natgillin/translations-raw huggingface dataset:
Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Povišene koncentracije TNF-a pronađene su također u sinoviji i psorijatičnim plakovima bolesnika s psorijatičnim artritisom te u serumu i sinovijalnom tkivu bolesnika s ankilozantnim spondilitisom.
For patients who received 50 mg once weekly throughout the study, the efficacy responses continued to improve with 71% achieving PASI 75 at week 24.
U bolesnika koji su primali 50 mg jednom tjedno tijekom ispitivanja odgovor s obzirom na djelotvornost nastavio se poboljšavati sa 71% bolesnika koji su dosegli PASI 75 u 24. tjednu.
Patients in the Enbrel 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).
Bolesnici liječeni kombinacijom Enbrela i metotreksata imali su značajno više ACR 20, ACR 50, ACR 70 odgovore i poboljšanje ocjena na ljestvici DAS i upitniku HAQ i u 24. i u 52. tjednu u odnosu na bolesnike u bilo kojoj od skupina s monoterapijom (rezultati su prikazani u sljedećoj tablici).
There have been reports of hypoglycaemia following initiation of Enbrel in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients.
U bolesnika koji uzimaju lijekove za liječenje šećerne bolesti, nakon uvođenja Enbrela bila je zabilježena hipoglikemija, koja je zahtijevala smanjenje antidijabetika u nekih od tih bolesnika.
This will help reduce foaming (lots of bubbles) (see Diagram 5).
Tako će se smanjiti stvaranje pjene (puno mjehurića) (vidjeti sliku 5).
Adult patients treated with Enbrel and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either Enbrel or anakinra alone (historical data).
U odraslih bolesnika koji su istodobno liječeni Enbrelom i anakinrom opažena je povećana stopa ozbiljnih infekcija u usporedbi s bolesnicima koji su liječeni samo Enbrelom ili samo anakinrom (povijesni podaci).
ACR 20 and 50 responses were higher in patients treated with Enbrel at 3 and 6 months than in patients treated with placebo (ACR 20: Enbrel 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively: ACR 50: Enbrel 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p<0.01 Enbrel vs placebo at all timepoints for both ACR 20 and ACR 50 responses).
Učestalost odgovora ACR 20 i 50 bila je veća u bolesnika liječenih Enbrelom tijekom 3 i 6 mjeseci nego u bolesnika liječenih placebom (ACR 20: Enbrel 62% i 59%, placebo 23% i 11% nakon 3 odnosno 6 mjeseci; ACR 50: Enbrel 41% i 40%, placebo 8% i 5% nakon 3, odnosno 6 mjeseci; p<0,01 Enbrel u odnosu na placebo u svim vremenskim točkama za ACR 20 i ACR 50 odgovore).
There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
Rijetka su izvješća o bolesnicima, uključujući i bolesnike s pozitivnim reumatoidnim faktorom, kod kojih su se razvila autoprotutijela vezana uz sindrom nalik lupusu ili osipi koji kliničkom slikom i nalazom biopsije odgovaraju subakutnom kutanom ili diskoidnom lupusu.
T oxic epidermal necrolysis
Toksična epidermalna nekroliza
These include the alcohol swab from the Enbrel carton and a cotton ball or gauze.
Pribor uključuje jastučić natopljen alkoholom i kutije Enbrela i komadić vate ili gaze.
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.
Preporučena je primjena Enbrela u bolesnika kako je definirano u dijelu 4.1. Bolesnici koji „nisu pokazali odgovor“ u ciljnoj populaciji definirani su kao oni s nedostatnim odgovorom (PASI<50 ili PGA manji od dobar) ili pogoršanjem bolesti za vrijeme liječenja, a koji su liječeni adekvatnom dozom tijekom dovoljno dugog razdoblja da postignu odgovor sa svakim od 3 glavna raspoloživa sistemska lijeka.
• Latex: The needle cover is made from latex (dry natural rubber).
