natgillin/translations-raw huggingface dataset:
ORENCIA contains the active substance abatacept, a protein produced in cell cultures.
Zdravilo ORENCIA vsebuje zdravilno učinkovino abatacept, ki je beljakovina, pridobljena na celičnih kulturah.
Because there is a higher incidence of infections and malignancies in the elderly in general, caution should be used when treating the elderly (see section 4.8).
Ker je pojavnost okužb in novotvorb pri starostnikih na splošno večja, je pri zdravljenju starostnikov potrebna previdnost (glejte poglavje 4.8).
The efficacy response over time in this study appeared consistent with studies that included an intravenous loading dose, however, the effect of no intravenous load on the onset of efficacy has not been formally studied.
V tej študiji je bila učinkovitost s časom podobna kot v študijah, ki so vključevale začetni intravenski odmerek, vendar pa vpliva neuporabe začetnega intravenskega odmerka na nastop učinka niso formalno raziskovali.
Always handle the ORENCIA syringe carefully, especially when you are around other people, and children.
Z zdravilom ORENCIA v napolnjeni injekcijski brizgi morate vedno rokovati previdno, še posebej v prisotnosti drugih oseb in otrok.
A. Check the expiry date and batch number on the carton The expiry date can be found on the ORENCIA carton and on each syringe.
A. Preverite datum izteka roka uporabnosti zdravila in številko serije na ovojnini Datum izteka roka uporabnosti zdravila je naveden na škatli zdravila ORENCIA in na vsaki injekcijski brizgi.
No clinical impact of these antibody responses was detected, and no safety concerns were observed upon reinitiation of abatacept therapy.
Kliničnega pomena tega protitelesnega odziva niso ugotovili, pri ponovni uvedbi zdravljenja z abataceptom pa niso opazili težav z varnostjo.
Other reactions potentially associated with hypersensitivity to the medicinal product, such as hypotension, urticaria, and dyspnea, that occurred within 24 hours of ORENCIA infusion, were uncommon.
Druge reakcije, ki bi lahko bile povezane s preobčutljivostjo na zdravilo, kot so hipotenzija, urtikarija in dispneja, ter so se pojavile v 24 urah po infundiranju zdravila ORENCIA, so bile po pogostnosti občasne.
b 61% of patients were previously treated with TNF inhibitor.
b 61% bolnikov se je predhodno zdravilo z zaviralcem TNF.
The efficacy of subcutaneous abatacept in children 2 to 17 years of age is based on pharmacokinetic exposure and extrapolation of established efficacy from intravenous abatacept in pJIA patients and subcutaneous abatacept in adult patients with RA, and is supported by data from an ongoing clinical study.
Učinkovitost subkutane uporabe abatacepta pri otrocih, starih od 2 do 17 let, temelji na farmakokinetični izpostavljenosti in ekstrapolaciji ugotovljene učinkovitosti pri intravenski uporabi abatacepta pri bolnikih s pJIA in subkutane uporabe abatacepta pri odraslih bolnikih z RA, podprta pa je tudi s podatki iz klinične študije, ki še poteka.
In rats, abatacept had no undesirable effects on male or female fertility.
Pri podganah abatacept ni imel neželenih učinkov na plodnost samcev ali samic.
Before you are given ORENCIA, your doctor will examine you for tuberculosis or do a skin test. if you have viral hepatitis tell your doctor.
Pred začetkom zdravljenja z zdravilom ORENCIA vas bo zdravnik pregledal na tuberkulozo ali pa izvedel kožni test. če imate virusni hepatitis, to povejte svojemu zdravniku.
Antibodies directed against the abatacept molecule were assessed by ELISA assays in 3,985 rheumatoid arthritis patients treated for up to 8 years with abatacept.
Protitelesa proti molekuli abatacepta so z ELISA testi ugotavljali pri 3.985 bolnikih z revmatoidnim artritisom, ki so se z abataceptom zdravili do 8 let.
The GDH-PQQ based glucose monitoring systems may react with the maltose present in ORENCIA, resulting in falsely elevated blood glucose readings on the day of infusion.
