FrancophonIA/ELRC3.0 huggingface dataset:
English: If latent tuberculosis is diagnosed, appropriate anti-tuberculosis prophylaxis in accordance with local recommendations must be initiated before starting treatment with Trudexa.
Slovenian: Če se odkrije latentna tuberkuloza, je treba pred začetkom zdravljenja s Trudexo uvesti ustrezno protituberkulozno profilakso v skladu z lokalnimi priporočili.
English: • anaemia, low white blood cell counts;
Slovenian: • anemija, zmanjšanje števila belih krvnih celic;
English: • Never put the pre-filled pens that you have used into your normal household rubbish bin.
Slovenian: • Odrabljenih napolnjenih injekcijskih peresnikov nikdar ne zavrzite med običajne gospodinjske odpadke.
English: Maintenance of remission and response rates are presented in Table 10.
Slovenian: Vzdrževanje remisije in deleže odziva prikazuje tabela 10.
English: However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Trudexa treatment.
Slovenian: Ker se človeški imunoglobulini izločajo v mleku, ženske ne smejo dojiti vsaj pet mesecev po zadnjem zdravljenju s Trudexo.
English: This will include a thorough medical history, a chest X-ray and a tuberculin test.
Slovenian: To bo vključevalo natančno poizvedbo o vašem zdravju v preteklosti, rentgensko slikanje prsnih organov in tuberkulinski test.
English: It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion.
Slovenian: Ni znano, ali se adalimumab izloča v materinem mleku in ali se po zaužitju sistemsko absorbira.
English: When you do this, if you accidentally push some solution back into the vial, pull slowly back in the plunger to draw the entire contents of the vial back into the syringe.
Slovenian: Če pri tem nazaj v vialo potisnete nekaj raztopine, bat počasi potegnite nazaj, da boste celotno vsebino viale dobili nazaj v brizgo.
English: The impact of longterm treatment with Trudexa on the development of autoimmune diseases is unknown.
Slovenian: Vpliv dolgoročnega zdravljenja s Trudexo na nastanek avtoimunskih bolezni ni znan.
English: NA NA 24.0% 58.9%
Slovenian: NP 24,0% 58,9%
English: Trudexa should not affect your ability to drive or use machinery.
Slovenian: Trudexa naj ne bi vplivala na vašo sposobnost upravljanja vozil in strojev.
English: For Trudexa, no clinical data on exposed pregnancies are available
Slovenian: Za Trudexo ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
English: The primary end point in Studies I, II and III and the secondary endpoint in Study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
Slovenian: Primarna končna točka v raziskavah I, II in III ter sekundarna končna točka v raziskavi IV je bil odstotek bolnikov, ki so po 24 oz. 26 tednih dosegli odziv 20 po ACR.
English: Usually, Trudexa is used with methotrexate.
Slovenian: Trudexo ponavadi uporabljamo z metotreksatom.
English: Study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Slovenian: Raziskava IV je v prvi vrsti ocenila varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let.
English: With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Slovenian: S sedanjim znanjem možnega tveganja za razvoj limfomov ali drugih malignomov pri bolnikih, zdravljenih z zaviralcem TNF, ni mogoče izključiti.
English: If active tuberculosis is diagnosed, Trudexa therapy must not be initiated (see section 4.3).
Slovenian: Če se odkrije aktivna tuberkuloza, se zdravljenja s Trudexo ne sme začeti (glejte poglavje 4.3).
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section
Slovenian: Aktivna tuberkuloza ali druge hude okužbe, npr. sepsa, in oportunistične okužbe (glejte poglavje 4.4).
English: • urinary disturbances (such as blood in urine, increased urinary frequency);
Slovenian: • motnje na sečilih (npr. kri v urinu, pogostejše uriniranje);
English: Patients in Studies I, II and III were tested at multiple timepoints for antibodies to adalimumab during the 6 to 12 month period.
Slovenian: Pri bolnikih v študijah I, II in III so v obdobju od 6 do 12 mesecev ob različnih časih večkrat določali protitelesa proti adalimumabu.
English: Among those, 66 patients showed no progression of structural damage defined by a change in the TSS of zero or less.
Slovenian: Med temi bolniki jih 66 ni kazalo napredovanja strukturne prizadetosi izražene s spremembo celotne Sharpove ocene 0 ali manj.
English: In Study V, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score (see Table 6).
Slovenian: V študiji V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte tabelo 6).
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: • increased menstrual bleeding;
Slovenian: • močnejše menstruacijske krvavitve;
English: Administration of Trudexa without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1).
Slovenian: Uporaba Trudexe brez metotreksata je zvečala nastajanje protiteles, zvečala očistek in zmanjšala učinkovitost adalimumaba (glejte poglavje 5.1).
