FrancophonIA/ELRC3.0 huggingface dataset:
English: Respiratory, thoracic, and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg, 20 mg or 30 mg of apremilast.
Maltese: Kull pillola miksija b'rita fiha 10 mg, 20 mg or 30 mg ta' apremilast.
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).
Maltese: L-esponiment f'individwi anzjani (minn 65 sa 85 sena) hu madwar 13% ogħla fl-AUC u madwar 6% ogħla fis-Cmax għal apremilast minn dak f'individwi żgħar (minn 18 sa 55 sena).
English: PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, IL-17 and other inflammatory cytokines.
Maltese: L-inibizzjoni ta' PDE4 iżżid illivelli ta' cAMP intraċellulari, li sussegwentement jirregolaw 'l isfel ir-rispons infjammatorju billi jimmodulaw l-espressjoni ta' TNF-α, IL-23, IL-17 u cytokines infjammatorji oħrajn.
English: Apremilast pharmacokinetics are linear, with a dose-proportional increase in systemic exposure in the dose range of 10 to 100 mg daily.
Maltese: Il-farmakokinetika ta' apremilast hi lineari, b'żieda proporzjonali għad-doża f'esponiment sistemiku fil-medda tad-doża ta' 10 sa 100 mg kuljum.
English: The pharmacokinetics of apremilast and its major metabolite M12 are not affected by moderate or severe hepatic impairment.
Maltese: Il-farmakokinetika ta' apremilast u l-metabolit maġġuri tiegħu M12, ma jiġux affettwati minn indeboliment moderat jew sever tal-fwied.
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.
Maltese: In vitro, apremilast hu sottostrat, u inibitur dgħajjef ta' P-glikoproteina (IC50>50µM).
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.
Maltese: Wara l-għoti orali apremilast radjutikkettat, madwar 58% u 39% tar-radjoattività tiġi rkuprata fl-awrina u fl-ippurgar, rispettivament, b'madwar 3% u 7% tad-doża radjuattiva li tiġi rkuprata fl-awrina u fl-ippurgar, rispettivament.
English: Patients 65 years of age or older may be at a higher risk of complications.
Maltese: Pazjenti li jkollhom 65 sena jew aktar jistgħu ikunu f'riskju ogħla ta' kumplikazzjonijiet.
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.
Maltese: It-titjib fil-funzjoni fiżika kif evalwat mid-dominju HAQ-DI u SF36v2PF, u l-punteġġi tal-FACITgħeja kienu miżmuma fl-istudji ta' estensjoni open-label għal sa 5 snin ta' kura.
English: In
Maltese: ċ
English: Week 16 Week 32 Week 52
Maltese: Ġimgħa 16 Ġimgħa 32 Ġimgħa 52
English: Change in SF-36 MCS h, mean± SD
Maltese: Bidla f'DLQIg, medja± SD - 2.1 Bidla f'SF-36 MCS h, medja± SD
English: • The ‘treatment initiation pack' will also contain enough tablets for another 8 days at the recommended dose (days 7 to 14).
Maltese: • Il-‘pakkett tal-bidu tal-kura' se jkun fih ukoll biżżejjed pilloli għal 8 ijiem oħra fid-doża rakkomandata (jiem 7 sa 14).
English: Otezla should be dose reduced to 30 mg once daily in patients with severe renal impairment (see sections 4.2 and 5.2).
Maltese: Id-doża ta' Otezla għandha titnaqqas għal 30 mg darba kuljum f'pazjenti b'indeboliment sever talkliewi (ara sezzjonijiet 4.2 u 5.2).
English: The median duration of PsA disease was 5 years.
Maltese: It-tul medjan tal-mard PsA kien ta' 5 snin.
English: Patients who achieved PASI-75 at week 32
Maltese: Pazjenti li kisbu PASI-75 f'ġimgħa 32
English: • The one-month standard pack contains 56 x 30 mg film-coated tablets.
Maltese: • Il-pakkett standard ta' xahar fih 56 x 30 mg pillola miksija b'rita.
English: Patient weight was measured routinely in clinical studies.
Maltese: Il-piż tal-pazjenti tkejjel ta' rutina fl-istudji kliniċi.
English: After randomised withdrawal from therapy at week 32, approximately 70% of patients in Study ESTEEM 1, and 65.6% of patients in Study ESTEEM 2, regained PASI-75 (ESTEEM 1) or PASI-50 (ESTEEM 2) responses after re-initiation of apremilast treatment.
