natgillin/translations-raw huggingface dataset:
During the first 4-month treatment period of intravenous and subcutaneous abatacept in 409 patients with pJIA, the most common adverse reactions were nasopharyngitis (3.7% patients) and upper respiratory tract infection (2.9% patients).
Med prvimi 4 meseci intravenskega in subkutanega zdravljenja z abataceptom so bili pri 409 bolnikih s pJIA najpogostejši neželeni učinki nazofaringitis (3,7% bolnikov) in okužba zgornjih dihal (2,9% bolnikov).
Don't press on the plunger head until you begin your injection.
Na glavo bata ne smete pritisniti, dokler zdravila ne začnete injicirati.
If you are already on intravenous ORENCIA treatment and wish to transition to ORENCIA subcutaneous, you should receive a subcutaneous injection instead of your next intravenous infusion, followed by weekly subcutaneous injections of ORENCIA.
Če se z zdravilom ORENCIA že zdravite intravensko in boste zdravljenje zamenjali za podkožno, morate podkožno injekcijo prejeti namesto naslednje intravenske infuzije, nato pa podkožne injekcije zdravila ORENCIA prejemati enkrat na teden.
B. Position the syringe and inject ORENCIA Hold the syringe by its body in one hand between your thumb and index finger (Figure 5).
B. Namestitev injekcijske brizge in injiciranje zdravila ORENCIA S palcem in kazalcem ene roke primite brizgo za njeno telo (slika 5).
At 24 months, 20.8 % (66/318) of patients on abatacept and 25.3 % (83/328) on adalimumab had discontinued.
V 24 mesecih je bilo zdravljenje prekinjeno pri 20,8 % (66/318) bolnikov, ki so se zdravili z abataceptom, in 25,3 % (83/328) bolnikov, ki so se zdravili z adalimumabom.
Position the ClickJect Pen so you can see the viewing window and it's at a 90º angle to the injection site.
Injekcijski peresnik ClickJect primite tako, da vidite nadzorno okence in ga namestite na mesto injiciranja pod kotom 90º.
Uncommon (may affect up to 1 in 100 people): blood in urine ear infection
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): kri v urinu, okužbe ušes
Should you have any questions, ask your pharmacist.
Če imate o tem kakršno koli vprašanje, se posvetujte s farmacevtom.
In this study children and adolescents with moderately to severely active pJIA, ages 2 to 17 years (46 patients in the 2 to 5 year age cohort and 173 patients in the 6 to 17 year age cohort) with an inadequate response or intolerance to at least one DMARD, which may have included biologic agents, were treated.
V tej študiji so se zdravili otroci in mladostniki z zmerno do hudo aktivnim pJIA, stari od 2 do 17 let (46 bolnikov v kohorti bolnikov, starih od 2 do 5 let, in 173 bolnikov v kohorti bolnikov, starih od 6 do 17 let) z nezadostnim odzivom ali intoleranco za vsaj enega od imunomodulirajočih protirevmatičnih zdravil, kar je lahko vključevalo tudi biološka zdravila.
How to use ORENCIA
Kako uporabljati zdravilo ORENCIA
Among the patients who entered the open-label 12 month period, 59% (125/213) of patients receiving continuous abatacept plus methotrexate treatment and 48% (92/192) of patients who initially received methotrexate and switched to combination with abatacept had no progression.
Med bolniki, ki so bili vključeni v odprto 12-mesečno obdobje do napredovanja bolezni ni prišlo pri 59% (125/213) bolnikov, ki so kontinuirano prejemali abatacept in metotreksat, in pri 48% (92/192) bolnikov, ki so v začetku prejemali metotreksat in so nato prešli na kombinirano zdravljenje z abataceptom.
ORENCIA should not be used in pregnant women unless clearly necessary.
Zdravila ORENCIA se ne sme uporabljati pri nosečnicah, če to ni nujno potrebno.
Patients were allowed to receive stable doses of concomitant methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial.
Bolniki so med preskušanjem lahko prejemali stabilne odmerke metotreksata, sulfasalazina, leflunomida, hidroksiklorokina, nizke odmerke kortikosteroidov (v odmerkih, enakovrednih ≤ 10 mg prednizona) in/ali nesteroidna protivnetna zdravila (NSAID).