• Lateks: poklopac igle napravljen je od lateksa (suhe prirodne gume).
In the double-blind period, patients received Enbrel 50 mg weekly or placebo for 12 weeks.
U dvostruko slijepom razdoblju bolesnici su primali Enbrel 50 mg tjedno ili placebo tijekom 12 tjedana.
All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g., persistent cough, wasting/weight loss, low-grade fever) appear during or after Enbrel treatment.
Svim bolesnicima treba savjetovati da potraže liječnički savjet u slučaju pojave znakova/simptoma koji upućuju na tuberkulozu (npr. stalni kašalj, mršavljenje/gubitak tjelesne težine, subfebrilnost) za vrijeme ili nakon liječenja Enbrelom.
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
U bolesnika koji su primali 25 mg dvaput tjedno kroz cijelo ispitivanje PASI 75 odgovor nastavio se poboljšavati između 12. i 36. tjedna.
Your doctor or nurse will tell you how to inject Enbrel.
Vaš liječnik ili medicinska sestra pokazat će Vam pravilnu tehniku injiciranja Enbrela.
In the toxicological studies with Enbrel, no dose-limiting or target organ toxicity was evident.
U toksikološkim ispitivanjima Enbrela nije zabilježena toksičnost koja bi ograničavala dozu, kao ni toksičnost prema ciljnim organima.
• if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Enbrel (listed in section 6).
• ako ste Vi ili dijete za koje skrbite alergični na etanercept ili neki drugi sastojak Enbrela (naveden u dijelu 6.).
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.
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 Enbrel tijekom 3 mjeseca.
Each vial should be used for just one dose in one patient, and any remaining solution should be discarded.
Jednu bočicu treba uporabiti samo za jednu dozu u jednog bolesnika, a preostalu otopinu treba baciti.
The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of Enbrel in adult patients with rheumatoid arthritis, and the majority were mild.
Vrsta i udio štetnih događaja u bolesnika s juvenilnim idiopatskim artritisom bili su slični onima zabilježenim u ispitivanjima Enbrela u odraslih bolesnika s reumatoidnim artritisom i uglavnom blagi.
Int erst it ial lung disease (including pneumonitis and pulmonary fibrosis)*
Intersticijska plućna bolest (uključujući pneumonitis i plućnu fibrozu)*
Contents of the pack and other information Instructions for preparing and giving an injection of Enbrel (See overleaf)
Sadržaj pakiranja i druge informacije Upute za pripremu i primjenu injekcija Enbrel (vidjeti na poleđini)
Additionally, the pharmacokinetics of Enbrel in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
Nadalje, farmakokinetika Enbrela u bolesnika s reumatoidnim artritisom, ankilozantnim spondilitisom i plak psorijazom je slična.
Congestive heart failure (Cardiac failure congestive) Physicians should use caution when using Enbrel in patients who have congestive heart failure (CHF).
Kongestivno zatajenje srca (Kongestivno srčano zatajenje) Liječnici moraju biti oprezni prilikom propisivanja Enbrela bolesnicima koji boluju od kongestivnog zatajenja srca.
Adding water for injections
Dodavanje vode za injekcije
This combination has not demonstrated increased clinical benefit; such use is not recommended (see section 4.4).
Ova kombinacija nije pokazala povećanu kliničku korist te se stoga istodobna primjena ova dva lijeka ne preporučuje (vidjeti dio 4.4).
If you forget to inject Enbrel
Ako ste zaboravili primijeniti Enbrel
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.
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.
• Nervous system and eye disorders: Tell your doctor if the child has multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
• Poremećaji živčanog sustava i oka: obavijestite svog liječnika ako dijete boluje od multiple skleroze, optičkog neuritisa (upala vidnog živca) ili transverznog mijelitisa (oblik upale kralježnične moždine).
Some vaccines, such as oral polio vaccine, should not be given while using Enbrel.
