natgillin/translations-raw huggingface dataset:
There is insufficient evidence of the efficacy of Trudexa in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied (see Table 7). 
Zaradi majhnega števila bolnikov ni dovolj dokazov o učinkovitosti Trudexe pri bolnikih s psoriatično artropatijo, podobno ankilozirajočemu spondilitisu (glejte tabelo 7).
• nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances; 
• bolezni živčevja (npr. multipla skleroza in vnetje očesnega živca), motnje okusa;
The data in Table 1 is based on the controlled Studies (I − IX,CLASSIC I, GAIN AND CHARM) (described in section 5.1) involving 3271 patients receiving Trudexa and 1809 patients receiving placebo or active comparator during the controlled period. 
Podatki v tabeli 1 temeljijo na kontroliranih študijah (I−IX, CLASSIC I, GAIN in CHARM) (opisanih v poglavju 5.1), ki zajemajo 3271 bolnikov, ki so med kontroliranim obdobjem dobivali Trudexo, in 1809 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
In clinical trials an increased risk of serious infections in patients receiving Trudexa has been shown, and reports from the post-marketing setting support this finding. 
V kliničnih preskušanjih so pri bolnikih, ki so prejemali Trudexo, ugotovili večje tveganje za resne okužbe; pomarketinška poročila to potrjujejo.
In patients not given concomitant methotrexate, the incidence was 12.4%, compared to 0.6% when adalimumab was used as add-on to methotrexate. 
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 12,4%, pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 0,6%.
• flu like symptoms, chest pain, swelling of the feet. 
• simptomi podobni gripi, bolečine v prsih, otekanje stopal.
The active substance is adalimumab. 
Zdravilna učinkovina je adalimumab.
Trudexa treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or Crohn's disease. 
Zdravljenje s Trudexo mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa ali Crohnove bolezni.
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of Studies I − IX, CLASSIC I, GAIN and CHARM was 5.7% for patients taking Trudexa and 5.3% for control treated patients. 
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, kontroliranim delom raziskav I-IX, CLASSIC I, GAIN in CHARM, je bil 5,7% v skupini, ki je prejemala Trudexo, in 5,3% v kontrolni skupini.
The incidence of serious infections was 0.03 per patient year in Trudexa treated patients and 0.03 per patient year in placebo and active control − treated patients. 
Incidenca resnih okužb je bila 0,03 na bolnik-leto med bolniki, ki so dobivali Trudexo, in 0,03 na bolnik-leto med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
Patients in steroid-free remission for >=90 daysa 
Bolniki v remisiji brez steroidov za ≥ 90 dnia
• You might get infections more easily while you are receiving Trudexa treatment including serious infections, tuberculosis, opportunistic infections and sepsis that may, in rare cases, be life-threatening. 
• Med zdravljenjem s Trudexo se lahko poveča dovzetnost za okužbe, vključno z resnimi okužbami, tuberkulozo, oportunističnimi okužbami in sepso, ki so lahko v redkih primerih smrtno nevarne.
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 Trudexa. 
Vsem bolnikom je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se jim med uporabo Trudexe pojavijo znaki ali simptomi krvnih diskrazij (npr. trajno zvišana telesna temperatura, podplutbe, krvavitve, bledica).
• With one quick, short motion, push needle all the way into skin 
• S hitrim, kratkim gibom iglo v celoti zabodite v kožo.
The usual dose regimen for Crohn's disease is 80 mg at week 0 and followed by 40 mg every other week starting at week 2. 
Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg 0. teden, čemur sledi 40 mg vsak drugi teden od 2. tedna naprej.
Set up the following items on a clean surface. 
Na čisto površino pripravite naslednje:
• Other side effects that have been observed in patients taking Trudexa: 
Drugi neželeni učinki, zabeleženi pri bolnikih, ki so jemali Trudexo:
The blinded period was followed by an open − label period during which patients received Trudexa 40 mg every other week subcutaneously for up to an additional 28 weeks. 
Slepljenemu obdobju je sledilo odprto obdobje, med katerim so bolniki dobivali 40 mg Trudexe vsak drugi teden subkutano, do največ dodatnih 28 tednov.
For induction treatment, Trudexa should be given in combination with corticosteroids. 
Za indukcijsko zdravljenje morate Trudexo uporabiti v kombinaciji s kortikosteroidi.
