FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who are underweight at the start of treatment should have their body weight monitored regularly.
Danish: Patienter, som er undervægtige ved behandlingsstart, bør få deres legemsvægt kontrolleret regelmæssigt.
English: Day 6 & thereafter AM AM PM AM PM AM PM AM PM AM PM 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg
Danish: Dag 6 & derefter AM AM PM AM PM AM PM AM PM AM PM 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg
English: It is not known whether apremilast, or its metabolites, are excreted in human milk.
Danish: Det er ukendt, om apremilast eller dets metabolitter udskilles i human mælk.
English: Subjects with missing data were counted as nonresponders.
Danish: Personer med manglende data blev regnet som non-responders.
English: Before starting treatment with Otezla, inform your doctor if you are suffering from symptoms of worsening depression with suicidal thinking or behaviour, especially if you take any additional medicines since some of those could increase the probability of these side effects.
Danish: Før du påbegynder behandling med Otezla, skal du fortælle det til lægen, hvis du lider af symptomer på forværret depression med selvmordstanker eller -adfærd, især hvis du tager andre lægemidler, fordi nogle af disse kan øge sandsynligheden for disse bivirkninger.
English: • severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)
Danish: • svær allergisk reaktion (kan omfatte hævelse af ansigt, læber, mund, tunge eller hals, som kan føre til vejrtræknings- eller synkebesvær)
English: The number of patients with arthritis mutilans and predominant spondylitis subtypes was too small to allow meaningful assessment.
Danish: Antallet af patienter med arthritis mutilans og prædominant spondylitis-undertyper var for lille til at gøre en meningsfyldt vurdering mulig.
English: Pharmacotherapeutic group: Immunosupressants, selective immunosuppressants, ATC code: L04AA32
Danish: Farmakoterapeutisk klassifikation: Immunsuppresiva, selektive immunsuppressiva, ATC-kode: L04AA32
English: • inflammation and swelling of the tubes in your lungs (bronchitis)
Danish: • betændelse og hævelse af kanalerne i dine lunger (bronkitis).
English: • phenytoin, phenobarbital and carbamazepine - medicines used in the treatment of seizures or epilepsy
Danish: • phenytoin, phenobarbital og carbamazepin - lægemidler, der anvendes til behandling af krampeanfald eller epilepsi
English: The exposure in elderly subjects (65 to 85 years of age) is about 13% higher in AUC and about 6% higher in Cmax for apremilast than that in young subjects (18 to 55 years of age).
Danish: Eksponeringen hos ældre personer (i alderen 65 til 85 år) er ca. 13 % højere i AUC, og ca. 6 % højere i Cmax for apremilast end eksponeringen hos unge personer (i alderen 18 til 55 år).
English: • Once the recommended dose has been reached, you will only get the 30 mg tablet strength in your prescribed packs.
Danish: • Når den anbefalede dosis er blevet nået, vil du kun få tabletter med styrken 30 mg i dine ordinerede pakninger.
English: ACR 20/50/70 responses were maintained at week 24.
Danish: ACR 20/50/70-respons blev opretholdt efter uge 24.
English: Long-term experience in open-label extension studies with apremilast was generally comparable to the 52-week studies.
Danish: Langvarig erfaring med åbne forlængelsesstudier med apremilast var generelt sammenlignelig med studierne i 52 uger.
English: You should not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Otezla.
Danish: Du bør ikke blive gravid, mens du tager dette lægemiddel, og du bør anvende en sikker præventionsmetode i løbet af behandlingen med Otezla.
English: Similar ACR responses were observed in patients with different PsA subtypes, including DIP.
Danish: Der blev observeret lignende ACR-respons hos patienter med forskellige PsA-undertyper, herunder DIP.
English: Carcinogenicity studies in mice and rats showed no evidence of carcinogenicity related to treatment with apremilast.
Danish: Studier af karcinogenicitet hos mus og rotter gav intet bevis på karcinogenicitet relateret til behandling med apremilast.
English: Co-administration with food does not alter the bioavailability therefore, apremilast can be administered with or without food.
Danish: Samtidig administration af mad ændrer ikke biotilgængeligheden, og derfor kan apremilast administreres sammen med eller uden mad.
English: Patients 65 years of age or older may be at a higher risk of complications.
Danish: Patienter i alderen 65 år og derover kan have større risiko for at få komplikationer.
English: Approximately one-third of patients had not received prior phototherapy, conventional systemic or biologic therapy.
