FrancophonIA/ELRC3.0 huggingface dataset:
English: The injection site is the place on the body where you are going to use the pre-filled syringe.
Slovenian: Mesto injiciranja je predel telesa, na katerem boste uporabili napolnjeno injekcijsko brizgo.
English: • Do not inject into areas where the skin is tender, bruised, red, scaly or hard.
Slovenian: • Zdravila ne injicirajte v predele, kjer je koža bolj občutljiva, podpluta, rdeča, luskasta ali trda.
English: Abbreviation: sPGA-static Physician Global Assessment a. p < 0.0001 compared with placebo
Slovenian: Okrajšava: sPGA-statična zdravnikova splošna ocena a. p < 0,0001 v primerjavi s placebom
English: If you stop using Erelzi
Slovenian: Če ste prenehali uporabljati zdravilo Erelzi
English: 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 etanercept (11%) than in placebo-treated patients (5%).
Slovenian: Pri bolnikih z revmatoidnim artritisom, ki so jih testirali na antinuklearna protitelesa (ANA - antinuclear antibodies), je bil odstotek tistih, ki so razvili nova pozitivna ANA (≥ 1:40), večji pri bolnikih, ki so prejemali etanercept (11 %), kot pri tistih, ki so prejemali placebo (5 %).
English: Store in the refrigerator between 2 °C to 8 °C.
Slovenian: Shranjujte jo v hladilniku pri temperaturi od 2 °C do 8 °C.
English: TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body's defences against infection and cancer.
Slovenian: Zaviralci TNF, kot je etanercept, vplivajo na imunski sistem in lahko zmanjšajo sposobnost organizma za obrambo pred okužbami in rakom.
English: Physicians should use caution when using Erelzi in patients who also have moderate to severe alcoholic hepatitis.
Slovenian: Zdravniki naj bodo pazljivi, kadar uporabljajo zdravilo Erelzi pri bolnikih, ki imajo tudi zmeren do hud alkoholni hepatitis.
English: The 1st click indicates that the injection has started.
Slovenian: 1. klik pomeni, da se je injiciranje začelo.
English: • Request to show the Patient Alert Card to any treating doctor
Slovenian: • napotek, da je treba opozorilno kartico za bolnika pokazati vsem zdravnikom, ki zdravijo bolnika;
English: The needle guard will help to prevent needle stick injuries to anyone who handles the pre-filled syringe.
Slovenian: Zapiralo igle pomaga preprečiti poškodbe zaradi vbodov z iglo za vsakogar, ki rokuje z napolnjeno injekcijsko brizgo.
English: • The green indicator shows the progress of the injection.
Slovenian: • Zeleni indikator kaže potek injiciranja.
English: Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of etanercept compared to the 349 adult rheumatoid arthritis patients.
Slovenian: Nekateri neželeni učinki so bili pogosteje opaženi pri 69 bolnikih z juvenilnim idiopatskim artritisom, ki so etanercept prejemali 3 mesece, v primerjavi s 349 odraslimi bolniki z revmatoidnim artritisom.
English: Although no clinical trials have been performed evaluating etanercept therapy in patients with multiple sclerosis, clinical trials of other TNF antagonists in patients with multiple sclerosis have shown increases in disease activity.
Slovenian: Čeprav niso opravili kliničnih preskušanj za ovrednotenje zdravljenja z etanerceptom pri bolnikih z multiplo sklerozo, so klinična preskušanja drugih zaviralcev TNF pri teh bolnikih pokazala zvečano aktivnost bolezni.
English: However, any of the above symptoms may indicate an allergic reaction to Erelzi, so you should seek immediate medical attention.
Slovenian: Resne alergijske reakcije so redke, vendar pa lahko katerikoli od zgoraj navedenih simptomov kaže na pojav alergijske reakcije na zdravilo Erelzi, zato morate nemudoma poiskati zdravniško pomoč.
English: In another observational multi-country registry study comparing the risk of adverse pregnancy outcomes in women exposed to etanercept during the first 90 days of pregnancy (n = 425) to those exposed to nonbiologic drugs (n = 3497), there was no observed increased risk of major birth defects (crude odds ratio [OR] = 1.22, 95% CI: 0.79 - 1.90; adjusted OR = 0.96, 95% CI: 0.58 - 1.60 after adjusting for country, maternal disease, parity, maternal age and smoking in early pregnancy).
