FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of Hefiya should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Slovenian: Če se bolniku pojavi nova resna okužba ali sepsa, je treba uporabo zdravila Hefiya prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okužba ni obvladana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Slovenian: ZUNANJA ŠKATLA ZA VEČKRATNO PAKIRANJE (VKLJUČUJE MODRI OKVIRČEK)
English: If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.
Slovenian: Če je z 40 mg vsak teden ali 80 mg vsak drugi teden dosežen zadosten odziv na zdravljenje, se lahko odmerek pozneje zmanjša na 40 mg vsak drugi teden.
English: Immunosuppression
Slovenian: Imunosupresija
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Slovenian: Adalimumab 40 mg so vsak drugi teden ocenili v dveh randomiziranih 24-tedenskih dvojno slepih, s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa - Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6,3), ki se niso odzvali ustrezno na konvencionalno terapijo.
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Hefiya therapy and regularly during treatment to assess for preexisting or developing central demyelinating disorders.
Slovenian: Pri bolnikih z neinfekcijskim intermediarnim uveitisom je treba pred začetkom zdravljenja z zdravilom Hefiya in redno med zdravljenjem opravljati nevrološko oceno, da se oceni že obstoječe ali razvijajoče se demielinizirajoče bolezni osrednjega živčevja.
English: o DO NOT USE the syringe (see Figure D).
Slovenian: o Injekcijske brizge NE UPORABITE (glejte sliko D).
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38 % (25 / 66) and 55 % (36 / 66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Slovenian: Med bolniki, ki so izgubili ustrezen odziv ob ponovni randomizaciji na placebo med podaljšanim odprtim preskušanjem, je po 12 tednih ponovne terapije PASI 75 znova doseglo 38 % (25/66), po 24 tednih pa 55 % (36/66) bolnikov.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Slovenian: • imunske bolezni, ki lahko prizadenejo pljuča, kožo in limfne vozle (najpogosteje v obliki stanja,
English: Upon completion of the first 104 weeks, 497 patients enrolled in an open-label extension phase in which 40 mg of adalimumab was administered every other week up to 10 years.
Slovenian: Po zaključenih prvih 104 tednih, so 497 bolnikov vključili v odprto nadaljevalno fazo, med katero so še do 10 let dobivali 40 mg adalimumaba vsak drugi teden.
English: The safety and efficacy of adalimumab were assessed in two randomized, double-blind placebocontrolled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Slovenian: Varnost in učinkovitost adalimumaba so ocenili v dveh randomiziranih dvojno slepih, s placebom kontroliranih študijah pri bolnikih z ne-radiografskim aksialnim spondiloartritisom (nr-axSpA).
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 so spontano poročali o okužbah (kot je nazofaringitis, okužbe zgornjih dihal in sinusitis), reakcijah na mestu injiciranja (eritem, srbenje, hemoragija, bolečina ali otekanje), glavobolu in mišičnoskeletni bolečini.
English: Patients who had been randomised to placebo in period A were assigned to receive adalimumab 40 mg every week in period B.
Slovenian: Bolniki, ki so jih randomizirali na placebo v obdobju A, so v obdobju B prejemali adalimumab 40 mg vsak teden.
English: A total of 347 stable responders participated in a withdrawal and retreatment evaluation in an openlabel extension study.
Slovenian: V odprti podaljšani študiji je v oceni prenehanja uporabe in ponovnega zdravljenja sodelovalo skupno 347 stabilnih odzivnih bolnikov.
English: • Push the needle all the way in to ensure that the medication can be fully administered
Slovenian: • Iglo potisnite do konca, da lahko v celoti injicirate zdravilo.
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Slovenian: Pomembno je, da zdravniku poveste, če imate simptome okužb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali težave z zobmi (glejte "Opozorila in previdnostni ukrepi").
English: • fatty liver (build-up of fat in liver cells);
Slovenian: • zamaščenost jeter (kopičenje maščobe v jetrnih celicah);
English: Psoriasis Study III (REACH) compared the efficacy and safety of adalimumab versus placebo in 72 patients with moderate to severe chronic plaque psoriasis and hand and/or foot psoriasis.
Slovenian: Študija pri psoriazi III (REACH) je primerjala učinkovitost in varnost adalimumaba v primerjavi s placebom pri 72 bolnikih z zmerno do hudo kronično psoriazo v plakih in psoriazo na dlaneh in/ali stopalih.
English: Concurrent treatment with azathioprine/6-mercaptopurine
Slovenian: Sočasna uporaba azatioprina/6-merkaptopurina
English: Table 15 efficacy response in placebo-controlled period for study nr-axSpA II
Slovenian: Odziv učinkovitosti v s placebom kontroliranem obdobju študije nr-axSpA II
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: The serum levels of free adalimumab (not bound to anti-adalimumab antibodies, AAA) were observed to be lower in patients with measurable AAA.
