FrancophonIA/ELRC3.0 huggingface dataset:
English: Fertility and early embryonic development
Slovenian: Plodnost in zgodnji razvoj zarodka
English: The median time to loss of 50% of their week 32 PASI improvement was 12.4 weeks.
Slovenian: Mediani čas do izgube 50 % njihovega izboljšanja PASI po 32 tednih je bil 12,4 tedna.
English: You may also experience sleeplessness, or depressive mood.
Slovenian: Pojavita se lahko tudi nespečnost ali depresivno razpoloženje.
English: Otezla has not been studied in children and adolescents, therefore it is not recommended for use in children and adolescents aged 17 years and under.
Slovenian: Pri otrocih in mladostnikih zdravila Otezla niso proučevali, zato njegova uporaba pri otrocih in mladostnikih, starih 17 let ali manj, ni priporočljiva.
English: Uncommon instances of suicidal thinking and behaviour (including suicide) were reported.
Slovenian: Poročali so o občasnih primerih samomorilnih misli in vedenja (vključno s samomorom).
English: Women of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati zanesljivo kontracepcijsko metodo, da preprečijo morebitno nosečnost med zdravljenjem.
English: • Swallow the tablets whole, preferably with water.
Slovenian: • Tablete pogoltnite cele, po možnosti z vodo.
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.
Slovenian: • aktivni psoriatični artritis - če ne morete jemati druge vrste zdravil, ki se imenujejo imunomodulirajoča protirevmatična zdravila (DMARDs), ali če ste poskusili z enim od teh zdravil, a ni delovalo;
English: Summary of adverse reactions in psoriatic arthritis (PsA) and/or psoriasis (PSOR)
Slovenian: Povzetek neželenih učinkov pri psoriatičnem artritisu (PsA) in/ali psoriazi (PSOR)
English: Also some other medicines can affect the way Otezla works.
Slovenian: Tudi nekatera druga zdravila lahko vplivajo na način delovanja zdravila Otezla.
English: In the event of unexplained and clinically significant weight loss, these patients should be evaluated by a medical practitioner and discontinuation of treatment should be considered.
Slovenian: V primeru nerazložene in klinično pomembne izgube telesne mase mora te bolnike oceniti zdravnik, v poštev pride prekinitev zdravljenja.
English: You may also experience sleeplessness (common), or depressive mood (common).
Slovenian: Pojavita se lahko tudi nespečnost (pogosto) ali depresivno razpoloženje (pogosto).
English: In case of an overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment is instituted.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo, da bolnika spremljamo glede vseh znakov ali simptomov neželenih učinkov in začnemo z ustreznim simptomatskim zdravljenjem.
English: Apremilast did not induce mutations in an Ames assay or chromosome aberrations in cultured human peripheral blood lymphocytes in the presence or absence of metabolic activation.
Slovenian: Apremilast ni induciral niti mutacij v Amesovem testu niti kromosomskih aberacij v limfocitih človeške periferne krvi v kulturi v prisotnosti ali odsotnosti presnovne aktivacije.
English: System Organ Class Frequency
Slovenian: Organski sistem Pogostnost
English: This is because Otezla can affect the way some other medicines work.
Slovenian: To je potrebno, ker zdravilo Otezla lahko vpliva na način delovanja nekaterih drugih zdravil.
English: In particular, tell your doctor or pharmacist before taking Otezla if you are taking any of the following medicines:
Slovenian: Še posebej obvestite zdravnika ali farmacevta, preden začnete jemati zdravilo Otezla, če jemljete katero od naslednjih zdravil:
English: If you have severe kidney problems then the recommended dose of Otezla is 30 mg once a day (morning dose).
Slovenian: Če imate hude težave z ledvicami, je priporočeni odmerek zdravila Otezla 30 mg enkrat na dan (jutranji odmerek).
English: ACR responses were maintained in the long-term open label extension studies for up to 5 years.
Slovenian: Odzivi ACR so v dolgoročnih odprtih podaljšanih študijah trajali do 5 let.
English: The long-term safety of apremilast 30 mg twice daily in patients with psoriatic arthritis and psoriasis was assessed for a total duration of treatment up to 5 years.
Slovenian: Dolgoročno varnost apremilasta v odmerku 30 mg dvakrat na dan pri bolnikih s psoriatičnim artritisom in psoriazo so ocenili za celotno trajanje zdravljenja do 5 let.
