FrancophonIA/ELRC3.0 huggingface dataset:
English: Oxidative metabolism of apremilast is primarily mediated by CYP3A4, with minor contributions from CYP1A2 and CYP2A6.
Danish: Den oxidative metabolisme af apremilast medieres primært af CYP3A4, med mindre bidrag fra CYP1A2 og CYP2A6.
English: • suicidal ideation or behaviour
Danish: • selvmordstanker eller -adfærd.
English: There was no clinically meaningful interaction between ketoconazole and apremilast.
Danish: Der var ingen klinisk meningsfyldte interaktioner mellem ketoconazol og apremilast.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Wallet card containing 2-week treatment initiation pack
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Yderkarton med blister, der indeholder 2-ugers indledende behandling
English: There are limited data about the use of apremilast in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af apremilast til gravide kvinder.
English: • Moderate to severe chronic plaque psoriasis - if you cannot use one of the following treatments or when you have tried one of these treatments and it did not work: - phototherapy - a treatment where certain areas of skin are exposed to ultraviolet light - systemic therapy - a treatment that affects the entire body rather than just one local area, such as ‘ciclosporin', ‘methotrexate' or ‘psoralen '.
Danish: • Moderat til svær kronisk plaque psoriasis - hvis du ikke kan bruge en af de følgende behandlinger, eller hvis du har prøvet en af disse behandlinger uden virkning: fototerapi -en behandling, hvor visse hudområder eksponeres over for ultraviolet lys systemisk behandling - en behandling, der påvirker hele kroppen i stedet for kun ét lokal område, såsom 'ciclosporin','methotrexat' eller 'psoralen'.
English: A total of 76.4% of patients were previously treated with only small-molecule DMARDs and 22.4% of patients were previously treated with biologic DMARDs, which includes 7.8% who had a therapeutic failure with a prior biologic DMARD.
Danish: I alt 76,4 % patienter blev tidligere kun behandlet med lille molekyle DMARDs, og 22,4 % af patienterne blev tidligere behandlet med biologiske DMARDs, som omfatter 7,8 % med behandlingssvigt med tidligere biologisk DMARD.
English: Apremilast was not clastogenic in an in vivo mouse micronucleus assay at doses up to 2,000 mg/kg/day.
Danish: Apremilast var ikke klastogent i en in vivo mikronukleus-analyse hos mus ved doser på op til 2.000 mg/kg/dag.
English: Responses observed in the apremilast treated group were similar in patients receiving and not receiving concomitant DMARDs, including MTX.
Danish: Respons, der blev observeret i gruppen behandlet med apremilast, var sammenligneligt hos patienter, der fik og ikke fik samtidig behandling med DMARDs, herunder MTX.
English: By reducing the activity of this enzyme, Otezla can help to control the inflammation associated with psoriatic arthritis and psoriasis, and thereby reduce the signs and symptoms of these conditions.
Danish: Ved at reducere aktiviteten af dette enzym, kan Otezla hjælpe med at kontrollere inflammationen forbundet med psoriasis artritis og psoriasis, og dermed reducere tegnene og symptomerne på disse sygdomme.
English: Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression (see section 4.8).
Danish: Der er observeret tilfælde af selvmordstanker og -adfærd, herunder selvmord, hos patienter med eller uden depression i anamnesen (se pkt.
English: Apremilast administered at doses of up to 50 mg twice daily did not prolong the QT interval in healthy subjects.
Danish: Apremilast administreret med doser på op til 50 mg to gange dagligt forlængede ikke QT-intervallet hos raske personer.
English: The adverse drug reactions were determined based on data from the apremilast clinical development programme and post-marketing experience.
Danish: Bivirkningerne blev bestemt på basis af data fra det kliniske udviklingsprogram for apremilast og fra erfaring efter markedsføring.
English: None of these patients had overt clinical consequences resulting from weight loss.
Danish: Ingen af disse patienter havde åbenlyse kliniske følgevirkninger af vægttabet.
English: Apremilast is well absorbed with an absolute oral bioavailability of approximately 73%, with peak plasma concentrations (Cmax) occurring at a median time (tmax) of approximately 2.5 hours.
Danish: Apremilast absorberes i høj grad med en absolut oral biotilgængelighed på ca. 73 %, med maksimale plasmakoncentrationer (Cmax), der opstår efter en mediantid (tmax) på ca. 2,5 timer.
English: The most common adverse reactions leading to discontinuation during the first 16 weeks of treatment are diarrhoea (1.7%), and nausea (1.5%) (frequencies are based on Phase III clinical studies).
