FrancophonIA/ELRC3.0 huggingface dataset:
English: Leave it to dry before injecting (see Figure E).
Slovenian: Pustite, da se pred injiciranjem posuši (glejte sliko E).
English: Congestive heart failure
Slovenian: Kongestivno srčno popuščanje
English: • Twist off the cap in the direction of the arrows (see Figure F).
Slovenian: • Pokrovček odvijte v smeri puščic (glejte sliko F).
English: Table 18 Ps study II (CHAMPION) efficacy results at 16 weeks placebo N = 53 n (%)
Slovenian: Preglednica 18 študija pri psoriazi II (CHAMPION) - rezultati učinkovitosti po 16 tednih placebo n = 53 n (%)
English: No clinical exposure data are available on the use of a loading dose in children < 6 years.
Slovenian: Klinični podatki o izpostavljenosti pri uporabi polnilnega odmerka pri otrocih, mlajših od 6 let, niso na voljo.
English: Full instructions for use are provided in the package leaflet.
Slovenian: Celotna navodila za uporabo so navedena v navodilu za uporabo.
English: Hefiya is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Slovenian: Zdravilo Hefiya se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih od 6 do 17 let.
English: • Use your pen within 5 minutes of removing the cap.
Slovenian: • Injekcijski peresnik uporabite v 5 minutah po odstranitvi pokrovčka.
English: The efficacy of adalimumab in those patients was reduced compared to that in anti-TNF naïve patients.
Slovenian: Učinkovitost adalimumaba je bila pri teh bolnikih manjša kot pri bolnikih, ki še niso dobivali anti-TNF.
English: • lung diseases causing shortness of breath (including inflammation);
Slovenian: • pljučna bolezen, ki povzroči kratko sapo (vključno z vnetjem);
English: • inject Hefiya 15-30 minutes after taking it out of the refrigerator for a more comfortable injection.
Slovenian: • zdravilo Hefiya injicirate 15-30 minut po tem, ko ste ga vzeli iz hladilnika, da bo občutek pri injiciranju prijetnejši.
English: 25, 40 and 40 mg
Slovenian: 25, 40 in 40 mg
English: A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p<0.001) (Figure 1).
Slovenian: Pri večjem deležu bolnikov, ki so prejemali adalimumab, v dvojno slepem obdobju ni prišlo do ponovnega zagona bolezni v primerjavi s tistimi, ki so prejemali placebo (70,4 % v primerjavi s 47,1 %, p < 0,001) (slika 1).
English: • high blood measurements for lactate dehydrogenase;
Slovenian: • visoke krvne vrednosti za laktat dehidrogenazo;
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 z adalimumabom 40 mg vsak drugi teden/metotreksatom, monoterapija z adalimumabom 40 mg 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: If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate.
Slovenian: Če imate zmeren do hud aktiven revmatoidni artritis, boste morda najprej dobili druga imunomodulirajoča zdravila, npr.
English: Adults with ulcerative colitis
Slovenian: Odrasli z ulceroznim kolitisom
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Slovenian: Med 68 bolniki iz skupine namenjene prenehanju zdravljenja, pri katerih je prišlo do ponovnega zagona bolezni, jih je 65 zaključilo 12 tednov trajajoče rešilno zdravljenje z adalimumabom, od tega jih je 37 (56,9 %) po 12 tednih ponovne odprte faze zdravljenja ponovno doseglo remisijo (ASDAS
English: At week 4 patients were randomised to 40 mg every other week, 40 mg every week, or placebo with a total study duration of 56 weeks.
Slovenian: Na 4. teden so bolnike randomizirali na 40 mg vsak drugi teden, 40 mg vsak teden ali placebo; v celoti je študija trajala 56 tednov.
English: On rare occasions, a specific and severe type of lymphoma has been observed in patients taking adalimumab.
Slovenian: V redkih primerih so pri bolnikih, ki dobivajo adalimumab, opazili specifično in resno obliko limfoma.