Neka cjepiva, kao oralno cjepivo protiv poliomijelitisa, ne bi se trebala davati za vrijeme liječenja Enbrelom.
Enbrel 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.
Liječenje Enbrelom 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.
In this study, most psoriatic arthritis patients receiving Enbrel were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had two-fold rises in titres compared to patients not receiving Enbrel.
U ovom ispitivanju je većina bolesnika s psorijatičnim artritisom koji su primali Enbrel mogla postići učinkovit imunološki odgovor B-stanica na pneumokokno polisaharidno cjepivo, iako su vrijednosti titra u agregatu bile umjereno niže, dok je nekoliko bolesnika imalo dvostruki porast titra u usporedbi s bolesnicima koji nisu primali Enbrel.
It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis.
Vrlo je važno da napomenete svom liječniku ako ste Vi ili dijete ikada imali tuberkulozu ili ste bili u bliskom dodiru s osobom koja je imala tuberkulozu.
At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5.
Na početku ispitivanja bolesnici su imali umjereni stupanj nesposobnosti s prosječnom ocjenom na upitniku HAQ od 1,4 do 1,5.
Setting up for an injection c.
Priprema za injekciju c.
Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of juvenile idiopathic arthritis or paediatric plaque psoriasis.
Liječenje Enbrelom treba započeti i nadzirati liječnik specijalist s iskustvom u dijagnostici i liječenju juvenilnog idiopatskog artritia ili plak psorijaze dječje dobi.
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.
Dugotrajna sigurnost primjene Enbrela kao monoterapije (n=103), Enbrela u kombinaciji s metotreksatom (n=294) ili metotreksata kao monoterapije (n=197) procijenjena je u trajanju do 3 godine u 594 djece u registru u dobi od 2 do 18 godina s juvenilnim idiopatskim artritisom od kojih je 39 bilo staro 2 do 3 godine.
In part 2, 6 of 25 (24%) patients remaining on Enbrel experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p=0.007).
U drugom dijelu ispitivanja 6 od 25 (24%) bolesnika koji su ostali na Enbrelu imalo je pogoršanje bolesti u usporedbi s 20 od 26 (77%) bolesnika koji su primali placebo (p=0,007).
Enbrel is administered by subcutaneous injection.
Enbrel se primjenjuje supkutanom injekcijom.
After the 12-week double-blind treatment period, all patients received Enbrel 0.8 mg/kg (up to 50 mg) once weekly for additional 24 weeks.
Nakon dvostruko slijepog razdoblja liječenja u trajanju od 12 tjedana svi bolesnici dobivali su Enbrel 0,8 mg/kg (do 50 mg) jednom tjedno u trajanju od dodatna 24 tjedna.
You or the child should not use Enbrel with medicines that contain the active substance anakinra or abatacept.
Ni Vi, niti dijete ne biste smjeli primjenjivati Enbrel s lijekovima koji sadrže anakinru ili abatacept kao djelatnu tvar.
Take the Enbrel carton containing the pre-filled syringes out of the refrigerator and place it on the flat work surface.
Izvadite kutiju s napunjenim štrcaljkama Enbrela iz hladnjaka i postavite je na ravnu radnu površinu.
Do NOT remove the needle cover while allowing it to reach room temperature.
NEMOJTE uklanjati poklopac igle dok čekate da dosegne sobnu temperaturu.
• Nervous system and eye disorders: Tell your doctor if you or the child have multiple sclerosis, optic neuritis (inflammation of the nerves of the eyes) or transverse myelitis (inflammation of the spinal cord).
• Poremećaji živčanog sustava i oka: obavijestite svog liječnika ako Vi ili dijete bolujete od multiple skleroze, optičkog neuritisa (upala vidnog živca) ili transverznog mijelitisa (oblik upale kralježnične moždine).
Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF-antagonist therapy are not available.
Odgovarajući podaci o liječenju bolesnika zaraženih HBVom kombinacijom antivirusne terapije i antagonista TNF-a nisu dostupni.
