FrancophonIA/ELRC3.0 huggingface dataset:
English: • AMGEVITA can be used during breast-feeding.
Slovenian: • Zdravilo AMGEVITA se lahko uporablja med dojenjem.
English: AMGEVITA in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Slovenian: Zdravilo AMGEVITA je v kombinaciji z metotreksatom indicirano za zdravljenje aktivnega poliartikularnega juvenilnega idiopatskega artritisa pri bolnikih od 2.leta starosti, ki se ne odzovejo ustrezno na eno ali več imunomodulirajočih antirevmatičnih zdravil (disease-modifying anti-rheumatic drugs - DMARDs).
English: ACR 50 6 months 12 months
Slovenian: ACR 50 6 mesecev 12 mesecev
English: A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p < 0.001) (Figure 1).
Slovenian: Pri večjem deležu bolnikov, ki so prejemali adalimumab, v dvojno slepem obdobju ni prišlo do ponovnega zagona bolezni v primerjavi s tistimi, ki so prejemali placebo (70,4 % v primerjavi s 47,1 %, p < 0,001) (slika 1).
English: Administration of live vaccines (e.g., BCG vaccine) to infants exposed to AMGEVITA in utero is not recommended for 5 months following the mother's last AMGEVITA injection during pregnancy.
Slovenian: Uporaba živih cepiv (npr. BCG cepiva) pri dojenčkih, ki so bili izpostavljeni zdravilu AMGEVITA in utero, ni priporočljiva še 5 mesecev po materini zadnji injekciji zdravila AMGEVITA med nosečnostjo.
English: The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex) (see section 4.4).
Slovenian: Pokrovček igle na napolnjenem injekcijskem peresniku vsebuje suho naravno gumo (derivat lateksa) (glejte poglavje 4.4).
English: Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo.
Slovenian: Adalimumab je pokazal statistično večje izboljšanje skupnega števila točk v HAQ-S vprašalniku in točk v telesno komponenti (Physical Component Score (PCS)) v SF-36 vprašalniku od začetka do 12. tedna v primerjavi s placebom.
English: Uncommon (may affect up to 1 in 100 people) • elevated bilirubin measurement (liver blood test).
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) • povečane vrednosti bilirubina (krvni test jeterne funkcije).
English: Stretch the skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches (5 centimetres) wide.
Slovenian: Kožo čvrsto raztegnite tako, da palec in prste razmaknete v nasprotni smeri in tako ustvarite približno 5 centimetrov širok predel.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases.
Slovenian: Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom, sta vnetni bolezni.
English: Place your finger or thumb on edge of tray to secure it while you remove the syringe.
Slovenian: S prstom ali palcem primite za rob pretisnega omota, da se ne premika, medtem ko boste vzeli brizgo iz njega.
English: After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Slovenian: Čez nadaljnja dva tedna nadaljujte z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden, kot vam bo predpisal zdravnik.
English: F. Stretch or pinch your injection site to create a firm surface.
Slovenian: F. Raztegnite ali stisnite mesto injiciranja, da boste ustvarili trdno površino.
English: ACR 70 6 months 12 months
Slovenian: ACR 70 6 mesecev 12 mesecev
English: If you are about to undergo surgery or dental procedures please inform your doctor that you are taking AMGEVITA.
Slovenian: • Če boste imeli kirurški poseg ali poseg na zobeh, prosimo, povejte svojemu zdravniku, da jemljete zdravilo AMGEVITA.
English: Subjects (n = 215, 54.7%) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Slovenian: Preiskovanci (n = 215, 54,7 %), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa so bili obravnavani kot neodzivni bolniki.
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at Weeks 16, 20, 24, and 28) during the open-label period were then randomised to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Slovenian: Bolniki, ki so v odprti fazi dosegli trajno remisijo za vsaj 12 tednov (N = 305) (ASDAS < 1,3 v 16., 20., 24. in 28. tednu), so bili nato randomizirani tako, da so prejemali bodisi nadaljevalno zdravljenje z adalimumabom 40 mg vsak drugi teden (N = 152) ali placebo (N = 153) dodatnih 40 tednov v dvojno slepem, s placebom kontroliranem obdobju (celotno trajanje študije 68 tednov).
English: The pre-filled syringe must be protected from light, and discarded if not used within the 14-day period.
Slovenian: Napolnjena injekcijska brizga mora biti zaščitena pred svetlobo in zavržena, če je ne uporabite v obdobju 14 dni.
English: Seventy-nine (20.1%) patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Slovenian: Devetinsedemdeset (20,1 %) bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9,4 %) bolnikov pa glukokortikoide.