During the cumulative study period when all subjects treated with abatacept in 7 SC studies were included, the frequency of injection site reactions was 4.6% (116/2,538) with an incidence rate of 1.32 per 100 person-years.
Med kumulativnim obdobjem študije, ko so bile vključene vse osebe, ki so se v 7 študijah subkutane uporabe abatacepta zdravile z abataceptom, je pogostnost reakcij na mestu injiciranja znašala 4,6% (116/2.538), stopnja pojavnosti pa 1,32 na 100 bolnik-let.
Abatacept has been studied in patients with active rheumatoid arthritis in placebo-controlled clinical trials (2,653 patients with abatacept, 1,485 with placebo).
Abatacept so raziskovali pri bolnikih z aktivnim revmatoidnim artritisom v s placebom nadzorovanih kliničnih preskušanjih (2.653 bolnikov je prejemalo abatacept, 1.485 placebo).
Study V patients were randomised to receive this same fixed dose of abatacept or 3 mg/kg infliximab or placebo for 6 months.
V študiji V so bili bolniki randomizirani tako, da so 6 mesecev prejemali ta isti fiksni odmerek abatacepta, 3 mg/kg infliksimaba ali placebo.
Allow the syringe to rest at room temperature for 30 to 60 minutes before you inject.
Injekcijsko brizgo pred injiciranjem pustite na sobni temperaturi za 30 do 60 minut.
o Patient alert card: o A warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using ORENCIA o That ORENCIA treatment may increase the risk of infections and allergic reactions.
o Opozorilna kartica za bolnika: o Opozorilo vsem zdravstvenim delavcem, ki kakor koli zdravijo bolnika, tudi v nujnih primerih, da bolnik uporablja zdravilo ORENCIA.
Study SC-I was a randomised, double-blind, double-dummy noninferiority study administered to patients stratified by body weight (< 60 kg, 60 to 100 kg, > 100 kg) that compared the efficacy and safety of abatacept administered subcutaneously and intravenously in subjects with rheumatoid arthritis (RA), receiving background methotrexate (MTX), and experiencing an inadequate response to MTX (MTX-IR).
Študija SC-I je bila randomizirana, dvojno slepa, dvojno zakrita študija neinferiornosti pri bolnikih, razvrščenih v skupine glede na telesno maso (< 60 kg, 60 do 100 kg, > 100 kg), ki je primerjala učinkovitost in varnost subkutane in intravenske uporabe abatacepta pri bolnikih z revmatoidnim artritisom (RA), ki so se zdravili z metotreksatom (MTX), odziv na zdravljenje z metotreksatom pa ni bil zadosten (MTX-IR).
Check the liquid in the pre-filled syringe through the viewing window.
Preverite tekočino v napolnjeni injekcijski brizgi preko preglednega okenca.
125 mg/mL orange plunger
125 mg/ml oranžen bat
ORENCIA is supplied as a powder for solution for infusion.
Zdravilo ORENCIA je na voljo kot prašek za raztopino za infundiranje.
Clinical efficacy and safety in adult psoriatic arthritis
Klinična učinkovitost in varnost pri odraslih s psoriaznim artritisom
The open label period of the study provided an assessment of the ability of abatacept to maintain efficacy for subjects originally randomised to abatacept and the efficacy response of those subjects who were switched to abatacept following treatment with infliximab.
Na osnovi odprtega obdobja študije so ocenili, da abatacept ohrani učinkovitost pri osebah, ki so bile izvorno randomizirane na abatacept, in učinkovitost odziva pri tistih osebah, pri katerih je bilo zdravljenje z abataceptom uvedeno po predhodnem zdravljenju z infliksimabom.
Use your thumb to push the plunger down, pressing firmly until the plunger will go no further, and all of the medicine has been injected (Figure 6).
Pritisk na bat naj bo dovolj močan vse dokler bat ne gre več naprej in ste injicirali celotno količino zdravila (slika 6).
Serious infections at least possibly related to treatment were reported in 1.5% of abatacept-treated patients and 1.1% of placebo-treated patients.
O resnih okužbah, ki bi lahko bile povezane z zdravljenjem, so poročali pri 1,5% bolnikov, ki so prejemali abatacept, in 1,1% bolnikov, ki so prejemali placebo.
