FrancophonIA/ELRC3.0 huggingface dataset:
English: In Study ESTEEM 1, patients randomised to apremilast at the start of the study who did not achieve a PASI75 response at week 32 were permitted to use concomitant topical therapies and/or UVB phototherapy between weeks 32 to 52.
Danish: I studiet ESTEEM 1 fik patienterne, der blev randomiseret til apremilast ved begyndelsen af studiet, og som ikke opnåede et PASI-75-respons efter uge 32 lov til at anvende samtidige topikale behandlinger og/eller UVB-lysbehandling fra uge 32 til uge 52.
English: Following 52 weeks of treatment, patients could continue on open-label apremilast 30 mg within the long-term extension of the ESTEEM 1 and ESTEEM 2 studies for a total duration of treatment up to 5 years (260 weeks).
Danish: Efter 52 ugers behandling kunne patienterne fortsætte i et åbent studie med apremilast 30 mg i de langvarige forlængelser af ESTEEM 1- og ESTEEM 2-studierne i en total behandlingsvarighed på op til 5 år (260 uger).
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
English: The safety and efficacy of apremilast were evaluated in two multicentre, randomised, double-blind, placebocontrolled studies (Studies ESTEEM 1 and ESTEEM 2) which enrolled a total of 1,257 patients with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of ≥ 10%, Psoriasis Area and Severity Index (PASI) score ≥ 12, static Physician Global Assessment (sPGA) of ≥ 3 (moderate or severe), and who were candidates for phototherapy or systemic therapy.
Danish: Sikkerheden og virkningen af apremilast blev evalueret i to randomiserede, dobbeltblindede, placebokontrollerede multicenterstudier (studie ESTEEM 1 og ESTEEM 2), hvor i alt 1.257 patienter med moderat til svær plaque psoriasis indgik, som havde en involvering af legemsoverfladearealet (body surface area, BSA) på ≥ 10 %, indeks over areal og sværhedsgrad af psoriasis (psoriasis area and severity index, PASI)-score ≥ 12, statisk lægens samlede vurdering (physician global assessment, sPGA) på ≥ 3 (moderat eller svær), og som var kandidater for lysbehandling eller systemisk behandling.
English: Apremilast undergoes extensive metabolism with only 3% and 7% of the administered parent compound recovered in urine and faeces, respectively.
Danish: Apremilast gennemgår omfattende metabolisering, med en genfinding i urin og fæces på kun hhv. 3 % og 7 % af det administrerede udgangsstof.
English: Hence, apremilast coadministered with substrates of CYP enzymes is unlikely to affect the clearance and exposure of active substances that are metabolised by CYP enzymes.
Danish: Derfor er det ikke sandsynligt, at clearance og eksponering over for aktive stoffer, der metaboliseres af CYP-enzymer påvirkes, når apremilast administreres sammen med substrater for CYP-enzymer.
English: DMARDs N=159
Danish: N = 159
English: Figure 1 Proportion of ACR 20/50/70 responders through week 52 in the pooled analysis of studies PALACE 1, PALACE 2 and PALACE 3 (NRI*)
Danish: Figur 1 Andelen af ACR 20/50/70-personer, der responderede til og med uge 52 i den samlede analyse af studie PALACE 1, PALACE 2 ogPALACE 3 (NRI*)
English: Suicidal ideation and behaviour
Danish: Ikke almindelig Selvmordstanker og -adfærd
English: Reduced foetal weights and retarded ossification of the supraoccipital bone of the skull were observed at 40 and 80 mg/kg/day.
Danish: Nedsat fostervægt og forsinket ossifikation af supraoccipitalbenet i kraniet blev observeret ved 40 og 80 mg/kg/dag.
English: Among 832 patients initially randomised to apremilast 30 mg twice daily, 443 patients (53%) entered the open-label extension studies of ESTEEM 1 and ESTEEM 2, and of these 115 patients (26%) were still on treatment at week 260.
Danish: Blandt 832 patienter, der indledningsvis blev randomiseret til apremilast 30 mg to gange dagligt, indgik 443 patients (53 %) i de åbne forlængelsesstudier ESTEEM 1 og ESTEEM 2, og ud af disse var 115 patienter (26 %) stadig i behandling ved uge 260.