Maltese: Wara li ġew irtirati b'mod każwali mit-terapija f'ġimgħa 32, madwar 70% tal-pazjenti fi Studju ESTEEM 1, u 65.6% tal-pazjenti fi studju ESTEEM 2, reġgħu kisbu risponsi
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).
Maltese: Otezla, waħdu jew flimkien ma' Mediċini Antirewmatiċi li Jibdlu l-Marda (Disease Modifying Antirheumatic Drugs (DMARDs)), hu indikat għall-kura ta' artrite psorjatika attiva (PsA) f'pazjenti adulti li kellhom rispons inadegwat jew li kienu intolleranti għal terapija fil-passat b'DMARD (ara sezzjoni 5.1).
English: The 20 mg tablets also contain iron oxide yellow (E172).
Maltese: Il-pilloli ta' 20 mg fihom ukoll iron oxide yellow (E172).
English: Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 114 mg ta' lactose (bħala lactose monohydrate).
English: Migraine* Tension headache* Headache*
Maltese: Uġigħ ta' ras minħabba tensjoni* Uġigħ ta' ras*
English: Change in Pruritus VASf (mm), mean± SD Change in DLQIg, mean± SD
Maltese: Bidla fil-Ħakk VASf (mm), medja± SD
English: DMARDs N=162
Maltese: N=162
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.
Maltese: Fi 8 individwi b'indeboliment sever tal-kliewi li ngħataw doża waħda ta' 30 mg apremilast, l-AUC u s-Cmax ta' apremilast żdiedu b'madwar 89% u 42%, rispettivament.
English: Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets apremilast
Maltese: Otezla 10 mg pilloli miksija b'rita Otezla 20 mg pilloli miksija b'rita Otezla 30 mg pilloli miksija b'rita apremilast
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.
Maltese: Madwar 30% tal-pazjenti kollha kienu rċivew fototerapija fil-passat u 54% kienu rċivew terapija konvenzjonali sistematika u/jew bijoloġika fototerapija għall-kura ta' psorjasi (li tinkludi kura li ma rnexxietx), b'37% li kienu rċivew terapija sistemika konvenzjonali fil-passat u 30% li kienu rċivew terapija bijoloġika fil-passat.
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.
Maltese: • Artrite psorjatika attiva- jekk ma tistax tuża tip ieħor ta' mediċina li tissejjaħ ‘Disease-Modifying Antirheumatic Drugs' (DMARDs) jew meta tkun ippruvajt xi waħda minn dawn il-mediċini u ma tkunx ħadmet.
English: In a pre- and postnatal study, apremilast was administered orally to pregnant female mice at dosages of 10, 80 and 300 mg/kg/day from gestation day (GD) 6 to Day 20 of lactation.
Maltese: Fi studju ta' qabel u wara t-twelid, apremilast ingħata mill-ħalq lil ġrieden nisa tqal f'dożaġġi ta' 10, 80 u 300 mg/kg/jum minn jum tal-ġestazzjoni (GD) 6 sa Jum 20 tat-treddigħ.
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.
Maltese: Fi studju kombinat dwar il-fertilità ta' ġrieden nisa u t-tossiċità fl-iżvilupp embrijufetali b'dożaġġi orali ta' 10, 20, 40, u 80 mg/kg/jum, il-piżijiet assoluti u/jew relattivi tal-qalb tal-ommijiet ġrieden żdiedu f'dożi ta' 20, 40, u 80 mg/kg/jum.
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).
Maltese: Fi studji ESTEEM 1 u ESTEEM 2, titjib sinifikanti fil-psorjasi tal-qorriegħa ta' mill-inqas severità moderata (≥3), imkejjel mill-proporzjon ta' pazjenti li kisbu Evalwazzjoni Globali tat-Tabib ta' Psorjasi tal-Qorriegħa (ScPGA) (Scalp Psoriasis Physician's Global Assessment (ScPGA)) ta' bla mard (0) jew minima (1) f'ġimgħa 16, ġew osservati f'pazjenti li kienu qed jirċievu apremilast meta mqabbla ma' pazjenti kkurati bi plaċebo (p< 0.0001 għaż-żewġ studji).
English: DMARDs N=168
Maltese: N=168
English: DMARDs N=169
Maltese: N=169
English: Of these patients, 12% achieved a PASI-75 response at week 52 with apremilast plus topical and/or phototherapy treatment.
Maltese: Minn dawn il-pazjenti, 12% kisbu rispons PASI-75 f'ġimgħa 52 b'apremilast flimkien ma' kura topika u/jew fototerapija.
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).
