FrancophonIA/ELRC3.0 huggingface dataset:
English: If your child develops a fever that does not go away, bruises or bleeds very easily or looks very pale, call your doctor right away.
Danish: Hvis dit barn får feber, som ikke vil forsvinde, blå mærker eller bløder meget let eller er meget bleg, skal du omgående henvende dig til din læge.
English: In the open-label extension for RA study V, ACR response rates were maintained when followed for up to 10 years.
Danish: I det åbne forlængelsesstudie RA V blev ACR respons bibeholdt når patienterne blev fulgt i op til 10 år.
English: Kromeya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Danish: Kromeya er indiceret til behandling af voksne med alvorlig aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på konventionel behandling.
English: Placebo/ MTX
Danish: Placebo/ MTXa
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: Rates of discontinuation of corticosteroids or immunomodulators are presented in Table 25.
Danish: Rater for seponering af kortikosteroider eller immunmodulerende lægemidler er vist i tabel 25.
English: Idiopathic thrombocytopenic purpura
Danish: Idiopatisk trombocytopenisk purpura
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: Kromeya 40 mg/0,8 ml injektionsvæske, opløsning til pædiatrisk brug kan opbevares ved temperaturer op til max. 25°C i en periode på op til 14 dage.
English: Note: Treatment failure at or after week 6 (study UV I), or at or after week 2 (study UV II), was counted as event.
Danish: Note: Behandlingssvigt i eller efter uge 6 (Studie UV I) eller i eller efter uge 2 (Studie UV II) blev talt med som hændelser.
English: 7.2 When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.
Danish: 7.2 Når affaldsbeholderen til skarpe genstande er næsten fuld, skal du bortskaffe den i henhold til lokale retningslinjer, der beskriver den rigtige måde at bortskaffe en affaldsbeholder til skarpe genstande.
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.
Danish: I studie UC-II var 21/41 (51%) af de adalimumab-behandlede patienter, der var i remission i uge 8, også i remission i uge 52.
English: Standard dose
Danish: Lav-dosis Standarddosis
English: 2.1 Wash your hands with soap, water and dry them well.
Danish: 2.1 Vask hænderne med sæbe og vand, og tør dem grundigt.
English: 1.7 Leave the syringe at room temperature for 30 minutes to allow the medicine to warm up.
Danish: 1.7 Lad injektionssprøjten hvile ved stuetemperatur i 30 minutter, så lægemidlet kan blive varmet op.
English: Table 16 Ps study IV efficacy results at 16, 26 and 52 weeks
Danish: Tabel 16 Ps studie IV Effektresultater ved 16, 26 and 52 uger
English: Patients received adalimumab 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1 - 0.4 mg/kg weekly (up to 25 mg).
Danish: Patienterne fik adalimumab 0,8 mg/kg hver anden uge (op til 40 mg), 0,4 mg/kg hver anden uge (op til 20 mg) eller methotrexat 0,1- 0,4 mg/kg ugentlig (op til 25 mg).
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p< 0.001) in the adalimumab group (at week 48).
Danish: Sammenlignet med placebo reducerede adalimumab progressionshastigheden, hvormed de perifere led destrueres, målt ved ændring i mTSS fra baseline (gennemsnit + SD) 0,8 ± 2,5 i placebogruppen (ved uge 24) sammenlignet med 0,0 1,9 i adalimumab-gruppen (ved uge 48) (p<0,001).
English: Figure K Warning: Do not use the syringe if:
Danish: Figur K Advarsel: Du må ikke bruge injektionssprøjten:
English: • If your child is about to have surgery or dental procedures tell your doctor that he/she is taking Kromeya.
Danish: • Hvis dit barn skal opereres eller have tandbehandling, skal du fortælle din læge, at han/hun tager Kromeya.
English: Kromeya is contraindicated in moderate to severe heart failure (see section 4.3).
Danish: Kromeya kontraindikeres ved moderat til alvorlig hjerteinsufficiens (se pkt.
English: • adults with non-infectious uveitis with inflammation affecting the back of the eye
Danish: • Voksne med ikke-infektiøs uveitis (regnbuehindebetændelse) med inflammation, som påvirker den bagerste del af øjet.
English: Warning: Do not touch the vial adapter.
Danish: Advarsel: Du må ikke røre ved adapteren.
English: The Kromeya pre-filled syringe is supplied in a glass syringe with needleguard and finger flanges.
Danish: Kromeya fyldt injektionssprøjte er en glassprøjte med kanylebeskyttelse og fingerkrave.
