natgillin/translations-raw huggingface dataset:
A total of 401 patients were enrolled, from which 203 were treated with Enbrel.
Sodeloval je 401 bolnik in od tega so bili 203 zdravljeni z zdravilom Enbrel.
Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Enbrel.
Ti simptomi namreč lahko kažejo na pojav življenjsko ogrožajoče bolezni krvi, pri kateri bo zdravljenje z zdravilom Enbrel morda treba prekiniti.
For psoriatic arthritis patients with multiple joint involvement, Enbrel can improve your ability to do normal daily activities.
Pri bolnikih s psoriatičnim artritisom in prizadetostjo več sklepov lahko zdravilo Enbrel izboljša sposobnost opravljanja običajnih vsakdanjih dejavnosti.
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with Enbrel, relative to placebo (p < 0.001).
Rezultat indeksa invalidnosti je bil bistveno boljši v vseh časovnih točkah pri bolnikih s psoriatičnim artritisom, zdravljenih z zdravilom Enbrel, v primerjavi s placebom (p < 0,001).
• The risk of Congestive Heart Failure (CHF).
• tveganje za kongestivno srčno popuščanje (KSP)
A placebo-controlled trial, in which 89 adult patients were treated with Enbrel in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown Enbrel to be an effective treatment for Wegener's granulomatosis.
S placebom nadzorovano preskušanje, v katerem je 89 odraslih bolnikov poleg standardnega zdravljenja (vključno s ciklofosfamidom ali metotreksatom in glukokortikoidi) jemalo zdravilo Enbrel z medianim časom zdravljenja 25 mesecev, ni pokazalo učinkovitosti zdravila Enbrel za zdravljenje Wegenerjeve granulomatoze.
The difference between Enbrel alone and methotrexate alone was also significant (p<0.05).
Pomembna je bila tudi razlika med monoterapijo z zdravilom Enbrel in monoterapijo z metotreksatom (p < 0,05).
Autoantibody formation Treatment with Enbrel may result in the formation of autoimmune antibodies (see section 4.8).
Tvorba avtoprotiteles Zdravljenje z zdravilom Enbrel lahko sproži nastajanje avtoimunskih protiteles (glejte poglavje 4.8).
If the needle is not correctly lined up, you will feel constant resistance as it goes through the stopper and no “pop”.
Če igla ne bo pravilno poravnana, boste pri prodiranju skozi zamašek ves čas čutili odpor in ne bo “poka”.
Consequently, Enbrel should not be used in patients for the treatment of alcoholic hepatitis.
Zato zdravila Enbrel ne smemo uporabljati pri bolnikih za zdravljenje alkoholnega hepatitisa.
Method of administration Enbrel is administered by subcutaneous injection (see section 6.6).
Način uporabe Zdravilo Enbrel se daje s subkutano injekcijo (glejte poglavje 6.6).
The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with Enbrel than in the control group.
Pojavnost nekožnih malignih obolenj različnih tipov je bila pomembno večja pri bolnikih, zdravljenih z zdravilom Enbrel, kot pri tistih v kontrolni skupini.
If any serious allergic or anaphylactic reaction occurs, Enbrel therapy should be discontinued immediately and appropriate therapy initiated.
Če se pojavi kakršnakoli resna alergijska ali anafilaktična reakcija, je treba zdravljenje s tem zdravilom takoj prekiniti in uvesti ustrezno zdravljenje.
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 Enbrel therapy (see Vaccinations, above).
Za pediatrične bolnike priporočamo, da pred začetkom zdravljenja z zdravilom Enbrel, če je le mogoče, opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje (glejte Cepljenja zgoraj).
These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Pojavljali so se glavoboli (19 %, 1,7 dogodka na bolnik-leto), navzea (9 %, 1,0 dogodek na bolnik-leto), bolečine v trebuhu (19 %, 0,74 dogodka na bolnik-leto) in bruhanje (13 %, 0,74 dogodka na bolnik-leto).
Based on the review of the literature and spontaneous reporting presented in this PSUSA, covering the period from 03 February 2018 to 02 February 2019, as well as cumulative data since the European birth date, the PRAC considered that a causal relationship between inflammatory bowel disease and etanercept cannot be excluded and therefore recommends that the product information of medicinal products containing the active substance etanercept should be updated as follows: update of section 4.8 of the SmPC to add inflammatory bowel disease with a frequency uncommon.
