natgillin/translations-raw huggingface dataset:
PVC/ aluminium foil blisters containing 14 film-coated tablets, in pack sizes of 56 tablets and 168 tablets.
Pretisni omoti iz PVC/aluminijeve folije, ki vsebujejo po 14 filmsko obloženih tablet, v velikostih pakiranja po 56 tablet in 168 tablet.
The clinical benefit of apremilast was also demonstrated regardless of prior psoriasis medication usage and response to prior psoriasis treatments.
Klinična koristnost apremilasta je bila dokazana tudi neodvisno od predhodne uporabe zdravil za psoriazo in odziva na predhodna zdravila za psoriazo.
Carcinogenicity studies
Študije kancerogenosti
In vitro, apremilast is not an inhibitor or inducer of cytochrome P450 enzymes.
In vitro apremilast ni zaviralec ali spodbujevalec encimov citokromom P450.
What Otezla is used for Otezla is used to treat adults with the following conditions:
Za kaj uporabljamo zdravilo Otezla Zdravilo Otezla uporabljamo za zdravljenje odraslih z naslednjimi stanji:
• Once the recommended dose has been reached, you will only get the 30 mg tablet strength in your prescribed packs.
• Ko boste dosegli priporočeni odmerek, boste v predpisanih pakiranjih prejemali le še tablete jakosti 30 mg.
In these patients, ACR 20/50/70 responses at week 52 were of 57%, 25%, and 11% respectively.
Pri teh bolnikih so bili odzivi ACR 20/50/70 po 52 tednih 57 %, 25 % oziroma 11 %.
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).
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.
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.
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.
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.
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.
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
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
Day 1 - Day 7
1. dan - 7. dan
No dosage adjustment is necessary for elderly patients.
Prilagajanje odmerjanja pri starejših bolnikih ni potrebno.
• depression
• depresija.
Pharmacotherapeutic group: Immunosupressants, selective immunosuppressants, ATC code: L04AA32
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA32
It is not known whether apremilast, or its metabolites, are excreted in human milk.
Ni znano, ali se apremilast ali njegovi presnovki izločajo v materinem mleku pri ljudeh.
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
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
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
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
• headaches, migraines or tension headaches
• glavobol, migrena ali tenzijski glavobol,
Morning Dose
Jutranji odmerek
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Wallet card containing 2-week treatment initiation pack
PODATKI NA ZUNANJI OVOJNINI Zgibanka, ki vsebuje pakiranje za 2-tedensko začetno zdravljenje
Apremilast was not clastogenic in an in vivo mouse micronucleus assay at doses up to 2,000 mg/kg/day.
Apremilast ni bil klastogen v mišjem mikronukleusnem testu in vivo v odmerkih do 2.000 mg/kg/dan.
The primary endpoint was the percentage of patients achieving American College of Rheumatology (ACR) 20 response at week 16.
Primarni končni opazovani dogodek je bil delež bolnikov, ki so v 16. tednu dosegli odziv ACR 20 po American College of Rheumatology (ACR).
• 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.
• 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.
How and when to take Otezla
Kako in kdaj jemati zdravilo Otezla
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.
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.
• 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 '.
• 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'.
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).
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).
Therefore, the use of strong CYP3A4 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin and St. John's Wort) with apremilast is not recommended.
Zato uporaba močnih spodbujevalcev encima CYP3A4 (npr. rifampicina, fenobarbitala, karbamazepina, fenitoina in šentjanževke) z apremilastom ni priporočljiva.
* 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.
* 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.
There have been post-marketing reports of severe diarrhoea, nausea, and vomiting associated with the use of apremilast.
Iz obdobja trženja so poročali o hudi driski, navzei in bruhanju, povezanih z uporabo apremilasta.
In psoriatic arthritis, treatment with Otezla results in an improvement in swollen and painful joints, and can improve your general physical function.
Pri psoriatičnem artritisu zdravljenje z zdravilom Otezla povzroči izboljšanje oteklih in bolečih sklepov in lahko izboljša vaše splošno telesno delovanje.
The adverse drug reactions were determined based on data from the apremilast clinical development programme and post-marketing experience.
Neželene učinke zdravila so določili na podlagi podatkov, pridobljenih v programu kliničnega razvoja apremilasta in izkušenj po prihodu zdravila na trg.
There is no meaningful difference in the PK of apremilast between mild or moderate renally impaired subjects and matched healthy subjects (N=8 each).