Slovenian: Ugotovljeno je bilo, da so koncentracije prostega adalimumaba (tiste, ki ni vezan na protitelesa proti adalimumabu) v serumu manjše pri bolnikih, ki imajo merljivo raven teh protiteles.
English: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3-month trial of systemic antibiotic therapy.
Slovenian: Varnost in učinkovitost adalimumaba so raziskali v randomiziranih, dvojno slepih študijah, kontroliranih s placebom in v odprti podaljšani študiji pri odraslih bolnikih z zmerno do hudo obliko hidradenitis suppurativa (HS), ki imajo intoleranco, kontraindikacijo ali se ne odzovejo zadovoljivo pri vsaj 3-mesečnem preskušanju sistemske antibiotične terapije.
English: Thirty-three (18 %) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 146 (79 %) patients with NSAIDs at baseline.
Slovenian: 33 (18 %) bolnikov je bilo na začetku sočasno zdravljenih z modifikatorji bolezni ali protirevmatskimi zdravili in 146 (79 %) bolnikov z nesteroidnimi antirevmatiki.
English: Psoriasis Study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Slovenian: Študija pri psoriazi IV je primerjala učinkovitost in varnost adalimumaba v primerjavi s placebom pri 217 odraslih bolnikih z zmerno do hudo psoriazo nohtov.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post marketing setting.
Slovenian: Med obdobjem trženja so bili opisani malignomi (nekateri s smrtnim izidom) pri otrocih, mladostnikih in mladih odraslih (starih do 22 let), ki so dobivali antagoniste TNF, vključno z adalimumabom
English: Hefiya is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Slovenian: Zdravilo Hefiya je indicirano za zdravljenje hude psoriaze v plakih pri otrocih in mladostnikih od 4. leta starosti, ki so se neustrezno odzvali na ali niso ustrezni kandidati za topikalno zdravljenje in fototerapije.
English: • Cotton ball or gauze
Slovenian: • košček vate ali gaze
English: Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
Slovenian: V kliničnih študijah s sočasno uporabo anakinre in etanercepta, drugega antagonista TNF, so opazili hude okužbe brez dodatnih kliničnih prednosti v primerjavi z etanerceptom samim.
English: Patients received either placebo or 20 mg adalimumab (if < 30 kg) or 40 mg adalimumab (if ≥ 30 kg) every other week in combination with their baseline dose of methotrexate.
Slovenian: Bolniki so prejeli placebo ali 20 mg adalimumaba (če so tehtali manj kot 30 kg) ali 40 mg adalimumaba (če so tehtali 30 kg ali več) vsak drugi teden v kombinaciji z izhodiščnim odmerkom metotreksata.
English: Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg injections in one day).
Slovenian: Čez dva tedna (29. dan) nadaljujte z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (aplicirano v obliki dveh 40 mg injekcij v enem dnevu).
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
Slovenian: • okužbe dihalnega trakta (vključno s prehladom, izcedkom iz nosu, okužbo sinusov, pljučnico);
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab.
Slovenian: Kljub profilaktičnemu zdravljenju za tuberkulozo, so se pri bolnikih, zdravljenih z adalimumabom,
English: Among patients who were not in response at week 4, 43 % of adalimumab maintenance patients responded by week 12 compared to 30 % of placebo maintenance patients.
Slovenian: Med bolniki, ki so bili 4. teden brez odziva, se je do 12. tedna odzvalo 43 % tistih, ki so vzdrževalno dobivali adalimumab, in 30 % tistih, ki so vzdrževalno dobivali placebo.
English: 20, 25 and 40 mg
Slovenian: 20, 25 in 40 mg
English: • difficulty sleeping;
Slovenian: • anksioznost; • otežkočeno spanje;
English: Among those, 154 patients (90.6 %) had ACR 20 responses; 127 patients (74.7 %) had ACR 50 responses; and 102 patients (60.0 %) had ACR 70 responses.
Slovenian: Med temi je 154 bolnikov (90,6 %) imelo odziv 20 po ACR; 127 bolnikov (74,7 %) je imelo odziv 50 po ACR; in 102 bolnika (60,0 %) sta imela odziv 70 po ACR.
English: The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2-< 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Slovenian: Varnost in učinkovitost adalimumaba so ocenili v odprti, multicentrični študiji pri 32 otrocih (starih od 2 do < 4 leta ali starih 4 leta ali več in s telesno maso < 15 kg) z zmernim do zelo aktivnim poliartikularnim JIA.
English: Patients were randomised to 40 mg of adalimumab or placebo every other week for 24 weeks.
