natgillin/translations-raw huggingface dataset:
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.
Od 832 bolnikov, ki so jih v začetku randomizirali na apremilast 30 mg dvakrat na dan, se je 443 bolnikov (53 %) vključilo v odprti podaljšani študiji ESTEEM 1 in ESTEEM 2, in od teh se je 115 bolnikov (26 %) v 260. tednu še vedno zdravilo.
MARKETING AUTHORISATION NUMBER(S) EU/1/14/981/002 56 film-coated tablets EU/1/14/981/003 168 film-coated tablets
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/981/002 56 filmsko obloženih tablet EU/1/14/981/003 168 filmsko obloženih tablet
In Study ESTEEM 1, patients randomised to apremilast at the start of the study who did not achieve a PASI75 response at week 32 were permitted to use concomitant topical therapies and/or UVB phototherapy between weeks 32 to 52.
V študiji ESTEEM 1 je bilo bolnikom, ki so bili v začetku študije randomizirani na apremilast in ki po 32 tednih niso dosegli odziva PASI 75, dovoljeno med 32. in 52. tednom sočasno uporabljati topikalna zdravila in/ali UVB fototerapijo.
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).
V študijah ESTEEM 1 in ESTEEM 2 so dokazali signifikantno izboljšanje kakovosti življenja, izmerjene z dermatološkim indeksom kakovosti življenja (Dermatology Life Quality Index (DLQI)) in s SF-36v2MCS pri bolnikih, ki so prejemali apremilast, v primerjavi z bolniki, ki so prejemali placebo (preglednica 4).
Apremilast-treated patients demonstrated statistically significant improvement in physical function, as assessed by the disability index of the health assessment questionnaire (HAQ-DI) change from baseline, compared to placebo at weeks 16 in PALACE 1, PALACE 2 and PALACE 3 and in the pooled studies Improvement in HAQ-DI scores was maintained at week 24.
Bolniki, zdravljeni z apremilastom, so pokazali statistično signifikantno izboljšanje telesnih funkcij, ocenjeno s spremembo od izhodišča, s pomočjo indeksa invalidnosti vprašalnika za oceno zdravstvenega stanja (HAQ-DI - disability index of the health assessment questionnaire) v primerjavi s placebom po 16 tednih v študijah PALACE 1, PALACE 2 in PALACE 3 in v združenih študijah.
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.
V združeni študiji toksičnosti za plodnost mišjih samic in razvoj zarodka in plodu s peroralnimi odmerki 10, 20, 40 in 80 mg/kg/dan se je absolutna in/ali relativna masa srca pri samicah-materah zvečala pri 20, 40 in 80 mg/kg/dan.
During the Randomised Treatment Withdrawal Phase (weeks 32-52), patients originally randomised to apremilast who achieved at least a 75% reduction in their PASI score (PASI-75) (ESTEEM 1) or a 50% reduction in their PASI score (PASI-50) (ESTEEM 2) were re-randomised at week 32 to either placebo or apremilast 30 mg twice daily.
Med fazo odtegnitve randomiziranega zdravljenja (od 32. do 52. tedna) so bolnike, ki so bili prvotno randomizirani na apremilast in so dosegli vsaj 75-odstotno izboljšanje rezultata PASI (PASI 75) (ESTEEM 1) ali 50-odstotno izboljšanje rezultata PASI (PASI 50) (ESTEEM 2), v 32. tednu ponovno randomizirali na placebo oziroma na apremilast 30 mg dvakrat dnevno.
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
EU/1/14/981/002 - velikost pakiranja 56 tablet EU/1/14/981/003 - velikost pakiranja 168 tablet
• The other ingredients in the tablet core are cellulose microcrystalline, lactose monohydrate,
• Druge sestavine jedra tablete so mikrokristalna celuloza, laktoza monohidrat, premreženi natrijev karmelozat in magnezijev stearat.
In both studies, patients were randomised 2:1 to apremilast 30 mg twice daily or placebo for 16 weeks (placebo-controlled phase) and from weeks 16-32, all patients received apremilast 30 mg twice daily (maintenance phase).
