FrancophonIA/ELRC3.0 huggingface dataset:
English: No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient years during an adalimumab trial in paediatric patients with chronic plaque psoriasis.
Danish: Der blev ikke observeret nogen maligniteter hos 77 pædiatriske patienter med en samlet eksponering på 80,0 patientår i adalimumab-studier hos pædiatriske patienter med kronisk plaque-psoriasis.
English: EU/1/18/1287/004 1 pre-filled pen EU/1/18/1287/005 2 pre-filled pens
Danish: EU/1/18/1287/004 1 fyldt pen EU/1/18/1287/005 2 fyldte penne
English: Mean steady-state trough levels of approximately 7 µg / ml were observed in Crohn's disease patients who received a maintenance dose of 40 mg adalimumab every other week.
Danish: Gennemsnitlige dal-niveauer på omtrent 7 µg/ml ved steady state blev set hos patienter med Crohns sygdom, som fik vedligeholdelsesdosis på 40 mg adalimumab hver anden uge.
English: Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn's disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Danish: Adalimumabs sikkerhed og virkning ved induktions- og vedligeholdelsesbehandling med doser afhængige af legemsvægt (< 40 kg eller ≥ 40 kg) er undersøgt i et randomiseret, dobbeltblindet klinisk multicenterstudie med 192 pædiatriske patienter i alderen 6 til 17 (inklusive) år med moderat til svær Crohns sygdom (CD), defineret som Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
English: Polyarticular juvenile idiopathic arthritis (pJIA)
Danish: Polyartikulær juvenil idiopatisk artrit (pJIA)
English: • inflammation of the eye lid and eye swelling;
Danish: • betændelse i øjenlåget og hævede øjne
English: Ulcerative colitis is an inflammatory disease of the bowel.
Danish: Colitis ulcerosa er en inflammatorisk (betændelseslignende) sygdom i mave-tarm-kanalen.
English: Hefiya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Danish: Hefiya er indiceret til behandling af voksne med non-infektiøs intermediær, posterior og pan-uveitis, som har haft utilstrækkeligt respons på kortikosteroider, som har behov for steroidbesparende behandling, eller som ikke er egnet til behandling med kortikosteroider.
English: Hefiya dose for paediatric patients with plaque psoriasis Patient weight
Danish: Hefiya-dosis til pædiatriske patienter med plaque-psoriasis Patientvægt
English: Tachycardia
Danish: Takykardi
English: Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
Danish: Efter markedsføring er der rapporteret om sjældne tilfælde af hepatosplenisk T-cellelymfom hos patienter i behandling med adalimumab (se punkt 4.4).
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Hefiya therapy.
Danish: Før behandling med Hefiya påbegyndes, anbefales det, hvis det er muligt, at bringe pædiatriske patienter ajour med alle immuniseringer i overensstemmelse med gældende immuniseringsvejledninger.
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more
Danish: Unge med hidrosadenitis suppurativa fra12 til 17 år, som vejer 30 kg eller mere
English: • do not shake the syringe.
Danish: • ikke ryster sprøjten
English: Systemic infections (including sepsis, candidiasis and influenza), intestinal infections (including gastroenteritis viral), skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), ear infections, oral infections (including herpes simplex, oral herpes and tooth infections), reproductive tract infections (including vulvovaginal mycotic infection), urinary tract infections (including pyelonephritis), fungal infections, joint infections
Danish: Systemiske infektioner (inklusive sepsis, candidiasis og influenza), intestinale infektioner (inklusive viral gastroenteritis), hud- og bløddelsinfektioner (inklusive paronychia, cellulitis, impetigo, nekrotiserende fasciitis og herpes zoster), øreinfektioner, orale infektioner (inklusive herpes simplex, oral herpes og tandinfektioner),
English: Upon completion of the first 104 weeks, 497 patients enrolled in an open-label extension phase in which 40 mg of adalimumab was administered every other week up to 10 years.
Danish: Efter at have gennemført de første 104 uger blev 497 patienter optaget i et åbent forlængelsesstudie, hvor 40 mg adalimumab blev administreret hver anden uge i op til 10 år.
English: Crohn's disease is an inflammatory disease of the gut.