Danish: Ca. en tredjedel af patienterne havde ikke fået tidligere lysbehandling, konventionel systemisk eller biologisk behandling.
English: You should not use Otezla while breast-feeding.
Danish: Du bør ikke anvende Otezla, mens du ammer.
English: Name and address of the manufacturer responsible for batch release Celgene Distribution B.V.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Celgene Distribution B.V.
English: The risks and benefits of starting or continuing treatment with apremilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended.
Danish: Risiciene og fordelene ved igangsætning og fortsættelse af behandling med apremilast skal vurderes omhyggeligt, hvis patienterne rapporterer om tidligere eller aktuelle psykiske symptomer, eller hvis der planlægges samtidig behandling med andre lægemidler, som kan forårsage psykiske hændelser.
English: In the event of overdose, symptomatic and supportive care is advised.
Danish: I tilfælde af overdosering, rådes der til symptomatisk og støttende behandling.
English: If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time.
Danish: Hvis det er nær ved tidspunktet for deres næste dosis, må den glemte dosis ikke tages, og den næste dosis skal tages til normal tid.
English: This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.
Danish: Det tilhører en gruppe af lægemidler, der kaldes phosphodiesterase 4-hæmmere, som hjælper med at reducere inflammation.
English: During pivotal trials the greatest improvement was observed within the first 24 weeks of treatment.
Danish: I pivotale studier blev den største bedring observeret i løbet af de første 24 ugers behandling.
English: Effects of apremilast on pregnancy included embryofoetal loss in mice and monkeys, and reduced foetal weights and delayed ossification in mice at doses higher than the currently recommended highest human dose.
Danish: Virkningen af apremilast på graviditeten omfattede embryoføtalt tab hos mus og aber og reduceret fostervægt og forsinket ossifikation hos mus ved doser over den aktuelt anbefalede højeste humane dosis.
English: Clinical response at week 16 in studies ESTEEM 1 and ESTEEM 2 (FAS a, LOCFb) ESTEEM 1
Danish: Klinisk respons efter uge 16 i studierne ESTEEM 1 og ESTEEM 2 (FAS a LOCFb) ESTEEM 1
English: Total Daily Dose
Danish: Daglig dosis i alt
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister (Particulars printed directly onto the wallet card with the blank blister sealed inside)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blister (mærkning printet direkte på yderkartonen med den blanke blister forseglet indeni).
English: Uncommon instances of suicidal thinking and behaviour (including suicide) were reported.
Danish: Der er indberettet ikke almindelige tilfælde af selvmordstanker og -adfærd (herunder selvmord).
English: If your doctor considers you to be underweight, and you observe an unintentional loss of body weight while being treated with Otezla, you should talk to your doctor.
Danish: Hvis din læge anser dig for at være undervægtig, og du observerer en utilsigtet nedgang i legemsvægten, mens du bliver behandlet med Otezla, skal du kontakte lægen.
English: The major circulating inactive metabolite is the glucuronide conjugate of O-demethylated apremilast (M12).
Danish: Den primære cirkulerende inaktive metabolit er glucuronidkonjugatet for O-demethyleret apremilast (M12).
English: • Otezla is for oral use.
Danish: • Otezla er til oral anvendelse.
English: Accumulation is minimal when apremilast is administered once daily and approximately 53% in healthy subjects and 68% in patients with psoriasis when administered twice daily.
Danish: Akkumulationen er minimal, når apremilast administreres én gang dagligt, og ca. 53 % hos raske personer og 68 % hos patienter med psoriasis, når det administreres to gange dagligt.
English: • if you are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for apremilast eller et af de øvrige indholdsstoffer i Otezla (angivet i punkt 6).
English: There is little information about the effects of Otezla in pregnancy.
Danish: Der er kun få oplysninger om Otezlas virkning under graviditeten.
English: How and when to take Otezla
Danish: Hvordan og hvornår skal du tage Otezla?
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi og toksicitet efter gentagne doser.
English: Week 16 Week 32 Week 52
Danish: Uge 16 Uge 32 Uge 52
English: Warnings and precautions Talk to your doctor or pharmacist before taking Otezla.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Otezla.
English: Based on the study design, patients whose tender and swollen joint counts had not improved by at least 20% were considered non-responders at week 16.
Danish: Baseret på studiedesignet blev patienterne for hvilke antallet af ømme og hævede led, som ikke blev forbedret med mindst 20 %, anset for ikke at respondere efter uge 16.
