FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who develop HBV reactivation, Cimzia should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Slovenian: Pri bolnikih, pri katerih se razvije reaktivacija HBV, je treba zdravljenje z zdravilom Cimzia prekiniti, ter začeti z učinkovito protivirusno terapijo in ustreznim podpornim zdravljenjem.
English: • This is followed by a maintenance dose of 200 mg every 2 weeks.
Slovenian: • Temu sledi vzdrževalni odmerek 200 mg vsak 2. teden.
English: In the CIMPACT study, the primary efficacy endpoint was the proportion of patients achieving PASI 75 at Week 12.
Slovenian: V študiji CIMPACT je bil primarni opazovani dogodek učinkovitosti delež bolnikov, ki so v 12. tednu dosegli PASI 75.
English: In addition, since certolizumab pegol is a protein that is degraded in the gastrointestinal tract after oral administration, the absolute bioavailability is expected to be very low in a breastfed infant.
Slovenian: Poleg tega je certolizumab pegol beljakovina, ki se po peroralnem zaužitju razgradi v prebavilih, zato je absolutna biološka uporabnost pri dojenem otroku pričakovano zelo majhna.
English: The primary efficacy endpoint was the ASAS20 response rate at Week 12.
Slovenian: Primarni cilj študije učinkovitosti je bil odziv ASAS20 v 12. tednu.
English: Improvements in all afore mentioned outcomes were maintained through Week 48.
Slovenian: Izboljšanja vseh zgoraj omenjenih izidov so se ohranila vseskozi do 48. tedna.
English: • the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate.
Slovenian: • zdravljenju zmernega do hudega aktivnega revmatoidnega artritisa (RA) pri odraslih bolnikih, pri katerih je bil odziv na imunomodulirajoča antirevmatična zdravila (DMARD), vključno z MTX, neustrezen.
English: Use of TNF-antagonists has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease, including multiple sclerosis.
Slovenian: Uporaba zdravil, ki zavirajo TNF, je bila v redkih primerih povezana s pojavom ali poslabšanjem kliničnih simptomov in/ali radiografskih dokazov demielizinirajoče bolezni, vključno z multiplo sklerozo.
English: • worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
Slovenian: • poslabšanje stanja, imenovanega dermatomiozitis (viden kot kožni izpuščaj, ki ga spremlja mišična šibkost)
English: • You can now remove the used pen by pulling the pen straight up carefully from the skin.
Slovenian: • Uporabljeni peresnik lahko odstranite tako, da ga previdno potegnete iz kože naravnost navzgor.
English: In both studies, the safety profile for these patients was consistent with the safety profile in rheumatoid arthritis and previous experience with Cimzia.
Slovenian: Varnostni profil pri teh bolnikih je bil v obeh študijah skladen z varnostnim profilom pri revmatoidnem artritisu in s prejšnjimi izkušnjami z zdravilom Cimzia.
English: Table 1 Adverse reactions in clinical trials and postmarketing System Organ Class
Slovenian: Preglednica 1 Neželeni učinki v kliničnih študijah in v obdobju trženja Organski sistem
English: • Remove the following items from the Cimzia pack and set them up on a clean flat surface:
Slovenian: • Iz škatlice z zdravilom Cimzia vzemite naslednje pripomočke in jih razporedite po čisti, ravni površini:
English: What you need to know before you use Cimzia
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Cimzia
English: Among patients remaining in the study, ACR 20, 50 and 70 response rates were maintained through Week 216.
Slovenian: Med bolniki, ki so ostali v študiji, so odzivi ACR 20, ACR 50 in ACR 70 trajali do 216. tedna.
English: - Do not heat the medication - let it warm up on its own.
Slovenian: - Zdravila ne segrevajte - naj se segreje samo.
English: Patients who miss a dose should be advised to inject the next dose of Cimzia as soon as they remember and then continue injecting subsequent doses as instructed.
Slovenian: Bolnikom, ki so izpustili odmerek, svetujemo, da si naslednji odmerek zdravila Cimzia vbrizgajo takoj, ko je to mogoče, ter nato z aplikacijo nadaljnjih odmerkov nadaljujejo po navodilih.
