FrancophonIA/ELRC3.0 huggingface dataset:
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Idacio, and in accordance with local recommendations.
Danish: Hvis der diagnosticeres latent tuberkulose, skal profylaktisk behandling mod tuberkulose påbegyndes i overensstemmelse med lokale anbefalinger, inden behandling med Idacio startes.
English: Idacio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Danish: Idacio er indiceret til behandling af voksne med alvorlig aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på konventionel behandling.
English: Patients treated with Idacio should be given the patient reminder card.
Danish: Patienter i Idacio-behandling bør få udleveret et særligt patientkort.
English: Table 29 Time to treatment failure in studies UV I and UV II
Danish: Tabel 29 Tid til behandlingssvigt i studie UV I og UV II
English: If your child received Idacio during her pregnancy, her baby may have a higher risk for getting an infection.
Danish: Hvis dit barn har fået Idacio, imens hun var gravid, kan hendes spædbarn have en højere risiko for at få en infektion.
English: Idacio is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Danish: Idacio bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6-17 år.
English: Idacio 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: Idacio 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: If your doctor decides that methotrexate is inappropriate, Idacio can be given alone.
Danish: Hvis din læge beslutter, at behandling med methotrexat ikke er hensigtsmæssig, kan Idacio anvendes alene.
English: Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Danish: Lungeemboli1), interstitiel lungesygdom, kronisk obstruktiv lungesygdom, pneumonitis, pleuraeffusion1)
English: Clinical response (CR-100) Patients in steroid-free remission for >=90 daysa
Danish: Klinisk remission Klinisk respons (CR-100) Patienter i steroid-fri remission i ≥90 dagea
English: • Your child might get infections more easily while receiving Idacio treatment.
Danish: • Dit barn kan lettere få infektioner under behandling med Idacio.
English: • Do not use the Idacio pre-filled syringe if it has been dropped or crushed, as the pre-filled syringe may be broken even if you cannot see the break.
Danish: • Du må ikke bruge Idacio fyldt injektionssprøjte, hvis du er kommet til at tabe eller klemme den, da den fyldte injektionssprøjte kan være beskadiget, uden at du kan se det.
English: Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Idacio.
Danish: Patienter, som har behov for en mindre dosis end 40 mg, bør bruge Idacaio 40 mg i hætteglas.
English: Idacio 40 mg solution for injection in pre-filled syringe EU/1/19/1356/002
Danish: Idacio 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte EU/1/19/1356/002
English: NA 4.5% 23.2% a RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Danish: NA NA 4,5% 23,2% a RA-studie I efter 24 uger, RA-studie II efter 26 uger og RA-studie III efter 24 og 52 uger b 40 mg adalimumab givet hver anden uge c MTX = methotrexat **p < 0,01, adalimumab over for placebo
English: Idacio dose for paediatric patients with Crohn's disease
Danish: Idacio-dosis til pædiatriske patienter med Crohns sygdom
English: • If your child experiences allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Idacio and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Danish: • Hvis dit barn får allergiske reaktioner med symptomer som trykken i brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så undlad at injicere mere Idacio, og kontakt straks din læge, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Idacio and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Danish: • Hvis du får allergiske reaktioner med symptomer som trykken i brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så undlad at injicere mere Idacio, og kontakt straks din læge, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: Antibiotics may be continued during treatment with Idacio if necessary.
Danish: Hvis det er nødvendigt, kan behandling med antibiotika fortsættes under Idacio-behandlingen.
English: Keep this patient reminder card with you or your child during treatment and for 4 months after your (or your child's) last injection of Idacio.
Danish: Opbevar patientkortet på dit barn i løbet af dit barns behandling og i 4 måneder efter din (eller dit barns) sidste injektion med Idacio.
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Idacio.
Danish: Det anbefales, at patienten vasker sine HS-læsioner dagligt med topikal antiseptisk vask under Idacio-behandlingen.
English: Tell your doctor if you are taking azathioprine or mercaptopurine with Idacio.
Danish: Fortæl din læge, hvis du får lægemidlerne azathioprin eller mercaptopurin sammen med Idacio.
