FrancophonIA/ELRC3.0 huggingface dataset:
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 teže.
English: Ankylosing spondylitis (AS)
Slovenian: Ankilozirajoči spondilitis (AS)
English: failure (months)
Slovenian: srednji čas do neuspeha (meseci)
English: Concurrent administration of biologic DMARDs or TNF-antagonists
Slovenian: Sočasna uporaba bioloških DMARD ali antagonistov TNF
English: • leukaemia (cancer affecting the blood and bone marrow);
Slovenian: • levkemija (rak, ki prizadene kri in kostni mozeg);
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 μg/ml (95% CI: 1-6 μg/ml).
Slovenian: Navidezna koncentracija adalimumaba v plazmi, ki doseže polovico največje verjetnosti Ped ACR 50 odziva (EC50) je bila 3 μg/ml (95 % IZ: 1-6 μg/ml).
English: The efficacy and safety of adalimumab were assessed in five randomised, double-blind and wellcontrolled studies.
Slovenian: Učinkovitost in varnost adalimumaba so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih študijah.
English: Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1) lichenoid skin reaction1)
Slovenian: brazgotinjenje redki multiformni eritem1) sindrom Stevens-Johnson1), angioedem1), kožni vaskulitis1), lihenoidna reakcija1)
English: o The syringe is ready for use (see Figure C).
Slovenian: o Injekcijska brizga je pripravljena za uporabo (glejte sliko C).
English: • When needed (for example when you are travelling), Hefiya may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Slovenian: • Če je potrebno (na primer kadar potujete), lahko zdravilo Hefiya hranite pri sobni temperaturi (do 25 °C) največ 14 dni - zagotovite, da bo zaščiteno pred svetlobo.
English: You should not take Hefiya with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection.
Slovenian: Zdravila Hefiya ne smete jemati z zdravili, ki vsebujejo učinkovini anakinro ali abatacept zaradi povečanega tveganja za resne okužbe.
English: What Hefiya is and what it is used for
Slovenian: Kaj je zdravilo Hefiya in za kaj ga uporabljamo
English: • Alcohol wipe
Slovenian: • alkoholni zloženec
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: Safety of the recommended adalimumab dose in the adolescent HS population is based on cross-indication safety profile of adalimumab in both adults and paediatric patients at similar or more frequent doses (see section 5.2).
Slovenian: Varnost priporočenega odmerka adalimumaba pri populaciji mladostnikov s HS temelji na varnostnem profilu indikacij adalimumaba pri odraslih in pediatričnih bolnikih pri podobnih ali pogostejših odmerkih (glejte poglavje 5.2).
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: • heart problems that can cause shortness of breath or ankle swelling;
Slovenian: • težave s srcem, ki lahko povzročijo kratko sapo ali otekanje gležnjev;
English: • Hold the syringe as shown (see Figure I).
Slovenian: • Injekcijsko brizgo držite, kot je prikazano (glejte sliko I).
English: • do not use the syringe if the seals of the blister are broken, as it may not be safe for you to use.
Slovenian: • ne uporabljate injekcijske brizge, če so pečati pretisnega omota zlomljeni, saj uporaba za vas morda ni varna.
English: Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus.
Slovenian: Simptomi lahko vključujejo mehke nodule (vozliče) in abscese (ognojke), iz katerih lahko izteka gnoj.
English: These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Slovenian: To vključuje redka poročila o pancitopeniji, aplastični anemiji, centralnih in perifernih demielinizacijskih dogodkih in poročila o lupusu, z lupusom povezanimi stanji in sindromom Stevens-Johnson.
English: • The 1st click indicates the injection has started.
Slovenian: • 1. klik pomeni, da se je injiciranje začelo.
English: Moderate to severe heart failure (NYHA class III / IV) (see section 4.4).
Slovenian: Zmerno do hudo srčno popuščanje (razred III/IV po NYHA) (glejte poglavje 4.4).
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 1000 bolnikov-let zdravljenja.
English: It is recommended that you use an antiseptic wash daily on the affected areas.
Slovenian: Priporočljivo je, da na prizadetih področjih vsak dan uporabite antiseptično čistilno tekočino.
English: 3 defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post-Baseline visits
Slovenian: 3 definiran kot zaprtje vseh fistul, ki so bile prisotne ob začetku študije na vsaj 2 zaporednih obiskih po začetku
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Hefiya.