English: • changed numbers of blood cells, including low red cell count (anaemia), low platelet counts,
Slovenian: • spremembe števila krvnih celic, vključno z majhnim številom rdečih krvnih celic (anemija),
English: • With the other hand, hold the syringe at a 45-degree angle to the skin.
Slovenian: • Z drugo roko primaknite brizgo h koži pod kotom 45 stopinj.
English: In all situations described below, the benefit/risk balance of Cimzia therapy should be very carefully considered.
Slovenian: V vseh situacijah, opisanih v nadaljevanju, je treba zelo skrbno pretehtati prednosti in tveganja zdravljenja z zdravilom Cimzia.
English: The CPK elevations in the axSpA study were mostly mild to moderate, transient in nature and of unknown clinical significance with no cases leading to withdrawal.
Slovenian: V axSpA študiji so bila zvišanja CPK vrednosti večinoma blaga do zmerna, prehodne narave in neznanega kliničnega pomena, brez primerov prekinitve zdravljenja.
English: The solution is clear to opalescent, colourless to yellow.
Slovenian: Raztopina je bistra do opalescentna, brezbarvna do rumena.
English: • skin cancers, pre-cancerous skin lesions
Slovenian: • kožni rak, predrakave kožne lezije
English: Previous treatment with one TNF-antagonist was allowed and 20% of patients had prior TNF-antagonist exposure.
Slovenian: Predhodno zdravljenje z zaviralci TNF je bilo dovoljeno in 20 % bolnikov je bilo predhodno zdravljenih z zaviralci TNF.
English: p value was estimated from an ANCOVA model on the ranks with treatment, region, time since RA diagnosis at Baseline (≤4 months vs >4 months) as factors and Baseline rank as a covariate.
Slovenian: p vrednost je bila ocenjena iz modela ANCOVA s faktorji za zdravljenje, področje in čas od diagnoze RA v izhodiščni vrednosti (≤ 4 mesecev v primerjavi z > 4 mesecev) in izhodiščno vrednostjo kot kovariata.
English: Latex-sensitivity
Slovenian: Občutljivost na lateks
English: - If you are at risk of or are a carrier of or have active HEPATITIS B VIRUS (HBV) infection, Cimzia may increase the risk of reactivation in people who carry this virus.
Slovenian: - Če pri vas obstaja tveganje za okužbo z VIRUSOM HEPATITISA B (HBV), če ste njegov prenašalec ali pa imate aktivno okužbo, lahko pri osebah, ki so prenašalci virusa, zdravilo Cimzia poveča tveganje reaktivacije.
English: However, population pharmacokinetic analysis based on subjects with mild renal impairment showed no effect of creatinine clearance.
Slovenian: Vendar pa populacijska farmaokinetična analiza oseb z blagimi motnjami v delovanju ledvic ni pokazala nobenega učinka na očistek kreatinina.
English: Eighteen percent of patients reported a history of psoriatic arthritis at baseline.
Slovenian: Osemnajst odstotkov bolnikov je ob izhodišču poročalo o psoriatičnem artritisu v anamnezi.
English: Since tumour necrosis factor (TNF) mediates inflammation and modulates cellular immune responses, the possibility exists for TNF-antagonists, including Cimzia, to cause immunosupression, affecting host defences against infections and malignancies.
Slovenian: Ker tumorje nekrotizirajoči faktor (TNF) deluje kot prenašalec vnetja in modulira imunske odzive celic, obstaja možnost, da zaviralci TNF, vključno z zdravilom Cimzia, povzročijo imunosupresijo ter prizadenejo obrambo organizma proti okužbam in malignim obolenjem.
English: Certolizumab pegol plasma concentrations measured in 14 infants at birth were Below the Limit of Quantification (BLQ) in 13 samples; one was 0.042 µg/ml with an infant/mother plasma ratio at birth of 0.09%.
Slovenian: Koncentracije certolizumab pegola v plazmi, izmerjene pri 14 dojenčkih ob rojstvu, so bile pri 13 vzorcih pod mejo kvantifikacije (BLQ-Below the Limit of Quantification); pri enem vzorcu je bila koncentracija 0,042 µg/ml, razmerje koncentracij v plazmi pri materi in dojenčkom ob rojstvu pa je bilo 0,09 %.
