natgillin/translations-raw huggingface dataset:
In order to minimize the risk for the most critical side effects “infection” and “worsening of congestive heart failure” of Erelzi, a Patient Alert Card has been developed. 
Opozorilna kartica za bolnika je bila razvita, da bi zmanjšali tveganje za najbolj resne neželene učinke zdravila Erelzi, torej za “okužbo” in “poslabšanje kongestivnega srčnega popuščanja”.
Thus, the combined use of Erelzi and anakinra is not recommended (see sections 4.5 and 4.8). 
Ta kombinacija ni pokazala povečane klinične koristi, zato uporaba zdravila Erelzi skupaj z anakinro ni priporočljiva (glejte poglavji 4.5 in 4.8).
• Only remove the cap when you are ready to use the pen. 
• Pokrovček snemite šele takrat, ko boste pripravljeni za uporabo injekcijskega peresnika.
For polyarthritis or extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more, the usual dose is 25 mg given twice a week or 50 mg given once a week. 
Običajni odmerek etanercepta za zdravljenje poliartritisa ali razširjenega oligoartritisa pri bolnikih, starejših od 2 let in ki tehtajo 62,5 kg ali več, in za zdravljenje artritisa, povezanega z entezitisom, ali psoriatičnega artritisa pri bolnikih, starejših od 12 let in ki tehtajo 62,5 kg ali več, je 25 mg dvakrat na teden ali 50 mg enkrat na teden.
These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of therapy. 
Take bolnike je treba ves čas zdravljenja in še več tednov po prekinitvi zdravljenja spremljati glede znakov in simptomov aktivne okužbe s HBV. O sočasnem protivirusnem zdravljenju in zdravljenju z zaviralci TNF pri bolnikih, okuženih s HBV, ni zadostnih podatkov.
Etanercept showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score. 
Ankylosing Spondylitis Functional Index; indeks Bath za ocenjevanje aktivnosti ankilizirajočega spondilitisa), rezultatom splošnega zdravstvenega stanja EuroQol 5D in rezultatom telesne komponente SF-36, v primerjavi s placebom.
EU/1/17/1195/008 12 pre-filled syringes 
EU/1/17/1195/008 12 napolnjenih injekcijskih brizg
In clinical trials, no interactions have been observed when etanercept was administered with glucocorticoids, salicylates (except sulfasalazine), non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate. 
salicilati (razen sulfasalazina), nesteroidnimi protivnetnimi zdravili (NSAIDs), analgetiki ali metotreksatom.
Erelzi is supplied as a pre-filled syringe containing a clear or slightly opalescent, colourless to slightly yellowish solution for injection (injection). 
Zdravilo Erelzi je na voljo v napolnjeni injekcijski brizgi, ki vsebuje bistro do rahlo opalescentno, brezbarvno do rahlo rumenkasto raztopino za injiciranje (injekcijo).
Each pack contains 1, 2 or 4 pre-filled syringes with a needle guard, multipacks contain 12 (3 packs of 4) 25 mg or 50 mg pre-filled syringes with a needle guard or 8 (2 packs of 4) or 24 (6 packs of 4) 25 mg pre-filled syringes with a needle guard. 
Eno pakiranje vsebuje 1, 2 ali 4 napolnjene injekcijske brizge z zapiralom igle, skupno pakiranje vsebuje 12 (3 pakiranja po 4) 25-mg ali 50-mg napolnjenih injekcijskih brizg z zapiralom igle ali 8 (2 pakiranji po 4) ali 24 (6 pakiranj po 4) 25-mg napolnjenih injekcijskih brizg z zapiralom igle.
Patients currently on methotrexate therapy (stable for ≥ 2 months) could continue at a stable dose of ≤ 25 mg/week methotrexate. 
≥ 2 meseca), so lahko nadaljevali s stalnim odmerkom metotreksata ≤ 25 mg/teden.
• Cotton ball or gauze 
• kosem vate ali zloženec iz gaze
There have been post-marketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4). 