Maltese: Fi studju dwar it-tossiċità fl-iżvilupp embrijufetali fix-xadini, dożaġġi orali ta' 20, 50, 200, u 1000 mg/kg/jum irriżultaw f'żieda relata mad-doża ta' telf qabel it-twelid (korrimenti) f'dożaġġi ta' 50 mg/kg/jum u ogħla; l-ebda effett relatat mal-artiklu tat-test fit-telf qabel it-twelid ma ġie osservat f'doża ta' 20 mg/kg/jum (1.4 drabi tal-esponiment kliniku).
English: An initial titration schedule is required as shown below in Table 1.
Maltese: Skeda ta' titrazzjoni inizjali hi meħtieġa kif muri hawn taħt f'Tabella 1.
English: Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10.These pro- and anti-inflammatory mediators have been implicated in psoriatic arthritis and psoriasis.
Maltese: Dawn il-medjaturi pro- u antiinfjammatorji ġew implikati f'artrite psorjatika u psorjasi.
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.
Maltese: 2 u PALACE 3, intwera titjib sinifikanti fil-kwalità tal-ħajja assoċjata mas-saħħa, kif imkejjel mit-tibdil mil-linja bażi fid-dominju tal-iffunzjonar fiżiku (PF) u l-punteġġi tax-Short Form Health Survey verżjoni 2 (SF-36v2), u fil-Evalwazzjoni Funzjonali ta' Terapija ta' Mard Kroniku - Għeja (FACIT-għeja) (Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-fatigue) f'pazjenti kkurati b'apremilast meta mqabbla ma' plaċebo f'ġimgħat 16 u 24.
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.
Maltese: Apremilast jiġi assorbit tajjeb, b'bijodisponibilità orali assoluta ta' madwar 73%, b'konċentrazzjonijiet massimi fil-plażma (Cmax) li seħħew f'ħin medjan (tmax) ta' madwar 2.5 sigħat.
English: At weeks 16 and 24 improvements in parameters of peripheral activity characteristic of psoriatic arthritis (e.g. number of swollen joints, number of painful/tender joints, dactylitis and enthesitis) and in the skin manifestations of psoriasis were seen in the apremilast-treated patients.
Maltese: F'ġimgħat 16 u 24, it-titjib fil-parametri tal-attività periferali karatteristika ta'artrite psorjatika (eż. numru ta' ġogi minfuħin, numru ta' ġogi bl-uġigħ/sensittivi, entesitie u dattilite) u filmanifestazzjonijiet tal-ġilda ta' psorjasi ġew osservati f'pazjenti kkurati b'apremilast.
English: The no observed effect level (NOEL) for female fertility was 10 mg/kg/day (1.0-fold clinical exposure).
Maltese: Il-livell tal-ebda effett avvers osservat (NOEL) għall-fertilità fin-nisa kien ta' 10 mg/kg/jum (1.0 darba tal-esponiment kliniku).
English: There was no pharmacokinetic interaction between apremilast and methotrexate in psoriatic arthritis patients.
Maltese: Ma kien hemm l-ebda interazzjoni farmakokinetika bejn apremilast u methotrexate f'pazjenti b'artrite psorjatika.
English: Patients who achieved PASI-50 at week 32
Maltese: Pazjenti li kisbu PASI-50 f'ġimgħa 32
English: Reduced foetal weights and retarded ossification of the supraoccipital bone of the skull were observed at 40 and 80 mg/kg/day.
Maltese: Tnaqqis fil-piżijiet fetali u dewmien fl-ossifikazzjoni tal-għadma supraokkipitali tal-kranju ġew osservati f'dożi ta' 40 u 80 mg/kg/jum.
English: Hypersensitivity reactions are uncommonly observed (see section 4.3).
Maltese: Reazzjonijiet ta' sensittività eċċessiva jiġu osservati b'mod mhux komuni (ara sezzjoni 4.3).
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).
Maltese: L-iktar reazzjonijiet avversi komuni li wasslu għat-twaqqif matul l-ewwel 16-il ġimgħa ta' kura kienu dijarea (1.7%), u dardir (1.5%) (il-frekwenzi huma bbażati fuq studji kliniċi ta' Fażi
English: DMARDs N=167
Maltese: N=167
English: Approximately one-third of patients had not received prior phototherapy, conventional systemic or biologic therapy.
Maltese: Madwar terz tal-pazjenti ma kinux irċivew fototerapija, terapija konvenzjonali sistemika jew bijoloġika fil-passat.
English: Detailed and updated information on this medicine is available by scanning the QR code on the outer packaging with a smartphone.
