FrancophonIA/ELRC3.0 huggingface dataset:
English: • Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after their last Hulio injection.
Danish: • Dit barn bør overveje brugen af passende prævention for at forhindre graviditet og fortsætte brugen mindst 5 måneder efter den sidste behandling med Hulio.
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: Hulio is used to treat hidradenitis suppurativa in adults, and adolescents from 12 years of age.
Danish: Hulio bruges til at behandle hidrosadenitis suppurativa hos voksne og unge fra 12 år.
English: Solution for injection 1 pre-filled pen, 2 alcohol pads 2 pre-filled pens, 2 alcohol pads 6 pre-filled pens, 6 alcohol pads
Danish: Injektionsvæske, opløsning 1 fyldt pen, 2 alkoholservietter 2 fyldte penne, 2 alkoholservietter 6 fyldte penne, 6 alkoholservietter
English: If these medicines do not work well enough your child will be given Hulio to reduce the signs and symptoms of his/her Crohn's disease.
Danish: Hvis disse lægemidler ikke virker godt nok, vil dit barn få Hulio for at mindske tegn og symptomer på hans/hendes Crohns sygdom.
English: adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 9).
Danish: Der blev observeret en signifikant mindre radiografisk progression hos adalimumab-/methotrexat- patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se tabel 9).
English: Each single pack containing 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 sterile needle, 1 sterile vial adapter and 2 alcohol pads.
Danish: En enkeltstykpakning indeholder 1 hætteglas (0,8 ml steril væske), 1 tom steril injektionssprøjte, 1 steril kanyle, 1 steril hætteglasadapter og 2 alkoholservietter.
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: • DO NOT put the clear needle cap back on the needle.
Danish: • SÆT IKKE den klare kanylehætte tilbage på kanylen.
English: Adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 11).
Danish: Der blev observeret en signifikant mindre radiografisk progression hos adalimumab-/methotrexat-patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se tabel 11).
English: There is limited experience in the initiation of treatment with adalimumab alone.
Danish: Der er begrænset erfaring med initiering af behandling med Hulio alene.
English: If your child has mild heart failure and are being treated with Hulio, your child's heart failure status must be closely monitored by the doctor.
Danish: Hvis dit barn har lettere hjerteinsufficiens og behandles med Hulio skal hans/hendes hjerteinsufficiens følges nøje af barnets læge.
English: Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of adalimumab/MTX was administered every other week up to 10 years.
Danish: Efter at have gennemført de første 52 uger blev 457 patienter optaget i et åbent forlængelsesstudie, hvor 40 mg adalimumab/MTX blev administreret hver anden uge i op til 10 år.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON - VIAL MULTIPACK (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE KARTON - HÆTTEGLAS MULTIPAKNING (UDEN BLÅ BOKS)
English: • DO NOT wipe the needle or syringe.
Danish: • TØR IKKE kanylen eller sprøjten af.
English: c Based on rank analysis d Joint Space Narrowing
Danish: c Baseret på ranganalyse d Ledspalteforsnævring
English: Do not use this medicine after the expiry date which is stated on the label/ carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten/pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Hulio Dose for Patients with Enthesitis-Related Arthritis Patient Weight
Danish: Hulio-dosis til patienter med entesopatirelateret artrit Patientvægt
English: Pulmonary embolism1),
Danish: Ikke almindelig Lungeemboli1),
English: The usual dose regimen is 40 mg initially, followed by 20 mg two weeks later.
Danish: Den sædvanlige startdosis er 40 mg, efterfulgt af 20 mg 2 uger senere.
English: Hulio is used to treat ulcerative colitis in adults.
Danish: Hulio bruges til at behandle colitis ulcerosa hos voksne.
English: Hulio 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 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: Hulio er indiceret til behandling af moderat til svær aktiv colitis ulcerosa hos voksne, som ikke har responderet tilfredsstillende på konventionel behandling inklusive glukokortikoider og 6-mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 μg/ml for patients ≥ 40 kg (160/80 mg) and 10.6±6.1 μg/ml for patients < 40 kg (80/40 mg).
Danish: De gennemsnitlige dal-serumkoncentrationer (±SD) af adalimumab, som blev opnået ved uge 4, var 15,7 ± 6,6 μg/ml for patienter ≥ 40 kg (160/80 mg) og 10,6 ± 6,1 μg/ml for patienter < 40 kg (80/40 mg).
English: • Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended.
Danish: • Brug ikke den 40 mg fyldte injektionssprøjte, hvis du har fået ordineret en anden dosis end
English: • Take a single pen out of the fridge at least 30 minutes before you intend to use it to allow the contents to reach room temperature.