Sistemi za merjenje glukoze, ki temeljijo na GDH-PQQ, lahko reagirajo z maltozo, prisotno v zdravilu ORENCIA, kar ima za posledico lažno povečane odčitke koncentracije krvnega sladkorja na dan infundiranja.
Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis.
Rekonstitucijo in redčenje je treba izvesti v skladu s pravili dobre prakse.
*Note: the figure shows the 50 mg pre-filled syringe Proceed to Step 3
*Opomba: slika prikazuje 50 mg napolnjeno injekcijsko brizgo Nadaljujte s 3. korakom.
Do not speed up the warming process in way, such as using the microwave or placing the syringe in warm water.
Ne pospešujte postopka segrevanja, na primer z uporabo mikrovalovne pečice ali namakanjem injekcijske brizge v toplo vodo.
Your doctor will advise you on suitable methods.
Ustrezno obliko kontracepcije vam bo svetoval zdravnik.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
V primeru prevelikega odmerjanja priporočamo, da se bolnika nadzira glede pojava katerega koli znaka ali simptoma neželenih učinkov in uvede ustrezno simptomatsko zdravljenje.
Serious infections were reported in 0.8% (1/119), 3.4% (4/116) and 0% (0/116) patients.
O resnih okužbah so poročali pri 0,8 % (1/119), 3,4 % (4/116) in 0 % (0/116) bolnikov.
When receiving ORENCIA, patients that require blood glucose monitoring should be advised to consider methods that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods.
Bolnikom, ki potrebujejo merjenje koncentracije krvnega sladkorja, je treba svetovati, da naj med zdravljenjem z zdravilom ORENCIA uporabljajo teste, ki ne reagirajo z maltozo, npr. testi na osnovi glukoza dehidrogenaza nikotin adenin dinukleotidne (GDH-NAD), glukoza oksidazne ali glukoza heksokinazne metode.
The side effects experienced in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those experienced in adults as described above, with the following differences:
Neželeni učinki o katerih so poročali pri otrocih in mladostnikih s poliartikularnim juvenilnim idiopatskim artritisom so podobni kot pri odraslih, ki so opisani zgoraj, z naslednjimi izjemami:
The results from studies II, III, and VI are shown in Table 6.
Rezultati iz študij II, III in VI so prikazani v preglednici 6.
e DAS28-CRP Remission is defined as a DAS28-CRP score < 2.6 f Per protocol data is presented in table.
e DAS28-CRP remisija je opredeljena kot ocena DAS28-CRP < 2,6 f Podatki po protokolu so predstavljeni v preglednici.
* n = 119 for Abatacept SC + MTX; n = 116 for MTX
* n = 119 za abatacept s.c. + MTX; n = 116 za MTX
Dose selection: see section 3 ‘How to use ORENCIA' of the Package Leaflet
Določitev odmerka: glejte poglavje 3 ‘Kako uporabljati zdravilo ORENCIA' v navodilu za uporabo.
In study IV, there were 37 patients with COPD treated with intravenous abatacept and 17 treated with placebo.
V študiji IV je 37 bolnikov s KOPB prejemalo abatacept intravensko, 17 pa placebo.
The most frequently reported autoimmune-related disorders other than the indication being studied during the cumulative period were psoriasis, rheumatoid nodule, and Sjogren's syndrome.
Bolezni, povezane z avtoimunskimi procesi, razen raziskovane indikacije, o katerih so v kumulativnem obdobju poročali najpogosteje, so bile psoriaza, revmatoidni vozlič in Sjögrenov sindrom.
DO NOT use if past the expiry date.
NE uporabljajte po datumu izteka roka uporabnosti.
Two patients (2/117, 1.7%) using the SC prefilled pen experienced local injection site reactions.
Pri dveh bolnikih (2/117; 1,7 %), ki sta s.c. uporabljala napolnjen injekcijski peresnik, so poročali o pojavu lokalnih reakcij na mestu injiciranja.
Have the syringe ready for use immediately after you have prepared your injection site.
Injekcijsko brizgo imejte pripravljeno, da jo boste lahko uporabili takoj po pripravi mesta za injiciranje.
50 mg 25 kg to less than 50kg 87.5mg 50 kg or more
50 mg 25 kg do manj kot 50kg 87,5mg 50 kg ali več
The safety and efficacy of ORENCIA in children below 2 years of age have not been established.
