FrancophonIA/ELRC3.0 huggingface dataset:
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.
Maltese: Fi studji kliniċi f'pazjenti b'artrite psorjatika, apremilast immodula b'mod sinifikanti, iżda ma inibixxiex b'mod sħiħ, il-livelli ta' proteini fil-plażma ta' IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3, u TNF-α.
English: PASIc 75, n (%) sPGAd of Clear or Almost Clear, n (%) PASI 50, n (%) PASI 90, n (%) Percent Change BSAe (%) mean± SD
Maltese: 75, n (%) sPGAd ta' Bla Mard jew Kważi Bla Mard, n (%) PASI 50, n (%) PASI 90, n (%) Bidla Perċentwali fil-BSAe medja± SD
English: DMARDs N=497
Maltese: N=497
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.
Maltese: In vitro, apremilast għandu ftit jew l-ebda effett inibitorju (IC50>10µM) fuq Trasportatur Organiku tal-Katjoni (OCT) (Organic Anion Transporter (OAT))1 u OAT3, Organic Cation Transporter (OCT)2, Polypeptide Organika li Tittrasporta l-Anjoni (OATP) (Organic Anion Transporting Polypeptide (OATP))1B1 u OATP1B3, jew proteina reżistenti għal kanċer tas-sider (BRCP) (breast cancer resistance protein (BCRP)) u mhuwiex sottostrat għal dawn it-trasportaturi.
English: There was no pharmacokinetic interaction between apremilast and oral contraceptives containing ethinyl estradiol and norgestimate.
Maltese: Ma kien hemm l-ebda interazzjoni farmakokinetika bejn apremilast u kontraċettivi orali li jkun fihom ethinyl estradiol u norgestimate.
English: INFORMATION IN BRAILLE Otezla 30 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Otezla 30 mg
English: A total of 18% of patients had a history of psoriatic arthritis.
Maltese: Total ta' 18% tal-pazjenti kellhom storja medika ta' artrite psorjatika.
English: DMARDs N=159
Maltese: N=159
English: Otezla 30 mg tablets apremilast
Maltese: Otezla 30 mg pilloli apremilast
English: PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells.
Maltese: PDE4 hu PDE speċifiku għal adenosine monophosphate ċikliku (cAMP) (cyclic adenosine monophosphate (cAMP)-specific PDE) u l-PDE dominanti f'ċelluli infjammatorji.
English: • hives (urticaria)
Maltese: • ħorriqija (urtikarja)
English: There is no evidence of immunotoxic, dermal irritation, or phototoxic potential.
Maltese: M'hemm l-ebda evidenza ta' potenzjal immunotossiku, irritazzjoni tal-ġilda, jew fototossiċità.
English: Pharmacotherapeutic group: Immunosupressants, selective immunosuppressants, ATC code: L04AA32
Maltese: Immunosoppressanti, immunosoppressanti selettivi, Kodiċi ATC:
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
Maltese: *p ≤ 0.01 għal apremilast vs. plaċebo **p ≤ 0.001 għal apremilast vs. plaċebo a N hu n-numru ta' pazjenti bħala magħżula b'mod każwali u kkurati.
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
Maltese: Statika tat-Tabib) e BSA = Body Surface Area (Erja tas-Superfiċje tal-Ġisem) f VAS = Visual Analog Scale (Skala Analoga Viżwali); 0 = l-aħjar, 100 = l-agħar g DLQI = Dermatology Life Quality Index (Indiċi tal-kwalità tal-Ħajja tad-Dermatoloġija); 0 = l-aħjar, 30 = l-agħar h SF-36 MCS = Medical Outcome Study Short Form 36-Item Health Survey, Sommarju tal-Komponent Mentali
English: PVC/ aluminium foil blisters containing 14 film-coated tablets, in pack sizes of 56 tablets and 168 tablets.
Maltese: Folji tal-fojl tal-aluminju/PVC li fihom 14-il pillola miksija b'rita, f'pakketti tad-daqsijiet ta' 56 pillola u 168 pillola.
English: • phenytoin, phenobarbital and carbamazepine - medicines used in the treatment of seizures or epilepsy
Maltese: • phenytoin, phenobarbital u carbamazepine - mediċini li jintużaw fil-kura ta' aċċessjonijiet jew epilessija
English: Similar ACR responses were observed in patients with different PsA subtypes, including DIP.
Maltese: Risponsi ACR simili ġew osservati f'pazjenti b'sottotipi differenti ta' PsA, li jinkludu DIP.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
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.
