FrancophonIA/ELRC3.0 huggingface dataset:
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of AMGEVITA therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Slovenian: Pri bolnikih z neinfekcijskim intermediarnim uveitisom je treba pred začetkom zdravljenja z zdravilom AMGEVITA in redno med zdravljenjem opravljati nevrološko oceno, da se oceni že obstoječe ali razvijajoče se demielinizirajoče bolezni osrednjega živčevja.
English: Patients received adalimumab 0.8 mg/kg every other week (up to 40 mg), 0.4 mg/kg every other week (up to 20 mg), or methotrexate 0.1-0.4 mg/kg weekly (up to 25 mg).
Slovenian: Bolniki so prejemali adalimumab v odmerkih 0,8 mg/kg vsak drugi teden (do največ 40 mg), 0,4 mg/kg vsak drugi teden (do največ 20 mg) ali 0,1 - 0,4 mg/kg metotreksata na teden (do največ 25 mg).
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 (mg/dl)).
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 daysa Week 56
Slovenian: Klinična remisija Klinični odziv (CR-100) Bolniki v remisiji brez steroidov za ≥ 90 dnia
English: With the yellow cap off, place the pre-filled pen on your skin at 90 degrees.
Slovenian: Rumeni pokrovček mora biti odstranjen; prislonite napolnjeni injekcijski peresnik na kožo pod kotom 90 stopinj.
English: ● Do not put the needle cap back onto the syringe.
Slovenian: ● Ne nameščajte pokrovčka igle nazaj na brizgo.
English: The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Slovenian: Pokrovček igle na napolnjenem injekcijskem pereseniku vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroči alergijske reakcije.
English: The safety and efficacy of adalimumab were assessed in two randomised, 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: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the openlabel extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks of retreatment, 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: In the controlled portions of adalimumab clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Slovenian: V kontroliranih delih kliničnih preizkušanj z adalimumabom z antagonisti TNF je bilo opaženih več primerov malignomov, vključno z limfomi, tako pri bolnikih, ki so prejemali antagonist TNF, kot pri kontrolnih bolnikih.
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7%) in the adalimumab-treated women with RA and 5/74 (6.8%) in the untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52) and 16/152 (10.5%) in the adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16).
Slovenian: Razmerje nosečnosti, ki so se končale vsaj z enim živorojenim otrokom z večjim defektom ob rojstvu, je bilo 6/69 (8,7 %) pri nosečnicah, zdravljenih z adalimumabom z RA, in 5/74 (6,8 %) pri nezdravljenih nosečnicah z RA (neprilagojeno razmerje obetov 1,31, 95 % interval zaupanja 0,38-4,52), ter 16/152 (10,5 %) pri nosečnicah, zdravljenih z adalimumabom s CB, in 3/32 (9,4 %) pri nezdravljenih nosečnicah s CB (neprilagojeno razmerje obetov 1,14, 95 % interval zaupanja 0,31-4,16).
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab-treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Slovenian: V kontroliranih delih preskušanj, ki podpirajo vlogo za pridobitev dovoljenja za promet adalimumaba pri odraslih, ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za AS, psoriatičnim artritisom, psoriazo, hidradenitis suppurativa, Crohnovo boleznijo, ulceroznim kolitisom in uveitisom so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95 % interval zaupanja) 6,8 (4,4; 10,5) na 1000 bolnikov-let med 5291 bolniki, ki so dobivali adalimumab, in 6,3 (3,4; 11,8) na 1000 bolnikov-let med 3444 kontrolnimi bolniki (pri prvih je zdravljenje mediano trajalo 4,0 meseca in pri drugih 3,8 meseca).
English: Administration of AMGEVITA 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 AMGEVITA prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okužba ni obvladana.
English: Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab versus placebo pairwise comparison of proportions ** p < 0.001 for adalimumab versus placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline
Slovenian: Klinični odgovor pomeni znižanje ocene Mayo od začetka za ≥ 3 in ≥ 30% ter znižanje podocene rektalne krvavitve [RBS] ≥ 1 ali absolutna RBS 0 ali 1; *p < 0,05 za parno primerjavo deležev med adalimumabom in placebom **p < 0,001 za parno primerjavo deležev med adalimumabom in placebom a Od tistih, ki so izhodiščno prejemali kortikosteroide
English: Important: Keep the skin stretched or pinched while injecting.
Slovenian: Pomembno: Kožo med injiciranjem držite raztegnjeno ali stisnjeno.
English: Important: Always hold the pre-filled syringe by the syringe barrel.
Slovenian: Pomembno: Napolnjeno injekcijsko brizgo vedno držite za valj brizge.
English: Paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission
Slovenian: Študija Crohnove bolezni pri pediatričnih bolnikih: Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule
English: Available adalimumab data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Slovenian: Razpoložljivi podatki o adalimumabu kažejo, da se klinični odziv običajno pojavi v 12 tednih zdravljenja.
English: Clear and colourless to slightly yellow solution.
Slovenian: Bistra in brezbarvna do rahlo rumena raztopina.