Danish: De mest almindelige bivirkninger, der fører til seponering i løbet af de første 16 ugers behandling, er diarré (1,7 %) og kvalme (1,5 %) (hyppighederne er baseret på fase III kliniske studier).
English: • upper respiratory tract infections such as cold, runny nose, sinus infection
Danish: • infektioner i de øvre luftveje såsom forkølelse, rindende næse, sinusinfektion.
English: a Includes subjects re-randomised to APR 30 twice daily at week 32 with a baseline value and a post-baseline value at the evaluated study week.
Danish: a Omfatter personer, der igen blev randomiseret til APR 30 to gange dagligt efter uge 32 med en baseline-værdi og en post-baseline-værdi ved den evaluerede studieuge.
English: If you take more Otezla than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har taget for meget Otezla, bør du straks kontakte en læge eller tage på hospitalet.
English: The major secondary endpoint was the proportion of patients who achieved a sPGA score of clear (0) or almost clear (1) at week 16.
Danish: Det vigtigste sekundære endepunkt var andelen af patienter, der opnåede et sPGA-score på klaret op (0) eller næsten klaret op (1) efter uge 16.
English: Treatment with Otezla should be initiated by specialists experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis.
Danish: Behandlingen med Otezla bør påbegyndes af specialister med erfaring i diagnose og behandling af psoriasis eller psoriasis artritis.
English: Apremilast has no or negligible influence on the ability to drive and use machines.
Danish: Apremilast påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with apremilast.
Danish: Hvis patienterne oplever nye eller forværrede psykiske symptomer, eller selvmordstanker eller selvmordsforsøg registreres, anbefales det at seponere behandlingen med apremilast.
English: In particular, tell your doctor or pharmacist before taking Otezla if you are taking any of the following medicines:
Danish: Du skal især fortælle det til lægen eller apotekspersonalet, hvis du tager nogle af de følgende lægemidler:
English: The clinical responses were maintained in the same parameters of peripheral activity and in the skin manifestations of psoriasis in the open-label extension studies for up to 5 years of treatment.
Danish: Det kliniske respons blev opretholdt i de samme parametre for perifer aktivitet og i hudmanifestationerne af psoriasis i de åbne forlængelsesstudier i op til 5 års behandling.
English: No such effects were observed when exposure in animals was at 1.3-fold the clinical exposure (see section 5.3).
Danish: Der blev ikke observeret sådanne virkninger, når eksponeringen hos dyr var 1,3 gange over den kliniske eksponering (se pkt.
English: • The other ingredients in the tablet core are cellulose microcrystalline, lactose monohydrate,
Danish: • Øvrige indholdsstoffer i tabletkernen: cellulose, mikrokrystallinsk, lactosemonohydrat,
English: • The recommended dose of Otezla is 30 mg twice a day after the titration phase is complete - one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food.
Danish: • Den anbefalede dosis Otezla er 30 mg to gange dagligt efter titreringsfasen er gennemført- en 30 mg dosis om morgenen og en 30 mg dosis om aftenen med ca. 12 timers mellemrum sammen med eller uden mad.
English: bN is based on subjects with moderate or greater scalp psoriasis at baseline who were re-randomised to APR 30 twice daily at week 32.
Danish: bN er baseret på personer med moderat eller større psoriasis i hårbunden ved baseline, der igen blev randomiseret til APR 30 to gange dagligt efter uge 32.
English: A total of 0.1% of patients treated with apremilast discontinued due to adverse reaction of weight decreased.
Danish: I alt 0,1 % af patienterne, der blev behandlet med apremilast, seponerede behandlingen på grund af bivirkningen vægttab.
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
Danish: Psoriasis artritis er en inflammatorisk ledsygdom, sædvanligvis ledsaget af psoriasis, en inflammatorisk hudsygdom.
English: Otezla is for oral use.
Danish: Otezla er til oral anvendelse.
English: • Do not use this medicine after the expiry date which is stated on the blister or on the wallet or on the carton after EXP.
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på blisteren eller på doseringskortet eller på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Day 1 - Day 7
Danish: Dag 1 - dag 7
English: Each pack of 27 film-coated tablets for a 2 week treatment schedule contains: 4 film-coated tablets of 10 mg
Danish: Hver pakning med 27 filmovertrukne tabletter til et 2-ugers behandlingsprogram indeholder: 4 filmovertrukne tabletter med 10 mg
English: You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have.
Danish: Du eller din omsorgsperson skal også straks underrette lægen om eventuelle ændringer i adfærd eller humør og om eventuelle selvmordstanker, du måtte have.
English: It is not known if this medicine passes into human milk.
