FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have rheumatoid arthritis and you do not receive methotrexate with your SOLYMBIC therapy, your doctor may decide to give 40 mg every week.
Danish: Hvis du har reumatoid artrit og ikke får methotrexat i kombination med din SOLYMBIC-behandling, kan lægen vælge at ordinere 40 mg hver uge.
English: Carriers of HBV who require treatment with SOLYMBIC should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Danish: Bærere af HBV, som kræver behandling med SOLYMBIC, bør overvåges tæt for tegn og symptomer på aktiv HBV-infektion gennem behandlingen og i adskillige måneder efter afslutningen af behandlingen.
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: SOLYMBIC treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which SOLYMBIC is indicated.
Danish: Behandling med SOLYMBIC bør initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af de sygdomme, som SOLYMBIC er indiceret til.
English: Two weeks later (day 29) continue with a dose of 40 mg every week.
Danish: To uger senere (Dag 29) fortsættes med en dosis på 40 mg hver uge.
English: a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b
Danish: RA-studie I efter 24 uger, RA-studie II efter 26 uger og RA-studie III efter 24 og 52 uger b
English: SOLYMBIC is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Danish: SOLYMBIC bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6-17 år.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 13).
Danish: Vurderinger af neglepsoriasis omfattede Modified Nail Psoriasis Severity Index (mNAPSI), Physician's Global Assessment of Fingernail Psoriasis (PGA-F) og Nail Psoriasis Severity Index (NAPSI) (se tabel 13).
English: If you received SOLYMBIC during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: Hvis du har fået SOLYMBIC, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion.
English: If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive SOLYMBIC.
Danish: - Hvis du har eller udvikler demyeliniserende sygdom som dissemineret sklerose vil din læge afgøre om du skal have eller fortsætte med at få SOLYMBIC.
English: Your doctor may recommend temporary discontinuation of SOLYMBIC.
Danish: Din læge kan anbefale midlertidig afbrydelse af behandling med SOLYMBIC.
English: It is important that you tell your baby's doctors and other health care professionals about your SOLYMBIC use during your pregnancy so they can decide when your baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller barnets læge og andre sundhedspersoner, at du fik SOLYMBIC under graviditeten, så de kan beslutte, hvornår dit spædbarn bør vaccineres.
English: Patients should be tested for HBV infection before initiating treatment with SOLYMBIC.
Danish: Patienter bør testes for HBV-infektion inden behandling med SOLYMBIC.
English: SOLYMBIC contains sodium
Danish: SOLYMBIC indeholder natrium
English: Should treatment be interrupted, SOLYMBIC 40 mg every week may be re-introduced (see section 5.1).
Danish: Hvis det bliver nødvendigt at afbryde behandlingen, kan der startes op igen med SOLYMBIC 40 mg hver uge (se pkt.
English: Treatment with SOLYMBIC can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Danish: Behandling med SOLYMBIC kan initieres i kombination med kortikosteroider og/eller andre ikke biologiske immunmodulerende lægemidler.
English: SOLYMBIC can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Danish: SOLYMBIC kan nedsætte antallet af knuder og bylder og lindre den smerte, som ofte er forbundet med sygdommen.
English: p-value a p-value b p-value c
Danish: p-værdi a p-værdi b p-værdi c
English: In patients who develop HBV reactivation, SOLYMBIC should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Danish: Hos patienter, der udvikler reaktivering af HBV, bør SOLYMBIC seponeres og effektiv anti-viral behandling med passende understøttende behandling initieres.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: If your doctor determines that methotrexate is inappropriate, SOLYMBIC can be given alone.
Danish: Hvis din læge ikke mener, at behandling med methotrexat er hensigtsmæssig, kan SOLYMBIC anvendes alene.
English: The benefits and risks of continued weekly therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosing frequency (see section 5.1).
Danish: Fordele og risici ved fortsat ugentlig behandling skal overvejes nøje hos patienter med utilstrækkeligt respons efter øget doseringshyppighed (se pkt.
English: Treatment with SOLYMBIC must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Danish: Behandling med SOLYMBIC skal ophøre hos patienter, som udvikler nye eller får forværrede symptomer på hjerteinsufficiens.
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 11 and 12).
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 11 og 12).
English: However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last SOLYMBIC treatment.
Danish: Eftersom humane immunglobuliner udskilles i mælken, må kvinder dog ikke amme i mindst fem måneder efter den sidste SOLYMBIC-behandling.
