FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0 % vs 11.4 %, respectively) and draining fistulas (30.0 % vs 13.9 %, respectively).
Slovenian: Približno dvakratni delež bolnikov v skupini, ki je prejemala placebo, je v primerjavi s tistimi, ki so bili v skupini z adalimumabom, v prvih 12. tednih študije HS-I in HS-II, doživelo poslabšanje abscesov (23,0 % v primerjavi z 11,4 %, v tem zaporedju) in fistul z izcedkom (30,0 % v primerjavi s 13,9 %, v tem zaporedju).
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, pokrite s srebrnimi luskami.
English: After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75 % relative to baseline), entered period B and received open-label 40 mg adalimumab every other week.
Slovenian: Po 16 tednih zdravljenja so bolniki, ki so dosegli odziv PASI vsaj 75 (izboljšanje ocene PASI za vsaj 75 % glede na izhodišče), vstopili v obdobje B, med katerim so odprto dobivali 40 mg adalimumaba vsak drugi teden.
English: Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods.
Slovenian: V študiji HS-I (PIONEER I) je bilo ocenjenih 307 bolnikov v dveh obdobjih zdravljenja.
English: Children, adolescents and adults with enthesitis-related arthritis
Slovenian: Otroci, mladostniki in odrasli z artritisom, povezanim z entezitisom
English: Imraldi is intended for treatment of:
Slovenian: Zdravilo Imraldi je namenjeno za zdravljenje:
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Slovenian: Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom, sta vnetni bolezni sklepov, ki se ponavadi pojavita v otroštvu.
English: A single Imraldi pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 28 days.
Slovenian: Imraldi se lahko shranjuje pri temperaturi največ do 25 ºC za obdobje do 28 dni.
English: • Put the syringe with needle, vial and vial adapter into a special sharps container.
Slovenian: • Odložite brizgo z iglo, vialo in adapter za vialo v poseben vsebnik za ostre predmete.
English: SPARCC MRI Spined,j a Assessments in SpondyloArthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Slovenian: SPARCC MRI hrbtenjačed,j a ASAS = ocena v spondiloartritičnem mednarodnem združenju (Assessments in Spondyloarthritis International Society) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index) c ASDAS = ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease Activity Score) d povprečna sprememba od začetka zdravljenja e N = 91 placebo in N = 87 adalimumab f hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein) (mg/l) g N = 73 placebo in N = 70 adalimumab h SPARCC = Kanadski raziskovalni konzorcij za spondiloartritis (Spondyloarthritis Research
English: If you stop using Imraldi
Slovenian: Če ste prenehali uporabljati zdravilo Imraldi
English: • Remove one box containing, one syringe, one vial adapter, one vial, two alcohol pads and one needle from the carton.
Slovenian: • Odprite eno škatlo, ki vsebuje eno brizgo, en adapter za vialo, eno vialo, dva alkoholna zloženca in eno iglo.
English: • SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose.
Slovenian: • POČASI potegnite beli nosilec bata ven, do 0,1 ml preko predpisanega odmerka.
English: After 5 years of adalimumab therapy, 74.0 % (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0 % (46/50) of patients continued to be in clinical response per PCDAI.
Slovenian: Po 5 letih zdravljenja z adalimumabom se je glede na PCDAI klinična remisija nadaljevala pri 74,0 % (37/50) od 50 bolnikov, ki so ostali v študiji, klinični odziv pa se je nadaljeval pri 92,0 % (46/50) bolnikov, ki so ostali v študiji.
English: Treatment with Imraldi may result in the formation of autoimmune antibodies.
Slovenian: Zdravljenje z zdravilom Imraldi lahko povzroči nastanek avtoimunskih protiteles.
English:  Do not remove the cap just yet!
Slovenian:  Pokrovčka za iglo še ne odstranite takoj!
English: Imraldi can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Slovenian: Zdravilo Imraldi je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV.
Slovenian: • Zdravniku morate povedati, če ste nosilec virusa hepatitisa B (HBV), če imate aktivno okužbo s HBV ali če mislite, da bi se lahko nalezli HBV.
English: • Do not use a damaged syringe.
Slovenian: • Ne uporabite poškodovane injekcijske brizge.
English: • DO NOT pull the white plunger rod completely out of the syringe.
Slovenian: • NE POTEGNITE belega nosilca bata popolnoma iz brizge.
English: The safety and efficacy of adalimumab were assessed in over 1,500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥220 and ≤450) in randomised, double blind, placebo-controlled studies.