Slovenian: V drugi opazovalni registrski študiji, ki so jo izvajali v več državah in v kateri so primerjali tveganje za neželene izide nosečnosti pri ženskah, izpostavljenih etanerceptu v prvih 90 dneh nosečnosti (n = 425), in pri ženskah, ki so bile izpostavljene nebiološkim zdravilom (n = 3.497), niso opazili povečanega tveganja za resne prirojene napake (grobo razmerje obetov [OR - Odds Ratio] = 1,22, 95 % IZ: 0,79-1,90; prilagojeno OR = 0,96, 95 % IZ: 0,58-1,60 po prilagoditvi glede na državo, materino bolezen, pariteto, starost matere in kajenje v zgodnji nosečnosti).
English: You have been prescribed a 50 mg strength of Erelzi.
Slovenian: Predpisana vam je bila jakost 50 mg zdravila Erelzi.
English: The pre-filled syringe has a needle guard that will be activated to cover the needle after the injection is finished.
Slovenian: Napolnjena injekcijska brizga ima zapiralo igle, ki se bo aktiviralo in po koncu injiciranja iglo prekrilo.
English: Choose your injection site:
Slovenian: Izberite mesto injiciranja:
English: If you have any questions, please talk to a doctor, nurse or pharmacist who is familiar with Erelzi.
Slovenian: Če imate kakršnakoli vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom, ki zdravilo Erelzi pozna.
English: Patients weighing less than 62.5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or the powder for solution for injection presentations (see below for dosing for specific indications).
Slovenian: Bolnikom, ki tehtajo manj kot 62,5 kg, je treba odmerek natančno izračunati na podlagi mg/kg in uporabiti zdravilo v obliki praška in vehikla za raztopino za injiciranje ali praška za raztopino za injiciranje (za odmerjanje pri specifičnih indikacijah glejte nadaljevanje).
English: • Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Erelzi in case the infection worsens.
Slovenian: • Hepatitis C: Povejte zdravniku, če imate vi ali vaš otrok hepatitis C. Zdravnik bo morda želel spremljati zdravljenje z zdravilom Erelzi za primer, če bi se okužba poslabšala.
English: • Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more.
Slovenian: • poliartritisa (pozitivnega ali negativnega za revmatoidni faktor) in razširjenega oligoartritisa pri bolnikih, starejših od 2 let, ki tehtajo 62,5 kg ali več.
English: • Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Erelzi.
Slovenian: • Okužbe/operacije: Če se pri vas ali otroku pojavi nova okužba ali če je pri vas ali otroku predvidena kakršnakoli večja operacija, bo zdravnik morda želel spremljati zdravljenje z zdravilom Erelzi.
English: Hold the syringe finger flange as shown.
Slovenian: Injekcijsko brizgo primite za držalo za prste, kot kaže slika.
English: It is recommended that the conduct of these tests should be recorded in the Patient's Alert Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Slovenian: Zdravnike predpisovalce opominjamo na nevarnost lažno negativnih rezultatov tuberkulinskega kožnega testa, še zlasti pri bolnikih, ki so hudo bolni ali imunokompromitirani.
English: Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation).
Slovenian: alergijske reakcije; vročina; izpuščaj; srbenje; protitelesa proti normalnemu tkivu (nastanek avtoprotiteles).
English: The long-term safety and effectiveness of etanercept 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.
Slovenian: Dolgoročna varnost in učinkovitost etanercepta 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.
English: Erelzi is administered by an injection under the skin (by subcutaneous injection).
Slovenian: Zdravilo Erelzi se injicira pod kožo (subkutano injiciranje).
English: Appropriate screening tests, i.e., tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Slovenian: tj. tuberkulinski kožni test in rentgensko slikanje prsnega koša (morda obstajajo nacionalna priporočila glede teh preiskav).
English: One rheumatoid arthritis patient mistakenly self-administered 62 mg etanercept subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
Slovenian: En bolnik z revmatoidnim artritisom si je pomotoma subkutano injiciral 62 mg etanercepta 2-krat tedensko 3 tedne, pri tem pa ni prišlo do pojava neželenih učinkov.
English: Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Slovenian: Zdravilo Erelzi je indicirano tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa pri odraslih, ki še niso dobivali metotreksata.
English: Such patients should be investigated urgently, including full blood count; if blood dyscrasias are confirmed, Erelzi should be discontinued.
