (8,7%) hos de adalimumabbehandlede kvinder med RA og 5/74 (6,8%) hos de ubehandlede kvinder med RA (ukorrigerede OR 1,31; 95% KI 0,38-4,52) og 16/152 (10,5%) hos de adalimumab-behandlede kvinder med CD og 3/32 (9,4%) hos ubehandlede kvinder med CD (ukorrigerede OR 1,14; 95% KI 0,31-4,16).
English: Maintenance of remission and response rates are presented in Table 22.
Danish: Rater for vedligeholdelse af remission- og respons er vist i Tabel 22.
English: 1.6 Place the remaining pre-filled pen(s) in its (their) original box back in the refrigerator (Figure E).
Danish: 1.6 De(n) tilbageværende pen(ne) lægges tilbage i køleskabet i den originale æske (figur E).
English: If your doctor considers that methotrexate is inappropriate, Kromeya can be given alone.
Danish: Hvis din læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan Kromeya anvendes alene.
English: All doses/schedules of adalimumab in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in RA study III the same was seen at week 52.
Danish: Alle doser/skemaer for adalimumab i alle fire studier viste statistisk signifikant større forbedring ifølge HAQ's fysiske funktionsevneindeks fra baseline til 6. måned sammenlignet med placebo, og i RA-studie III blev det samme set efter 52 uger.
English: • After the needle is inserted, release the pinched skin.
Danish: Figur P • Når kanylen er indført, skal du give slip på den sammenklemte hud.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 19).
Danish: Vurdering af neglepsoriasis inkluderede the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) og the Nail Psoriasis Severity Index (NAPSI) (se tabel 19).
English: Choose a different injection site (at least 2.5 centimeters away from the previous injection site) each time to reduce redness, irritation or other skin problems.
Danish: Vælg et nyt sted hver gang (mindst 2,5 cm fra det forrige injektionssted) for at reducere rødme, irritation og andre hudproblemer.
English: Table 19 Ps Study IV efficacy results at 16, 26 and 52 weeks
Danish: Tabel 19 Ps studie IV Effektresultater ved 16, 26 and 52 uger
English: • The liquid is clear, colorless, and free of particles (Figure H).
Danish: • at væsken er klar, farveløs og fri for partikler (figur H).
English: RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Danish: RA-studie II evaluerede 544 patienter, der var  18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel.
English: If he/she develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of his/her feet), you must contact your doctor immediately.
Danish: Hvis han/hun udvikler nye eller får forværrede symptomer på hjerteinsufficiens (f. eks. stakåndethed eller hævede fødder), skal du kontakte din læge øjeblikkeligt.
English: 7.3 When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.
Danish: 7.3 Når affaldsbeholderen til skarpe genstande er næsten fuld, skal du bortskaffe den i henhold til lokale retningslinjer, der beskriver den rigtige måde at bortskaffe en affaldsbeholder til skarpe genstande.
English: Psoriasis study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate and placebo in 271 patients.
Danish: I Psoriasis-studie II (CHAMPION) blev adalimumabs virkning og sikkerhed sammenlignet med methotrexat og placebo hos 271 patienter.
English: The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Danish: Adalimumabs sikkerhed og virkning undersøgt i et randomiseret, dobbeltblindet, kontrolleret studie hos 90 pædiatriske patienter fra 2 til < 18 år med aktiv JIA-associeret non-infektiøs anterior uveitis, som var refraktære overfor mindst 12 ugers behandling med methotrexat.
English: - Your doctor will also give you a patient reminder card, which contains important safety information that you need to be aware of before your child is given Kromeya and during treatment with Kromeya.
Danish: - Din læge vil også udlevere et patientkort, der indeholder vigtige sikkerhedsinformationer, som du skal være opmærksom på før og under dit barns behandling med Kromeya.
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 12).
Danish: I RA-studie V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i modificeret Total Sharp Score (se tabel 12).
English: 5.1 Choose an injection site on:
Danish: 5.1 Vælg et injektionssted:
English: In the pivotal controlled trials in adults and children, 12.9% of patients treated with adalimumab developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2% of patients receiving placebo or active control.
Danish: I de pivotale kontrollerede studier med voksne og børn havde 12,9 % af de patienter, som blev behandlet med adalimumab, reaktioner ved injektionsstedet (erythem og/eller kløe, blødning, smerter eller hævelse) sammenlignet med 7,2 % af de patienter, som fik placebo eller aktiv kontrol.
English: Kromeya 40 mg solution for injection in pre-filled syringe EU/1/19/1357/002
Danish: Kromeya 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte EU/1/19/1357/002
English: Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see Figure 2).
Danish: Begge studier viste en tidlig og vedvarende effekt af adalimumab på tid til behandlingssvigt versus placebo (se figur
English: EXP: MM/YYYY
Danish: EXP: MM/ÅÅÅÅ
English: If your child received Kromeya during her pregnancy, her baby may have a higher risk for getting an infection.
Danish: Hvis dit barn har fået Kromeya, imens hun var gravid, kan hendes spædbarn have en højere risiko for at få en infektion.
English: Tell your doctor if your child is taking azathioprine or mercaptopurine with Kromeya.
Danish: Fortæl din læge, hvis dit barn får lægemidlerne azathioprin eller mercaptopurin sammen med Kromeya.
English: Figure 2: Kaplan-Meier curves summarizing time to treatment failure on or after week 6 (study UV I) or week 2 (study UV II)
Danish: Figur 2: Kaplan-Meier-kurver, opsummerende tid til behandlingssvigt i eller efter uge 6 (Studie UV I) eller uge 2 (Studie UV II)
English: If your child stops using Kromeya
Danish: Hvis dit barn holder op med at tage Kromeya
English: 2.1 Wash your hands with soap and water (Figure G) and dry them well.