Danish: Det er ukendt, om dette lægemiddel udskilles i modermælk.
English: You may also experience sleeplessness, or depressive mood.
Danish: Du kan også opleve søvnløshed eller forstemthed.
English: The clinical benefit of apremilast was demonstrated across multiple subgroups defined by baseline demographics and baseline clinical disease characteristics (including psoriasis disease duration and patients with a history of psoriatic arthritis).
Danish: Den kliniske fordel af apremilast blev vist i flere undergrupper defineret af baseline-demografi og baseline klinisk sygdomskarakteristik (herunder varigheden af psoriasissygdommen og patienter med tidligere psoriasis artritis).
English: Apremilast was studied in healthy subjects at a maximum total daily dose of 100 mg (given as 50 mg twice daily) for 4.5 days without evidence of dose limiting toxicities.
Danish: Apremilast blev undersøgt hos raske personer med en maksimal daglig dosis på i alt 100 mg (givet som 50 mg to gange dagligt) i 4,5 dage, uden bevis for dosisbegrænsende toksiciteter.
English: In vitro, apremilast has little to no inhibitory effect (IC50>10µM) on Organic Anion Transporter (OAT)1 and OAT3, Organic Cation Transporter (OCT)2, Organic Anion Transporting Polypeptide (OATP)1B1 and OATP1B3, or breast cancer resistance protein (BCRP) and is not a substrate for these transporters.
Danish: Apremilast har kun en lille eller ingen hæmmende virkning (IC50 > 10µM) på organisk aniontransporter (OAT)1 og OAT3, organisk kationtransporter (OCT)2, organisk aniontransporterende polypeptid (OATP)1B1 og OATP1B3 eller brystcancerresistensprotein (BCRP) in vitro, og det er ikke et substrat for disse transportere.
English: Otezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1).
Danish: Otezla, alene eller i kombination med sygdomsmodificerende antireumatiske lægemidler (disease modifying antirheumatic drugs, DMARDs) er indiceret til behandling af aktiv psoriasis artritis (PsA) hos voksne patienter, som har haft et utilstrækkeligt respons eller som har være intolerante over for en tidligere DMARD-behandling (se pkt.
English: • common cold (nasopharyngitis)
Danish: • almindelig forkølelse (nasofaryngitis)
English: For patients who remained on apremilast in the open label extension of ESTEEM 1 and ESTEEM 2 studies, improvements were generally maintained in PASI score, affected BSA, itch, nail and quality of life measures for up to 5 years.
Danish: For patienter, som fortsatte med apremilast i forlængelsen af de åbne studier ESTEEM 1- og ESTEEM 2, blev forbedringerne generelt opretholdt i PASI-score, påvirket BSA, målinger af kløe, negle og livskvalitet i op til 5 år.
English: The other most commonly reported adverse reactions include upper respiratory tract infections (8.4%), headache (7.9%), and tension headache (7.2%) and are mostly mild to moderate in severity.
Danish: De andre mest almindeligt rapporterede bivirkninger omfatter infektioner i de øvre luftveje (8,4 %), hovedpine (7,9 %) og spændingshovedpine (7,2 %) og er for det meste lette til moderate i sværhedsgrad.
English: The pharmacokinetics of apremilast and its major metabolite M12 are not affected by moderate or severe hepatic impairment.
Danish: Farmakokinetikken for apremilast og den primære metabolit M12 er ikke påvirket af moderat til svært nedsat leverfunktion.
English: The frequencies of adverse drug reactions are those reported in the apremilast arms of the four Phase III studies in PsA (n = 1,945) or the two Phase III studies in PSOR (n=1184) (highest frequency from either data pool is represented in Table 2).
Danish: Hyppighederne af bivirkningerne er dem, der blev rapporteret i apremilastarmene i de fire fase III-studier af PsA (n = 1.945) eller de to fase III-studier af PSOR (n = 1.184) (største hyppighed fra hver datapool vises i tabel 2).
English: The recommended dose of apremilast is 30 mg taken orally twice daily, approximately 12 hours apart (morning and evening), with no food restrictions.
Danish: Den anbefalede dosis af apremilast er 30 mg, der tages oralt to gange dagligt med ca. 12 timers mellemrum (om morgenen og aftenen), uden fødevarerestriktioner.
English: In these patients, ACR 20/50/70 responses at week 52 were of 57%, 25%, and 11% respectively.
Danish: Hos disse patienter var ACR 20/50/70-respons efter uge 52 hhv. 57 %, 25 % og 11 %.
