FrancophonIA/ELRC3.0 huggingface dataset:
English: o DO NOT use the pen if the liquid is cloudy, discoloured, or has particles in it.
Danish: o BRUG IKKE pennen, hvis væsken er grumset, misfarvet eller indeholder partikler.
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2° - 8°C).
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/ml with concomitant methotrexate.
Danish: Efter administration af 24 mg/m2 (op til maksimalt 40 mg) subkutant hver anden uge til patienter med entesopatirelateret artrit i alderen 6 til 17 år var den gennemsnitlige dal-serumkoncentration ved steady state af adalimumab (målt ved uge 24) 8,8 ± 6,6 μg/ml for adalimumab uden samtidig methotrexat og 11,8 ± 4,3 μg/ml med samtidig methotrexat.
English: Table 9: Radiographic Mean Changes Over 12 Months in RA Study III
Danish: Tabel 9: Gennemsnitlige radiografiske ændringer gennem 12 måneder i RA-studie III
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: Gennemsnitlige dal-niveauer på omtrent 8 μg/ml ved steady state blev set hos patienter med Crohns sygdom, som fik vedligeholdelsesdosis på 40 mg adalimumab hver anden uge.
English: In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 μg/ml.
Danish: Hos voksne patienter med uveitis resulterede en startdosis på 80 mg adalimumab i uge 0 efterfulgt af 40 mg adalimumab hver anden uge fra uge 1 i en gennemsnitskoncentration på ca. 8-10 μg/ml ved steady state.
English: • bleeding in the stomach;
Danish: • blodprop i lungerne;
English: Hulio 40 mg injection adalimumab Subcutaneous use SC
Danish: Hulio 40 mg injektionsvæske adalimumab
English: If needed, cover the injection site with a plaster.
Danish: Du kan eventuelt sætte et plaster på injektionsstedet.
English: The safety and efficacy of adalimumab were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double-masked, placebo-controlled studies (UV I and II).
Danish: Adalimumabs sikkerhed og effekt blev undersøgt i to randomiserede, dobbeltblindede, placebokontrollerede studier (UV I og II) hos voksne patienter med non-infektiøs intermediær, posterior og panuveitis, patienter med isoleret anterior uveitis blev ekskluderet.
English: However, some may be serious and require urgent medical treatment.
Danish: De fleste bivirkninger er af let til moderat grad. Der kan dog forekomme mere alvorlige bivirkninger, som kræver øjeblikkelig behandling.
English: This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 0,8 ml dosis, dvs. det er i det væsentlige ”natriumfri”.
English: • 80 mg at week 0 and 40 mg at week 2
Danish: • 80 mg ved uge 0 og 40 mg ved uge 2
English: If this dose does not work well enough, your child's doctor may increase the dose frequency to 20 mg every week.
Danish: Hvis denne dosis ikke virker godt nok, vil dit barns læge muligvis øge dosis til 20 mg en gang om ugen.
English: Table 7: ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Danish: Tabel 7: ACR-respons i placebokontrollerede studier (Procent af patienter)
English: In monotherapy, some patients who experience a decrease in their response to Hulio 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Danish: Ved adalimumab alene kan det være en fordel for visse patienter, der oplever faldende respons på Hulio 40 mg hver anden uge, at øge dosis til 40 mg adalimumab hver uge eller 80 mg hver anden uge.
English: The pre-filled syringes should be stored in the fridge (between 2°C to 8°C).
Danish: Den fyldte injektionssprøjte bør opbevares i køleskab (2°C til 8°C).
English: Twist the syringe until the needle is firmly attached.
Danish: Drej sprøjten, indtil kanylen sidder fast.
English: • 6 pre-filled pens (with 6 alcohol pads)
Danish: • 6 fyldte penne (med 6 alkoholservietter)
English: Pull the needle cap straight off the pen.
Danish: Fjern din tommelfinger fra stemplet.
English: Step 10 - Flip down pink needle cover and remove needle cap Hold the syringe with the needle pointing up.