English: Improvements in DLQI were maintained through week 52 in subjects who were re-randomised to apremilast at week 32 (Table 5).
Danish: Forbedringer i DLQI blev opretholdt til og med uge 52 hos personer, der igen blev randomiseret til apremilast efter uge 32 (tabel 5).
English: In PALACE 1, PALACE 2 and PALACE 3, improvements in Disease Activity Scale (DAS) 28 C-reactive protein (CRP) and in the proportion of patients achieving a modified PsA response criteria (PsARC) were greater in the apremilast group, compared to placebo at week 16 (nominal p-value p< 0.0004, p-value ≤0.0017, respectively).
Danish: I PALACE 1, PALACE 2 og PALACE 3 var forbedringer i sygdomsaktivitetsskala (disease activity scale, DAS) 28 C-reaktivt protein (CRP) og i andelen af patienter, der opnåede et modificeret PsA-responskriterium (PsARC), større med apremilast-gruppen sammenlignet med placebo efter uge 16 (nominel p-værdi p < 0,0004 hhv. p-værdi ≤ 0,0017).
English: Otezla 30 mg film-coated tablets EU/1/14/981/002 - pack size of 56 tablets EU/1/14/981/003 - pack size of 168 tablets
Danish: EU/1/14/981/002 - pakningsstørrelse på 56 tabletter EU/1/14/981/003 - pakningsstørrelse på 168 tabletter
English: Among patients who remained on the apremilast treatment, to which they were initially randomised at study start, improvement in physical function and FACIT- fatigue was maintained through week 52.
Danish: Blandt patienter, der forblev på den apremilastbehandling de blev randomiseret til ved studiestart, blev forbedringer i fysisk funktion og FACITfatigue opretholdt til og med uge 52.
English: Patients with hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Danish: Patienter med nedsat leverfunktion Dosisjustering er ikke nødvendig for patienter med nedsat leverfunktion (se pkt.
English: The NOEL in the mouse for maternal toxicity and F1 generation was 10 mg/kg/day (1.3-fold clinical AUC).
Danish: NOEL hos mus for maternal toksicitet og F1-dannelse var 10 mg/kg/dag (1,3 gange klinisk AUC).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/981/002 56 film-coated tablets EU/1/14/981/003 168 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/981/002 56 filmovertrukne tabletter EU/1/14/981/003 168 filmovertrukne tabletter
English: In a combined female mouse fertility and embryo-foetal developmental toxicity study with oral dosages of 10, 20, 40, and 80 mg/kg/day, absolute and/or relative heart weights of maternal animals were increased at 20, 40, and 80 mg/kg/day.
Danish: I et kombineret studie af hunmusenes fertilitet og embryoføtal udviklingstoksicitet med orale doseringer på 10, 20, 40 og 80 mg/kg/dag, var absolut og/eller relativ vægt af hjertet hos moderdyr forhøjet med 20, 40 og 80 mg/kg/dag.
English: In studies PALACE 1, PALACE 2 and PALACE 3, significant improvements were demonstrated in healthrelated quality of life, as measured by the changes from baseline in the physical functioning (PF) domain of the Short Form Health Survey version 2 (SF-36v2), and in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-fatigue) scores in patients treated with apremilast compared to placebo at weeks 16 and 24.
Danish: I studie PALACE 1, PALACE 2 og PALACE 3 blev der vist signifikante forbedringer i helbredsrelateret livskvalitet, målt ved ændringer fra baseline i fysisk funktion (PF)-domæne af den korte formular for sundhedsundersøgelsen version 2 (short form health survey version 2, SF-36v2) samt i den funktionelle vurdering af behandling af kronisk sygdom - træthed (functional assessment of chronic illness therapy - fatigue, FACIT-fatigue)-scoringer hos patienter i behandling med apremilast sammenlignet med placebo efter uge 16 og 24.
English: Of the patients with at least a PASI-50 response who were re-randomised to placebo at week 32, 24.2% were PASI-50 responders at week 52.
