FrancophonIA/ELRC3.0 huggingface dataset:
English: Physicians should exercise caution when considering the use of Erelzi in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes.
Croatian: Liječnik mora pristupiti s oprezom liječenju Erelzijem bolesnika s anamnezom recidivirajućih ili kroničnih infekcija ili s postojećim stanjem koje ih može činiti sklonijima infekciji, kao što je uznapredovala ili loše kontrolirana šećerna bolest.
English: Erelzi should only be used during pregnancy if clearly needed.
Croatian: Erelzi se tijekom trudnoće smije primjenjivati samo ako je to posve neophodno.
English: With twice-weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses.
Croatian: Pretpostavlja se da su koncentracije u stanju dinamičke ravnoteže, pri doziranju dva puta tjedno, otprilike dvostruko veće od onih zabilježenih nakon jednokratnih doza.
English: • Twist off the cap in the direction of the arrows.
Croatian: • Poklopac skinite okretom u smjeru strelica.
English: EU/1/17/1195/012 12 pre-filled SensoReady pens
Croatian: EU/1/17/1195/012 12 napunjenih SensoReady brizgalica
English: Erelzi treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Croatian: Liječenje Erelzijem treba započeti i nadzirati liječnik specijalist s iskustvom u dijagnostici i liječenju reumatoidnog artritisa, juvenilnog idiopatskog artritisa, psorijatičnog artritisa, ankilozantnog spondilitisa, aksijalnog spondiloartrtitisa bez radiološkog dokaza, plak psorijaze ili plak psorijaze dječje dobi.
English: • Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Erelzi needs to be used with caution under these circumstances.
Croatian: • Kongestivno zatajenje srca: obavijestite svog liječnika ako ste Vi ili dijete imali kongestivno zatajenje srca, jer je u tom slučaju potreban oprez prilikom primjene Erelzija.
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).
Croatian: Bolesnici su bez liječenja praćeni s obzirom na pojavu reaktivnog pogoršanja bolesti (engl. rebound) (PASI ≥150% u odnosu na početni), kao i vrijeme do relapsa (definirano kao gubitak najmanje polovice poboljšanja postignutog između početka i 24. tjedna).
English: Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.
Croatian: Liječenje aktivnog i progresivnog psorijatičnog artritisa u odraslih u slučaju prethodnog neodgovarajućeg odgovora na terapiju antireumatskim lijekovima koji modificiraju tijek bolesti.
English: The proportion of patients treated with etanercept who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients.
Croatian: Udio bolesnika liječenih etanerceptom u kojih su se razvila protutijela na kardiolipin bio je podjednako povećan kao u bolesnika koji su primali placebo.
English: In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which etanercept was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with etanercept or sulfasalazine alone.
Croatian: U kliničkom ispitivanju s odraslim bolesnicima koji su primali uobičajene doze sulfasalazina, kojima je dodan etanercept, bolesnici u skupini s ovom kombinacijom imali su statistički značajan pad prosječnog broja broja leukocita u usporedbi sa skupinama koje su liječene samo etanerceptom ili samo sulfasalazinom.
English: Rare ≥ 1/10,000 to
Croatian: Rijetko ≥ 1/10 000 i
English: There may be a small amount of blood at the injection site.
Croatian: Na mjestu primjene moglo bi biti malo krvi.
English: If a caregiver is giving you the injection, the outer upper arms may also be used.
Croatian: Ako Vam injekciju daje osoba koja Vas njeguje, može se iskoristiti i gornji dio nadlaktice.
English: Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).
Croatian: Liječenje odraslih s umjerenom do teškom plak psorijazom koji nisu pokazali odgovor na drugu sustavnu terapiju, uključujući ciklosporin, metotreksat ili psoralen i ultraljubičastu-A svjetlost (PUVA)
English: Mean (SE) annualized change from baseline in total sharp score
Croatian: Srednja vrijednost (SE) godišnje promjene ukupnog rezultata na Sharpovoj ljestvici u odnosu na početnu vrijednost
English: Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain.
