natgillin/translations-raw huggingface dataset:
Adult patients treated with etanercept and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either etanercept or anakinra alone (historical data).
Pri odraslih bolnikih, zdravljenih z etanerceptom in anakinro, so opazili večjo stopnjo resnih okužb kot pri bolnikih, zdravljenih samo z etanerceptom ali samo z anakinro (retrospektivni podatki).
disodium hydrogen phosphate heptahydrate, and water for injections.
natrijev hidrogenfosfat heptahidrat in voda za injekcije.
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.
Učinkovitost etanercepta pri bolnikih z ankilozirajočim spondilitisom je bila ocenjena v 3 randomiziranih dvojno slepih študijah, kjer so primerjali uporabo 25 mg etanercepta dvakrat tedensko s placebom.
Concurrent administration of etanercept and anakinra has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
Sočasna uporaba etanercepta in anakinre je bila povezana s povečanim tveganjem za pojav resnih okužb in nevtropenije v primerjavi z zdravljenjem samo z etanerceptom.
Do not mix the Benepali solution with any other medicine.
Raztopine zdravila Benepali ne smete mešati z nobenim drugim zdravilom.
These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice-weekly.
Te povprečne koncentracije so bile podobne koncentracijam, ki so jih opazili pri odraslih bolnikih s psoriazo v plakih, zdravljenih s 25 mg etanercepta dvakrat na teden.
• Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present.
• Raztopine ne uporabljajte, če je drugačne barve, motna, ali če so prisotni delci, ki ne ustrezajo opisu zgoraj.
Inspect the pre-filled syringe:
Preglejte napolnjen injekcijski peresnik:
The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with etanercept compared to none of placebo-treated patients).
Tudi odstotek bolnikov, ki so razvili nova pozitivna avtoprotitelesa proti dvojno vijačni DNK, je bil večji, merjeno z radioimunskimi testi (15 % pri etanerceptu in 4 % pri placebu) in s testom na Crithidia luciliae (3 % pri etanerceptu, in 0 % pri placebu).
One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of etanercept (n = 57) or placebo (n = 55) twice a week for 24 weeks.
Randomizirali so sto dvanajst (112) bolnikov, ki so 24 tednov dvakrat na teden dobivali 25-mg odmerek etanercepta (n = 57) ali placebo (n = 55).
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients.
V kliničnih študijah zdravljenja z etanerceptom, ki so trajale več kot 2 leti in so vključevale 351 bolnikov z ankilozirajočim spondilitisom, so poročali o 6 primerih malignega obolenja.
• psoriatic arthritis; • severe axial spondyloarthritis including ankylosing spondylitis;
• hud aksialni spondilartritis, vključno z ankilozirajočim spondilitisom;
ACR Responsesa
Odzivi ACRa
• Do not reuse the Benepali pre-filled syringe.
• Napolnjene injekcijske igle zdravila Benepali ne uporabite ponovno.
Radiographic progression: Comparison of etanercept vs. methotrexate in patients with RA of < 3 years duration
Radiografsko napredovanje: Primerjava etanercepta in metotreksata pri bolnikih z RA, ki je trajal < 3 leta
The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 mg/kg (up to a maximum of 50 mg per dose) given once weekly.
Priporočeni odmerek je 0,4 mg/kg telesne mase (do največ 25 mg na odmerek) 2-krat na teden v obliki subkutane injekcije z razmikom med odmerki od 3 do 4 dni ali 0,8 mg/kg (do največ 50 mg na odmerek) enkrat na teden.
In the double-blind period, patients received etanercept 50 mg weekly or placebo for 12 weeks.
V dvojno slepem obdobju so bolniki prejemali etanercept v odmerku 50 mg na teden ali placebo 12 tednov.
Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF.
Etanercept je kompetitivni antagonist vezave TNF na receptorje na površini celice in torej zavira biološko aktivnost TNF.
• Do not rub the injection site.
• Mesta injiciranja ne drgnite.
In the 2-year activecontrolled study where patients were treated with either etanercept alone, methotrexate alone or etanercept in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
V dveletni študiji, nadzorovani z učinkovino, v kateri so bili bolniki zdravljeni z etanerceptom, metotreksatom ali kombinacijo enteracepta in metotreksata, je bila stopnja pogostnosti resnih okužb v treh skupinah podobna.
Benepali is a biosimilar medicinal product.