Maltese: Informazzjoni ddettaljata u aġġornata dwar din il-mediċina hija disponibbli jekk wieħed jiskennja lkodiċi QR fuq il-pakkett ta' barra bi smartphone.
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.
Maltese: Apremilast ġie studjat f'individwi b'saħħithom f'doża totali massima ta' kuljum ta' 100 mg (mogħtija bħala 50 mg darbtejn kuljum) għal 4.5 jiem mingħajr evidenza ta' tossiċitajiet li jillimitaw id-doża.
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).
Maltese: Mill-esperjenza ta' wara t-tqegħid fis-suq, pazjenti li jkollhom ≥ 65 sena jistgħu jkunu f'riskju ogħla ta' kumplikazzjonijiet ta' dijarea, dardir u rimettar severi (ara sezzjoni 4.4).
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.
Maltese: Il-proporzjon ta' pazjenti li kisbu risponsi PASI-50, -75 u -90, u punteġġ sPGA ta' bla mard (0) jew kważi bla mard (1), huma ppreżentati f'Tabella 4 hawn taħt.
English: A total of 0.1% of patients treated with apremilast discontinued due to adverse reaction of weight decreased.
Maltese: Total ta' 0.1% ta' pazjenti kkurati b'apremilast ma komplewx minħabba reazzjoni avversa ta' tnaqqis fil-piż.
English: Decreased appetite*
Maltese: Tnaqqis fl-aptit*
English: Frequent bowel movements Upper abdominal pain* Gastroesophageal reflux disease
Maltese: Tipporga ta' spiss Uġigħ fil-parti ta' fuq tal-addome* Mard tar-rifluss gastroesofageali
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/981/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/981/001
English: Day 6 onwards
Maltese: Jum 6 u wara
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).
Maltese: Fi studji ESTEEM 1 u ESTEEM 2, titjib sinifikanti fil-kwalità tal-ħajja kif imkejjel mill-Indiċi talKwalità tal-Ħajja: Dermatoloġija (DLQI) (Dermatology Life Quality Index (DLQI)) u l-SF-36v2MCS, intwera f'pazjenti li kienu qed jirċievu apremilast meta mqabbla ma' pazjenti kkurati bi plaċebo (Tabella 4).
English: Apremilast 30 mg twice daily
Maltese: Apremilast 30 mg darbtejn kuljum +/DMARDs
English: The use of low potency topical corticosteroids on the face, axillae, and groin, coal tar shampoo and/or salicylic acid scalp preparations was permitted throughout the studies.
Maltese: L-użu ta' kortikosterojdi topiċi ta' qawwa baxxa fuq il-wiċċ, axillae, u groin, coal tar shampoo u jew preparazzjoni għall-qorriegħa u/jew salicylic acid, kienu permessi matul l-istudji.
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.
Maltese: Fi studji f'annimali fil-ġrieden, l-ebda effetti avversi fuq il-fertilità ma ġew osservati fl-irġiel f'livelli ta' esponiment li kienu 3 darbiet tal-esponiment kliniku, u fin-nisa f'livelli ta' esponiment li kienu darba tal-esponiment kliniku.
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).
Maltese: Fi studji ESTEEM 1 u ESTEEM 2, titjib sinifikanti (tnaqqis) fil-psorjasi tad-dwiefer, kif imkejjel permezz tal-medja ta' bidla perċentwali fl-Indiċi tas-Severità ta' Psorjasi tad-Dwiefer (NAPSI - Nail Psoriasis Severity Index) mil-linja bażi, ġew osservati f'pazjenti li kienu qed jirċievu apremilast meta mqabbla ma' pazjenti kkurati bi plaċebo f'ġimgħa 16 (p< 0.0001 u p=0.0052, rispettivament).
English: • The 30 mg film-coated tablet also contains iron oxide yellow (E172) and iron oxide black (E172).
Maltese: • Il-pilloli miksija b'rita ta' 30 mg fiha wkoll iron oxide yellow (E172) u iron oxide black (E172).
English: 4 film-coated tablets of 20 mg
Maltese: 4 pilloli miksija b'rita ta' 20 mg
English: Among patients who were initially randomised to apremilast 30 mg twice daily treatment, the change from baseline in the HAQ-DI score at week 52 was -0.333 in the apremilast 30 mg twice daily group in a pooled analysis of the open label phase of studies PALACE 1, PALACE 2 and PALACE 3.