Danish: • Tag en enkelt pen ud af køleskabet mindst 30 minutter, før du skal bruge den, så den kan nå stuetemperatur.
English: You may first be given other disease-modifying medicines, such as methotrexate.
Danish: Du kan først behandles med anden sygdomsdæmpende medicin såsom methotrexat.
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 ved uge 0 og 2, 160 mg adalimumab ved uge 0 og 80 mg ved uge 2, 80 mg ved uge 0 og 40 mg ved uge 2 og 40 mg ved uge 0 og 20 mg ved uge 2.
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0% vs 11.4%, respectively) and draining fistulas (30.0% vs 13.9%, respectively).
Danish: Ca. dobbelt så mange patienter i placebogruppen som i adalimumab-gruppen oplevede forværring af abscesser (henholdsvis 23,0% vs. 11,4%) og suppurerende fistler (henholdsvis 30,0% vs. 13,9%) i de første 12 uger af HS-studie I og II.
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: 192 pædiatriske patienter med en eksponering på 498,1 patientår i adalimumab-studier med pædiatriske patienter med Crohns sygdom.
English: Table 23: Maintenance of Clinical Remission and Response (Percent of Patients) Placebo
Danish: Vedligeholdelse af klinisk remission og respons (Procentdel af patienterne) Placebo
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.8 ml single dose vial contains 40 mg of adalimumab.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver 0,8 ml enkeltdosishætteglas indeholder 40 mg adalimumab.
English: • You might get infections more easily while you are receiving Hulio treatment.
Danish: • Infektioner kan opstå lettere under behandling med Hulio.
English: Preparing the Hulio injection
Danish: Forberedelse til Hulio-injektion
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 18).
Danish: Hos patienter med minimum et delvist respons på adalimumab 40 mg ugentlig ved uge 12 var HiSCRraten ved uge 36 højere hos patienter, der fortsatte med ugentlig adalimumab, end hos de patienter, hvor doseringshyppigheden blev reduceret til hver anden uge eller behandlingen afbrudt (Se tabel 18).
English: Phase OL-LI 16 weeks Ped ACR 30 response (n/N)
Danish: Pædiatrisk ACR 30respons (n/N)
English: Adults with non-infectious uveitis affecting the back of the eye
Danish: Voksne med ikke-infektiøs uveitis (regnbuehindebetændelse), der påvirker det bageste i øjet.
English: Table 12: Ped ACR 30 Responses in the JIA study
Danish: Tabel 12: Pædiatrisk ACR 30-respons i JIA-studiet
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 HiSCRraten ved uge 36 højere hos patienter, der fortsatte med ugentlig adalimumab, end hos de patienter, hvor doseringshyppigheden blev reduceret til hver anden uge eller behandlingen afbrudt (Se tabel 22).
English: Table 7: Distribution of patients by age and adalimumab dose received during the OL LI phase
Danish: Tabel 7: Fordelingen af patienter i henhold til alder og modtaget adalimumab-dosis i den åbne indkøringsfase
English: The safety profile for patients with uveitis treated with adalimumab every other week was consistent with the known safety profile of adalimumab.
Danish: Sikkerhedsprofilen for patienter med uveitis, som behandles med adalimumab hver anden uge, var den samme som den kendte sikkerhedsprofil for adalimumab.
English: o DO NOT use the pen if past the expiry date.
Danish: o Pennen MÅ IKKE anvendes, hvis den angivne udløbsdato er overskredet.
English: Table 10: ACR Responses in RA Study V (percent of patients)
Danish: Tabel 10: ACR-respons i RA-studie V (procentdel af patienter)
English: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab /methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Danish: I RA-studie V var forbedringen i HAQ funktionsevneindeks og den fysiske komponent fra SF 36 større (p < 0,001) for adalimumab/methotrexat-kombinationsterapi end for methotrexat-monoterapi og adalimumab-monoterapi ved uge 52.
English: N Failure N (%)
Danish: N Behandlings -svigt N (%)
English: The recommended dose of Hulio for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Danish: Den anbefalede Hulio-dosis til patienter med Crohns sygdom fra 6 til 17 år er baseret på legemsvægt (tabel 4).
English: Hulio packs should be stored in the fridge (between 2 to 8°C) until needed for use.
Danish: Hulio-æsker skal opbevares i køleskab (2 - 8°C) før brug.
English: At 10 years, 79 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Danish: 79 af 207 patienter, der oprindeligt blev behandlet med 40 mg adalimumab hver anden uge, blev radiografisk evalueret efter 10 år.