English: If you forget to take Trudexa:
Slovenian: Če ste pozabili vzeti Trudexo
English: Rare hearing loss
Slovenian: redki izguba sluha
English: In patients who develop HBV reactivation, Trudexa 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 Trudexe prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
English: There is a window on each side of the pen through which you can see the Trudexa solution inside the syringe.
Slovenian: Na obeh straneh peresnika je okence; skozi okenci lahko vidite raztopino Trudexa v notranjosti brizge.
English: If you do not respond well enough to these medicines, you will be given Trudexa to reduce the signs and symptoms of your disease.
Slovenian: Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov bolezni dobili Trudexo.
English: Table 5: Radiographic Mean Changes Over 12 Months in Study III
Slovenian: Tabela 5: Povprečne rentgenografske spremembe v 12 mesecih raziskave III
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku .
English: The safety and efficacy of Trudexa were assessed in over 1400 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 Trudexe so ocenili pri več kot 1400 bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
English: Important information about some of the ingredients of Trudexa This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Trudexa To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v odmerku, kar pomeni, da je količina zanemarljiva.
English: This alert card contains important safety information that you need to be aware of before you are given Trudexa and during treatment with Trudexa.
Slovenian: Ta opozorilna izkaznica vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete Trudexo in med zdravljenjem z njo.
English: Trudexa is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Trudexa je indicirana za zdravljenje hude, aktivne Crohnove bolezni pri bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
English: • After injecting Trudexa, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Slovenian: • Po injiciranju Trudexe porabljeno brizgo takoj zavrzite v poseben vsebnik, kot vam je naročil zdravnik, medicinska sestra ali farmacevt.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Trudexa and is positive for antibodies against double-stranded DNA, further treatment with Trudexa should not be given (see section 4.8).
Slovenian: Če se bolniku po zdravljenju s Trudexo pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja s Trudexo ne sme nadaljevati (glejte poglavje 4.8).
English: With your other hand, pull the grey cap (1) straight off and discard cap.
Slovenian: Z drugo roko snemite sivi pokrovček (1) naravnost dol in ga zavrzite.
English: In this situation, the benefit/risk balance of therapy with Trudexa should be very carefully considered.
Slovenian: V takšnih primerih je treba zelo natančno pretehtati korist in tveganje zdravljenja s Trudexo.
English: If you do not respond well enough to these medicines, you will be given Trudexa to treat your rheumatoid arthritis.
Slovenian: Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili Trudexo.
English: Study III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Slovenian: V študijah III in V je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
English: Of particular importance are infections such as pneumonia, pyelonephritis, septic arthritis and septicaemia.
Slovenian: Posebno pomembne okužbe so npr. pljučnica, pielonefritis, septični artritis in septikemija.
English: Uncommon blood creatine phosphokinase increased, activated partial thromboplastin time prolonged, autoantibodies present
Slovenian: Preiskave občasni zvišanje kreatin fosfokinaze v krvi, podaljšan aktivirani parcialni tromboplastinski čas, prisotna avtoprotitelesa
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Trudexa should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo Trudexe nemudoma prekiniti in uvesti ustrezno zdravljenje.
English: Adverse events at least possibly causally-related to adalimumab for Studies I − IX, CLASSIC I, GAIN and CHARM, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common≥ 1/100 < 1/10; uncommon≥ 1/1000 to ≤ 1/100) and rare < 1/1000 in Table 1 below.
Slovenian: Klinični in laboratorijski neželeni učinki, ki so vsaj potencialno vzročno povezani z adalimumabom v študijah I-IX, CLASSIC I, GAIN in CHARM, so navedeni po organskih sistemih in pogostnosti: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100) in redki (≥1/10.000 do <1/1.000) v tabeli 1 spodaj.
English: Preclinical data on postnatal toxicity and fertility effects of adalimumab are not available (see section 5.3).
Slovenian: Predkliničnih podatkov o poporodni toksičnosti adalimumaba in njegovih učinkih na plodnost ni (glejte poglavje 5.3).
English: The Trudexa pre-filled pen is available in packs containing 1, 2, 4, and 6 pre-filled pens.
Slovenian: Napolnjeni injekcijski peresnik Trudexa je na voljo v pakiranjih, ki vsebujejo 1, 2, 4 ali 6 napolnjenih injekcijskih peresnikov.
English: • Double vision;
Slovenian: • dvojni vid;
English: Data from the open-label extension phase indicate that the reduction in rate of progression of structural damage is maintained for 60 months in a subset of patients.
Slovenian: Podatki iz odprte podaljšane faze kažejo, da se upočasnitev napredovanja strukturne prizadetosti sklepov ohrani vseh 60 mesecev v tej podskupini bolnikov.