V obeh študijah so bolnike randomizirali v razmerju 2:1 na apremilast 30 mg dvakrat dnevno ali placebo za 16 tednov (s placebom nadzorovana faza), od.
Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation.
Bolnike in skrbnike je treba poučiti, naj o morebitnem spremenjenem vedenju ali razpoloženju in morebitnih samomorilnih mislih obvestijo zdravnika, ki jim je predpisal zdravilo.
Placebo patients who were considered non-responders were rerandomised 1:1 in a blinded fashion to either apremilast 20 mg twice daily or 30 mg twice daily.
Bolnike na placebu, ki so jih opredelili za neodzivne na zdravljenje, so v razmerju 1:1 še enkrat slepo randomizirali na apremilast 20 mg dvakrat na dan ali 30 mg dvakrat na dan.
Following 52 weeks of treatment, patients could continue on open label apremilast 20 mg or 30 mg within the long-term extension of the PALACE 1, PALACE 2, and PALACE 3 studies for a total duration of treatment up to 5 years (260 weeks).
Po 52 tednih zdravljenja so bolniki lahko nadaljevali z odprtim apremilastom v odmerku 20 mg ali 30 mg v dolgoročno podaljšanih študijah PALACE 1, PALACE 2 in PALACE 3, tako da je zdravljenje v celoti trajalo do 5 let (260 tednov).
Body weight loss
Izguba telesne mase
Warnings and precautions Talk to your doctor or pharmacist before taking Otezla.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Otezla se posvetujte z zdravnikom ali farmacevtom.
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%.
Skupno je 14,3 % bolnikov, ki so prejemali apremilast, opazilo zmanjšanje telesne mase med 5 in 10 %, medtem ko je 5,7 % bolnikov, ki so prejemali apremilast, opazilo izgubo telesne mase, večjo od 10 %.
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.
Pri bolnikih, zdravljenih z apremilastom, so v 16. in 24. tednu opazili izboljšanje parametrov periferne aktivnosti, značilne za psoriatični artritis (npr. število oteklih sklepov, število bolečih/občutljivih sklepov, daktilitis in entezitis), in kožnih znakov psoriaze.
The no observed effect level (NOEL) for female fertility was 10 mg/kg/day (1.0-fold clinical exposure).
Raven brez opaznega učinka (no observed effect level (NOEL)) za plodnost samic je bila 10 mg/kg/dan (1,0-kratna klinična izpostavljenost).
If you experience severe diarrhoea, nausea, or vomiting, you should talk to your doctor.
Če imate hudo drisko, vas sili na bruhanje ali bruhate, povejte zdravniku.
MARKETING AUTHORISATION NUMBER(S) Otezla 10 mg, 20 mg, 30 mg film-coated tablets (initiation pack) EU/1/14/981/001
Otezla 10 mg, 20 mg, 30 mg filmsko obložene tablete (pakiranje za začetek zdravljenja) EU/1/14/981/001
• The one-month standard pack contains 56 x 30 mg film-coated tablets.
• Enomesečno standardno pakiranje vsebuje 56 x 30 mg filmsko obloženih tablet.
Apremilast undergoes extensive metabolism with only 3% and 7% of the administered parent compound recovered in urine and faeces, respectively.
Apremilast se obsežno presnavlja, tako da v urinu prestrežemo le 3 % in v blatu le 7 % dane izhodne spojine.
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).
Pri bolnikih s hudo okvaro ledvic (eGFR manj kot 30 ml/min/1,73 m2 ali CLcr < 30 ml/min) je treba zmanjšati odmerek apremilasta na 30 mg enkrat dnevno.
Treatment with apremilast resulted in significant improvements in the signs and symptoms of PsA, as assessed by the ACR 20 response criteria compared to placebo at weeks 16.