Ni pomembnih razlik v farmakokinetiki apremilasta med preskušanci z blago ali zmerno okvaro ledvic in primerljivimi zdravimi preskušanci (N=8 vsakih).
• inflammation and swelling of the tubes in your lungs (bronchitis)
• vnetje in otekanje sapnic v pljučih (bronhitis),
Apremilast administered at doses of up to 50 mg twice daily did not prolong the QT interval in healthy subjects.
Apremilast, ki so ga dajali v odmerkih do 50 mg dvakrat dnevno, pri zdravih preskušancih ni podaljševal intervala QT.
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.
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.
The same information is also available on the following URL: www.otezla-eu-pil.com.
Iste informacije so na voljo tudi na spletni strani: www.otezla-eu-pil.com.
Elderly patients No dose adjustment is required for this patient population (see sections 4.8 and 5.2).
Starejši bolniki Pri starejših bolnikih prilagajanje odmerka ni potrebno (glejte poglavji 4.8 in 5.2).
If you are 65 years of age or older, you might have a higher risk of complications of severe diarrhoea, nausea and vomiting.
Če ste stari 65 let ali več, lahko pri vas obstaja večje tveganje za zaplete s hudo drisko, siljenjem na bruhanje in bruhanjem.
Clinical response at week 16 in studies ESTEEM 1 and ESTEEM 2 (FAS a, LOCFb) ESTEEM 1
Klinični odziv v 16. tednu v študijah ESTEEM 1 in ESTEEM 2 (FAS a LOCFb)
Evening Dose
Večerni odmerek
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.
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.
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.
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.
Please notify your doctor immediately of any feelings of depression, suicidal thoughts or suicidal behaviour you may have.
Zdravnika nemudoma obvestite o morebitnih občutkih depresivnosti, samomorilnih misli ali o samomorilnem vedenju, ki bi se morda pojavili.
Each pack of 27 film-coated tablets for a 2 week treatment schedule contains: 4 film-coated tablets of 10 mg
Eno pakiranje 27 filmsko obloženih tablet za 2-tedensko shemo zdravljenja vsebuje: 4 filmsko obložene tablete po 10 mg
Patients who are underweight at the start of treatment should have their body weight monitored regularly.
Bolnike, ki imajo v začetku zdravljenja premajhno telesno maso, je treba v rednih presledkih kontrolirati glede njihove telesne mase.
It is likely that pup developmental effects observed during the first week of the postnatal period were related to the apremilast-related pup toxicity (decreased pup weight and viability) and/or lack of maternal care (higher incidence of no milk in the stomach of pups).
Verjetno so bili toksični učinki na razvoj mladičev, ki so jih opazili v prvem tednu postnatalnega obdobja, povezani z apremilastom (zmanjšana telesna masa in sposobnost za življenje mladičev) in/ali pomanjkanjem materine nege (pogostnejša odsotnost mleka v želodcu mladičev).
Hence, apremilast coadministered with substrates of CYP enzymes is unlikely to affect the clearance and exposure of active substances that are metabolised by CYP enzymes.
Zato ni verjetno, da bi apremilast, ki ga dajemo sočasno s substrati encimov CYP, vplival na očistek in izpostavljenost aktivnim substancam, ki jih presnavljajo encimi CYP.
The other most commonly reported adverse reactions include upper respiratory tract infections (8.4%), headache (7.9%), and tension headache (7.2%) and are mostly mild to moderate in severity.
Drugi neželeni učinki, o katerih najpogosteje poročajo, vključujejo okužbe zgornjih dihal (8,4 %), glavobol (7,9 %) in tenzijski glavobol (7,2 %) in so po izraženosti večinoma blagi do zmerni.
Patients and caregivers should be instructed to notify the prescriber of any suicidal ideation (see section 4.4).
Bolnike in skrbnike je treba poučiti, naj o morebitnih samomorilnih mislih obvestijo zdravnika, ki je predpisal zdravilo (glejte poglavje 4.4).
In psoriasis, treatment with Otezla results in a reduction in psoriatic skin plaques and other signs and symptoms of the disease.
Pri psoriazi zdravljenje z zdravilom Otezla povzroči zmanjšanje psoriatičnih kožnih plakov in drugih znakov in simptomov bolezni.
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.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Sočasno dajanje močnega spodbujevalca encima citokrom P450 3A4 (CYP3A4), rifampicina, je povzročilo zmanjšanje sistemske izpostavljenosti apremilastu, kar lahko povzroči izgubo njegove učinkovitosti.