English: Day 8 - Day 14
Danish: Dag 8 - dag 14
English: Also some other medicines can affect the way Otezla works.
Danish: Andre lægemidler kan også påvirke den måde, Otezla virker på.
English: Apremilast can be co-administered with methotrexate.
Danish: Apremilast kan administreres sammen med methotrexat.
English: Decreased appetite*
Danish: Almindelig Nedsat appetit*
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 15. januar 2015 Dato for den seneste fornyelse: 23. august 2019
English: Apremilast can be co-administered with oral contraceptives.
Danish: Apremilast kan administreres sammen med oral kontraception.
English: If your condition has not improved after six months of treatment, you should talk to your doctor.
Danish: Hvis din sygdom ikke er i bedring efter seks måneders behandling, skal du kontakte lægen.
English: The plasma clearance of apremilast is on average about 10 L/hr in healthy subjects, with a terminal elimination half-life of approximately 9 hours.
Danish: Plasmaclearance for apremilast er i gennemsnit ca. 10 l/t hos raske personer, med en terminal eliminationstid på ca. 9 timer.
English: Please see additional warning in section 4.4 for patients who are underweight at beginning of treatment.
Danish: 4.4 for patienter, der er undervægtige i begyndelsen af behandlingen.
English: • Active psoriatic arthritis - if you cannot use another type of medicine called ‘Disease-Modifying Antirheumatic Drugs' (DMARDs) or when you have tried one of these medicines and it did not work.
Danish: • Aktiv psoriasis artritis - hvis du ikke kan bruge en anden lægemiddeltype, der kaldes 'sygdomsmodificerende antireumatiske lægemidler (disease-modifying antirheumatic drugs, DMARDs) eller hvis du har prøvet et af disse lægemidler, og det ikke virkede.
English: If it is close to the time for your next dose, just skip the missed dose.
Danish: Hvis det er tæt på tidspunktet for din næste dosis, skal du blot springe den glemte dosis over.
English: Patients with pre-existing enthesopathy (63%) or pre-existing dactylitis (42%) were enrolled.
Danish: Patienter med eksisterende entesopati (63 %) eller eksisterende daktylitis (42 %) indgik.
English: Apremilast was used as a monotherapy (34.8%) or in combination with stable doses of small molecule DMARDs (65.2%).
Danish: Apremilast blev anvendt som monobehandling (34,8 %) eller i kombination med stabile doser af lavmolekylære DMARDs (65,2 %).
English: Genotoxicity studies
Danish: Genotoksicitetsstudier
English: In the event of unexplained and clinically significant weight loss, these patients should be evaluated by a medical practitioner and discontinuation of treatment should be considered.
Danish: Hvis der opstår uforklarligt og klinisk signifikant vægttab, bør disse patienter evalueres af en læge, og det bør overvejes at seponere behandlingen.
English: In clinical studies and post-marketing experience, uncommon cases of suicidal ideation and behaviour, were reported, while completed suicide was reported post-marketing.
Danish: I kliniske studier og ifølge erfaringer efter markedsføringen er der rapporteret om ikke almindelige tilfælde af selvmordstanker og -adfærd, mens der er rapporteret om gennemført selvmord efter markedsføringen.
English: It is likely that pup developmental effects observed during the first week of the postnatal period were related to the apremilast-related pup toxicity (decreased pup weight and viability) and/or lack of maternal care (higher incidence of no milk in the stomach of pups).
Danish: Det er sandsynligt, at de udviklingsmæssige virkninger på ungerne, der blev observeret i løbet af den første uge af den postnatale periode var relateret til apremilastrelateret toksicitet af apremilast (nedsat vægt og levedygtighed af ungerne) og/eller manglende moderlig omsorg (større forekomst af, at der ikke var mælk i maven på ungerne).
English: In case of an overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment is instituted.
Danish: I tilfælde af en overdosis anbefales det, at patienten overvåges for tegn eller symptomer på bivirkninger, og relevant symptomatisk behandling iværksættes.
English: Hence, clinically relevant drug-drug interactions are unlikely when apremilast is co-administered with drugs that are substrates or inhibitors of these transporters.
Danish: Derfor er klinisk relevante lægemiddelinteraktioner ikke sandsynlige, når apremilast administreres sammen med lægemidler, der er substrater eller hæmmere af disse transportere.
