natgillin/translations-raw huggingface dataset:
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).
Rheumatoid arthritis clinical trials: in controlled rheumatoid arthritis clinical trials (Studies I − IV), elevations of ALT were similar in patients receiving adalimumab or placebo.
Klinična preskušanja pri revmatoidnem artritisu: V kontroliranih kliničnih preskušanjih pri revmatoidnem artritisu (študije I − IV) so bila zvišanja ALT pri bolnikih, ki so dobivali adalimumab, podobna kot pri tistih, ki so dobivali placebo.
Wipe your skin by using the enclosed alcohol pad, using a circular motion.
S krožnim gibom obrišite kožo s priloženo alkoholno blazinico.
• One pre-filled pen of Trudexa • One alcohol pad
• en napolnjen injekcijski peresnik Trudexe • en alkoholni zloženec
People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma.
Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom (rak limfatičnega sistema).
Study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Študija V je ocenila 799 odraslih bolnikov, ki še niso dobivali metotreksata in so imeli zmerno do zelo aktiven zgoden revmatoidni artritis (povprečno trajanje bolezni manj kot 9 mesecev).
It is recommended that the conduct of these tests should be recorded in the patient alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Zdravniki se morajo zavedati tveganja za lažno negativne izvide tuberkulinskega kožnega testa, zlasti pri hudo bolnih ali imunsko oslabelih bolnikih.
Uncommon mood disorders, anxiety (including nervousness and agitation)
Psihiatrične motnje občasni motnje počutja, anksioznost (vključno z živčnostjo in agitiranostjo)
In postmarketing, serious allergic reactions including anaphylaxis have been reported very rarely following Trudexa administration.
V pomarketinškem obdobju so po uporabi Trudexe v zelo redkih primerih poročali o resnih alergijskih reakcijah, vključno z anafilaksijo.
Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last Trudexa treatment.
Ženske v rodni dobi morajo za preprečitev nosečnosti uporabljati ustrezno kontracepcijsko zaščito in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju s Trudexo.
Prior to Trudexa treatment:
Pred zdravljenjem s Trudexo:
Patients in steroid-free remission for >=90 daysa * p < 0.001 for Trudexa versus placebo pairwise comparisons of proportions ** p < 0.02 for Trudexa versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Bolniki v remisiji brez steroidov za ≥ 90 dnia * p < 0,001 za parne primerjave deležev med Trudexo in placebom ** p < 0,02 za parne primerjave deležev med Trudexo in placebom a Od tistih, ki so izhodiščno dobivali kortikosteroide.
If you are unsure, please contact your doctor.
Če niste gotovi, se posvetujte s svojim zdravnikom.
80/40 mg N = 75
Trudexa 80/40 mg n = 75
Study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had insufficient efficacy to methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexateintolerant) every week and whose methotrexate dose remained constant at 12.5 to 25 mg every week.
Raziskava III je ocenila 619 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek metotreksata ostal stalen od 12,5 do 25 mg vsak teden.
A
in
In patients with early rheumatoid arthritis (disease duration of less than 3 years) (Study V), elevations of ALT were more common in the combination arm (Trudexa /methotrexate) compared to the methotrexate monotherapy arm or the Trudexa monotherapy arm.
Pri bolnikih z zgodnjim revmatoidnim artritisom (trajanje bolezni manj kot 3 leta) (študija V) so bila zvišanja ALT pogostejša v kraku, v katerem so uporabljali kombinacijo (Trudexa/metotreksat), kot v kraku, v katerem so uporabljali monoterapijo z metotreksatom, ali v kraku, v katerem so uporabljali monoterapijo s Trudexo.
In controlled and open label studies with Trudexa, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated histoplasmosis, pneumocystis carinii pneumonia, aspergillosis and listeriosis).
V kontroliranih in odprtih študijah s Trudexo so poročali o resnih okužbah (vključno s smrtno nevarnimi okužbami, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana histoplazmoza, pljučnica zaradi Pnevmocystis Carinii, aspergiloza in listerioza).
Each pack contains 1 pre-filled syringe with needleguard for hospital administration or administration by a caregiver, with 1 alcohol pad.
Eno pakiranje vsebuje 1 napolnjeno injekcijsko brizgo s ščitnikom za iglo za bolnišnično uporabo oz. uporabo zdravstvenih delavcev in 1 alkoholni zloženec.
In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
V kontroliranih delih kliničnih preizkušanj z zaviralci TNF je bilo opaženih več primerov malignomov, vključno z limfomi tako pri bolnikih, ki so prejemali zaviralec TNF, kot pri kontrolnih bolnikih.