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 Hefiya.
English: • There may be a small amount of blood at the injection site.
Slovenian: • Na mestu injiciranja je lahko malo krvi.
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB04
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB04.
English: These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Slovenian: Takšne okužbe se pri uporabnikih antagonistov TNF niso pojavljale vedno, zato je v primerih njihovega nastanka prihajalo do zamud pri ustreznem zdravljenju, kar je včasih povzročilo smrt.
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: If you forget to give yourself an injection, you should inject the next dose of Hefiya as soon as you remember.
Slovenian: Če pozabite dati injekcijo, si morate naslednji odmerek zdravila Hefiya injicirati, čim se spomnite.
English: Sarcoidosis1), vasculitis
Slovenian: občasni sarkoidoza1), vaskulitis
English: The impact of longterm treatment with adalimumab on the development of autoimmune diseases is unknown.
Slovenian: Vpliv dolgoročnega zdravljenja z adalimumabom na nastanek avtoimunskih bolezni ni znan.
English: The criteria determining treatment failure were worsening or sustained non-improvement in ocular inflammation, partial improvement with development of sustained ocular co-morbidities or worsening of ocular co-morbidities, non-permitted use of concomitant medications, and suspension of treatment for an extended period of time.
Slovenian: Merila, s katerimi so določali neuspeh zdravljenja, so bili poslabšanje ali vztrajno neizboljšanje očesnega vnetja, delno izboljšanje z razvojem trajnih sočasnih očesnih bolezni ali poslabšanjem sočasnih očesnih bolezni, nedovoljena uporaba sočasnih zdravil ter prekinitev zdravljenja za daljše časovno obdobje.
English: Across all indications in clinical trials patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
Slovenian: Bolniki z zvišanim ALT, ne glede na indikacijo v kliničnih preskušanjih, so bili asimptomatski in v večini primerov so bila zvišanja prehodna ter so izzvenela med nadaljnim zdravljenjem.
English: week 26
Slovenian: 26. teden
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: week 52
Slovenian: 52. teden
English: The proportions of subjects with PedACR50 / 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: What you need to know before you use Hefiya Do not use Hefiya
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Hefiya Ne uporabljajte zdravila Hefiya
English: Return the syringe and the package it came in to the pharmacy.
Slovenian: Injekcijsko brizgo in ovojnino, v kateri ste jo dobili, vrnite v lekarno.
English: Treatment with Hefiya should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Slovenian: Zdravljenja z zdravilom Hefiya se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
English: Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with adalimumab.
Slovenian: Nekaterim bolnikom, ki so bili uspešno zdravljeni zaradi aktivne tuberkuloze, se je med terapijo z adalimumabom ponovno razvila tuberkuloza.
English: Administration of adalimumab without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Slovenian: Uporaba adalimumaba brez metotreksata je zvečala nastajanje protiteles, zvečala očistek in zmanjšala učinkovitost adalimumaba (glejte poglavje 5.1).
English: • If you are about to have surgery or dental procedures tell your doctor that you are taking Hefiya.
Slovenian: • Če boste imeli kirurški poseg ali poseg na zobeh, povejte svojemu zdravniku, da jemljete zdravilo Hefiya.
English: • double vision;
Slovenian: • dvojni vid;
English: • Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
Slovenian: • Zdravniku povejte, če ste živeli na območju ali ste potovali v predele, kjer so pogoste glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
English: Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Slovenian: Luskavica v plakih lahko prizadene tudi nohte, ki postanejo krušljivi, zadebeljeni in se dvignejo od nohtne posteljice, kar je lahko boleče.
English: Tuberculosis
Slovenian: Tuberkuloza
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: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive).
Slovenian: Reaktivacijo hepatitisa B so opažali pri bolnikih, ki so dobivali antagonist TNF (vključno z adalimumabom) in ki so bili kronični nosilci virusa (tj. pozitivni na površinski antigen).
English: At week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see table 21).
Slovenian: V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 21).
English: • ulcerative colitis and
Slovenian: • ulceroznega kolitisa in
English: • Slowly release the plunger and allow the needle safety guard to automatically cover the exposed needle (see Figure K).
Slovenian: • Počasi spuščajte bat in pustite, da varnostni ščitnik za iglo samodejno zapre izpostavljeno iglo (glejte sliko K).