English: You may also experience sleeplessness (common), or depressive mood (common).
Danish: Du kan også opleve søvnløshed (almindelig) eller forstemthed (almindelig).
English: Apremilast pharmacokinetics are linear, with a dose-proportional increase in systemic exposure in the dose range of 10 to 100 mg daily.
Danish: Farmakokinetikken for apremilast er lineær, med en dosisproportional forhøjelse i systemisk eksponering i dosisintervallet fra 10 til 100 mg dagligt.
English: ACR responses were maintained in the long-term open label extension studies for up to 5 years.
Danish: ACR-responset blev opretholdt i de langvarige åbne forlængelsesstudier i op til 5 år.
English: Clinical improvement measured by sPGA, PASI-50 and PASI-90 responses were also demonstrated at week 16.
Danish: Klinisk forbedring målt ved sPGA-, PASI-50- og PASI-90respons blev også vist efter uge 16.
English: A risk to the breastfed infant cannot be excluded, therefore apremilast should not be used during breast-feeding.
Danish: En risiko for det ammede barn kan ikke udelukkes, og derfor bør apremilast ikke anvendes under amning.
English: PVC/ aluminium foil blisters containing 14 film-coated tablets, in pack sizes of 56 tablets and 168 tablets.
Danish: Blistre af PVC/aluminiumsfolie indeholdende 14 filmovertrukne tabletter i pakningsstørrelser på 56 og 168 tabletter.
English: The primary endpoint was the percentage of patients achieving American College of Rheumatology (ACR) 20 response at week 16.
Danish: Det primære endepunkt var procentdelen af patienter, der opnåede et respons i henhold til American College of Rheumatology (ACR) 20 efter uge 16.
English: If you stop taking Otezla
Danish: Hvis du holder op med at tage Otezla
English: • headaches, migraines or tension headaches
Danish: • hovedpine, migræne eller spændingshovedpine
English: The long-term safety of apremilast 30 mg twice daily in patients with psoriatic arthritis and psoriasis was assessed for a total duration of treatment up to 5 years.
Danish: Den langvarige sikkerhed af apremilast 30 mg to gange dagligt hos patienter med psoriasis artritis og psoriasis blev vurderet for en total behandlingsvarighed på op til 5 år.
English: The mean observed weight loss in patients treated for up to 52 weeks with apremilast was 1.99 kg. A total of 14.3% of patients receiving apremilast had observed weight loss between 5-10% while 5.7% of the patients receiving apremilast had observed weight loss greater than 10%.
Danish: Det gennemsnitlige observerede vægttab hos patienter i behandling i op til 52 uger med apremilast var 1,99 kg. I alt 14,3 % af patienterne, der fik apremilast, havde et observeret vægttab på mellem 5-10 %, mens 5,7 % af patienterne, der fik apremilast, havde et observeret vægttab på over 10 %.
English: Cellulose microcrystalline
Danish: Cellulose, mikrokrystallinsk
English: Otezla contains lactose (a type of sugar).
Danish: Otezla indeholder lactose (en form for sukker).
English: Week 16 Week 32
Danish: Uge 16 Uge 32
English: The adverse reactions observed in patients treated with apremilast are listed below by system organ class (SOC) and frequency for all adverse reactions.
Danish: De observerede bivirkninger hos patienter i behandling med apremilast er opstillet nedenunder efter systemorganklasse (SOC) og hyppighed for alle bivirkninger.
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D barcode carrying the unique identifier included
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Placebo 30 mg twice daily APR*
Danish: Placebo 30 mg to gange dagligt APR*
English: The median time to loss of 50% of their week 32 PASI improvement was 12.4 weeks.
Danish: Den mediane tid til tab af 50 % af deres PASI-forbedring efter uge 32, var 12,4 uger.
English: Diarrhoea* Nausea*
Danish: Diarré* Kvalme*
English: In general, PASI responses were achieved by week 16 and were maintained through week 32.
Danish: Generelt blev PASI-responset opnået efter uge 16, og det blev opretholdt til og med uge 32.
English: No dosage adjustment is necessary for elderly patients.
Danish: Dosisjustering er ikke nødvendig for ældre patienter.
English: Psoriasis is an inflammatory disease of the skin, which can cause red, scaly, thick, itchy, painful patches on your skin and can also affect your scalp and nails.