English: • hepatitis (liver inflammation);
Danish: • hepatitis (leverbetændelse)
English: 2.1 Wash your hands well with soap and water (Figure F) and dry them.
Danish: 2.1 Vask dine hænder grundigt med sæbe og vand (figur F) og tør dem.
English: Kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Danish: Kromeya kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtmæssig (for effektivitet ved monoterapi se pkt 5.1).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Tell your doctor if you are taking azathioprine or mercaptopurine with Kromeya.
Danish: Fortæl din læge, hvis du får lægemidlerne azathioprin eller mercaptopurin sammen med Kromeya.
English: Time to treatment failure at or after week 2 in study UV II
Danish: Tid til behandlingssvigt i eller efter uge 2 i Studie UV II
English: Clinical response (CR-100) Patients in steroid-free remission for >=90 days a
Danish: Klinisk remission Klinisk respons (CR-100) Patienter i steroid-fri remission i ≥90 dagea
English: Maintenance of remission and response rates are presented in Table 21.
Danish: Rater for vedligeholdelse af remission- og respons er vist i Tabel 21.
English: Step 5 Clean the Injection Site
Danish: Trin 5 Rengør injektionsstedet
English: The recommended Kromeya induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Danish: Det anbefalede Kromeya induktions-dosis-regime til voksne patienter med moderat til svær aktiv Crohns sygdom er 80 mg i uge 0 efterfulgt af 40 mg i uge 2.
English: • If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Kromeya.
Danish: • Hvis dit barn har eller udvikler demyeliniserende sygdom (en sygdom, der påvirker det isolerende lag rundt om nerverne såsom dissemineret sklerose) vil din læge afgøre, om han/hun skal have eller fortsætte med at få Kromeya.
English: You are advised to avoid becoming pregnant and must use adequate contraception while using Kromeya and for at least 5 months after the last Kromeya injection.
Danish: Du rådes til at undgå at blive gravid og skal bruge passende prævention, imens du bruger Kromeya og i mindst 5 måneder efter sidste Kromeya injektion.
English: • If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Kromeya.
Danish: • Hvis du har eller udvikler demyeliniserende sygdom (en sygdom, der påvirker det isolerende lag rundt om nerverne såsom dissemineret sklerose) vil din læge afgøre, om du skal have eller fortsætte med at få Kromeya.
English: Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Danish: Tilgængelige data tyder på, at klinisk respons normalt opnås inden for 12 ugers behandling.
English: If these medicines do not work well enough, you will be given Kromeya to treat your rheumatoid arthritis.
Danish: Hvis disse lægemidler ikke virker godt nok, kan du få Kromeya til behandling af din reumatoide artrit.
English: If you think your child may be pregnant or is planning to have a baby, ask your doctor or pharmacist for advice before they use this medicine.
Danish: Hvis dit barn er gravid eller ammer, har mistanke om, at dit barn er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før de tager dette lægemiddel.
English: Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Danish: Plaque-psoriasis er en hudlidelse, som forårsager røde, skællende, skorpede pletter på huden dækket med sølvfarvede skæl.
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia pruritus
Danish: Forværring eller nye udbrud af psoriasis (herunder palmoplantar pustuløs psoriasis) 1), urticaria, tendens til blå mærker (inklusive purpura), dermatitis (inklusive eksem), onychoclasis, hyperhidrosie alopeci1), pruritus
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 14 and 15).
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 14 og 15).
English: Kromeya dose for paediatric patients with Crohn's disease
Danish: Kromeya-dosis til pædiatriske patienter med Crohns sygdom
English: 6.1 Remove the needle cap • Hold the pre-filled pen upwards and pull the needle cap straight off (Figure L).
Danish: 6.1 Fjern kanylehætten • Hold pennen, så den peger opad, og træk kanylehætten lige af (figur L).
English: It is important that you tell her baby's doctors and other health care professionals about her Kromeya use during her pregnancy before the baby receives any vaccine (for more information see section on vaccination).
Danish: Det er vigtigt, at du fortæller hendes spædbarns læge og andre sundhedspersoner, at hun fik Kromeya under graviditeten, før spædbarnet får nogen vaccinationer (for mere information, se afsnittet om vaccinationer).
English: Via delle Magnolie 15 Loc. frazione Zona Industriale 70026 - Modugno (BA) Italy
Danish: Loc. frazione Zona Industriale 70026 - Modugno (BA) Italien
English: 2.5 Wipe the entire vial top with an alcohol pad and throw the pad away.
