FrancophonIA/ELRC3.0 huggingface dataset:
English: Physical signs of maternal toxicity associated with delivering pups were also observed in one mouse at each of 80 and 300 mg/kg/day.
Slovenian: Telesne znake toksičnosti za mater, povezane s skotitvijo mladičev, so opazili tudi pri eni miši pri odmerku 80 mg/kg/dan in pri eni miši pri odmerku 300 mg/kg/dan.
English: 4 film-coated tablets of 20 mg
Slovenian: 4 filmsko obložene tablete po 20 mg
English: Reduced foetal weights and retarded ossification of the supraoccipital bone of the skull were observed at 40 and 80 mg/kg/day.
Slovenian: Zmanjšano maso plodov in zapoznelo osifikacijo supraokcipitalne kosti lobanje so ugotovili pri 40 in 80 mg/kg/dan.
English: What Otezla looks like and contents of the pack
Slovenian: Izgled zdravila Otezla in vsebina pakiranja
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.
Slovenian: Od 497 bolnikov, ki so bili v začetku randomizirani na apremilast 30 mg dvakrat na dan, se je 375 bolnikov (75 %) vključilo v dolgoročne podaljšane študije, in od teh se je 221 bolnikov (59 %) v 260. tednu še vedno zdravilo.
English: The safety of apremilast was not evaluated in PsA or PSOR patients with moderate or severe renal impairment in the clinical studies.
Slovenian: Pri bolnikih s PsA ali PSOR z zmerno ali hudo okvaro ledvic varnosti apremilasta v kliničnih študijah niso ocenjevali.
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*)
Slovenian: Delež bolnikov z odzivom ACR 20/50/70 do 52. tedna z analizo podatkov združenih študij PALACE 1, PALACE 2 in PALACE 3 (NRI*)
English: Among patients who remained on the apremilast treatment to which they were randomised at study start, DAS28(CRP) score and PsARC response were maintained through week 52.
Slovenian: Pri bolnikih, ki so ostali na zdravljenju z apremilastom, na katerega so bili randomizirani že v začetku študije, sta oba parametra, to je rezultat DAS28 (CRP) in odziv PsARC po 52 tednih še vedno trajala.
English: At week 24, all remaining placebo-treated patients were switched to either apremilast 20 or 30 mg twice daily.
Slovenian: Po 24 tednih so vsem preostalim bolnikom, ki so prejemali placebo, začeli dajati apremilast 20 mg ali 30 mg dvakrat na dan.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg, 20 mg or 30 mg of apremilast.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 10 mg, 20 mg ali 30 mg apremilasta.
English: Apremilast is the major circulating component following oral administration.
Slovenian: Apremilast je glavna spojina, ki po peroralnem dajanju kroži v telesu.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Slovenian: Predklinični podatki na podlagi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
English: a Includes subjects re-randomised to APR 30 twice daily at week 32 with a baseline value and a post-baseline value at the evaluated study week.
Slovenian: 16. teden 32. teden 52. teden a Vključuje preskušance, ki so bili po 32 tednih ponovno randomizirani na APR 30 dvakrat na dan z izhodiščno vrednostjo in s po-izhodiščno vrednostjo v ocenjevanem tednu študije.
English: There was no pharmacokinetic interaction between apremilast and oral contraceptives containing ethinyl estradiol and norgestimate.
Slovenian: Med apremilastom in peroralnimi kontracepcijskimi sredstvi, ki vsebujejo etinilestradiol in norgestimat, ni bilo farmakokinetičnih interakcij.
English: DMARDs N=496
Slovenian: N=496
English: Patients with hepatic impairment The safety of apremilast was not evaluated in PsA or PSOR patients with hepatic impairment.
Slovenian: Bolniki z okvaro jeter Varnosti apremilasta pri bolnikih s PsA ali PSOR, ki imajo okvaro jeter, niso ocenjevali.
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.
Slovenian: V študije je bilo vključenih 1.493 bolnikov, ki so po randomizaciji prejemali placebo ali dvakrat dnevno apremilast 20 mg ali apremilast 30 mg.
English: The risks and benefits of starting or continuing treatment with apremilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended.
Slovenian: Če bolniki poročajo o predhodnih ali obstoječih psihiatričnih simptomih ali v primeru načrtovanega sočasnega zdravljenja z drugimi zdravili, ki lahko povzročijo psihiatrične dogodke, je treba skrbno oceniti tveganja in koristi uvedbe ali nadaljevanja zdravljenja z apremilastom.
