natgillin/translations-raw huggingface dataset:
Prescribers should exercise caution in considering the use of Trudexa in patients with pre-existing or recent-onset central nervous system demyelinating disorders.
Pri odločanju za uporabo Trudexe pri bolnikih z že prej obstoječimi ali nedavno nastalimi demielinizirajočimi boleznimi osrednjega živčevja je potrebna previdnost.
What Trudexa is and what it is used for Before you use Trudexa How to use Trudexa Possible side effects 5 How to store Trudexa Further information
Kaj je zdravilo Trudexa in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Trudexa Kako uporabljati zdravilo Trudexa Možni neželeni učinki
The needle cover of the syringe contains natural rubber (latex).
Pokrovček igle na brizgi vsebuje naravno gumo (lateks).
Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after Trudexa administration.
Po uporabi Trudexe se je zmanjšala tudi serumska raven matriksnih metaloproteinaz (MMP-1 in MMP-3), ki povzročajo remodeliranje tkiva, odgovorno za uničenje hrustanca.
In Study IV, the ACR 20 response of patients treated with Trudexa plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
V raziskavi IV je bil odziv 20 po ACR pri bolnikih, zdravljenih s Trudexo in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0,001).
Table 2 Undesirable Effects in Postmarketing Surveillance and Phase IV Clinical Studies
Tabela 2 Neželeni učinki med postmarketinškim nadzorom in kliničnimi študijami IV. faze
There have been reports of serious and severe opportunistic infections associated with Trudexa therapy, for example pneumocystis carinii pneumonia, disseminated histoplasmosis, listeriosis and aspergillosis.
Opisani so primeri resnih in hudih oportunističnih okužb, povezanih s terapijo s Trudexo, npr. pnevmocistična pljučnica, diseminirana histoplazmoza, listerioza in aspergiloza.
Psoriatic arthritis clinical trials: elevations in ALT were more common in psoriatic arthritis patients (Studies VI-VII) compared with patients in rheumatoid arthritis clinical studies.
Klinična preskušanja pri psoriatičnem artritisu: Zvišanja ALT so bila pri bolnikih s psoriatičnim artritisom (študiji VI-VII) pogostejša kot pri bolnikih v kliničnih študijah pri revmatoidnem artritisu.
In the twelve controlled trials, the rate of infection was 1.49 per patient year in the Trudexa treated patients and 1.42 per patient year in the placebo and active control-treated patients.
V dvanajstih kontroliranih preskušanjih je bil delež okužb 1,49 na bolnik-leto med bolniki, ki so dobivali Trudexo, in 1,42 na bolnik-leto med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
Erosion score JSNd score amethotrexate b95% confidence intervals for the differences in change scores between methotrexate and Trudexa.
Ocena erozij Ocena ZSŠd ametotreksat b95% intervali zaupanja za razlike v spremembi ocen med metotreksatom in Trudexo cna podlagi analize rangov dzožitev sklepne špranje
In rheumatoid arthritis, methotrexate is continued while using Trudexa.
Pri revmatoidnem artritisu se uporaba metotreksata med uporabo Trudexe nadaljuje.
Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Poleg tega je pri bolnikih z revmatoidnim artritisom z dolgotrajno, zelo aktivno vnetno boleznijo zvečano osnovno tveganje za limfome, kar komplicira oceno tveganja.
Each pack contains 1 vial with an empty sterile syringe and 2 alcohol pads.
Eno pakiranje vsebuje 1 vialo s prazno sterilno injekcijsko brizgo in 2 alkoholna zloženca.
Study VI with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
V njej so zdravili 313 odraslih, ki se niso ustrezno odzvali na terapijo z nesteroidnimi protivnetnimi zdravili; približno 50% od teh je jemalo metotreksat.
Therapy continued beyond 12 weeks did not result in significantly more responses (see section
Zdravljenje prek 12. tedna ni prineslo značilno več odzivov (glejte poglavje 4.2).
A rapid decrease in CRP levels was also observed in patients with Crohn's disease.
Pri pacientih s Crohnovo boleznijo so opazili tudi naglo znižanje koncentracij CRP.
Trudexa has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Dokazano je, da Trudexa upočasni napredovanje rentgenografsko merjene prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
• Do not put either of the caps back on the pre-filled pen.
• Ne enega ne drugega pokrovčka ne natikajte nazaj na napolnjeni injekcijski peresnik.
Like all medicines, Trudexa can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi Trudexa neželene učinke , ki pa se ne pojavijo pri vseh bolnikih.
Study VI
Študija VI
This study evaluated the efficacy of Trudexa 40 mg every other week/methotrexate combination therapy, Trudexa 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Ta študija je ocenila učinkovitost treh shem (kombinirana terapija s Trudexo 40 mg vsak drugi teden/metotreksatom, monoterapija s Trudexo 40 mg vsak drugi teden in monoterapija z metotreksatom) za zmanjšanje znakov in simptomov ter hitrosti napredovanja sklepne okvare pri revmatoidnem artritisu v obdobju 104 tednov.
A patient who requires surgery while on Trudexa should be closely monitored for infections, and appropriate actions should be taken.
Bolnika, ki med zdravljenjem s Trudexo potrebuje operacijo, je treba natančno nadzirati glede okužb in ustrezno ukrepati.
• asthma, shortness of breath;
• astma, hitra zadihanost;
Concurrent administration of TNF-antagonists and anakinra
Sočasna uporaba antagonistov TNF in anakinre
NA NA 4.5% 23.2% a Study I at 24 weeks, Study II at 26 weeks , and Study III at 24 and 52 weeks b 40 mg Trudexa administered every other week c MTX = methotrexate
NP 4,5% 23,2% a Raziskava I po 24 tednih, raziskava II po 26 tednih in raziskava III po 24 in 52 tednih b 40 mg Trudexe vsak drugi teden c MTX = metotreksat
In Studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dl) values) improved at 24 or 26 weeks compared to placebo.
V raziskavah I-IV so se v primerjavi s placebom po 24 oz. 26 tednih izboljšali vsi posamezni elementi meril odziva po ACR (število bolečih in oteklih sklepov, zdravnikova in bolnikova ocena aktivnosti bolezni in bolečin, vrednost indeksa invalidnosti (HAQ) in vrednost CRP (mg/dl)).
Trudexa, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, Studies VI and VII.
Uporabo Trudexe 40 mg vsak drugi teden so pri bolnikih z zmernim do hudim aktivnim psoriatičnim artritisom proučili v dveh s placebom kontroliranih študijah, študiji VI in študiji VII.
The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg every other week and every week subcutaneous dosing.
Najnižje koncentracije adalimumaba v serumu v stanju dinamičnega ravnovesja so naraščale približno sorazmerno odmerku po 20, 40 in 80 mg vsak drugi teden in vsak teden subkutano.
When combining controlled portions of ten trials (I-IX and CHARM) and ongoing open label extension studies with a median duration of approximately 2. years including 4843 patients and over 13000 patient-years of therapy, the observed rate of malignancies, other than lymphoma and nonmelanoma skin cancers is approximately 13.6 per 1000 patient years.
Če vzamemo skupaj kontrolirane dele desetih preskušanj (I-IX in CHARM) in potekajoče nadaljevalne študije z medianim trajanjem približno 2 leti s 4843 bolniki in prek 13000 bolnik-leti zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 13,6 na 1000 bolnik-let.
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