English: Concomitant administration of SOLYMBIC with other biologic DMARDS (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section
Danish: Samtidig administration af SOLYMBIC og andre biologiske DMARDs (f.eks, anakinra og abatacept) eller andre TNF-antagonister anbefales ikke på grund af en øget risiko for infektioner, herunder alvorlige infektioner og andre potentielle farmakologiske interaktioner (se pkt.
English: Clinical remission 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 dage a
English: If active tuberculosis is diagnosed, SOLYMBIC therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må SOLYMBIC-terapi ikke påbegyndes (se pkt.
English: Patients who develop a new infection while undergoing treatment with SOLYMBIC, should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, der udvikler en ny infektion under behandling med SOLYMBIC, bør monitoreres nøje og gennemgå en fuldstænding diagnostisk evaluering.
English: Asthma,
Danish: • astma,
English: Figure 1: Kaplan-Meier curves summarising 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: Usually, SOLYMBIC is used with methotrexate.
Danish: Normalt gives SOLYMBIC sammen med methotrexat.
English: Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment b
Danish: Patienter med minimum et delvist respons på adalimumab 40 mg ugentlig efter 12 ugers behandling b
English: Total body weight (kg)
Danish: Total legemsvægt (kg)
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of SOLYMBIC in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Danish: Inden start af behandling med SOLYMBIC skal profylaktisk behandling mod tuberkulose også overvejes hos patienter med adskillige eller signifikante risikofaktorer for tuberkulose på trods af en negative test for tuberkulose samt hos patienter, der tidligere har haft latent eller aktiv tuberkulose, hvor det ikke har kunnet bekræftes, at behandlingen har været tilstrækkelig.
English: • autoantibodies present in the blood.
Danish: • tilstedeværelse af autoantistoffer i blodet.
English: Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see figure 1).
Danish: Begge studier viste en tidlig og vedvarende effekt af adalimumab på tid til behandlingssvigt versus placebo (se figur 1).
English: Vascular arterial occlusion, Thrombophlebitis
Danish: Vaskulær arteriel okklusion, Tromboflebit
English: Undesirable effects in paediatric patients
Danish: Bivirkninger hos pædiatriske patientert
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with SOLYMBIC and is positive for antibodies against double-stranded DNA, further treatment with SOLYMBIC should not be given (see section 4.8).
Danish: Hvis en patient efter behandling med SOLYMBIC udvikler symptomer, der tyder på et lupus-lignende syndrom, og er positiv for antistoffer mod dobbelt-strenget DNA, bør der ikke gives yderligere behandling med SOLYMBIC (se pkt.
English: 1 p value for standard dose versus low dose comparison Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at baseline for at least 2 consecutive post-baseline visits
Danish: 1 p-værdi for sammeligning af standard-dosis versus lav-dosis 2 immunmodulerende lægemidler kunne kun seponeres ved eller efter uge 26 efter investigators skøn, hvis patienten opfyldte det kliniske respons-kriterium 3 defineret som lukning af alle fistler, som var åbne ved baseline, ved mindst 2 på hinanden følgende besøg efter baseline-besøget
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of SOLYMBIC should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med SOLYMBIC straks ophøre og egnet behandling påbegyndes.
English: Not known Worsening of symptoms of dermatomyositis
Danish: Forværring af dermatomyositis-symptomer
English: During treatment with SOLYMBIC, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Danish: Under behandling med SOLYMBIC, bør andre samtidige behandlinger (f.eks., kortikosteroider og/eller immunmodulerende midler) optimeres.
English: If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting SOLYMBIC.
Danish: - Hvis du har en infektion, herunder langvarig eller lokaliseret infektion (f.eks. bensår), bør du kontakte din læge, før du begynder at bruge SOLYMBIC.
English: A. Remove the number of SOLYMBIC pre-filled syringes you need from the package.
Danish: A. Tag det antal SOLYMBIC fyldte injektionssprøjter, du skal bruge, ud af pakningen.
English: SOLYMBIC is a clear and colourless to slightly yellow solution.
Danish: SOLYMBIC er en klar og farveløs til lysegul opløsning.
English: The effects of SOLYMBIC in pregnant women are not known and so the use of SOLYMBIC in pregnant women is not recommended.
Danish: Virkningen af SOLYMBIC hos gravide er ikke kendt, hvorfor SOLYMBIC ikke anbefales til gravide.
English: b at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Danish: b ved uge 24 og 36 efter nytildeling af behandling ved uge 12 (fra ugentlig adalimumab)
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of SOLYMBIC should be promptly discontinued.