Danish: Crohns sygdom er en inflammatorisk sygdom i mave-tarm-kanalen.
English: Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 26 weeks followed by open-label adalimumab treatment for an additional 26 weeks.
Danish: Patienterne fik en startdosis på 80 mg adalimumab efterfulgt af 40 mg hver anden uge (med start en uge efter den første dosis) eller placebo i 26 uger efterfulgt af åben adalimumab-behandling i yderligere 26 uger.
English: There is limited safety experience of surgical procedures in patients treated with adalimumab.
Danish: Der er begrænset erfaring med sikkerhed efter kirurgiske indgreb hos patienter i behandling med adalimumab.
English: Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to week 12, with a maximum dose of 25 mg or an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
Danish: Patienterne fik placebo og en startdosis på 7,5 mg methotrexat og derefter dosisøgning op til uge 12 til en maksimum-dosis på 25 mg eller en startdosis på 80 mg adalimumab efterfulgt af 40 mg hver anden uge (med start en uge efter den første dosis) i 16 uger.
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10 % BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Danish: Adalimumabs sikkerhed og virkning blev undersøgt hos voksne patienter med kronisk plaque-psoriasis (≥ 10 % BSA-involvering og PASI ≥ 12 eller ≥ 10), som var kandidater til systemisk behandling eller lysbehandling i randomiserede, dobbeltblindede studier.
English: Each pen contains 40 mg/0.8 ml of Hefiya.
Danish: Hver pen indeholder 40 mg/0,8 ml Hefiya.
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg / ml (without concomitant methotrexate) and 8 to 9 µg / ml (with concomitant methotrexate), respectively.
Danish: Efter subkutan administration af 40 mg adalimumab hver anden uge hos voksne patienter med reumatoid artrit (RA) var dal-steady state-koncentrationerne på henholdsvis cirka 5 µg/ml (uden kombination med methotrexat) og 8-9 µg/ml (i kombination med methotrexat).
English: • abnormal blood measurements for sodium;
Danish: • unormale blodmålinger af natrium
English: PsA study I
Danish: PsA-studie I
English: Table 20 paediatric plaque psoriasis efficacy results at 16 weeks
Danish: Tabel 20 Effektresultater ved uge 16 for pædiatrisk plaque-psoriasis
English: Thus, it is not possible to administer Hefiya to paediatric patients that require less than a full 40 mg dose.
Danish: Derfor er det ikke muligt at administrere Hefiya til pædiatriske patienter, som kræver mindre end en hel 40 mg dosis.
English: In patients with polyarticular JIA who were 2 to < 4 years old or aged 4 and above weighing < 15 kg dosed with adalimumab 24 mg / m2, the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg / ml (101 % CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg / ml (71.2 % CV) with concomitant methotrexate.
Danish: Hos patienter med polyartikulær JIA, som var 2 til <4 år eller 4 år og derover med en vægt <15 kg, som blev doseret med adalimumab 24 mg/m2, var den gennemsnitlige dal-serumkoncentration af adalimumab ved steady state 6,0 ± 6,1 µg/ml (101 % CV) for adalimumab uden samtidig methotrexat og 7,9 ± 5,6 µg/ml (71,2 % CV) med samtidig methotrexat.
English: If this dose does not work well enough, your doctor may increase the dose frequency to 20 mg every week.
Danish: Hvis denne dosis ikke virker godt nok, kan lægen øge dosis til 20 mg hver uge.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER SPRØJTEETIKET
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Hefiya.
Danish: Du kan få synsforstyrrelser og en fornemmelse af, at rummet drejer rundt (svimmelhed), efter du har taget Hefiya.
English: • fever;
Danish: • feber
English: The rate (95 % confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient years among control patients.
Danish: Hyppigheden (95 % konfidensinterval) af ikke-melanom hudkræft var 8,8 (6,0-13,0) pr. 1.000 patientår blandt adalimumab-behandlede patienter og 3,2 (1,3-7,6) pr. 1.000 patientår blandt kontrolpatienterne.