Slovenian: Varnost in učinkovitost adalimumaba so ocenili pri več kot 1.500 bolnikih z zmerno do zelo aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group.
Slovenian: Z indukcijskima shemama 160/80 mg in 80/40 mg so do 8. tedna ugotovili podobne deleže remisij; neželeni učinki so bili pogostejši v skupini s shemo 160/80 mg.
English: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);
Slovenian: • sindrom Stevens-Johnson (zgodnji znaki vključujejo slabo počutje, povišano telesno temperaturo, glavobol in izpuščaj);
English: Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see Section 5.1) and to improve physical function.
Slovenian: Z rentgenskim slikanjem je bilo dokazano, da adalimumab upočasni hitrost napredovanja prizadetosti perifernih sklepov pri bolnikih s poliartikularno, simetrično podvrsto bolezni (glejte poglavje 5.1) in izboljša telesno funkcijo.
English: • Wash your hands thoroughly
Slovenian: • Dobro si umijte roke.
English: 2616LR Delft The Netherlands
Slovenian: 2616LR Delft
English: Keep this Patient Reminder Card with you during your treatment and for 4 months after your (or your child's) last injection of Imraldi.
Slovenian: To Opozorilno kartico za bolnika imejte pri sebi ves čas zdravljenja z zdravilom Imraldi in še 4 mesece po tem, ko ste vi (ali vaš otrok) prejeli zadnjo injekcijo zdravila Imraldi.
English: • Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.
Slovenian: • Zdravniku morate povedati, če je vaš otrok v preteklosti imel ponavljajoče se okužbe ali druge bolezni, ki zvečujejo tveganje za okužbe.
English: Keep this Patient Reminder Card with you or your child during his/her treatment and for 4 months after your child's last injection of Imraldi.
Slovenian: To Opozorilno kartico za bolnika imejte vi ali vaš otrok pri sebi ves čas njegovega zdravljenja z zdravilom Imraldi in še 4 mesece po tem, ko je vaš otrok prejel zadnjo injekcijo zdravila Imraldi.
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 (40 mg adalimumaba vsak teden, 40 mg adalimumaba vsak drugi teden ali placebo od 12. do 35. tedna).
English: • angioedema (localized swelling of the skin);
Slovenian: • angioedem (lokalizirano otekanje kože);
English: o 1) One 1 ml syringe o 2) One vial adapter o 3) One vial for paediatric use of Imraldi for injection o 4) Two alcohol swabs o 5) One needle
Slovenian: o 1) eno 1 ml brizgo o 2) en adapter za vialo o 3) eno vialo zdravila Imraldi za injiciranje za otroke o 4) dva alkoholna zloženca o 5) eno iglo
English: Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18 % vs. 9 % respectively, p=0.031) and study UC-II (17 % vs. 9 % respectively, p=0.019).
Slovenian: Bolniki, ki so za indukcijo dobili 160/80 mg adalimumaba, so 8. teden v primerjavi s placebom dosegli klinično remisijo v statistično značilno večjem odstotku tako v študiji UC-I (18 % v primerjavi z 9 %, p = 0,031) kot v študiji UC-II (17 % v primerjavi z 9 %, p = 0,019).
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Imraldi and contact your doctor immediately since, in rare cases, these reactions can be life-threatening.
Slovenian: • Če imate alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Imraldi ne injicirajte več in se takoj posvetujte z zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
English: During treatment with Imraldi, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Slovenian: Med zdravljenjem z zdravilom Imraldi je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
English: 6) Throwing away supplies
Slovenian: 6) Kako zavreči ostanke
English: You should record the date when the syringe is first removed from refrigerator, and the date after which it should be discarded.
Slovenian: Zapisati si morate datum, ko je bila brizga vzeta iz hladilnika, in datum, po katerem jo je potrebno zavreči.
English: Once removed from the refrigerator for room temperature storage, the syringe must be used within 28 days or discarded, even if it is returned to the refrigerator.
Slovenian: Ko ga enkrat, namesto v hladilniku, shranjujete pri sobni temperaturi, morate peresnik porabiti v 28 dneh ali pa zavreči, tudi če ga vrnete v hladilnik.
English: It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Imraldi.
Slovenian: Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom Imraldi opravijo vsa predvidena cepljenja za njihovo starost, če je le mogoče.
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS.
Slovenian: Hidradenitis suppurativa pri mladostnikih (starejših od 12 let, ki tehtajo najmanj 30 kg) Kliničnih študij z adalimumabom pri mladostnikih s HS ni.