Danish: For patienter, som udvikler tegn og symptomer såsom feber, utilpashed, vægttab, svedeture, hoste, dyspnø, og/eller pulmonale infiltrater eller anden alvorlig systemisk sygdom med eller uden samtidig shock, bør en invasiv svampeinfektion mistænkes, og administration af SOLYMBIC skal omgående afbrydes.
English: Patients treated with SOLYMBIC should be given the special alert card.
Danish: Patienter i SOLYMBIC-behandling bør få udleveret et særligt patientkort.
English: if you have moderate or severe heart failure.
Danish: - Hvis du lider af moderat til alvorlig hjerteinsufficiens.
English: Very common Elevated liver enzymes Uncommon Cholecystitis and cholelithiasis, Hepatic steatosis, Bilirubin increased
Danish: Meget almindelig Forhøjede leverenzymer Ikke almindelig Kolecystit og cholelithiasis, Hepatisk steatose, Forhøjet bilirubin
English: Table 23 Time to treatment failure in studies UV I and UV II
Danish: Tid til behandlingssvigt i studie UV I og UV II
English: Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Danish: Administration af levende vacciner til spædbørn, som har været eksponeret for adalimumab i utero, anbefales ikke i 5 måneder efter moderens sidste adalimumab-injektion under graviditeten.
English: ACR 20 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 Week 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Week 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864
Danish: Uge 52 45,9 % 41,2 % 61,6 % <0,001 <0,001 0,317 Uge 104 42,8 % 36,9 % 59,0 % <0,001 <0,001 0,162 ACR 70 Uge 52 27,2 % 25,9 % 45,5 % <0,001 <0,001 0,656 Uge 104 28,4 % 28,1 % 46,6 % <0,001 <0,001 0,864
English: If adequate response is achieved with an increased dosing frequency, the dose may subsequently be reduced to 40 mg every other week.
Danish: Hvis der opnås tilstrækkeligt respons med en øget doseringshyppighed, kan dosis efterfølgende reduceres til 40 mg hver anden uge.
English: • A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using Solymbic.
Danish: • En advarsel til det sundhedspersonale, der på et vilkårligt tidspunkt måtte behandle patienten (også i akutte tilfælde), om, at patienten får Solymbic.
English: Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Danish: Adalimumab/methotrexat-kombinationsterapi var klinisk og statistisk bedre end methotrexat-monoterapi (p<0,001) og adalimumab-monoterapi (p< 0,001) i opnåelsen af lav sygdomstilstand hos patienter med nylig diagnosticeret moderat til alvorlig reumatoid artrit.
English: Rates of discontinuation of corticosteroids or immunomodulators are presented in table 21.
Danish: Raten for seponering af kortikosteroider eller immunmodulerende lægemidler er vist i tabel 21.
English: Arrhythmia, Congestive heart failure Cardiac arrest
Danish: Kongestiv hjertesvigt Hjertestop
English: What SOLYMBIC contains - The active substance is adalimumab.
Danish: SOLYMBIC indeholder - Aktivt stof: adalimumab.
English: Physicians should exercise caution when considering the use of SOLYMBIC in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Danish: Læger bør være forsigtige, når de overvejer brug af SOLYMBIC til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler.
English: As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting SOLYMBIC.
Danish: - Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med adalimumab, vil lægen undersøge dig for tegn og symptomer på tuberkulose, før behandling med SOLYMBIC påbegyndes.
English: Hypokalaemia, Uric acid increased, Blood sodium abnormal, Hypocalcaemia, Hyperglycaemia, Hypophosphataemia, Dehydration
Danish: Hypokaliæmi, Forhøjet urinsyre, Unormal blod-natrium, Hypokalcæmi, Hyperglykæmi, Hypofosfatæmi, Dehydrering
English: Formation of antiadalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Danish: Dannelse af adalimumabantistoffer er forbundet med øget clearence og reduceret effekt af adalimumab.
English: E. Pull the needle cap straight out and away from your body when you are ready to inject.
Danish: E. Træk kanylehætten lige af og væk fra kroppen, når du er klar til at give injektionen.
English: This inflammation leads to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Danish: Inflammationen fører til nedsat syn og/eller fluer i øjet (sværm af uklarheder i øjet, som bevæger sig i synsfeltet).
English: • Relevant information on the safety concerns of serious infections, sepsis, tuberculosis and opportunistic infections; congestive heart failure; demyelinating disorders; malignancies to be addressed by the additional risk minimisation measures (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable).
