FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients may first be given other disease-modifying medicines, such as methotrexate.
Slovenian: Bolniki morda najprej dobijo druga imunomodulirajoča zdravila, npr. metotreksat.
English: • In some patients the body may fail to produce enough of the blood cells to fight off infections or help you to stop bleeding.
Slovenian: • Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic za premagovanje okužb ali ustavitev krvavitve.
English: • Imraldi is a liquid that is clear and colourless.
Slovenian: • Zdravilo Imraldi je bistra in brezbarvna tekočina.
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Imraldi.
Slovenian: Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom Imraldi.
English: In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.
Slovenian: Na splošno so bili neželeni učinki pri pediatričnih bolnikih po pogostnosti in vrsti podobni neželenim učinkom, opaženim pri odraslih bolnikih.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Imraldi in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Slovenian: O uporabi protituberkuloznega profilaktičnega zdravljenja morate pred uvedbo zdravila Imraldi razmisliti tudi pri bolnikih z več ali pomembnimi faktorji tveganja za tuberkulozo kljub negativnemu testu za tuberkulozo in pri bolnikih z anamnezo latentne ali aktivne tuberkuloze, pri katerih ni mogoče potrditi ustreznega zdravljenja.
English: • If a large air bubble or air gap can be seen near the syringe tip, SLOWLY push the white plunger rod into the syringe until fluid begins to enter the syringe tip.
Slovenian: • Če opazite velik zračni mehurček ali zračni presledek pri konici brizge, POČASI potisnite beli nosilec bata v brizgo, dokler ne začne tekočina vstopati v konico brizge.
English: If the remaining volume is less than the prescribed dose volume, DO NOT use the syringe and contact your healthcare provider.
Slovenian: Če je preostala količina manjša od količine predpisanega odmerka, brizge, NE UPORABITE in se posvetujte z zdravnikom.
English: Analysis Treatment
Slovenian: Analiza Zdravljenje
English: • Use each vial only once.
Slovenian: • Vsako vialo uporabite samo enkrat.
English: In CD study III, at week 4, 58 % (499/854) of patients were in clinical response and were assessed in the primary analysis.
Slovenian: V študiji pri Crohnovi bolezni III je imelo 4. teden klinični odziv 58 % (499/854) bolnikov; ti so bili ocenjeni v primarni analizi.
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Slovenian: Raziskava embrio-fetalne razvojne toksičnosti/perinatalnega razvoja je bila narejena pri opicah Cynomolgus z odmerki 0,30 in 100 mg/kg (od 9 do 17 opic na skupino) in ni pokazala znakov okvare plodov zaradi adalimumaba.
English: Drop outs due to reasons other than treatment failure were censored at the time of dropping out.
Slovenian: Prekinitve sodelovanja zaradi razlogov, ki niso bili posledica neuspeha zdravljenja, so bile cenzurirane ob prekinitvi sodelovanja.
English: Patients who had been randomised to placebo in Period A were assigned to receive placebo in Period B.
Slovenian: Bolniki, ki so jih randomizirali na placebo v obdobju A, so v obdobju B prejemali placebo.
English: • tuberculosis
Slovenian: • tuberkuloza
English: If active tuberculosis is diagnosed, Imraldi therapy must not be initiated (see section 4.3).
Slovenian: Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Imraldi ne sme začeti (glejte poglavje 4.3).
English: • DO NOT touch the needle.
Slovenian: • Igle se NE DOTIKAJTE.
English: Patients were permitted to be either disease-modifying, anti-rheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Slovenian: Bolniki so bili lahko bodisi naivni za imunomodulirajoča antirevmatična zdravila bodisi so ohranili svojo prejšnjo revmatološko terapijo pod pogojem, da je bila ta terapija stabilna vsaj 28 dni.
English: Treatment with Imraldi should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Slovenian: Zdravljenja z zdravilom Imraldi se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
English: Also, this medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Slovenian: Poleg tega to zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v 0,8 ml odmerku, kar v bistvu pomeni "brez natrija".
English: Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika svojega otroka ali farmacevta, če vaš otrok jemlje, je pred kratkim jemal ali pa bo morda začel jemati katero koli drugo zdravilo.
English: • elevated bilirubin measurement (liver blood test).
Slovenian: • povečane vrednosti bilirubina (krvni test jetrne funkcije).
English: At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [p = 0.014]).
