natgillin/translations-raw huggingface dataset:
• After injecting Trudexa, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
• Po injiciranju Trudexe porabljeno brizgo takoj zavrzite v poseben vsebnik, kot vam je naročil zdravnik, medicinska sestra ali farmacevt.
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).
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).
With your other hand, pull the grey cap (1) straight off and discard cap.
Z drugo roko snemite sivi pokrovček (1) naravnost dol in ga zavrzite.
In this situation, the benefit/risk balance of therapy with Trudexa should be very carefully considered.
V takšnih primerih je treba zelo natančno pretehtati korist in tveganje zdravljenja s Trudexo.
If you do not respond well enough to these medicines, you will be given Trudexa to treat your rheumatoid arthritis.
Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili Trudexo.
Study III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
V študijah III in V je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
Of particular importance are infections such as pneumonia, pyelonephritis, septic arthritis and septicaemia.
Posebno pomembne okužbe so npr. pljučnica, pielonefritis, septični artritis in septikemija.
Uncommon blood creatine phosphokinase increased, activated partial thromboplastin time prolonged, autoantibodies present
Preiskave občasni zvišanje kreatin fosfokinaze v krvi, podaljšan aktivirani parcialni tromboplastinski čas, prisotna avtoprotitelesa
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Trudexa should be discontinued immediately and appropriate therapy initiated.
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo Trudexe nemudoma prekiniti in uvesti ustrezno zdravljenje.
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.
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.
Preclinical data on postnatal toxicity and fertility effects of adalimumab are not available (see section 5.3).
Predkliničnih podatkov o poporodni toksičnosti adalimumaba in njegovih učinkih na plodnost ni (glejte poglavje 5.3).
The Trudexa pre-filled pen is available in packs containing 1, 2, 4, and 6 pre-filled pens.
Napolnjeni injekcijski peresnik Trudexa je na voljo v pakiranjih, ki vsebujejo 1, 2, 4 ali 6 napolnjenih injekcijskih peresnikov.
• Double vision;
• dvojni vid;
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.
Podatki iz odprte podaljšane faze kažejo, da se upočasnitev napredovanja strukturne prizadetosti sklepov ohrani vseh 60 mesecev v tej podskupini bolnikov.
INFORMATION IN BRAILLE Trudexa 40 mg
PODATKI V BRAILLOVI PISAVI Trudexa 40 mg
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/0.8 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 40 mg/0,8 ml
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.
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.
You should not take Trudexa with medicines containing the active substance, anakinra.
Trudexe ne smete jemati z zdravili, ki vsebujejo učinkovino anakinro.
• With the needle still in the vial, turn the vial upside down at eye level.
• Medtem ko je igla še vedno v viali, v višini oči obrnite vialo na glavo.
• Remove the plastic cap from the Trudexa vial.
• Z viale Trudexe odstranite plastični pokrovček.
Study IIIa**
Raziskava IIIa**
The results for the 40 mg every other week dose are summarised in Table 3.
Rezultati odmerka 40 mg vsak drugi teden so strnjeni v tabeli 3.
Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells.
Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah jajčnika kitajskega hrčka.
Your doctor will decide if you should receive Trudexa.
Ta bo presodil, ali lahko dobivate Trudexo.
Administration of adalimumab is not recommended during pregnancy.
Uporaba adalimumaba med nosečnostjo ni priporočljiva.
• Each new injection should be given at least 3 cm from the last injection site.
• Vsako naslednjo injekcijo morate dati vsaj 3 cm od mesta prejšnje injekcije.
Do not press the plum activation button until properly positioned as this will result in discharge of medication.
Ne pritisnite temnomodrega sprožilnega gumba, dokler ni pravilno nameščen, ker boste sicer iztisnili zdravilo.
• If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Trudexa.
• Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo Trudexe posvetujte s svojim zdravnikom.
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.
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.
With the vial upright on a flat surface, such as a table, insert the needle straight through the centre ring of the grey stopper.
Vialo postavite pokonci na ravno površino, npr. na mizo, in zabodite iglo naravnost skozi osrednji obroč sivega zamaška.
• Trudexa should not be used if you have moderate to severe heart failure.
• Trudexe ne smete dobiti, če imate zmerno do hudo srčno popuščanje.
Patients treated with Trudexa should be given the special alert card.
Bolniki, ki se zdravijo s Trudexo, morajo dobiti posebno opozorilno izkaznico.
During treatment with Trudexa, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Med zdravljenjem s Trudexo je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
A. MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
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).
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).
Study Ia**
Raziskava Ia**
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.
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.
Clinical remission Clinical response (CR-100)
Klinična remisija Klinični odziv (CR-100)
Very common (≥ 1/10 patients): • injection site reactions (including pain, swelling, redness or itching).