English: Table 13 efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms response placebo N=107
Slovenian: kontrolirani s placebom - študija I zmanjšanje znakov in simptomov odziv placebo n = 107
English: Before your injection
Slovenian: Pred injiciranjem
English: The safety profile for patients with uveitis treated with adalimumab every other week was consistent with the known safety profile of adalimumab.
Slovenian: Varnostni profil za bolnike z uveitisom, ki so bili vsak drugi teden zdravljeni z adalimumabom, je v skladu z znanim varnostnim profilom adalimumaba.
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: MTX N = 110 n (%)
Slovenian: metotreksat n = 110 n (%)
English: • dehydration;
Slovenian: • dehidracija;
English: Preclinical data on postnatal toxicity of adalimumab are not available (see section 5.3).
Slovenian: Predkliničnih podatkov o poporodni toksičnosti adalimumaba ni (glejte poglavje 5.3).
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 spondilitisu
English: placebo adalimumab 40 mg weekly placebo adalimumab 40 mg weekly hidradenitis suppurativa clinical response (HiSCR)a
Slovenian: placebo adalimumab 40 mg vsak teden placebo adalimumab 40 mg vsak teden klinični odziv pri hidradenitis suppurativa (HiSCR)a
English: In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Slovenian: V študijah revmatoidnega artritisa I- IV so bolniki, zdravljeni z adalimumabom, v primerjavi s prejemniki placeba dosegli statistično značilen odziv 20 in 50 po ACR že en do dva tedna po začetku zdravljenja.
English: Hepatitis B reactivation
Slovenian: Reaktivacija hepatitisa B
English: Hefiya can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Zdravilo Hefiya se lahko uporablja skupaj z metotreksatom ali nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (sulfasalazinom, hidroksiklorokinom, leflunomidom in pripravki zlata za injiciranje), kortikosteroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili.
English: • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Slovenian: • Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča zdravila, vključno z metotreksatom, ni zadosten.
English: Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after adalimumab administration.
Slovenian: Po uporabi adalimumaba se je zmanjšala tudi serumska raven matriksnih metaloproteinaz (MMP-1 in MMP-3), ki povzročajo remodeliranje tkiva, odgovorno za uničenje hrustanca.
English: Hefiya is a biosimilar medicinal product.
Slovenian: Zdravilo Hefiya je podobno biološko zdravilo.
English: However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Slovenian: Poleg tega so iz obdobja trženja zdravila poročali tako o jetrni odpovedi kot tudi o hudih boleznih jeter, ki lahko vodijo v jetrno odpoved, kot je hepatitis, vključno z avtoimunskim hepatitisom, pri bolnikih, ki so prejemali adalimumab.
English: • nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Slovenian: • bolezni živčevja (kot je vnetje optičnega živca v očesu in sindrom Guillain-Barré, stanje, ki lahko povzroči šibkost mišic, nenormalna občutenja, mravljinčenje v rokah in zgornjem delu telesa);
English: Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (< 1 %) to “moderate” (48 %) to “severe” (46 %) to “very severe” (6 %).
Slovenian: PASI 19,7, izhodiščna PGA pa je segala od "blage" (< 1 %), "zmerne" (48 %) in "hude" (46 %) do "zelo hude" (6 %).
English: There is a known association between intermediate uveitis and central demyelinating disorders.
Slovenian: Znana je zveza med intermediarnim uveitisom in demielinizirajočimi boleznimi osrednjega živčevja.
English: • intestinal infections (including gastroenteritis);
Slovenian: • črevesne okužbe (vključno z gastroenteritisom);
English: Study nr-axSpA I
Slovenian: Študija nr-axSpA I
English: • Look at the expiration date (EXP) on your pen.
Slovenian: • Poglejte datum izteka roka uporabnosti (EXP) na injekcijskem peresniku.
English: Do not use the syringe if the expiration date has passed.
Slovenian: Injekcijske brizge ne uporabite, če je rok uporabnosti že potekel.
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 (see section 4.5).
