FrancophonIA/ELRC3.0 huggingface dataset:
English: Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis
Danish: Ikke almindelig Neurologiske infektioner (inklusive viral meningitis, opportunistiske infektioner og tuberkulose (inklusive kokcidioidomykose, histoplasmose og mycobakterium avium complex-infektion), bakterielle infektioner, øjeninfektioner, diverticulitis1)
English: Low Dose 20/10 mg eow N = 95
Danish: Lav-dosis 20/10 mg hver anden uge N = 95
English: Room spinning sensation and vision disturbances may occur after taking Humira.
Danish: Du kan få synsforstyrrelser og en fornemmelse af at rummet drejer rundt efter at have taget Humira.
English: • leukemia (cancer affecting the blood and bone marrow);
Danish: • leukæmi (kræft som påvirker blod og knoglemarv);
English: Humira is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Danish: Humira bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6-17 år.
English: • reactivation of hepatitis B
Danish: • genopblussen af hepatitis B
English: • You will need a special container for waste, such as a sharps container or as instructed by your nurse, doctor or pharmacist.
Danish: • Du har brug for en særlig beholder til medicin affald, som fx en kanyle boks eller som din læge, sygeplejerske eller farmaceut har instrueret dig.
English: Humira is administered by injection under the skin (by subcutaneous injection).
Danish: Humira indgives ved injektion under huden (subkutan injektion).
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
Danish: • luftvejsinfektioner (inklusive forkølelse, løbende næse, bihulebetændelse, lungebetændelse)
English: • DO NOT pull the white plunger rod completely out of the syringe.
Danish: • Træk IKKE stemplet helt ud af sprøjten.
English: Tell your doctor immediately if you notice any of the following
Danish: Kontakt omgående lægen, hvis du får følgende symptomer
English: Insert the needle all the way into the skin at about a 45-degree angle with one quick, short motion.
Danish: Pres kanylen med en hurtig, kort bevægelse helt ind i huden i en vinkel på 45°.
English: SPARCC MRI Spine d,j
Danish: SPARCCh MRI sakroiliakaleddened,i
English: The results for the 40 mg every other week dose are summarised in Table 4.
Danish: Resultaterne for 40 mg hver anden uge er opstillet i tabel 4.
English: If a faster response is required, your child's doctor may prescribe a first dose of 160 mg, followed by 80 mg two weeks later.
Danish: Hvis et hurtigere respons er nødvendigt, kan dit barns læge ordinere en startdosis på 160 mg, efterfulgt af 80 mg 2 uger senere.
English: Suomi/Finland AbbVie Oy
Danish: България АбВи ЕООД
English: • musculoskeletal pain
Danish: • muskuloskeletale smerter
English: • Do not attempt to inject your child until you are sure that you understand how to prepare and give the injection.
Danish: • Forsøg ikke at injicere dit barn, før du er sikker på, hvordan du skal forberede og give injektionen.
English: • Rheumatoid arthritis,
Danish: • Reumatoid artrit,
English: • Vaccinations: if possible children should be up to date with all vaccinations before using Humira.
Danish: • Vaccinationer: hvis det er muligt, skal dit barn føres ajour med alle vaccinationer, før behandling med Humira startes.
English: The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Danish: Øvrige indholdsstoffer: mannitol, citronsyremonohydrat, natriumcitrat, natriumdihydrogenphosphatdihydrat, dinatriumphosphatdihydrat, natriumchlorid, polysorbat 80, natriumhydroxid og vand til injektionsvæske.
English: Do not use the pre-filled pen and call your doctor or pharmacist if the
Danish: Blommefarvet aktiveringsknap Brug ikke den fyldte pen og kontakt din læge eller apotekspersonalet, hvis
English: 1 sterile injection syringe 1 sterile needle 1 sterile vial adapter 2 alcohol pads
Danish: 1 steril injektionssprøjte 1 steril kanyle 1 steril hætteglasadapter 2 alkoholservietter
English: Tell your doctor immediately if your child experiences symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.
Danish: Fortæl straks din læge, hvis dit barn oplever ændringer i sit syn, svaghed i arme eller ben eller følsesløshed eller en snurrende fornemmelse et sted i kroppen.
English: Excipients: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Danish: Hjælpestoffer: mannitol, citronsyremonohydrat, natriumcitrat, natriumdihydrogenphosphatdihydrat, dinatriumphosphatdihydrat, natriumchlorid, polysorbat 80, natriumhydroxid og vand til injektionsvæsker.
English: • While still holding the syringe upright at the graduated area, remove the vial adapter with the vial by twisting the vial adapter off with the other hand.
Danish: • Mens du stadig holder sprøjten på områet med inddelinger og med spidsen opad, fjernes hætteglasadapteren med hætteglas ved at dreje den af med den anden hånd.