Zelo pogosto (≥1/10 bolnikov): • reakcije na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo in srbenjem).
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).
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).
• Please make sure you also have a list of all your other medicines with you at any visit to a health care professional.
• Poskrbite, da boste na vsak pregled pri zdravniku prinesli spisek vseh drugih zdravil, ki jih uporabljate.
• If you have multiple sclerosis, your doctor will decide if you should receive Trudexa.
• Če imate multiplo sklerozo, bo zdravnik presodil, ali lahko dobivate Trudexo.
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.
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.
If a patient receiving Trudexa shows prolonged/atypical symptoms/signs of infections or general deterioration, prevalent opportunistic conditions must be considered.
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.
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.
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.
• The needle cover of the syringe contains natural rubber (latex).
• Pokrovček igle na brizgi vsebuje naravno gumo (lateks).
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.
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.
The infections consisted primarily of upper respiratory tract infections, bronchitis and urinary tract infections.
Pri okužbah je šlo predvsem za okužbe zgornjih dihal, bronhitis in okužbe sečil.
**p < 0.01, Trudexa versus placebo
**p < 0,01, Trudexa v prim.
• Do NOT shake the vial.
• Viale NE STRESAJTE.
• If you are about to undergo surgery or dental procedures please inform your doctor that you are taking Trudexa.
• Če boste imeli kirurški poseg ali poseg na zobeh, prosimo, povejte svojemu zdravniku, da jemljete Trudexo.
Take one dose tray containing a pre-filled pen of Trudexa from the refrigerator.
Vzemite enoodmerni ovitek z napolnjenim injekcijskim peresnikom Trudexa iz hladilnika.
Liver Enzyme Elevations
Zvišanje jetrnih encimov
• Some vaccines should not be given while receiving Trudexa.
• Med zdravljenjem s Trudexo se ne sme uporabljati nekaterih cepiv.
The following instructions explain how to inject Trudexa.
Spodnja navodila pojasnjujejo, kako injicirati Trudexo.
The conduct of these tests should be recorded on your Patient Alert Card.
Izvedbo teh preiskav je treba zabeležiti na opozorilni izkaznici.
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.
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.
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.
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.
Trudexa can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Trudexo je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljne zdravljenje z metotreksatom ni primerno.
Trudexa has not been studied in children or in patients with hepatic or renal impairment.
Trudexa ni raziskana pri otrocih in bolnikih z okvaro jeter ali ledvic.
You will see a yellow indicator move into the windows during the injection.
Med injiciranjem boste videli pomikanje rumenega kazalnika v okence.
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.
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.
The symptoms described above can be signs of the below listed side effects, which have been observed with Trudexa:
Opisani simptomi so lahko znaki naslednjih neželenih učinkov, ugotovljenih med uporabo Trudexe:
CLASSIC I and GAIN induction of remission and response rates are presented in Table 9.
Indukcijo remisije in deleže odziva v študijah CLASSIC I in GAIN prikazuje tabela 9.
In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
V klinični raziskavi z drugim antagonistom TNF so opažali poslabšanje kongestivnega srčnega popuščanja in večjo umrljivost zaradi kongestivnega srčnega popuščanja.
• lower respiratory tract infections (such as bronchitis, pneumonia);
• okužbe spodnjih dihal (npr. bronhitis, pljučnica);
Gently tap the syringe to make any bubbles rise to the top of the syringe near the needle.
Obzirno potrkajte po brizgi, da se bodo mehurčki dvignili na vrh brizge, blizu igle.
3) Injecting Trudexa
3) Injiciranje Trudexe
• If you are allergic (hypersensitive) to adalimumab or any of the other ingredients of Trudexa.
• če ste alergični na (preobčutljivi za) za adalimumab ali katerokoli sestavino zdravila Trudexa.
The white needle sleeve will move down over the needle and lock into place over the needle tip.
Bel tulec igle se bo pomaknil navzdol prek igle in se bo zaskočil nad njeno konico.
In patients with Crohn's disease, adalimumab antibodies were identified in 7/269 subjects (2.6%) treated with adalimumab.
Pri bolnikih s Crohnovo boleznijo so identificirali protitelesa proti adalimumabu pri 7 od 269 oseb (2,6%), ki so bile zdravljene z adalimumabom.
Trudexa can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs.
Trudexo se lahko uporablja skupaj z metotreksatom ali nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (sulfasalazinom, hidroksiklorokinom, leflunomidom in pripravki zlata za injiciranje), steroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili.
The percent of Trudexa-treated patients achieving ACR 20, 50 and 70 responses was consistent across trials I, II and III.
Odstotek bolnikov, zdravljenih s Trudexo, ki so dosegli odziv 20, 50 in 70 po ACR, se je v raziskavah I, II in III skladal.
Cases of worsening congestive heart failure have also been reported in patients receiving Trudexa.