Croatian: parametra procjene ankilozantnog spondilitisa (Assessment in Ankylosing Spondylitis (ASAS)) (opća procjena bolesnika, bol u leđima, BASFI i upala) te odsutnost pogoršanja preostalog parametra.
English: Erelzi should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years or weighing less than 62.5 kg, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years or weighing less than 62.5 kg, or in children with psoriasis below the age of 6 years or weighing less than 62.5 kg.
Croatian: Erelzi se obično ne bi smio primjenjivati u djece s poliartikularnim artritisom ili produljenim oligoartritisom mlađe od 2 godine ili tjelesne težine manje od 62,5 kg, kao ni u djece s artritisom povezanim s entezitisom ili psorijatičnim artritisom mlađe od 12 godina ili tjelesne težine manje od
English: Worsening of cardiac failure congestive (see section 4.4)
Croatian: Novi nastupi kongestivnog srčanog zatajenja (vidjeti dio 4.4)
English: Caution should be exercised when administering Erelzi in patients previously infected with HBV.
Croatian: Nužan je oprez u slučaju davanja Erelzija bolesnicima koji su prethodno bili zaraženi HBV-om.
English: The active substance is etanercept.
Croatian: Djelatna tvar je etanercept.
English: • Reminder that Erelzi should not be used in children and adolescents weighing less than 62.5 kg.
Croatian: • podsjetnik da Erelzi nije za primjenu u djece i adolescenata tjelesne težine manje od 62,5 kg
English: If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgotten dose.
Croatian: nemojte primijeniti dvostruku dozu (dvije doze u jednom danu) kako biste nadoknadili zaboravljenu dozu.
English: Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)*
Croatian: (uključujući pneumoniju, celulitis, bakterijski artritis, sepsu i parazitarnu infekciju)*
English: This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in adults with non-radiographic axial spondyloarthritis, four studies in adults with plaque psoriasis, three studies in juvenile idiopathic arthritis and one study in paediatric patients with plaque psoriasis.
Croatian: Klinička djelotvornost i sigurnost Ovaj dio prikazuje podatke iz četiri randomizirana, kontrolirana ispitivanja u odraslih s reumatoidnim artritisom, jednog ispitivanja u odraslih s psorijatičnim artritisom, jednog ispitivanja u odraslih s ankilozantnim spondilitisom, jednog ispitivanja u odraslih s aksijalnim spondiloartritisom bez radiološkog dokaza, četiri ispitivanja u odraslih s plak psorijazom, tri ispitivanja juvenilnog idiopatskog artritisa i jednog ispitivanja u pedijatrijskih bolesnika s plak psorijazom.
English: • Not known (frequency cannot be estimated from the available data): Merkel cell carcinoma (a type of skin cancer); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash).
Croatian: Karcinom Merkelovih stanica (vrsta raka kože); pretjerana aktivacija bijelih krvnih stanica povezana s upalom (sindrom aktivacije makrofaga); ponovna pojava hepatitisa B (infekcija jetre); pogoršanje stanja koje se naziva dermatomiozitis (upala mišića i slabost s pratećim osipom kože).
English: • Psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more.
Croatian: • Psorijatični artritis u bolesnika od navršenih 12 godina života i tjelesne težine 62,5 kg ili više.
English: Erelzi contains sodium
Croatian: Erelzi sadrži natrij
English: Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
Croatian: Alternativno, dokazana je sigurnost primjene i djelotvornost 50 mg etanercepta primijenjenog jednom tjedno (vidjeti dio 5.1).
English: A single 50 mg/ml injection of etanercept was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Croatian: Jedna injekcija etanercepta od 50 mg/ml bila je ekvivalentna dvjema istodobno primjenjenim injekcijama od 25 mg/ml.
English: Take the blister out of the refrigerator and leave it unopened for about 15-30 minutes so that it reaches room temperature.
Croatian: Uzmite blister iz hladnjaka i ostavite ga neotvorenim oko 15-30 minuta kako bi dosegao sobnu temperaturu.
English: If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
Croatian: Ako se za vrijeme ili nakon terapije pojave simptomi tuberkuloze (poput stalnog kašlja, gubitka tjelesne težine, malaksalosti, blago povišene temperature) ili bilo koje druge infekcije, odmah obavijestite liječnika.