Uncommon chest pain, oedema, influenza like illness
občasni bolečina v prsih, edemi, gripi podobna bolezen
Hepatobiliary Disorders reactivation of hepatitis B
Bolezni jeter, žolčnika in žolčevodov reaktiviranje hepatitisa B
• upper respiratory tract infections (including cold, runny nose, sinus infection);
• okužbe zgornjih dihal (vključno s prehladom, izcedkom iz nosu, okužbo obnosnih votlin);
During Trudexa treatment:
Med zdravljenjem s Trudexo:
Use during lactation
Uporaba med obdobjem dojenja
• Arm or leg weakness.
• šibkost rok ali nog.
In patients not given concomitant methotrexate, the incidence was 13.5% (24/178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate.
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 13,5% (24/178 bolnikov), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 7% (14 od 198 bolnikov).
Impaired renal and/or hepatic function
Okvarjeno delovanje ledvic in/ali jeter
In Study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Trudexa and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Trudexa monotherapy at week 52 and responses were sustained at week 104 (see Table 4).
V študiji V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija s Trudexo in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija s Trudexo, odzivi pa so se ohranili do 104. tedna (glejte tabelo 4).
Neoplasms benign and malignant (including cysts and polyps)
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
Injecting Trudexa
Injiciranje Trudexe
Check the expiry date on the pre-filled pen label (EXP:).
Preverite datum izteka roka uporabnosti na peresniku (Uporabno do).
A loading dose of 160 mg Trudexa on week 0 followed by 80 mg Trudexa on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ml during the induction period.
Polnilni odmerek 160 mg Trudexe na 0. teden, ki mu sledi 80 mg Trudexe 2. teden, doseže med obdobjem indukcije najnižjo koncentracijo v serumu približno 12 µg/ml.
With your index finger or your thumb, press the plum coloured button on top once you are ready to begin the injection (see below).
Ko ste pripravljeni na začetek injiciranja (glejte spodaj), s palcem ali kazalcem enkrat pritisnite temnomodri gumb na vrhu.
Trudexa 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals.
Trudexa 40 mg raztopina za injiciranje v viali (steklo tipa I) za enkratno uporabo, opremljeni z gumijastim zamaškom, aluminijsko obrobo in dvižno zaporko.
• Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.
• znaki in simptomi, ki nakazujejo bolezni krvi, npr. trdovratna zvišana telesna temperatura, modrice, krvavitve, bledica.
You will then hear a ‘click' as the needle is released, and you will feel a small prick as the needle advances.
Ko se bo igla sprožila, boste zaslišali "klik", in ob njenem vbodu boste začutili droben bodljaj.
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Pomožne snovi so manitol, citronska kislina monohidrat, natrijev citrat, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, polisorbat 80, natrijev hidroksid in voda za injekcije.
In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week.
Med monoterapijo lahko nekaterim bolnikom, ki se jim odziv zmanjša, koristi zvečanje odmerka adalimumaba na 40 mg vsak teden.
The recommended Trudexa induction dose regimen for adult patients with severe Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Priporočena shema odmerjanja Trudexe med indukcijo je pri odraslih bolnikih s hudo Crohnovo boleznijo 80 mg 0. teden in nato 40 mg 2. teden.
Antibody formation was lower when Trudexa was given together with methotrexate in comparison with use as monotherapy.
Če je bila Trudexa uporabljena skupaj z metotreksatom, je bilo nastajanje protiteles v primerjavi z monoterapijo manjše.
The rate (95% confidence interval) of non-melanoma skin cancers was 7.6 (4.7, 12.4) per 1000 patient-years among Trudexa-treated patients and 2.0 (0.5, 8.2) per 1000 patient-years among control patients.
Delež (95% interval zaupanja) nemelanomskih kožnih rakov je bil 7,6 (4,7, 12,4) na 1000 bolnik-let med bolniki, ki so dobivali Trudexo, in 2,0 (0,5, 8,2) na 1000 bolnik-let med kontrolnimi bolniki.
The Trudexa vial is a glass vial containing a solution of adalimumab.
Viala s Trudexo je steklena viala, ki vsebuje raztopino adalimumaba.
Non-serious allergic reactions associated with Trudexa were uncommon during clinical trials.
S Trudexo povezane alergijske reakcije, ki niso bile resne, so se v kliničnih raziskavah pojavljale občasno.
• If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
• Če se pri vas pojavijo simptomi, ki nakazujejo okužbo, npr. zvišanje telesne temperature, trdovraten kašelj, hujšanje ali brezvoljnost, takoj poiščite zdravniško pomoč.