CLASSIC I: Infliximab Naive Patients 
CLASSIC I: Bolniki, ki še niso dobivali infliksimaba
Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 37 (9.4%) patients with glucocorticoids. 
Devetinsedemdeset (20,1%) bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9,4%) bolnikov pa glukokortikoide.
In Studies I-IV, Trudexa-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment. 
V študijah I-IV so s Trudexo zdravljeni bolniki v primerjavi s prejemniki placeba dosegli statistično značilen odziv 20 in 50 po ACR že en do dva tedna po začetku zdravljenja.
• Swollen face, hands, feet; 
• oteklost obraza, dlani in stopal;
The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells. 
Zdravilna učinkovina, adalimumab, je humano monoklonsko protitelo, pridobljeno iz gojenih celic.
After treatment with Trudexa, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed compared to baseline in patients with rheumatoid arthritis. 
Po zdravljenju s Trudexo so pri bolnikih z revmatoidnim artritisom opažali hitro znižanje reaktantov akutne faze vnetja (C-reaktivnega proteina (CRP) in hitrosti sedimentacije eritrocitov (SR)) in serumskih citokinov (IL-6) v primerjavi z izhodiščem.
Crohn's disease clinical trials: in controlled clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo. 
Klinična preskušanja pri Crohnovi bolezni: V kontroliranih kliničnih preskušanjih je bilo zvišanje ALT podobno pri bolnikih, ki so dobivali adalimumab, in pri tistih, ki so dobivali placebo.
Following subcutaneous administration of 40 mg of Trudexa every other week in rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 µg/ml (without concomitant methotrexate) and 8 to 9 µg/ml (with concomitant methotrexate), respectively. 
Po subkutani uporabi 40 mg Trudexe vsak drugi teden pri bolnikih z revmatoidnim artritisom (RA) so bile povprečne najmanjše koncentracije v stanju dinamičnega ravnovesja približno 5 µg/ml (brez sočasne uporabe metotreksata) in od 8 do 9 µg/ml (s sočasno uporabo metotreksata).
Additional Adverse Reactions from Postmarketing Surveillance or Phase IV Clinical Trials 
Dodatne neželene reakcije iz obdobja postmarketinškega spremljanja ali kliničnih preizkušanj IV. faze
Adalimumab binds to a specific protein (tumour necrosis factor or TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. 
Adalimumab se veže na specifično beljakovino (tumorje nekrotizirajoči faktor ali TNFα), ki je pri vnetnih boleznih, kakršne so revmatoidni artritis, psoriatični artritis in ankilozirajoči spondilitis, prisoten v večji koncentraciji.
Patients were randomised to 40 mg of Trudexa or placebo every other week for 24 weeks. 
Bolnike so randomizirali na 40 mg Trudexe ali placebo vsak drugi teden za 24 tednov.
Table 4: ACR Responses in Study V (percent of patients) 
Tabela 4: Odzivi ACR v študiji V (odstotek bolnikov)
Table 9: Induction of Clinical Remission and Response (Percent of Patients) 
Tabela 9: Indukcija klinične remisije in odziva (odstotek bolnikov)
Among those, 86, 72, and 41 patients had ACR 20/50/70 response, respectively at month 60. 
Med temi je imelo 60. mesec 86 bolnikov odziv po ACR 20, 72 bolnikov odziv po ACR 50 in 41 bolnikov odziv po ACR 70.
Preparing the Trudexa dose for injection 
Priprava odmerka Trudexe za injiciranje
In patients with psoriatic arthritis, adalimumab antibodies were identified in 38/376 subjects (10%) treated with adalimumab. 
Med bolniki s psoriatičnim artritisom so protitelesa proti adalimumabu ugotovili pri 38/376 (10%) tistih, ki so dobivali adalimumab.
In patients with ankylosing spondylitis antibodies were identified in 17/204 subjects (8.3%) treated with adalimumab. 
Med bolniki z ankilozirajočim spondilitisom so protitelesa ugotovili pri 17/204 (8,3%) tistih, ki so dobivali adalimumab.
113/207 of patients originally treated with 40 mg Humira every other week were evaluated radiographically at 5 years. 
113 od 207 bolnikov, ki so bili zdravljeni s 40 mg Trudexe vsak drugi teden, so rentgenografsko ocenili po 5-ih letih.