Slovenian: Bolnike so randomizirali na 40 mg adalimumaba ali placebo vsak drugi teden za 24 tednov.
English: BASDAIb 50 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
Slovenian: BASDAIb 50 2. teden 12. teden 24. teden ***,** 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)
English: If this dose does not work well enough, your doctor may increase the dose frequency to 20 mg every week.
Slovenian: Če ta odmerek ne deluje dovolj dobro, lahko zdravnik vašega otroka poveča pogostnost odmerjanja na 20 mg vsak teden.
English: In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg / dl) values) improved at 24 or 26 weeks compared to placebo.
Slovenian: V študijah revmatoidnega artritisa I-IV so se v primerjavi s placebom po 24 oz. 26 tednih izboljšali vsi posamezni elementi meril odziva po ACR (število bolečih in oteklih sklepov, zdravnikova in bolnikova ocena aktivnosti bolezni in bolečin, vrednost indeksa invalidnosti (HAQ) in vrednost CRP
English: * p < 0.05, *** p < 0.001, adalimumab versus placebo a among all randomised patients.
Slovenian: * p < 0,05, *** p < 0,001, adalimumab v primerjavi s placebom a med vsemi randomiziranimi bolniki.
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab / methotrexate combination therapy (63.8 % and 61.2 % respectively) compared to methotrexate monotherapy (37.4 % and 33.5 % respectively, p < 0.001) and adalimumab monotherapy (50.7 %, p < 0.002 and 44.5 %, p < 0.001 respectively).
Slovenian: Po 52 oz. 104 tednih zdravljenja je bil v skupini s kombinirano terapijo z adalimumabom in metotreksatom odstotek bolnikov brez napredovanja bolezni (sprememba prilagojene Sharpove ocene od izhodišča ≤ 0,5) značilno večji (63,8 % oz. 61,2 %) kot v skupinah, ki sta prejemali monoterapijo z metotreksatom (37,4 % in 33,5 %, p < 0,001) ali monoterapijo z adalimumabom (50,7 %, p < 0,002, oz. 44,5 %, p < 0,001).
English: PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal antiinflammatory drug therapy and of these, approximately 50 % were taking methotrexate.
Slovenian: V njej so zdravili 313 odraslih, ki se niso ustrezno odzvali na terapijo z nesteroidnimi protivnetnimi zdravili; približno 50 % od teh je jemalo metotreksat.
English: Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure-response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Slovenian: Učinkovitost adalimumaba za zdravljenje mladostnikov s HS je napovedana na podlagi dokazane učinkovitosti in razmerja med izpostavljenostjo in odzivom pri odraslih bolnikih s HS ter verjetnosti, da so potek bolezni,
English: • adults with non-infectious uveitis with inflammation affecting the back of the eye.
Slovenian: • odraslih z neinfekcijskim uveitisom, kjer vnetje prizadene zadnji del očesa,
English: Endoscopic studies in intestinal mucosa have shown evidence of mucosal healing in adalimumab-treated patients.
Slovenian: Endoskopske študije črevesne sluznice so pokazale znake celjenja sluznice pri bolnikih, zdravljenih z adalimumabom.
English: Methotrexate should be continued during treatment with Hefiya.
Slovenian: Med zdravljenjem z zdravilom Hefiya je treba še naprej uporabljati metotreksat.
English: For patients who dose-escalated from eow to weekly regimen, the mean (± SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg / ml (40 / 20 mg, weekly) and 6.7 ± 3.5 μg / ml (20 / 10 mg, weekly).
Slovenian: Pri bolnikih, ki so prešli iz režima vsak drugi teden na režim vsak teden, so bile srednje (± SD) serumske koncentracije adalimumaba v 52. tednu 15,3 ± 11,4 μg/ml (40/20 mg, tedensko) in 6,7 ± 3,5 μg/ml (20/10 mg, tedensko).
English: In Study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo.
Slovenian: V študiji I so v primerjavi s placebom ugotovili tudi značilno izboljšanje telesne in duševne komponente ocene SF-36.
English: Hefiya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Slovenian: Zdravilo Hefiya je indicirano za zdravljenje neinfekcijskega intermediarnega, posteriornega uveitisa in panuveitisa pri odraslih bolnikih, ki se niso zadostno odzvali na zdravljenje s kortikosteroidi, pri bolnikih s potrebo po zmanjšani uporabi kortikosteroidov ali pri bolnikih, pri katerih je zdravljenje s kortikosteroidi neprimerno.
English: In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see table 8).
Slovenian: V študiji revmatoidnega artritisa V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija z adalimumabom in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 8).