Danish: 2.1 Vask dine hænder med sæbe og vand (figur G) og tør dem grundigt.
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 23.
Danish: Ved uge 4 blev patienterne på basis af deres legemsvægt på det tidspunkt randomiseret 1:1 til enten lav-dosis- eller standard-dosis-vedligeholdelsesregime som vist i tabel 23.
English: • Abdomen (inject at least 5 centimeters away from the belly button).
Danish: • i maven (injicér mindst 5 cm fra navlen).
English: Safety guard extended
Danish: Udvidet sikkerhedsmekanisme
English: 10 kg to < 30 kg
Danish: 10 kg til < 30 kg
English: 15 kg to < 30 kg
Danish: 15 kg til < 30 kg
English: Keep this patient reminder card with you or your child during treatment and for 4 months after your (or your child's) last injection of Kromeya.
Danish: Opbevar patientkortet på dit barn i løbet af dit barns behandling og i 4 måneder efter din (eller dit barns) sidste injektion med Kromeya.
English: The Kromeya pre-filled pen contains a pre-filled syringe with Kromeya.
Danish: Kromeya fyldt pen indeholder en fyldt injektionssprøjte med Kromeya.
English: Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; p < 0.05 for adalimumab vs. placebo pairwise comparison of proportions **p < 0.001 for adalimumab vs. placebo pairwise comparison of proportions a
Danish: Klinisk respons er fald fra baseline i Mayo score på > 3 point og > 30 % samt et fald i rektal blødning-subscore [RBS] på > 1 eller en absolut RBS på 0 eller 1; *p<0,05 for adalimumab versus placebo ved parvis sammeligning af andelene **p<0,001 for adalimumab versus placebo ved parvis sammeligning af andelene a Af de patienter, der fik steroid ved baseline
English: Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Danish: Alvorlige infektioner, inklusive sepsis, forårsaget af bakterier, mykobakterier, invasive svampe, parasittereller virus eller andre opportunistiske infektioner såsom listeriose, legionellose og pneumocystis er blevet rapporteret hos patienter, som fik adalimumab.
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 10).
Danish: I RA-studie V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i modificeret Total Sharp Score (se tabel 10).
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
Danish: Hudkræft eksklusive melanom (inklusive basal celle-karcinom og spinocellulært karcinom), benign neoplasmer
English: Kromeya dose for paediatric patients with plaque psoriasis
Danish: Kromeya-dosis til pædiatriske patienter med plaque psoriasis
English: • symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
Danish: • symptomer på nerveproblemer som snurren og prikken, følelsesløshed, dobbeltsyn eller svaghed i arme og ben
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Danish: I et åbent forlængelsesstudie med patienter, hvis dosis blev trappet op fra 40 mg hver anden uge til 40 mg ugentlig på grund af PASI-respons under 50 %, opnåede 26,4% (92/349) og 37,8 % (132/349) af patienterne PASI 75-respons ved henholdvis uge 12 og 24.
English: • If your child experiences allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Kromeya and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Danish: • Hvis dit barn får allergiske reaktioner med symptomer som trykken i brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så undlad at injicere mere Kromeya, og kontakt straks din læge, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: • Lift the pre-filled pen from your skin (Figure Q).
Danish: • Løft pennen væk fra huden (figur Q).
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Kromeya, and in accordance with local recommendations.
Danish: Hvis der diagnosticeres latent tuberkulose, skal profylaktisk behandling mod tuberkulose påbegyndes i overensstemmelse med lokale anbefalinger, inden behandling med Kromeya startes.
English: Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia.
Danish: I kliniske studier er der set andre alvorlige infektioner inklusive pneumoni, pyelonephritis, septisk artritis og septikæmi.
English: • Do not shake the syringe or the vial.
Danish: • Ryst ikke sprøjten eller hætteglasset.
English: If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Other medicines and Kromeya
Danish: Brug af anden medicin sammen med Kromeya
English: Amongst those who responded (Pediatric ACR 30) at week 24 (n=27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Danish: Blandt de børn, som responderede (pædiatrisk ACR-30) ved uge 24 (n=27 ud af 30 patienter), blev pædiatrisk ACR 30-respons opretholdt i op til 60 uger i åben-label-fasen hos de patienter, som fik adalimumab gennem hele denne periode.
English: General disorders and administration site conditions*
Danish: Almene symptomer og reaktioner på administrationsstedet *
English: Kromeya is used to treat:
Danish: Kromeya bruges til at behandle
English: Thus additional caution should be exercised in considering Kromeya treatment of these patients (see section 4.8).
Danish: Der bør derfor udvises ekstra forsigtighed, hvis behandling med Kromeya overvejes til sådanne patienter (se pkt.
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Kromeya and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Danish: • Hvis du får allergiske reaktioner med symptomer som trykken i brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så undlad at injicere mere Kromeya, og kontakt straks din læge, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.
Danish: Hvis du udvikler nye eller får forværrede symptomer på hjerteinsufficiens (f. eks. stakåndethed eller hævede fødder), skal du kontakte din læge øjeblikkeligt.
English: • WATCH the syringe plunger to make sure it moves all the way down to the bottom (Figure P).
Danish: • HOLD ØJE MED stemplet for at sikre, at det kommer helt i bund (figur P).
English: 95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
Danish: Erosion score JSNd score amethotrexat b95% Konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab.
English: • inflammations.
Danish: • inflammationer