• If you have mild heart failure and you are being treated with Trudexa , your heart failure status must be closely monitored by your doctor. 
• Če imate blago srčno popuščanje in se zdravite s Trudexo, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
Table 10: Maintenance of Clinical Remission and Response (Percent of Patients) 
Tabela 10: Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
• If you develop symptoms of heart failure (shortness of breath or swelling of the feet) seek medical attention immediately. 
• Če doživite simptome srčnega popuščanja (težko dihanje ali otekanje nog), takoj poiščite zdravniško pomoč.
METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Subkutana uporaba
40 mg Trudexa every week 
40 mg Trudexe vsak teden
In CLASSIC I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg Trudexa at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2. 
V študiji CLASSIC I so 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg Trudexe 0. teden in 80 mg 2. teden, 80 mg 0. teden in 40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
• serious infections (such as sepsis [blood poisoning]), joint infection, fungal infections; 
• resne okužbe (npr. sepsa [zastrupitev krvi]), okužba sklepa, glivične okužbe;
• Look at the expiry date on the syringe. 
• Preverite datum izteka roka uporabnosti na brizgi.
Check that the small grey needle cover of the syringe has been removed with the cap. 
Preverite, da ste s pokrovčkom vred odstranili tudi malo sivo pokrivalo igle na brizgi.
In CHARM, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2. 
V tej študij je 854 bolnikov po odprtem protokolu dobilo 80 mg 0. teden in 40 mg 2. teden.
Nervous system disorders demyelinating disorders (e.g. optic neuritis) 
Bolezni živčevja demielinizirajoče bolezni (npr. optični nevritis)
Instructions for preparing and giving an injection of Trudexa: 
Navodila za pripravo in injiciranje Trudexe
Psoriatic arthritis and ankylosing spondylitis 
Psoriatični arthritis in ankilozirajoči spondilitis
Trudexa is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. 
Trudexa je indicirana za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
There were 114 out of 207 patients who continued on Humira 40 mg every other week for 60 months. 
114 od 207 bolnikov je nadaljevalo z jemanjem 40 mg Trudexe vsak drugi teden 60 mesecev.
• elevated liver enzymes; 
• zvišanje jetrnih encimov;
In the twelve controlled trials, 16% of patients treated with Trudexa developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 10% of patients receiving placebo or active control. 
V dvanajstih kontroliranih preskušanjih je reakcije na mestu injiciranja (eritem in/ali srbenje, krvavitve, bolečine ali oteklost) imelo 16% bolnikov, ki so dobivali Trudexo, in 10% bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
NAME OF THE MARKETING AUTHORISATION HOLDER Abbott Laboratories Ltd 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Abbott Laboratories Ltd
1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe in pouch and 2 alcohol pads, all in a blister. 
1 viala (0,8 ml sterilne raztopine), 1 prazna sterilna injekcijska brizga v vrečki in 2 alkoholna zloženca, vse v pretisnem omotu.
• increased lipid values, appetite disorders; 
• zvišani lipidi, motnje apetita;
This leaflet was last approved in {MM/YYYY} 
Navodilo je bilo odobreno {MM/LLLL}
The observed rate of nonmelanoma skin cancers is approximately 9.0 per 1000 patient years, and the observed rate of lymphomas is approximately 1.2 per 1000 patient years. 
Ugotovljeni delež nemelanomskih kožnih rakov je približno 9,0 na 1000 bolnik-let, ugotovljeni delež limfomov pa približno 1,2 na 1000 bolnik-let.
What the Trudexa vial looks like and contents of the pack 
Izgled zdravila Trudexa in vsebina pakiranja
Patients should be instructed to seek medical advice if signs/symptoms (e.g., persistent cough, wasting/weight loss, low grade fever) suggestive of a tuberculosis infection occur during or after therapy with Trudexa. 
Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem s Trudexo ali po njem doživijo znake ali simptome (npr. trdovraten kašelj, hujšanje/izgubljanje teže, nekoliko zvišano telesno temperaturo), ki nakazujejo tuberkulozno okužbo.
There is no apparent correlation between the presence of anti-adalimumab antibodies and adverse events. 
Med prisotnostjo protiteles proti adalimumabu in neželenimi učinki ni očitne korelacije.
HOW TO USE TRUDEXA 
KAKO UPORABLJATI ZDRAVILO TRUDEXA
Methotrexate should be continued during treatment with Trudexa. 