Danish: Trin 10 - Pres det lyserøde kanylehus ned og fjern kanylehætten Tag fat i sprøjten med kanylen pegende opad.
English: • stroke;
Danish: • rysten;
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6± 5.6 μg/ml (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 μg/ml (47.7% CV) with concomitant methotrexate.
Danish: Efter administration af 24 mg/m2 (op til maksimalt 40 mg) subkutant hver anden uge til patienter med polyartikulær juvenil idiopatisk artrit (JIA), som var 4 til 17 år, var den gennemsnitlige dalserumkoncentration ved steady state (værdier målt fra uge 20 til 48) af adalimumab 5,6 ± 5,6 μg/ml (102%CV) for adalimumab uden samtidig methotrexat og 10,9 ± 5,2μg/ml (47,7% CV) med samtidig methotrexat.
English: Table 9: ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Danish: Tabel 9: ACR-respons i placebokontrollerede studier (Procent af patienter)
English: In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg eow thereafter, and 246 patients received placebo.
Danish: I studie UC-II fik 248 patienter 160 mg adalimumab ved uge 0, 80 mg ved uge 2 og derefter 40 mg hver anden uge.
English: In controlled Phase 3 trials of adalimumab in patients with plaque psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of adalimumabtreated patients and 1.8% of control-treated patients.
Danish: I kontrollerede fase 3-studier med adalimumab hos patienter med plaque-psoriasis med en kontrolperiode på 12 til 24 uger forekom ALAT-stigninger ≥ 3 x ULN hos 1,8% af de adalimumabbehandlede patienter og hos 1,8% af de kontrol-behandlede patienter.
English: Step 9 - Dispose syringe & cap Dispose of the used syringe and cap in an approved sharps disposal container.
Danish: Trin 9 - Bortskaffelse af sprøjte & hætte Den brugte injektionssprøjte og hætte lægges i en særlig kanyleboks.
English: Each vial contains one 40 mg dose of adalimumab.
Danish: Et hætteglas indeholder 40 mg adalimumab.
English: If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
Danish: Hvis der kommer nye hudlæsioner under eller efter behandlingen, skal du fortælle det til din læge.
English: Disease-related hospitalisations and surgeries were statistically significantly reduced with adalimumab compared with placebo at week 56.
Danish: Ved uge 56 var sygdomsrelaterede indlæggelser og antallet af operationer reduceret statistisk signifikant med adalimumab sammenlignet med placebo.
English: Table 11: Radiographic Mean Changes Over 12 Months in RA Study III
Danish: Tabel 11: Gennemsnitlige radiografiske ændringer gennem 12 måneder i RA-studie III
English: Adolescents with hidradenitis suppurativa from 12 years of age, weighing at least 30 kg
Danish: Unge med hidrosadenitis suppurativa fra 12 år, som vejer 30 kg eller mere
English: Do not mix any other medicine into the same syringe or vial with the Hulio solution.
Danish: Hulio-injektion må ikke blandes med anden medicin i samme sprøjte eller hætteglas.
English: • DO NOT shake the syringe.
Danish: • RYST IKKE sprøjten.
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine.
Danish: Ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis er inflammatoriske (betændelseslignende) sygdomme i rygsøjlen.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)*
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of adalimumab-treated patients and 1.6% of control-treated patients.
Danish: I kontrollerede kliniske fase 3-studier med adalimumab hos patienter med reumatoid artrit og psoriasisartrit med en kontrolperiode på 4 til 104 uger forekom ALAT-stigninger ≥ 3 x ULN hos 3,7% af de adalimumab-behandlede patienter og hos 1,6% af de kontrol-behandlede patienter.
English: Hulio is used to treat psoriatic arthritis in adults.
Danish: Hulio bruges til at behandle psoriasisartrit hos voksne.
English: 1 sterile injection syringe 1 sterile needle
Danish: 1 steril injektionssprøjte 1 steril kanyle
English: o DO NOT use other heat sources such as a microwave oven or hot water to warm the vial.
Danish: o OPVARM IKKE Hulio-hætteglasset på nogen måde i f.eks. mikroovn eller varmt vand.