English: Other disorders - Patients with chronic obstructive pulmonary disease (COPD), or who are heavy smokers, may be at increased risk for cancer with Cimzia treatment.
Slovenian: - Bolniki s kronično obstruktivno pljučno boleznijo (KOPB) ali bolniki, ki so hudi kadilci, so med zdravljenjem z zdravilom Cimzia lahko izpostavljeni povečanemu tveganju za nastanek raka.
English: - After a short pause, ava will automatically pull the cartridge in further.
Slovenian: - Po krajši pavzi naprava ava avtomatsko povleče vložek.
English: Additionally, the observed incidence of antibodies in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medicinal products, and underlying disease.
Slovenian: Poleg tega lahko na opazovano pogostnost protiteles v testu vpliva več dejavnikov, med drugim ravnanje z vzorcem, čas jemanja, sočasno jemanje drugih zdravil in osnovna bolezen.
English: Cimzia in combination with methotrexate can also be used to treat severe, active and progressive rheumatoid arthritis without previous use of methotrexate or other medicines.
Slovenian: Zdravilo Cimzia v kombinaciji z metotreksatom se lahko uporablja tudi za zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa brez predhodne uporabe metotreksata ali drugih zdravil.
English: The symptoms described above can be due to some of the side effects listed below, which have been observed with Cimzia:
Slovenian: Zgoraj opisani simptomi so lahko posledica nekaterih v nadaljevanju navedenih neželenih učinkov, ki so jih opazili pri zdravljenju z zdravilom Cimzia:
English: A risk for development of hepatosplenic T-cell lymphoma in patients treated with Cimzia cannot be excluded.
Slovenian: Tveganja za razvoj hepatospleničnega limfoma celic T pri bolnikih, zdravljenih z zdravilom Cimzia, ni mogoče izključiti.
English: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB05
Slovenian: Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci tumorjenekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB05
English: Treatment with Cimzia may result in the formation of antinuclear antibodies (ANA) and, uncommonly, in the development of a lupus-like syndrome (see section 4.8).
Slovenian: Zdravljenje z zdravilom Cimzia lahko pripelje do tvorbe avtoprotiteles (ANA) in v redkih primerih do razvoja lupusu podobnega sindroma (glejte poglavje 4.8).
English: • Continue to hold the pre-filled pen in place firmly against the skin until a second “click” is heard and the viewing window turns orange.
Slovenian: • Napolnjeni injekcijski peresnik še naprej čvrsto držite potisnjenega v kožo, dokler ne slišite drugi ˝klik˝ in se okence obarva oranžno.
English: Patients were evaluated in a double-blind placebo-controlled manner through Week 48.
Slovenian: Bolniki so bili ocenjeni na dvojno slepi, s placebom nadzorovan način, do konca 48. tedna.
English: Among patients remaining in the study, who had both baseline values and week 204 values, inhibition of inflammatory signs in both the sacroiliac joints (n=72) and spine (n=82) was largely maintained through Week 204 in the overall axial spondyloarthritis population as well as in both the AS and the nr-axSpA subpopulations.
Slovenian: Med bolniki, ki so ostali v študiji, in so imeli tako osnovne vrednosti kot tudi vrednosti v 204. tednu, je inhibicija vnetnih znakov v sakroilikalnih sklepih (n=72) in hrbtenici (n=82) trajala do 204. tedna pri celotni populaciji z aksialnim spondiloartritisom kot tudi pri podpopulacijah z AS in nr-axSpA.
English: Allée de la Recherche 60 B-1070 Bruxelles Belgium
Slovenian: Allée de la Recherche 60 B-1070 Bruselj Belgija
English: Cimzia should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Zdravilo Cimzia moramo pri bolnikih z blagim srčnim popuščanjem (razred NYHA I/II) uporabljati previdno.
English: These diseases are inflammatory diseases of the spine.
Slovenian: Ti bolezni sta vnetni bolezni hrbtenice.