English: INFORMATION IN BRAILLE Trudexa 40 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Trudexa 40 mg
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/0.8 ml
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 40 mg/0,8 ml
English: Health-related quality of life and physical function was assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in Study III.
Slovenian: Z zdravjem povezano kakovost življenja in telesno funkcijo so v štirih originalnih ustreznih in dobro kontroliranih raziskavah ocenjevali z indeksom invalidnosti z vprašalnikom HAQ (Health Assessment Questionnaire) in je bila v raziskavi III vnaprej določena primarna končna točka po 52 tednih.
English: You should not take Trudexa with medicines containing the active substance, anakinra.
Slovenian: Trudexe ne smete jemati z zdravili, ki vsebujejo učinkovino anakinro.
English: • With the needle still in the vial, turn the vial upside down at eye level.
Slovenian: • Medtem ko je igla še vedno v viali, v višini oči obrnite vialo na glavo.
English: • Remove the plastic cap from the Trudexa vial.
Slovenian: • Z viale Trudexe odstranite plastični pokrovček.
English: Study IIIa**
Slovenian: Raziskava IIIa**
English: The results for the 40 mg every other week dose are summarised in Table 3.
Slovenian: Rezultati odmerka 40 mg vsak drugi teden so strnjeni v tabeli 3.
English: Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
Slovenian: Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah jajčnika kitajskega hrčka.
English: Your doctor will decide if you should receive Trudexa.
Slovenian: Ta bo presodil, ali lahko dobivate Trudexo.
English: Administration of adalimumab is not recommended during pregnancy.
Slovenian: Uporaba adalimumaba med nosečnostjo ni priporočljiva.
English: • Each new injection should be given at least 3 cm from the last injection site.
Slovenian: • Vsako naslednjo injekcijo morate dati vsaj 3 cm od mesta prejšnje injekcije.
English: Do not press the plum activation button until properly positioned as this will result in discharge of medication.
Slovenian: Ne pritisnite temnomodrega sprožilnega gumba, dokler ni pravilno nameščen, ker boste sicer iztisnili zdravilo.
English: • If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Trudexa.
Slovenian: • Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo Trudexe posvetujte s svojim zdravnikom.
English: Other side effects that have been observed in patients taking Trudexa: tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered); lung disease.
Slovenian: Drugi neželeni učinki, zabeleženi pri bolnikih, ki so jemali Trudexo: tuberkuloza in druge oportunistične okužbe (okužbe, ki se pojavijo, kadar se zmanjša odpornost proti boleznim); pljučna bolezen.
English: With the vial upright on a flat surface, such as a table, insert the needle straight through the centre ring of the grey stopper.
Slovenian: Vialo postavite pokonci na ravno površino, npr. na mizo, in zabodite iglo naravnost skozi osrednji obroč sivega zamaška.
English: • Trudexa should not be used if you have moderate to severe heart failure.
Slovenian: • Trudexe ne smete dobiti, če imate zmerno do hudo srčno popuščanje.
English: Patients treated with Trudexa should be given the special alert card.
Slovenian: Bolniki, ki se zdravijo s Trudexo, morajo dobiti posebno opozorilno izkaznico.
English: During treatment with Trudexa, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Slovenian: Med zdravljenjem s Trudexo je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
English: A. MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: Trudexa 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 Trudexo, 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: Study Ia**
Slovenian: Raziskava Ia**
English: In the pivotal trials, anti-adalimumab antibodies were identified in 58/1053 (5.5%) patients treated with adalimumab, compared to 2/370 (0.5%) on placebo.
Slovenian: V ključnih preskušanjih so protitelesa proti adalimumabu odkrili pri 58/1053 (5,5%) bolnikov, zdravljenih z adalimumabom, in pri 2/370 (0,5%), ki so dobivali placebo.
English: Clinical remission Clinical response (CR-100)
Slovenian: Klinična remisija Klinični odziv (CR-100)
English: Very common (≥ 1/10 patients): • injection site reactions (including pain, swelling, redness or itching).
Slovenian: Zelo pogosto (≥1/10 bolnikov): • reakcije na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo in srbenjem).
English: 478 of the enrolled patients (32%) were defined as having a severe disease (CDAI score > 300 and concomitant corticosteroid and/or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Slovenian: Pri 478 zajetih bolnikih (32%) je bila bolezen opredeljena kot huda (seštevek CDAI > 300 ter sočasno zdravljenje s kortikosteroidom in//ali imunosupresivom), kar ustreza populaciji, opredeljeni pri indikacijah (glejte poglavje 4.1).
English: • Please make sure you also have a list of all your other medicines with you at any visit to a health care professional.
Slovenian: • Poskrbite, da boste na vsak pregled pri zdravniku prinesli spisek vseh drugih zdravil, ki jih uporabljate.