Danish: Ud af patienterne med mindst et PASI-50-respons, der igen blev randomiseret til placebo efter uge 32, var 24,2 % PASI-50-responders efter uge 52.
English: In vitro, apremilast is a substrate, and a weak inhibitor of P-glycoprotein (IC50>50µM), however clinically relevant drug interactions mediated via P-gp are not expected to occur.
Danish: Apremilast er et substrat og en svag hæmmer for P-glykoprotein (IC50 > 50µM) in vitro.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg, 20 mg or 30 mg of apremilast.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 10 mg, 20 mg eller 30 mg apremilast.
English: Croscarmellose sodium
Danish: Croscarmellosenatrium
English: 19 film-coated tablets of 30 mg
Danish: 19 filmovertrukne tabletter med 30 mg
English: How Otezla works
Danish: Sådan virker Otezla
English: Of the patients with at least a PASI-75 response who were re-randomised to placebo at week 32 during a Randomised Treatment Withdrawal Phase, 11.7% were PASI-75 responders at week 52.
Danish: Ud af patienterne med mindst et PASI-75-respons, der igen blev randomiseret til placebo efter uge 32 i løbet af en randomiseret seponeringsfase af behandlingen, var 11,7 % PASI-75-responders efter uge 52.
English: 4 film-coated tablets of 20 mg
Danish: 4 filmovertrukne tabletter med 20 mg
English: Following 52 weeks of treatment, patients could continue on open label apremilast 20 mg or 30 mg within the long-term extension of the PALACE 1, PALACE 2, and PALACE 3 studies for a total duration of treatment up to 5 years (260 weeks).
Danish: Efter 52 ugers behandling kunne patienterne fortsætte i de åbne studier med apremilast 20 mg eller 30 mg i de langvarige forlængelser af PALACE 1-, PALACE 2- og PALACE 3-studierne i en behandlingsvarighed på i alt op til 5 år (260 uger).
English: Among 497 patients initially randomised to apremilast 30 mg twice daily, 375 (75%) patients entered the long term extension studies, and of these, 221 patients (59%) were still on this treatment at week 260.
Danish: Blandt 497 patienter, der indledningsvis blev randomiseret til apremilast 30 mg to gange dagligt, indgik 375 (75 %) af patienterne i de langvarige forlængelsesstudier, og ud af disse var 221 patienter (59 %) stadig i denne behandling ved uge 260.
English: Other medicines and Otezla
Danish: Brug af anden medicin sammen med Otezla
English: Do not store above 30ºC.
Danish: Må ikke opbevares ved temperaturer over 30 ºC.
English: *p ≤ 0.01 for apremilast vs. placebo **p ≤ 0.001 for apremilast vs. placebo a N is the number of patients as randomised and treated
Danish: **p ≤ 0,001 for apremilast vs. placebo.
English: Otezla works by reducing the activity of an enzyme in the body called ‘phosphodiesterase 4', which is involved in the process of inflammation.
Danish: Otezla virker ved at reducere aktiviteten af et enzym i kroppen, der kaldes
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Diarré, kvalme og opkastning
English: 4.5 Interaction with other medicinal products and other forms of interaction Co-administration of strong cytochrome P450 3A4 (CYP3A4) enzyme inducer, rifampicin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of apremilast.
Danish: Samtidig administration af den kraftige cytokrom-P450 3A4 (CYP3A4) enzyminducer rifampicin førte til en reduktion af den systemiske eksponering over for apremilast, hvilket kan føre til et tab af apremilasts virkning.
English: • frequent bowel movements
Danish: • hyppige afføringer
English: In Studies ESTEEM 1 and ESTEEM 2, significant improvements in quality of life as measured by the Dermatology Life Quality Index (DLQI) and the SF-36v2MCS were demonstrated in patients receiving apremilast compared with placebo-treated patients (Table 4).
Danish: I studie ESTEEM 1 og ESTEEM 2 blev der vist signifikante forbedringer i livskvalitet, målt ved dermatologi livskvalitetsindeks (dermatology life quality index, DLQI) og SF-36v2MCS hos patienter, der fik apremilast, sammenlignet med placebobehandlede patienter (tabel 4).