Maltese: Fi provi kliniċi f'pazjenti bi psorjasi, apremilast naqqas il-ħxuna epidermali ta' leżjonijiet fil-ġilda, l-infiltrazzjoni ta' ċelluli infjammatorji, u l-espressjoni ta' ġeni proinfjammatorji, li jinkludu dawk għal nitric oxide synthase (iNOS) induċibbli, IL-12/IL-23p40, IL-17A, IL-22 u IL-8.
English: There is limited pharmacokinetic data in subjects over 75 years of age in clinical trials.
Maltese: Hemm dejta farmakokinetika limitata f'individwi li għandhom aktar minn 75 sena fl-istudji kliniċi.
English: Otezla 20 mg tablets
Maltese: Otezla 20 mg pilloli
English: The mean apparent volume of distribution (Vd) is 87 L, indicative of extravascular distribution.
Maltese: Il-medja tal-volum apparenti tad-distribuzzjoni (Vd) hu ta' 87 L, li jindika distribuzzjoni extravaskulari.
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
Maltese: Otezla 30 mg pilloli miksija b'rita EU/1/14/981/002 - daqs tal-pakkett ta' 56 pillola EU/1/14/981/003 - daqs tal-pakkett ta' 168 pillola
English: MARKETING AUTHORISATION NUMBER(S) Otezla 10 mg, 20 mg, 30 mg film-coated tablets (initiation pack) EU/1/14/981/001
Maltese: Otezla 10 mg, 20 mg, 30 mg pilloli miksija b'rita (pakkett tal-bidu) EU/1/14/981/001
English: Otezla 10 mg, 20 mg, 30 mg film-coated tablets (initiation pack) PVC/ aluminium foil blisters containing 27 film-coated tablets (4 x10 mg, 4x 20 mg, 19 x 30 mg).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Otezla 10 mg, 20 mg, 30 mg pilloli miksija b'rita (pakkett tal-bidu) Folji tal-fojl tal-aluminju/PVC li fihom 27 pillola miksija b'rita (4 x 10 mg, 4 x 20 mg, 19 x 30 mg).
English: For pre-clinical fertility data, see section 5.3.
Maltese: Għal dejta ta' qabel l-użu kliniku dwar il-fertilità, ara sezzjoni 5.3.
English: *NRI: None responder imputation.
Maltese: *NRI: Imputazzjoni ta' persuna li ma rrispondietx.
English: Diarrhoea* Nausea*
Maltese: Dijarea* Dardir*
English: • St John's Wort - a herbal medicine for mild anxiety and depression.
Maltese: • St John's Wort - mediċina li ġejja mill-ħxejjex li tintuża għal ansjetà ħafifa u depressjoni.
English: DMARDs N=496
Maltese: N=496
English: Patients received apremilast in combination with one or more of the following: methotrexate (MTX, ≤ 25 mg/week, 54.5%), sulfasalazine (SSZ, ≤ 2 g/day, 9.0%), and leflunomide (LEF; ≤ 20 mg/day, 7.4%).
Maltese: Il-pazjenti rċivew apremilast flimkien ma' wieħed jew aktar minn dawn li ġejjin: methotrexate (MTX, ≤ 25 mg/ġimgħa, 54.5%), sulfasalazine (SSZ, ≤ 2 g/jum, 9.0%), u leflunomide (LEF; ≤ 20 mg/jum, 7.4%).
English: Apremilast is contraindicated during pregnancy (see section 4.3).
Maltese: Apremilast hu kontra-indikat waqt it-tqala (ara sezzjoni 4.3).
English: In clinical studies, apremilast has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and salicylic acid scalp preparations) and UVB phototherapy.
Maltese: Fi studji kliniċi, apremilast ingħata fl-istess ħin ma' terapija topika (li tinkludi kortikosterojdi, coal tar shampoo u preparazzjonijiet għall-qorriegħa ta' salicylic acid) u fototerapija UVB.
English: Day 5
Maltese: Jum 5
English: The primary endpoint was the percentage of patients achieving American College of Rheumatology (ACR) 20 response at week 16.
Maltese: Il-punt aħħari primarju kien il-perċentwali ta' pazjenti li kisbu rispons American College of Rheumatology (ACR) 20 f'ġimgħa 16.
English: Week 1
Maltese: Jum 1
English: Apremilast dose should be reduced to 30 mg once daily in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2 or CLcr < 30 mL/min).
Maltese: Id-doża ta' apremilast għandha tiġi mnaqqsa għal 30 mg darba kuljum f'pazjenti b'indeboliment sever tal-kliewi (eGFR ta' inqas minn 30 mL/min/1.73 m2 jew CLcr < 30 mL/min).