English: It is important that you tell the baby's doctors and other health care professionals about Hulio use during your child's pregnancy so they can decide when your child's baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik Hulio under graviditeten, så de kan beslutte, hvornår dit spædbarn bør vaccineres.
English: Each box contains 1 vial, 1 sterile injection syringe, 1 sterile needle, 1 sterile vial adapter and 2 alcohol pads.
Danish: Hver æske indeholder 1 hætteglas, 1 steril injektionssprøjte, 1 steril kanyle, 1 steril hætteglasadapter og 2 alkoholservietter.
English: Table 20: Paediatric Plaque Psoriasis Efficacy Results at 16 weeks MTXa N=37
Danish: Effektresultater ved uge 16 for pædiatrisk plaque-psoriasis MTXa N=37
English: • Your child might get infections more easily while he/she is receiving Hulio treatment.
Danish: • Dit barn kan lettere få infektioner under behandling med Hulio.
English: • DO NOT expel any air bubble(s).
Danish: • Du må IKKE presse eventuelle luftbobler ud.
English: Table 8: ACR Responses in RA Study V (percent of patients)
Danish: Tabel 8: ACR-response i RA-studie V (procentdel af patienter)
English: Adalimumab 40 mg weekly N = 70
Danish: Adalimumab 40 mg ugentligt N = 70
English: Solution for injection Multipack: 2 packs of 1 vial each.
Danish: Injektionsvæske, opløsning Multipakning: 2 æsker med hver 1 hætteglas.
English: • DO NOT inject into skin that is red, hard, bruised, or tender.
Danish: • INJICER IKKE i et område, hvor huden er rød, hård, har mærker eller er øm.
English: If these medicines do not work well enough, you will be given Hulio to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Danish: Hvis du ikke reagerer tilstrækkeligt godt på disse lægemidler, vil du få Hulio til behandling af din polyartikulære juvenile idiopatiske artrit eller entesopatirelateret artrit.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/007 2 vials (2 packs of 1)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1319/007 2 hætteglas (2 æsker med hver 1)
English: Injection syringe
Danish: Injektionssprøjte Kanyle
English: Hulio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Danish: Hulio er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos pædiatriske patienter (fra 6 år), som har haft utilstrækkeligt respons på konventionel behandling inklusive primær ernæringsbehandling og kortikosteroidbehandling og/eller immunmodulerende behandling, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
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-<4 år eller 4 år og derover med en vægt <15 kg, som blev doseret med adalimumab 24 mg/m2, var den gennemsnitlige 'dal'-steady state-serumadalimumab 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: • excessive night urination;
Danish: • hyppig vandladning om natten;
English: • 1 sharps disposal container (not included in Hulio pack)
Danish: • 1 kanyleboks (medfølger ikke i Hulio-pakningen)
English: Table 16: Ps Study IV Efficacy Results at 16, 26 and 52 weeks Endpoint
Danish: Tabel 16: Ps-studie IV Effektresultater ved uge 16, 26 og 52
English: The recommended dose of Hulio for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Danish: Den anbefalede dosis af Hulio til voksne patienter med reumatoid artrit er 40 mg adalimumab givet som enkeltdosis ved subkutan injektion hver anden uge.
English: Each pre-filled syringe is for single-use only and contains one 40 mg dose of adalimumab.
Danish: Hver fyldt injektionssprøjte er kun til engangsbrug og indeholder en 40 mg dosis af adalimumab.
English: Hulio is used to treat children and adolescents aged 2 to 17 years with chronic non-infectious uveitis who have inflammation affecting the front of the eye.
Danish: Hulio bruges til at behandle børn fra 2-17 år med kronisk ikke-infektiøs uveitis (regnbuehindebetændelse), som påvirker den forreste del af øjet.
English: • DO NOT touch the needle.
Danish: • RØR IKKE ved kanylen.
English: • pale complexion, dizziness, persistent fever, bruising or bleeding very easily.
Danish: • bleghed, svimmelhed, vedvarende feber, tendens til blå mærker eller blødning.
English: • indigestion, bloating, heart burn;
Danish: • fordøjelsesbesvær, oppustethed, halsbrand;
English: - The other ingredients are monosodium glutumate, sorbitol, methionine, polysorbate 80,
Danish: - Øvrige indholdsstoffer: mononatriumglutumat, sorbitol, methionin, polysorbat 80, saltsyre og vand til injektionsvæsker.
English: • nervous system problems
Danish: • forstyrrelser i nervesystemet
English: If you forget to give your child an injection, you should inject the next dose of Hulio as soon as you remember.