English: Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
Danish: Forsøg ikke at injicere dig selv, før du er sikker på, hvordan du skal forberede og give injektionen.
English: Leukopenia (including neutropenia and agranulocytosis), anaemia
Danish: Blod og lymfesystem * Meget almindelig Leukopeni (inklusive neutropeni og agranulocytose), anæmi
English: An asterisk (*) appears in the SOC column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Danish: En stjerne (*) i systemorganklassekolonen indikerer, at der findes yderligere information andre steder i pkt.
English: Humira is used to treat rheumatoid arthritis in adults.
Danish: Humira bruges til at behandle reumatoid artrit hos voksne.
English: Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
Danish: Psoriasisartrit er en betændelsessygdom i leddene, som er forbundet med psoriasis.
English:  PASI 75
Danish: PASI 75b
English: • DO NOT touch the needle.
Danish: • Rør IKKE ved kanylen
English: • vasculitis (inflammation of blood vessels)
Danish: • vaskulitis (betændelse i blodkar)
English: The recommended Humira dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Danish: Den anbefalede Humira-dosis til patienter med plaque-psoriasis fra 4 til 17 år er baseret på legemsvægt (tabel 3).
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of Humira.
Danish: Ved brug af Humira er der også rapporteret om letale og livstruende infektioner (inklusive sepsis, opportunistiske infektioner og tuberkulose), HBV-reaktivering og forskellige maligniteter (inklusive leukæmi, lymfomer og hepatosplenisk T-celle-lymfom).
English: • autoantibodies present in the blood
Danish: • tilstedeværelse af autoantistoffer i blodet
English: Disease-related hospitalisations and surgeries were statistically significantly reduced with adalimumab compared with placebo at Week 56.
Danish: I uge 56 var sygdomsrelaterede indlæggelser og antallet af operationer reduceret statistisk signifikant med adalimumab sammenlignet med placebo.
English: • Push the white plunger rod all the way back in to push the liquid medication back into the vial.
Danish: • Skub stempelstangen tilbage igen for at få medicinen tilbage i hætteglasset.
English: • opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
Danish: • opportunistiske infektioner (som inkludererer tuberkulose og andre infektioner, som forekommer, når modstandskraften mod sygdom er nedsat)
English: First dose of 40 mg, followed by 40 mg one week later.
Danish: Startdosis på 40 mg, efterfulgt af 40 mg en uge senere.
English: Humira is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Danish: Humira er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos voksne patienter, som på trods af et fuldt og adækvat behandlingsforløb med glukokortikoid og/eller immunsuppressivum ikke har responderet tilfredsstillende, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: STEP 6
Danish: TRIN 6
English: • For example, if the prescribed dose is 0.5 ml, DO NOT push the white plunger rod past the 0.5 ml position.
Danish: • Hvis barnet fx skal have en dosis på 0,5 ml, må du IKKE skubbe den hvide stempelstang længere end til 0,5 mærket
English: The patients received 24 mg/m2 body surface area (BSA) of Humira up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks.
Danish: Patienterne fik Humira 24 mg/m2 legemsoverfladeareal op til maksimalt 20 mg som subkutan injektion hver anden uge i mindst 24 uger.
English: In the open-label extension, improvement in the signs and symptoms was maintained with Humira therapy through Week 156.
Danish: Forbedring af tegn og symptomer blev opretholdt med Humira-behandling i den åbne forlængelsesfase op til uge 156.
English: Your doctor may tell you to stop using Humira for some time.
Danish: Din læge kan bede dig om midlertidigt at stoppe med at tage Humira.
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg Humira on Week 0 followed by 80 mg on Week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/ml at Week 2 and Week 4.
Danish: Hos voksne patienter med hidrosadenitis suppurativa blev der med en dosis på 160 mg Humira i uge 0 efterfulgt af 80 mg ved uge 2 opnået dal-serumkoncentrationer af adalimumab på ca. 7 til 8 μg/ml ved uge 2 og uge 4.
English: • opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered);
Danish: • opportunistiske infektioner (som inkludererer tuberkulose og andre infektioner, som forekommer, når modstandskraften mod sygdom er nedsat);
English: • sensation of heart beating irregularly such as skipped beats
Danish: • fornemmelse af uregelmæssige hjerteslag såsom oversprungne slag
English: • You will need a special container for waste, such as a sharps container or as instructed by your nurse,
Danish: • Du har brug for en særlig beholder til medicinaffald, såsom en kanyleboks eller som lægen,
English: Hold the pre-filled pen with the grey cap (1) pointing up.
Danish: Hold den fyldte pen med den grå hætte (1) pegende opad.
English: Do not touch the area again before injecting.
Danish: Berør ikke området igen før injektionen
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of Humira in paediatric patients with plaque psoriasis.