Med zdravljenjem s Trudexo je treba še naprej uporabljati metotreksat.
Total Sharp score 
Celotna Sharpova ocena
• lung disease. 
• pljučna bolezen.
Trudexa has been shown to slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function. 
Dokazano je, da Trudexa upočasni okvaro sklepnega hrustanca in kosti, ki jo povzroča ta bolezen in izboljšuje telesno delovanje.
At week 52, 42.9% of patients who received Trudexa/methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Trudexa monotherapy. 
Po 52. tednih je klinično remisijo (DAS28 < 2,6) doseglo 42,9% bolnikov, ki so dobivali kombinirano terapijo s Trudexo/metotreksatom, 20,6% bolnikov, ki so dobivali metotreksat v monoterapiji, in 23,4% bolnikov, ki so dobivali Trudexo v monoterapiji.
Most patients continued on Trudexa after the infection resolved. 
Večina bolnikov je po ozdravitvi okužbe nadaljevala zdravljenje s Trudexo.
PO Box 1, N-1330 Fornebu Martin Linges vei 25, N-1367 Snarøya Tlf: + 47 81 55 99 20 
Abbott Norge AS PO Box 1, N-1330 Fornebu Martin Linges vei 25, N-1367 Snarøya Tlf: + 47 81 55 99 20
N/A N/A *** p < 0.001 for all comparisons between Trudexa and placebo * p < 0.05 for all comparisons between Trudexa and placebo N/A not applicable 
*** p < 0,001 za vse primerjave med Trudexo in placebom * p < 0,05 za vse primerjave med Trudexo in placebom np ne pride v poštev
Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified total Sharp score ≤ 0.5) was significantly higher with Trudexa/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Trudexa monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively). 
Po 52 oz. 104 tednih zdravljenja je bil v skupini s kombinirano terapijo s Trudexo in metotreksatom odstotek bolnikov brez napredovanja bolezni (sprememba prilagojene Sharpove ocene od izhodišča ≤ 0,5) značilno večji (63,8% oz. 61,2%) kot v skupinah, ki sta prejemali monoterapijo z metotreksatom (37,4% in 33,5%, p < 0,001) ali monoterapijo s Trudexo (50,7%, p < 0,002, oz. 44,5%, p < 0,001).
Thereafter, patients enrolled in an open-label extension phase in which 40 mg of Trudexa was administered every other week up to 60 months. 
Potem so bolnike vključili v odprto nadaljevalno fazo, med katero so dobivali 40 mg Trudexe vsak drugi teden v obdobju do 60 mesecev.
In GAIN, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Trudexa at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2. 
V študiji GAIN so 325 bolnikov, ki so se nehali odzivati na infliksimab ali ga niso prenesli, randomizirali bodisi na 160 mg Trudexe 0. teden in 80 mg 2. teden bodisi na placebo 0. in 2. teden.
Week 12 
2. teden 12. teden
Do not use Trudexa: 
Ne uporabljajte zdravila Trudexa
Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Trudexa therapy. 
Bolnike, ki jih ogroža okužba s HBV, je treba pred začetkom zdravljenja s Trudexo oceniti glede znakov okužbe s HBV v preteklosti.
In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients. 
V eksploracijskem kliničnem preskušanju infliksimaba, drugega zdravila proti TNF, pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB), so med prejemniki infliksimaba zabeležili več malignomov, večinoma pljuč ali glave in vratu, kot med primerjalnimi bolniki.
NAME OF THE MARKETING AUTHORISATION HOLDER Abbott Laboratories Ltd. 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Abbott Laboratories Ltd.
If you have rheumatoid arthritis and you do not receive methotrexate with your Trudexa therapy, your doctor may decide to give 40 mg adalimumab every week. 
Če imate revmatoidni artritis in če hkrati s Trudexo ne dobivate metotreksata, vam bo zdravnik morda predpisal 40 mg adalimumaba vsak teden.
• dizziness, including vertigo, headache; 
• omotica, vključno z vrtoglavico, glavobol;
In patients not given concomitant methotrexate, the incidence was 16/185 (8.6%), compared to 1/19 (5.3%) when adalimumab was used as add-on to methotrexate. 
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 16/185 (8,6%), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 1/19 (5,3%).
NEVER recap a needle. 