Pancitopenija in aplastična anemija V obdobju trženja so poročali o pancitopeniji in aplastični anemiji, nekateri od teh primerov so bili tudi smrtni (glejte poglavje 4.4).
The efficacy of etanercept in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice-weekly administration of 25 mg etanercept with placebo. 
Odrasli bolniki z ankilozirajočim spondilitisom Učinkovitost etanercepta pri bolnikih z ankilozirajočim spondilitisom je bila ocenjena v 3 randomiziranih dvojno slepih študijah, kjer so primerjali uporabo 25 mg etanercepta dvakrat tedensko s placebom.
Citric acid anhydrous Sodium citrate dihydrate Sodium chloride 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi brezvodna citronska kislina natrijev citrat dihidrat natrijev klorid saharoza
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. 
Ankilozirajoči spondilitis (AS) Zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, če je bil odziv na konvencionalno zdravljenje nezadosten.
The box contains Erelzi pre-filled syringe(s) individually sealed in a plastic blister. 
Erelzi, od katerih je vsaka posebej zapakirana v plastičen pretisni omot.
Re-introduction of treatment with etanercept after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received etanercept without interruption of therapy based on results of open-label studies. 
Po podatkih iz odprtih študij so bile velikosti odziva po ponovni uvedbi zdravljenja z etanerceptom po prekinitvah, ki so trajale do 24 mesecev, enake kot pri bolnikih, ki so prejemali etanercept brez prekinitve zdravljenja.
At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients. 
V 24. tednu je 56 % bolnikov doseglo PASI 75 v skupini, zdravljeni z etanerceptom, v skupini s placebom pa 5 %
Post-marketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with etanercept. 
Pri bolnikih, zdravljenih z etanerceptom, so v obdobju trženja poročali o zelo redkih primerih karcinoma Merklovih celic.
Differences from adults and other special considerations are discussed in the following paragraphs. 
Spodaj so opisane razlike glede na odrasle bolnike in druge posebnosti.
depression/personality disorder, cutaneous ulcer, oesophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection. 
apendicitis, gastroenteritis, depresija/osebnostne motnje, kožne razjede, ezofagitis/gastritis, streptokokni septični šok (streptokoki skupine A), sladkorna bolezen tipa I in okužbe mehkih tkiv ter postoperativnih ran.
Patients should be tested for HBV infection before initiating treatment with Erelzi. 
Pred uvedbo zdravljenja z zdravilom Erelzi je treba bolnike testirati na okužbo s HBV.
Radiographic progression: comparison of etanercept vs. methotrexate vs. etanercept in combination with methotrexate in patients with RA of 6 months to 20 years duration (12 month results) 
Radiografsko napredovanje: primerjava med etanerceptom, metotreksatom in kombinacijo etanercepta in metotreksata pri bolnikih z RA, ki je trajal 6 mesecev do 20 let (rezultati pri 12 mesecih)
• Instruction to immediately seek for medical attention after developing or worsening of symptoms for congestive heart failure 
• navodilo, da mora bolnik ob pojavu ali poslabšanju simptomov kongestivnega srčnega popuščanja takoj poiskati zdravniško pomoč;
Contents of the pack and other information Instructions for Use of the Erelzi pre-filled syringe (see overleaf) 
Vsebina pakiranja in dodatne informacije Navodila za uporabo zdravila Erelzi napolnjena injekcijska brizga
• Use the pen within 5 minutes of removing the cap. 
• Po odstranitvi pokrovčka morate injekcijski peresnik uporabiti v roku 5 minut.
It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Erelzi therapy (see Vaccinations, above). 
opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje (glejte Cepljenja zgoraj).
This device will be provided to HCPs to support (self-) injection training and is intended to be used and trained in the HCP office or during a home care program 
Ta pripomoček, namenjen uporabi in poučevanju v ambulanti zdravstvenega delavca oziroma v programu zdravstvene oskrbe na domu, bodo prejeli zdravstveni delavci za pomoč pri usposabljanju za
In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of etanercept and methotrexate did not result in unexpected safety findings, and the safety profile of etanercept when given in combination with methotrexate was similar to the profiles reported in studies of etanercept and methotrexate alone. 