Thus the combined use of Enbrel and anakinra is not recommended (see sections 4.5 and 4.8).
Stoga se ne preporučuje kombinirana primjena Enbrela i anakinre (vidjeti dijelove 4.5 i
• Inspect the expiry dates on both the Enbrel vial label and the water for injections.
• Provjerite rok valjanosti na naljepnici bočice Enbrela i vode za injekciju.
Gently tap the syringe to make any bubbles rise to the top of the syringe, near the needle (see Diagram 8).
Nježno kucnite po štrcaljki kako bi se mjehurići zraka podigli prema vrhu, blizu igle (vidjeti sliku 8).
The known side effects of Enbrel include the following in groups of decreasing frequency:
Poznate nuspojave Enbrela uključuju sljedeće i prikazane su slijedom prema sve manjoj učestalosti:
In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
Osim toga, u dvostruko slijepom, placebom kontroliranom ispitivanju u odraslih bolesnika koji su primali osnovnu terapiju metotreksatom, opaženo je da bolesnici koji su liječeni Enbrelom i anakinrom imaju povećanu stopu ozbiljnih infekcija (7%) i neutropenije u odnosu na bolesnike liječene samo Enbrelom (vidjeti dijelove 4.4 i 4.8).
Antibodies to Enbrel
Protutijela na Enbrel
The Enbrel solution should not be mixed with any other medicine before use.
Otopinu Enbrela ne treba miješati niti s jednim drugim lijekom prije primjene.
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.
Prosječna maksimalna serumska koncentracija zabilježena u zdravih dobrovoljaca nakon jednokratne supkutane doze Enbrela od 25 mg iznosila je 1,65  0,66 g/ml, a površina ispod krivulje iznosila je 235  96,6 µg•h/ml.
Patients currently on methotrexate therapy (stable for ≥ 2 months) could continue at a stable dose of ≤ 25 mg/week methotrexate.
Bolesnici koji su u tom trenutku primali metotreksat (stabilni > 2 mjeseca) mogli su nastaviti s njegovom primjenom u stalnoj dozi od < 25 mg tjedno.
The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex).
Poklopac igle napunjene brizgalice sadrži suhu prirodnu gumu (derivat lateksa).
Preparing the Enbrel dose for injection
Priprema doze Enbrela za injekciju
The long-term safety of Enbrel in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
Nije provjerena dugoročna sigurnost primjene Enbrela u kombinaciji s drugim antireumatskim lijekovima koji modificiraju tijek bolesti.
At 24 weeks, 56% of patients in the Enbrel-treated group had achieved the PASI 75 compared to 5% of placebotreated patients.
Nakon 24 tjedna, 56% bolesnika u grupi liječenoj Enbrelom postiglo je PASI 75 u usporedbi s 5% u skupini na placebu.
• if the child you are caring for is allergic to etanercept or any of the other ingredients of Enbrel (listed in section 6).
• ako je dijete za koje skrbite alergično na etanercept ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life threatening, or requiring hospitalisation or intravenous antibiotics) was observed.
U placebom kontroliranim ispitivanjima nije primijećeno povećanje incidencije ozbiljnih infekcija (sa smrtnim ishodom, opasnih po život ili onih koje su zahtijevale hospitalizaciju ili intravensku primjenu antibiotika).
Patients should be tested for HBV infection before initiating treatment with Enbrel.
Bolesnici se trebaju testirati na HBV infekciju prije započinjanja terapije Enbrelom.
Abbreviation: sPGA-static Physician Global Assessment.
b. Dermatologist Static Global Assessment (Dermatološka statička globalna procjena).
The double-blind period was followed by an open-label period during which all patients receive Enbrel 50 mg weekly for up to an additional 92 weeks.
Nakon dvostruko slijepog razdoblja uslijedilo je otvoreno razdoblje ispitivanja tijekom kojeg su svi bolesnici primali Enbrel 50 mg jednom tjedno do dodatna 92 tjedna.