Na podlagi pregleda literature in spontanega poročanja, predstavljenega v tej enotni oceni redno posodobljenih poročil o varnosti zdravila (PSUSA), ki zajema obdobje od 3. februarja 2018 do 2. februarja 2019, ter kumulativnih podatkov od datuma pridobitve dovoljenja za promet z zdravilom v Evropi, odbor PRAC meni, da ni mogoče izključiti vzročne povezanosti med vnetno črevesno boleznijo in etanerceptom, zato priporoča posodobitev informacij o zdravilih, ki vsebujejo učinkovino etanercept, in sicer kot sledi: posodobitev poglavja 4.8 povzetka glavnih značilnosti zdravila tako, da bo vključevalo vnetno črevesno bolezen s pogostnostjo ''občasni''.
Enbrel is not recommended for the treatment of Wegener's granulomatosis.
Zdravila Enbrel ni priporočljivo uporabljati za zdravljenje Wegenerjeve granulomatoze.
During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three Enbrel doses.
V prvih 12 tednih dvojno slepega obdobja zdravljenja so bolniki dobivali placebo ali enega od navedenih odmerkov zdravila Enbrel.
Patients who “failed to respond to” in the target population is defined by insufficient response (PASI<50 or PGA less than good), or worsening of the disease while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the three major systemic therapies as available.
Bolnike v ciljni populaciji, ki ''se niso odzvali'', opredeljuje nezadosten odziv (PASI  50 ali PGA [PGA - Physician Global Assessment] manj kot dober) ali poslabšanje bolezni med zdravljenjem, ko je bolnik prejemal najmanj vsako od treh glavnih razpoložljivih sistemskih zdravljenj v zadostnem odmerku in dovolj časa, da je bilo mogoče oceniti odziv.
The efficacy of Enbrel versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing Enbrel with other systemic therapies.
Učinkovitosti zdravila Enbrel v primerjavi z drugimi sistemskimi zdravljenji pri bolnikih z zmerno do hudo psoriazo (ki se odziva na druga sistemska zdravljenja) niso ovrednotili s študijami, v katerih bi neposredno primerjali zdravilo Enbrel z drugimi sistemskimi terapijami.
Treatment with Enbrel should not be initiated in patients with active infections, including chronic or localised infections.
Zdravljenja z zdravilom Enbrel ne smete uvesti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi okužbami.
Enbrel is prescribed for the treatment of the following diseases in children and adolescents
Zdravilo Enbrel se predpisuje za zdravljenje naslednjih bolezni pri otrocih in mladostnikih:
There was some evidence to support a benefit of re-treatment with Enbrel in patients initially responding to treatment.
Nekaj podatkov kaže na ugoden odziv na ponovno zdravljenje z zdravilom Enbrel pri bolnikih, ki so se prvotno odzvali na zdravljenje.
Start again with a new Enbrel vial, water for injections, syringe, needle and swabs.
V tem primeru začnite z novo vialo zdravila Enbrel, vodo za injekcije, brizgo, iglo in blazinicami.
Your doctor or nurse will tell you how to inject Enbrel.
Zdravnik ali medicinska sestra vas bosta natančno poučila, kako si injicirate zdravilo Enbrel.
• Tuberculosis: As cases of tuberculosis have been reported in patients treated with Enbrel, your doctor will check for signs and symptoms of tuberculosis before starting Enbrel.
Tuberkuloza: Ker so pri bolnikih, ki so se zdravili z zdravilom Enbrel, poročali o primerih tuberkuloze, se bo vaš zdravnik prepričal, da nimate znakov ali simptomov tuberkuloze, preden se boste začeli zdraviti z zdravilom Enbrel.
Another study found no increased risk of birth defects when the mother had received Enbrel in pregnancy.
V drugi študiji niso ugotovili povečanega tveganja za prirojene napake, kadar je mati med nosečnostjo prejemala zdravilo Enbrel.
However, it cannot be excluded that the combination of Enbrel with methotrexate could be associated with an increase in the rate of infections.
Vendar pa ni mogoče izključiti možnosti, da se lahko stopnja pogostnosti okužb pri zdravljenju s kombinacijo zdravila Enbrel in metotreksata poveča.
Paediatric population See Summary of the safety profile, above.
Glejte Povzetek varnostnega profila zgoraj.