English: Tell your doctor IMMEDIATELY if you notice any of the following side effects:
Slovenian: NEMUDOMA obvestite svojega zdravnika, če ste opazili katerega od naslednjih neželenih učinkov:
English: A pharmacodynamic model based on the Phase III trial data predicts that around 15% of the patients develop antibodies in 6 months at the recommended dose regimen (200 mg every 2 weeks following a loading dose) without MTX co-treatment.
Slovenian: Farmakodinamski model, oblikovan na osnovi rezultatov študije faze III, predvideva, da se pri približno 15 % bolnikov v 6 mesecih ob priporočenem režimu odmerjanja (200 mg enkrat na dva tedna po udarnem odmerku) brez sočasnega zdravljenja z MTX razvijejo protitelesa.
English: At both Week 12 and 52, ASAS 40 responses were significantly greater than placebo.
Slovenian: V 12. in 52. tednu so bili odzivi ASAS 40 bistveno večji kot pri placebu.
English: - Position ava at a right angle on your skin with the screen facing you.
Slovenian: - Namestite napravo ava na kožo pod desnim kotom, tako da je zaslon obrnjen proti vam.
English: - Avoid removing ava from the skin during the injection to ensure that you receive the full dose.
Slovenian: - Med injiciranjem se izogibajte umikanju naprave ava s kože, da boste zagotovo prejeli polni odmerek
English: Inject within 5 minutes of removing the needle cap.
Slovenian: Injicirajte v 5 minutah po odstranitvi pokrovčka z igle.
English: • sexual dysfunction
Slovenian: • motnje spolne funkcije
English: Of the 850 patients randomized to receive placebo or Cimzia in these placebo-controlled studies, 29% of patients were naïve to prior systemic therapy for the treatment of psoriasis.
Slovenian: Med 850 bolniki, ki so bili v teh s placebom nadzorovanih študijah randomizirani za prejemanje placeba ali zdravila Cimzia, 29 % bolnikov predhodno še ni bilo zdravljenih s sistemsko terapijo za zdravljenje psoriaze.
English: Similar to the placebo-controlled studies, antibody positivity was associated with reduced efficacy in some patients.
Slovenian: Podobno kot pri s placebom nadzorovanih študijah so bili pozitivni rezultati na protitelesa povezani z zmanjšano učinkovitostjo pri nekaterih bolnikih.
English: The clearance following subcutaneous dosing in patients with psoriasis was 14 ml/h with an inter-subject variability of 22.2% (CV).
Slovenian: Očistek po subkutanem dajanju bolnikom s psoriazo je bil 14 ml/h z 22,2 % razlikami med osebami (CV).
English: Inhibition of radiographic progression was maintained with Cimzia treatment up to Week 48 in the subset of patients at higher risk of radiographic progression (patients with a Baseline mTSS score of > 6).
Slovenian: Radiografsko potrjeno zaviranje napredovanja bolezni se je z zdravljenjem z zdravilom Cimzia ohranilo do 48. tedna v podskupini bolnikov z večjim tveganjem za radiografsko potrjeno napredovanje bolezni (bolniki z izhodiščno vrednostjo pri oceni mTSS > 6).
English: • When “Remove and discard used medication” is shown, pull out the medication using the needle cap.
Slovenian: • Ko se prikaže ˝Remove and discard used medication˝, izvlecite vložek s pomočjo pokrovčka igle.
English: If inactive (‘latent') tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Slovenian: V primeru suma na neaktivno (latentno) tuberkulozo se je potrebno posvetovati z zdravnikom, ki je strokovnjak za tuberkulozo.
English: Patients must have been intolerant to or had an inadequate response to at least two NSAIDs.
Slovenian: Bolniki prav tako niso prenašali ali so imeli neustrezen odziv na vsaj dve zdravili NSAID.
English: The clinical significance of low levels certolizumab pegol for infants is unknown.
Slovenian: Klinični pomen majhnih koncentracij certolizumab pegola pri dojenčkih ni znan.
English: To complete your injection: o Repeat Step 2 (Choosing and preparing an injection site), using a different injection site o Press ava firmly against the skin to begin the injection again, then o Press the (Start/Pause button).