English: * p< 0.0001 for apremilast vs placebo, except for ESTEEM 2 PASI 90 and Change in SF-36 MCS where p=0.0042 and p=0.0078, respectively.
Maltese: 2 PASI 90 u Bidla f'SF-36 MCS fejn p=0.0042 u p=0.0078, rispettivament.
English: Vomiting*
Maltese: Emigranja*
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.
Maltese: Is-sigurtà u effikaċja ta' apremilast ġew evalwati f'żewġ studji multiċentriċi, li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo (studji ESTEEM 1 u ESTEEM 2) li rreġistraw total ta' 1,257 pazjent bi psorjasi tal-plakka minn moderata sa severa, li kellhom involviment ta' erja tas-superfiċje tal-ġisem (BSA - body surface area) ta' ≥ 10%, punteġġ ta' Indiċi taż-Żona ta' Psorjasi u Severità (PASI) (Psoriasis Area and Severity Index (PASI)) ta' ≥ 12, Evalwazzjoni Globali tat-Tabib statika (sPGA) (static Physician Global Assessment (sPGA)) ta' ≥ 3 (moderata jew severa), u li kienu kandidati għal fototerapija jew terapija sistemika.
English: There was no clinically meaningful interaction between ketoconazole and apremilast.
Maltese: Ma kien hemm l-ebda interazzjoni klinikament sinifikanti bejn ketoconazole u apremilast.
English: In these patients, ACR 20/50/70 responses at week 52 were of 57%, 25%, and 11% respectively.
Maltese: F'dawn il-pazjenti, ir-risponsi ACR 20/50/70 f'ġimgħa 52 kienu ta' 57%, 25%, u 11% rispettivament.
English: In vitro, apremilast is not an inhibitor or inducer of cytochrome P450 enzymes.
Maltese: In vitro, apremilast mhuwiex inibitur jew induttur tal-enzimi ta' ċitokrom P450.
English: The same information is also available on the following URL: www.otezla-eu-pil.com.
Maltese: L-istess informazzjoni hija disponibbli wkoll fuq ilURL li ġej: www.otezla-eu-pil.com
English: Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators.
Maltese: Apremilast, inibitur orali ta' molekuli żgħar ta' phosphodiesterase 4 (PDE4), jaħdem b'mod intraċellulari biex jimmodula netwerk ta' medjaturi proinfjammatorji u antiinfjammatorji.
English: Week 2
Maltese: Jum 2
English: Apremilast was not clastogenic in an in vivo mouse micronucleus assay at doses up to 2,000 mg/kg/day.
Maltese: Apremilast ma kienx klastoġeniku f'assaġġ in vivo tal-mikronukleu talġrieden f'dożi sa 2,000 mg/kg/jum.
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).
Maltese: 2 u PALACE 3, titjib fl-Iskala tal-Attività tal-Marda (DAS - Disease Activity Scale) 28 C-proteina reattiva (CRP) u fil-proporzjon ta' pazjenti li kisbu kriterja ta' rispons PsA modifikat (PsARC) kienu akbar fil-grupp ta' apremilast, meta mqabbla ma' placebo f'ġimgħa 16 (valur p nominali p<0.0004, valur p<0.
English: A total of 1,493 patients were randomised and treated with either placebo, apremilast 20 mg or apremilast 30 mg given orally twice daily.
Maltese: Total ta' 1,493 pazjent intgħażlu b'mod każwali u ġew ikkurati jew bi plaċebo, apremilast 20 mg jew apremilast 30 mg, mogħti mill-ħalq darbtejn kuljum.
English: The 30 mg tablets also contain iron oxide yellow (E172) and iron oxide black (E172).
Maltese: Il-pilloli ta' 30 mg fihom ukoll iron oxide yellow (E172) u iron oxide black (E172).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/981/002 56 film-coated tablets EU/1/14/981/003 168 film-coated tablets
Maltese: EU/1/14/981/002 56 pillola miksija b'rita EU/1/14/981/003 168 pillola miksija b'rita
English: Clinical improvement measured by sPGA, PASI-50 and PASI-90 responses were also demonstrated at week 16.
Maltese: Titjib kliniku mkejjel minn risponsi sPGA, PASI-50 u PASI-90, intwerew ukoll f'ġimgħa 16.
English: Otezla contains lactose (a type of sugar).
Maltese: Otezla fih il-lactose (tip ta' zokkor).
English: Name and address of the manufacturer responsible for batch release Celgene Distribution B.V.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Celgene Distribution B.V.
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).