Slovenian: Sočasna uporaba adalimumaba z drugimi biološkimi DMARD (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 (glejte poglavje 4.5).
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: 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: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
Slovenian: • znake in simptome, ki nakazujejo bolezni krvi, npr. dolgotrajno zvišana telesna temperatura,
English: c p = 0.083, adalimumab 0.8 mg / kg versus MTX
Slovenian: c p = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
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 adalimumaba 40 mg 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: • increased uric acid in the blood;
Slovenian: • povečana sečna kislina v krvi;
English: MTX = methotrexate ** p < 0.01, adalimumab versus placebo
Slovenian: MTX = metotreksat ** p < 0,01, adalimumab v prim.
English: • if you drop your pen, do not use it if it looks damaged, or if you dropped it with the cap removed.
Slovenian: • če injekcijski peresnik spustite, ga ne uporabite, če je videti poškodovan ali če ste ga spustili z odstranjenim pokrovčkom;
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
English: It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hefiya.
Slovenian: Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom Hefiya prejmejo vsa cepljenja, predvidena za njihovo starost, če je le mogoče.
English: Haematologic reactions
Slovenian: Hematološke reakcije
English: MTX = methotrexate b p = 0.027, adalimumab 0.8 mg / kg versus MTX
Slovenian: MTX = metotreksat b p = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX
English: • systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,
Slovenian: • sistemski eritematozni lupus (bolezen imunskega sistema, vključno z vnetjem kože, srca, pljuč,
English: Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Slovenian: Z rentgenskim slikanjem je bilo dokazano, da adalimumab upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
English: Subjects (n = 215, 54.7 %) who failed to achieve ASAS 20 at weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Slovenian: Preiskovanci (n = 215, 54,7 %), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa so bili obravnavani kot neodzivni bolniki.
English: Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients (local recommendations may apply).
Slovenian: Pri vseh bolnikih je treba narediti ustrezne presejalne preiskave (tj. tuberkulinski kožni test in rentgensko slikanje prsnih organov)
English: − The active substance is adalimumab.
Slovenian: - Učinkovina je adalimumab.
English: In the post marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Slovenian: Med obdobjem trženja so bili opisani primeri levkemije pri bolnikih, zdravljenih z antagonistom TNF.
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.452.73) 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: The safety profile for patients with HS treated with adalimumab weekly was consistent with the known safety profile of adalimumab.
Slovenian: Varnostni profil bolnikov s HS, ki so bili tedensko zdravljeni z adalimumabom, je v skladu z znanim varnostnim profilom adalimumaba.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: • Crohn's disease,
Slovenian: • Crohnove bolezni,
English: The solution should be colourless to slightly yellowish as well as clear to slightly opalescent.
Slovenian: Raztopina mora biti brezbarvna do rahlo rumenkasta ter bistra do rahlo opalescentna.
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6 % (median percent change -88.9 %) in patients in the adalimumab group compared to -11.6 % (median percent change -50.0 %) in patients in the placebo group.
Slovenian: Primarni opazovani dogodek je bil odstotek spremembe od izhodiščne vrednosti do 12. tedna v številu aktivnih sklepov z artritisom (oteklina, ki ni nastala zaradi deformacije ali sklepi z zmanjšano gibljivostjo ter bolečino in/ali občutljivostjo); slednji je bil dosežen s povprečnim zmanjšanjem za -62,6 % (mediana sprememba -88,9 %) pri skupini bolnikov, ki je prejemala adalimumab, v primerjavi z -11,6 % (mediana sprememba -50,0 %) v skupini bolnikov, ki je prejemala placebo.
English: In the open-label extension for RA study V, ACR response rates were maintained when followed for up to 10 years.
Slovenian: V odprtem podaljšanju študije revmatoidnega artritisa V so se stopnje odzivov po ACR ohranile tudi do 10 let.