Slovenian: o Ponovite korak 2 (Izbira in priprava mesta za injiciranje), vendar uporabite drugo mesto injiciranja o Pritisnite napravo ava tesno h koži, da se ponovno začne injiciranje.
English: Co-administration of Cimzia with methotrexate had no significant effect on the pharmacokinetics of methotrexate.
Slovenian: Sočasna uporaba zdravila Cimzia in metotreksata ni imela pomembnega učinka na farmakokinetiko metotreksata.
English: Do not try to touch the needle as it could activate the pre-filled pen.
Slovenian: Ne poskušajte se je dotakniti, ker bi lahko s tem aktivirali napolnjeni injekcijski peresnik.
English: One Cimzia pack contains:
Slovenian: Eno pakiranje zdravila Cimzia vsebuje:
English: If you forget to use Cimzia
Slovenian: Če ste pozabili uporabiti zdravilo Cimzia
English: One case of lymphoma was also observed in the Phase III psoriatic arthritis clinical trial.
Slovenian: En primer limfoma so opazili v fazi III kliničnega preskušanja zdravljenja psoriatičnega artritisa.
English: There is no evidence that Cimzia therapy has an effect on coagulation in vivo.
Slovenian: Nobenih dokazov ni, da zdravljenje z zdravilom Cimzia vpliva na koagulacijo in vivo.
English: In the placebo-controlled trial in patients with non-radiographic axial spondyloarthritis, using a more sensitive and drug tolerant assay than in previous trials, the overall incidence of patients who were antibody positive to certolizumab pegol was 97% (248/255 patients) after up to 52 weeks of treatment.
Slovenian: V s placebom nadzorovanem preskušanju pri bolnikih z neradiografskim aksialnim spondiloartritisom z uporabo bolj občutljivega in na zdravilo odpornejšega testa v primerjavi s prejšnjimi preskušanji je bila skupna incidenca bolnikov, ki so bili pozitivni na protitelesa proti certolizumab pegolu, 97 % (248/255 bolnikov) do 52. tedna zdravljenja.
English: Serious infections also included invasive opportunistic infections (e.g. pneumocystosis, fungal oesophagitis, nocardiosis and herpes zoster disseminated).
Slovenian: Med resnimi okužbami so bile invazivne oportunistične okužbe (npr. pnevmocistoza, glivični ezofagitis, nokardioza in diseminirani herpes zoster).
English: • Additional risk minimisation measures The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Cimzia are provided with a physician information pack containing the following:
Slovenian: Imetnik dovoljenja za promet mora pred dajanjem zdravila na trg zagotoviti, da prejmejo vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Cimzia, paket z informacijami za zdravnike, ki vsebuje:
English: Overall, 16% of patients had prior TNF-antagonist exposure.
Slovenian: Celokupno je 16 % bolnikov že predhodno uporabljalo zaviralce TNF.
English: The use of adequate contraception should be considered for women of childbearing potential.
Slovenian: Pri ženskah v rodni dobi je treba razmisliti o uporabi ustrezne kontracepcije.
English: Cimzia was administered subcutaneously in combination with oral MTX for a minimum of 6 months with stable doses of at least 10 mg weekly for 2 months in both trials.
Slovenian: Zdravilo Cimzia so dobivali subkutano v kombinaciji s peroralnim MTX najmanj 6 mesecev ob stabilnih odmerkih najmanj 10 mg tedensko 2 meseca v obeh študijah.
English: Do not stop using Cimzia without talking to your doctor first.
Slovenian: Če ste prenehali uporabljati zdravilo Cimzia Zdravila Cimzia ne smete prenehati uporabljati, ne da bi se prej posvetovali z zdravnikom.
English: Manufacturer UCB Pharma S.A. Chemin du Foriest B-1420 Braine l'Alleud Belgium
Slovenian: Izdelovalec UCB Pharma S.A. Chemin du Foriest B-1420 Braine l'Alleud Belgija
English: *These events have been related to the class of TNF-antagonists, but incidence with certolizumab pegol is not known.
Slovenian: *Te dogodke povezujejo s skupino zaviralcev TNF, vendar pa pogostnost pri zdravljenju s certolizumab pegolom ni znana.
English: Take care not to touch the needle or let the needle touch any surface.