English: Injection steps
Danish: Injektionstrin
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see section 5.1).
Danish: Benefit/risk-forholdet ved fortsat langtidsbehandling skal løbende evalueres (se pkt.
English: • 1 vial adapter (2)
Danish: • 1 hætteglasadapter (2)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1319/007
English: Cerebrovascular accident 1), tremor, neuropathy
Danish: tremor, neuropati
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 ved uge 0 efterfulgt af 40 mg hver anden uge med start i uge 1) i op til 80 uger med en gennemsnitlig behandlingstid 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: Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Danish: Fortsat behandling bør overvejes nøje, hvis patienten ikke responderer inden for denne periode.
English: • Once syringe is firmly attached to the needle, remove the clear needle packaging.
Danish: • Tag den klare emballage af kanylen.
English: Each pre-filled syringe has a safety feature, this will retract and cover the needle after the plunger is released.
Danish: Den fyldte injektionssprøjte har en sikkerhedsfunktion (kanylehus), så kanylen efter injektionen automatisk trækkes tilbage og dækkes.
English: Adalimumab 40 mg eow N=814 n (%)
Danish: Adalimumab 40 mg/kg hver anden uge N=814 n (%)
English: NAME OF THE MEDICINAL PRODUCT Hulio 40 mg/0.8 ml solution for injection adalimumab
Danish: LÆGEMIDLETS NAVN Hulio 40 mg/0,8 ml injektionsvæske, opløsning adalimumab
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1319/008
English: Hulio 40 mg solution for injection in pre-filled syringe Hulio 40 mg solution for injection in single-use pre-filled syringe with an automatic needle guard.
Danish: Hulio 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte Hulio 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte med automatisk kanylebeskyttelse.
English: Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
Danish: Behandling ud over 16 uger skal nøje overvejes hos patienter, som ikke responderer inden for denne periode.
English: Hulio 40 mg solution for injection in pre-filled syringe Hulio 40 mg solution for injection in pre-filled pen
Danish: Hulio 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte Hulio 40 mg injektionsvæske, opløsning i fyldt pen
English: NAME OF THE MEDICINAL PRODUCT Hulio 40 mg solution for injection in pre-filled pen adalimumab
Danish: LÆGEMIDLETS NAVN Hulio 40 mg injektionsvæske, opløsning i fyldt pen adalimumab
English: Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Danish: Hulio er indiceret til behandling af aktiv moderat til svær hidrosadenitis suppurativa (svedkirtelbetændelse) hos voksne og unge fra 12 år, hvor responset på konventionel systemisk HSbehandling har været utilstrækkelig (se pkt.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 20.
Danish: Studiets primære effektmål var klinisk remission ved uge 26, defineret som PCDAI score ≤ 10. Rater for klinisk remission og klinisk respons (defineret som reduktion i PCDAI-score på mindst 15 point fra baseline) er vist i tabel 20.
English: EU/1/18/1319/006 6 pack
Danish: EU/1/18/1319/006 6 æsker
English: A 40 mg paediatric vial is available for patients who need to administer less than the full 40 mg dose.
Danish: Hulio fås også som et 40 mg hætteglas til pædiatriske patienter, der skal have en dosis, der ligger under den fulde dosis på 40 mg.
English: The Hulio pre-filled pen is made of plastic with a stopper and a needle with a needle cap. Each pack contains 1, 2 or 6 pre-filled pens with 2, 2 or 6 alcohol pads.
Danish: Hver pakning indeholder 1, 2 eller 6 fyldte penne med 2, 2 eller 6 alkoholservietter.
English: Hypersensitivity, allergies (including seasonal allergy)
Danish: Overfølsomhed, allergier (inklusive sæsonbestemt allergi) Ikke almindelig Sarkoidose1) vasculitis
English: 56 patients (69.1%) had ACR 50 responses; and 43 patients (53.1%) had ACR 70 responses.
Danish: Blandt disse havde 64 patienter (79,0%) ACR 20-respons, 56 patienter (69,1%) ACR 50-respons og 43 patienter (53,1%) ACR 70-respons.