Danish: Hvis du glemmer at give dit barn en injektion, bør du injicere den næste dosis af Hulio, så snart du kommer i tanke om det. Fortsæt dernæst med at injicere næste dosis som planlagt på den oprindeligt fastlagte dag, som om du ikke havde glemt en dosis.
English: Put the used syringe, needle, vial and vial adapter in a sharps disposal container after use.
Danish: Efter anvendelse skal sprøjten, kanylen og kanyleadapteren bortskaffes i en kanyleboks.
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: Hulio is administered by injection under the skin (subcutaneous use).
Danish: Hulio indgives ved injektion under huden (subkutan injektion).
English: If you forget to give yourself an injection, you should inject the next dose of Hulio as soon as you remember.
Danish: Hvis du glemmer at give dig selv en injektion, bør du injicere den næste dosis af Hulio, så snart du kommer i tanke om det. Fortsæt dernæst med at injicere næste dosis som planlagt på den oprindeligt fastlagte dag, som om du ikke havde glemt en dosis.
English: • 160 mg at week 0 and 80 mg at week 2
Danish: • 160 mg ved uge 0 og 80 mg ved uge 2
English: Step 14 - Push plunger to inject solution Let go of the squeezed skin.
Danish: Trin 14 - Tryk stemplet ned for at injicere opløsningen Slip huden.
English: Figure 3: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study
Danish: Figur 3: Kaplan-Meier-kurver, opsummerende tid til behandlingssvigt i det pædiatriske uveitis-studie
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Danish: I studie UC-I blev 390 TNF-antagonist-naïve patienter randomiseret til at få enten placebo ved uge 0 og 2, 160 mg adalimumab ved uge 0 efterfulgt af 80 mg ved uge 2, eller 80 mg adalimumab ved uge 0 efterfulgt af 40 mg ved uge 2.
English: 6 months 12 months
Danish: 6 måneder
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 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: Insert the syringe tip into the vial adapter and twist it clockwise until firmly attached.
Danish: Indsæt spidsen af sprøjten i hætteglasadapteren, og drej sprøjten med uret, indtil den sidder fast.
English: Hulio is also available as a pre-filled syringe or a pre-filled pen.
Danish: Hulio fås også som fyldt injektionssprøjte eller fyldt pen.
English: 6 months 6.7% 52.4% 8.2% 22.1% 9.5% 39.1% 12 months
Danish: 6 måneder 6,7% 52,4% 8,2% 22,1% 9,5% 39,1% 12 måneder NA NA NA NA 9,5% 41,5% ACR 70
English: Table 8: Ped ACR 30 Responses in the JIA study
Danish: Tabel 8: Pædiatrisk ACR 30-respons i JIA-studiet
English: DO NOT try to reinsert the white plunger rod.
Danish: PRØV IKKE at sætte det hvide stempel tilbage i sprøjten.
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 plaquepsoriasis (≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI ) ≥ 12 eller ≥ 10), som var kandidater til systemisk behandling eller lysbehandling i randomiserede, dobbeltblindede studier.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - VIAL MULTIPACK (WITH BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - HÆTTEGLAS MULTIPAKNING (MED BLÅ BOKS)
English: Hulio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Danish: Hulio er indiceret til behandling af pædiatrisk kronisk non-infektiøs anterior uveitis hos børn fra 2 år, som har haft utilstrækkeligt respons på konventionel behandling eller, som er intolerante eller, som ikke er egnet til konventionel behandling.
English: Table 16: ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Danish: Tabel 16: ACR-respons i placebokontrollerede psoriasisartrit-studier (Procentdel af patienter)
English: Their doctor may recommend temporarily stopping Hulio.
Danish: Lægen kan anbefale midlertidig afbrydelse af behandling med Hulio.
English: ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo.
Danish: ***, **, * Statistisk signifikant ved henholdvis p < 0,001, < 0,01 og < 0,05 for alle sammenligninger mellem adalimumab og placebo.
English: After injection, if slight bleeding occurs from the injection site, lightly press a gauze or cotton ball against the site for a few seconds.
Danish: Hvis det bløder lidt efter injektionen, kan du presse en vatkugle eller en gazeserviet let mod huden i et par sekunder.
English: All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Danish: Alle patienter fik åben induktionsbehandling med doser baseret på deres baseline-legemsvægt: henholdsvis 160 mg ved uge 0 og 80 mg ved uge 2 til patienter ≥ 40 kg og 80 mg henholdsvis 40 mg til patienter < 40 kg.