NIKDAR ne nameščajte pokrovčka nazaj na iglo.
The long half-life of adalimumab should be taken into consideration if a surgical procedure is planned. 
Če je predviden kirurški poseg, je treba upoštevati dolgi razpolovni čas adalimumaba.
Week 56 
52. teden
Serious infections, sepsis, tuberculosis and other opportunistic infections, including fatalities, have been reported with Trudexa. 
Med uporabo Trudexe so bile opisane resne okužbe, sepsa, tuberkuloza in druge oportunistične okužbe, tudi s smrtnimi primeri.
Trudexa was evaluated in over 3000 patients in all rheumatoid arthritis clinical trials. 
V vseh kliničnih preskušanjih pri revmatoidnem artritisu so Trudexo ocenili pri več kot 3000 bolnikih.
The following instructions explain how to give yourself an injection of Trudexa using the pre-filled pen. 
Naslednja navodila pojasnjujejo, kako si injicirate Trudexo z napolnjenim injekcijskim peresnikom.
Doses of 20 or 40 mg of Trudexa were given by subcutaneous injection every other week with placebo on alternative weeks or every week for 26 weeks; placebo was given every week for the same duration. 
Bolniki so 26 tednov dobivali odmerka 20 ali 40 mg Trudexe v subkutani injekciji vsak drugi teden s placebom vsak vmesni teden ali vsak teden; placebo so dobivali vsak teden enako dolgo.
Trudexa is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. 
Trudexa je indicirana za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
Slowly press the plunger to push the bubbles out of the syringe and into the vial. 
Počasi potisnite bat, da boste mehurčke iztisnili iz brizge v vialo.
In cases where a more rapid response is required your doctor may prescribe a dose of 160 mg at week 0 (as 4 injections in one day or 2 injections per day for two consecutive days), 80 mg (2 injections) at week 2, and thereafter as 40 mg (1 injection) every other week. 
Kadar je potreben hitrejši odziv, vam zdravnik lahko predpiše odmerek 160 mg 0. teden (v 4 injekcijah na en dan ali v 2 injekcijah dva dni zapored), 80 mg (2 injekciji) 2. teden in potem 40 mg (1 injekcija) vsak drugi teden.
Trudexa has been studied both in rheumatoid arthritis and psoriatic arthritis patients taking Trudexa as monotherapy and those taking concomitant methotrexate. 
Trudexo so raziskali tako pri bolnikih z revmatoidnim artritisom in psoriatičnim artritisom, ki so Trudexo jemali v monoterapiji, kot pri tistih, ki so jo jemali hkrati z metotreksatom.
Adverse Reaction 
Neželena reakcija
Some patients who experience decrease in their response may benefit from an increase in dose intensity to 40 mg Trudexa every week. 
Nekaterim bolnikom, ki se jim odziv zmanjša, lahko koristi povečanje odmerka Trudexe na 40 mg vsak teden.
• If you experience allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Trudexa and contact your doctor immediately. 
• Če doživite alergijske reakcije, npr. tiščanje v prsih, piskajoče dihanje, omotico, otekanje ali izpuščaj, Trudexe ne injicirajte več in se takoj posvetujte s svojim zdravnikom.
Manufacturer: 
Pakiranja:
During the controlled portions of ten Trudexa trials at least 12 weeks in duration (I-IX and CHARM) in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 5.7 (3.3, 10.1) per 1000 patient-years among 2887 Trudexa treated patients versus a rate of 4.1 (1.5, 10.9) 1 per 1000 patient-years among 1570 control patients (median duration of treatment was 5.7 months for Trudexa and 5.5 months for controltreated patients). 
V kontroliranih delih desetih preskušanj Trudexe (I-IX in CHARM), ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom in Crohnovo boleznijo so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95% interval zaupanja) 5,7 (3,3, 10,1) na 1000 bolnik-let med 2887 bolniki, ki so dobivali Trudexo, in 4,1 (1,5, 10.9) na 1000 bolnik-let med 1570 kontrolnimi bolniki (pri prvih je zdravljenje mediano trajalo 5,7 meseca in pri drugih 5,5 meseca).
The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.4 per 1000 patient years, respectively (see section 4.4). 
Ugotovljeni delež nemelanomskih rakov je približno 0,2 na 1000 bolnik-let in limfomov približno 0,4 na 1000 bolnik-let (glejte poglavje 4.4).