Maltese: Otezla hu indikat għall-kura ta' psorjasi tal-plakka moderata sa severa kronika f'pazjenti adulti li naqsu milli jirrispondu għal, jew li għandhom kontraindikazzjoni għal, jew li huma intolleranti għal terapija sistematika oħra, li tinkludi cyclosporine, methotrexate jew psoralen u dawl ultraviolet-A (PUVA).
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.
Maltese: Għalhekk, l-użu ta' indutturi qawwija tal-enzimi ta' ċitokrom CYP3A4 (eż. rifampicin, phenobarbital, carbamazepine, phenytoin u St.
English: Day 1 - Day 7
Maltese: Jum 1 - Jum 7
English: Uncommon instances of suicidal thinking and behaviour (including suicide) were reported.
Maltese: Ġew irrapportati każijiet mhux komuni ta' ħsieb u mġiba suwiċidali (inkluż suwiċidju).
English: Embryo-foetal development
Maltese: Żvilupp embrijufetali
English: • difficulty sleeping (insomnia)
Maltese: • diffikultà biex torqod (insomnija)
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%).
Maltese: Il-punteġġ medju PASI fil-linja bażi kien ta' 19.07 (medjan 16.80), u l-proporzjon ta' pazjenti b'punteġġ sPGA ta' 3 (moderat) u 4 (sever) fil-linja bażi kien ta' 70.0% u 29.8%, rispettivament, b'involviment BSA medju fil-linja bażi ta' 25.
English: Human plasma protein binding of apremilast is approximately 68%.
Maltese: It-twaħħil ta' apremilast mal-proteina fil-plażma umana hu ta' madwar 68%.
English: • The three-month standard pack contains 168 x 30 mg film-coated tablets.
Maltese: • Il-pakkett standard ta' tliet xhur fih 168 x 30 mg pillola miksija b'rita.
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.
Maltese: Fost it-832 pazjent li inizjalment intgħażlu b'mod każwali għal apremilast 30 mg darbtejn kuljum, 443 pazjent (53%) daħlu fl-istudji ta' estensjoni open-label ESTEEM 1 u ESTEEM 2, u minn dawn 115-il pazjent (26%) kienu għadhom fuq il-kura f'ġimgħa 260.
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva(i) jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: • inflammation and swelling of the tubes in your lungs (bronchitis)
Maltese: • infjammazzjoni u nefħa tat-tubi fil-pulmun (bronkite)
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
Maltese: Artrite psorjatika hi marda infjammatorja tal-ġogi, normalment akkumpanjata minn psorjasi, marda infjammatorja tal-ġilda.
English: 20 mg (brown)
Maltese: 20 mg (kannella)
English: After 40 weeks of treatment with apremilast, there was a decrease in plasma protein levels of IL-17 and IL-23, and an increase in IL-10.
Maltese: Wara 40 ġimgħa ta' kura b'apremilast, kien hemm tnaqqis fil-livelli ta' proteini fil-plażma ta' IL-17 u IL-23, u żieda f'IL-10.
English: The NOEL in the mouse for maternal toxicity and F1 generation was 10 mg/kg/day (1.3-fold clinical AUC).
Maltese: LNOEL fil-ġrieden għat-tossiċità materna u l-ġenerazzjoni F1 kien ta' 10 mg/kg/jum (1.3 darba talAUC kliniku).
English: Responses observed in the apremilast treated group were similar in patients receiving and not receiving concomitant DMARDs, including MTX.
Maltese: Risponsi osservati fil-grupp ikkurat b'apremilast kienu simili f'pazjenti li kienu qed jirċievu u li ma kinux qed jirċievu DMARDs fl-istess ħin, li jinkludu MTX.
English: Increased numbers of early resorptions and reduced numbers of ossified tarsals were observed at 20, 40, and 80 mg/kg/day.
Maltese: Ġiet osservata żieda fin-numri ta' assorbimenti mill-ġdid u tnaqqis fin-numri ta' tarsals ossifikati f'dożi ta' 20, 40, u 80 mg/kg/jum.
English: The safety and efficacy of apremilast in children aged 0 to 17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' apremilast fi tfal minn età 0 sa 17-il sena għadhom ma ġewx determinati s'issa.
English: N
Maltese: C.
English: The dose of apremilast should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockcroft-Gault equation).
Maltese: Iddoża ta' apremilast għandha titnaqqas għal 30 mg darba kuljum f'pazjenti b'indeboliment sever talkliewi (tneħħija tal-kreatinina ta' inqas minn 30 mL kull minuta kif stmata mill-Cockroft-Gault equation).
English: Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 57 mg ta' lactose (bħala lactose monohydrate).
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).