English: SPARCCh MRI Sacroiliac Jointsd,i
Slovenian: SPARCCh MRI sakroiliakalnih sklepov d,i
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see table 22).
Slovenian: Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu, je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden, ali pri katerih je bilo zdravljenje ukinjeno (glej preglednico 22).
English: How to use AMGEVITA
Slovenian: Kako uporabljati zdravilo AMGEVITA
English: AMGEVITA slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Slovenian: Zdravilo AMGEVITA upočasni okvaro sklepnega hrustanca in kosti, ki jo povzroča ta bolezen in izboljšuje telesno delovanje.
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity.
Slovenian: Neklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Step 3: Inject G. Hold the stretch or pinch.
Slovenian: 3. korak: Injiciranje G. Držite kožno gubo.
English: Finger flange Label and expiration date
Slovenian: Oprijemalo za prste Nalepka brizge in rok uporabnosti
English: Based on the observed data approach, 222 (80.4%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7%) were in steroid-free quiescence.
Slovenian: Na osnovi pristopa z opaženimi podatki je bilo 222 (80,4 %) bolnikov v remisiji (brez aktivnih vnetnih lezij, ocena celic sprednje očesne komore ≤ 0,5+, motnost steklovine ≤ 0,5+) ob sočasnem jemanju steroidov v odmerku ≤ 7,5 mg na dan in pa 184 bolnikov (66,7 %), ki so bili v remisiji in brez steroidov.
English: Amongst those who responded at week 16 (n = 144), the paediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Slovenian: Med bolniki, ki so se odzvali 16. teden (n = 144), so se odzivi »Pediatric ACR« 30/50/70/90 v odprti podaljšani fazi ohranili do 6 let pri tistih, ki so ves čas študije dobivali adalimumab.
English: JSNd score a methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and adalimumab c Based on rank analysis d Joint Space Narrowing
Slovenian: Ocena erozij Ocena ZSŠd ametotreksat b95% intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom cna podlagi analize rangov dzožitev sklepne špranje
English: *P < 0.05, ***P < 0.001, adalimumab versus placebo a Among all randomised patients b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0 - 10; 0 = no skin pain, 10 = skin pain as bad as you can imagine
Slovenian: * P < 0,05, ***P < 0,001, adalimumab v primerjavi s placebom a Med vsemi randomiziranimi bolniki b Med bolniki z izhodiščnim rezultatom 3 ali več pri ocenjevanju bolečine, povezane s hidradenitis suppurativa, po numerični ocenjevalni lestvici od 0 do 10; 0 = brez bolečin na koži, 10 = najhujša možna bolečina na koži
English: Should treatment be interrupted, AMGEVITA 40 mg every week or 80 mg every other week may be re-introduced (see section 5.1).
Slovenian: Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom AMGEVITA odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
English: In controlled and open-label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Slovenian: V kontroliranih in odprtih študijah pri odraslih in otrocih z adalimumabom so poročali o resnih okužbah (vključno s smrtno nevarnimi okužbami, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana ali zunajpljučna histoplazmoza, blastomikoza, kokcidioidomikoza, pnevmocistoza, kandidaza, aspergiloza in listerioza).
English: Consequently, AMGEVITA can be used during breastfeeding.
Slovenian: Posledično se zdravilo AMGEVITA lahko uporablja med dojenjem.
English: Put the original package with any unused pre-filled pens back in the refrigerator.
Slovenian: Originalno pakiranje z neuporabljenimi napolnjenimi injekcijskimi peresniki dajte nazaj v hladilnik.
English: 40 mg adalimumab every week
Slovenian: 40 mg adalimumaba vsak teden
English: AMGEVITA can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Zdravilo AMGEVITA se lahko uporablja skupaj z metotreksatom ali nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (sulfasalazinom, hidroksiklorokinom, leflunomidom in pripravki zlata za injiciranje), steroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili (NSAID).
English: No ALT elevations ≥ 3 X ULN occurred in the phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Slovenian: Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z adalimumabom pri pediatričnih bolnikih s psoriazo v plakih.
English: Figure 3: Kaplan-Meier curves summarising time to treatment failure in the paediatric uveitis study
Slovenian: Slika 3: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
English: Note: P# = Placebo (number of events/number at risk); A# = Adalimumab (number of events/number at risk).
Slovenian: Opomba: P# = Placebo (število dogodkov/število rizičnih preiskovancev); A# = adalimumab (število dogodkov/število rizičnih preiskovancev).