Slovenian: Take bolnike je treba nemudoma pregledati, vključno s pregledom celotne krvne slike, in v primeru diagnosticiranja krvne diskrazije prekiniti zdravljenje z zdravilom Erelzi.
English: • Brief introduction to the aim of the Patient Alert Card
Slovenian: • kratka predstavitev namena opozorilne kartice za bolnika;
English: At week 104, 8 subjects had progressed to a score of bilateral Grade 2 on spinal X-ray according to the modified New York Radiological Grade, indicative of axial spondyloarthropathy.
Slovenian: Po 104 tednih je 8 preskušancev napredovalo do stopnje 2 obojestransko, merjene z rentgenskim slikanjem hrbtenice, kar po spremenjenih newyorških merilih za radiološko oceno kaže na aksialno spondiloartropatijo.
English: Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with etanercept due to the development of neutralising antibodies in rodents.
Slovenian: Študij kancerogenosti in standardnih raziskav plodnosti in postnatalne toksičnosti zaradi tvorbe nevtralizirajočih protiteles pri glodalcih niso opravili.
English: Your doctor will decide how long you should use Erelzi and whether retreatment is needed based on your response.
Slovenian: Zdravnik bo na podlagi vašega odziva na zdravilo določil, koliko časa morate uporabljati zdravilo Erelzi in ali je potrebno ponovno zdravljenje.
English: What you additionally need for your injection:
Slovenian: Dodatni pripomočki, ki jih potrebujete pri injiciranju:
English: These instructions are to help you to inject correctly using the Erelzi SensoReady pen.
Slovenian: Ta navodila vam bodo pomagala, da boste pri injiciranju zdravila Erelzi pravilno uporabljali injekcijski peresnik SensoReady.
English: Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.
Slovenian: Zdravljenje aktivnega in progresivnega psoriatičnega artritisa pri odraslih, če je bil odziv na predhodnje zdravljenje z imunomodulirajočimi antirevmatičnimi zdravili nezadosten.
English: Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
Slovenian: Študija 2 je ocenila 652 bolnikov s kronično psoriazo v plakih in je imela enaka vključitvena merila kot študija 1, le da so imeli bolniki ob presejanju še minimalen predel s psoriazo in vrednost indeksa PASI vsaj 10.
English: Erelzi should be discarded if not used within four weeks after removal from the refrigerator.
Slovenian: Zdravilo Erelzi zavrzite, če ga ne porabite v štirih tednih po odvzemu iz hladilnika.
English: If you have psoriasis, you should NOT inject directly into any raised, thick, red, or scaly skin patches or lesions (“psoriasis skin lesions”).
Slovenian: Če imate luskavico, si NE injicirajte v izbočene, odebeljene, pordele ali luskave dele kože ali v lezije ("psoriatične kožne lezije").
English: INSTRUCTIONS ON USE ‘QR code to be included' + www.erelzi.eu
Slovenian: ‘Vključiti kodo QR' + www.erelzi.eu
English: • Never try to re-use your pen.
Slovenian: • Že uporabljenega injekcijskega peresnika nikoli ne poskušajte ponovno uporabiti.
English: Erelzi 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.
Slovenian: Zdravilo Erelzi 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.
English: Patients were observed off treatment for the occurrence of rebound (PASI ≥ 150% of baseline) and for the time to relapse (defined as a loss of at least half of the improvement achieved between baseline and week 24).
Slovenian: Bolnike so brez zdravljenja spremljali glede povratnih znakov (PASI ≥ 150 % izhodiščnega) in časa do recidiva (opredeljenega kot izginotje vsaj polovice izboljšanja, doseženega med izhodiščem in 24. tednom).
English: Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Slovenian: Stevens-Johnsonov sindrom, kožni vaskulitis (vključno s preobčutljivostnim vaskulitisom), multiformni eritems, lihenoidne reakcije toksična epidermalna nekroliza
English: • Psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more.
Slovenian: • psoriatičnega artritisa pri bolnikih, starejših od 12 let, ki tehtajo 62,5 kg ali več.
English: Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Slovenian: Zdravilo Erelzi je mogoče uporabiti kot monoterapijo, kadar bolnik ne prenese metotreksata ali kadar trajno zdravljenje z metotreksatom ni primerno.