English: • Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);
Slovenian: • kožni vaskulitis (vnetje krvnih žil v koži); • sindrom Stevens-Johnson (smrtno nevarna reakcija z gripi podobnimi simptomi in mehurjastim izpuščajem);
English: At week 52, 42.9 % of patients who received adalimumab / methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6 % of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Slovenian: Po 52. tednih je klinično remisijo (DAS28 (CRP) < 2,6) doseglo 42,9 % bolnikov, ki so dobivali kombinirano terapijo z adalimumabom/metotreksatom, 20,6 % bolnikov, ki so dobivali metotreksat v monoterapiji, in 23,4 % bolnikov, ki so dobivali adalimumab v monoterapiji.
English: After 12 weeks of therapy, patients who had received adalimumab in period A were re-randomised in period B to 1 of 3 treatment groups (adalimumab 40 mg every week, adalimumab 40 mg every other week, or placebo from week 12 to week 35).
Slovenian: Po 12 tednih terapije so bolnike, ki so prejemali adalimumab v obdobju A, ponovno randomizirali v obdobju B v eno izmed treh skupin zdravljenja (adalimumab 40 mg vsak teden, adalimumab 40 mg vsak drugi teden ali placebo od 12. do 35. tedna).
English: 117 / 276 patients from CD study I and 272 / 777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Slovenian: Med odprtim obdobjem zdravljenja z adalimumabom so vsaj 3 leta spremljali 117/276 bolnikov iz študije I Crohnove bolezni ter 272/777 bolnikov iz študij II in III Crohnove bolezni.
English: • symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
Slovenian: • simptome težav z živci, kot je mravljinčenje; omrtvelost, dvojni vid ali šibkost rok ali nog,
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more The recommended dose of Hefiya is an initial dose of 40 mg, followed by 40 mg one week later.
Slovenian: Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila Hefiya je začetni odmerek 40 mg, ki mu sledi 40 mg en teden kasneje.
English: • swollen face, hands, feet;
Slovenian: • oteklost obraza, dlani in stopal;
English: • a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel;
Slovenian: • razširitev v steni večje arterije, vnetje in krvni strdek v veni, zamašitev žile;
English: Myocardial infarction1), arrhythmia, congestive heart failure
Slovenian: pogosti tahikardija občasni miokardni infarkt1) aritmija kongestivno srčno popuščanje redki zastoj srca
English: No other disease-modifying anti-rheumatic drugs were allowed.
Slovenian: Uporaba drugih imunomodulirajočih zdravil ni bila dovoljena.
English: There is insufficient evidence of the efficacy of adalimumab in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Slovenian: Zaradi majhnega števila bolnikov ni dovolj dokazov o učinkovitosti adalimumaba pri bolnikih s psoriatično artropatijo, podobno ankilozirajočemu spondilitisu.
English: • sicca syndrome (including dry eyes and dry mouth);
Slovenian: • Sjögrenov sindrom (vključno s suhimi očmi in suhimi usti);
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21 / 41 (51 %) were in remission at week 52.
Slovenian: V študiji UC-II je bilo 21/41 bolnikov (51 %), ki so bili zdravljeni z adalimumabom in so dosegli remisijo 8. teden, v remisiji 52. teden.
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hefiya treatment.
Slovenian: Nosečnost in dojenje • Premisliti morate o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še 5 mesecev po zadnjem zdravljenju z zdravilom Hefiya.
English: Hefiya is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Slovenian: Zdravilo Hefiya je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
English: The usual dose regimen is 40 mg adalimumab initially followed by 20 mg two weeks later.
Slovenian: Običajni začetni odmerek je 40 mg adalimumaba, ki mu sledi 20 mg dva tedna kasneje.
English: Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Slovenian: Luskavica v plakih je vnetna bolezen kože, pri kateri nastajajo rdeče, kosmičaste, krastave lise na koži,
English: Hefiya is injected under the skin (subcutaneous use).
Slovenian: Zdravilo Hefiya se injicira pod kožo (subkutana uporaba).
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (table 14).
Slovenian: Rezultati po 12. tednu so pokazali statistično pomembno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so bili zdravljeni z adalimumabom v primerjavi s placebom (preglednica 14).
English: • sensation of heart beating rapidly;
Slovenian: • občutek hitrega bitja srca;
English: Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer.
Slovenian: let ali več zdravljenih 19 preiskovancev, od tega 11 iz izhodiščne starostne skupine od 4 do 12 let in 8 iz izhodiščne starostne skupine od 13 do 17 let.
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Slovenian: Varnost in učinkovitost adalimumaba so ocenili v multicentrični, randomizirani, dvojno slepi študiji pri 46 pediatričnih bolnikih (starih od 6 do 17 let) z zmernim artritisom, povezanim z entezitisom.