Varnost in učinkovitost zdravila ORENCIA pri otrocih, mlajših od 2 let, nista bili dokazani.
Your doctor may start your ORENCIA treatment with or without a one-time dose of powder for concentrate for solution for infusion (given to you into a vein, usually in your arm, over a period of 30 minutes).
Zdravnik lahko zdravljenje z zdravilom ORENCIA uvede z enkratnim odmerkom zdravila v obliki praška za koncentrat za raztopino za infundiranje (ki ga boste prejeli v žilo, običajno na roki, v obliki 30 minutne infuzije) ali brez njega.
For ITT; n=736, 721 for subcutaneous (SC) and intravenous (IV) abatacept,
Za vse vključene bolnike: n=736 za subkutano (s.c.) uporabo abatacepta in n=721 za intravensko (i.v.)
Paediatric pJIA population
Pediatrična populacija s pJIA
All injection site reactions were described as mild to moderate (hematoma, pruritus, or erythema) and generally did not necessitate drug discontinuation.
Vse reakcije na mestu injiciranja so bile opisane kot blage do zmerne (hematom, srbenje ali rdečina), zdravljenja pa zaradi njih običajno ni bilo treba prekiniti.
ORENCIA lessens the immune system's attack on normal tissues by interfering with the immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis.
Zdravilo ORENCIA zmanjšuje napad imunskega sistema na normalna tkiva tako, da vpliva na imunske celice (imenovane limfociti T), ki sodelujejo pri razvoju revmatoidnega artritisa.
Because immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate.
Ker so analize imunogenosti specifične za zdravilo, primerjava med odstotki protiteles pri uporabi tega zdravila in uporabi drugih zdravil ni primerna.
The efficacy and safety of intravenous abatacept were assessed in randomised, double-blind, placebocontrolled clinical trials in adult patients with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria.
Učinkovitost in varnost intravenske uporabe abatacepta so vrednotili v randomiziranih, dvojno slepih, s placebom nadzorovanih kliničnih preskušanjih pri odraslih bolnikih z aktivnim revmatoidnim artritisom, diagnosticiranim po kriterijih Ameriškega združenja za revmatologijo (ACR - American College of Rheumatology).
Description of selected adverse reactions Infections
Opis izbranih neželenih učinkov Okužbe
Check the expiry date printed on the label.
Preverite datum izteka roka uporabnosti, ki je naveden na nalepki.
Before you use the pre-filled syringe for the first time, make sure your doctor, nurse or pharmacist shows you the right way to use it.
Poskrbite, da vam pred prvo uporabo napolnjene injekcijske brizge zdravnik, medicinska sestra ali farmacevt pokaže njeno pravilno uporabo.
P-valuea
P-vrednosta
At a dose of 200 mg/kg, representing 11-fold a human exposure at 10 mg/kg based on AUC, limited changes in immune function (a 9-fold increase in the mean T-cell-dependent antibody response in female pups and inflammation of the thyroid of 1 female pup out of 10 male and 10 female pups evaluated at this dose) were observed.
Pri odmerku 200 mg/kg, kar je na osnovi AUC 11-krat večja izpostavljenost od izpostavljenosti človeka pri odmerku 10 mg/kg, so opazili omejene spremembe imunske funkcije (9-kratno povečanje srednjega T-celičnega protitelesnega odziva pri mladičih ženskega spola in vnetje ščitnice pri 1 mladiču ženskega spola od 10 mladičev moškega in 10 mladičev ženskega spola, pri katerih je bil ta odmerek ovrednoten).
50 mg 25 kg to less than 50 kg 87.5 mg 50 kg or more
50 mg 25 kg do manj kot 50 kg 87,5 mg 50 kg ali več
Study V continued for an additional 6 months with the abatacept and infliximab groups only.
Študija V se je nadaljevala dodatnih 6 mesecev le v skupinah, ki so prejemale abatacept ali infliksimab.
In vitro, abatacept attenuates human T lymphocyte activation as measured by decreased proliferation and cytokine production.
Abatacept in vitro zmanjša aktivacijo humanih limfocitov T, kar se kaže z manjšo proliferacijo in produkcijo citokinov.