Danish: Der forekom ingen ALAT-stigninger ≥ 3 x ULN i fase 3-studier af Humira hos pædiatriske patienter med plaque-psoriasis.
English: • Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
Danish: • Forsøg ikke at injicere dig selv, før du er sikker på, hvordan du skal forberede og give injektionen.
English: The recommended dose of Humira is 40 mg every other week.
Danish: Den anbefalede dosis Humira er 40 mg hver anden uge.
English: Pull the plum safety cap (labelled ‘2') straight off to expose the plum coloured activation button.
Danish: Træk den blommefarvede sikkerhedshætte (mærket '2') lige af.
English: • eye infections
Danish: • øjeninfektioner
English: Humira is administered by subcutaneous injection.
Danish: Humira administreres som subkutan injektion.
English: Myocardial infarction arrhythmia, congestive heart failure
Danish: Ikke almindelig Myokardieinfarkt1), arytmi,kongestiv hjertesvigt Sjælden
English: • People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
Danish: • Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (kræft som påvirker lymfesystemet) og leukæmi (kræft som påvirker blod og knoglemarv).
English: • With your free hand, pick up the needle package with the yellow syringe connector facing down.
Danish: • Tag pakningen med kanylen op med din frie hånd, den gule vedhæftning til sprøjten skal vende nedad.
English: • Do not use the pre-filled syringe if the liquid is cloudy or has particles
Danish: • Brug ikke den fyldte injektionssprøjte, hvis væsken er uklar eller indeholder partikler
English: Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patientswho are candidates for systemic therapy.
Danish: Humira er indiceret til behandling af moderat til svær kronisk plaque-psoriasis hos voksne patienter, hvor systemisk behandling er relevant.
English: STEP 4
Danish: TRIN 4
English: In patients not given concomitant methotrexate, the incidence was 13.5% (24/178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate.
Danish: Hos patienter, der ikke samtidig fik methotrexat, var forekomsten 13,5 % (24/178 patienter), sammenlignet med 7 % (14 ud af 198 patienter), når adalimumab blev anvendt som tillæg til methotrexat.
English: • low blood measurements for phosphate
Danish: • lave blodmålinger af fosfat
English: The recommended adolescent HS dosing schedule is 40 mg every other week.
Danish: Det anbefalede HS-doseringsregime til unge er 40 mg Humira hver anden uge.
English: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight
Danish: Reumatoid artrit, psoriasisartrit, ankyloserende spondylitis eller aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis Alder eller vægt
English: The recommended dose of Humira is an initial dose of 20 mg, followed by 20 mg one week later.
Danish: Den anbefalede startdosis af Humira er 20 mg, efterfulgt af 20 mg en uge senere.
English: Humira Dose for Patients with Enthesitis-Related Arthritis
Danish: Humira-dosis til patienter med entesopati relateret artrit Patient vægt
English: Figure 1: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II)
Danish: Figur 1: Kaplan-Meier- kurver opsummere tid til behandlingssvigt i eller efter uge 6 (Studie UV I) eller uge 2 (Studie UV II)
English: In controlled and open label adult and paediatric studies with Humira, 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 Humira 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: STEP 7
Danish: TRIN 7
English: Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section
Danish: Humira er indiceret til behandling af aktiv entesopatirelateret artrit hos patienter fra 6 år, som har haft et utilstrækkeligt respons på, eller som er intolerante over for, konventionel behandling (se pkt.
English: In patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years, anti-adalimumab antibodies were identified in 15.8% (27/171) of patients treated with adalimumab.
Danish: Hos patienter med polyartikulær juvenil idiopatisk arthritis, som var fra 4 til 17 år, blev der påvist antistoffer mod adalimumab hos 15,8 % (27/171) af patienterne, der blev behandlet med adalimumab.
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at Weeks 0 and 2, 160 mg Humira at Week 0 followed by 80 mg at Week 2, or 80 mg Humira 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 i uge 0 og 2, 160 mg Humira i uge 0 efterfulgt af 80 mg i uge 2, eller 80 mg Humira i uge 0 efterfulgt af 40 mg i uge 2.
English: Patients remained on stable doses of NSAIDs and or prednisone ( 0.2 mg/kg/day or 10 mg/day maximum).
Danish: Patienterne fortsatte på faste doser NSAID og/eller prednison (≤ 0,2 mg/kg/dag eller maksimalt
English: 2 pre-filled pens 2 alcohol pads
Danish: 2 fyldte penne 2 alkoholservietter
English: • increased uric acid in the blood
Danish: • forhøjet urinsyre i blodet
English: On rare occasions, an uncommon and severe type of lymphoma has been seen in patients taking Humira.
Danish: I sjældne tilfælde er der set en ikke almindelig og alvorlig type af lymfom hos patienter, som tog Humira.
English: You will be instructed by your child's doctor or his/her assistant on the technique of injection and the amount to give to your child. Do not attempt to give your child an injection until you are sure that you understand how to prepare and give the injection.