Slovenian: Pazite, da se igle ne dotaknete s prsti, oziroma da se z njo česa ne dotaknete.
English: After proper training, the injection can be self-administered or given by another person, for example a family member or friend.
Slovenian: Če so bili za to ustrezno usposobljeni, si lahko bolniki zdravilo injicirajo sami ali pa to stori nekdo drug, na primer družinski član ali prijatelj.
English: If new skin lesions appear during or after therapy with Cimzia or existing skin lesions change appearance, tell your doctor.
Slovenian: Če se med zdravljenjem z zdravilom Cimzia ali po njem pojavijo nove kožne tvorbe ali pa se že obstoječe tvorbe spremenijo, o tem obvestite svojega zdravnika.
English: Patients had a mean time since diagnosis at baseline of 2.9 months and were DMARD naïve (including MTX).
Slovenian: Bolniki so imeli povprečni čas od postavitve diagnoze 2,9 meseca in se še niso zdravili z antirevmatiki DMARD (vključno z MTX).
English: Certolizumab pegol does not cross-react with rodent TNF.
Slovenian: Certolizumab pegol ne reagira navzkrižno z glodalčjim TNF.
English: The de-conjugated PEG component is rapidly eliminated from plasma and is to an unknown extent excreted renally.
Slovenian: Dekonjugirana komponenta PEG se hitro izloči iz plazme, nato pa v neznani količini iz telesa preko ledvic.
English: No mutagenic or clastogenic effects were demonstrated in preclinical studies.
Slovenian: Predklinične študije niso pokazale mutagenih ali klastrogenih učinkov.
English: This effect has been observed with the PTT-Lupus Anticoagulant (LA) test and Standard Target Activated Partial Thromboplastin time (STA-PTT) Automate tests from Diagnostica Stago, and the HemosIL APTT-SP liquid and HemosIL lyophilised silica tests from Instrumentation Laboratories.
Slovenian: Tak učinek so opazili pri naslednjih testih: PTT-LA (Lupus Anticoagulant) in STA-PTT (Standard Target Activated Partial Thromboplastin time) Automate proizvajalca Diagnostica Stago, ter HemosIL APTT-SP tekočina in HemosIL liofilizirani silicijev dioksid proizvajalca Instrumentation Laboratories.
English: Of the 783 patients initially randomised to active treatment in RA-I, 508 completed 52 weeks of placebocontrolled treatment and entered the open-label extension study.
Slovenian: Od 783 bolnikov, ki so bili na začetku randomizirano izbrani za aktivno zdravljenje v študiji RA-I, jih je 508 zaključilo 52tedensko s placebom nadzorovano zdravljenje in vstopilo v odprt podaljšek študije.
English: PEGylation, the covalent attachment of PEG polymers to peptides, delays the elimination of these entities from the circulation by a variety of mechanisms, including decreased renal clearance, decreased proteolysis, and decreased immunogenicity.
Slovenian: Pegilacija, kovalentna vezava polimerov polietilenglikola (PEG) na peptide, zakasni izločanje teh spojin iz krvnega obtoka prek različnih mehanizmov, vključno z zmanjšanjem ledvičnega očistka, proteolize in imunogenosti.
English: Cimzia has a high affinity for human TNFα and binds with a dissociation constant (KD) of 90 pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes.
Slovenian: Zdravilo Cimzia ima visoko afiniteto za humani TNF-α in se veže z disociacijsko konstanto 90 pM. TNF-α je bistven provnetni citokin, ki ima osrednjo vlogo v procesu vnetja.
English: These results were maintained over 52 weeks of treatment in DMARD-naïve subjects.
Slovenian: Ti rezultati so bili pridobljeni v 52 tednih zdravljenja bolnikov, ki se predhodno niso zdravili z DMARD.
English: If you develop new or worsening symptoms of heart failure (e.g. shortness of breath or swelling of your feet), you must contact your doctor immediately.
Slovenian: Če se pri vas pojavijo novi ali se poslabšajo obstoječi simptomi srčnega popuščanja (npr. kratka sapa ali otekanje stopal), se takoj posvetujte s svojim zdravnikom.