English: The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7 ± 6.6 μg/mL for patients ≥ 40 kg (160/80 mg) and 10.6 ± 6.1 μg/mL for patients < 40 kg (80/40 mg).
Slovenian: Srednje (±SD) serumske koncentracije adalimumaba, dosežene v 4. tednu, so bile 15,7 ± 6,6 μg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6.1 μg/ml pri bolnikih < 40 kg (80/40 mg).
English: ● Do not use the pre-filled pen if: - The medicine is cloudy or discoloured, or contains flakes or particles.
Slovenian: ● Ne uporabite napolnjenega injekcijskega peresnika, če: - je zdravilo motno ali obarvano ali vsebuje kosmiče ali delce.
English: AMGEVITA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Slovenian: Zdravilo AMGEVITA je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki so kandidati za sistemsko zdravljenje.
English: Week 2 Week 12 Week 24 ***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Slovenian: ***,** Statistično značilno pri p < 0,001, < 0,01 za vse primerjave med adalimumabom in placebom po 2, 12 in 24 tednih a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index)
English: The primary endpoint was the percent change from baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Slovenian: Primarni opazovani dogodek je bil odstotek spremembe od izhodiščne vrednosti do 12. tedna v številu aktivnih sklepov z artritisom (oteklina, ki ni nastala zaradi deformacije ali sklepi z zmanjšano gibljivostjo ter bolečino in/ali občutljivostjo); slednji je bil dosežen s povprečnim zmanjšanjem za -62,6 % (mediana sprememba -88,9 %) pri skupini bolnikov, ki je prejemala adalimumab v primerjavi z -11,6 % (mediana sprememba -50,0 %) v skupini bolnikov, ki je prejemala placebo.
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see table 10).
Slovenian: V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 10).
English: The observed rate of nonmelanoma skin cancers is approximately 9.6 per 1,000 patient-years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient-years.
Slovenian: Ugotovljeni delež nemelanomskih kožnih rakov je približno 9,6 na 1000 bolnikov-let, ugotovljeni delež limfomov pa približno 1,3 na 1000 bolnikov-let.
English: Alternatively, if a patient has stopped AMGEVITA and signs and symptoms of disease recur, AMGEVITA may be re-administered.
Slovenian: Če bolnik neha uporabljati zdravilo AMGEVITA, pa se znaki in simptomi bolezni ponovijo, je mogoče zdravilo AMGEVITA znova uvesti.
English: In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Slovenian: V študijah revmatoidnega artritisa I - IV so z adalimumabom zdravljeni bolniki v primerjavi s prejemniki placeba dosegli statistično značilen odziv 20 in 50 po ACR že en do dva tedna po začetku zdravljenja.
English: ● Do not recycle the pre-filled pen or sharps disposal container or throw them into the household waste.
Slovenian: ● Ne reciklirajte napolnjenega injekcijskega peresnika ali vsebnika za ostre odpadke ter ju ne vrzite med gospodinjske odpadke.
English: Dermatitis (including eczema), Onychoclasis,
Slovenian: dermatitis (vključno z ekcemom),
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD
Slovenian: Prilagojeno razmerje obetov (z ozirom na izhodiščne razlike) je bilo 1,10 (95 % interval zaupanja 0,45-2,73) z RA in CB skupaj.
English: For a more comfortable injection, leave the pre-filled pen at room temperature for 15 to 30 minutes before injecting.
Slovenian: Da bo injiciranje bolj udobno, pustite napolnjen injekcijski peresnik za 15 do 30 minut na sobni temperaturi, preden začnete z injiciranjem.
English: Treatment with AMGEVITA may result in the formation of autoimmune antibodies.
Slovenian: Zdravljenje z zdravilom AMGEVITA lahko povzroči nastanek avtoimunskih protiteles.
English: Figure 1: Kaplan-Meier Curves Summarising Time to Flare in Study nr-axSpA II
Slovenian: Slika 1: Kaplan-Meier-jeve krivulje povzemajo čas do ponovnega zagona bolezni v študiji nr-axSpA II
English: Physicians should exercise caution when considering the use of AMGEVITA in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Slovenian: Pri odločanju za uporabo zdravila AMGEVITA je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
English: • ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12.
Slovenian: • ≥ 40 kg: 40 mg vsak teden ali 80 mg vsak drugi teden Če se bolnik ne odzove na zdravljenje do 12.tedna, je potrebno skrbno premisliti o nadaljevanju zdravljenja.