English: Among patients who were initially randomised to apremilast 30 mg twice daily treatment, ACR 20/50/70 response rates were maintained through week 52 in the pooled studies PALACE 1, PALACE 2 and PALACE 3 (Figure 1).
Danish: Blandt patienter, der indledningsvist blev randomiseret til behandling med apremilast 30 mg to gange dagligt blev ACR 20/50/70-responsraterne opretholdt til og med uge 52 i de samlede studier PALACE 1, PALACE 2 og PALACE 3 (figur 1).
English: Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets apremilast
Danish: Otezla 10 mg filmovertrukne tabletter Otezla 20 mg filmovertrukne tabletter Otezla 30 mg filmovertrukne tabletter apremilast
English: In Study ESTEEM 2, approximately 80.3% of patients re-randomised to apremilast at week 32 had a PASI50 response at week 52.
Danish: I studiet ESTEEM 2 havde ca. 80,3 % af patienterne, der igen blev randomiseret til apremilast efter uge 32 et PASI-50-respons efter uge 52.
English: In Study ESTEEM 1, approximately 61% of patients re-randomised to apremilast at week 32 had a PASI-75 response at week 52.
Danish: I studiet ESTEEM 1 havde ca. 61 % af patienterne, der igen blev randomiseret til apremilast efter uge 32 et PASI-75-respons efter uge 52.
English: Day 5
Danish: Dag 5
English: a FAS = Full Analysis Set b LOCF= Last Observation Carried forward c PASI = Psoriasis Area and Severity Index d sPGA = Static Physician Global Assessment e BSA = Body Surface Area f VAS = Visual Analog Scale; 0 = best, 100 = worst g DLQI = Dermatology Life Quality Index; 0 = best, 30 = worst h SF-36 MCS = Medical Outcome Study Short Form 36-Item Health Survey, Mental Component Summary
Danish: * p < 0,0001 for apremilast vs. placebo, undtagen for ESTEEM 2 PASI 90 og ændring i SF-36 MCS, hvor p=0,0042 og p=0,0078, hhv. a FAS = fuldstændigt analysesæt (full analysis set) b LOCF= sidste observation ført fremad (last observation carried forward) c PASI = indeks over areal og sværhedsgrad af psoriasis (psoriasis area and severity index) d sPGA = lægens samlede vurdering (static physician global assessment) e BSA = legemsoverfladeareal (body surface area) f VAS = visuel analogskala (visual analog scale) 0 = bedst, 100 = værst g DLQI = dermatologi livskvalitetsindeks (dermatology life quality index) 0 = bedst, 30 = værst h SF-36 MCS = kort helbredsspørgeskema medicinsk udfald af studiet, helbredsundersøgelse med 36 dele, oversigt af mentan komponent
English: Detailed and updated information on this medicine is available by scanning the QR code on the outer packaging with a smartphone.
Danish: Detaljerede og opdaterede oplysninger om dette lægemiddel kan ses ved at scanne QR-koden på den ydre emballage med en smarttelefon.De samme oplysninger kan også ses ved at klikke på følgende URL: www.otezla-eu-pil.com.
English: In clinical trials in patients with psoriasis, apremilast decreased lesional skin epidermal thickness, inflammatory cell infiltration, and expression of pro-inflammatory genes, including those for inducible nitric oxide synthase (iNOS), IL-12/IL-23p40, IL-17A, IL-22 and IL-8.
Danish: Efter 40 ugers behandling med apremilast var der en reduktion i plasmaproteinniveauerne af IL-17 og IL-23, samt en forhøjelse i IL-10. I kliniske studier hos patienter med psoriasis reducerede apremilast epidermis-fortykkelse af hudlæsionerne, inflammatorisk celleinfiltration og ekspressionen af proinflammatoriske gener, herunder generne for inducerbart nitrogenoxidsyntase (iNOS), IL-12/IL23p40, IL-17A, IL-22 og IL-8.
English: DMARDs N=496
Danish: N = 496
English: Insomnia Depression
Danish: Almindelig Insomni
English: What psoriatic arthritis is
Danish: Hvad er psoriasis artritis?
