FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
Danish: I kliniske studier er der observeret alvorlige infektioner i forbindelse med samtidig administration af anakinra og en anden TNF-antagonist, etanercept, uden yderligere klinisk virkning end ved anvendelse af etanercept alene.
English: Paediatric plaque psoriasis
Danish: Pædiatrisk plaque-psoriasis
English: Subcutaneous use.
Danish: Subkutan anvendelse.
English: Serious adverse reactions have been reported for adalimumab.
Danish: Der er rapporteret alvorlige bivirkninger for adalimumab.
English: Hefiya may have a minor influence on the ability to drive and use machines.
Danish: Hefiya kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: 10, 20 and 25 mg
Danish: 10, 20 og 25 mg
English: Adalimumab, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Danish: Adalimumab 40 mg hver anden uge blev undersøgt hos patienter med moderat til alvorlig aktiv psoriasisartrit i to placebokontrollerede studier, PsA-I og PsA-II.
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: • if you drop your pen, do not use it if it looks damaged, or if you dropped it with the cap removed.
Danish: • hvis du taber pennen, så brug den ikke, hvis den ser ud til at være beskadiget, eller hvis du tabte den, uden at hætten var på.
English: If you forget to use Hefiya
Danish: Hvis du har glemt at tage Hefiya
English: By week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (table 15).
Danish: Ved uge 68 viste patienter, som fik forsat behandling med adalimumab statistisk signifikant større forbedring af tegn og symptomer på aktiv nr-axSpA sammenlignet med patienter, som blev allokeret til seponering af behandling i studiets dobbeltblindede periode (Tabel 15).
English: Contact your pharmacist if the pen fails any of the above mentioned checks.
Danish: Kontakt dit apotekspersonale, hvis pennen ikke kan klare alle ovenstående tjek.
English: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3-month trial of systemic antibiotic therapy.
Danish: Adalimumabs sikkerhed og virkning blev undersøgt i randomiserede, dobbeltblindede, placebokontrollerede studier og et åbent forlængelsesstudie hos voksne patienter med moderat til svær hidrosadenitis suppurativa (HS), som var intolerante, havde en kontraindikation eller et utilstrækkeligt respons på mindst 3 måneders forsøg med systemisk antibiotikabehandling.
English: Pulmonary fibrosis1)
Danish: Lungefibrose1)
English: • If you have an infection, including long-term or localised infection (for example leg ulcer), consult your doctor before starting Hefiya.
Danish: • Hvis du har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), skal du kontakte din læge, før du begynder at bruge Hefiya.
English: No dose recommendations can be made.
Danish: Dosisanbefaling kan ikke gives.
English: Deafness, tinnitus
Danish: Ikke almindelig Døvhed, tinnitus
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab.
Danish: På trods af profylaktisk behandling mod tuberkulose er der forekommet tilfælde af reaktivering af tuberkulose hos patienter i behandling med adalimumab.
English: Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Danish: Psoriasisartrit er en betændelsessygdom i leddene, som er forbundet med psoriasis.
English: Rare
Danish: Sjælden
English: In CD study I and CD study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80 / 40 mg and 160 / 80 mg compared to placebo and was seen at weeks 26 and 56 in CD study III as well among the adalimumab treatment groups compared to the placebo group.
Danish: I CD-studie I og CD-studie II blev der i uge 4 opnået statistisk signifikante forbedringer i total score i det sygdomsspecifikke inflammatorisk tarmsygdomsspørgeskema (IBDQ) hos patienter randomiseret til adalimumab 80/40 mg og 160/80 mg sammenlignet med placebo, og i CD-studie III blev det også set ved uge 26 og 56 hos de adalimumab-behandlede grupper sammenlignet med placebogruppen.
English: The solution should be colourless to slightly yellowish as well as clear to slightly opalescent.
Danish: Opløsningen skal være farveløs til let gullig samt klar til let opaliserende.
English: Table 11 distribution of patients by age and adalimumab dose received during the OL LI phase age group number of patients at baseline n (%) Minimum, median and maximum dose
Danish: Tabel 11 Fordelingen af patienter i henhold til alder og modtaget adalimumab-dosis i den åbne indkøringsfase aldersgruppe antal patienter ved baseline n (%)
English: 40 mg every other week
Danish: 40 mg hver anden uge
English: Study nraxSpA I evaluated patients with active nr-axSpA.