English: In Study ESTEEM 2, approximately 80.3% of patients re-randomised to apremilast at week 32 had a PASI50 response at week 52.
Slovenian: V študiji ESTEEM 2 je imelo približno 80,3 % bolnikov, ki so jih po 32 tednih ponovno randomizirali na apremilast, po 52 tednih odziv PASI 50.
English: • common cold (nasopharyngitis)
Slovenian: • navadni prehlad (nazofaringitis),
English: Otezla is for oral use.
Slovenian: Zdravilo Otezla je za peroralno uporabo.
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).
Slovenian: V študiji toksičnosti za razvoj zarodka in plodu pri opici so peroralni odmerki 20, 50, 200 in 1.000 mg/kg/dan povzročili z odmerkom povezane pogostejše predporodne izgube (splave) pri odmerkih 50 mg/kg/dan in večjih odmerkih; nobenih učinkov, povezanih s predmetom testiranja, na predporodne izgube niso opazili pri 20 mg/kg/dan (1,4-kratna klinična izpostavljenost).
English: Pre- and post-natal development
Slovenian: Razvoj pred rojstvom in po rojstvu
English: Frequent bowel movements Upper abdominal pain* Gastroesophageal reflux disease
Slovenian: pogosti bruhanje* dispepsija pogosto iztrebljanje bolečina v zgornjem delu trebuha* gastroezofagealna refluksna bolezen občasni krvavitev v prebavilih
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.
Slovenian: V združeni študiji toksičnosti za plodnost mišjih samic in razvoj zarodka in plodu s peroralnimi odmerki 10, 20, 40 in 80 mg/kg/dan so ugotovili podaljšanje estrusnih ciklov in podaljšanje časa do parjenja pri 20 mg/kg/dan in večjih odmerkih; kljub temu so se vse miši parile in pogostnost brejosti ni bila prizadeta.
English: Respiratory, thoracic, and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti kašelj
English: Day 5
Slovenian: 5. dan
English: Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 57 mg laktoze (v obliki laktoze monohidrata).
English: Each film-coated tablet contains 171 mg of lactose (as lactose monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 171 mg laktoze (v obliki laktoze monohidrata).
English: The pharmacokinetics of apremilast and its major metabolite M12 are not affected by moderate or severe hepatic impairment.
Slovenian: Zmerna ali huda okvara jeter ne vpliva na farmakokinetiko apremilasta in njegovega glavnega presnovka M12.
English: Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 114 mg laktoze (v obliki laktoze monohidrata).
English: Day 4
Slovenian: 4. dan
English: In both studies, the mean percent improvement in PASI from baseline remained stable during the Randomised Treatment Withdrawal Phase for patients re-randomised to apremilast at week 32 (Table 5).
Slovenian: V obeh študijah je pri bolnikih, ki so jih ponovno randomizirali na apremilast po 32 tednih, povprečno odstotno izboljšanje PASI od izhodišča v fazi odtegnitve randomiziranega zdravljenja ostalo stabilno (preglednica 5).
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.
Slovenian: Od bolnikov z odzivom vsaj PASI 50, ki so jih po 32 tednih ponovno randomizirali na placebo, jih je po 52 tednih 24,2 % imelo odziv PASI 50.
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).
Slovenian: Pri bolnikih s hudo okvaro ledvic (očistek kreatinina manjši od 30 ml/min, ocenjen s Cockcroft-Gaultovo enačbo) je treba zmanjšati odmerek apremilasta na 30 mg enkrat dnevno.
English: Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets apremilast
Slovenian: Otezla 10 mg filmsko obložene tablete Otezla 20 mg filmsko obložene tablete Otezla 30 mg filmsko obložene tablete apremilast
English: Common
Slovenian: ZDRUŽENE
English: Patients who were re-randomised to placebo and who lost PASI-75 response (ESTEEM 1) or lost 50% of the PASI improvement at week 32 compared to baseline (ESTEEM 2) were retreated with apremilast 30 mg twice daily.
Slovenian: Bolnike, ki so bili ponovno randomizirani na placebo in ki so izgubili odziv PASI 75 (ESTEEM 1) ali ki so izgubili odziv PASI 50 (ESTEEM 2) v 32. tednu v primerjavi z izhodiščem, so še enkrat zdravili z apremilastom 30 mg dvakrat dnevno.
English: 20 mg (brown)
Slovenian: 20 mg (rjava)
English: In Study ESTEEM 1, approximately 61% of patients re-randomised to apremilast at week 32 had a PASI-75 response at week 52.