English: The number of patients with arthritis mutilans and predominant spondylitis subtypes was too small to allow meaningful assessment.
Slovenian: Pri bolnikih z artritisom mutilansom in prevladujočimi podtipi spondilitisa je bilo število premajhno za smiselno oceno.
English: All developmental effects were observed during the first week of the postnatal period; no apremilast-related effects were seen during the remaining pre- and post-weaning periods, including sexual maturation, behavioural, mating, fertility and uterine parameters.
Slovenian: Vse učinke na razvoj so opazili v prvem tednu postnatalnega obdobja; nobenih z apremilastom povezanih učinkov niso ugotovili med preostalimi obdobji pred odstavljanjem in po odstavljanju, vključno s spolnim dozorevanjem in parametri vedenja, parjenja, plodnosti in maternice.
English: If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time.
Slovenian: Če je takrat že skoraj čas za naslednji odmerek, naj ne vzame izpuščenega odmerka in naj ob rednem času vzame naslednji odmerek.
English: Subjects who discontinued early prior to the time point and subjects who did not have sufficient data for a definitive determination of response status at the time point are counted as non-responders.
Slovenian: Preskušance, ki so predčasno prekinili sodelovanje v študiji, in preskušance, ki niso imeli dovolj podatkov za dokončno opredelitev stopnje odziva na zdravljenje v določeni časovni točki, so opredelili kot neodzivne.
English: The major circulating inactive metabolite is the glucuronide conjugate of O-demethylated apremilast (M12).
Slovenian: Poglavitni neaktivni presnovek je glukuronidni konjugat O-demetiliranega apremilasta (M12).
English: In clinical studies and post-marketing experience, uncommon cases of suicidal ideation and behaviour, were reported, while completed suicide was reported post-marketing.
Slovenian: V kliničnih študijah in pri izkušnjah v obdobju trženja so poročali o občasnih primerih samomorilnih misli in vedenja, o izvedenem samomoru pa so poročali v obdobju trženja.
English: Response Rate +/- SE (%)
Slovenian: Stopnja odzivnosti +/- SE
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.
Slovenian: Klinični odzivi so trajali v istih parametrih periferne aktivnosti in v kožnih manifestacijah psoriaze v odprtih podaljšanih študijah do 5 let zdravljenja.
English: There are limited data about the use of apremilast in pregnant women.
Slovenian: Podatki o uporabi apremilasta pri nosečnicah so omejeni.
English: Apremilast was detected in milk of lactating mice (see section 5.3).
Slovenian: Apremilast so našli v mleku miši v obdobju laktacije (glejte poglavje 5.3).
English: Patient weight was measured routinely in clinical studies.
Slovenian: Telesno maso bolnikov so v kliničnih študijah merili rutinsko.
English: Patients 65 years of age or older may be at a higher risk of complications.
Slovenian: Pri bolnikih, starih 65 let in več, obstaja večje tveganje za pojav zapletov.
English: A total of 0.1% of patients treated with apremilast discontinued due to adverse reaction of weight decreased.
Slovenian: V celoti je 0,1 % bolnikov, zdravljenih z apremilastom, prekinilo zdravljenje zaradi neželenega učinka zmanjšane telesne mase.
English: What you need to know before you take Otezla
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Otezla
English: Oxidative metabolism of apremilast is primarily mediated by CYP3A4, with minor contributions from CYP1A2 and CYP2A6.
Slovenian: Oksidativno presnovo apremilasta primarno posreduje CYP3A4, z manjšim prispevkom CYP1A2 in CYP2A6.
English: The recommended dose of apremilast is 30 mg taken orally twice daily, approximately 12 hours apart (morning and evening), with no food restrictions.
Slovenian: Priporočeni odmerek apremilasta je 30 mg peroralno dvakrat na dan, približno 12 ur narazen (zjutraj in zvečer), brez omejitev glede hrane.
English: There is limited pharmacokinetic data in subjects over 75 years of age in clinical trials.
Slovenian: V kliničnih preskušanjih je malo farmakokinetičnih podatkov za preskušance, starejše od 75 let.
English: Similar ACR responses were observed in patients with different PsA subtypes, including DIP.
Slovenian: Podobne odzive po ACR so opazili pri bolnikih z različnimi podtipi PsA, vključno z DIP.
English: The plasma clearance of apremilast is on average about 10 L/hr in healthy subjects, with a terminal elimination half-life of approximately 9 hours.