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
Psoriatični artritis je vnetna bolezen sklepov, ki jo običajno spremlja psoriaza (luskavica), vnetna bolezen kože.
• upper respiratory tract infections such as cold, runny nose, sinus infection
• okužbe zgornjih dihal, na primer prehlad, izcedek iz nosu, okužba obnosnih votlin,
If you stop taking Otezla
Če ste prenehali jemati zdravilo Otezla
In both studies, the primary endpoint was the proportion of patients who achieved PASI-75 at week 16.
V obeh študijah je bil primarni končni opazovani dogodek delež bolnikov, ki so do 16. tedna dosegli PASI 75.
Apremilast is contraindicated during pregnancy (see section 4.3).
Apremilast je med nosečnostjo kontraindiciran (glejte poglavje 4.3).
Film-coated tablet Treatment initiation pack
filmsko obložena tableta pakiranje za začetek zdravljenja
Week 16 Week 32
16. teden 32. teden
Further improvements in nail psoriasis were observed at week 32 in patients continuously treated with apremilast.
Nadaljnje izboljšanje psoriaze nohtov so ugotovili v 32. tednu pri bolnikih, ki so se ves čas zdravili z apremilastom.
Apremilast is extensively metabolised by both CYP and non-CYP mediated pathways including oxidation, hydrolysis, and conjugation, suggesting inhibition of a single clearance pathway is not likely to cause a marked drug-drug interaction.
Apremilast se obsežno presnavlja z encimi CYP in s CYP neodvisnimi presnovnimi potmi, vključno z oksidacijo, hidrolizo in konjugacijo, kar kaže na to, da inhibicija ene same presnovne poti verjetno ne bo povzročila znatne interakcije med zdravili.
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).
Klinično koristnost apremilasta so prikazali v več podskupinah, opredeljenih z izhodiščnimi demografskimi parametri in izhodiščnimi značilnostmi klinične bolezni (vključno s trajanjem psoriaze in bolniki z anamnezo psoriatičnega artritisa).
What Otezla is and what it is used for What you need to know before you take Otezla How to take Otezla
Kaj je zdravilo Otezla in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Otezla Kako jemati zdravilo Otezla Možni neželeni učinki
Change in SF-36 MCS h, mean± SD
SD sprememba DLQIg, povprečje ± SD sprememba SF-36 MCS h, povprečje± SD
You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have.
Vi ali vaš skrbnik nemudoma obvestite zdravnika o morebitnih spremembah vedenja ali razpoloženja in o morebitnih samomorilnih mislih.
Improved physical function as assessed by the HAQ-DI and the SF36v2PF domain, and the FACIT-fatigue scores were maintained in the open-label extension studies for up to 5 years of treatment.
Izboljšano telesno delovanje, ocenjeno s HAQ-DI in domeno SF36v2PF, in rezultati FACIT-utrujenost so trajali v odprtih podaljšanih študijah do 5 let zdravljenja.
For initial dose titration in this group, it is recommended that apremilast be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped (see section 5.2).
Za začetno titriranje odmerka v tej skupini se priporoča, da se apremilast titrira samo zjutraj, kot je navedeno v preglednici 1, večerni odmerki pa naj se izpustijo (glejte poglavje 5.2).
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%).
Bolniki so prejemali apremilast v kombinaciji z enim ali več od naslednjih zdravil: metotreksat (MTX, ≤ 25 mg/teden, 54,5 %), sulfasalazin (SSZ, ≤ 2 g/dan, 9,0 %) in leflunomid (LEF; ≤ 20 mg/dan, 7,4 %).
If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with apremilast.
Če bolniki občutijo nove psihiatrične simptome oziroma se obstoječi poslabšajo, ali če se ugotovi, da imajo samomorilne misli ali so poskusili storiti samomor, se priporoča prekinitev zdravljenja z apremilastom.
ACR 20/50/70 responses were maintained at week 24.
Odzivi ACR 20/50/70 so bili nadalje prisotni v 24. tednu zdravljenja.
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.
Po 40 tednih zdravljenja z apremilastom sta se zmanjšali koncentraciji plazemskih beljakovin IL-17 in IL-23, koncentracija IL-10 pa se je zvečala.
• bleeding in the bowel or in the stomach
• krvavitev v črevo ali želodec,
Treatment with Otezla should be initiated by specialists experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis.