O primerih poslabšanja kongestivnega srčnega popuščanja so poročali tudi pri bolnikih, ki so prejemali Trudexo.
• Make sure that the plunger is fully inserted into the syringe.
• Prepričajte se, da je bat do konca potisnjen v brizgo.
Trudexa 40 mg every other week was assessed in 393 patients in two randomised, 24 week double − blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Trudexo 40 mg vsak drugi teden so ocenili v dveh randomiziranih 24-tedenskih dvojno slepih, s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa - Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6,3), ki se niso odzvali ustrezno na konvencionalno terapijo.
If the needle is correctly lined up, you should feel a slight resistance and then a “pop” as the needle goes through the centre of the stopper.
Če je igla pravilno naravnana, boste čutili rahel upor in potem "pok", ko igla predre osrednji del zamaška.
TNF-antagonists including Trudexa have been associated in rare cases with new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease.
Antagonisti tumorje nekrotizirajočega faktorja (TNF), s Trudexo vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni.
You should continue to inject Trudexa for as long as your doctor has told you.
Trudexo je treba injicirati toliko časa, kolikor vam je naročil zdravnik.
Study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Raziskava II je ocenila 544 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno.
In the larger study (VIII) with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Trudexa compared to placebo.
Rezultati obsežnejše študije (VIII) pri 315 bolnikih so pri bolnikih, ki so dobivali Trudexo, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s placebom.
Population pharmacokinetic analyses with data from over 1300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Analize populacijske farmakokinetike s podatki za več kot 1300 bolnikov z revmatoidnim artritisom so pokazale trend k večjemu navideznemu očistku adalimumaba z večanjem telesne teže.
Physicians should exercise caution when considering the use of Trudexa 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.
Pri odločanju za uporabo Trudexe 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.
Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with Trudexa.
Bolnike je treba pred, med in po zdravljenju s Trudexo natančno kontrolirati glede okužb, vključno s tuberkulozo.
Trudexa Mark your calendar with the stickers provided to remind you of the date for your next dose.
Trudexa S priloženimi nalepkami si na koledarju označite datum, ko morate vzeti naslednji odmerek.
Alternatively, if a patient has stopped Trudexa and signs and symptoms of disease recur, Trudexa may be re-administered.
Če bolnik neha uporabljati Trudexo, pa se znaki in simptomi bolezni ponovijo, je mogoče Trudexo znova uvesti.
Rare necrotising fasciitis, viral meningitis, diverticulitis
redki nekrotizirajoči faciitis, virusni meningitis, divertikulitis
• Look at the expiry date on the vial.
• Preverite datum izteka roka uporabnosti na viali.
In a study of 64 patients with rheumatoid arthritis that were treated with Trudexa, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-and B cells and NK-cells, monocyte/macrophages, and neutrophils.
V raziskavi 64 bolnikov z revmatoidnim artritisom, zdravljenih s Trudexo, niso odkrili znakov zavrtja odložene preobčutljivosti, znižanja koncentracije imunoglobulinov ali spremembe števila efektorskih celic T in B, naravnih celic ubijalk, monocitov/makrofagov ali nevtrofilcev.
Patients treated with Trudexa usually experienced improvement in haematological signs of chronic inflammation.
S Trudexo zdravljenim bolnikom so se ponavadi izboljšali hematološki znaki kroničnega vnetja.
• You should not be treated with Trudexa if you have a severe infection.
• Trudexe ne smete dobiti, če ste zboleli s katero od hudih okužb.
Trudexa is intended for treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Trudexa je namenjena za zdravljenje revmatoidnega artritisa, psoriatičnega artritisa in ankilozirajočega spondilitisa.
• With the needle still inserted in the vial, check the syringe for air bubbles.
• Medtem ko je igla še vedno v viali, preverite, ali so v brizgi zračni mehurčki.
1 st injection: _______________________ Following injections:
Datumi zdravljenja s Trudexo: 1. injekcija: _______________________ Naslednje injekcije:
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.
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.
Patients who develop a new infection while undergoing treatment with Trudexa should be monitored closely.
Bolnike, pri katerih se med zdravljenjem s Trudexo pojavi nova okužba, je treba natančno nadzirati.
Trudexa can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Trudexo je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
Respiratory, thoracic and mediastinal disorders interstitial lung disease, including pulmonary fibrosis
Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijska bolezen pljuč, vključno s pljučno fibrozo
Study IIa**
Raziskava IIa**
Table 6: Radiographic Mean Changes at Week 52 in Study V
Tabela 6: Povprečne rentgenografske spremembe po 52 tednih študije V
Treatment with Trudexa may result in the formation of autoimmune antibodies.
Zdravljenje s Trudexo lahko povzroči nastanek avtoimunskih protiteles.