If you stop using Enbrel
Če ste prenehali uporabljati zdravilo Enbrel
If re-treatment with Enbrel is indicated, the same guidance on treatment duration should be followed.
Če je indicirano ponovno zdravljenje z zdravilom Enbrel, se moramo ravnati po istih smernicah glede trajanja zdravljenja.
Although no clinical trials have been performed evaluating Enbrel therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
Čeprav niso opravili kliničnih preskušanj za ovrednotenje zdravljenja z zdravilom Enbrel pri bolnikih z multiplo sklerozo, so klinična preskušanja drugih antagonistov TNF pri teh bolnikih pokazala zvečano aktivnost bolezni.
Enbrel has not been studied in children aged less than 2 years.
Zdravila Enbrel niso preskušali pri otrocih, mlajših od 2 let.
After a single subcutaneous dose of 25 mg Enbrel, the average maximum serum concentration observed in healthy volunteers was 1.65 ± 0.66 µg/ml, and the area under the curve was 235 ± 96.6 µg•hr/ml.
Po enkratnem subkutanem odmerku 25 mg zdravila Enbrel je bila povprečna največja koncentracija zdravila v serumu pri zdravih prostovoljcih 1,65  0,66 g/ml, površina pod krivuljo pa 235  96,6 g·h/ml.
No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel.
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, ki prejemajo zdravilo Enbrel, ni na voljo.
The safety and efficacy of Enbrel in patients with chronic infections have not been evaluated.
Varnost in učinkovitost zdravila Enbrel pri bolnikih s kroničnimi okužbami nista bili ovrednoteni.
The package leaflet is updated accordingly.
Skladno s tem je treba posodobiti tudi navodilo za uporabo.
If Enbrel has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Če zdravilo Enbrel po 12 tednih nima nobenega učinka na otrokovo stanje, vam bo zdravnik morda naročil, da prenehajte uporabljati to zdravilo.
If the needle is correctly lined up, you should feel a slight resistance and then a “pop” as the needle goes through the centre of the stopper.
Če držite iglo v pravilnem položaju, boste začutili rahel odpor in potem “pok”, ko bo igla predrla osrednji del zamaška.
After 12 weeks of treatment, patients in the placebo group began treatment with blinded Enbrel (25 mg twice a week); patients in the active treatment groups continued to week 24 on the dose to which they were originally randomised.
Po 12 tednih zdravljenja so bolniki v skupini s placebom začeli slepo zdravljenje z zdravilom Enbrel (25 mg dvakrat na teden), bolniki v skupinah z aktivnim zdravljenjem pa so do 24. tedna nadaljevali z odmerkom, na katerega so bili prvotno randomizirani.
In clinical trials, no interactions have been observed when Enbrel was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate.
Med kliničnimi preskušanji niso opazili nobenih interakcij med zdravilom Enbrel in glukokortikoidi, salicilati (razen sulfasalazina), nesteroidnimi protivnetnimi zdravili (NSAIDs), analgetiki ali metotreksatom.
In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with Enbrel or placebo for moderate to severe alcoholic hepatitis, Enbrel was not efficacious, and the mortality rate in patients treated with Enbrel was significantly higher after 6 months.
faze, v kateri so proučevali 48 hospitaliziranih bolnikov, zdravljenih z zdravilom Enbrel ali placebom zaradi zmernega do hudega alkoholnega hepatitisa, zdravilo Enbrel ni bilo učinkovito in stopnja smrtnosti bolnikov, zdravljenih z zdravilom Enbrel, je bila po 6 mesecih pomembno večja.
Serious infections affect fewer than 1 in 100 patients treated with Enbrel.
Med zdravljenjem z zdravilom Enbrel so se resne okužbe pojavile pri manj kot 1 od 100 bolnikov.
In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which Enbrel was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with Enbrel or sulfasalazine alone.
V klinični študiji odraslih bolnikov, ki so prejemali ustaljene odmerke sulfasalazina, ki mu je bilo dodano zdravilo Enbrel, se je pri bolnikih v skupini s kombinacijo obeh zdravil statistično pomembno zmanjšala povprečna koncentracija belih krvničk v primerjavi s skupinama, zdravljenima samo z zdravilom Enbrel ali samo s sulfasalazinom.
Note - If you are unable to start the injection as described, press the pen more firmly against your skin, then press the grey button again.
Opozorilo - Če ne morete začeti injiciranja, kakor je opisano, peresnik močneje pritisnite ob kožo in nato znova pritisnite sivi gumb.