To be administered as a 30-minute intravenous infusion at the dose specified in Table 1.
Zdravilo je treba aplicirati v obliki 30-minutne intravenske infuzije v odmerku, ki je naveden v preglednici 1.
• Please make sure you also have a list of all your other medicines with you at any visit to a health care professional.
• Pri vsakem obisku zdravnika imejte s seboj seznam vseh drugih zdravil, ki jih uporabljate.
Remove one Pen from the refrigerator and let it rest at room temperature (about 25°C) for 30 minutes.
Iz hladilnika vzemite en injekcijski peresnik in ga pustite 30 minut na sobni temperaturi (približno 25 °C).
Keep this card with you for 3 months after the last ORENCIA dose, since side effects may occur a long time after your last dose of ORENCIA.
To kartico imejte pri sebi še najmanj 3 mesece po uporabi zadnjega odmerka zdravila ORENCIA, saj se neželeni učinki lahko pojavijo še daljši čas po uporabi zadnjega odmerka.
If you have received ORENCIA while you were pregnant, it is important that you inform the baby's health care personnel before any vaccinations are given to your baby.
Če ste zdravilo ORENCIA prejeli med nosečnostjo, je pomembno, da o tem obvestite zdravstvene delavce, ki skrbijo za otroka, preden otrok prejme katero koli cepivo.
The safety and efficacy of subcutaneous abatacept were assessed in a single-arm, open-label study designed with a primary endpoint of steady-state trough concentration (cmin) at 4 months (short-term period) in the 6 to 17 year age cohort.
Varnost in učinkovitost subkutane uporabe abatacepta so vrednotili v enoskupinski, odprti študiji, katere primarni izid je bila najmanjša koncentracija (Cmin) v stanju dinamičnega ravnovesja po 4 mesecih (kratkoročno obdobje) v starostni kohorti 6 do 17 let.
You may notice a drop of fluid leaving the needle.
Morda boste opazili kapljico tekočine, ki izhaja iz igle.
In study SC-III, structural joint damage was assessed by MRI.
V študiji SC-III so strukturne poškodbe sklepa ocenili z magnetnoresonančnim slikanjem (MRI).
Patients with known malignancies were not included in these clinical trials.
V ta klinična preskušanja bolniki z znanimi novotvorbami niso bili vključeni.
e DAS28-CRP Remission is defined as a DAS28-CRP score < 2.6
e DAS28-CRP remisija je opredeljena kot ocena DAS28-CRP < 2,6
The most frequently reported adverse reactions (≥ 5%) among abatacept-treated patients were headache, nausea, and upper respiratory tract infections (including sinusitis).
Pri bolnikih, ki so prejemali abatacept, so najpogosteje (≥ 5%) poročali o glavobolu, slabosti in okužbah zgornjih dihal (vključno s sinuzitisom).
1 silicone-free syringe
1 injekcijska brizga brez silikona
Of the 219 patients entering the study, 56 (25.6%) had previously been treated with biologic DMARD therapy (including TNF inhibitors and tocilizumab).
Od 219 bolnikov, vključenih v študijo, se jih je 56 (25,6 %) predhodno zdravilo z biološkim DMARD zdravljenjem (vključno z zaviralci TNF in tocilizumabom).
The pre-filled syringe has a flange extender that makes it easier to hold and inject, and a needle guard that automatically covers the needle after a complete injection.
Napolnjena injekcijska brizga ima razširjeno držalo za prsta, kar olajša držanje in injiciranje zdravila in varovalo za iglo, ki po končanem injiciranju samodejno prekrije iglo.
Possible serious side effects include serious infections, malignancies (cancer) and allergic reactions, as listed below.
Kot je navedeno v nadaljevanju, možni resni neželeni učinki vključujejo hude okužbe, novotvorbe (rak) in alergijske reakcije.
Patients treated with abatacept subcutaneously also achieved similar ACR 50 and 70 responses as those patients receiving abatacept intravenously at 6 months.
Po 6 mesecih zdravljenja so bili pri bolnikih, ki so abatacept prejemali subkutano, doseženi tudi podobni odzivi ACR 50 in 70 kot pri bolnikih, ki so abatacept prejemali intravensko.