V 16. tednu je zdravljenje z apremilastom povzročilo signifikantno izboljšanje znakov in simptomov PsA, ocenjeno s kriteriji odziva po ACR 20, v primerjavi s placebom.
Among 497 patients initially randomised to apremilast 30 mg twice daily, 375 (75%) patients were still on this treatment on week 52.
Od 497 bolnikov, ki so bili v začetku randomizirani na apremilast 30 mg dvakrat dnevno, se je 375 (75 %) bolnikov v 52. tednu še vedno zdravilo.
The maternal and developmental NOEL in the mouse was 10 mg/kg/day (1.3-fold clinical exposure).
NOEL za mater in razvoj pri miših je bila 10 mg/kg/dan (1,3-kratna klinična izpostavljenost).
The improvements were generally maintained in subjects who were re-randomised to apremilast at week 32 through week 52 (Table 5).
Izboljšanja so na splošno trajala pri preskušancih, ki so jih po 32 tednih ponovno randomizirali na apremilast, do 52. tedna (preglednica 5).
Physical signs of maternal toxicity associated with delivering pups were also observed in one mouse at each of 80 and 300 mg/kg/day.
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.
4 film-coated tablets of 20 mg
4 filmsko obložene tablete po 20 mg
Reduced foetal weights and retarded ossification of the supraoccipital bone of the skull were observed at 40 and 80 mg/kg/day.
Zmanjšano maso plodov in zapoznelo osifikacijo supraokcipitalne kosti lobanje so ugotovili pri 40 in 80 mg/kg/dan.
What Otezla looks like and contents of the pack
Izgled zdravila Otezla in vsebina pakiranja
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.
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.
The safety of apremilast was not evaluated in PsA or PSOR patients with moderate or severe renal impairment in the clinical studies.
Pri bolnikih s PsA ali PSOR z zmerno ali hudo okvaro ledvic varnosti apremilasta v kliničnih študijah niso ocenjevali.
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*)
Delež bolnikov z odzivom ACR 20/50/70 do 52. tedna z analizo podatkov združenih študij PALACE 1, PALACE 2 in PALACE 3 (NRI*)
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.
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.
At week 24, all remaining placebo-treated patients were switched to either apremilast 20 or 30 mg twice daily.
Po 24 tednih so vsem preostalim bolnikom, ki so prejemali placebo, začeli dajati apremilast 20 mg ali 30 mg dvakrat na dan.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg, 20 mg or 30 mg of apremilast.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 10 mg, 20 mg ali 30 mg apremilasta.
Apremilast is the major circulating component following oral administration.
Apremilast je glavna spojina, ki po peroralnem dajanju kroži v telesu.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Predklinični podatki na podlagi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
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.
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.
There was no pharmacokinetic interaction between apremilast and oral contraceptives containing ethinyl estradiol and norgestimate.
Med apremilastom in peroralnimi kontracepcijskimi sredstvi, ki vsebujejo etinilestradiol in norgestimat, ni bilo farmakokinetičnih interakcij.
DMARDs N=496
N=496
Patients with hepatic impairment The safety of apremilast was not evaluated in PsA or PSOR patients with hepatic impairment.
Bolniki z okvaro jeter Varnosti apremilasta pri bolnikih s PsA ali PSOR, ki imajo okvaro jeter, niso ocenjevali.
A total of 1,493 patients were randomised and treated with either placebo, apremilast 20 mg or apremilast 30 mg given orally twice daily.
V študije je bilo vključenih 1.493 bolnikov, ki so po randomizaciji prejemali placebo ali dvakrat dnevno apremilast 20 mg ali apremilast 30 mg.
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.
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.
In Study ESTEEM 2, approximately 80.3% of patients re-randomised to apremilast at week 32 had a PASI50 response at week 52.
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.
• common cold (nasopharyngitis)
• navadni prehlad (nazofaringitis),
Otezla is for oral use.
Zdravilo Otezla je za peroralno uporabo.
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).
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).