Danish: Dit barns læge eller dennes assistent vil instruere dig i hvordan du skal injicere dit barn og hvor meget du skal give.
English: People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukemia (a cancer that affects the blood and bone marrow).
Danish: Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (kræft som påvirker lymfesystemet) og leukæmi (kræft som påvirker blod og knoglemarv).
English: If you do not respond well enough to these medicines, you will be given Humira to treat your polyarticular juvenile idiopathic arthritis or enthesitisrelated arthritis.
Danish: Hvis du ikke reagerer tilstrækkeligt godt på disse lægemidler, vil du få Humira til behandling af din polyartikulære juvenile idiopatiske artrit eller entesopatirelateret artrit.
English: STEP 2
Danish: TRIN 2
English: Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Danish: Det får dem til at smuldre, blive fortykket og løftet fra neglelejet, hvilket kan være smertefuldt.
English: Hepatitis reactivation of hepatitis B autoimmune hepatitis
Danish: Hepatit reaktivering af hepatitis B1) autoimmun hepatit1)
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among Humira-treated patients and 0.6 (0.1, 4.5) per 1,000 patientyears among control patients.
Danish: Hos disse hudkræfttilfælde forekom planocellulært karcinom med en hyppighed (95 % konfidensinterval) på 2,7 (1,4-5,4) pr. 1.000 patientår blandt de Humira-behandlede patienter og 0,6 (0,1-4,5) pr. 1.000 patientår blandt kontrolpatienterne.
English: Look at the expiry date on the syringe.
Danish: Kontrollér udløbsdatoen på injektionssprøjten.
English: Humira is used to treat moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years.
Danish: Humira bruges til at behandle moderat til alvorlig Crohns sygdom hos børn og unge fra 6 år til 17 år.
English: • Hidradenitis suppurativa
Danish: • Hidrosadenitis suppurativa
English: Figure 2: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II)
Danish: Figur 2: Kaplan-Meier- kurver opsummere tid til behandlingssvigt i eller efter uge 6 (Studie UV I) eller uge 2 (Studie UV II)
English: Consequently, Humira can be used during breastfeeding.
Danish: Humira kan som konsekvens heraf anvendes ved amning.
English: • You might get infections more easily while you are receiving Humira treatment.
Danish: • Infektioner kan opstå lettere under behandling med Humira.
English: • abnormal blood measurements for sodium
Danish: • unormale blodmålinger af natrium
English: Squeeze the skin at your child's injection site with your other hand to make a raised area and hold it firmly.
Danish: Klem om barnets hud på injektionsstedet med den anden hånd for at hæve området og hold fast
English: Week 52 62.6% 54.4% 72.8% 0.013 < 0.001 0.043 Week 104 56.0% 49.3% 69.4% 0.002 < 0.001 0.140 ACR 50
Danish: Uge 104 56,0% 49,3% 69,4% 0,002 <0,001 0,140
English: • Push the white plunger rod gently into the syringe until the syringe contains the prescribed amount of liquid.
Danish: • Skub den hvide stempelstang forsigtigt til sprøjten kun indeholder den foreskrevne dosis.
English: It is important to tell your doctor if your child has had or has a serious heart condition (see “Warnings and precautions”).
Danish: Det er vigtigt at informere lægen, hvis dit barn har eller har haft en alvorlig hjertesygdom (se ” Advarsler og forsigtighedsregler”).
English: Please check with your doctor before your child receives any vaccines.
Danish: Tal med lægen, før dit barn får nogen form for vaccine.
English: p < 0.01
Danish: < 0,001c
English: • shortness of breath with physical activity or upon lying down or swelling of the feet
Danish: • stakåndethed ved fysisk aktivitet eller når du ligger ned, eller hævede fødder
English: • tremor (shaking)
Danish: • ødem (hævelse)
English: Humira is used to treat children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye
Danish: Humira bruges til at behandle børn fra 2 år med kronisk ikke-infektiøs uveitis (regnbuehindebetændelse), som påvirker påvirker forreste del af øjet.
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 g/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: Humira is used to treat ulcerative colitis in adults.
Danish: Humira bruges til at behandle colitis ulcerosa hos voksne.
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
Danish: • Du bør overveje brugen af passende prævention for at forhindre graviditet og fortsætte brugen mindst 5 måneder efter den sidste behandling med Humira.
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at Week 16 (see Tables 17 and 18).
Danish: I Psoriasis-studie I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75-respons i forhold til baseline ved uge 16 (se Tabel 17 og 18).
English: If these medicines do not work well enough, your child will be given Humira to treat his/her enthesitis-related arthritis.
Danish: Hvis disse lægemidler ikke virker godt nok, vil dit barn få Humira til behandling af hans/hendes entesopatirelaterede artrit.