Zdravilo Benepali je podobno biološko zdravilo.
Icepharma hf. Sími: + 354 800 9836
Genesis Pharma S.A. Sími: + 354 800 9836
Check the expiry date on the pre-filled syringe label.
Preverite datum izteka roka uporabnosti na nalepki napolnjenega injekcijskega peresnika.
• moderate or severe rheumatoid arthritis;
• zmeren ali hud revmatoidni artritis;
Merkel cell carcinoma (see section 4.4)
Merklovih celic (glejte poglavje 4.4)
Adult patients with non-radiographic axial spondyloarthritis The efficacy of etanercept in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Odrasli bolniki z radiografsko nezaznavnim aksialnim spondilartritisom Učinkovitost etanercepta so pri bolnikih z radiografsko nezaznavnim aksialnim spondilartritisom (nr-AxSpa) ocenili v randomizirani 12-tedenski, dvojno slepi, s placebom nadzorovani študiji.
Patients with paediatric plaque psoriasis (aged 4 to 17 years) were administered 0.8 mg/kg (up to a maximum dose of 50 mg per week) of etanercept once weekly for up to 48 weeks.
Bolniki s pediatrično psoriazo v plakih (stari od 4 do 17 let) so prejemali po 0,8 mg/kg (do največjega odmerka 50 mg na teden) etanercepta enkrat na teden do 48 tednov.
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).
V analizi, v kateri je veljalo, da je pri vseh bolnikih, ki so iz katerega koli razloga izpadli iz študije, bolezen napredovala, je bil odstotni delež bolnikov brez napredovanja bolezni (sprememba TSS ≤ 0,5) po 12 mesecih večji v skupini z enteraceptom kot v skupini s placebom (73 % proti 47 %, p ≤ 0,001).
Pull the needle cover straight off and dispose of it in the bin or sharps container.
Pokrov igle povlecite naravnost navzdol in ga zavrzite v koš za smeti ali vsebnika za ostre odpadke.
The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and rubber plunger.
Injekcijska brizga v peresniku je izdelana iz prozornega stekla tipa I z iglo velikost 27 iz nerjavečega jekla, gumijastim pokrovčkom igle in gumijastim batom.
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.
Varnost in učinkovitost 50 mg etanercepta (dve subkutani injekciji po 25 mg) enkrat na teden so ocenili v dvojno slepi, s placebom nadzorovani študiji pri 420 bolnikih z aktivnim revmatoidnim artritisom.
In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received etanercept were observed compared with younger patients.
V študijah 3. faze pri revmatoidnem artritisu, psoriatičnem artritisu in ankilozirajočem spondilitisu pri bolnikih, starih 65 let ali več, ki so prejeli etanercept, na splošno niso opazili nobenih razlik glede neželenih učinkov, resnih neželenih učinkov in resnih okužb v primerjavi z mlajšimi bolniki.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS OF 8 AND 24 (WITH BLUE BOX)
VEČODMERNO PAKIRANJA S PO 8 IN 24 (Z BLUE BOX)
The device will click when the injection begins.
Ko se začne injiciranje, boste zaslišali klik.
In each case Benepali is used, usually when other widely used treatments have not worked well enough or are not suitable for you.
V vseh primerih se zdravilo Benepali običajno uporablja šele po neuspešnem zdravljenju z drugimi običajnimi oblikami zdravljenja, ali če te oblike zdravljenja za vas niso primerne.
• Signs of lupus or lupus-like syndrome, such as weight changes, persistent rash, fever, joint or muscle pain, or fatigue;
• znaki lupusa ali lupusu podobnega sindroma, kot so spremembe telesne mase, trdovraten kožni izpuščaj, vročina, bolečina v sklepih ali mišicah ali utrujenost;
• Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or the lips;
• znaki srčnega popuščanja ali poslabšanja srčnega popuščanja, npr. utrujenost ali kratka sapa pri telesnem naporu, otekanje gležnjev, občutek polnosti v vratu ali trebuhu, kratka sapa ali kašelj ponoči, modrikasti nohti ali ustnice;
Components inside the pre-filled syringe may be broken.
Deli v napolnjeni injekcijski igli so se morda zlomili.