Danish: • Relevant information om de sikkerhedsmæssige problemer med alvorlige infektioner, sepsis, tuberkulose og opportunistiske infektioner; hjerteinsufficiens; demyeliniserende sygdomme; maligniteter, der skal tages hånd om med de yderligere risikominimeringsforanstaltninger (fx alvorlighed, sværhedsgrad, hyppighed, tid indtil indtræden, bivirkningens reversibilitet).
English: Table 6 Radiographic mean changes over 12 months in RA study III
Danish: Gennemsnitlige radiografiske ændringer gennem 12 måneder i RA-studie III
English: Table 20 Paediatric CD study PCDAI clinical remission and response
Danish: Pædiatrisk CD-studie PCDAI klinisk remission og respons
English: At week 12, a significantly higher proportion of patients in study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 15).
Danish: En signifikant højere andel af patienterne i HS-II-studie oplevede et klinisk relevant fald i HS-relateret hudsmerte (se tabel 15) ved uge 12.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire-medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (study HS-I).
Danish: Ved uge 12 blev der påvist større forbedringer fra baseline sammenlignet med placebo i hud-specifik sundhedsrelateret livskvalitet målt ved “Dermatology Life Quality Index“ (DLQI; HS-studie I og II), den globale patienttilfredshed med lægemiddelbehandlingen målt ved ”Treatment Satisfaction Questionnaire - medication” (TSQM; HS-studie I og II) og fysisk helbred målt ved ”physical component summary score” af SF-36 (HS-studie I).
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with SOLYMBIC should be considered prior to initiating therapy (see Other opportunistic infections).
Danish: Hos patienter, som har været eksponeret for tuberkulose, og patienter, som har rejst i områder med høj risiko for tuberkulose eller endemisk mykose, såsom histoplasmose, kokcidioidomykose eller blastomykose, skal risiko og fordele ved behandling med SOLYMBIC overvejes, inden behandlingen iværksættes (se Opportunistiske infektioner).
English: There have been cases of cancers other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
Danish: - Der har været tilfælde af kræft, der er forskellig fra lymfom hos patienter med en specifik lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL), der var i behandling med en anden TNF-hæmmer.
English: SOLYMBIC is also used to treat severe plaque psoriasis in children and adolescents weighing either 23 to 28 kg or 47 kg or greater for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Danish: SOLYMBIC bruges også til at behandle alvorlig plaque-psoriasis hos børn og unge, der vejer enten 23 til 28 kg eller 47 kg eller derover, hos hvem lokal behandling og lysbehandlinger enten ikke har virket godt nok eller ikke er egnede.
English: Tell your doctor as soon as possible if you notice any of the following:
Danish: Kontakt lægen så hurtigt som muligt, hvis du får følgende symptomer:
English: NA 4.5% 23.2%
Danish: NA NA NA 4,5 % 23,2 %
English: Table 22 Response, remission and mucosal healing in study UC-II (percent of patients)
Danish: Respons, remission og slimhindeheling i studie UC-II (Procent patienter)
English: Children or adolescents with plaque psoriasis
Danish: Børn og unge med plaque psoriasis
English: SOLYMBIC contains the active substance adalimumab, a selective immuno suppressive agent.
Danish: SOLYMBIC indeholder det aktive stof adalimumab, et selektivt immunsupprimerende stof.
English: Therefore, the combination of SOLYMBIC and anakinra is not recommended (see section 4.5).
Danish: Kombination af SOLYMBIC og anakinra anbefales ikke (se pkt.
English: There is no relevant use of adalimumab in the paediatric population in the indications, ankylosing spondylitis and psoriatic arthritis.
Danish: Det er ikke relevant at bruge adalimumab til den pædiatriske population i indikationerne ankyloserende spondylitis og psoriasisartrit.
English: A patient who requires surgery while on SOLYMBIC should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som har behov for et kirurgisk indgreb under behandling med SOLYMBIC, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: Other medicines and SOLYMBIC
Danish: Brug af anden medicin sammen med SOLYMBIC
English: Bruising (including purpura), Dermatitis (including eczema), Onychoclasis,
Danish: Tendens til blå mærker (inklusive purpura), Dermatitis (inklusive eksem), Onychoclasis,
English: ● Put the used SOLYMBIC syringe in a sharps disposal container immediately after use.
Danish: ● Læg den brugte SOLYMBIC-sprøjte i en kanylebøtte straks efter brug.