English: Frequent bowel movements Upper abdominal pain* Gastroesophageal reflux disease
Danish: Hyppige afføringer Øvre abdominalsmerter* Gastroøsofageal reflukssygdom
English: Underweight patients
Danish: Undervægtige patienter
English: In clinical studies in patients with psoriatic arthritis, apremilast significantly modulated, but did not fully inhibit, plasma protein levels of IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3, and TNF-α.
Danish: I kliniske studier hos patienter med psoriasis artritis modulerede apremilast signifikant, men det hæmmede ikke fuldstændigt plasmaproteinniveauerne af IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3 og TNF-α.
English: From post-marketing experience, elderly patients ≥ 65 years of age may be at a higher risk of complications of severe diarrhoea, nausea and vomiting (see section 4.4).
Danish: Ifølge erfaringer efter markedsføringen kan ældre patienter ≥ 65 år have en højere risiko for komplikationer med svær diarré, kvalme og opkastning (se pkt.
English: Psoriatic arthritis and psoriasis are usually lifelong conditions and there is currently no cure.
Danish: Psoriasis artritis og psoriasis er normalt sygdomme, der varer hele livet, og de kan ikke på nuværende tidspunkt helbredes.
English: Patients who achieved PASI-50 at week 32
Danish: Patienter, der opnåede PASI-50 efter uge 32
English: There is no meaningful difference in the PK of apremilast between mild or moderate renally impaired subjects and matched healthy subjects (N=8 each).
Danish: Der er ingen meningsfyldt forskel i farmakokinetikken af apremilast mellem personer med let eller moderat nyrefunktion og matchede raske personer (N=8 af hver).
English: Patients who achieved PASI-75 at week 32
Danish: Patienter, der opnåede PASI-75 efter uge 32
English: If you have severe kidney problems then the recommended dose of Otezla is 30 mg once a day (morning dose).
Danish: Hvis du har svære nyreproblemer, er den anbefalede dosis af Otezla 30 mg én gang dagligt (morgendosis).
English: For initial dose titration in this group, it is recommended that apremilast be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped (see section 5.2).
Danish: For den indledende dosistitrering i denne gruppe anbefales det, at apremilast kun titreres med AM-skemaet, som er anført i tabel 1, og at PM-doserne springes over (se pkt.
English: People with severe kidney problems
Danish: Personer med svære nyreproblemer
English: Patients with each subtype of PsA were enrolled in the 3 studies, including symmetric polyarthritis (62.0%), asymmetric oligoarthritis (26.9%), distal interphalangeal (DIP) joint arthritis (6.2%), arthritis mutilans (2.7%), and predominant spondylitis (2.1%).
Danish: Patienter med hver undertype PsA indgik i de 3 studier, herunder symmetrisk polyartritis (62,0 %), asymmetrisk oligoartritis (26,9 %), artritis i det distale interfalangeale (DIP) led (6,2 %), arthritis mutilans (2,7 %) og prædominant spondylitis (2,1 %).
English: The proportion of patients achieving PASI-50, -75 and -90 responses, and sPGA score of clear (0) or almost clear (1), are presented in Table 4 below.
Danish: Andelen af patienter, der opnåede PASI-50-, -75- og -90-respons, og sPGA-score på klaret op (0) eller næsten klaret op (1) vises i tabel 4 nedenfor.
English: croscarmellose sodium and magnesium stearate.
Danish: croscarmellosenatrium og magnesiumstearat.
English: Further improvements in nail psoriasis were observed at week 32 in patients continuously treated with apremilast.
Danish: Yderligere forbedringer i neglepsoriasis blev observeret efter uge 32 hos patienter, der kontinuerligt blev behandlet med apremilast.
English: Following oral administration of radiolabelled apremilast, about 58% and 39% of the radioactivity is recovered in urine and faeces, respectively, with about 3% and 7% of the radioactive dose recovered as apremilast in urine and faeces, respectively.
Danish: Efter oral administration af radioaktivt mærket apremilast, genfindes ca. hhv. 58 % og 39 % i urin og fæces, hvoraf ca. hhv. 3 % og 7 % af den radioaktive dosis genfindes som apremilast i urin og fæces.
English: Magnesium stearate
Danish: Magnesiumstearat.
English: What you need to know before you take Otezla
Danish: Det skal du vide, før du begynder at tage Otezla
English: • Do not use this medicine if you notice any damage or signs of tampering to the medicine packaging.
Danish: • Brug ikke lægemidlet, hvis du bemærker, at pakningen er beskadiget eller udviser tegn på at have været åbnet.
English: There have been post-marketing reports of severe diarrhoea, nausea, and vomiting associated with the use of apremilast.
Danish: Der er indberettet tilfælde efter markedsføringen af svær diarré, kvalme og opkastning i forbindelse med brugen af apremilast.