Slovenian: V študiji ESTEEM 1 je imelo približno 61 % bolnikov, ki so jih po 32 tednih ponovno randomizirali na apremilast, po 52 tednih odziv PASI 75.
English: • Otezla is for oral use.
Slovenian: • Zdravilo Otezla je namenjeno za peroralno uporabo.
English: Proportion of patients with ACR responses in studies PALACE 1, PALACE 2 and PALACE 3 and pooled studies at week 16
Slovenian: Delež bolnikov z odzivi po ACR v 16. tednu v študijah PALACE 1, PALACE 2 in PALACE 3 ločeno in združeni iz vseh treh študij.
English: 30 mg (beige)
Slovenian: 30 mg (bež)
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.
Slovenian: Od bolnikov z odzivom vsaj PASI 75, ki so jih po 32 tednih med fazo odtegnitve randomiziranega zdravljenja ponovno randomizirali na placebo, jih je po 52 tednih 11,7 % imelo odziv PASI 75.
English: • The treatment initiation pack is a folding wallet containing 27 film-coated tablets: 4 x 10 mg tablets, 4
Slovenian: • Pakiranje za začetek zdravljenja je zgibanka, ki vsebuje 27 filmsko obloženih tablet: 4 x 10 mg tablete, 4 x 20 mg tablete in 19 x 30 mg tablet.
English: • The 20 mg film-coated tablet also contains iron oxide yellow (E172).
Slovenian: • 20-miligramska filmsko obložena tableta vsebuje tudi rumeni železov oksid (E172).
English: Otezla has also been shown to improve the quality of life in patients with psoriasis or psoriatic arthritis.
Slovenian: Prav tako se je izkazalo, da zdravilo Otezla pri bolnikih s psoriazo ali psoriatičnim artritisom izboljšuje kakovost življenja.
English: There was no pharmacokinetic interaction between apremilast and methotrexate in psoriatic arthritis patients.
Slovenian: Pri bolnikih s psoriatičnim artritisom ni bilo farmakokinetičnih interakcij med apremilastom in metotreksatom.
English: Upper respiratory tract infection Nasopharyngitis*
Slovenian: Infekcijske in parazitske bolezni pogosti bronhitis okužba zgornjih dihal nazofaringitis*
English: • Otezla 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
Slovenian: • Otezla 20 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje 20 mg apremilasta.
English: The 30 mg tablets also contain iron oxide yellow (E172) and iron oxide black (E172).
Slovenian: 30-miligramske tablete vsebujejo tudi rumeni železov oksid (E172) in črni železov oksid (E172).
English: Diarrhoea, nausea, and vomiting
Slovenian: Driska, navzea in bruhanje
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).
Slovenian: Med bolniki, ki so bili v začetku randomizirani na zdravljenje z apremilastom 30 mg dvakrat dnevno, so odzivi ACR 20/50/70 v združenih študijah PALACE 1, PALACE 2 in PALACE 3 trajali do 52. tedna zdravljenja (slika 1).
English: Clinical improvement measured by sPGA, PASI-50 and PASI-90 responses were also demonstrated at week 16.
Slovenian: Po 16 tednih zdravljenja je bilo dokazano tudi klinično izboljšanje, merjeno z odzivi sPGA, PASI 50 in PASI 90.
English: Week ACR 50 Week ACR 70 Week
Slovenian: Endpoint ACR 50 ACR 70
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).
Slovenian: V študijah ESTEEM 1 in ESTEEM 2 so pri bolnikih, ki so prejemali apremilast, v primerjavi z bolniki, ki so prejemali placebo, opazili pomembno izboljšanje psoriaze lasišča vsaj zmerne izraženosti (≥3), izmerjene z deležem bolnikov, ki so po 16 tednih dosegli zdravnikovo globalno oceno psoriaze lasišča (ScPGA) brez vidnih bolezenskih sprememb (0) ali skoraj brez vidnih bolezenskih sprememb (1) (p< 0,0001 v obeh študijah).
English: • The 30 mg film-coated tablet also contains iron oxide yellow (E172) and iron oxide black (E172).
Slovenian: • 30-miligramska filmsko obložena tableta vsebuje tudi rumeni železov oksid (E172) in črni železov oksid (E172).
English: • Otezla 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.
Slovenian: • Otezla 30 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje 30 mg apremilasta.
English: • This is a total daily dose of 60 mg. By the end of day 6 you will have reached this recommended dose.