V dveletnem nadzorovanem kliničnem preskušanju pri bolnikih z revmatoidnim artritisom ni bilo pri kombiniranem zdravljenju z etanerceptom in metotreksatom nepričakovanih ugotovitev glede varnosti;
These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection. 
bronhitis, burzitis, celulitis, holecistitis, diareja, divertikulitis, endokarditis (sum nanj), gastroenteritis, hepatitis B, herpes zoster, razjeda na nogi, okužba ustne votline, osteomielitis, otitis, peritonitis,
Radiographic progression at 12 months was significantly less in the etanercept group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below). 
Po 12 mesecih zdravljenja je bilo radiografsko napredovanje pri bolnikih, ki so jih zdravili z etanerceptom, statistično pomembno manjše kot pri bolnikih, ki so jih zdravili z metotreksatom; kombinacija obeh zdravil pa je radiografsko napredovanje upočasnila statistično pomembno učinkoviteje kot eno samo zdravilo (glejte spodnjo sliko).
Responses of patients with psoriatic arthritis in a placebo-controlled trial Percent of Patients 
Odzivi bolnikov s psoriatičnim artritisom v preskušanju, nadzorovanem s placebom
Multipack: 12 (3 packs of 4) pre-filled SensoReady pens. 
raztopina za injiciranje Skupno pakiranje: 12 (3 pakiranja s po 4) napolnjenih injekcijskih peresnikov SensoReady
Remember to take the blister out of the refrigerator and allow it to reach room temperature before preparing it for injection (15-30 minutes). 
Pred pripravljanjem brizge za injiciranje ne pozabite pretisnega omota vzeti iz hladilnika in ga pustiti, da doseže sobno temperaturo (15-30 minut).
Some vaccines, such as oral polio vaccine, should not be given while using Erelzi. 
Med zdravljenjem z zdravilom Erelzi nekaterih cepiv, npr. peroralnega cepiva proti otroški paralizi, ni dovoljeno uporabljati.
The SensoReady pen contains a clear or slightly opalescent, colourless to slightly yellowish solution for injection (injection). 
Napolnjen injekcijski peresnik SensoReady vsebuje bistro do rahlo opalescentno, brezbarvno do rahlo rumenkasto raztopino za injiciranje (injekcijo).
The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study. 
Učinkovitost etanercepta je bila ugotovljena v randomizirani, dvojno slepi klinični študiji, nadzorovani s placebom.
Each pre-filled syringe contains 25 mg of etanercept or 50 mg of etanercept. 
Ena napolnjena injekcijska brizga vsebuje 25 mg etanercepta ali 50 mg etanercepta.
Patients in the etanercept in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below). 
Pri bolnikih, ki so prejemali etanercept v kombinaciji z metotreksatom, so bili odzivi ACR 20, ACR 50 in ACR 70 ter izboljšanja na lestvicah ocene stopnje bolezni (DAS - Disease Activity Score)
• This medicine has been prescribed for you or a child in your care. 
• Zdravilo je bilo predpisano vam ali otroku, za katerega skrbite, osebno in ga ne smete dajati drugim.
Your injection: 
Injiciranje:
4 pre-filled syringes with a needle guard. 
4 napolnjene injekcijske brizge z zapiralom igle.
• Keep holding the pen firmly against your skin. 
• Injekcijski peresnik še naprej močno pritiskajte v kožo.
• Signs of serious infections such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints; 
• znaki resnih okužb, npr. visoka vročina, ki jo lahko spremljajo kašelj, kratka sapa, mrzlica,
In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving etanercept during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy. 
V eni študiji pri otrocih z juvenilnim idiopatskim artritisom, starih od 4 do 17 let, se je pri 43 od 69 otrok (62 %) med trimesečnim zdravljenjem z etanerceptom v času študije (prvi del,
• Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision; 
• znaki rakavih obolenj: rak• znaki avtoimunskih reakcij (reakcije, pri katerih se tvorijo protitelesa, ki lahko poškodujejo normalna telesna tkiva), kot so bolečina, srbenje, oslabelost,
A 25 mg strength of Erelzi is available for doses of 25 mg. 