At baseline 79% of 219 patients enrolled and treated in the study were taking methotrexate (mean dose at study entry, 12.3 mg/m2/week) and 21% of patients received abatacept monotherapy.
V izhodišču je 79 % od 219 bolnikov, ki so bili vključeni in zdravljeni v študiji, jemalo metotreksat (srednji odmerek ob vstopu v študijo 12,3 mg/m2/teden), 21 % bolnikov pa se je zdravilo z abataceptom v monoterapiji.
During the 24-month cumulative period of the pJIA SC study (4-month short term period plus 20-month extension period), a higher frequency of infections was reported in the 2 to 5 year age cohort (87.0%) compared to that reported in the 6 to 17 year age cohort (68.2%).
Med 24-mesečnim kumulativnim obdobjem v študiji s.c. uporabe pri pJIA (4-mesečno kratkoročno obdobje in 20-mesečno podaljšano obdobje) so poročali o večji pogostnosti okužb v kohorti bolnikov, starih od 2 do 5 let (87,0 %), v primerjavi s kohorto bolnikov, starih od 6 do 17 let (68,2 %).
Response rates at the end of Period A, at the end of Period B and after 5 years exposure in Period C are summarized in Table 9:
Deleži odziva ob koncu obdobja A, ob koncu obdobja B in po 5 letih zdravljenja v obdobju C so povzeti v preglednici 9:
Very common (may affect more than 1 in 10 people): infections of the upper airway (including infections of the nose, throat and sinuses).
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): okužbe zgornjih dihal (vključno z okužbami nosu, žrela in sinusov).
Response rates at the end of Period A, at the end of Period B and after 5 years exposure in Period C are summarized in Table 10:
Deleži odziva ob koncu obdobja A, ob koncu obdobja B in po 5 letih zdravljenja v obdobju C so povzeti v preglednici 10:
ORENCIA can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.
Zdravilo ORENCIA se lahko uporablja v monoterapiji v primeru intolerance za metotreksat, ali če zdravljenje z metotreksatom ni primerno.
If any serious allergic or anaphylactic reaction occurs, intravenous or subcutaneous ORENCIA therapy should be discontinued immediately and appropriate therapy initiated, and the use of ORENCIA should be permanently discontinued.
V primeru pojava kakršne koli resne alergijske ali anafilaksijske reakcije je treba zdravljenje z zdravilom ORENCIA v obliki intravenske infuzije ali subkutane injekcije nemudoma prekiniti in uvesti ustrezno zdravljenje.
During the 12-week pre-filled pen period of the substudy, there were no deaths or related SAEs.
Med 12-tedenskim obdobjem podštudije uporabe napolnjenega injekcijskega peresnika niso poročali o smrtnih primerih ali resnih neželenih učinkih.
Remove the flip-top from the vial and wipe the top with an alcohol swab.
Z vrha viale odstranite dvižno zaporko in vrh obrišite z alkoholnim tamponom.
MRI Synovitis Score
MRI ocena sinovitisa
If a single intravenous dose is given to start the treatment, the first subcutaneous injection of ORENCIA should be given within a day of the intravenous infusion, followed by the weekly 125 mg subcutaneous injections.
Če bo zdravnik zdravljenje uvedel z enkratnim intravenskim odmerkom, boste prvo podkožno injekcijo zdravila ORENCIA prejeli še isti dan kot intravensko infuzijo, nato pa boste podkožne injekcije v odmerku 125 mg prejemali enkrat na teden.
Before you use the ClickJect Pen for the first time, make sure your healthcare provider shows you the right way to use it.
Poskrbite, da vam pred prvo uporabo ClickJect injekcijskega peresnika zdravstveni delavec pokaže njegovo pravilno uporabo.
In the 2 to 5 year age cohort, the overall rate of seropositivity during the cumulative period including post abatacept follow-up was 15.2% (7/46): 10.9% (5/46) on treatment and 37.5% (3/8) after discontinuation of abatacept (≥ 28 days after the last dose).