English: DO NOT use any item after the date shown on the box.
Slovenian: Zdravila NE UPORABLJAJTE po izteku roka uporabnosti, navedenega na škatli.
English: Carefully pull off the needle cap.
Slovenian: Previdno snemite pokrovček za iglo.
English: The combination of Imraldi and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Slovenian: Kombinacija zdravila Imraldi in abatacepta ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
English: Adalimumab treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Slovenian: Bolniki, ki so dobivali adalimumab, so imeli po 12 tednih značilno večje izboljšanje (ki se je ohranilo do 24. tedna) SF36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisuAnkylosing Spondylitis Quality of Life Questionnaire).
English: • Do not use the 40 mg pre-filled syringe if doses other than 40 mg are recommended.
Slovenian: • Ne uporabite 40 mg napolnjenega injekcijskega peresnika, če je priporočen drugačen odmerek kot 40 mg.
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Slovenian: PASI 75 in PGA čisto ali minimalno, sta se povečevali z zvečanjem koncentracije adalimumaba, obe s podobno navidezno EC50, za približno 4,5 μg/ml (95% IZ 0,4-47,6 in 1,9-10,5).
English: ASDASc Inactive Disease
Slovenian: ASASa delno izboljšanje ASDASc neaktivna bolezen
English: Week 56
Slovenian: 56. teden
English: On rare occasions, a specific and severe type of lymphoma has been observed in patients taking Imraldi.
Slovenian: V redkih primerih so pri bolnikih, ki dobivajo zdravilo Imraldi, opazili specifično in resno obliko limfoma.
English: Table 21 Efficacy Results at 12 Weeks, HS Studies I and II
Slovenian: Rezultati učinkovitosti v 12. tednu, HS študiji I in II Študija HS I
English: • Before you inject, ask your doctor or nurse to show you how to use your pre-filled syringe.
Slovenian: • Pred injiciranjem prosite zdravnika ali medicinsko sestro, da vam pokažeta, kako uporabljati napolnjeno injekcijsko brizgo.
English: Pull the syringe away from your skin.
Slovenian: Povlecite injekcijsko brizgo stran od kože.
English: • Merkel cell carcinoma (a type of skin cancer);
Slovenian: • karcinom Merklovih celic (tip kožnega raka);
English: What Imraldi is and what it is used for
Slovenian: Kaj je zdravilo Imraldi in za kaj ga uporabljamo
English: • Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
Slovenian: • Zdravniku morate povedati, če ste imeli v preteklosti ponavljajoče se okužbe ali druge bolezni, ki zvečujejo tveganje za okužbe.
English: Adalimumab, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Slovenian: Uporabo 40 mg adalimumaba vsak drugi teden so pri bolnikih z zmernim do hudim aktivnim psoriatičnim artritisom proučili v dveh s placebom kontroliranih študijah, študijah pri psoriatičnem artritisu I in II.
English: Continue to hold
Slovenian: Še naprej držite peresnik
English: Imraldi is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Slovenian: Zdravilo Imraldi je indicirano za zdravljenje Crohnove bolezni pri otrocih, starih 6 do 17 let.
English: 104 Week 28.4% 28.1% 46.6% <0.001 <0.001 0.864 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: 104. teden 28,4 % 28,1 % 46,6 % < 0,001 < 0,001 0,864 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: When needed (for example when you are travelling), a single Imraldi pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 28 days - be sure to protect it from light.
Slovenian: Če je potrebno (na primer kadar potujete), lahko posamezno napolnjeno injekcijsko brizgo zdravila Imraldi hranite pri sobni temperaturi (do 25 ºC) za največ do 28 dni - zagotovite, da bo zaščitena pred svetlobo.
English: In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B, - NK-cells, monocyte/macrophages, and neutrophils.
Slovenian: V študiji 64 bolnikov z revmatoidnim artritisom, zdravljenih z adalimumabom, niso odkrili znakov zavrtja odložene preobčutljivosti, znižanja koncentracije imunoglobulinov ali spremembe števila efektorskih celic T in B, naravnih celic ubijalk, monocitov/makrofagov ali nevtrofilcev.
English: If you forget to use Imraldi
Slovenian: Če ste pozabili uporabiti zdravilo Imraldi
English: Your doctor or nurse should make sure you can use your syringe correctly.
Slovenian: Zdravnik ali medicinska sestra naj se prepričata, da znate injekcijsko brizgo pravilno uporabljati.
English: DO NOT over-tighten.
Slovenian: Brizge NE STRESAJTE.