Danish: Studie nr-axSpA I evaluerede patienter med aktiv nr-axSpA.
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Danish: Saltsyre (til pH-justering) Natriumhydroxid (til pH-justering) Vand til injektionsvæsker
English: Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Danish: Ikke almindelig lungeemboli1), interstitiel lungesygdom kronisk obstruktiv lungesygdom, pneumonitis, pleuraeffusion1)
English: Amongst those who responded at week 16 (n = 144), the paediatric ACR 30 / 50 / 70 /90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Danish: Blandt de patienter, som responderede ved uge 16 (n=144), blev pædiatrisk ACR 30/50/70/90responser opretholdt i op til seks år i den åbne forlængelsesfase hos dem, der fik adalimumab gennem hele studiet.
English: Therefore, the combination of adalimumab and anakinra is not recommended (see section 4.5).
Danish: Kombination af adalimumab og anakinra anbefales ikke (se pkt.
English: Disposing of used pens” at the end of this Instructions for Use.
Danish: Bortskaffelse af brugte penne” i slutningen af denne brugsvejledning.
English: • raised bilirubin measurement (liver blood test).
Danish: • forhøjede bilirubinmålinger (leverblodtest)
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Hefiya.
Danish: Alle patienter og specielt patienter, som tidligere har fået omfattende immunsuppresiv behandling, og psoriasis-patienter, der tidligere har været behandlet med PUVA, skal undersøges for ikke-melanom hudkræft inden og under behandling med Hefiya.
English: Adults with non-infectious uveitis
Danish: Voksne med ikke-infektiøs uveitis
English: Table 12 ped ACR 30 responses in the JIA study stratum
Danish: Tabel 12 Pædiatrisk ACR 30-respons i JIA-studiet stratum
English: Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Danish: Adalimumab er ikke undersøgt hos patienter under 6 år med entesopatirelateret artrit.
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Hefiya therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.
Danish: Hvis du har reumatoid artrit og ikke får methotrexat i kombination med din Hefiya-behandling, kan lægen vælge at ordinere 40 mg adalimumab hver uge eller 80 mg hver anden uge.
English: 25, 40 and 40 mg
Danish: 25, 40 og 40 mg
English: discontinued corticosteroids
Danish: seponering af kortikosteroider
English: week 26
Danish: uge 26
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: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 64.3 % and at week 96 was 65.1 %.
Danish: Blandt patienter, der som minimum var delvise respondere ved uge 12, og som fik fortsat ugentlig adalimumab-behandling, var HiSCR-raten ved uge 48; 68,3 % og ved uge 96; 65,1 %.
English: • throw away the used pen right away after use.
Danish: • smid den brugte pen bort, straks efter at du har brugt den.
English: The observed rate of non-melanoma skin cancers is approximately 9.6 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient years.
Danish: Den fundne hyppighed af ikke-melanom hudkræft er cirka 9,6 pr. 1.000 patientår og den fundne hyppighed af lymfomer er cirka 1,3 pr. 1.000 patientår.
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see table 22).
Danish: Hos patienter med minimum et delvist respons på adalimumab 40 mg ugentlig ved uge 12 var HiSCR-raten ved uge 36 højere hos patienter, der fortsatte ugentlig adalimumab, end hos de patienter, hvor doseringshyppigheden blev reduceret til hver anden ugen eller hvor behandlingen blev afbrudt (Se tabel 22).
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 adalimumabtreated 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: The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg subcutaneous dosing every other week and every week.
Danish: Dalserumkoncentration af adalimumab ved steady state blev forøget omtrent proportionalt med doser på 20, 40 og 80 mg ved subkutan dosering hver anden uge og hver uge.
English: The number of all cause hospitalisations in the adalimumab treatment group was 0.18 per patient year vs. 0.26 per patient year in the placebo group and the corresponding figures for UC-related hospitalisations were 0.12 per patient year vs. 0.22 per patient year.