Slovenian: Povprečni plazemski očistek apremilasta je pri zdravih preskušancih okrog 10 l/h, končni razpolovni čas izločanja pa približno 9 ur.
English: This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.
Slovenian: Ta pripada skupini zdravil, ki se imenujejo zaviralci fosfodiesteraze 4, ki pomagajo zmanjšati vnetje.
English: Effects of apremilast on pregnancy included embryofoetal loss in mice and monkeys, and reduced foetal weights and delayed ossification in mice at doses higher than the currently recommended highest human dose.
Slovenian: Učinki apremilasta na nosečnost so vključevali izgubo zarodka in ploda pri miših in opicah in zmanjšano telesno maso ploda ter zapoznelo osifikacijo pri miših pri odmerkih, ki so bili večji od trenutno priporočenega največjega odmerka za človeka.
English: Responses observed in the apremilast treated group were similar in patients receiving and not receiving concomitant DMARDs, including MTX.
Slovenian: Odzivi, ki so jih opazili v skupini, zdravljeni z apremilastom, so bili podobni pri bolnikih, ki niso in ki so sočasno prejemali DMARDs, vključno z MTX.
English: There is no evidence of immunotoxic, dermal irritation, or phototoxic potential.
Slovenian: Ni znakov možne imunotoksičnosti, kožnega draženja ali fototoksičnosti.
English: For pre-clinical fertility data, see section 5.3.
Slovenian: Za predklinične podatke o plodnosti glejte poglavje 5.3.
English: People with severe kidney problems
Slovenian: Ljudje, ki imajo hude težave z ledvicami
English: PVC/ aluminium foil blisters containing 14 film-coated tablets, in pack sizes of 56 tablets and 168 tablets.
Slovenian: Pretisni omoti iz PVC/aluminijeve folije, ki vsebujejo po 14 filmsko obloženih tablet, v velikostih pakiranja po 56 tablet in 168 tablet.
English: The clinical benefit of apremilast was also demonstrated regardless of prior psoriasis medication usage and response to prior psoriasis treatments.
Slovenian: Klinična koristnost apremilasta je bila dokazana tudi neodvisno od predhodne uporabe zdravil za psoriazo in odziva na predhodna zdravila za psoriazo.
English: Carcinogenicity studies
Slovenian: Študije kancerogenosti
English: In vitro, apremilast is not an inhibitor or inducer of cytochrome P450 enzymes.
Slovenian: In vitro apremilast ni zaviralec ali spodbujevalec encimov citokromom P450.
English: What Otezla is used for Otezla is used to treat adults with the following conditions:
Slovenian: Za kaj uporabljamo zdravilo Otezla Zdravilo Otezla uporabljamo za zdravljenje odraslih z naslednjimi stanji:
English: • Once the recommended dose has been reached, you will only get the 30 mg tablet strength in your prescribed packs.
Slovenian: • Ko boste dosegli priporočeni odmerek, boste v predpisanih pakiranjih prejemali le še tablete jakosti 30 mg.
English: In these patients, ACR 20/50/70 responses at week 52 were of 57%, 25%, and 11% respectively.
Slovenian: Pri teh bolnikih so bili odzivi ACR 20/50/70 po 52 tednih 57 %, 25 % oziroma 11 %.
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).
Slovenian: Izkušnje iz obdobja trženja kažejo, da lahko pri starejših bolnikih, starih ≥ 65 let, obstaja večje tveganje za pojav zapletov s hudo drisko, navzeo in bruhanjem (glejte poglavje 4.4.
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.
Slovenian: Apremilast se dobro absorbira z absolutno peroralno biološko uporabnostjo približno 73 %, najvišja koncentracija v plazmi (Cmax) pa nastopi v medianem času (tmax) približno 2,5 ur.
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.
Slovenian: Približno 30 % vseh bolnikov je prejelo predhodno fototerapijo, 54 % pa je prejelo predhodna konvencionalna sistemska in/ali biološka zdravila za zdravljenje psoriaze (z neuspehi zdravljenja vred), od tega jih je 37 % prejemalo predhodno konvencionalno sistemsko terapijo, 30 % pa predhodno biološko terapijo.