Zdravljenje z zdravilom Otezla morajo uvesti specialisti, ki imajo izkušnje v diagnostiki in zdravljenju psoriaze ali psoriatičnega artritisa.
In addition, in Study ESTEEM 1, significant improvement in the Work Limitations Questionnaire (WLQ-25) Index was achieved in patients receiving apremilast compared to placebo.
Poleg tega so v študiji ESTEEM 1 dosegli signifikantno izboljšanje indeksa v vprašalniku o delovnih omejitvah (WLQ-25) pri bolnikih, ki so prejemali apremilast, v primerjavi s placebom.
Otezla works by reducing the activity of an enzyme in the body called ‘phosphodiesterase 4', which is involved in the process of inflammation.
Zdravilo Otezla deluje tako, da v telesu zmanjšuje aktivnost encima, ki se imenuje ‘fosfodiesteraza 4' in je vpleten v proces vnetja.
PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells.
PDE4 je fosfodiesteraza, specifična za ciklični adenozinmonofosfat (cAMP), in prevladujoča fosfodiesteraza v vnetnih celicah.
Otezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1).
Zdravilo Otezla, samo ali v kombinaciji z imunomodulirajočimi protirevmatičnimi zdravili (DMARDs - Disease Modifying Antirheumatic Drugs), je indicirano za zdravljenje aktivnega psoriatičnega artritisa (PsA) pri odraslih bolnikih, ki so se nezadostno odzvali na predhodno zdravljenje z DMARD ali ga niso prenašali (glejte poglavje 5.1).
MARKETING AUTHORISATION NUMBER(S) EU/1/14/981/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/981/001
8 subjects with severe renal impairment to whom a single dose of 30 mg apremilast was administered, the AUC and Cmax of apremilast increased by approximately 89% and 42%, respectively.
Pri 8 preskušancih s hudo okvaro ledvic, ki jim je bil dan enkraten odmerek 30 mg apremilasta, se je AUC apremilasta zvečala za približno 89 % in Cmax za približno 42 %.
The most commonly reported adverse reactions with apremilast are gastrointestinal (GI) disorders including diarrhoea (15.7%) and nausea (13.9%).
Neželeni učinki, o katerih pri apremilastu najpogosteje poročajo, so gastrointestinalne (GI) motnje, ki vključujejo drisko (15,7 %) in navzeo (13,9 %).
Patients previously treated with DMARDs or biologics who received apremilast achieved a greater ACR 20 response at week 16 than patients receiving placebo.
Bolniki, predhodno zdravljeni z DMARDs ali biološkimi zdravili, ki so prejemali apremilast, so po 16 tednih dosegli večji odziv ACR 20 kot bolniki, ki so prejemali placebo.
In the PsA or PSOR clinical studies, the safety profile observed in patients with mild renal impairment was comparable to patients with normal renal function.
V kliničnih študijah PsA ali PSOR je bil varnostni profil, ki so ga opazili pri bolnikih z blago okvaro ledvic, primerljiv tistemu pri bolnikih z normalnim delovanjem jeter.
Apremilast can be co-administered with methotrexate.
Apremilast lahko dajemo sočasno z metotreksatom.
Patients with each subtype of PsA were enrolled in the 3 studies, including symmetric polyarthritis (62.0%), asymmetric oligoarthritis (26.9%), distal interphalangeal (DIP) joint arthritis (6.2%), arthritis mutilans (2.7%), and predominant spondylitis (2.1%).
V te 3 študije vključeni bolniki so imeli vse podtipe PsA, vključno s simetričnim poliartritisom (62,0 %), asimetričnim oligoartritisom (26,9 %), artritisom distalnih interfalangealnih (DIP) sklepov (6,2 %), artritisom mutilansom (2,7 %) in predominantnim spondilitisom (2,1 %).
You should not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Otezla.
Medtem ko jemljete to zdravilo, ne smete zanositi, med zdravljenjem z zdravilom Otezla pa morate uporabljati zanesljivo kontracepcijsko metodo.
In addition, apremilast demonstrated a treatment benefit across multiple manifestations of psoriasis including pruritus, nail disease, scalp involvement and quality of life measures.
Poleg tega je apremilast pokazal koristnost zdravljenja pri številnih manifestacijah psoriaze, vključno s pruritusom, psoriazo nohtov, psoriazo lasišča in merilih kakovosti življenja.