English: Please notify your doctor immediately of any feelings of depression, suicidal thoughts or suicidal behaviour you may have.
Danish: Du bedes straks underrette lægen om en eventuel følelse af depression, selvmordstanker eller-adfærd, som du måtte have.
English: The mean baseline PASI score was 19.07 (median 16.80), and the proportion of patients with sPGA score of 3 (moderate) and 4 (severe) at baseline was 70.0% and 29.8%, respectively with a mean baseline BSA involvement of 25.19% (median 21.0%).
Danish: Den gennemsnitlige PASI-score var 19,07 (median 16,80), og andelen af patienter med sPGA-score på 3 (moderat) og 4 (svær) ved baseline var hhv. 70,0 % og 29,8 %, med en gennemsnitlig BSAinvolvering ved baseline på 25,19 % (median 21,0 %).
English: Upper respiratory tract infection Nasopharyngitis*
Danish: Infektion af de øvre luftveje Nasofaryngitis*
English: These GI adverse reactions are mostly mild to moderate in severity, with 0.3% of diarrhoea and 0.3% of nausea reported as severe.
Danish: Bivirkningerne i mave-tarm-kanalen er for det meste lette til moderate i sværhedsgrad, med 0,3 % diarré og 0,3 % kvalme, der blev rapporteret som svære.
English: Otezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Danish: Otezla er indiceret til behandling af moderat til svær kronisk plaque psoriasis hos voksne patienter, som ikke responderede på, eller som har en kontraindikation over for, eller er intolerante over for anden systemisk behandling, herunder ciclosporin, methotrexat eller psoralen og ultraviolet-A lys (PUVA).
English: Improved physical function as assessed by the HAQ-DI and the SF36v2PF domain, and the FACIT-fatigue scores were maintained in the open-label extension studies for up to 5 years of treatment.
Danish: Forbedret fysisk funktion vurderet ved HAQ-DI- og SF36v2PF-domæner og FACIT-træthedsscorer blev opretholdt i de åbne forlængelsesstudierne i op til 5 års behandling.
English: • The film-coating contains poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide red (E172).
Danish: • Filmovertrækket indeholder poly(vinylalkohol), titandioxid (E171), - macrogol (3350), talcum,
English: In psoriatic arthritis, treatment with Otezla results in an improvement in swollen and painful joints, and can improve your general physical function.
Danish: Ved psoriasis artritis fører behandlingen med Otezla til en forbedring af de hævede og smertefulde led, og det kan forbedre den generelle fysiske funktion.
English: What plaque psoriasis is
Danish: Hvad er plaque psoriasis?
English: Therefore, the use of strong CYP3A4 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin and St. John's Wort) with apremilast is not recommended.
Danish: Derfor bør kraftige CYP3A4 enzyminducere (f.eks. rifampicin, phenobarbital, carbamazepin, phenytoin og prikbladet perikon) ikke anvendes sammen med apremilast.
English: Persistence of effect among subjects randomised to APR 30 twice daily at week 0 and rerandomised to APR 30 twice daily at week 32 to week 52
Danish: Opretholdelse af virkningen blandt personer, der blev randomiseret til APR 30 to gange dagligt efter uge 0, og randomiseret igen til APR 30 to gange dagligt fra uge 32 til uge 52.
English: In both studies, the mean percent improvement in PASI from baseline remained stable during the Randomised Treatment Withdrawal Phase for patients re-randomised to apremilast at week 32 (Table 5).
Danish: I begge studier forblev den gennemsnitlige procentvise forbedring i PASI fra baseline stabil under den randomiserede seponeringsfase af behandlingen for patienter, der blev randomiseret igen til apremilast efter uge 32 (tabel 5).
English: 8 subjects with severe renal impairment to whom a single dose of 30 mg apremilast was administered, the AUC and Cmax of apremilast increased by approximately 89% and 42%, respectively.
Danish: Hos 8 personer med svært nedsat nyrefunktion, som fik en enkelt dosis på 30 mg apremilast administreret, blev AUC og Cmax for apremilast forhøjet med hhv. 89 % og 42 %.
English: In animal studies in mice, no adverse effects on fertility were observed in males at exposure levels 3-fold clinical exposure and in females at exposure levels 1-fold clinical exposure.
Danish: I dyrestudier hos mus blev der ikke observeret nogen bivirkning på fertiliteten hos hanner ved eksponeringsniveauer, der var 3 gange den kliniske eksponering, og hos hunner ved eksponeringsniveauer, der var 1 gang den kliniske eksponering.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/981/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/981/001