English: • As cases of tuberculosis have been reported in patients treated with Imraldi, your doctor will check you for signs and symptoms of tuberculosis before starting Imraldi.
Slovenian: • Ker so bili pri bolnikih, zdravljenih z zdravilom Imraldi, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom Imraldi preiskal glede znakov in simptomov tuberkuloze.
English: The adjusted OR (accounting for baseline differences) was 1.10 (95 % CI 0.45-2.73) with RA and CD combined.
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: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p <0.001).
Slovenian: V študiji revmatoidnega artritisa IV je bil odziv 20 po ACR pri bolnikih, zdravljenih z adalimumabom in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0,001).
English: This study evaluated the efficacy of adalimumab 40 mg every other week/methotrexate combination therapy, adalimumab 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Slovenian: Ta študija je ocenila učinkovitost treh shem (kombinirano zdravljenje s 40 mg adalimumaba vsak drugi teden/metotreksatom, monoterapija s 40 mg adalimumaba vsak drugi teden in monoterapija z metotreksatom) za zmanjšanje znakov in simptomov ter hitrosti napredovanja sklepne okvare pri revmatoidnem artritisu v obdobju 104 tednov.
English: • Prepare the syringe by partially peeling the package open from the end closest to white plunger rod.
Slovenian: • Pripravite brizgo: delno odprite njeno ovojnino tako, da jo odlepite od konca, ki je najbližji belemu nosilcu bata.
English: Imraldi may be available as a vial, a pre-filled syringe and/or a pre-filled pen.
Slovenian: Zdravilo Imraldi je lahko na voljo kot viala, napolnjena injekcijska brizga in/ali napolnjen injekcijski peresnik.
English: TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Slovenian: Antagonisti tumorje nekrotizirajočega faktorja (TNF), z adalimumabom vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni osrednjega živčnega sistema, vključno z multiplo sklerozo in optičnim nevritisom, in periferne demielinizirajoče bolezni, vključno z Guillain-Barréjevim sindromom.
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»Paediatric ACR« 30/50/70/90 v odprti podaljšani fazi ohranili do 6 let pri tistih, ki so ves čas študije dobivali adalimumab.
English: Should treatment be interrupted, Imraldi 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Slovenian: Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom Imraldi z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
English: Read all of this leaflet carefully before your child starts using this medicine because it contains important information.
Slovenian: Preden vaš otrok začne uporabljati to zdravilo, natančno preberite navodilo, ker vsebuje pomembne podatke!
English: Patients receiving MTX who achieved a ≥PASI 50 response at week 8 and/or 12 did not receive further dose increases.
Slovenian: Bolnikom, ki so dobivali metotreksat in so 8. in/ali 12. teden dosegli odziv PASI ≥ 50, odmerka niso več povečevali.
English: Imraldi is used to treat
Slovenian: Zdravilo Imraldi se uporablja za zdravljenje
English: Imraldi 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Slovenian: Imraldi 40 mg raztopina za injiciranje v viali za enkratno uporabo (steklo tipa I), opremljeni z zamaški iz gume, folijami iz aluminija in tesnili "flip-off".
English: Imraldi is a biosimilar medicinal product.
Slovenian: Zdravilo Imraldi je podobno biološko zdravilo.
English: Alternatively, if a patient has stopped Imraldi and signs and symptoms of disease recur, Imraldi may be re-administered.
Slovenian: Če bolnik neha uporabljati zdravilo Imraldi, pa se znaki in simptomi bolezni ponovijo, je mogoče zdravilo Imraldi znova uvesti.
English: Hold the white plunger rod in and turn the vial and syringe upside down.
Slovenian: Držite beli nosilec bata in obrnite vialo in brizgo tako, da je viala zgoraj.
English: • Use one of the alcohol pads to wipe the vial stopper.
Slovenian: • Uporabite enega od alkoholnih zložencev in z njim obrišite zamašek viale.
English: Of 342 subjects originally randomized to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Slovenian: Od 342 oseb, ki so bile od začetka randomizirane na monoterapijo z adalimumabom ali kombinirano zdravljenje z adalimumabom/metotreksatom in so bile vključene v odprto podaljšanje študije, je 171 bolnikov zaključilo 10-letno zdravljenje z adalimumabom.
English: A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used.
Slovenian: Za oceno so uporabili modificirani celotni seštevek po Sharpu (modified Total Sharp Score, mTSS), ki je vključil distalne interfalangealne sklepe (tj. ni bil enak TSS, ki se uporablja za revmatoidni artritis).