English: What AMGEVITA looks like and contents of the pack
Slovenian: Izgled zdravila AMGEVITA in vsebina pakiranja
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to  2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Slovenian: 673 bolnikov z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni [BASDAI] je bila 7,0), ki so nezadostno reagirali na vsaj dva NSAID ali niso prenašali NSAID ali s kontraindikacijo za NSAID, je bilo vključenih v odprto fazo študije nr-axSpA II, v kateri so prejemali adalimumab 40 mg vsak drugi teden 28 tednov.
English: MTX N = 110 n (%)
Slovenian: metotreksat N = 110 n (%)
English: After week 2, patients in both adalimumab arms received 40 mg every other week.
Slovenian: Po 2. tednu so bolniki v obeh krakih z adalimumabom prejemali 40 mg vsak drugi teden.
English: In the phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6% (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Slovenian: V preskušanju faze 3 z adalimumabom pri bolnikih s pediatrično Crohnovo boleznijo, kjer so ocenjevali učinkovitost in varnost dveh telesni masi prilagojenih vzdrževalnih režimov odmerjanja, ki sta sledila telesni masi prilagojenemu začetnemu zdravljenju do 52 tednov zdravljenja, so se pojavila zvišanja ALT ≥ 3 x ULN pri 2,6 % (5/192) bolnikov, od katerih so štirje sočasno prejemali imunosupresive ob začetku preskušanja.
English: Prescribers should exercise caution in considering the use of AMGEVITA in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of AMGEVITA should be considered if any of these disorders develop.
Slovenian: Pri odločanju za uporabo zdravila AMGEVITA pri bolnikih z že prej obstoječimi ali nedavno nastalimi demielinizirajočimi boleznimi osrednjega ali perifernega živčevja je potrebna previdnost; če se razvije katera od teh bolezni, je treba razmisliti o prenehanju zdravljenja z zdravilom AMGEVITA.
English: In paediatric uveitis, there is no experience in the treatment with AMGEVITA without concomitant treatment with methotrexate.
Slovenian: Izkušenj z zdravilom AMGEVITA pri zdravljenju uveitisa pri pediatričnih bolnikih brez sočasnega zdravljenja z metotreksatom ni.
English: For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5 ± 5.6 μg/mL for the standard dose group and 3.5 ± 2.2 μg/mL for the low dose group.
Slovenian: Pri bolnikih, ki so ostali na njihovi randomizirani terapiji, so bile srednje najmanjše koncentracije adalimumaba v 52.tednu 9,5 ± 5,6 μg/ml v skupini s standardnim odmerkom in 3,5 ± 2,2 μg/ml v skupini z majhnim odmerkom.
English: A patient who requires surgery while on AMGEVITA should be closely monitored for infections, and appropriate actions should be taken.
Slovenian: Bolnika, ki med zdravljenjem z zdravilom AMGEVITA potrebuje operacijo, je treba natančno nadzirati glede okužb in ustrezno ukrepati.
English: The mean trough concentrations were maintained in patients who continued to receive adalimumab treatment every other week for 52 weeks.
Slovenian: Srednje najmanjše koncentracije so se pri bolnikih, ki so 52 tednov še naprej prejemali zdravljenje z adalimumabom vsak drugi teden, ohranile.
English: AMGEVITA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Slovenian: Zdravilo AMGEVITA je indicirano za zdravljenje aktivne zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri odraslih in mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
English: The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Slovenian: Najpogosteje poročani neželeni učinki so okužbe (kot je nazofaringitis, okužbe zgornjih dihal in sinusitis), reakcije na mestu injiciranja (eritem, srbenje, hemoragija, bolečina ali otekanje), glavobol in mišičnoskeletna bolečina.
English: Efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms
Slovenian: Odzivi učinkovitosti v študiji pri ankilozirajočem spondilitisu, kontrolirani s placebom - študija I zmanjšanje znakov in simptomov Odziv placebo N = 107
English: A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in psoriasis study I, and continued adalimumab in the open-label extension trial.
Slovenian: Skupno je 233 bolnikov, ki so imeli 16. in 33. teden odziv PASI 75, v študiji psoriaze I prejemalo stalno zdravljenje z adalimumabom 52 tednov ter so zdravljenje z adalimumabom nadaljevali v odprtem podaljšanem preskušanju.
English: Serious infections were seen in clinical studies with concurrent use of anakinra and another TNFantagonist, etanercept, with no added clinical benefit compared to etanercept alone.
Slovenian: V kliničnih študijah s sočasno uporabo anakinre in drugega antagonista TNF, etanercepta, so opazili hude okužbe brez dodatnih kliničnih prednosti v primerjavi z etanerceptom samim.
English: ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Slovenian: Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebo (odstotek bolnikov)