English: CD Study I and CD Study II induction of remission and response rates are presented in Table 22.
Danish: Tabel 22 viser rater for induktion af remission og respons i CD-studie I og CD-studie II.
English: • muscle spasms;
Danish: • muskelkramper;
English: • gallbladder inflammation, gallbladder stones;
Danish: • betændelse i galdeblæren, galdesten;
English: Adalimumab 40 mg eow N=108 n (%)
Danish: Adalimumab 40 mg/kg hver anden uge N=108 n (%)
English: Throwing away supplies
Danish: Bortskaffelse af udstyr
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Hulio 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Danish: Hulio 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt 0,8 ml enkeltdosis-injektionssprøjte indeholder 40 mg adalimumab.
English: Children or adolescents from 6 to 17 years weighing less than 40 kg:
Danish: Børn og unge fra 6 til 17 år, der vejer mindre end 40 kg:
English: Adolescents with hidradenitis suppurativa (from 12 to 17 years of age, weighing at least 30 kg)
Danish: Unge med hidrosadenitis suppurativa fra 12 til 17 år, som vejer 30 kg eller mere)
English: The usual dose regimen is 80 mg initially (as two 40 mg injections in one day), followed by 40 mg two weeks later.
Danish: Den sædvanlige startdosis er 80 mg (som to 40 mg injektioner på samme dag), efterfulgt af 40 mg 2 uger senere.
English: The recommended dose of Hulio for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Danish: Den anbefalede Hulio-dosis til voksne patienter med uveitis er en startdosis på 80 mg efterfulgt af 40 mg hver anden uge med start en uge efter den første dosis.
English: Preparing the pre-filled syringe
Danish: Vedligeholdt slimhindeheling
English: The recommended Hulio induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Danish: Det anbefalede Hulio dosis-induktionsregime til voksne patienter med moderat til svær colitis ulcerosa er 160 mg ved uge 0 (givet som fire 40 mg injektioner på en dag eller som to 40 mg injektioner pr. dag i to på hinanden følgende dage) og 80 mg ved uge 2 (givet som to 40 mg injektioner på en dag).
English: In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 μg/ml during the induction period.
Danish: Hos patienter med Crohns sygdom, blev der i induktionsperioden med induktionsregime på 80 mg adalimumab i uge 0 fulgt af 40 mg adalimumab i uge 2, opnået dal-serumkoncentrationer af adalimumab på ca. 5,5 μg/ml.
English: DO NOT twist the needle cap.
Danish: DREJ IKKE på kanylehætten.
English: Österreich Mylan Österreich GmbH
Danish: Deutschland Mylan Healthcare GmbH
English: If these medicines do not work well enough, you will be given Hulio to reduce the signs and symptoms of your disease.
Danish: Hvis du ikke har tilstrækkelig virkning af denne medicin, kan du få Hulio for at mindske symptomerne på din sygdom.
English: Your child's doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual recommended dose.
Danish: Dit barns læge kan også ordinere en induktionsdosis på 40 mg, som kan administreres en uge før start af den sædvanlige dosis.
English: Step 9 - Detach syringe from vial adapter and attach needle Remove the vial adapter by twisting it off the syringe.
Danish: Trin 9 - Fjern hætteglasadapter fra sprøjten og påsæt kanylen Fjern hætteglasadapteren ved at dreje den af sprøjten.
English: In period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0 and 80 mg at week 2 and 40 mg every week starting at week 4 to week 11.
Danish: I periode A fik patienterne placebo eller adalimumab med en startdosis på 160 mg ved uge 0, 80 mg ved uge 2 og 40 mg hver uge fra uge 4 til uge 11.
English: Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Danish: Hulio er indiceret til behandling af aktiv moderat til svær hidrosadenitis suppurativa (svedkirtelbetændelse) hos unge patienter fra 12 år, hvor responset på konventionel systemisk HSbehandling har været utilstrækkelig (se pkt.