English: Patients with hepatic impairment The safety of apremilast was not evaluated in PsA or PSOR patients with hepatic impairment.
Danish: Sikkerheden af apremilast blev ikke evalueret hos patienter med PsA eller PSOR med nedsat leverfunktion.
English: Elderly patients No dose adjustment is required for this patient population (see sections 4.8 and 5.2).
Danish: Ældre patienter Dosisjustering er ikke nødvendig for denne patientpopulation (se pkt.
English: Otezla 30 mg tablets apremilast
Danish: Otezla 30 mg tabletter apremilast
English: System Organ Class Frequency
Danish: Systemorganklasse Hyppighed Bivirkning mediastinum
English: ACR 20a
Danish: 20a
English: Vomiting*
Danish: Opkastning*
English: n/m (%)
Danish: PASI 50, n (%)
English: Otezla 20 mg tablets
Danish: Otezla 20 mg tabletter
English: • The treatment initiation pack is a folding wallet containing 27 film-coated tablets: 4 x 10 mg tablets, 4
Danish: • Pakningen med den indledende behandling er en yderkarton, der indeholder 27 filmovertrukne tabletter: 4 x 10 mg tabletter, 4 x 20 mg tabletter og 19 x 30 mg tabletter.
English: In Studies ESTEEM 1 and ESTEEM 2, significant improvements in scalp psoriasis of at least moderate severity (≥3), measured by the proportion of patients achieving Scalp Psoriasis Physician's Global Assessment (ScPGA) of clear (0) or minimal (1) at week 16, were observed in patients receiving apremilast compared to placebo-treated patients (p< 0.0001 for both studies).
Danish: I studie ESTEEM 1 og ESTEEM 2 blev der observeret signifikante forbedringer i psoriasis i hårbunden af en mindst moderat sværhedsgrad (≥3), målt ved andelen af patienter, der opnåede psoriasis i hårbunden lægens samlede vurdering (scalp psoriasis physician's global assessment, ScPGA) på klaret op (0) eller minimal (1) efter uge 16, hos patienter, der fik apremilast, sammenlignet med placebobehandlede patienter (p < 0,0001 for begge studier).
English: Day
Danish: Tidspunkt
English: • indigestion or heartburn
Danish: • fordøjelsesbesvær eller halsbrand
English: The maternal and developmental NOEL in the mouse was 10 mg/kg/day (1.3-fold clinical exposure).
Danish: NOEL for moderdyr og udvikling hos mus var 10 mg/kg/dag (1,3 gange klinisk eksponering).
English: Otezla should be dose reduced to 30 mg once daily in patients with severe renal impairment (see sections 4.2 and 5.2).
Danish: Dosis af Otezla bør reduceres til 30 mg én gang dagligt hos patienter med svært nedsat nyrefunktion (se pkt.
English: If you take more Otezla than you should
Danish: Hvis du har taget for meget Otezla
English: In Studies ESTEEM 1 and ESTEEM 2, significant improvements (reductions) in nail psoriasis, as measured by the mean percent change in Nail Psoriasis Severity Index (NAPSI) from baseline, were observed in patients receiving apremilast compared to placebo-treated patients at week 16 (p< 0.0001 and p=0.0052, respectively).
Danish: I studie ESTEEM 1og ESTEEM 2 blev der observeret signifikante forbedringer (reduktioner) i neglepsoriasis, målt ved den gennemsnitlige procentvise ændring i indeks over sværhedsgrad af neglepsoriasis (nail psoriasis severity index, NAPSI) fra baseline hos patienter, der fik apremilast, sammenlignet med placebobehandlede patienter efter uge 16 (p < 0,0001 hhv. p=0,052).
English: • Otezla 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
Danish: • Otezla 20 mg filmovertrukne tabletter: hver filmovertrukket tablet indeholder 20 mg apremilast.
English: • The 20 mg film-coated tablet also contains iron oxide yellow (E172).
Danish: • Den filmovertrukne tablet med 20 mg indeholder også jernoxid, gul (E172).
English: No dose adjustment is needed in patients with mild and moderate renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nedsat nyrefunktion.
English: Each film-coated tablet contains 20 mg of apremilast.