English: Overall, 20 subjects were treated for 60 weeks or longer.
Slovenian: Vsega skupaj je bilo 60 tednov ali več zdravljenih 20 preiskovancev.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin)
English: 10 6336 Langkampfen AUSTRIA
Slovenian: 10 6336 Langkampfen AVSTRIJA
English: • children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Slovenian: • otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
English: The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage (see section 5.1).
Slovenian: Koristi in tveganja nadaljevanja zdravljenja z 40 mg vsak teden ali 80 mg vsak drugi teden je treba ponovno natančno pretehtati pri bolniku z nezadostnim odzivom na zdravljenje po povečanju odmerka (glejte poglavje 5.1).
English: • cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);
Slovenian: • rak, vključno z rakom, ki zajame limfni sistem (limfom) in melanomom (vrsta kožnega raka);
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: Children and adolescents with chronic non-infectious uveitis from 2 years of age
Slovenian: Otroci in mladostniki s kroničnim neinfekcijskim uveitisom, starejši od 2 let
English: During the study, most subjects used concomitant MTX, with fewer reporting use of corticosteroids or NSAIDs.
Slovenian: Med študijo je večina preiskovancev sočasno uporabljala metotreksat, manj pa jih je navedlo uporabo kortikosteroidov ali NSPVZ.
English: If active tuberculosis is diagnosed, Hefiya therapy must not be initiated (see section 4.3).
Slovenian: Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Hefiya ne sme začeti (glejte poglavje 4.3).
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Slovenian: Med vzdrževalnim zdravljenjem, je mogoče kortikosteroide postopoma zmanjšati v skladu s smernicami za klinično prakso.
English: ASAS partial remission BASDAIb 50
Slovenian: ASAS delno izboljšanje BASDAIb50
English: At week 12 and week 24, PedACR30 response was 93.5 % and 90.0 %, respectively, using the observed data approach.
Slovenian: 12. teden je bil odziv PedACR30 93,5 % in 24. teden 90,0 % (z uporabo pristopa z opaženimi podatki).
English: The recommended adolescent HS dosing schedule is 40 mg every other week.
Slovenian: Priporočena shema odmerjanja pri mladostnikih s HS je 40 mg vsak drugi teden.
English: Corticosteroid taper was permitted after week 8.
Slovenian: Po 8. tednu je bilo dovoljeno postopno zmanjševanje kortikosteroida.
English: Hefiya treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Hefiya is indicated.
Slovenian: Zdravljenje z zdravilom Hefiya mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Hefiya indicirano.
English: Therefore, the combination of adalimumab and anakinra is not recommended (see section 4.5).
Slovenian: Zato kombinacija adalimumaba in anakinre ni priporočljiva (glejte poglavje 4.5).
English: Ankylosing Spondylitis Disease Activity Score d partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Slovenian: d Delni zagon bolezni je določen kot ASDAS ≥ 1,3 vendar < 2,1 pri dveh zaporednih obiskih.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Hefiya 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 Hefiya razmisliti tudi pri bolnikih s hudimi 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: This includes any possible side effects not listed in this leaflet (see section 4).
Slovenian: Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu (glejte poglavje 4).
English: • high blood pressure;
Slovenian: • visok krvni tlak;
English: Due to its inhibition of TNFα, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Slovenian: Ker adalimumab zavira TNFα, bi njegova uporaba med nosečnostjo lahko okrnila normalne imunske odzive novorojenčka.
English: • unusual infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered;
Slovenian: • nenavadne okužbe (vključujejo tuberkulozo in druge okužbe, ki se pojavijo ob slabši telesni odpornosti na bolezen);
English: • non-infectious uveitis.
Slovenian: • neinfekcijskega uveitisa
English: Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus.
Slovenian: Zdravnik vas mora testirati na HBV. Adalimumab lahko pri nosilcih HBV reaktivira okužbo s tem virusom.
English: If you use more Hefiya than you should
Slovenian: Če ste uporabili večji odmerek zdravila Hefiya, kot bi smeli
English: Patients on Hefiya may receive concurrent vaccinations, except for live vaccines.
Slovenian: Bolniki, ki prejemajo zdravilo Hefiya, lahko sočasno dobijo cepiva, razen živih cepiv.