Study IV primarily assessed safety in patients with active rheumatoid arthritis requiring additional intervention in spite of current therapy with non-biological and/or biological DMARDs; all DMARDs used at enrollment were continued.
Študija IV je predvsem vrednotila varnost pri bolnikih z aktivnim revmatoidnim artritisom, ki so potrebovali dodatno ukrepanje kljub trenutnemu zdravljenju z nebiološkimi in/ali biološkimi imunomodulirajočimi protirevmatičnimi zdravili.
Their pJIA subtypes at disease onset were: oligoarticular (16%), polyarticular (64%; 20% of the total were rheumatoid factor positive), and systemic (20%).
Podtipi pJIA ob začetku bolezni so bili: oligoartikularni (16 %), poliartikularni (64 %; 20 % vseh je bilo pozitivnih na revmatoidni faktor) in sistemski (20 %).
Study SC-I compared the safety of abatacept including injection site reactions following subcutaneous or intravenous administration.
V študiji SC-I so primerjali varnost abatacepta, vključno z reakcijami na mestu injiciranja, po subkutani ali intravenski aplikaciji.
In the 6 to 17 year age cohort 132 (76.3%) patients completed 2 years.
V kohorti bolnikov, starih od 6 do 17 let, je 2-letno obdobje zaključilo 132 (76,3 %) bolnikov.
Tuberculosis (TB): You should be screened for TB prior to ORENCIA treatment.
Tuberkuloza (TBC): Pred začetkom zdravljenja z zdravilom ORENCIA je treba izvesti presejalno testiranje za tuberkulozo.
Studies indicate that naive T lymphocyte responses are more affected by abatacept than memory T lymphocyte responses.
Študije kažejo, da abatacept bolj vpliva na naivni T limfocitni odziv kot pa na spominski T limfocitni odziv.
Dates of ORENCIA Treatment:
Datum zdravljenja z zdravilom ORENCIA:
Of the 190 patients with pJIA treated with intravenous ORENCIA, one (0.5%) patient discontinued due to non-consecutive infusion reactions, consisting of bronchospasm and urticaria.
Od 190 bolnikov s pJIA, ki so se zdravili z zdravilom ORENCIA intravensko je bil en bolnik (0,5%) izključen iz študije zaradi infuzijske reakcije, ki je vključevala bronhospazem in urtikarijo in ni neposredno sledila infundiranju zdravila.
This medicine contains 34.5 mg sodium (main component of cooking/table salt) per maximum dose of 4 vials (8.625 mg sodium per vial).
To zdravilo vsebuje 34,5 mg natrija (glavne sestavine kuhinjske soli) na največji odmerek 4 viale (8,625 mg natrija na vialo).
The pharmacokinetics of abatacept is similar in adult RA and paediatric pJIA patients except for the higher SC absorption in pJIA patients.
Farmakokinetika abatacepta je pri odraslih bolnikih z RA in pri pediatričnih bolnikih s pJIA podobna, razen večje s.c. absorpcije pri bolnikih s pJIA.
• See the ORENCIA package leaflet for more information.
• Za več informacij glejte navodilo za uporabo zdravila ORENCIA.
The results were measured using the Genant-modified total Sharp score (TSS) and its components, the erosion score and joint space narrowing (JSN) score.
Rezultate so vrednotili na osnovi skupne Sharpove ocene, modificirane po Genantu (TSS - Genantmodified total Sharp score) in njenih komponent, ocene erozije in ocene zožitve sklepne špranje (JSN - joint space narrowing).
There is a theoretical concern that treatment with abatacept might increase the risk for autoimmune processes in adults and children, for example deterioration of multiple sclerosis.
Teoretično se pri zdravljenju z abataceptom lahko poveča tveganje za avtoimunske procese pri odraslih in otrocih, na primer poslabšanje multiple skleroze.
In the substudy of study VI, patients who had achieved remission at 2 years (DAS 28 ESR < 2.6) and after at least 1 year of treatment with abatacept in study VI were eligible to enter a substudy.
V podštudijo študije VI so bili vključeni bolniki, ki so glede na doseženo remisijo po 2 letih (DAS 28 sedimentacija eritrocitov < 2,6) in zdravljenje z abataceptom v študiji VI vsaj 1 leto, bili primerni za vključitev v podštudijo.