Danish: Antallet af indlæggelser forårsaget af enhver årsag var 0,18 pr. patientår versus 0,26 pr. patientår i placebogruppen, og de tilsvarende tal for UC-relaterede indlæggelser var 0,12 pr. patientår versus 0,22 pr. patientår.
English: 506 (62.2)b a percent of patients achieving PASI75 response was calculated as centreadjusted rate b p<0.001, adalimumab vs. placebo
Danish: 506 (62,2)b a procent af patienterne, som opnåede PASI 75-respons beregnet med justering for centervariation b p<0,001, adalimumab versus placebo
English: • Store your outer carton of syringes in a refrigerator, between 2°C to 8°C.
Danish: • Opbevar din pakning med sprøjter i et køleskab mellem 2 °C og 8 °C.
English: Paediatric uveitis
Danish: Pædiatrisk uveitis
English: Table 26 paediatric CD study PCDAI clinical remission and response standard dose 40 / 20 mg eow N = 93
Danish: Tabel 26 Pædiatrisk CD-studie PCDAI klinisk remission og respons standard-dosis 40/20 mg hver anden uge N = 93
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Hefiya.
Danish: Alle patienter bør rådes til at søge læge omgående, hvis de under behandling med Hefiya udvikler tegn og symptomer på bloddyskrasi (f.eks. vedvarende feber, blå mærker, blødning, bleghed).
English: • sensation of heart beating irregularly such as skipped beats;
Danish: • fornemmelse af uregelmæssige hjerteslag såsom oversprungne slag
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Danish: Der er forekommet reaktivering af hepatitis B hos kroniske bærere af denne virus, som fik en TNFantagonist herunder adalimumab (dvs. overflade-antigen-positive-patienter).
English: Cerebrovascular accident1), tremor, neuropathy
Danish: Ikke almindelig Cerebrovaskulært attak1), tremor, neuropati Sjælden
English: If these medicines do not work well enough, you will be given Hefiya.
Danish: Hvis denne anden medicin ikke virker godt nok, vil du blive tilbudt Hefiya.
English: PASI 75 and PGA of clear or minimal response rates in these patients were 74.7 % and 59.0 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Danish: PASI 75- og PGA clear/minimal responsrater hos disse patienter var henholdsvis 74,7 % og 59, 0 % efter yderligere 108 ugers åben-behandling (i alt 160 uger).
English: • fatty liver (build-up of fat in liver cells);
Danish: • fedtholdig lever (ophobning af fedt i levercellerne)
English: Correct
Danish: Korrekt
English: • throw away the used syringe right away after use.
Danish: • smid den brugte sprøjte bort, straks efter du har brugt den.
English: • cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
Danish: • kræft inklusive kræft, der rammer lymfesystemet (lymfom) og modermærkekræft
English: In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Danish: I et eksplorativt klinisk studie, hvor anvendelsen af et andet TNF-antagonist infliximab blev undersøgt hos patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL), blev der rapporteret om flere maligniteter, primært i lunger eller hoved og hals, hos infliximab-behandlede patienter end hos kontrolpatienter.
English: • Twist off the cap in the direction of the arrows (see Figure F).
Danish: • Drej hætten af i pilenes retning (se Figur F).
English: Hefiya is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Danish: Hefiya bruges til at behandle polyartikulær juvenil idiopatisk artrit hos børn og unge i alderen fra 2 til 17 år og entesopatirelateret artrit hos børn og unge i alderen 6-17 år.
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Danish: 673 patienter med aktiv nr-axSpA (gennemsnitlig baseline score for sygdomsaktivitet [BASDAI] var 7,0), som havde utilstrækkeligt respons på ≥ 2 NSAIDs, eller var intolerante over for eller havde en kontraindikation mod NSAIDs, deltog i den åbne periode af studie nr-axSpA II, hvor de fik adalimumab 40 mg hver anden uge i 28 uger.
English: In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during adalimumab trials in paediatric patients with Crohn's disease.
Danish: Desuden blev der ikke observeret maligniteter hos 192 pædiatriske patienter med en eksponering på 498,1 patientår i adalimumab-studier med pædiatriske patienter med Crohns sygdom.
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 procentvis ændring -50,0 %) hos patienter i placebo-gruppen.