Danish: 2.5 Aftør hele toppen af hætteglasset med en spritserviet, og smid servietten ud.
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Danish: Der er endvidere rapporteret melanom og Merkelcelle karcinom hos patienter i behandling med TNF-antagonister inklusive adalimumab (se pkt.
English: • Do not use an Kromeya pre-filled syringe that has been frozen or left in direct sunlight.
Danish: • Du må ikke bruge en Kromeya fyldt injektionssprøjte, der har været frossen eller har ligget i direkte sollys.
English: • Always hold the syringe by the clear needle guard.
Danish: • Tag altid fat om injektionssprøjten ved den gennemsigtige kanylebeskyttelse.
English: • The expiration date on the vial has passed.
Danish: • hvis udløbsdatoen på etiketten er overskredet.
English: p value*
Danish: P-værdi*
English: Put it on a clean flat surface.
Danish: Læg den på en ren, plan flade.
English: 7.2 Throw away the used syringe with the protected needle and the vial with attached vial adapter into a sharps container.
Danish: 7.2 Kassér den brugte sprøjte med den sikrede kanyle og hætteglasset med fastgjort adapter i affaldsbeholderen til skarpe genstande.
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Danish: PASI 75 og PGA clear eller minimal steg med stigende adalimumab-koncentration, begge med sammenlignelig tilsyneladende EC50 på omkring 4,5 μg/ml (henholdsvis 95% CI 0,4-47,6 og
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 g/ml for patienter  40 kg (160/80 mg) og 10,6±6,1 g/ml for patienter < 40 kg (80/40 mg).
English: The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 11.
Danish: Fordelingen af patienter i henhold til alder samt modtaget minimums-, median- og maksimumsdosis i den åbne indkøringsfase er vist i tabel 11.
English: JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1)
Danish: Erosion score 3,7 (2,7-4,7) 1,7 (1,0-2,4) 0,8 (0,4-1,2) < 0,001 0,0082 < 0,001
English: • cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
Danish: • kræft inclusive kræft, der rammer lymfesystemet (lymfom) og modermærkekræft
English: Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
Danish: Hos patienter i adalimumab-behandling blev signifikant forbedring af tegn på inflammation, målt ved hs-CRP og MRI af både sakroiliakaleddene og rygsøjlen, opretholdt frem til henholdvis uge 156 og uge 104.
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: Significant improvements at week 16 from baseline compared to placebo (Studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Danish: Der blev vist signifikante forbedringer i DLQI (Dermatology Life Quality Index) i forhold til baseline ved uge 16 sammenlignet med placebo (studie I og II) og MTX (studie II).
English: Adalimumab was evaluated in over 3000 patients in all rheumatoid arthritis clinical trials.
Danish: Adalimumab er vurderet hos mere end 3.000 patienter i de kliniske reumatoid artrit-studier.
English: - if your child has a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
Danish: • hvis dit barn har en alvorlig infektion, herunder tuberkulose, sepsis (blodforgiftning) eller andre usædvanlige infektioner, der er forbundet med et svækket immunforsvar.
English: If you receive Kromeya during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: Hvis du har fået Kromeya, mens du var gravid, kan dit spædbarn have en højere risiko for at få en infektion.
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
Danish: • luftvejsinfektioner (herunder forkølelse, løbende næse, bihulebetændelse, lungebetændelse)
English: Kromeya is injected under the skin (subcutaneous use).
Danish: Kromeya injiceres under huden (subkutan anvendelse).
English: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Danish: Sikkerhed og effekt af gentagne doser af adalimumab blev undersøgt hos voksne patienter med moderat til svær aktiv colitis ulcerosa (Mayo-score 6 til 12 med endoskopi-subscore på 2 til 3) i randomiserede, dobbeltblinde placebokontrollerede studier.
English: • The expiration date on syringe has not passed (Figure K).
Danish: • at udløbsdatoen ikke er overskredet (figur K).
English: • The expiration date on the pre-filled pen has not passed (Figure I).
Danish: • at pennens udløbsdato ikke er overskredet (figur I).
English: Preclinical data on fertility effects of adalimumab are not available.
Danish: Der er ingen tilgængelige prækliniske data vedrørende adalimumabs effekt på fertilitet.
English: In CD study I and CD study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CD study III as well among the adalimumab treatment groups compared to the placebo group.