In study SC-I, abatacept was given subcutaneously to patients after a single loading dose of intravenous abatacept and then every week thereafter.
V študiji SC-I so bolniki abatacept prejeli subkutano po enkratnem začetnem intravenskem odmerku abatacepta, nato pa so ga prejemali enkrat na teden.
Dose-dependent reductions were observed with abatacept in serum levels of soluble interleukin2 receptor, a marker of T lymphocyte activation; serum interleukin-6, a product of activated synovial macrophages and fibroblast-like synoviocytes in rheumatoid arthritis; rheumatoid factor, an autoantibody produced by plasma cells; and C-reactive protein, an acute phase reactant of inflammation.
Opazili so od odmerka odvisno zmanjšanje topnega receptorja za interlevkin-2 v serumu, označevalca aktivacije limfocitov T; serumskega interlevkina-6, produkta aktiviranih sinovijskih makrofagov in fibroblastom podobnih sinoviocitov pri revmatoidnem artritisu; revmatoidnega faktorja, avtoprotiteles, ki jih proizvajajo plazmatke in C-reaktivnega proteina, reaktanta akutne faze vnetja.
ORENCIA is given to you into a vein, usually in your arm, over a period of 30 minutes.
Zdravilo ORENCIA boste prejeli v žilo, običajno v roko, v obliki 30 minutne infuzije.
After proper training in subcutaneous injection technique, a patient may self-inject with ORENCIA if a physician/healthcare professional determines that it is appropriate.
Po ustreznem usposabljanju iz tehnike subkutanega injiciranja si bolnik lahko zdravilo ORENCIA injicira sam, če zdravnik/zdravstveni delavec presodi, da je to primerno.
In patients assessed for anti-abatacept antibodies after discontinuation of abatacept (> 42 days after last dose), 103 of 1,888 (5.5%) were seropositive.
Pri bolnikih, ki so bili na protitelesa proti abataceptu preiskani po prekinitvi zdravljenja z abataceptom (> 42 dni po prejemu zadnjega odmerka), so seropozitivnost ugotovili pri 103 od 1.888 bolnikov (5,5%).
if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) tell your doctor.
če ste imeli tuberkulozo (TBC) ali imate simptome tuberkuloze (dolgotrajni kašelj, zmanjševanje telesne mase, ravnodušnost, rahlo zvišana telesna temperatura), to povejte svojemu zdravniku.
Unless they had discontinued due to safety reasons, all patients who completed, or had a flare during Period B or were non-responders in Period A were offered entry into Period C, the open-label extension, which assessed long-term safety and efficacy.
Če bolniki niso bili izključeni iz študije zaradi varnostnih razlogov, so bili vsi bolniki, ki so dokončali obdobje B študije ali se jim je bolezen med obdobjem B študije poslabšala ter bolniki brez odziva na zdravljenje v obdobju A študije, vključeni v obdobje C, odprto podaljšano fazo študije, ki je vrednotila dolgotrajno varnost in učinkovitost.
The active substance is abatacept.
Učinkovina je abatacept.
In rats, abatacept had no undesirable effects on male or female fertility (see section 5.3).
Pri podganah abatacept ni imel neželenih učinkov na plodnost samcev ali samic (glejte poglavje 5.3).
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
Psoriazni artritis je vnetna bolezen sklepov, ki jo običajno spremlja psoriaza (luskavica), vnetna bolezen kože.
Study V: abatacept or infliximab versus placebo
Študija V: abatacept ali infliksimab v primerjavi s placebom
Population pharmacokinetic analyses did not detect any effect of methotrexate, NSAIDs, and corticosteroids on abatacept clearance (see section 5.2).
Pri analizah populacijske farmakokinetike učinkov metotreksata, nesteroidnih protivnetnih zdravil in kortikosteroidov na očistek abatacepta niso odkrili (glejte poglavje 5.2).
Studies I, II, III, V, and VI required patients to have at least 12 tender and 10 swollen joints at randomisation.
V študije I, II, III, V in VI so bili vključeni bolniki, ki so ob randomizaciji imeli vsaj 12 občutljivih in 10 oteklih sklepov.