English: If you forget to use Idacio
Danish: Hvis du har glemt at tage Idacio
English: Important Information Only use Idacio pre-filled pen if your healthcare professional has trained you how to use it correctly.
Danish: Vigtig information Du må kun bruge Idacio fyldt pen, hvis din læge eller andet sundhedspersonale har vist dig, hvordan du skal bruge den fyldte pen korrekt.
English: Table 24 Maintenance of clinical remission and response (percent of patients) Placebo
Danish: Tabel 24 Vedligeholdelse af klinisk remission og respons (Procent af patienterne) Placebo
English: Placebo/ MTXa Adalimumab/MTX
Danish: Placebo/MTXAdalimumab/MTX
English: Impaired healing * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies
Danish: 4.3, 4.4 og 4.8 ** inklusive åben-label forlængelsesstudie
English: Figure S Warning: Call your healthcare - professional or pharmacist if:
Danish: Figur S Advarsel: Kontakt lægen eller apotekspersonalet:
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Idacio.
Danish: Alle patienter bør rådes til at søge læge omgående, hvis de under behandling med Idacio, udvikler tegn og symptomer på bloddyskrasi (f.eks. vedvarende feber, blå mærker, blødning, bleghed).
English: Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; *p < 0.05 for adalimumab vs. placebo pairwise comparison of proportions **p < 0.001 for adalimumab vs. placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline
Danish: Klinisk respons er fald fra baseline i Mayo score på > 3 point og > 30 % samt et fald i rektal blødning-subscore [RBS] på > 1 eller en absolut RBS på 0 eller 1; *p<0,05 for adalimumab versus placebo ved parvis sammeligning af andelene **p<0,001 for adalimumab versus placebo ved parvis sammeligning af andelene a Af de patienter, der fik steroid ved baseline
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 Idacio.
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 Idacio.
English: The recommended Idacio 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 Idacio 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 is about to have surgery or dental procedures tell your doctor that he/she is taking Idacio.
Danish: • Hvis dit barn skal opereres eller have tandbehandling, skal du fortælle din læge, at han/hun tager Idacio.
English: • hidradenitis suppurativa,
Danish: • Hidrosadenitis suppurativa,
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 Idacio.
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 Idacio.
English: Idacio 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: Idacio 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: If your child stops using Idacio
Danish: Hvis dit barn holder op med at tage Idacio
English: It is important that you tell her baby's doctors and other health care professionals about her Idacio 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 Idacio under graviditeten, før spædbarnet får nogen vaccinationer (for mere information, se afsnittet om vaccinationer).
English: • Do not use an Idacio pre-filled syringe that has been frozen or left in direct sunlight.
Danish: • Du må ikke bruge en Idacio fyldt injektionssprøjte, der har været frossen eller har ligget i direkte sollys.
English: Table 24 Time to treatment failure in studies UV I and UV II
Danish: Tabel 24 Tid til behandlingssvigt i studie UV I og UV II
English: Figure A 1.3 Remove the box from the refrigerator (Figure B).
Danish: Figur A 1.3 Tag æsken ud af køleskabet (figur B).
English: Should treatment be interrupted, Idacio 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Danish: Hvis det bliver nødvendigt at afbryde behandlingen, kan der startes op igen med Idacio 40 mg hver uge eller 80 mg hver anden uge (se pkt.
English: You are advised to avoid becoming pregnant and must use adequate contraception while using Idacio and for at least 5 months after the last Idacio injection.
Danish: Du rådes til at undgå at blive gravid og skal bruge passende prævention, imens du bruger Idacio og i mindst 5 måneder efter sidste Idacio injektion.
English: If you receive Idacio during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: Hvis du har fået Idacio, mens du var gravid, kan dit spædbarn have en højere risiko for at få en infektion.
English: • The name on the pre-filled pen says Idacio (Figure I).
Danish: • at der står Idacio på pennen (figur I).
English: If your doctor considers that methotrexate is inappropriate, Idacio can be given alone.