English: The safety and efficacy of etanercept were assessed in a two-part study in 69 children with polyarticular-course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Slovenian: Otroci z juvenilnim idiopatskim artritisom Varnost in učinkovitost etanercepta je bila ugotovljena v dvodelni študiji pri 69 otrocih s poliartikularnim potekom juvenilnega idiopatskega artritisa z različnimi tipi nastopa bolezni (poliartritis, oligoartritis, sistemski nastop).
English: • Request to ask the doctor to list other medications that may increase the risk of infection on the alert card
Slovenian: • napotek bolniku, naj zdravnika prosi, da na opozorilno kartico za bolnika vpiše druga zdravila, ki bi lahko povečala tveganje za okužbo.
English: Tell your doctor if you or the child develop any change in the appearance of the skin or growths on the skin.
Slovenian: če se pri vas ali otroku razvije kakšna sprememba videza kože ali rašče na koži.
English: Patients with a significant exposure to varicella virus should temporarily discontinue Erelzi therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Slovenian: Bolniki, ki so zelo izpostavljeni virusu noric, naj začasno prekinejo zdravljenje z zdravilom Erelzi, v poštev pa pridejo tudi za profilaktično zdravljenje z imunoglobulinom proti virusu varicella-zoster.
English: Do not open the outer box until you are ready to use this medicine.
Slovenian: Zunanjo škatlo odprite šele takrat, ko boste pripravljeni za injiciranje zdravila.
English: Your doctor may decide if you or the child need less anti-diabetic medicine while using Erelzi.
Slovenian: Zdravnik lahko odloči, da boste vi ali otrok med uporabo zdravila Erelzi potrebovali manj zdravila za zdravljenje sladkorne bolezni.
English: Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1.
Slovenian: Etanercept je dimer himerne beljakovine, ustvarjen z genskim inženirstvom s spajanjem zunajcelične vezalne domene receptorja2 za humani tumorje nekrotizirajoči faktor (TNFR2/p75) in domene Fc humanega imunoglobulina IgG1.
English: • Dispose of the used pen in a sharps disposal container (i.e. a puncture-resistant closable container, or similar).
Slovenian: • Uporabljen injekcijski peresnik odvrzite v zbiralnik za ostre predmete (torej v vsebnik iz materiala, ki ga ni mogoče prebosti, vsebnik pa je mogoče zapreti ali v podoben vsebnik).
English: • The recommended site is the front of the thighs.
Slovenian: • Za to je priporočeno mesto na sprednjem delu stegen.
English: For psoriasis in patients from the age of 6 years and weighing 62.5 kg or more, the usual dose is 50 mg and should be given once weekly.
Slovenian: Za psoriazo pri bolnikih od 6. leta starosti naprej in ki tehtajo 62,5 kg ali več, je običajni odmerek 50 mg, dajati pa ga je treba enkrat na teden.
English: Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis The usual dose is 25 mg given twice a week or 50 mg once a week as an injection under the skin.
Slovenian: Revmatoidni artritis, psoriatični artritis in aksialni spondilartritis, vključno z ankilozirajočim spondilitisom Običajni odmerek je 25 mg dvakrat na teden ali 50 mg enkrat na teden v obliki podkožne injekcije.
English: How to use Erelzi
Slovenian: Kako uporabljati zdravilo Erelzi
English: Adjusted mean change from baseline was 3.8 for etanercept treated (n = 95) versus 0.8 for placebo treated (n = 105) patients (p < 0.001).
Slovenian: Prilagojena povprečna sprememba od izhodišča je bila 3,8 pri bolnikih, zdravljenih z etanerceptom (n = 95), in 0,8 pri bolnikih, ki so prejemali placebo (n = 105) (p < 0,001).
English: • Twist off the cap in the direction of the arrows.
Slovenian: • Pokrovček zasukajte in potegnite v smeri puščice.
English: By touching them, the needle guard may be activated too early.
Slovenian: Z dotikom lahko namreč prezgodaj aktivirate zapiralo igle.
English: scaly or hard.
Slovenian: čisto ali skoraj čisto
English: Do not use if the liquid is cloudy, discoloured, or has large lumps, flakes, or coloured particles.
Slovenian: Raztopine ne uporabljajte, če je raztopina motna, obarvana ali ima velike kose, kosmiče ali barvaste delce.
English: What Erelzi looks like and contents of the pack
Slovenian: Izgled zdravila Erelzi in vsebina pakiranja
English: • There may be a small amount of blood at the injection site.