Zdravilo Erelzi je na voljo v jakosti 25 mg za odmerke 25 mg.
Serious infections experienced by etanercept-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess. 
gastroenteritis, pljučnica, holecistitis, osteomielitis, gastritis, apendicitis, streptokokni fasciitis, miozitis, septični šok, divertikulitis in absces.
In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received etanercept. 
V združeni zbirki podatkov iz kliničnih preskušanj je bila celokupna pojavnost oportunističnih okužb pri 15.402
Holding your pen: • Hold the pen at 90 degrees to the cleaned injection site. 
• Injekcijski peresnik držite pravokotno nad očiščenim mestom injiciranja (pod kotom 90 stopinj).
• Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Erelzi. 
• Norice: Povejte zdravniku, če ste bili vi ali otrok med zdravljenjem z zdravilom Erelzi izpostavljeni noricam.
Instructions for use of the Erelzi SensoReady pen 
Navodila za uporabo injekcijskega peresnika SensoReady z zdravilom Erelzi
Your Erelzi pre-filled syringe with needle guard and add-on finger flange 
Vaše zdravilo Erelzi napolnjena injekcijska brizga z zapiralom igle in držalom za prste
Erelzi is available in strengths of 25 mg and 50 mg. 
Zdravilo Erelzi je na voljo v jakostih 25 mg in 50 mg.
This combination has not demonstrated increased clinical benefit. 
Ta kombinacija ni pokazala povečane klinične koristi, zato njena uporaba ni priporočljiva
There have been reports of IBD and uveitis in JIA patients being treated with etanercept (see section 4.8). 
Pri bolnikih z JIA, ki so se zdravili z etanerceptom, so poročali o KVČB in uveitisu (glejte poglavje 4.8).
Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike whitegrey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon). 
melanom (vrsta kožnega raka); kombinacija znižanja števila trombocitov in rdečih ter belih krvnih celic; motnje živčevja (s hudo mišično oslabelostjo ter z znaki in simptomi, podobnimi multipli sklerozi ali vnetje očesnih živcev ali hrbtenjače); tuberkuloza; nastanek kongestivnega srčnega popuščanja; epileptični napadi; lupus ali lupusu podoben sindrom (med simptomi so lahko trdovraten izpuščaj, vročina, bolečine v sklepih in utrujenost); kožni izpuščaj, ki lahko povzroči močno mehurjenje in luščenje kože; lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah); vnetje jeter, ki je posledica delovanja imunskega sistema proti tkivu lastnega telesa (avtoimunski hepatitis; pri bolnikih, ki sočasno prejemajo metotreksat, je občasen); imunska bolezen, ki lahko prizadene pljuča, kožo in bezgavke (sarkoidoza); vnetje ali brazgotinjenje pljuč (pri bolnikih, ki sočasno prejemajo metotreksat, je vnetje ali brazgotinjenje pljuč občasno).
After your injection: 
Po injiciranju:
Contact your doctor if the green indicator is not visible. 
Če zelenega indikatorja ni videti, obvestite zdravnika.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for use of the Erelzi pre-filled syringe” or “Instructions for use of the Erelzi SensoReady pen”. 
Obsežna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7 "Navodila za uporabo zdravila Erelzi napolnjena injekcijska brizga" ali "Navodila za uporabo zdravila Erelzi SensoReady injekcijski peresnik".
Mean (SE) annualized change from baseline in total sharp score 
Povprečna (SE) sprememba skupne Sharpove ocene od izhodišča na leto
After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the Erelzi solution in the syringe to reach room temperature. 
Ko brizgo vzamete iz hladilnika, počakajte približno 15 do 30 minut, da se raztopina zdravila Erelzi v brizgi segreje na sobno temperaturo.
The usual dose is 25 mg twice a week or 50 mg once a week. 