Mean (SE) annualized change from baseline in total sharp score Time
Povprečna (SE) sprememba skupne Sharpove ocene od izhodišča na leto Čas
• Severe psoriasis in patients from the age of 6 years and weighing 62.5 kg or more who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
• za zdravljenje hude psoriaze pri bolnikih, starejših od 6 let in s telesno maso 62,5 kg ali več, ki so se nezadostno odzvali na fototerapije ali druge sistemske terapije (ali jih niso prenašali).
Benepali, 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.
Dokazali so, da zdravilo Benepali ali samo ali v kombinaciji z metotreksatom upočasni hitrost napredovanja poškodb sklepov, merjenih z rentgenskim slikanjem, in izboljša telesno funkcijo.
In another open-label single-arm study, 60 patients with extended oligoarthrits (15 patients aged 2 to 4, 23 patients aged 5 to 11 and 22 patients aged 12 to 17 years old), 38 patients with enthesitis-related arthritis (12 to 17 years old), and 29 patients with psoriatic arthritis (12 to 17 years old) were treated with etanercept at a dose of 0.8 mg/kg (up to a maximum of 50 mg per dose) administered weekly for 12 weeks.
V drugi odprti študiji z eno skupino se je z etanerceptom v odmerku 0,8 mg/kg (do največ 50 mg na odmerek) enkrat na teden zdravilo 60 bolnikov z razširjenim oligoartritisom (15 bolnikov, starih od 2 do 4 leta, 23 bolnikov, starih od 5 do 11 let, in 22 bolnikov, starih od 12 do 17 let), 38 bolnikov z artritisom, povezanim z entezitisom (starih od 12 do 17 let) in 29 bolnikov s psoriatičnim artritisom (starih od 12 do 17 let).
• Trouble swallowing or breathing
• težave pri požiranju ali dihanju;
Responses of patients with psoriatic arthritis in a placebo-controlled trial
Odzivi bolnikov s psoriatičnim artritisom v preskušanju, nadzorovanem s placebom
• Signs of blood disorders, such as bleeding, bruising, or paleness;
• znaki krvnih bolezni, npr. krvavitve, podplutbe ali bledica;
Caution should be exercised in patients being treated with Benepali who have a previous history of blood dyscrasias.
Previdnost je potrebna pri bolnikih, zdravljenih z zdravilom Benepali, ki imajo krvno diskrazijo v anamnezi.
 Psoriatic arthritis in patients from the age of 12 years and weighing 62.5 kg or more.
• psoriatičnega artritisa pri bolnikih, starejših od 12 let in s telesno maso 62,5 kg ali več.
No information is available if the use of Benepali effects the ability to drive or use machines.
Ni informacij o tem, ali uporaba zdravila Benepali vpliva na sposobnost upravljanja vozil in strojev.
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 Benepali treatment.
Vsem bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če se med zdravljenjem z zdravilom Benepali ali po njem pojavijo znaki/simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hiranje/hujšanje, nekoliko zvišana telesna temperatura).
There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with etanercept from post-marketing sources, including a very small number of cases indicating a positive rechallenge (see section 4.4).
Viri iz obdobja trženja so poročali o kronični vnetni črevesni bolezni in uveitisu pri bolnikih z JIA, ki so se zdravili z etanerceptom, vključno z zelo majhnim številom primerov, ki kažejo na ponoven pojav bolezni ob naslednjem dajanju zdravila (glejte poglavje 4.4).
At week 104, the mean change from baseline in the SPARCC score measured on MRI for all etanercept-treated subjects was 4.64 for the SIJ (n=153) and 1.40 the spine (n=154).
Pri vseh bolnikih, ki so prejemali etanercept, je po 104 tednih povprečna sprememba od izhodišča za rezultat SPARCC, merjen z magnetnoresonančnim slikanjem, znašala 4,64 za SIJ (n = 153) in 1,40 za hrbtenico (n = 154).
Infections (including colds, sinusitis, bronchitis, urinary tract infections and skin infections); injection site reactions (including bleeding, bruising, redness, itching, pain, and swelling).
Okužbe (vključno s prehladi, sinuzitisom, bronhitisom, okužbami sečil in okužbami kože); reakcije na mestu injiciranja (vključno s krvavitvami, podplutbami, rdečino, srbenjem, bolečino in oteklino).
Undesirable effects in paediatric patients with juvenile idiopathic arthritis In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients.
Neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom Na splošno so bili neželeni učinki pri otrocih z juvenilnim idiopatskim artritisom po vrsti in pogostnosti podobni tistim pri odraslih.
36 months.