English: Serious infections experienced by etanercept-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Croatian: U bolesnika liječenih etanerceptom pojavile su se ozbiljne infekcije koje su uključivale celulitis, gastroenteritis, pneumoniju, kolecistitis, osteomijelitis, gastritis, apendicitis, streptokokni fasciitis, miozitis, septični šok, divertikulitis i apsces.
English: During a randomised withdrawal period, significantly more patients re-randomised to placebo experienced disease relapse (loss of PASI 75 response) compared with patients re-randomised to etanercept.
Croatian: Tijekom randomiziranog razdoblja prekida terapije, značajno više bolesnika koji su ponovno randomizirani u skupinu s placebom ušlo je u recidiv bolesti (gubitak odgovora PASI 75) u usporedbi s bolesnicima koji su ponovno randomizirani u skupinu s etanerceptom.
English: Radiographic progression: comparison of etanercept vs. methotrexate in patients with RA of < 3 years duration
Croatian: Radiološka progresija: usporedba etanercepta s metotreksatom u bolesnika s RA u trajanju od < 3 godine
English: Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis
Croatian: Psorijatični artritis, ankilozantni spondilitis i aksijalni spondiloartritis bez radiološkog dokaza
English: In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 µg•hr/ml and 474 µg•hr/ml for 50 mg etanercept once weekly (N = 154) and 25 mg twice weekly (N = 148), respectively.
Croatian: U populacijskoj farmakokinetičkoj analizi u bolesnika s ankilozantnim spondilitisom AUC etanercepta u stanju dinamičke ravnoteže iznosio je 466 µg•hr/ml za etanercept od 50 mg jednom tjedno (N = 154) i 474 µg•hr/ml za etanercept od 25 mg dvaput tjedno (N = 148).
English: In an open-label, single-dose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Croatian: U otvorenom, ukriženom ispitivanju dva načina liječenja jednokratnom dozom u zdravih dobrovoljaca pronašlo se da je etanercept primijenjen kao jednokratna injekcija od 50 mg/ml bioekvivalentan dvjema istodobno primijenjenim injekcijama od 25 mg/ml.
English: How to use Erelzi
Croatian: Kako primjenjivati Erelzi
English: 74.5% †,ϕ
Croatian: 65,5% 74,5% †,φ
English: A new and unused Erelzi SensoReady pen.
Croatian: Nova i neupotrijebljena Erelzi SensoReady brizgalica
English: Methotrexate (n = 228)
Croatian: Metotreksat(n = 228)
English: In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their etanercept dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
Croatian: U ispitivanju 3 u većine bolesnika (77%) koji su na početku randomizirani u skupinu koja je dobivala etanercept u dozi od 50 mg dvaput tjedno pa je njihova doza etanercepta snižena nakon 12 tjedna na 25 mg dvaput tjedno odgovor PASI 75 održan je do kraja 36. tjedna.
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.
Croatian: Neki štetni događaji zabilježeni su češće u 69 bolesnika s juvenilnim idiopatskim artritisom u usporedbi s 349 odraslih bolesnika s reumatoidnim artritisom koji su primali etanercept tijekom 3 mjeseca.
English: In a polyarticular-course juvenile idiopathic arthritis trial with etanercept, 69 patients (aged 4 to 17 years) were administered 0.4 mg etanercept/kg twice weekly for three months.
Croatian: U ispitivanju etanercepta u bolesnika s juvenilnim idiopatskim artritisom 69 bolesnika (u dobi od 4 do 17 godina) primalo je 0,4 mg etanercepta/kg dva puta na tjedan tijekom 3 mjeseca.
English: PASI 50 14 58* 70 74* 77 9
Croatian: PASI 50 14 58* 70 74* 77 9 64* 77* PASI 75 4 34* 44 49* 59 3 34* 49* DSGA b, bez promjena ili gotovo bez promjena
English: Do not remove the cap until you are ready to inject.
Croatian: Nemojte uklanjati poklopac dok niste spremni ubrizgati lijek.
English: 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.