Slovenian: Ta priporočeni odmerek boste dosegli ob koncu 6. dne.
English: In addition, at week 32, subjects who did not achieve a PASI-75 response in ESTEEM 1, or a PASI-50 response in ESTEEM 2, were permitted to use topical psoriasis therapies and/or phototherapy in addition to apremilast 30 mg twice daily treatment.
Slovenian: Preskušanci, ki do 32. tedna niso dosegli odziva PASI 75 v študiji ESTEEM 1 ali odziva PASI 50 v študiji ESTEEM 2, so smeli poleg zdravljenja z apremilastom 30 mg dvakrat dnevno uporabljati lokalna zdravila za psoriazo in/ali fototerapijo.
English: Accumulation is minimal when apremilast is administered once daily and approximately 53% in healthy subjects and 68% in patients with psoriasis when administered twice daily.
Slovenian: Kopičenje je minimalno, če dajemo apremilast enkrat na dan, in približno 53 % pri zdravih preskušancih in 68 % pri bolnikih s psoriazo, kadar ga dajemo dvakrat na dan. Sočasno dajanje apremilasta s hrano ne spreminja njegove biološke uporabnosti, zato lahko apremilast dajemo s hrano ali brez nje.
English: Each film-coated tablet contains 20 mg of apremilast.
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg apremilasta.
English: • Otezla 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
Slovenian: • Otezla 10 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje 10 mg apremilasta.
English: bN is based on subjects with moderate or greater scalp psoriasis at baseline who were re-randomised to APR 30 twice daily at week 32.
Slovenian: bN temelji na preskušancih z zmerno ali hudo psoriazo lasišča v izhodišču, ki so jih po 32 tednih ponovno randomizirali na APR 30 dvakrat na dan. Preskušance z manjkajočimi podatki so upoštevali, kot da se niso odzvali na zdravljenje.
English: The 20 mg tablets also contain iron oxide yellow (E172).
Slovenian: 20-miligramske tablete vsebujejo tudi rumeni železov oksid (E172).
English: Bronchitis
Slovenian: ZDRAVILOM
English: Each film-coated tablet contains 30 mg of apremilast.
Slovenian: Ena filmsko obložena tableta vsebuje 30 mg apremilasta.
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
Slovenian: **p ≤ 0,001 za apremilast proti placebu.
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.
Slovenian: Merili so spremembe v telesnem delovanju (PF - Physical Functioning) s pomočjo kratkega vprašalnika o zdravstvenem stanju, verzija 2 (SF-36v2), in funkcijsko oceno zdravljenja kronične bolezni - utrujenost (FACIT - utrujenost; Functional Assessment of Chronic Illness Therapy - Fatigue) pri bolnikih, zdravljenih z apremilastom v primerjavi s placebom, od izhodišča do 16. in 24. tedna.
English: Each film-coated tablet contains 10 mg of apremilast.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg apremilasta.
English: NAME OF THE MEDICINAL PRODUCT Otezla 30 mg tablets apremilast
Slovenian: IME ZDRAVILA Otezla 30 mg tablete apremilast
English: No dose adjustment is necessary for patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter prilagajanje odmerka ni potrebno.
English: • frequent bowel movements
Slovenian: • pogosto iztrebljanje blata,
English: Nervous system disorders
Slovenian: Načrt titriranja odmerka
English: Otezla 10 mg film-coated tablets
Slovenian: Otezla 10 mg filmsko obložene tablete
English: The proportion of patients with ACR 20/50/70 (responses in studies PALACE 1, PALACE 2 and PALACE 3, and the pooled data for studies PALACE 1, PALACE 2 and PALACE 3) for apremilast 30 mg twice daily at week 16 are shown in Table 3.
Slovenian: Delež bolnikov, pri katerih je prišlo v 16. tednu zdravljenja z apremilastom 30 mg dvakrat dnevno do odzivov ACR 20/50/70 (odzivi v študijah PALACE 1, PALACE 2 in PALACE 3 ločeno ter združeni podatki za študije PALACE 1, PALACE 2 in PALACE 3), je prikazan v preglednici 3.
English: DMARDs N=162
Slovenian: N=162
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.
Slovenian: Pri bolnikih, ki so bili v začetku randomizirani na zdravljenje z apremilastom 30 mg dvakrat dnevno, je bila v 52. tednu v združeni analizi odprte faze študij PALACE 1, PALACE 2 in PALACE 3 v tej skupini sprememba rezultata HAQ-DI od izhodišča -0,333.