Odmerek je 25 mg dvakrat na teden ali 50 mg enkrat na teden.
Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including etanercept. 
Pri bolnikih, zdravljenih z antagonisti TNF, vključno z etanerceptom, so poročali o melanomu in nemelanomskem kožnem raku (NMSC - Non-Melanoma Skin Cancer).
Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly. 
Če je treba, je zdravilo mogoče uporabljati tudi v odmerku 50 mg dvakrat na teden do 12 tednov, čemur po potrebi sledi odmerek 25 mg dvakrat na teden ali 50 mg enkrat na teden.
For rheumatoid arthritis, Erelzi is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you. 
Pri zdravljenju revmatoidnega artritisa se zdravilo Erelzi običajno uporablja skupaj z metotreksatom.
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the etanercept in combination with methotrexate group compared with the etanercept alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05). 
TSS ≤ 0,5) je bil po 24 mesecih večji v skupini, ki je dobivala etanercept v kombinaciji z metotreksatom, kakor v skupinah, ki sta dobivali etanercept ali metotreksat v monoterapiji (62 %, 50 % in 36 %, p < 0,05).
CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure 
Bolezni živčevja demielinizirajoči pojavi v CŽS, ki kažejo na multiplo sklerozo, ali lokalizirana demielinizirajoča stanja, kot sta optični nevritis in transverzni mielitis (glejte poglavje 4.4), demielinizacija perifernega živčevja, vključno z
Leave it to dry before injecting. 
Pred injiciranjem naj se koža posuši.
Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) 
Kronična vnetna črevesna bolezen (KVČB) in uveitis pri bolnikih z juvenilnim idiopatskim artritisom
In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with etanercept or placebo for moderate to severe alcoholic hepatitis, etanercept was not efficacious, and the mortality rate in patients treated with etanercept was significantly higher after 6 months. 
faze, v kateri so proučevali 48 hospitaliziranih bolnikov, zdravljenih z etanerceptom ali placebom zaradi zmernega do hudega alkoholnega hepatitisa,
How to use the Erelzi pre-filled syringe 
Kako uporabljati napolnjeno injekcijsko brizgo z zdravilom Erelzi
In study 4, the etanercept-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p < 0.0001). 
V študiji 4 je bil v 12. tednu delež bolnikov z odzivom PASI 75 večji v skupini, zdravljeni z etanerceptom (38 %), kot v skupini, ki je dobivala placebo (2 %) (p < 0,0001).
The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of etanercept in adult patients with rheumatoid arthritis, and the majority were mild. 
Neželeni učinki pri bolnikih z juvenilnim idiopatskim artritisom so bili po vrstah in deležih podobni tistim, opisanim v preskušanjih etanercepta pri odraslih bolnikih z revmatoidnim artritisom.
• Cancer: Tell your doctor if you have or have ever had lymphoma (a type of blood cancer) or any other cancer before you are given Erelzi. 
• Rak: Preden boste prejeli zdravilo Erelzi, povejte zdravniku, če imate ali ste kdaj imeli limfom
The other ingredients are: citric acid anhydrous, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid and water for injections. 
Druge sestavine so: brezvodna citronska kislina, natrijev citrat dihidrat, natrijev klorid, saharoza, L-lizinijev klorid, natrijev hidroksid (za uravnavanje pH- vrednosti), solna kislina (za uravnavanje pHvrednosti) in voda za injekcije.
A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Erelzi to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease. 
Pri bolnikih z demielinizirajočimi obolenji, ki so obstajala že prej ali so nastopila pred kratkim, ali pri tistih, ki imajo povečano tveganje za razvoj demielinizirajoče bolezni, je treba pred zdravljenjem z z zdravilom Erelzi skrbno pretehtati tveganja in koristi, vključno z nevrološko oceno.
From the start of part 2, the median time to flare was ≥ 116 days for patients who received etanercept and 28 days for patients who received placebo. 
≥ 116 dni pri bolnikih na etanerceptu in 28 dni pri bolnikih na placebu.