Croatian: Djelotvornost etanercepta u ankilozantnom spondilitisu ispitivana je u 3 randomizirana, dvostruko slijepa ispitivanja uspoređujući etanercept 25 mg primijenjen dva puta tjedno s placebom.
English: The safety and efficacy of etanercept in patients with chronic infections have not been evaluated.
Croatian: Nisu procijenjene djelotvornost i sigurnost primjene etanercepta u bolesnika s kroničnom infekcijom.
English: 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 12 months was higher in the etanercept group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001).
Croatian: U analizi u kojoj se smatralo da su svi bolesnici koji su iz bilo kojeg razloga prekinuli sudjelovanje u ispitivanju imali napredovanje bolesti, postotak bolesnika bez progresije (promjena TSS ≤ 0,5) nakon 12 mjeseci bio je veći u skupini na etanerceptu u usporedbi s placebo skupinom (73% naspram 47%, p≤0,001).
English: The safety and efficacy profiles of the 50 mg once-weekly and 25 mg twice-weekly regimens were similar.
Croatian: Profili sigurnosti primjene i djelotvornosti 50 mg jednom tjedno i 25 mg dva puta tjedno bili su slični.
English: INFORMATION IN BRAILLE Erelzi 25 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Erelzi 25 mg
English: There have been reports of hypoglycaemia following initiation of etanercept in patients receiving medicinal product for diabetes, necessitating a reduction in anti-diabetic medicinal products in some of these patients.
Croatian: U bolesnika koji uzimaju lijekove za liječenje šećerne bolesti, nakon uvođenja etanercepta bila je zabilježena hipoglikemija, koja je zahtijevala smanjenje antidijabetika u nekih od tih bolesnika.
English: 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.
Croatian: Za poliartikularni artritis ili produljeni oligoartritis u bolesnika u dobi od navršene 2 godine i tjelesne težine 62,5 kg ili više ili artritis povezan s entezitisom ili psorijatični artritis u bolesnika u dobi od navršenih 12 godina i tjelesne težine 62,5 kg ili više, uobičajena doza je 25 mg primijenjena dva puta tjedno ili 50 mg primijenjena jednom tjedno.
English: Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)*
Croatian: (uključujuć i infekciju gornjih dišnih puteva, bronhitis, cistitis, kožnu infekciju)*
English: Significant improvement was also observed for the ASAS partial remission and BASDAI 50.
Croatian: Značajno poboljšanje također je uočeno za djelomičnu remisiju
English: Pairwise comparison p-values: * = p < 0.05 for comparisons of etanercept vs. methotrexate, † = p < 0.05 for comparisons of etanercept + methotrexate vs. methotrexate and ϕ = p < 0.05 for comparisons of etanercept + methotrexate vs. etanercept.
Croatian: + metotreksat p-vrijednosti za usporedbu parova: * = p < 0,05 za usporedbu etanercepta s metotreksatom, † = p < 0,05 za usporedbu etanercepta + metotreksat u odnosu na metotreksat i φ = p < 0,05 za usporedbu etanercepta + metotreksat u odnosu na etanercept.
English: • Vaccinations: If possible, children should be up to date with all vaccinations before using Erelzi.
Croatian: • Cijepljenje: ako je moguće, u djece bi trebalo obaviti cijepljenje prema trenutno važećem kalendaru cijepljenja, prije nego se započne liječenje Erelzijem.
English: For a more comfortable injection, take the pen out of the refrigerator 15-30 minutes before injecting to allow it to reach room temperature.
Croatian: Za manje nelagodnu injekciju izvadite brizgalicu iz hladnjaka 15-30 minuta prije ubrizgavanja kako bi mogla doseći sobnu temperaturu.
English: INFORMATION IN BRAILLE Erelzi 50 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Erelzi 50 mg
English: Key elements of the Erelzi Patient Alert Card
Croatian: Ključni elementi Kartice s upozorenjima za bolesnika
English: Erelzi is available in strengths of 25 mg and 50 mg.
Croatian: Erelzi je dostupan u jačinama od 25 mg i 50 mg.
English: A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-treated psoriatic arthritis patients.