V kohorti bolnikov, starih od 2 do 5 let, je celokupen delež seropozitivnosti v kumulativnem obdobju, vključno z obdobjem spremljanja po uporabi abatacepta, znašal 15,2 % (7/46): 10,9 % (5/46) med zdravljenjem in 37,5 % (3/8) po ukinitvi zdravljenja z abataceptom (≥ 28 dni po uporabi zadnjega odmerka).
In a pre- and postnatal development study in rats, limited changes in immune function were observed at 11-fold higher than a human 10 mg/kg dose based on AUC (see section 5.3).
Pri študijah prenatalnega in postnatalnega razvoja pri podganah so pri odmerkih, ki so bili na osnovi AUC 11-krat večji od odmerka 10 mg/kg pri človeku, opazili manjše spremembe imunske funkcije (glejte poglavje 5.3).
† p < 0.05, abatacept plus MTX vs MTX plus placebo a Fixed dose approximating 10 mg/kg (see section 4.2).
† p < 0,05, abatacept in MTX v primerjavi z MTX in placebom a Fiksni odmerek približno 10 mg/kg (glejte poglavje 4.2).
During the 24-week placebo-controlled period in the larger study PsA-II, the proportion of patients with adverse reactions was similar in the abatacept and placebo treatment groups (15.5% and 11.4%, respectively).
Med 24-tedenskim, s placebom nadzorovanim obdobjem, je bil v večji študiji PsA-II delež bolnikov z neželenimi učinki v skupini, ki je prejemala abatacept, podoben kot v skupini, ki je prejemala placebo (15,5% oziroma 11,4%).
There is limited experience with the use of abatacept in combination with TNF-inhibitors (see section 5.1).
Izkušenj z uporabo abatacepta v kombinaciji z zaviralci TNF je malo (glejte poglavje 5.1).
Needle guard (extended over needle)
Varovalo za iglo (sega preko igle)
Hypertension, blood pressure increased Uncommon Hypotension, hot flush, flushing, vasculitis, blood pressure decreased
Žilne bolezni pogosti hipertenzija, zvišanje krvnega tlaka občasni hipotenzija, navali vročine, vročinski oblivi, vaskulitis, znižanje krvnega tlaka
Over the 2 year study period, 3.8 % (12/318) and 1.5 % (5/328) patients treated with abatacept SC and adalimumab SC respectively reported autoimmune disorders mild to moderate in severity (e.g., psoriasis, Raynaud's phenomenon, erythema nodosum).
V 2-letnem obdobju študije so pri 3,8 % (12/318) bolnikov, ki so se zdravili z abataceptom s.c., in 1,5 % (5/328) bolnikov, ki so se zdravili z adalimumabom s.c., poročali o avtoimunskih boleznih blage do zmerne jakosti (npr. psoriaza, Raynaudov fenomen, nodozni eritem).
Twenty-two of 48 evaluable patients showed significant neutralizing activity.
Pomembna nevtralizirajoča aktivnost je bila ugotovljena pri 22 od 48 preiskanih bolnikov.
Clinical efficacy and safety in adult rheumatoid arthritis
Klinična učinkovitost in varnost pri odraslih z revmatoidnim artritisom
The progression of structural damage was lower in patients receiving continuous abatacept plus methotrexate treatment (for 24 months) compared to patients who initially received methotrexate plus placebo (for 12 months) and were switched to abatacept plus methotrexate for the next 12 months.
Pri bolnikih, ki so kontinuirano prejemali abatacept in metotreksat (24 mesecev) je bila progresija strukturnih poškodb manjša kot pri bolnikih, ki so v začetku prejemali metotreksat in placebo (12 mesecev) in so nato za naslednjih 12 mesecev prešli na zdravljenje z abataceptom in metotreksatom.
Patients entered in the trial were a mean 10.6 years of age with mean disease duration of 2.4 years.
Bolniki, ki so bili vključeni v preskušanje, so bili v povprečju stari 10,6 let, bolezen pa je v povprečju trajala 2,4 leta.
In rats and rabbits, abatacept exposure was up to 29-fold a human 10 mg/kg exposure based on AUC.
Pri podganah in kuncih je bila izpostavljenost abataceptu na osnovi AUC do 29-krat večja od izpostavljenosti človeka pri odmerku 10 mg/kg.