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 3month 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: For patients who dose escalated from every other week 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 UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg every other week thereafter, and 246 patients received placebo.
Slovenian: V študiji UC-II je 248 bolnikov dobilo 160 mg adalimumaba 0. teden, 80 mg 2. teden in nato 40 mg vsak drugi teden, 246 bolnikov pa je dobivalo placebo.
English: 0.8 mL of solution.
Slovenian: 0,8 ml
English: At week 16, more patients randomised to adalimumab 0.8 mg/kg had positive efficacy responses (e.g. PASI 75) than those randomised to 0.4 mg/kg every other week or MTX.
Slovenian: V 16. tednu se je več bolnikov, ki so bili randomizirani na adalimumab 0,8 mg/kg, pozitivno odzvalo v smislu učinkovitosti (npr. PASI 75) kot tistih, ki so bili randomizirani na odmerek 0,4 mg/kg vsak drugi teden ali metotreksat.
English: b 2-sided P value from log rank test. c NE = not estimable.
Slovenian: b 2-stranska vrednost p testa log-rank.
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: If you have rheumatoid arthritis and you do not receive methotrexate with your AMGEVITA therapy, your doctor may decide to give 40 mg every week or 80 mg every other week.
Slovenian: Če imate revmatoidni artritis in hkrati z zdravilom AMGEVITA ne dobivate metotreksata, vam bo zdravnik morda predpisal 40 mg vsak teden ali 80 mg vsak drugi teden.
English: c p = 0.031
Slovenian: ** p < 0,01
English: Alopecia1),
Slovenian: čezmerno znojenje, alopecija1),
English: Multipack: 6 (3 packs of 2) SureClick pre-filled pens.
Slovenian: Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih peresnikov SureClick.
English: If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away.
Slovenian: Če dobite zvišano telesno temperaturo, ki ne mine, če se vam pojavljajo podplutbe, zlahka zakrvavite ali ste zelo bledi, se takoj posvetujte s svojim zdravnikom.
English: The combination of AMGEVITA and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Slovenian: Kombinacija zdravila AMGEVITA in abatacepta ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
English: These trials included rheumatoid arthritis patients with short term and longstanding disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Slovenian: Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), aksialnim spondiloartritisom (ankilozirajočim spondilitisom in aksialnim spondiloartritisom brez radiografskega dokaza za AS), psoriatičnim artritisom, Crohnovo boleznijo, ulceroznim kolitisom, psoriazo, hidradenitis suppurativa in uveitisom.
English: Vaccinations: if possible children should be up to date with all vaccinations before using AMGEVITA.
Slovenian: • Cepljenja: če je mogoče, naj vaš otrok pred začetkom uporabe zdravila AMGEVITA opravi vsa potrebna cepljenja.
English: Pack size of one pre-filled syringe.
Slovenian: Velikost pakiranja z eno napolnjeno injekcijsko brizgo.
English: Placebo/MTXadalimumab /MTX (95% confidence intervalb)
Slovenian: placebo/MTXa adalimumab /MTX 40 mg vsak drugi teden placebo/MTXadalimumab/ MTX (95 % interval zaupanjab)
English: Methotrexate should be continued during treatment with AMGEVITA.
Slovenian: Med zdravljenjem z zdravilom AMGEVITA je treba še naprej uporabljati metotreksat.
English: Starting at Week 4
Slovenian: Vzdrževalni odmerek z začetkom v 4. tednu
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Slovenian: Razpoložljivi podatki kažejo, da se klinični odziv ponavadi pojavi v 12 tednih zdravljenja.
English: ● The needle cover of the AMGEVITA pre-filled pen is made from dry natural rubber, which contains latex.
Slovenian: ● Pokrovček igle na napolnjenem injekcijskem peresniku zdravila AMGEVITA vsebuje suho naravno gumo, ki vsebuje lateks.
English: F. Pinch your injection site to create a firm surface.
Slovenian: F. Na mestu injiciranja kožo stisnite v kožno gubo, da boste ustvarili trdno površino.
English: a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Slovenian: a Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U b Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U c Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in monoterapije z metotreksatom z Mann-Whitneyevim testom U
English: Do not give AMGEVITA to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
Slovenian: Zdravila AMGEVITA ne smete dati otroku s poliartikularnim juvenilnim idiopatskim artritisom, če je star manj kot 2 leti.
English: Coagulation and bleeding disorders (including activated partial thromboplastin time prolonged), Autoantibody test positive (including double stranded DNA antibody),
Slovenian: pogosti koagulacija in motnje krvavenja (vključno s podaljšanim aktiviranim parcialnim tromboplastinskim časom), prisotnost avtoprotiteles (vključno s protitelesi proti dvovijačni DNA), zvišanje laktat dehidrogenaze v krvi
English: AMGEVITA is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.
Slovenian: Zdravilo AMGEVITA je indicirano za zdravljenje odraslih s hudim aksialnim spondiloartritisom brez radiografskega dokaza za AS, toda z objektivnimi znaki vnetja s povišanimi CRP in/ali MRI, ki so nezadostno reagirali na ali ne prenašajo nesteroidnih protivnetnih zdravil.