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
Slovenian: Trajanje učinka med preskušanci, randomiziranimi na APR 30 dvakrat na dan v tednu 0 in ponovno randomiziranimi na APR 30 dvakrat na dan v 32. tednu do 52. tedna
English: Day 1 - Day 7
Slovenian: 1. dan - 7. dan
English: No dosage adjustment is necessary for elderly patients.
Slovenian: Prilagajanje odmerjanja pri starejših bolnikih ni potrebno.
English: • depression
Slovenian: • depresija.
English: Pharmacotherapeutic group: Immunosupressants, selective immunosuppressants, ATC code: L04AA32
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA32
English: It is not known whether apremilast, or its metabolites, are excreted in human milk.
Slovenian: Ni znano, ali se apremilast ali njegovi presnovki izločajo v materinem mleku pri ljudeh.
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
Slovenian: a FAS = celotni nabor za analizo (Full Analysis Set) b LOCF= zadnje opazovanje preneseno naprej (Last Observation Carried forward) c PASI = indeks površine in jakosti psoriaze (Psoriasis Area and Severity Index) d sPGA = statična zdravnikova splošna ocena (Static Physician Global Assessment) e BSA = telesna površina (Body Surface Area) f VAS = vizualna analogna lestvica (Visual Analog Scale); 0 = brez srbenja, 100 = močno srbenje g DLQI = dermatološki indeks kakovosti življenja (Dermatology Life Quality Index); 0 = brez vpliva, 30 = zelo velik vpliv h SF-36 MCS = kratek vprašalnik o zdravstvenem stanju s 36 postavkami, povzetek duševne komponente (Medical Outcome Study Short
English: Day 6 & thereafter AM AM PM AM PM AM PM AM PM AM PM 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg
Slovenian: 6. dan in naprej zjutraj zjutraj zvečer zjutraj zvečer zjutraj zvečer zjutraj zvečer zjutraj zvečer 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg
English: • headaches, migraines or tension headaches
Slovenian: • glavobol, migrena ali tenzijski glavobol,
English: Morning Dose
Slovenian: Jutranji odmerek
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Wallet card containing 2-week treatment initiation pack
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zgibanka, ki vsebuje pakiranje za 2-tedensko začetno zdravljenje
English: Apremilast was not clastogenic in an in vivo mouse micronucleus assay at doses up to 2,000 mg/kg/day.
Slovenian: Apremilast ni bil klastogen v mišjem mikronukleusnem testu in vivo v odmerkih do 2.000 mg/kg/dan.
English: The primary endpoint was the percentage of patients achieving American College of Rheumatology (ACR) 20 response at week 16.
Slovenian: Primarni končni opazovani dogodek je bil delež bolnikov, ki so v 16. tednu dosegli odziv ACR 20 po American College of Rheumatology (ACR).
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.
Slovenian: • Priporočeni odmerek zdravila Otezla je 30 mg dvakrat na dan, potem ko je končana faza titracije - en 30-miligramski odmerek zjutraj in en 30-miligramski odmerek zvečer, približno 12 ur narazen, s hrano ali brez nje.
English: How and when to take Otezla
Slovenian: Kako in kdaj jemati zdravilo Otezla
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.
Slovenian: In vitro ima apremilast malo ali nič zaviralnega učinka (IC50>10µM) na prenašalca organskih anionov (OAT)1 in OAT3, prenašalca organskih kationov (OCT)2, polipeptidna prenašalca organskih anionov (OATP)1B1 in OATP1B3 ali na protein odpornosti proti raku dojke (BCRP) in ni substrat teh prenašalcev.
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 '.
Slovenian: • zmerna do huda kronična psoriaza v plakih - če ne morete uporabljati enega od naslednjih načinov zdravljenja ali če ste poskusili z enim od teh načinov zdravljenja, in ni delovalo: fototerapija - zdravljenje, pri katerem so določeni predeli kože izpostavljeni ultravijolični svetlobi, sistemsko zdravljenje - zdravljenje z zdravili, ki vplivajo na vse telo, ne samo na en predel telesa, na primer ‘ciklosporin', ‘metotreksat' ali 'psoralen'.
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).
Slovenian: Najpogostejša neželena učinka, ki privedeta do prekinitve jemanja zdravila v prvih 16 tednih zdravljenja, sta driska (1,7 %) in navzea (1,5 %) (pogostnosti temeljijo na kliničnih študijah 3. faze).
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.
Slovenian: Zato uporaba močnih spodbujevalcev encima CYP3A4 (npr. rifampicina, fenobarbitala, karbamazepina, fenitoina in šentjanževke) z apremilastom ni priporočljiva.