Maltese: Il-benefiċċju kliniku ta' apremilast intwera f'sottogruppi multipli definiti mid-demografija fil-linja bażi u mill-karatteristiċi kliniċi fil-linja bażi (li jinkludi t-tul tal-mard tal-psorjasi u pazjenti bi storja medika ta' artrite psorjatika).
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.
Maltese: L-għoti flimkien tal-induttur qawwi tal-enzimi ta' ċitokrom P450 3A4 (CYP3A4), rifampicin, irriżulta fi tnaqqis tal-esponiment sistemiku ta' apremilast, li jista' jirriżulta f'telf ta' effikaċja ta' apremilast.
English: The safety and efficacy of apremilast were evaluated in 3 multi-centre, randomised, double-blind, placebocontrolled studies (Studies PALACE 1, PALACE 2, and PALACE 3) of similar design in adult patients with active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with small molecule or biologic DMARDs.
Maltese: Is-sigurtà u l-effikaċja ta' apremilast ġew evalwati fi 3 studji multiċentriċi, li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo (studji PALACE 1, PALACE 2, u PALACE 3) li kellhom disinn simili, f'pazjenti adulti b'PsA attiva (≥ 3 ġogi minfuħin u ≥ 3 ġogi sensittivi) minkejja kura fil-passat b'DMARDs ta' molekuli żgħar jew bijoloġiċi.
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.
Maltese: Ir-risponsi kliniċi kienu miżmuma fl-istess parametri tal-attività periferali u fil-manifestazzjonijiet talġilda ta' psorjasi fl-istudji ta' estensjoni open-label għal sa 5 snin ta' kura.
English: Fertility and early embryonic development
Maltese: Fertilità u żvilupp embrijoniku bikri
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*)
Maltese: Il-proporzjon ta' pazjenti b'ACR 20/50/70 (risponsi fi studji PALACE 1, PALACE
English: In a male mouse fertility study, apremilast at oral dosages of 1, 10, 25, and 50 mg/kg/day produced no effects on male fertility; the no observed adverse effect level (NOAEL) for male fertility was greater than 50 mg/kg/day 3-fold clinical exposure).
Maltese: Fi studju dwar il-fertilità fil-ġrieden, apremilast f'dożaġġi orali ta' 1, 10, 25, u 50 mg/kg/jum ma pproduċa l-ebda effetti fuq il-fertilità maskili; il-livell tal-ebda effett avvers osservat (NOAEL-no observed adverse effect level) għall-fertilità maskili kien aktar minn 50 mg/kg/jum 3 darbiet talesponiment kliniku).
English: Percent Change in PASI from baseline, mean (%) ± SDa
Maltese: Perċentwali f'PASI mil-linja bażi, medja (%) ± SDa
English: Co-administration of apremilast with multiple doses of rifampicin resulted in a decrease in apremilast area-under-the-concentration time curve (AUC) and maximum serum concentration (Cmax) by approximately 72% and 43%, respectively.
Maltese: L-għoti flimkien ta' apremilast ma' dożi multipli ta' rifampicin irriżulta fi tnaqqis fl-erja taħt il-kurva talkonċentrazzjoni-ħin (AUC) ta' apremilast u l-konċentrazzjoni massima fis-serum (Cmax) b'madwar 72% u 43%, rispettivament.
English: Otezla works by reducing the activity of an enzyme in the body called ‘phosphodiesterase 4', which is involved in the process of inflammation.
Maltese: Otezla jaħdem billi jnaqqas l-attività ta' enzima fil-ġisem li tissejjaħ ‘phosphodiesterase 4', li hi involuta fil-proċess tal-infjammazzjoni.
English: Apremilast can be co-administered with oral contraceptives.
Maltese: Apremilast jista' jingħata flimkien ma' kontraċettivi orali.
English: Each film-coated tablet contains 171 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 171 mg ta' lactose (bħala lactose monohydrate).
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.
Maltese: Total ta' 76.4% tal-pazjenti ġew ikkurati qabel b'DMARDs ta' molekuli żgħar biss, u 22.4% ta' pazjenti ġew ikkurati qabel b'DMARDs bijoloġiċi, li jinkludu 7.8% li kellhom falliment terapewtiku b'DMARD bijoloġiku fil-passat.
English: Take the medicine pack and this leaflet with you.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Apremilast undergoes extensive metabolism with only 3% and 7% of the administered parent compound recovered in urine and faeces, respectively.
Maltese: Apremilast jgħaddi minn metaboliżmu estensiv, bi 3% u 7% biss talkompost ġenitur mogħti li jiġi rkuprat fl-awrina u fl-ippurgar, rispettivament.