English: • If you have multiple sclerosis, your doctor will decide if you should receive Trudexa.
Slovenian: • Če imate multiplo sklerozo, bo zdravnik presodil, ali lahko dobivate Trudexo.
English: After proper training in injection technique, patients may self-inject with Trudexa if their physician determines that it is appropriate and with medical follow-up as necessary.
Slovenian: Bolniki, ki se naučijo pravilnega postopka injiciranja, si Trudexo lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
English: If a patient receiving Trudexa shows prolonged/atypical symptoms/signs of infections or general deterioration, prevalent opportunistic conditions must be considered.
Slovenian: Če se pri bolniku, ki dobiva Trudexo, pojavijo dolgotrajni oz. atipični simptomi ali znaki okužbe ali pa splošno poslabšanje, je treba pomisliti na prevalentne oportunistične bolezni.
English: Results from the Short Form Health Survey (SF 36) for all doses/schedules of Trudexa in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Slovenian: Te izsledke podpirajo rezultati SF 36 (Short Form Health Survey) za vse odmerke/sheme Trudexe v vseh štirih raziskavah, s statistično značilnim seštevkom PCS (Physical Component Summary) in statistično značilnima seštevkoma za področje bolečin in vitalnosti za odmerek 40 mg vsak drugi teden.
English: • The needle cover of the syringe contains natural rubber (latex).
Slovenian: • Pokrovček igle na brizgi vsebuje naravno gumo (lateks).
English: No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving Trudexa.
Slovenian: Študij, ki bi vključevale bolnike z anamnezo malignoma ali v katerih bi nadaljevali zdravljenje pri bolnikih, ki so razvili malignom med prejemanjem Trudexe, ni bilo.
English: The infections consisted primarily of upper respiratory tract infections, bronchitis and urinary tract infections.
Slovenian: Pri okužbah je šlo predvsem za okužbe zgornjih dihal, bronhitis in okužbe sečil.
English: **p < 0.01, Trudexa versus placebo
Slovenian: **p < 0,01, Trudexa v prim.
English: • Do NOT shake the vial.
Slovenian: • Viale NE STRESAJTE.
English: • If you are about to undergo surgery or dental procedures please inform your doctor that you are taking Trudexa.
Slovenian: • Če boste imeli kirurški poseg ali poseg na zobeh, prosimo, povejte svojemu zdravniku, da jemljete Trudexo.
English: Take one dose tray containing a pre-filled pen of Trudexa from the refrigerator.
Slovenian: Vzemite enoodmerni ovitek z napolnjenim injekcijskim peresnikom Trudexa iz hladilnika.
English: Liver Enzyme Elevations
Slovenian: Zvišanje jetrnih encimov
English: • Some vaccines should not be given while receiving Trudexa.
Slovenian: • Med zdravljenjem s Trudexo se ne sme uporabljati nekaterih cepiv.
English: The following instructions explain how to inject Trudexa.
Slovenian: Spodnja navodila pojasnjujejo, kako injicirati Trudexo.
English: The conduct of these tests should be recorded on your Patient Alert Card.
Slovenian: Izvedbo teh preiskav je treba zabeležiti na opozorilni izkaznici.
English: Carcinogenicity studies, and standard assessment of fertility and postnatal toxicity, were not performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and the development of neutralizing antibodies in rodents.
Slovenian: Z adalimumabom niso bile narejene raziskave kancerogenosti in 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: In post-marketing experience from January 2003, predominately in patients with rheumatoid arthritis, the reported rate of malignancies other than lymphomas and non-melanoma skin cancers is approximately 1.7 per 1000 patient years.
Slovenian: V obdobju pomarketinške uporabe od januarja 2003, pretežno pri bolnikih z revmatoidnim artritisom, je bil zabeleženi delež malignomov (razen limfomov in nemelanomskih kožnih rakov) približno 1,7 na 1000 bolnik-let.
English: Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Slovenian: Trudexo je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljne zdravljenje z metotreksatom ni primerno.
English: Trudexa has not been studied in children or in patients with hepatic or renal impairment.
Slovenian: Trudexa ni raziskana pri otrocih in bolnikih z okvaro jeter ali ledvic.
English: You will see a yellow indicator move into the windows during the injection.
Slovenian: Med injiciranjem boste videli pomikanje rumenega kazalnika v okence.
English: Among patients who were not in response at week 4, 43% of Trudexa maintenance patients responded by week 12 compared to 30% of placebo maintenance patients.
Slovenian: Med bolniki, ki so bili 4. teden brez odziva, se je do 12. tedna odzvalo 43% tistih, ki so vzdrževalno dobivali Trudexo, in 30% tistih, ki so vzdrževalno dobivali placebo.