Slovenian: V 16. tednu je statistično pomembno večji delež bolnikov, ki so prejemali adalimumab, dosegel PGA ‘'čisto'' ali ‘'skoraj čisto'' za dlani in/ali stopala v primerjavi z bolniki, ki so prejemali placebo (30,6 % proti 4,3 %, v tem zaporedju [p = 0,014]).
English: Again, SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose, this is important to get the proper dose and important in order to prevent air bubbles or air gaps in the liquid medication.
Slovenian: POČASI potegnite beli nosilec bata ven, tako da je 0,1 ml preko predpisanega odmerka; to je pomembno, da boste dobili pravilen odmerek in da boste preprečili zračne mehurčke ali zračne presledke v tekočem zdravilu.
English: Erosion Score JSNd Score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab.
Slovenian: Ocena erozij Ocena ZSŠd a metotreksat b 95-% intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom.
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Imraldi (see section 4.4).
Slovenian: Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom Imraldi posvetujejo z ustreznim specialistom (glejte poglavje 4.4).
English: HS Study II
Slovenian: Študija HS II
English: In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
Slovenian: V obdobju pomarketinške uporabe od januarja 2003 do decembra 2010, pretežno pri bolnikih z revmatoidnim artritisom, je bil zabeleženi delež malignomov približno 2,7 na 1.000 bolnikov-let zdravljenja.
English: Treatment with adalimumab 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Slovenian: Zdravljenje s 40 mg adalimumaba vsak teden statistično zmanjša tveganje za poslabšanje abscesov in fistul z izcedkom.
English: Double-Blind Response at Week 68
Slovenian: Odziv v 68. tednu
English: Induction of clinical remission (defined as CDAI <150) was evaluated in two studies, CD study I (CLASSIC I) and CD study II (GAIN).
Slovenian: Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, študiji pri Crohnovi bolezni I (CLASSIC I) in študiji pri Crohnovi bolezni II (GAIN).
English: Other medicines and Imraldi
Slovenian: Druga zdravila in zdravilo Imraldi
English: The frequency of serious infections among adalimumab treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%).
Slovenian: Pri bolnikih nad 65 let, ki so prejemali adalimumab, je bila pogostost resnih okužb večja (3,7 %) kot pri tistih pod 65 let starosti (1,5 %).
English: Always make sure your medicine is clear, free of particles, and has not expired.
Slovenian: Vedno se prepričajte, da je vaše zdravilo bistro, da v njem ni delcev ter da se rok uporabnosti zdravila še ni iztekel.
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Paediatric ACR 50 response, and Paediatric ACR 70 response.
Slovenian: Čeprav ni statistično značilno, je bilo pri večini bolnikov dokazano klinično izboljšanje sekundarnih opazovanih dogodkov, kot so število mest entezitisa, število občutljivih sklepov, število oteklih sklepov, odziv glede na merila Paediatric ACR 50 in Paediatric ACR 70.
English: • Remove the clear needle cap by pulling it straight up with your other hand.
Slovenian: • Odstranite prozorni pokrovček igle tako, da ga z drugo roko potegnete naravnost navzgor.
English: Dose + 0.1 ml
Slovenian: Odmerek + 0,1 ml
English: ASASa 40 ASAS 20 ASAS 5/6 ASAS partial remission BASDAIb 50
Slovenian: ASAS 5/6 ASAS delno izboljšanje
English: Reduction in HS-related skin pain was assessed using a Numeric Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 point scale.
Slovenian: Zmanjšanje bolečine, povezane s HS, so ocenili s pomočjo numerične ocenjevalne lestvice pri bolnikih, ki so imeli pri vključitvi v študijo izhodiščni rezultat 3 ali več na 11-stopenjski numerični ocenjevalni lestvici.
English: Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Slovenian: Analize populacijske farmakokinetike s podatki za več kot 1.300 bolnikov z revmatoidnim artritisom so pokazale trend k večjemu navideznemu očistku adalimumaba z večanjem telesne mase.
English: • cancer, including cancer of the lymph system (lymphoma) and melanoma (a type of skin cancer);
Slovenian: • rak, vključno z rakom limfnega sistema (limfomom) in melanomom (vrsto kožnega raka);
English: You might accidentally stick yourself or waste medication.
Slovenian: Poleg tega bi se lahko nehote zbodli ali pomotoma iztisnili zdravilo.