Slovenian: • Na mestu injiciranja se lahko pojavi nekaj krvi.
English: DSGAb, clear or almost clear *p ≤ 0.0001 compared with placebo a. No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving etanercept 25 mg BIW or 50 mg once weekly from week 13 to week 24. b. Dermatologist Static Global Assessment.
Slovenian: *p ≤ 0,0001 v primerjavi s placebom a. V študijah 2 in 4 po 24 tednih niso opravili statističnih primerjav s placebom, ker je skupina, ki je prvotno dobivala placebo, začela dobivati 25 mg etanercepta dvakrat na teden ali 50 mg enkrat na teden od 13. do 24. tedna.
English: Administration of Erelzi should be discontinued if a patient develops a serious infection.
Slovenian: Zdravljenje z zdravilom Erelzi je treba prekiniti, če pride do resne okužbe.
English: 28b a: p < 0.001, etanercept vs. placebo b: p = 0.002, etanercept vs. placebo
Slovenian: 28b a: p < 0,001, etanercept proti placebu b: p = 0,002, etanercept proti placebu
English: If re-treatment with etanercept is indicated, the above guidance on treatment duration should be followed.
Slovenian: Če je indicirano ponovno zdravljenje z etanerceptom, se ravnamo po zgornjih smernicah glede trajanja zdravljenja.
English: YOU MUST READ THIS BEFORE INJECTING.
Slovenian: pravilno nepravilno TO MORATE PREBRATI PRED INJICIRANJEM
English: Whether used alone or in combination with methotrexate, Erelzi can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
Slovenian: Zdravilo Erelzi samo ali v kombinaciji z metotreksatom lahko upočasni razvoj poškodb v sklepih zaradi revmatoidnega artritisa in izboljša sposobnost opravljanja vsakodnevnih opravil.
English: This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative.
Slovenian: vključno z etanerceptom, so poročali o reaktivaciji hepatitisa B. Poročila vključujejo tudi reaktivacijo hepatitisa B pri anti-HBc pozitivnih, vendar HBsAg negativnih bolnikih.
English: ASAS 20 2 weeks
Slovenian: ASAS 20 2 tedna
English: Some have occurred within a few weeks after initiating treatment with etanercept in patients who have underlying conditions (e.g., diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis (see section 4.4).
Slovenian: Nekatere okužbe so se pojavile nekaj tednov po začetku zdravljenja bolnikov, ki so imeli poleg revmatoidnega artritisa tudi druga obolenja (npr. sladkorno bolezen, kongestivno srčno popuščanje, aktivne ali kronične okužbe v anamnezi) (glejte poglavje 4.4).
English: Responses were measured using the ACR Pedi 30, defined as ≥ 30% improvement in at least three of six and ≥ 30% worsening in no more than one of six JRA core set criteria, including active joint count, limitation of motion, physician and patient/parent global assessments, functional assessment, and erythrocyte sedimentation rate (ESR).
Slovenian: Odzive so merili po lestvici ACR Pedi 30; izboljšanje je bilo določeno kot ≥ 30 % izboljšanje v vsaj treh od šestih glavnih kazalcev aktivnosti bolezni JRA in ≥ 30 % poslabšanje največ enega od šestih glavnih kazalcev aktivnosti bolezni JRA (število aktivno prizadetih sklepov, omejenost gibanja, zdravnikova splošna ocena, splošna ocena s strani bolnika ali staršev, ocena funkcionalnosti in hitrost sedimentacije eritrocitov).
English: Etanercept + Methotrexate (n = 231)
Slovenian: etanercept + metotreksat (n = 231)
English: In each of the JIA subtypes, the majority of patients met ACR Pedi 30 criteria and demonstrated clinical improvement in secondary endpoints such as number of tender joints and physician global assessment.
Slovenian: ACR Pedi 30 doseženi pri večini bolnikov, prav tako pa so pri večini bolnikov ugotovili tudi klinično izboljšanje pri sekundarnih opazovanih dogodkih, kot sta število občutljivih sklepov in zdravnikova splošna ocena.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for etanercept (biosimilars), the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za etanercept (podobna biološka zdravila) je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: The proportion of patients treated with etanercept who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients.
Slovenian: Delež bolnikov, ki so razvili protitelesa proti kardiolipinu, je bil podobno povečan pri etanerceptu v primerjavi s placebom.