You should consult your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby.
Ako ste trudni , mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet.
Do not rub the injection site.
Nemojte trljati mjesto ubrizgavanja.
Physicians should use caution when considering combination therapy with sulfasalazine.
Liječnici moraju biti oprezni kod razmatranja istodobne primjene Enbrela i sulfasalazina.
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count < 1000/mm3).
U ispitivanjima u kojima su odrasli bolesnici primali istodobno Enbrel i anakinru, opažena je povećana stopa ozbiljnih infekcija u usporedbi sa samo Enbrelom, dok je 2% bolesnika (3/139) razvilo neutropeniju (apsolutni broj neutrofila < 1000/mm
T uberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)*
Tuberkuloza, oportunistička infekcija (uključujući invazivne gljivične, protozoalne, bakterijske, atipične mikobakterijske, virusne infekcije i Legionellu)*
These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice weekly.
Te prosječne koncentracije bile su slične onima zabilježenim u odraslih bolesnika s plak psorijazom liječenih s 25 mg etanercepta dva puta tjedno.
To help you remember, it may be helpful to write in a diary which day(s) of the week Enbrel should be used.
Radi lakšeg pamćenja, može Vam pomoći vođenje dnevnika i bilježenje dana kada trebate primijeniti Enbrel.
Keep the pre-filled pens in the outer carton in order to protect from light.
Napunjene brizgalice čuvati u vanjskom pakiranju, radi zaštite od svjetlosti.
In plaque psoriasis, infiltration by inflammatory cells including T-cells leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Kod plak psorijaze infiltracija upalnim stanicama uključujući T stanice vodi do porasta razine TNF-a u psorijatičnim lezijama u usporedbi s razinama istih u koži koja nije promijenjena.
The safety and efficacy of Enbrel in patients with immunosuppression have not been evaluated.
Sigurnost primjene i djelotvornost Enbrela u bolesnika s imunosupresijom nisu ispitane.
There were no differences in rates of infection among patients treated with Enbrel and those treated with placebo for plaque psoriasis in placebo-controlled trials of up to 24 weeks duration.
Kod liječenja plak psorijaze nisu zabilježene razlike u stopi infekcija između bolesnika liječenih Enbrelom i onih koji su primali placebo u placebom kontroliranim ispitivanjima u trajanju do 24 tjedna.
In part 1, all patients received 0.4 mg/kg (maximum 25 mg per dose) Enbrel subcutaneously twice weekly.
U prvom dijelu ispitivanja svi su bolesnici primili 0,4 mg/kg (najviše 25 mg po dozi) Enbrela supkutano dva puta tjedno.
Your doctor may decide if you or the child need less anti-diabetic medicine while taking Enbrel.
Liječnik može odlučiti trebate li Vi ili dijete za vrijeme liječenja Enbrelom uzimati manju količinu antidijabetičkog lijeka.
TNF-antagonist therapy are not available.
om kombinacijom antiviralne terapije i antagonista TNF-a nisu dostupni.
Based on pharmacokinetic data (see section 5.2), no dose adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited.
Temeljem farmakokinetičkih podataka (vidjeti dio 5.2) u liječenju bolesnika s oštećenjem bubrega ili jetre nije potrebna prilagodba doza.
There is no known antidote to Enbrel.
Antidot za Enbrel nije poznat.
Patients also had plaque psoriasis with a qualifying target lesion ≥ 2 cm in diameter.
Bolesnici su također trebali imati plak psorijazu s kožnim promjenama promjera > 2 cm.
Keep the pre-filled syringes in the outer carton in order to protect from light.
Napunjene štrcaljke čuvati u vanjskom pakiranju, radi zaštite od svjetlosti.
The active substance in Enbrel is etanercept.
Djelatna tvar Enbrela je etanercept.
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).
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).