English: • mood swings (including depression);
Slovenian: • spremenljivo razpoloženje (vključno z depresijo);
English: Efficacy results
Slovenian: Rezultati učinkovitosti
English: • shortness of breath with exertion or upon lying down or swelling of the feet.
Slovenian: • težko dihanje ob naporu ali med ležanjem ali otekanje nog.
English: Detailed instructions on how to inject Hefiya are provided in section 7, “Instructions for use”.
Slovenian: Podrobna navodila za injiciranje zdravila Hefiya so navedena v poglavju 7, ''Navodila za uporabo''.
English: The active ingredient in Hefiya, adalimumab, is a monoclonal antibody.
Slovenian: Učinkovina v zdravilu Hefiya, adalimumab, je monoklonsko protitelo.
English: • signs of skin cancer such as a bump or open sore that doesn't heal;
Slovenian: • znake kožnega raka, kot sta bula ali odprta rana, ki se ne zaceli,
English: The safety of adalimumab in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months.
Slovenian: Varnost adalimumaba pri pediatričnih bolnikih s psoriazo v plakih je bila ocenjena za povprečno obdobje 13 mesecev.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Hefiya, and in accordance with local recommendations.
Slovenian: Če ugotovite latentno tuberkulozo, morate pred uvedbo zdravila Hefiya začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
English: • Hefiya should only be used during a pregnancy if needed.
Slovenian: • Zdravilo Hefiya se med nosečnostjo lahko uporablja samo, če je potrebno.
English: Throughout all 3 studies patients used topical antiseptic wash daily.
Slovenian: Tekom vseh treh študij so bolniki dnevno uporabljali topikalno antiseptično čistilno tekočino.
English: Cases of worsening congestive heart failure have also been reported in patients receiving adalimumab.
Slovenian: O primerih poslabšanja kongestivnega srčnega popuščanja so poročali pri bolnikih, ki so prejemali adalimumab.
English: The primary efficacy endpoint was the proportion of patients with no flare by Week 68 of the study.
Slovenian: Primarni opazovani dogodek kot merilo učinkovitosti je bil delež bolnikov brez ponovnega zagona bolezni do 68. tedna študije.
English: ACR responses were maintained in the open-label extension study for up to 136 weeks.
Slovenian: Odziv po ACR se je v odprti nadaljevalni študiji ohranil do 136 tednov.
English: This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test).
Slovenian: To bo vključevalo natančno zdravniško oceno vključno s poizvedbo o vašem zdravju v preteklosti in ustrezne preiskave (npr. rentgensko slikanje prsnih organov in tuberkulinski test).
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), Pediatric ACR 50 response, and Pediatric 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 Pediatric ARC 50 in Pediatric ARC 70.
English: • raised bilirubin measurement (liver blood test).
Slovenian: • povečane vrednosti bilirubina (krvni test jetrne funkcije).
English: Not included in your carton are (see Figure B):
Slovenian: Ni priloženo v škatli (glejte sliko B):
English: Your injection You must read this before injecting
Slovenian: Injiciranje Nujno preberite pred injiciranjem
English: The conduct and results of these tests should be recorded on your Patient Reminder Card.
Slovenian: Izvedbo in rezultate teh preiskav je treba zabeležiti na opozorilni kartici.
English: Rare
Slovenian: Redki
English: Maintenance of remission and response rates are presented in table 24.
Slovenian: Vzdrževanje remisije in deleže odziva prikazuje preglednica 24.
English: Hepatitis B virus
Slovenian: Virus hepatitisa B
English: Patients treated with adalimumab usually experienced improvement in haematological signs of chronic inflammation.
Slovenian: Bolnikom, zdravljenim z adalimumabom, so se ponavadi izboljšali hematološki znaki kroničnega vnetja.
English: If an alternate dose is required, other adalimumab products offering such an option should be used.
Slovenian: Če je potreben drugačen odmerek, je treba uporabiti druga zdravila z adalimumabom, ki omogočajo to možnost.
English: Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3 % on placebo and 10 % on adalimumab.
Slovenian: Med bolniki, pri katerih predhodno anti-TNF zdravljenje ni bilo uspešno, jih je 52. teden doseglo remisijo 3 % na placebu in 10 % na adalimumabu.
English: Thus additional caution should be exercised in considering Hefiya treatment of these patients (see section 4.8).
Slovenian: Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z zdravilom Hefiya pri teh bolnikih (glejte poglavje 4.8).