English: In patients who develop HBV reactivation, Imraldi should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Slovenian: Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo zdravila Imraldi prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
English: In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
Slovenian: V predvidenem kohortnem registru je bilo vključenih 257 žensk z revmatoidnim artritisom (RA) ali Crohnovo boleznijo (CB), zdravljenih z adalimumabom vsaj v prvem trimesečju nosečnosti, in 120 žensk z RA ali CB, ki niso bile zdravljene z adalimumabom.
English: Psoriasis study I (REVEAL) evaluated 1,212 patients within three treatment periods.
Slovenian: Študija pri psoriazi I (REVEAL) je ocenila 1.212 bolnikov v treh obdobjih zdravljenja.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Imraldi, and in accordance with local recommendations.
Slovenian: Če ugotovite latentno tuberkulozo, morate pred uvedbo zdravila Imraldi začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
English: If your medication is not clear, free of particles, or expired, do not use it.
Slovenian: Če vaše zdravilo ni bistro in brez delcev ali če se je rok uporabnosti iztekel, ga ne uporabite.
English: • Imraldi should only be used during a pregnancy if needed.
Slovenian: • Zdravilo Imraldi se med nosečnostjo lahko uporablja samo, če je potrebno.
English: After injecting Imraldi, confirm that the needle has retracted and immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Slovenian: Po injiciranju zdravila Imraldi se prepričajte, da je igla v celoti zdrsnila nazaj v ohišje injekcijske brizge in takoj zavrzite uporabljeno injekcijsko brizgo v poseben vsebnik, kot so vam naročili zdravnik, medicinska sestra ali farmacevt.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Imraldi and is positive for antibodies against double-stranded DNA, further treatment with Imraldi should not be given (see section 4.8).
Slovenian: Če se bolniku po zdravljenju z zdravilom Imraldi pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja z zdravilom Imraldi ne sme nadaljevati (glejte poglavje 4.8).
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Slovenian: Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji pri ankilozirajočem spondilitisu II pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
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, patofiziologija in učinek zdravila bistveno podobni kot pri odraslih bolniki, pri enaki ravni izpostavljenosti.
English: The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Slovenian: Mediani čas do neuspeha zdravljenja je bil 24,1 tedna za bolnike, ki so se zdravili s placebom, medtem ko medianega časa do neuspeha zdravljenja pri bolnikih, ki so bili zdravljeni z adalimumabom, ni bilo mogoče oceniti, ker je bilo zdravljenje neuspešno pri manj kot polovici teh bolnikov.
English: After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after administration.
Slovenian: Po subkutani uporabi enega samega 40 mg odmerka sta bili absorpcija in distribucija adalimumaba počasni in največja koncentracija v serumu je bila dosežena približno 5 dni po uporabi.
English: Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab (see section 4.8).
Slovenian: Poročali so tudi o melanomu in karcinomu Merklovih celic pri bolnikih, zdravljenih s TNF-antagonisti, vključno z adalimumabom (glejte poglavje 4.8).
English: Contains 2 cartons and each carton contains:
Slovenian: Vsebuje 2 škatli, vsaka od njiju pa vsebuje:
English: In rare cases, these infections may be life-threatening.
Slovenian: Te okužbe so lahko v redkih primerih smrtno nevarne.
English: The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is present at increased levels in the inflammatory diseases listed above.
Slovenian: Cilj adalimumaba je beljakovina, ki ji pravimo tumorje nekrotizirajoči faktor ali TNFα, katere ravni so zvišane pri zgoraj navedenih vnetnih boleznih.
English: • Set up the following items on a clean surface, DO NOT take them out of their individual packaging yet.
Slovenian: • Na čisto površino pripravite sledeče enote zdravila in jih NE JEMLJITE iz njihove posamezne ovojnine:
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Imraldi cannot be excluded (see section 4.8).
Slovenian: Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, ki dobivajo zdravilo Imraldi, ni mogoče izključiti (glejte poglavje 4.8).
English: The proportions of subjects with PaedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Slovenian: Deleži preiskovancev s PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
English: These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/or gold salts.
Slovenian: Terapije so vključevale metotreksat, leflunomid, hidroksiklorokin, sulfasalazin in/ali soli zlata.
English: solution for injection Contains 2 cartons each for a single injection only
Slovenian: raztopina za injiciranje Vsebuje 2 škatli, od katerih je vsaka samo za eno injiciranje
English: • Hold the syringe package and SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose (For example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
Slovenian: • Držite ovojnino brizge in POČASI potegnite beli nosilec bata ven, tako da je 0,1 ml preko predpisanega odmerka (če je npr. predpisani odmerek 0,5 ml, potegnite beli nosilec bata do 0,6 ml).