Danish: Hvis din læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan Idacio anvendes alene.
English: Idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Danish: Idacio er indiceret til behandling af moderat til svær kronisk plaque-psoriasis hos voksne patienter, hvor systemisk behandling er relevant.
English: After 12 weeks of therapy, patients who had received adalimumab in Period A were rerandomised in Period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Danish: Efter 12 ugers behandling blev patienterne, som havde fået adalimumab i periode A, randomiseret på ny i periode B til 1 af 3 behandlingsgrupper (adalimumab 40 mg hver uge, adalimumab 40 mg hver anden uge eller placebo fra uge 12 til uge 35).
English: Table 23 Maintenance of clinical remission and response (percent of patients) Placebo
Danish: Tabel 23 Vedligeholdelse af klinisk remission og respons (Procent af patienterne) Placebo
English: Get Familiar with your Idacio Pre-Filled Syringe Before Use
Danish: Bliv fortrolig med din Idacio fyldte pen Før brug
English: The recommended dose of Idacio 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 Idacio 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: Idacio is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Danish: Idacio bruges til at behandle hidrosadenitis suppurativa hos voksne og unge fra 12 år.
English: Initial dose of 40 mg, followed by
Danish: Startdosis på 40 mg, efterfulgt af 40
English: Idacio dose for paediatric patients with plaque psoriasis
Danish: Idacio-dosis til pædiatriske patienter med plaque psoriasis
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 Idacio.
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 Idacio.
English: The Idacio pre-filled syringe is supplied in a glass syringe with needle guard and finger flanges.
Danish: Idacio fyldt injektionssprøjte er en glassprøjte med kanylebeskyttelse og fingerkrave.
English: If these medicines do not work well enough, you will be given Idacio to treat your rheumatoid arthritis.
Danish: Hvis disse lægemidler ikke virker godt nok, kan du få Idacio til behandling af din reumatoide artrit.
English: Week 2 Week 12 Week 24 ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Danish: ***,** Statistisk signifikant på<0,001, <0,01 for alle sammenligning mellem adalimumab og placebo ved uge 2, 12 og 24 a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
English: Idacio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Danish: Idacio er indiceret til behandling af aktiv og progressiv psoriasisartrit hos voksne patienter, hvor responset på forudgående behandling med sygdomsmodificerende antireumatiske lægemidler har været utilstrækkelig.
English: It is important that you tell your baby's doctors and other health care professionals about your Idacio use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik Idacio under graviditeten, før dit barn får nogen vaccinationer (for mere information, se afsnittet om vaccinationer).
English: Table 22: Proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Danish: Tabel 22: Andel af patientera, som opnåede HiSCRb ved uge 24 og 36 efter tildeling af behandling ved uge 12 (fra ugentlig adalimumab)
English: Table 17: efficacy results at 12 weeks, HS studies I and II
Danish: Tabel 17: Effektresultater ved uge 12, HS-Studie I og II HS-studie I
English: Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Idacio.
Danish: Patienter bør instrueres i at søge læge, hvis der opstår sygdomstegn/symptomer, der tyder på tuberkulose (f.eks. vedvarende hoste, tæring/vægttab, lav feber, apati) under eller efter behandling med Idacio.
English: Table 23 Induction of clinical remission and response (percent of patients) CD study I: Infliximab naive patients
Danish: Tabel 23 Induktion af klinisk remission og respons (Procent af patienterne) CD-StudieI I: Infliximab naive patienter
English: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight
Danish: Rheumatoid artrit, psoriasisartrit, ankyloserende spondylitis eller aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis Alder eller vægt
English: Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Idacio for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Danish: Polyartikulær juvenil idiopatisk artrit hos børn fra 2 år Den anbefalede Idacio-dosis til patienter fra 2 år med polyartikulær juvenil idiopatisk artrit er baseret på legemsvægt (tabel 1).