If the child has any of the above symptoms he/she may be having an allergic reaction to Enbrel, so you should seek immediate medical attention.
Če ima otrok kateregakoli od zgoraj navedenih simptomov, ima mogoče alergijsko reakcijo na zdravilo Enbrel, zato morate nemudoma poiskati zdravniško pomoč.
If Enbrel has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
Če zdravilo Enbrel po 12 tednih nima nobenega učinka na vašo bolezen, vam zdravnik lahko naroči, da to zdravilo nehate uporabljati.
After cleaning, do not touch the stopper with your hands.
Po čiščenju se ga z rokami ne smete več dotikati.
In a group of 7,416 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
V skupini 7.416 bolnikov, zdravljenih z zdravilom Enbrel v kliničnih preskušanjih revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa in psoriaze, so poročali o 18 limfomih.
Of patients who demonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on Enbrel continued to improve from month 3 through month 7, while those who received placebo did not improve.
Od bolnikov, ki so dosegli klinični odziv do 90. dneva in se vključili v drugi del študije, se je pri nekaterih bolnikih, ki so ostali na zdravilu Enbrel, klinično stanje nadalje izboljševalo od 3. do 7. meseca zdravljenja, pri tistih, ki so v drugem delu študije prejemali placebo, pa izboljšanja ni bilo.
Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with Enbrel due to the development of neutralising antibodies in rodents.
Študij kancerogenosti in standardnih raziskav plodnosti in postnatalne toksičnosti zaradi tvorbe nevtralizirajočih protiteles pri glodalcih niso opravili.
Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA (≥1:40) was higher in patients treated with Enbrel (11%) than in placebo-treated patients (5%).
Pri bolnikih z revmatoidnim artritisom, ki so jih testirali na antinuklearna protitelesa (ANA), je bil odstotek tistih, ki so razvili nova pozitivna ANA ( 1:40), večji pri bolnikih, ki so prejemali zdravilo Enbrel (11 %), kot pri tistih, ki so prejemali placebo (5 %).
Compared to placebo, patients with rheumatic diseases treated with Enbrel had a significantly higher incidence of injection site reactions (36% vs. 9%).
V primerjavi s placebom je bila pri bolnikih z revmatskimi obolenji, zdravljenih z zdravilom Enbrel, pojavnost reakcij na mestu injiciranja pomembno večja (36 % proti 9 %).
Compared to placebo, treatment with Enbrel resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
V primerjavi s placebom je po dajanju zdravila Enbrel prišlo do izboljšanja pri ASAS 20, ASAS 50 in ASAS 70 že v 2 tednih od začetka zdravljenja.
The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
Primarni opazovani dogodek učinkovitosti v vseh štirih študijah je bil tisti delež bolnikov v vsaki zdravljeni skupini, ki je po 12 tednih dosegel PASI 75 (tj. vsaj 75 % izboljšanje indeksa PASIPsoriasis Area and Severity Index; indeks površine in izrazitosti psoriaze - v primerjavi z izhodiščem).
In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received Enbrel.
V združeni zbirki podatkov iz kliničnih preskušanj je bila celokupna pojavnost oportunističnih okužb pri 15.402 bolnikih, ki so prejeli Enbrel, 0,09 %.
The safety and efficacy of Enbrel in patients with immunosuppression have not been evaluated.
Varnost in učinkovitost zdravila Enbrel pri bolnikih z imunosupresijo nista bili ovrednoteni.
Physicians should use caution when using Enbrel in patients who also have moderate to severe alcoholic hepatitis.
Zdravniki naj bodo pazljivi, kadar uporabljajo zdravilo Enbrel pri bolnikih, ki imajo tudi zmeren do hud alkoholni hepatitis.
The proportion of patients treated with Enbrel who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients.
Delež bolnikov, ki so razvili protitelesa proti kardiolipinu, je bil podobno povečan pri zdravilu Enbrel v primerjavi s placebom.
Enbrel + Methotrexate (n = 231)
zdravilo Enbrel + metotreksat (n = 231)
Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Zdravilo Enbrel je indicirano tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa pri odraslih, ki še niso dobivali metotreksata.
Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo Enbrel je mogoče uporabiti kot monoterapijo, kadar bolnik ne prenese metotreksata ali kadar trajno zdravljenje z metotreksatom ni primerno.