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM1 with an IC50 of 0.1-0.2 nM).
Slovenian: Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in
English: You should continue to inject Imraldi for as long as your doctor has told you.
Slovenian: Nadaljevati morate z injiciranjem zdravila Imraldi tako dolgo, kot vam je naročil zdravnik.
English: People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone marrow).
Slovenian: Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom (rakom, ki prizadene limfatični sistem) in levkemijo (rakom, ki prizadene kri in kostni mozeg).
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data
Slovenian: * Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 ** Vključno pri podaljšanih študijah brez placeba
English: The needle might be dirty or damaged.
Slovenian: Možno je namreč, da je igla onesnažena ali poškodovana.
English: 4) Dose Preparation
Slovenian: 4) Priprava odmerka
English: Wait 15-30 minutes for your pre-filled syringe to reach to room temperature, which helps reduce your pain during injection.
Slovenian: Počakajte 15-30 minut, da napolnjena injekcijska brizga doseže sobno temperaturo, saj to pomaga zmanjšati bolečino med injiciranjem.
English: Patients should be tested for HBV infection before initiating treatment with Imraldi.
Slovenian: Bolnike je treba pred začetkom zdravljenja z zdravilom Imraldi testirati na okužbo s HBV.
English: Choose an injection site & clean skin
Slovenian: Izberite mesto za injiciranje in očistite kožo
English: Do not use this medicine after the expiry date which is stated on the label of the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na škatli poleg oznake “Uporabno do”.
English: Study nr-axSpA I evaluated patients with active nr-axSpA.
Slovenian: Študija nr-axSpA I je proučila bolnike z aktivnim nr-axSpA.
English: - If you have a severe infection, including tuberculosis (see “Warnings and precautions”).
Slovenian: - če imate hudo okužbo, vključno s tuberkulozo (glejte "Opozorila in previdnostni ukrepi").
English: Then lift your thumb to let the needle retract into the body of the syringe.
Slovenian: Nato dvignite palec, da bo igla zdrsnila v ohišje injekcijske brizge.
English: Should treatment be interrupted, Imraldi may be re-introduced as appropriate.
Slovenian: Če je treba zdravljenje prekiniti, je možno zdravljenje z zdravilom Imraldi znova uvesti, kakor je primerno.
English: Vision related effects were not numerically in favour of adalimumab for colour vision in study UVI and for colour vision, peripheral vision and near vision in study UV II.
Slovenian: Učinki, povezani z vidom, niso bili v korist adalimumaba v primeru barvnega vida v študiji UV I in v primeru barvnega vida, perifernega vida in vida na blizu v študiji UV II.
English: Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Slovenian: Sočasna uporaba adalimumaba z drugimi biološkimi DMARDS (tj. anakinra in abacept) ali z drugimi antagonisti TNF ni priporočljiva zaradi možnega povečanega tveganja za okužbe, vključno z resnimi okužbami, in drugih potencialnih farmakoloških interakcij.
English: Imraldi treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Imraldi is indicated.
Slovenian: Zdravljenje z zdravilom Imraldi mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Imraldi indicirano.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Imraldi should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila Imraldi nemudoma prekiniti in uvesti ustrezno zdravljenje.
English: Your doctor may recommend temporary discontinuation of Imraldi.
Slovenian: Zdravnik bo morda priporočil začasno prenehanje uporabe zdravila Imraldi.
English: If the prescribed dose is 0.5 ml, pull the white plunger rod out to 0.6 ml.
Slovenian: Če je predpisani odmerek 0,5 ml, potegnite beli nosilec bata ven do 0,6 ml.
English: If you forget to give yourself an injection, you should inject the next dose of Imraldi as soon as you remember.
Slovenian: Če si pozabite dati injekcijo, si morate naslednji odmerek zdravila Imraldi injicirati, čim se spomnite.
English: Taking these results into consideration, adalimumab is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Slovenian: upoštevanjem teh ugotovitev je adalimumab priporočljivo uporabljati v kombinaciji z metotreksatom, kot monoterapijo pa pri bolnikih, za katere uporaba metotreksata ni primerna (glejte poglavje 4.2).
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Slovenian: Primarna končna točka v študijah revmatoidnega artritisa I, II in III ter sekundarna končna točka v študiji revmatoidnega artritisa IV je bil odstotek bolnikov, ki so po 24 oz. 26 tednih dosegli odziv 20 po ACR.