Danish: Psoriasis er en inflammatorisk hudsygdom, der forårsager røde, skallende, tykke, kløende, smertefulde pletter på huden, og som også kan påvirke hårbunden og neglene.
English: Otezla contains the active substance ‘apremilast'.
Danish: Otezla indeholder det aktive stof 'apremilast'.
English: Apremilast is extensively metabolised by both CYP and non-CYP mediated pathways including oxidation, hydrolysis, and conjugation, suggesting inhibition of a single clearance pathway is not likely to cause a marked drug-drug interaction.
Danish: Apremilast metaboliseres i udstrakt grad af både CYP- og ikke-CYP-medierede veje, herunder oxidation, hydrolyse og konjugering, hvilket tyder på, at en hæmning af en enkelt clearancevej sandsynligvis ikke vil forårsage en markant lægemiddelinteraktion.
English: In both studies, the primary endpoint was the proportion of patients who achieved PASI-75 at week 16.
Danish: I begge studier var det primære endepunkt andelen af patienter, som opnåede PASI-75 efter uge 16.
English: There were no apremilast-related effects on duration of pregnancy, number of pregnant mice at the end of the gestation period, number of mice that delivered a litter, or any developmental effects in the pups beyond postnatal day 7.
Danish: Der var ingen apremilastrelaterede virkninger på drægtighedens varighed, antallet af drægtige mus ved slutningen af gestationsperioden, antallet af mus, der fødte et kuld eller nogen udviklingsmæssige virkninger på ungerne efter den postnatale dag 7.
English: Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt SOC og hyppighedsgruppering er bivirkningerne opstillet efter, hvor alvorlige de er.
English: PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells.
Danish: PDE4 er en cyklisk adenosinmonofosfat (cAMP)-specifik PDE, og den dominante PDE i inflammatoriske celler.
English: Hypersensitivity reactions are uncommonly observed (see section 4.3).
Danish: Overfølsomhedsreaktioner er ikke almindeligt observeret (se pkt.
English: Take the medicine pack and this leaflet with you.
Danish: Medbring lægemiddelpakningen og denne indlægsseddel.
English: Women of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment.
Danish: Kvinder i den fertile alder bør anvende en sikker kontraceptionsmetode for at undgå graviditet i løbet af behandlingen.
English: The clinical benefit of apremilast was also demonstrated regardless of prior psoriasis medication usage and response to prior psoriasis treatments.
Danish: Den kliniske fordel ved apremilast blev også vist uanset tidligere anvendelse af psoriasismedicin og respons på tidligere psoriasisbehandling.
English: For pre-clinical fertility data, see section 5.3.
Danish: For prækliniske fertilitetsdata, se pkt.
English: Embryo-foetal development
Danish: Embryoføtal udvikling
English: A total of 18% of patients had a history of psoriatic arthritis.
Danish: I alt 18 % af patienterne havde tidligere haft psoriasis artritis.
English: • difficulty sleeping (insomnia)
Danish: • søvnbesvær (insomni)
English: Approximately 30% of all patients had received prior phototherapy and 54% had received prior conventional systemic and/or biologic therapy for the treatment of psoriasis (including treatment failures), with 37% receiving prior conventional systemic therapy and 30% receiving prior biologic therapy.
Danish: Ca. 30 % af alle patienterne havde fået tidligere lysbehandling, og 54 % havde fået tidligere konventionel systemisk og/eller biologisk behandling for behandling af psoriasis (herunder behandlingssvigt), hvoraf 37 % fik tidligere konventionel systemisk behandling, og 30 % fik tidligere biologisk behandling.
English: These GI adverse reactions generally occur within the first 2 weeks of treatment and usually resolve within 4 weeks.
Danish: Disse bivirkninger i mave-tarm-kanalen opstår generelt i løbet af de første 2 ugers behandling, og de går normalt væk i løbet af 4 uger.
English: If you are 65 years of age or older, you might have a higher risk of complications of severe diarrhoea, nausea and vomiting.
Danish: Hvis du er 65 år eller ældre, kan du have en højere risiko for komplikationer med alvorlig diarré, kvalme og opkastning.
English: Apremilast did not induce mutations in an Ames assay or chromosome aberrations in cultured human peripheral blood lymphocytes in the presence or absence of metabolic activation.
Danish: Apremilast inducerede ikke mutationer i en Ames-analyse eller kromosomændringer i dyrkede perifere lymfocytter i humant blod ved tilstedeværelse eller fravær af metabolisk aktivering.