English: Visual impairment, conjunctivitis, blepharitis, eye swelling
Danish: Synsforstyrrelser, konjunktivitis, blepharitis, hævede øjne
English: Heart failure
Danish: Hjerteinsufficiens
English: Hefiya is used to treat moderate to severe plaque psoriasis in adults.
Danish: Hefiya bruges til at behandle moderat til alvorlig plaque-psoriasis hos voksne.
English: • adults with non-infectious uveitis with inflammation affecting the back of the eye.
Danish: • voksne med ikke-infektiøs uveitis (regnbuehindebetændelse), som påvirker den bagerste del af øjet.
English: • increased sweating;
Danish: • øget svedtendens
English: Completing your injection:
Danish: Afslut din injektion:
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3 % of adalimumabtreated patients and 0.6 % of control-treated patients.
Danish: I kontrollerede studier med adalimumab (startdosis på 160 mg i uge 0 og 80 mg i uge 2, efterfulgt af 40 mg hver uge med start i uge 4) hos patienter med hidrosadenitis suppurativa med en kontrolperiode af 12 til 16 ugers varighed, forekom ALAT-stigning ≥ 3 x ULN hos 0,3 % af patienterne i adalimumab-behandling og hos 0,6 % af patienterne i kontrol-behandling.
English: Figure B: items not included in the carton
Danish: Figur B: ting, der ikke er inkluderet i pakningen Se ”8.
English: Hefiya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: Hefiya er indiceret til behandling af moderat til svær aktiv colitis ulcerosa hos voksne, som ikke har responderet tilfredsstillende på konventionel behandling inklusive kortikosteroider og 6-mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: • low blood measurements for phosphate;
Danish: • lave blodmålinger af fosfat
English: Hefiya is available as a pre-filled syringe and a pre-filled pen (SensoReady).
Danish: Hefiya findes som en fyldt injektionssprøjte og en fyldt pen (SensoReady).
English: • injection site reactions (including pain, swelling, redness or itching);
Danish: • reaktioner ved injektionsstedet (herunder smerter, hævelse, rødme eller kløe)
English: Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Danish: Bemærk: P = Placebo (Antal med risiko (opblussen af sygdom)); A = Adalimumab (Antal med risiko (opblussen af sygdom)).
English: Thereafter, the usual dose is 40 mg every other week.
Danish: Derefter er den sædvanlige dosis 40 mg hver anden uge.
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at week 68 was 8.0 ± 4.6 µg/ml.
Danish: Efter subkutan administration af 40 mg adalimumab hver anden uge til voksne non-radiografisk aksial spondylartritis-patienter var den gennemsnitlige (±SD) dal-steady state-koncentration ved uge 68 8,0 ± 4,6 μg/ml.
English: Efficacy results
Danish: Effektresultater
English: Dosing regimen
Danish: Dosisregime
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.
Danish: Voksne med reumatoid artrit, psoriasisartrit, ankyloserende spondylitis eller aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis Den almindelige dosis til voksne med reumatoid artrit, ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis og til patienter med psoriasisartrit er 40 mg adalimumab hver anden uge som enkeltdosis.
English: Hefiya is used to treat rheumatoid arthritis in adults.
Danish: Hefiya bruges til at behandle reumatoid artrit hos voksne.
English: Thus, it is not possible to administer Hefiya to patients that require less than a full 40 mg dose.
Danish: Derfor er det ikke muligt at administrere Hefiya til patienter, som kræver mindre end en hel 40 mg dosis.
English: Hefiya is administered every other week via subcutaneous injection.
Danish: Hefiya administreres hver anden uge som subkutan injektion.
English: Exposure-response relationships between adalimumab concentration and efficacy in paediatric patients with severe chronic plaque psoriasis were established for PASI 75 and PGA clear or minimal, respectively.
Danish: Der er fundet eksponering-respons sammenhæng hos pædiatriske patienter med svær kronisk plaque-psoriasis mellem adalimumab-koncentration og virkning for henholdsvis PASI 75 og PGA
English: In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Danish: I CD-studie I blev 299 TNF-antagonist-naive patienter randomiseret til en af fire behandlingsgrupper: placebo i uge 0 og 2, 160 mg adalimumab i uge 0 og 80 mg i uge 2, 80 mg i uge 0 og 40 mg i uge 2, og 40 mg i uge 0 og 20 mg i uge 2.