English: DMARDs N=168
Slovenian: N=168
English: DMARDs N=169
Slovenian: N=169
English: Otezla 20 mg film-coated tablets
Slovenian: Otezla 20 mg filmsko obložene tablete
English: Reductions in maternal body weight and weight gain, and one death associated with difficulty in delivering pups were observed at 300 mg/kg/day.
Slovenian: Pri odmerku 300 mg/kg/dan so opazili zmanjšanje in zvečanje materine telesne mase in en primer smrti, povezan z oteženo skotitvijo mladičev.
English: croscarmellose sodium and magnesium stearate.
Slovenian: Jedro tablete mikrokristalna celuloza laktoza monohidrat premreženi natrijev karmelozat magnezijev stearat
English: What plaque psoriasis is
Slovenian: Kaj je psoriaza v plakih
English: DMARDs N=167
Slovenian: N=167
English: Otezla 30 mg film-coated tablets
Slovenian: Otezla 30 mg filmsko obložene tablete
English: Otezla 30 mg tablets apremilast
Slovenian: Otezla 30 mg filmsko obložene tablete apremilast
English: Change in Pruritus VASf (mm), mean± SD Change in DLQIg, mean± SD
Slovenian: PASI 90, n (%) odstotna sprememba BSAe povprečje± SD sprememba pruritusa VASf (mm), povprečje ±
English: No dose adjustment is needed in patients with mild and moderate renal impairment.
Slovenian: Pri bolnikih z blago in zmerno okvaro ledvic prilagajanje odmerka ni potrebno.
English: • hives (urticaria)
Slovenian: • koprivnica (urtikarija),
English: Fatigue
Slovenian: Dojenje
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.
Slovenian: Otezla 20 mg filmsko obložena tableta je rjava filmsko obložena tableta v obliki romba z vtisnjenim napisom “APR” na eni strani in “20” na drugi strani.
English: Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with “APR” engraved on one side and “10” on the opposite side.
Slovenian: Rožnata 10 mg filmsko obložena tableta v obliki romba, dolžine 8 mm, z vtisnjenim napisom “APR” na eni strani in “10” na drugi strani.
English: The Otezla 10 mg film-coated tablet is a pink, diamond shaped film-coated tablet with “APR” engraved on one side and “10” on the opposite side.
Slovenian: Otezla 10 mg filmsko obložena tableta je rožnata filmsko obložena tableta v obliki romba z vtisnjenim napisom “APR” na eni strani in “10” na drugi strani.
English: • stomach pain
Slovenian: • bolečina v želodcu,
English: Decreased appetite*
Slovenian: Presnovne in prehranske motnje pogosti zmanjšan apetit*
English: Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with “APR” engraved on one side and “20” on the opposite side.
Slovenian: Rjava 20 mg filmsko obložena tableta v obliki romba, dolžine 10 mm, z vtisnjenim napisom “APR” na eni strani in “20” na drugi strani.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta 56 filmsko obloženih tablet 168 filmsko obloženih tablet
English: The Otezla 30 mg film-coated tablet is a beige, diamond shaped film-coated tablet with “APR” engraved on one side and “30” on the opposite side.
Slovenian: Otezla 30 mg filmsko obložena tableta je bež filmsko obložena tableta v obliki romba z vtisnjenim napisom “APR” na eni strani in “30” na drugi strani.
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.
Slovenian: Ciklični AMP tudi modulira koncentracije protivnetnih citokinov, npr. IL-10.
English: Titanium dioxide (E171)
Slovenian: Filmska obloga polivinilalkohol titanov dioksid (E171) makrogol (3350) smukec rdeči železov oksid (E172)
English: Placebo
Slovenian: placebo DMARDs
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.
Slovenian: Bež 30 mg filmsko obložena tableta v obliki romba, dolžine 12 mm, z vtisnjenim napisom “APR” na eni strani in “30” na drugi strani.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 30 mg of apremilast.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 30 mg apremilasta.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva pogosti bolečina v hrbtu*
English: How to store Otezla
Slovenian: Kako jemati zdravilo Otezla
English: • weight loss
Slovenian: • izguba telesne mase,
English: Underweight patients
Slovenian: Bolniki s premajhno telesno maso
English: PASIc 75, n (%) sPGAd of Clear or Almost Clear, n (%) PASI 50, n (%) PASI 90, n (%) Percent Change BSAe (%) mean± SD
Slovenian: N PASIc 75, n (%)