Pre- and post-natal development
Razvoj pred rojstvom in po rojstvu
Frequent bowel movements Upper abdominal pain* Gastroesophageal reflux disease
pogosti bruhanje* dispepsija pogosto iztrebljanje bolečina v zgornjem delu trebuha* gastroezofagealna refluksna bolezen občasni krvavitev v prebavilih
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.
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.
Respiratory, thoracic, and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti kašelj
Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 57 mg laktoze (v obliki laktoze monohidrata).
Each film-coated tablet contains 171 mg of lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 171 mg laktoze (v obliki laktoze monohidrata).
The pharmacokinetics of apremilast and its major metabolite M12 are not affected by moderate or severe hepatic impairment.
Zmerna ali huda okvara jeter ne vpliva na farmakokinetiko apremilasta in njegovega glavnega presnovka M12.
Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 114 mg laktoze (v obliki laktoze monohidrata).
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).
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).
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.
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.
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).
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.
Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets apremilast
Otezla 10 mg filmsko obložene tablete Otezla 20 mg filmsko obložene tablete Otezla 30 mg filmsko obložene tablete apremilast
Common
ZDRUŽENE
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.
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.
20 mg (brown)
20 mg (rjava)
In Study ESTEEM 1, approximately 61% of patients re-randomised to apremilast at week 32 had a PASI-75 response at week 52.
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.
• Otezla is for oral use.
• Zdravilo Otezla je namenjeno za peroralno uporabo.
Proportion of patients with ACR responses in studies PALACE 1, PALACE 2 and PALACE 3 and pooled studies at week 16
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.
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.
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.
• The treatment initiation pack is a folding wallet containing 27 film-coated tablets: 4 x 10 mg tablets, 4
• 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.
• The 20 mg film-coated tablet also contains iron oxide yellow (E172).
• 20-miligramska filmsko obložena tableta vsebuje tudi rumeni železov oksid (E172).
Otezla has also been shown to improve the quality of life in patients with psoriasis or psoriatic arthritis.
Prav tako se je izkazalo, da zdravilo Otezla pri bolnikih s psoriazo ali psoriatičnim artritisom izboljšuje kakovost življenja.
There was no pharmacokinetic interaction between apremilast and methotrexate in psoriatic arthritis patients.
Pri bolnikih s psoriatičnim artritisom ni bilo farmakokinetičnih interakcij med apremilastom in metotreksatom.
Upper respiratory tract infection Nasopharyngitis*
Infekcijske in parazitske bolezni pogosti bronhitis okužba zgornjih dihal nazofaringitis*
• Otezla 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
• Otezla 20 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje 20 mg apremilasta.
The 30 mg tablets also contain iron oxide yellow (E172) and iron oxide black (E172).
30-miligramske tablete vsebujejo tudi rumeni železov oksid (E172) in črni železov oksid (E172).
Diarrhoea, nausea, and vomiting
Driska, navzea in bruhanje
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).
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).
Clinical improvement measured by sPGA, PASI-50 and PASI-90 responses were also demonstrated at week 16.
Po 16 tednih zdravljenja je bilo dokazano tudi klinično izboljšanje, merjeno z odzivi sPGA, PASI 50 in PASI 90.
Week ACR 50 Week ACR 70 Week
Endpoint ACR 50 ACR 70
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).
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).
• The 30 mg film-coated tablet also contains iron oxide yellow (E172) and iron oxide black (E172).
• 30-miligramska filmsko obložena tableta vsebuje tudi rumeni železov oksid (E172) in črni železov oksid (E172).
• Otezla 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.
• Otezla 30 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje 30 mg apremilasta.
• This is a total daily dose of 60 mg. By the end of day 6 you will have reached this recommended dose.
Ta priporočeni odmerek boste dosegli ob koncu 6. dne.
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.
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.
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.
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.
Each film-coated tablet contains 20 mg of apremilast.
Ena filmsko obložena tableta vsebuje 20 mg apremilasta.
• Otezla 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
• Otezla 10 mg filmsko obložene tablete: ena filmsko obložena tableta vsebuje 10 mg apremilasta.