English: Hefiya 40 mg solution for injection in single-use pre-filled SensoReady pen Hefiya is supplied in a single-use pre-filled syringe assembled into a triangular-shaped pen with transparent window and label (SensoReady).
Danish: Hefiya, 40 mg injektionsvæske, opløsning i fyldt SensoReady-engangspen Hefiya leveres i en fyldt engangssprøjte samlet til en trekantformet pen med transparent vindue og etiket (SensoReady pen).
English: Figure I: hold the syringe
Danish: Figur I: hold sprøjten
English: Patients were randomised to receive either 24 mg / m2 body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Danish: Patienterne blev randomiseret til at få enten adalimumab 24 mg/m2 legemsoverfladeareal (BSA) op til maksimalt 40 mg eller placebo hver anden uge i 12 uger.
English: Figure D: choose your injection site
Danish: Figur D: vælg dit injektionssted
English: Alternatively, if a patient has stopped Hefiya and signs and symptoms of disease recur, Hefiya may be re-administered.
Danish: Alternativt kan Hefiya gen-administreres, hvis patienten er stoppet behandling med Hefiya, og tegn og symptomer på sygdommen kommer igen.
English: Mean steady-state trough levels of approximately 8 µg / ml were observed in ulcerative colitis patients who received a maintenance dose of 40 mg adalimumab every other week.
Danish: Der blev observeret gennemsnitlige steady state dal-koncentrationer på omkring 8 µg/ml hos colitis ulcerosa-patienter, som fik en vedligeholdelsesdosis på 40 mg adalimumab hver anden uge.
English: Do not shake.
Danish: Må ikke rystes.
English: • sensation disorders such as tingling, prickling or numbness;
Danish: • følelsesforstyrrelser såsom snurren, prikken eller følelsesløshed
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan påvirke mere end 1 ud af 10 personer)
English: response placebo N=162
Danish: Respons placebo N=162
English: Table 4.
Danish: Tabel 4.
English: At week 12, a significantly higher proportion of patients treated with adalimumab versus placebo achieved HiSCR.
Danish: En signifikant større andel af patienterne, som fik behandling med adalimumab sammenlignet med placebo, opnåede HiSCR ved uge 12.
English: Once removed from the refrigerator for room temperature storage, your pre-filled pen must be used within 14 days or discarded, even if it is later returned to the refrigerator.
Danish: Når pennen er taget ud af køleskabet og har været opbevaret ved stuetemperatur, skal pennen bruges indenfor 14 dage eller kasseres, også selv om den senere lægges tilbage i køleskabet.
English: Excipients: adipic acid, citric acid monohydrate, sodium chloride, mannitol, polysorbate 80, hydrochloric acid, sodium hydroxide, water for injections.
Danish: Hjælpestoffer: adipinsyre, citronsyremonohydrat, natriumchlorid, mannitol, polysorbat 80, saltsyre, natriumhydroxid og vand til injektionsvæsker.
English: For patients who dose-escalated from eow to weekly regimen, the mean (± SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg / ml (40 / 20 mg, weekly) and 6.7 ± 3.5 μg / ml (20 / 10 mg, weekly).
Danish: Hos patienter, hvis dosering øgedes fra hver anden uge til ugentlig, var den gennemsnitlige (±SD) serumkoncentration af adalimumab 15,3±11,4 μg/ml (40/20 mg ugentlig) og 6,7±3,5 μg/ml (20/10 mg ugentlig) ved uge 52.
English: Adalimumab exposure in paediatric uveitis patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Danish: Adalimumab-eksponering hos pædiatriske uveitis-patienter blev estimeret ved anvendelse af populationsfarmakokinetisk modellering og simulering, baseret på farmakokinetik på tværs af indikationerne hos andre pædiatriske patienter (pædiatrisk psoriasis, juvenil idiopatisk artrit, pædiatrisk Crohns sygdom og entesopatirelateret artrit).
English: Following the administration of 0.8 mg / kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg / ml (79 % CV).