English: Table 21: Efficacy results at 12 weeks, HS Studies I and II
Danish: Tabel 21: Effektresultater ved uge 12, HS-Studie I og II HS-studie I
English: Table 22 Induction of clinical remission and response (percent of patients) CD study I: infliximab naive patients
Danish: Tabel 22 Induktion af klinisk remission og respons (Procent af patienterne) CD-StudieI I: Infliximab-naive patienter
English: Idacio is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Danish: Idacio bruges til at behandle hidrosadenitis suppurativa hos unge fra 12 år.
English: Always use this medicine exactly as your child's doctor or pharmacist has instructed.
Danish: Tag altid Idacio nøjagtigt som dit barns læge eller apotekspersonalet har anvist.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.8 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 0,8 ml
English: No clinical data are available on the use of an adalimumab loading dose in children < 6 years of age (see section 5.2).
Danish: Der foreligger ingen kliniske data om brugen af en adalimumab-induktionsdosis til børn < 6 år(se pkt.
English: Idacio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Danish: Idacio er indiceret til behandling af voksne med non-infektiøs intermediær, posterior og pan-uveitis, som har haft utilstrækkeligt respons på kortikosteroider, som har behov for steroidbesparende behandling, eller som ikke er egnet til behandling med kortikosteroider.
English: • Keep the Idacio pre-filled pen out of the reach of children.
Danish: • Opbevar Idacio fyldt pen utilgængeligt for børn.
English: Each box of Idacio pre-filled pen comes with two or six pre-filled pens.
Danish: Hver æske af Idacio fyldt pen indeholder to eller seks fyldte penne.
English: Your child is advised to avoid becoming pregnant and must use adequate contraception while using Idacio and for at least 5 months after the last Idacio injection.
Danish: Dit barn rådes til at undgå at blive gravid og skal bruge passende prævention, imens dit barn bruger Idacio og i mindst 5 måneder efter sidste Idacio injektion.
English: Single use components and medicine vial (adalimumab) for subcutaneous injection 40 mg/0.8 mL
Danish: Engangsudstyr og medicin i hætteglas (adalimumab) til subkutan injektion 40 mg/0,8 ml.
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%.
Danish: Blandt patienter, der som minimum var delvise respondere ved uge 12, og som fik fortsat ugentlig adalimumab-behandling, var HiSCR-raten ved uge 48; 68,3 % og ved uge 96; 65,1 %.
English: Idacio may have a minor influence on the ability to drive, cycle or use machines.
Danish: Idacio kan påvirke evnen til at føre motorkøretøj, cykle eller betjene maskiner i mindre grad.
English: Idacio is used to treat moderate to severe plaque psoriasis in adults.
Danish: Idacio bruges til at behandle moderat til alvorlig plaque-psoriasis hos voksne.
English: Talk to your child's doctor or pharmacist before using Idacio
Danish: Kontakt dit barns læge eller apotekspersonalet, før dit barn tager Idacio.
English: • If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Idacio.
Danish: • Hvis du har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), skal du kontakte din læge, før du begynder at bruge Idacio.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/0.8 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 40 mg/0,8 ml
English: Prescribers should exercise caution in considering the use of Idacio in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Idacio should be considered if any of these disorders develop.
Danish: Lægen bør udvise forsigtighed, når behandling med Idacio overvejes til patienter med allerede eksisterende eller nyligt opståede demyeliniserende sygdomme i centralnervesystemet eller det perifere, og seponering skal overvejes, hvis nogle af disse sygdomme forværres.
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: If you stop using Idacio
Danish: Hvis du holder op med at tage Idacio
English: Idacio dose for patients with polyarticular juvenile idiopathic arthrtis
Danish: Idacio-dosis til patienter med polyartikulær juvenil idiopatisk artrit
English: Idacio 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: Idacio er indiceret til behandling af moderat til svær aktiv colitis ulcerosa hos voksne, som ikke har responderet tilfredsstillende på konventionel behandling inklusive glukokortikoider og 6mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2 - 8°C).
English: • If your child has an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Idacio.
Danish: • Hvis dit barn har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), skal du kontakte din læge, før du begynder at bruge Idacio.
English: Adalimumab 80/40 mg N = 75
Danish: Adalimuma b 80/40 mg N = 75