Patients were randomised to receive placebo or abatacept 3 mg/kg, 10 mg/kg, or two doses of 30 mg/kg followed by 10 mg/kg, without escape for 24 weeks, followed by open label abatacept 10 mg/kg monthly intravenous every month.
Bolniki so bili randomizirani tako, da so prejeli placebo ali abatacept v odmerku 3 mg/kg, 10 mg/kg, ali dva odmerka po 30 mg/kg.Sledilo je prejemanje odmerka 10 mg/kg brez izključitve za 24 tednov, nato pa odprto zdravljenje z abataceptom v odmerku 10 mg/kg mesečno intravensko vsak mesec.
While TNF-inhibitors did not influence abatacept clearance, in placebo-controlled clinical trials, patients receiving concomitant treatment with abatacept and TNF-inhibitors experienced more infections and serious infections than patients treated with only TNF-inhibitors.
Zaviralci TNF sicer niso vplivali na očistek abatacepta, vendar pa je bilo v s placebom nadzorovanih kliničnih preskušanjih število okužb in hudih okužb večje pri bolnikih, ki so se sočasno zdravili z abataceptom in zaviralci TNF, kot pri bolnikih, ki so se zdravili samo z zaviralci TNF.
In addition, inflammation of the thyroid and pancreas was frequently seen in both juvenile and adult rats exposed to abatacept.
Poleg tega so tako pri mladičih kot odraslih podganah, ki so bile izpostavljene abataceptu, pogosto opažali vnetja ščitnice in trebušne slinavke.
Improvement in physical function in controlled trials Methotrexate-Naive Inadequate response to Methotrexate
Izboljšanje fizične funkcije v nadzorovanih kliničnih preskušanjih Brez predhodnega zdravljenja z metotreksatom
Liver function test abnormal (including transaminases increased)
Bolezni jeter, žolčnika in žolčevodov pogosti nenormalni izvidi testov jetrne funkcije (vključno z zvišanjem transaminaz)
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Dokazano je bilo, da je zdravilo kemično in fizikalno stabilno 24 ur, če se ga shranjuje pri temperaturi od 2°C - 8°C.
Population pharmacokinetic analysis of abatacept serum concentration data from patients with pJIA 6 to 17 years of age following administration of intravenous abatacept 10 mg/kg revealed that the estimated clearance of abatacept, when normalised for baseline body weight, was higher in pJIA patients (0.4 mL/h/kg for a child weighing 40 kg) versus adult rheumatoid arthritis patients.
Na osnovi podatkov o serumski koncentraciji abatacepta pri bolnikih s pJIA, starih od 6 do 17 let, po intravenski aplikaciji abatacepta v odmerku 10 mg/kg, je analiza populacijske farmakokinetike pokazala, da je vrednost ocenjenega očistka abatacepta, po normalizaciji na izhodiščno telesno maso, pri bolnikih s pJIA večja (0,4 ml/uro/kg za otroke s telesno maso 40 kg) kot pri odraslih bolnikih z revmatoidnim artritisom.
This medicinal product contains 0.014 mmol sodium (0.322 mg) per pre-filled pen, that is to say essentially ‘sodium- free'.
To zdravilo vsebuje 0,014 mmol natrija (0,322 mg) na napolnjen injekcijski peresnik, kar v bistvu pomeni “brez natrija”.
The absence of concomitant methotrexate (MTX) did not appear to be associated with a higher rate of seropositivity in Period B placebo recipients.
Kaže, da odsotnost sočasnega zdravljenja z metotreksatom (MTX) pri bolnikih, ki so v obdobju B študije prejemali placebo, ni bila povezana z večjim deležem seropozitivnosti.
Abatacept is not recommended for use in combination with TNF-inhibitors.
Uporabe abatacepta v kombinaciji z zaviralci TNF ne priporočamo.
- Remove the flip-top from the vial and wipe the top with an alcohol swab.
- Z vrha viale odstranite dvižno zaporko in vrh obrišite z alkoholnim tamponom.
Remove Needle Cover
Odstranite pokrovček igle
In SC-II, serious infections were reported in 3.8 % (12/318) of patients treated with abatacept SC weekly, none of which led to discontinuation and in 5.8 % (19/328) of patients treated with adalimumab SC every-other-week, leading to 9 discontinuations in the 24-month period.