English: The safety and efficacy of adalimumab were assessed in two randomized, double-blind placebocontrolled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Danish: Adalimumabs sikkerhed og virkning blev vurderet i to randomiserede dobbeltblindede, placebokontrollerede studier hos patienter med non-radiografisk aksial spondyloartritis (nr-axSpA).
English: In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see table 8).
Danish: I RA-studie V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat-naive, førte kombinationsbehandlingen med adalimumab og methotrexat til hurtigere og signifikant større ACR-respons end methotrexat-monoterapi og adalimumab-monoterapi i uge 52, og effekten blev opretholdt i 104 uger (se tabel 8).
English: Removing the cap of the pen:
Danish: Aftagning af pennens hætte:
English: The safety profile for patients with HS treated with adalimumab weekly was consistent with the known safety profile of adalimumab.
Danish: Sikkerhedsprofilen for patienter med HS, som fik ugentlig behandling med adalimumab var i overensstemmelse med adalimumabs kendte sikkerhedsprofil.
English: Hefiya can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Danish: Hefiya kan også anvendes til behandling af alvorlig aktiv og progressiv reumatoid artrit, der ikke tidligere er behandlet med methotrexat.
English: Adalimumab-treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24.
Danish: Patienter, der blev behandlet med adalimumab, viste en statistisk signifikant forbedring i den fysiske funktion, målt ved hjælp af HAQ og Short Form Health Survey (SF 36), sammenlignet med placebo ved uge 24.
English: Talk to your doctor or pharmacist before using Hefiya.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Hefiya.
English: • Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended.
Danish: • Brug ikke 40 mg fyldt injektionssprøjte, hvis det anbefales at bruge andre doser end 40 mg.
English: Children and adolescents with Crohn's disease
Danish: Børn og unge med Crohns sygdom
English: week 4 clinical remission clinical response (CR
Danish: Uge 4 klinisk remission klinisk respons (CR- 100)
English: MTX = methotrexate b p = 0.027, adalimumab 0.8 mg / kg versus MTX
Danish: MTX = methotrexat b p=0,027, adalimumab 0,8 mg/kg versus MTX
English: Adalimumab has not been studied in patients aged less than 2 years.
Danish: Adalimumab er ikke undersøgt hos patienter under 2 år.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Administration of adalimumab without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Danish: Administration af adalimumab uden methotrexat øgede antistofdannelsen og clearance og reducerede effekten af adalimumab (se pkt.
English: Patients participating in Studies HS-I and HS-II were eligible to enrol into an open-label extension study in which adalimumab 40 mg was administered every week.
Danish: Patienter, som deltog i HS-studie I og II, var kvalificerede til inklusion i et åbent forlængelsesstudie, hvor adalimumab 40 mg blev givet hver uge.
English: • Carefully pull the needle cap straight off to remove it from the syringe (see Figure G).
Danish: • Træk forsigtigt kanylehætten lige af for at fjerne den fra sprøjten (se Figur G).
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Danish: Der blev ikke observeret nogen maligniteter hos 249 pædiatriske patienter med en samlet eksponering på 655,6 patientår i adalimumab-studier hos patienter med juvenil idiopatisk artrit (polyartikulær juvenil idiopatiske artrit og entesopatirelateret artrit).
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Danish: I kontrollerede og åbne studier med voksne og pædiatriske patienter med adalimumab blev der rapporteret alvorlige infektioner (herunder dødelige infektioner, som forekom sjældent), inklusive rapporter om tuberkulose (herunder miliærtuberkulose og ekstra-pulmonær tuberkulose) og invasive opportunistiske infektioner (f.eks. dissemineret eller ekstrapulmonal histoplasmose, blastomykose, kokcidioimykose, pneumocytis, candidiasis, aspergillose og listeriose).
English: Juvenile idiopathic arthritis (JIA)
Danish: Juvenil idiopatisk artrit (JIA)
English: • vertigo (sensation of room spinning);
Danish: • vertigo (fornemmelse af at snurre rundt)
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of Hefiya is an initial dose of 40 mg, followed by 40 mg one week later.
Danish: Børn og unge fra 4 til 17 år, der vejer 30 kg eller mere Den anbefalede startdosis af Hefiya er 40 mg, efterfulgt af 40 mg en uge senere.