• skin disorders (such as psoriasis, eczema or infections), itchy rash, slow wound healing;
• bolezni kože (npr. luskavica, ekcem ali okužbe), srbeč izpuščaj, počasno celjenje ran;
Again, do NOT touch the needle or let it touch any surface.
Tudi zdaj pazite, da se igle pri tem NE DOTAKNETE ali se z njo česa ne dotaknete.
You are advised to avoid becoming pregnant and must use adequate contraception while using Trudexa and for at least 5 months after the last Trudexa treatment.
Priporočljivo je, da ne zanosite, zato morate med zdravljenjem s Trudexo in vsaj še 5 mesecev po zadnjem odmerku uporabljati ustrezno kontracepcijsko zaščito.
The additional adverse reactions in Table 2 have been reported from postmarketing surveillance or Phase IV clinical trials:
O dodatnih neželenih reakcijah (ki jih prikazuje tabela 2) so poročali v postmarketinških nadzorih ali kliničnih preskušanjih IV. faze:
Abbott Laboratories Ltd. Queenborough Kent ME11 5EL United Kingdom
Abbott Laboratories Ltd. Queenborough Kent ME11 5EL Velika Britanija
• See the Trudexa package leaflet for more information.
• Za podrobnejše informacije glejte navodilo za uporabo Trudexe.
What Trudexa contains
Kaj vsebuje zdravilo Trudexa
Uncommon systemic lupus erythematosus, angioedema, drug hypersensitivity, seasonal allergy
Bolezni imunskega sistema občasni sistemski eritematozni lupus, angioedem, preobčutljivost na zdravila, sezonska alergija redki serumska bolezen
There is limited safety experience of surgical procedures in patients treated with Trudexa.
Izkušnje z varnostjo operacij pri bolnikih, zdravljenih s Trudexo, so omejene.
Slowly pull the plunger back to draw solution into the syringe.
Počasi izvlecite bat, da boste raztopino potegnili v brizgo.
Table 3: ACR Responses in Placebo-Controlled Trials
Tabela 3: Odziv po ACR v raziskavah, kontroliranih s placebom
In Study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Trudexa/methotrexate combination therapy versus methotrexate monotherapy and Trudexa monotherapy at week 52, which was maintained through week 104.
V študiji V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji s Trudexo in metotreksatom po 52 tednih izboljšala bolj (p < 0,001) kot ob monoterapiji z metotreksatom ali ob monoterapiji s Trudexo; to se je ohranilo do 104. tedna.
Rare (< 1/1000)
Redko (≥1/10.000 do <1/1.000)
Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom
Abbott Laboratories Ltd Queenborough Kent ME11 5EL
Uncommon syncope, migraine, tremor, sleep disturbances
občasni sinkopa, migrena, tremor, motnje spanja redki multipla skleroza
ACR 20 Week 12 Week 24
ACR 20 12. teden
The rate (95% confidence interval) of lymphomas was 1.0 (0.2, 3.8) per 1000 patient-years among Trudexa-treated patients and 1.0 (0.1, 7.3) per 1000 patientyears among control patients.
Delež (95% interval zaupanja) limfomov je bil 1,0 (0,2, 3,8) na 1000 bolnik-let med bolniki, ki so dobivali Trudexo, in 1,0 (0,1, 7,3) na 1000 bolnik-let v kontrolni skupini bolnikov.
Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Trudexa.
Med zdravljenjem s Trudexo je mogoče nadaljevati z uporabo glukokortikoidov, salicilatov, nesteroidnih protivnetnih zdravil ali analgetikov.
All doses/schedules of Trudexa in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in Study III the same was seen at week 52.
V vseh štirih raziskavah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi odmerki/shemami Trudexe izboljšal statistično značilno bolj kot s placebom; v raziskavi III so isto ugotovili po 52 tednih.
Trudexa is contraindicated in moderate to severe heart failure (see section 4.3).
Pri bolnikih z zmernim do hudim srčnim popuščanjem je Trudexa kontraindicirana (glejte poglavje 4.3).
Common dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias)
Bolezni živčevja pogosti omotica (vključno z vrtoglavico), glavobol, motnje nevrološkega občutenja (vključno s parestezijami)
40 mg Trudexa every other week
40 mg Trudexe vsak drugi teden
The Trudexa pre-filled pen is a single-use grey- and plum-coloured pen which contains a glass syringe with Trudexa.
Napolnjeni injekcijski peresnik Trudexa je peresnik sive in temnomodre barve za enkratno uporabo, ki vsebuje stekleno brizgo z zdravilom Trudexa.
Placebo/MTXTRUDEXA/MTX (95% Confidence Intervalb)
40 mg vsak drugi teden placebo/MTXTRUDEXA/MTX (95% interval zaupanjab)