English: • inflammation of blood vessels in the skin;
Danish: • inflammation i hudens blodkar;
English: o DO NOT put the vial back in the fridge after it has reached room temperature.
Danish: o DU MÅ IKKE lægge hætteglasset tilbage i køleskabet efter det har været opbevaret ved stuetemperatur.
English: 1 box of Hulio vial for paediatric use
Danish: • 1 æske med Hulio hætteglas til børn
English: Hulio Dose for Paediatric Patients with Uveitis Patient Weight
Danish: Hulio-dosis til pædiatriske patienter med uveitis Patientvægt
English: The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially, followed by 40 mg every other week starting two weeks later.
Danish: Startdosis for Crohns sygdom er sædvanligvis 80 mg (som to 40 mg injektioner på samme dag), efterfulgt af 40 mg hver anden uge startende 2 uger senere.
English: • 1 pre-filled pen (with 2 alcohol pads)
Danish: • 1 fyldt pen (med 2 alkoholservietter)
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (Psoriasis Study III).
Danish: Adalimumabs sikkerhed og virkning er også blevet undersøgt i et randomiseret dobbeltblindet studie (Psoriasisstudie III) med voksne patienter med moderat til svær kronisk plaque-psoriasis og samtidig psoriasis på hænder og/eller fødder, som var kandidater til systemisk behandling.
English: Fill Marker
Danish: Nedsat helingsevne
English: Each pre-filled syringe or pre-filled pen contains 38.2 mg sorbitol (E420).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver fyldt injektionssprøjte eller fyldt pen indeholder 38,2 mg sorbitol (E420).
English: The double-blind period is followed by an openlabel (OL) period during which patients received 24 mg/m2 BSA of adalimumab up to a maximum of
Danish: Den dobbeltblindede periode blev efterfulgt af en åben periode (OL), hvor patienterne fik adalimumab 24 mg/m2 legemsoverfladeareal (BSA) op til maksimalt 40 mg hver anden uge subkutant i op til yderligere 192 uger.
English: Step 8 - End of injection, remove syringe
Danish: Trin 16 - Bortskaffelse af sprøjte og kanyle
English: 26 PlaceboControlled
Danish: Placebokontrollere t
English: In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomized to methotrexate monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, respectively.
Danish: I den åbne forlængelse af RA-studie V hos patienter oprindeligt randomiseret til henholdsvis methotrexat-monoterapi, adalimumab-monoterapi eller kombinationsbehandling med adalimumab og methotrexat, var den gennemsnitlige ændring fra baseline ved år 10 i modificeret Total Sharp Score10,8; 9,2 og 3,9.
English: • heart attack;
Danish: • hjertestop;
English: In period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0, 80 mg at week 2, and 40 mg every week starting at week 4 to week 11.
Danish: I periode A fik patienterne placebo eller adalimumab med en startdosis på 160 mg ved uge 0, 80 mg ved uge 2 og 40 mg hver uge ved uge 4 til uge 11.
English: The recommended Hulio dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Danish: Det anbefalede Hulio dosisregime til voksne patienter med hidrosadenitis suppurativa (HS) er 160 mg ved dag 1 (givet som fire injektioner á 40 mg på en dag eller som to injektioner á 40 mg pr. dag i to på hinanden følgende dage), efterfulgt af 80 mg to uger senere ved dag 15 (givet som to injektioner á 40 mg på en dag).
English: A loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/ml during the induction period.
Danish: Ved et induktionsregime på 160 mg adalimumab ved uge 0 fulgt af 80 mg adalimumab ved uge 2 blev der opnået dal-serumkoncentrationer af adalimumab på ca. 12 μg/ml i induktions-perioden.
English: Check with your healthcare provider for instructions on how to properly dispose of a filled sharps container.
Danish: Spørg din læge, sygeplejerske eller apotekspersonale om, hvordan kanyleboksen bortskaffes på forsvarlig vis.
English: Continued therapy should be carefully considered in a subject not responding by week 12.
Danish: Fortsat behandling bør overvejes nøje hos patienter, som ikke responderer inden for 12 uger.