Croatian: Ukupno su dvije zloćudne bolesti zabilježene u kliničkim ispitivanjima prosječnog trajanja 2 godine koja su uključivala 240 etanerceptom liječenih bolesnika s psorijatičkim artritisom.
English: The double-blind period was followed by an open-label period during which all patients received etanercept 50 mg weekly for up to an additional 92 weeks.
Croatian: Nakon dvostruko slijepog razdoblja uslijedilo je otvoreno razdoblje ispitivanja tijekom kojeg su svi bolesnici primali etanercept 50 mg jednom tjedno do dodatna 92 tjedna.
English: Your injection:
Croatian: Vaša injekcija:
English: • Swelling of the face, throat, hands, or feet
Croatian: • Tegobe s gutanjem ili disanjem, • Oticanje lica, grla, šaka ili stopala.
English: Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Croatian: Pokazalo se da etanercept, kada je primijenjen sam ili u kombinaciji s metotreksatom, usporava progresiju oštećenja zglobova određenu rendgenskim snimanjem, a isto tako poboljšava i fizičku funkciju.
English: This combination has not demonstrated increased clinical benefit; such use is not recommended (see section 4.4).
Croatian: Ova kombinacija nije pokazala povećanu kliničku korist te se stoga istodobna primjena ova dva lijeka ne preporučuje. (vidjeti dio 4.4.)
English: In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with etanercept alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and the combination of etanercept and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
Croatian: Drugo aktivno kontrolirano, dvostruko slijepo, randomizirano ispitivanje usporedilo je kliničku djelotvornost, sigurnost primjene i radiološku progresiju u bolesnika s RA koji su istodobno započeli liječenje samo etanerceptom (25 mg dva puta tjedno), samo metotreksatom (7,5 do 20 mg tjedno, medijan doze 20 mg) te kombinacijom etanercepta i metotreksata primijenjenih istodobno u 682 odrasla bolesnika s aktivnim reumatoidnim artritisom koji je trajao od 6 mjeseci do 20 godina
English: Dispose of the used syringe in a sharps container (closable, puncture-resistant container).
Croatian: Odložite upotrijebljenu štrcaljku u spremnik za oštre predmete (spremnik koji se može zatvoriti i otporan je na bušenje).
English: 39.8% †, ϕ
Croatian: 22,0% 39,8% †,φ
English: • Only remove the cap when you are ready to use the pen.
Croatian: • Skinite poklopac tek kad ste spremni upotrijebiti brizgalicu.
English: In a fourth study, the safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly vs. 25 mg etanercept administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Croatian: U četvrtom ispitivanju ocjenjivana je sigurnost primjene i djelotvornost etanercepta 50 mg (dvije s.c. injekcije od 25 mg) primijenjenog jednom tjedno naspram 25 mg etanercepta primijenjenog dva puta tjedno u dvostruko slijepom, placebom kontroliranom ispitivanju u 356 bolesnika s aktivnim ankilozantnim spondilitisom.
English: The safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA.
Croatian: Sigurnost i djelotvornost 50 mg etanercepta (dvije s.c. injekcije od 25 mg) jednom tjedno ispitivane su u dvostruko slijepom, placebom kontroliranom ispitivanju s 420 bolesnika s aktivnim RA.
English: The needle guard will help to prevent needle stick injuries to anyone who handles the pre-filled syringe.
Croatian: Štitnik igle pomaže u sprječavanju ozljeda slučajnim ubodom igle u svih osoba koje rukuju napunjenom štrcaljkom.
English: A higher rate of major birth defects was observed in one observational study comparing pregnancies exposed to etanercept (n = 370) during the first trimester with pregnancies not exposed to etanercept or other TNF-antagonists (n = 164) (adjusted odds ratio 2.4, 95% CI: 1.0 - 5.5).
Croatian: U jednom opservacijskom ispitivanju koje je uspoređivalo trudnoće koje su bile izložene etanerceptu (n=370) tijekom prvog tromjesečja sa trudnoćama koje nisu bile izložene etanerceptu ili drugim antagonistima TNF-a (n=164), zabilježena je viša stopa velikih urođenih mana (prilagođen omjer izgleda 2,4; 95% CI: 1,0-5,5).