V študiji SC-II so o resnih okužbah poročali pri 3,8 % (12/318) bolnikov, ki so se zdravili z abataceptom s.c. tedensko, vendar pa zdravljenja zaradi resne okužbe ni bilo treba prekiniti pri nobenem od teh bolnikov, in pri 5,8 % (19/328) bolnikov, ki so se zdravili z adalimumabom s.c. vsak drugi teden, zdravljenje pa je bilo v 24-mesečnem obdobju treba prekiniti pri 9 bolnikih z resno okužbo.
In study VI, the mean change in TSS at 12 months was significantly lower in patients treated with abatacept plus methotrexate compared to those treated with methotrexate plus placebo.
V študiji VI je bila povprečna sprememba vrednosti TSS po 12 mesecih signifikantno manjša pri bolnikih, ki so se zdravili z abataceptom in metotreksatom, kot pri bolnikih, ki so prejemali metotreksat in placebo.
By finding the right treatment plan for you, you may be able to slow down this disease process, which may help reduce long-term joint damage, as well as pain and fatigue and improve your overall quality of life.
To pomeni, da lahko kljub zdravljenju pride do poškodb sklepov, simptomi pa so pri tem lahko prisotni ali pa tudi ne. S pravilnim zdravljenjem se bolezenski proces lahko upočasni, preprečijo dolgoročne poškodbe sklepov, olajša bolečina in utrujenost ter izboljša splošna kakovost življenja.
Comprehensive instructions for the preparation and administration of ORENCIA in a pre-filled syringe are given in the package leaflet and “Important instructions for use”.
Podrobna navodila za pripravo in dajanje zdravila ORENCIA v napolnjeni injekcijski brizgi so navedena v navodilu za uporabo in “Pomembnih navodilih za uporabo”.
The incidence rate of autoimmune disorders in abatacept-treated patients during the double-blind period was 8.8 (7.6, 10.1) per 100 person-years of exposure and for placebo-treated patients was 9.6 (7.9, 11.5) per 100 person-years of exposure.
Stopnja pojavnosti avtoimunskih bolezni je pri bolnikih, ki so med dvojno slepim obdobjem prejemali abatacept, znašala 8,8 (7,6; 10,1) na 100 bolnik-let izpostavljenosti, pri bolnikih, ki so prejemali placebo pa 9,6 (7,9; 11,5) na 100 bolnik-let izpostavljenosti.
Do not give the injection in any areas with scars or stretch marks.
Ne injicirajte v predele z brazgotinami ali s strijami.
Listed in Table 1 are adverse reactions observed in clinical trials and post-marketing experience presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
V preglednici 1 so neželeni učinki, opaženi v kliničnih preskušanjih in med spremljanjem zdravila po prihodu na trg, navedeni glede na organski sistem in pogostnosti, pri čemer so uporabljene naslednje kategorije: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
No significant changes in PASI scores with abatacept treatment were seen over the 24-week doubleblind period.
V 24-tedenskem dvojno slepem obdobju pomembnih sprememb v oceni PASI pri zdravljenju z abataceptom niso opazili.
Upon reinitiating therapy, there were no injection reactions and no other safety concerns in patients who were withdrawn from subcutaneous therapy for up to 3 months relative to those who remained on subcutaneous therapy, whether therapy was reintroduced with or without an intravenous loading dose.
V primerjavi z bolniki, ki so se kontinuirano zdravili subkutano, pri bolnikih, pri katerih je bilo subkutano zdravljenje prekinjeno za največ 3 mesece, po ponovni uvedbi zdravljenja niso poročali o reakcijah na injiciranje ali o drugih težavah z varnostjo, in sicer ne glede na to, ali je bilo zdravljenje ponovno uvedeno z začetnim intravenskim odmerkom ali brez njega.
the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa (RA) pri odraslih bolnikih z nezadostnim odzivom na predhodno zdravljenje z enim ali več zdravili iz skupine imunomodulirajočih protirevmatičnih zdravil (DMARDs - disease-modifying anti-rheumatic drugs), vključno z metotreksatom (MTX) ali zaviralcem tumorje nekrotizirajočega faktorja-alfa