English: Week 16 Placebo-controlled
Slovenian: 16. teden Kontrolirana s placebom26.
English: AMGEVITA is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Slovenian: Zdravilo AMGEVITA se uporablja tudi za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih lokalno zdravljenje in zdravljenja s svetlobo nista dovolj dobro delovala ali pa nista primerna.
English: A. Remove the number of AMGEVITA pre-filled syringes you need from the package.
Slovenian: A. Vzemite potrebno število napolnjenih injekcijskih brizg zdravila AMGEVITA iz škatle.
English: After 12 weeks of therapy, patients who had received adalimumab in Period A were rerandomised 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: Important: Throw the needle cap into the sharps disposal container provided.
Slovenian: Pomembno: Pokrovček vrzite v vsebnik za ostre odpadke.
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: In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab-treated patients and 1.46 per patient year in the placebo and active control-treated patients.
Slovenian: V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je bil delež okužb 1,51 na bolnikov-let med bolniki, ki so dobivali adalimumab, in 1,46 na bolnikov-let med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
English: Endoscopic studies in intestinal mucosa have shown evidence of mucosal healing in adalimumabtreated patients.
Slovenian: Endoskopske študije črevesne sluznice so pokazale znake celjenja sluznice pri bolnikih, zdravljenih z adalimumabom.
English: AMGEVITA 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 AMGEVITA 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: 15 kg to < 30 kg
Slovenian: 15 kg do < 30 kg
English: AMGEVITA is injected under the skin (subcutaneous use).
Slovenian: Zdravilo AMGEVITA se injicira pod kožo (subkutana uporaba).
English: After single intravenous doses ranging from 0.25 to 10 mg/kg,
Slovenian: Po enem samem intravenskem odmerku od 0,25 do 10 mg/kg so bile koncentracije sorazmerne odmerku.
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%.
Slovenian: Med bolniki, ki z vsaj delnim odzivom v 12. tednu, in ki so prejemali neprekinjeno tedensko terapijo z adalimumabom vsak teden, je bila stopnja kliničnega odziva (HiSCR) v 48. tednu 68,3 % in v
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: AMGEVITA is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years and enthesitis-related arthritis in patients from 6 years.
Slovenian: Zdravilo AMGEVITA se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa pri bolnikih od 2. leta starosti, in artritisa, povezanega z entezitisom, pri bolnikih od 6. leta starosti.
English: AMGEVITA contains sodium
Slovenian: Zdravilo AMGEVITA vsebuje natrij
English: If there is blood, press a cotton ball or gauze pad on your injection site.
Slovenian: Če opazite kri, na mesto injiciranja pritisnite s kosmom vate ali zložencem iz gaze.
English: What AMGEVITA contains - The active substance is adalimumab.
Slovenian: Kaj vsebuje zdravilo AMGEVITA - Zdravilna učinkovina je adalimumab.
English: On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Slovenian: Na podlagi podatkov iz kliničnih preskušanj pri bolnikih z juvenilnim idiopatskim artritisom (JIA) (poliartikularnim idiopatskim artritisom (pJIA) in z artritisom, povezanim z entezitisom (ERA)) je bilo dokazano razmerje med izpostavljenostjo in odzivom med plazemskimi koncentracijami in PedACR 50 (PedACR - American College of Rheumatology pediatric) odzivom.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobnejše informacije o tem zdravilu so na voljo na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu
English: - The needle cap is missing or not securely attached.
Slovenian: - Manjka pokrovček igle ali ta ni varno nameščen.
English: a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate ** p < 0.01, adalimumab versus placebo
Slovenian: a Študija revmatoidnega artritisa I po 24 tednih, študija revmatoidnega artritisa II po 26 tednih in študija revmatoidnega artritisa III po 24 in 52 tednih b 40 mg adalimumaba vsak drugi teden c MTX = metotreksat **p < 0,01, adalimumab v prim.
English: In CD study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Slovenian: V študiji pri Crohnovi bolezni III je 854 bolnikov po odprtem protokolu dobilo 80 mg 0. teden in 40 mg 2. teden.
English: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Slovenian: Varnost in učinkovitost večkratnih odmerkov adalimumaba so ocenili pri odraslih z zmernim do zelo aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12 z endoskopsko podoceno 2 do 3) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
English: On a clean, well-lit work surface, place a new, pre-filled syringe.
Slovenian: Na čisto, dobro osvetljeno delovno površino položite nov napolnjen injekcijski peresnik.
English: Rhabdomyolysis, Systemic lupus erythematosus
Slovenian: občasni rabdomioliza, sistemski eritematozni lupus redki sindrom podoben lupusu1)
English: In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Slovenian: Opravljena je bila analiza, v kateri so vse bolnike, ki so izpadli iz študije zaradi neželenih učinkov ali nezadostne učinkovitosti, ali jim je bil povečan odmerek, obravnavali kot neodzivne; pri teh bolnikih sta bila po dodatnih 108 tednih odprtega zdravljenja (skupaj 160 tednov) delež odziva PASI 75 69,6 % in delež odziva PGA "čisto" ali "minimalno" 55,7 %.