Maltese: 333 fil-grupp ta' apremilast 30 mg darbtejn kuljum f'analiżi miġbura tal-fażi open label ta' studji PALACE 1, PALACE2 u PALACE 3.
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.
Maltese: Pillola miksija b'rita 30 mg, ta' lewn beige, b'forma ta' djamant, twila 12 mm, b'“APR” imnaqqxa fuq naħa waħda u “30” fuq in-naħa l-oħra.
English: In clinical studies and post-marketing experience, uncommon cases of suicidal ideation and behaviour, were reported, while completed suicide was reported post-marketing.
Maltese: Fi studji kliniċi u l-esperjenza ta' wara t-tqegħid fis-suq, ġew irrapportati każijiet mhux komuni ta' ideazzjoni u mġiba suwiċidali, filwaqt li suwiċidju komplut kien irrapportat wara t-tqegħid fis-suq.
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
Maltese: Persistenza tal-effett fost individwi li ntgħażlu b'mod każwali għal APR 30 darbtejn kuljum f'ġimgħa 0 u li ntgħażlu b'mod każwali mill-ġdid għal APR 30 darbtejn kuljum f'ġimgħa 32 sa ġimgħa 52
English: Apremilast can be coadministered with a potent CYP3A4 inhibitor such as ketoconazole.
Maltese: Apremilast jista' jingħata flimkien ma' inibitur potenti ta' CYP3A4 bħal ketoconazole.
English: Apremilast is associated with an increased risk of psychiatric disorders such as insomnia and depression.
Maltese: Apremilast huwa assoċjat ma' żieda fir-riskju ta' disturbi psikjatriċi bħan-nuqqas ta' rqad u ddipressjoni.
English: Not known side effects (frequency cannot be estimated from the available data):
Maltese: Effetti sekondarji mhux magħrufa (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli):
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%.
Maltese: Total ta' 14.3% tal-pazjenti li kienu qed jirċievu apremilast kellhom telf ta' piż osservat ta' bejn 5-10% filwaqt li 5.7% tal-pazjenti li kienu qed jirċievu apremilast kellhom telf ta' piż osservat ta' iktar minn 10%.
English: Do not take Otezla:
Maltese: Tiħux Otezla:
English: The adverse reactions observed in patients treated with apremilast are listed below by system organ class (SOC) and frequency for all adverse reactions.
Maltese: Ir-reazzjonijiet avversi osservati f'pazjenti kkurati b'apremilast huma elenkati hawn taħt skont issistema tal-klassifika tal-organi (SOC) u l-frekwenza għar-reazzjonijiet avversi kollha.
English: Severe renal impairment
Maltese: X'fih Otezla
English: In the PsA or PSOR clinical studies, the safety profile observed in patients with mild renal impairment was comparable to patients with normal renal function.
Maltese: Fl-istudji kliniċi dwar PsA jew PSOR, il-profil tas-sigurtà osservat f'pazjenti b'indeboliment ħafif talkliewi kien komparabbli ma' dak ta' pazjenti b'funzjoni normali tal-kliewi.
English: The maternal and developmental NOEL in the mouse was 10 mg/kg/day (1.3-fold clinical exposure).
Maltese: L-NOEL tal-omm u tal-iżvilupp fil-ġrieden kien ta' 10 mg/kg/jum (1.3 drabi talesponiment kliniku).
English: This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.
Maltese: Din tappartjeni għal grupp ta' mediċini msejħa inibituri ta' phosphodiesterase 4, li jgħinu biex inaqqsu l-infjammazzjoni.
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.
Maltese: Għalhekk, apremilast mogħti flimkien ma' sottostrati ta' enzimi ta' CYP mhuwiex probabbli li jaffettwa t-tneħħija u lesponiment tas-sustanzi attivi li jiġu metabolizzati minn enzimi ta' CYP.
English: x 20 mg tablets and 19 x 30 mg tablets.
Maltese: 19-il pillola miksija b'rita ta' 30 mg
English: The Otezla 20 mg film-coated tablet is a brown, diamond shaped film-coated tablet with “APR” engraved on one side and “20” on the opposite side.
Maltese: Il-pillola Otezla miksija b'rita ta' 20 mg hi ta' lewn kannella, b'forma ta' djamant, b'“APR” imnaqqxa fuq naħa waħda u “20” fuq in-naħa l-oħra.
English: Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression (see section 4.8).
Maltese: Każijiet ta' ideazzjoni u mġiba suwiċidali, inkluż suwiċidju, ġew osservati f'pazjenti bi jew mingħajr storja ta' dipressjoni (ara sezzjoni 4.8).