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.
Slovenian: * p< 0,0001 za apremilast proti placebu, razen za PASI 90 in spremembo v SF-36 MCS v študiji ESTEEM 2, kjer je bil p=0,0042 oziroma p=0,0078.
English: There have been post-marketing reports of severe diarrhoea, nausea, and vomiting associated with the use of apremilast.
Slovenian: Iz obdobja trženja so poročali o hudi driski, navzei in bruhanju, povezanih z uporabo apremilasta.
English: In psoriatic arthritis, treatment with Otezla results in an improvement in swollen and painful joints, and can improve your general physical function.
Slovenian: Pri psoriatičnem artritisu zdravljenje z zdravilom Otezla povzroči izboljšanje oteklih in bolečih sklepov in lahko izboljša vaše splošno telesno delovanje.
English: The adverse drug reactions were determined based on data from the apremilast clinical development programme and post-marketing experience.
Slovenian: Neželene učinke zdravila so določili na podlagi podatkov, pridobljenih v programu kliničnega razvoja apremilasta in izkušenj po prihodu zdravila na trg.
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).
Slovenian: Ni pomembnih razlik v farmakokinetiki apremilasta med preskušanci z blago ali zmerno okvaro ledvic in primerljivimi zdravimi preskušanci (N=8 vsakih).
English: • inflammation and swelling of the tubes in your lungs (bronchitis)
Slovenian: • vnetje in otekanje sapnic v pljučih (bronhitis),
English: Apremilast administered at doses of up to 50 mg twice daily did not prolong the QT interval in healthy subjects.
Slovenian: Apremilast, ki so ga dajali v odmerkih do 50 mg dvakrat dnevno, pri zdravih preskušancih ni podaljševal intervala QT.
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.
Slovenian: In vitro je apremilast substrat in šibek zaviralec P-glikoproteina (IC50>50µM), vendar ne pričakujemo, da bo prišlo do klinično pomembnih interakcij med zdravili, posredovanih s P-gp.
English: The same information is also available on the following URL: www.otezla-eu-pil.com.
Slovenian: Iste informacije so na voljo tudi na spletni strani: www.otezla-eu-pil.com.
English: Elderly patients No dose adjustment is required for this patient population (see sections 4.8 and 5.2).
Slovenian: Starejši bolniki Pri starejših bolnikih prilagajanje odmerka ni potrebno (glejte poglavji 4.8 in 5.2).
English: If you are 65 years of age or older, you might have a higher risk of complications of severe diarrhoea, nausea and vomiting.
Slovenian: Če ste stari 65 let ali več, lahko pri vas obstaja večje tveganje za zaplete s hudo drisko, siljenjem na bruhanje in bruhanjem.
English: Clinical response at week 16 in studies ESTEEM 1 and ESTEEM 2 (FAS a, LOCFb) ESTEEM 1
Slovenian: Klinični odziv v 16. tednu v študijah ESTEEM 1 in ESTEEM 2 (FAS a LOCFb)
English: Evening Dose
Slovenian: Večerni odmerek
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.
Slovenian: Apremilast so proučevali pri zdravih preskušancih v največjem celotnem dnevnem odmerku 100 mg (uporabljen v odmerku 50 mg dvakrat na dan) 4,5 dni brez znakov toksičnosti, ki bi omejevala odmerek.
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.
Slovenian: Skupno 76,4 % bolnikov je bilo pred vključitvijo zdravljenih le z nizkomolekularnimi DMARDs, 22,4 % bolnikov pa se je prej zdravilo z biološkimi DMARDs, kar vključuje 7,8 % bolnikov, pri katerih predhodno zdravljenje z biološkim DMARD ni bilo uspešno.
English: Please notify your doctor immediately of any feelings of depression, suicidal thoughts or suicidal behaviour you may have.
Slovenian: Zdravnika nemudoma obvestite o morebitnih občutkih depresivnosti, samomorilnih misli ali o samomorilnem vedenju, ki bi se morda pojavili.
English: Each pack of 27 film-coated tablets for a 2 week treatment schedule contains: 4 film-coated tablets of 10 mg
Slovenian: Eno pakiranje 27 filmsko obloženih tablet za 2-tedensko shemo zdravljenja vsebuje: 4 filmsko obložene tablete po 10 mg