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Slovenian: Bolniki, ki so v odprti fazi dosegli trajno remisijo za vsaj 12 tednov (N = 305) (ASDAS < 1,3 v 16., 20., 24. in 28. tednu), so bili nato randomizirani tako, da so prejemali bodisi nadaljevalno zdravljenje z adalimumabom 40 mg vsak drugi teden (N = 152) ali placebo (N = 153) dodatnih 40 tednov v dvojno slepem, s placebom kontroliranem obdobju (celotno trajanje študije 68 tednov).
English: Consequently, Hefiya can be used during breastfeeding..
Slovenian: Posledično se zdravilo Hefiya lahko uporablja med dojenjem.
English: If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines.
Slovenian: Če imate ankilozirajoči spondilitis ali aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis, boste najprej dobili druga zdravila.
English: Should treatment be interrupted, Hefiya 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 Hefiya z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Slovenian: Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z adalimumabom pri pediatričnih bolnikih s psoriazo v plakih.
English: • skin cancer;
Slovenian: • kožni rak;
English: Physicians should exercise caution when considering the use of Hefiya in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Slovenian: Pri odločanju za uporabo zdravila Hefiya je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
English: a time to treatment failure at or after week 6 in study UV I
Slovenian: Vrednostb čas do neuspeha zdravljenja v ali po 6. tednu v študiji UV I
English: Crohn's disease is an inflammatory disease of the gut.
Slovenian: Crohnova bolezen je vnetna bolezen črevesa.
English: Figure J: lift the needle straight out
Slovenian: Slika J: Potegnite iglo naravnost ven
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 in metotreksatom in so bile vključene v odprto podaljšanje študije, je 171 bolnikov zaključilo 10-letno zdravljenje z adalimumabom.
English: What Hefiya looks like and contents of the pack
Slovenian: Izgled zdravila Hefiya in vsebina pakiranja
English: Diplopia
Slovenian: Diplopija
English: Based on the observed data approach, 222 (80.4 %) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Slovenian: Na osnovi pristopa z opaženimi podatki je bilo 222 (80,4 %) bolnikov v remisiji (brez aktivnih vnetnih lezij, ocena celic sprednje očesne komore ≤ 0,5+, motnost steklovine ≤ 0,5+) ob sočasnem jemanju steroidov v odmerku 7,5 mg na dan in pa 184 bolnikov (66,7 %), ki so bili v remisiji in brez steroidov.
English: Neither carcinogenicity studies, nor a standard assessment of fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralising antibodies in rodents.
Slovenian: niti standardne ocene plodnosti ter poporodne toksičnosti, in sicer zato, ker ni ustreznih modelov za protitelo z omejeno navzkrižno reaktivnostjo z glodalskim TNF, in zaradi nastanka nevtralizirajočih protiteles pri glodalcih.
English: Muscle spasms (including blood creatine phosphokinase increased)
Slovenian: Neželeni učinki pogosti mišični spazmi (vključno s povišano kreatin fosfokinazo v krvi)
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more
Slovenian: Mladostniki s hidradenitis suppurativa, stari od 12 do 17 let, ki tehtajo 30 kg ali več
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see table 22).
Slovenian: Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu, je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden, kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden, ali pri katerih je bilo zdravljenje ukinjeno (glejte preglednico 22).
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Hefiya.
Slovenian: Vsem bolnikom je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se jim med uporabo zdravila Hefiya pojavijo znaki ali simptomi krvnih diskrazij (npr. trajno zvišana telesna temperatura, podplutbe, krvavitve, bledica).
English: If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away.
Slovenian: Če dobite zvišano telesno temperaturo, ki ne mine, ali če se vam pojavljajo podplutbe, zlahka zakrvavite ali ste zelo bledi, se takoj posvetujte s svojim zdravnikom.
English: • oedema (a build-up of fluid in the body which causes the affected tissue to swell);
Slovenian: • edem (kopičenje tekočine v telesu, ki povzroči otekanje prizadetega tkiva);
English: Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD.
Slovenian: Bolniki so morali biti neuspešno zdravljeni s konvencionalno terapijo (vključno s kortikosteroidom in/ali z imunomodulatorjem) zaradi Crohnove bolezni.