Danish: I CD-studie I og CD-studie II blev der i uge 4 opnået statistisk signifikante forbedringer i total score i det sygdoms-specifikke inflammatorisk tarmsygdoms-spørgeskema (IBDQ)hos patienter randomiseret til adalimumab 80/40 mg og 160/80 mg sammenlignet med placebo, og i CD-studie III blev det også set ved uge 26 og 56 hos de adalimumab-behandlede-grupper sammenlignet med placebo-gruppen.
English: Cerebrovascular accident tremor, neuropathy
Danish: Cerebrovaskulært attak1),tremor, neuropati
English: The incidence of serious infections was 0.04 per patient year in adalimumab treated patients and 0.03 per patient year in placebo and active control − treated patients.
Danish: Incidensen af alvorlige infektioner var 0,04 pr. patientår hos adalimumab-behandlede patienter og 0,03 pr. patientår hos placebo- og aktiv kontrolbehandlede patienter.
English: In CD study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
Danish: I CD-studie II blev 325 patienter, der ikke længere responderede eller var intolerante over for infliximab, randomiseret til at få enten 160 mg adalimumab i uge 0 og 80 mg i uge 2 eller placebo i uge 0 og 2.
English: Thereafter, the usual dose is 40 mg every other week.
Danish: Derefter den sædvanlige dosis på 40 mg hver anden uge.
English: Crohn's disease Age or body weight
Danish: Crohns sygdom Alder eller vægt
English: Transparent syringe housing
Danish: Gennemsigtigt sprøjtehus
English: At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [p = 0.014]).
Danish: Ved uge 16 havde en statistisk signifikant større andel af de patienter, som fik adalimumab, opnået PGA ”clear” eller ”almost clear” for psoriasis på hænder og/eller fødder sammenlignet med patienter, som fik placebo (30,6 % versus 4,3 % [P=0,014]).
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Kromeya.
Danish: Alle patienter og specielt patienter, som tidligere har fået omfattende immunsuppresiv behandling, og psoriasis-patienter, der tidligere har været behandlet med PUVA, skal undersøges for ikke-melanom hudkræft inden og under behandling med Kromeya.
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 clear eller minimal.
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double−blind, placebo−controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Danish: Adalimumab 40 mg hver anden uge blev undersøgt i to randomiserede, 24 ugers dobbelt-blinde placebokontrollerede studier med 393 patienter med aktiv ankyloserende spondylitis (gennemsnits score ved baseline for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,3 i alle grupper), som ikke havde responderet tilstrækkeligt på konventionel behandling.
English: The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 7.
Danish: Fordelingen af patienter i henhold til alder samt modtaget minimums-, median- og maksimumsdosis i den åbne indkøringsfase er vist i tabel 7.
English: Hepatosplenic T-cell lymphoma Merkel cell carcinoma (neuroendocrine carcinoma of the skin)
Danish: Hepatosplenisk T-celle-lymfom, Merkelcelle karcinom (neuroendokrint karcinom)1)
English: Citric acid monohydrate Sodium citrate
Danish: Citronsyremonohydrat Natriumcitrat
English: 40 mg Adalimumab every week
Danish: 40 mg Adalimumab hver uge
English: Subcutaneous use For single use only
Danish: Subkutan anvendelse Kun til engangsbrug.
English: • Lower stomach area (inject at least 5 centimeters away from the belly button).
Danish: • i nedre maveregion (injicér mindst 5 cm fra navlen).
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Danish: Hvis dit barn oplever bivirkninger, bør du tale med dit barns læge, sygeplejerske eller apoteket.
English: Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Danish: Andalimumab er ikke undersøgt hos patienter under 6 år med entesopatirelateret artrit.
English: The recommended dose of Kromeya for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Danish: Den anbefalede dosis af Kromeya til patienter med ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på AS og til patienter med psoriasisartrit er 40 mg adalimumab givet som enkeltdosis subkutan injektion hver anden uge.
English: Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Danish: Fortæl straks din læge, hvis du får symptomer såsom ændringer i dit syn, svaghed i arme eller ben eller følsesløshed eller en snurrende fornemmelse et sted i kroppen.
English: Hepatitis, reactivation of hepatitis B autoimmune hepatitis
Danish: Hepatit reaktivering af hepatitis B1) autoimmun hepatit1)
English: Vision related effects were not numerically in favour of adalimumab for colour vision in study UVI and for colour vision, peripheral vision and near vision in study UV II.
Danish: For synsrelaterede effekter havde adalimumab ikke numererisk en fordel ved farvesyn i Studie UV I og ved farvesyn, langsyn og nærsyn i studie UV II.