• Check your syringe contains 1 ml of water for injections.
Preverite, ali brizga vsebuje 1 ml vode za injekcije.
Patients treated with Enbrel should be given the Patient Alert Card.
Bolniki, ki se zdravijo z zdravilom Enbrel, naj prejmejo opozorilno kartico za bolnika.
Enbrel 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.
Pokazali so, da je zdravilo Enbrel od izhodišča do 12 tednov statistično pomembno izboljšalo večino ocen z zdravjem povezane kakovosti življenja in telesne funkcije, vključno z BASFI (BASFI - Bath 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.
TNF-antagonists, such as Enbrel, affect the immune system and their use may affect the body's defenses against infection and cancer.
Antagonisti TNF, kot je zdravilo Enbrel, vplivajo na imunski sistem in lahko zmanjšajo sposobnost organizma za obrambo pred okužbami in rakom.
The long-term safety and effectiveness of Enbrel 0.8 mg/kg (up to 50 mg) once weekly was assessed in an open-label extension study of 181 paediatric subjects with plaque psoriasis for up to 2 years beyond the 48 week study discussed above.
Dolgoročna varnost in učinkovitost zdravila Enbrel, v odmerkih 0,8 mg/kg (do 50 mg) enkrat na teden, je bila ovrednotena v odprti podaljšani študiji, v kateri je sodelovalo 181 otrok s psoriazo v plakih, ki so se zdravili do 2 leti po zaključku 48-tedenske študije, navedene zgoraj.
The use of Enbrel is not expected to affect the ability to drive or use machines.
Ni pričakovati, da bi zdravilo Enbrel vplivalo na sposobnost upravljanja vozil in strojev.
Such patients should be investigated urgently, including full blood count; if blood dyscrasias are confirmed, Enbrel should be discontinued.
Take bolnike je treba nemudoma pregledati, vključno s pregledom celotne krvne slike, in v primeru krvne diskrazije prekiniti zdravljenje s tem zdravilom.
Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of Enbrel compared to the 349 adult rheumatoid arthritis patients.
Nekateri neželeni učinki so bili pogosteje opaženi pri 69 bolnikih z juvenilnim idiopatskim artritisom, ki so zdravilo Enbrel prejemali 3 mesece, kot pri 349 odraslih bolnikih z revmatoidnim artritisom.
Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Bolniki, ki so zelo izpostavljeni virusu noric, naj začasno prekinejo zdravljenje z zdravilom Enbrel, v poštev pa pridejo tudi za profilaktično zdravljenje z imunoglobulinom proti virusu varicella-zoster.
The differences in TSS and JSN were not statistically significant between methotrexate and Enbrel 25 mg.
Razlike v ocenah TSS in JSN med metotreksatom in 25 mg zdravila Enbrel niso bile statistično pomembne.
• Wegener's granulomatosis: Enbrel is not recommended for the treatment of Wegener's granulomatosis, a rare inflammatory disease.
Wegenerjeva granulomatoza: Zdravilo Enbrel ni priporočljivo za zdravljenje redke vnetne bolezni Wegenerjeve granulomatoze.
Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Zdravilo Enbrel je v kombinaciji z metotreksatom indicirano za zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih, kadar odziv na zdravljenje z imunomodulirajočimi antirevmatičnimi zdravili, vključno z metotreksatom (če ta ni kontraindiciran), ni zadosten.
Long-term safety of Enbrel monotherapy (n=103), Enbrel plus methotrexate (n=294), or methotrexate monotherapy (n=197) were assessed for up to 3 years in a registry of 594 children aged 2 to 18 years with juvenile idiopathic arthritis, 39 of whom were 2 to 3 years of age.
Dolgoročno varnost zdravljenja z zdravilom Enbrel v monoterapiji (n = 103), zdravljenja z zdravilom Enbrel v kombinaciji z metotreksatom (n = 294) ali zdravljenja z metotreksatom v monoterapiji (n = 197) so ovrednotili za obdobje do 3 let na osnovi registra 594 otrok, starih od 2 do 18 let, z juvenilnim idiopatskim artritisom.
The long-term safety of Enbrel in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
Varnost dolgotrajnega kombiniranega zdravljenja z zdravilom Enbrel in drugimi imunomodulirajočimi antirevmatičnimi zdravili (DMARD - Disease-Modifying AntiRheumatic Drugs) ni bila ugotovljena.