Danish: Hver filmovertrukket tablet indeholder 20 mg apremilast.
English: • Otezla 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.
Danish: • Otezla 30 mg filmovertrukne tabletter: hver filmovertrukket tablet indeholder 30 mg apremilast.
English: PASIc 75, n (%) sPGAd of Clear or Almost Clear, n (%) PASI 50, n (%) PASI 90, n (%) Percent Change BSAe (%) mean± SD
Danish: PASI 90, n (%) Procent ændring BSAe (%)
English: In a monkey embryo-foetal developmental toxicity study, oral dosages of 20, 50, 200, and 1000 mg/kg/day resulted in a dose-related increase in prenatal loss (abortions) at dosages of 50 mg/kg/day and above; no test article-related effect in prenatal loss was observed at 20 mg/kg/day (1.4-fold clinical exposure).
Danish: I et embryoføtalt udviklingsstudie af toksicitet hos aber førte orale doser på 20, 50, 200 og 1000 mg/kg/dag til en dosisrelateret forøgelse af prænatalt tab (aborter) ved doseringer på 50 mg/kg/dag og derover.
English: • Otezla 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
Danish: • Otezla 10 mg filmovertrukne tabletter: hver filmovertrukket tablet indeholder 10 mg apremilast.
English: Each film-coated tablet contains 10 mg of apremilast.
Danish: Hver filmovertrukket tablet indeholder 10 mg apremilast.
English: Respiratory, thoracic, and mediastinal disorders
Danish: Luftveje, thorax og Almindelig Hoste
English: Each film-coated tablet contains 30 mg of apremilast.
Danish: Hver filmovertrukket tablet indeholder 30 mg apremilast.
English: Hypersensitivity
Danish: Ikke almindelig Overfølsomhed
English: Otezla contains lactose
Danish: Otezla indeholder lactose
English: The 20 mg tablets also contain iron oxide yellow (E172).
Danish: Tabletterne med 20 mg indeholder også jernoxid, gul (E172).
English: Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 57 mg lactose (som lactosemonohydrat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of apremilast.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 30 mg apremilast.
English: Severe renal impairment
Danish: Svær nedsat nyrefunktion
English: • The 30 mg film-coated tablet also contains iron oxide yellow (E172) and iron oxide black (E172).
Danish: • Den filmovertrukne tablet med 30 mg indeholder også jernoxid, gul (E172) og jernoxid, sort (E172).
English: In a combined female mouse fertility and embryo-foetal developmental toxicity study with oral dosages of 10, 20, 40, and 80 mg/kg/day, a prolongation of oestrous cycles and increased time to mating were observed at 20 mg/kg/day and above; despite this, all mice mated and pregnancy rates were unaffected.
Danish: I et kombineret studie af hunmusenes fertilitet og embryoføtal udviklingstoksicitet med orale doseringer på 10, 20, 40 og 80 mg/kg/dag, blev der observeret en forlængelse af østruscyklusser og en forlænget tid til parring ved 20 mg/kg/dag og derover.
English: Table 1: Dose titration schedule
Danish: Skema over dosistitrering
English: Each film-coated tablet contains 171 mg of lactose (as lactose monohydrate).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 171 mg lactose (som lactosemonohydrat).
English: Beige, diamond shaped 30 mg film-coated tablet of 12 mm length with “APR” engraved on one side and “30” on the opposite side.
Danish: Beige, diamantformet 30 mg filmovertrukket tablet med en længde på 12 mm, graveret med ”APR” på den ene side og med ”30” på den modsatte side.
English: No dose adjustment is necessary for patients with hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion.
English: The no observed effect level (NOEL) for female fertility was 10 mg/kg/day (1.0-fold clinical exposure).
Danish: NOEL for hunmusenes fertilitet var 10 mg/kg/dag (1,0 gange kliniske eksponering).
English: The 30 mg tablets also contain iron oxide yellow (E172) and iron oxide black (E172).
Danish: Tabletterne med 30 mg indeholder også: jernoxid, gul (E172) og jernoxid, sort (E172).
English: Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 114 mg lactose (som lactosemonohydrat).