Danish: Efter subkutan administration af 0,8 mg/kg (op til maksimalt 40 mg) hver anden uge til pædiatriske patienter med kronisk plaque-psoriasis var den gennemsnitlige dal-koncentration af adalimumab ved steady state 7,4 ± 5,8 µg/ml (± SD) (79 % CV).
English: Endoscopic studies in intestinal mucosa have shown evidence of mucosal healing in adalimumab-treated patients.
Danish: Endoskopiske undersøgelser af tarmslimhinden har vist tegn på heling af slimhinden hos patienter, som blevet behandlet med adalimumab.
English: Rheumatoid arthritis
Danish: Reumatoid artrit
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: • intestinal perforation (hole in the wall of the gut);
Danish: • perforering af tarmen (hul i tarmvæggen)
English: Figure F: clean your injection site
Danish: Figur F: rens dit injektionssted
English: In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4 % of adalimumab-treated patients and 2.4 % of control-treated patients.
Danish: I kontrollerede studier med adalimumab hos voksne patienter med uveitis (startdosis på 80 mg i uge 0 efterfulgt af 40 mg hver anden uge med start i uge 1) i op til 80 uger med en gennemsnitlig eksponering på 166,5 dage for patienter behandlet med adalimumab og 105,0 dage for patienter i kontrolarmen, forekom ALAT-stigning ≥ 3 x ULN hos 2,4 % af patienterne i adalimumab-armen og hos 2,4 % af patienterne i kontrol-armen.
English: Hefiya 40 mg / 0.8 ml injection adalimumab
Danish: Hefiya 40 mg / 0,8 ml injektion adalimumab
English: Each syringe contains 40 mg/0.8 ml of Hefiya.
Danish: Hver sprøjte indeholder 40 mg/0,8 ml Hefiya.
English: The blinded period was followed by an open-label period during which patients received adalimumab 40 mg every other week subcutaneously for up to an additional 28 weeks.
Danish: Den blindede periode blev efterfulgt af en åben periode, hvor patienterne modtog adalimumab 40 mg hver anden uge subkutant i op til yderligere 28 uger.
English: • You may see a drop of liquid at the end of the needle.
Danish: • Måske ser du en dråbe væske komme ud af kanylen.
English: Hefiya is used in adults to treat these conditions.
Danish: Hefiya bruges til at behandle disse sygdomme hos voksne.
English: clinical remission clinical response (CR-100) patients in steroid-free remission for > = 90 daysa week 56
Danish: klinisk remission klinisk respons (CR-100) patienter i steroid-fri remission i ≥90 dagea
English: EU/1/18/1287/006 6 pre-filled pens (3 packs of 2)
Danish: EU/1/18/1287/006 6 fyldte penne (3 pakninger a 2)
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), autoantibody test positive (including double stranded DNA antibody), blood lactate dehydrogenase increased
Danish: Positiv auto-antistoftest (inklusive dobbeltstrenget DNA-antistof), forhøjet blodlactatdehydrogenase
English: • facial oedema (swelling) associated with allergic reactions;
Danish: • ødem (hævelse) i ansigtet forbundet med allergiske reaktioner
English: adalimumab 40 mg weekly N = 70
Danish: adalimumab 40 mg ugentlig N = 70
English: The rate (95 % confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient years among control patients.
Danish: Hyppigheden (95 % konfidensinterval) af lymfomer var 0,7 (0,2-2,7) pr. 1.000 patientår blandt de adalimumab-behandlede patienter og 0,6 (0,1-4,5) pr. 1.000 patientår blandt kontrolpatienterne.
English: Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks.
Danish: Patienter, der fik opblussen af sygdommen i den dobbeltblindede periode, fik lov til at få rescue-behandling med adalimumab 40 mg hver anden uge i mindst 12 uger.
English: • eye infections;
Danish: • øjeninfektioner
English: In rheumatoid arthritis, methotrexate is continued while using Hefiya.
Danish: Hvis du har reumatoid artrit, kan du fortsætte med methotrexat under behandling med Hefiya.
English: Cartons contain 1 and 2 pre-filled pens of Hefiya.
Danish: Pakningerne indeholder 1 og 2 fyldte penne med Hefiya.