36 mesecev
(Scoreb) Baseline (Scoreb) Week 52
(Ocenab) Izhodišče 5,5 (Ocenab) 52. teden 3,0
Paediatric patients weighing 62.5 kg or more can be dosed 25 mg given twice a week or 50 mg given once a week using a fixed-dose pre-filled syringe or pre-filled pen.
Pediatrični bolniki s telesno maso 62,5 kg ali več lahko prejmejo odmerek 25 mg dvakrat na teden ali odmerek 50 mg enkrat na teden kot fiksni odmerek v napolnjeni injekcijski brizgi ali napolnjenem peresniku.
Multipack: 8 (2 packs of 4) pre-filled syringes Multipack: 24 (6 packs of 4) pre-filled syringes
Večodmerno pakiranje: 8 (2 pakiranja s po 4) napolnjenimi injekcijskimi brizgami Večodmerno pakiranje: 24 (6 pakiranja s po 4) napolnjenimi injekcijskimi brizgami
Various malignancies have also been reported with use of etanercept, including cancers of the breast, lung, skin and lymph glands (lymphoma).
Pri uporabi etanercepta so poročali tudi o pojavu različnih malignih obolenj, vključno z rakom dojke, pljuč, kože in bezgavk (limfom).
Additionally, the pharmacokinetics of etanercept in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
Farmakokinetika etanercepta pri bolnikih z revmatoidnim artritisom, ankilozirajočim spondilitisom in psoriazo v plakih je podobna.
• Do not use the pre-filled syringe if the needle cover is missing or not securely attached.
• Ne uporabljajte napolnjene injekcijske igle, če manjka pokrovček igle ali če ta ni dobro pritrjen.
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
V drugi dvojno slepi randomizirani študiji, nadzorovani z učinkovino, so primerjali klinično učinkovitost, varnost in radiografsko napredovanje pri bolnikih z revmatoidnim artritisom, ki so jih zdravili samo z etanerceptom (25 mg 2-krat na teden), samo z metotreksatom (7,5 do 20 mg na teden, mediani odmerek 20 mg) ali z etanerceptom in metotreksatom (s sočasnim začetkom), in sicer pri
• Signs of serious infections (including pneumonia, deep skin infections, joint infections and blood infection), such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints;
• znaki resnih okužb (vključno s pljučnico, globokimi okužbami kože, okužbami sklepov in okužbo krvi), npr. visoka vročina, ki jo lahko spremljajo kašelj, kratka sapa, mrzlica, šibkost ali vroč, rdeč, občutljiv, boleč predel na koži ali sklepih;
Position the pre-filled pen approximately 90 degrees to the skin.
Napolnjen injekcijski peresnik nastavite na kožo pod kotom približno 90 stopinj.
Doses of 10 mg or 25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months.
Odmerki 10 mg ali 25 mg etanercepta so bili dani subkutano (s.c.) 2-krat tedensko do 24 mesecev.
• Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Benepali, and contact your doctor immediately.
• Alergijske reakcije: Če se pri vas ali otroku pojavi alergijska reakcija, npr. tiščanje v prsnem košu, piskajoče dihanje, omotica ali izpuščaj, prenehajte injicirati zdravilo Benepali in nemudoma obvestite zdravnika.
No studies on the effects on the ability to drive and use machines have been performed.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Študij o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
The efficacy of etanercept was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with methotrexate.
V randomizirani študiji, nadzorovani z učinkovino, so s slepo radiografsko oceno kot primarnim opazovanim dogodkom primerjali učinkovitost etanercepta z učinkovitostjo metotreksata pri 632 odraslih bolnikih z aktivnim revmatoidnim artritisom (trajanje bolezni manj kot 3 leta), ki se pred tem nikoli niso zdravili z metotreksatom.
There is generally no applicable use of etanercept in children aged below 6 years in the indication plaque psoriasis.
Etanercepta se običajno ne uporablja za zdravljenje psoriaze v plakih pri otrocih, mlajših od 6 let.
Discontinuation of treatment should be considered in patients who show no response after 4 months.
Pri bolnikih, ki po 4 mesecih zdravljenja ne pokažejo odziva, je treba razmisliti o prekinitvi zdravljenja.
If re-treatment with Benepali is indicated, the above guidance on treatment duration should be followed.
Če je indicirano ponovno zdravljenje z zdravilom Benepali, se ravnamo po zgornjih smernicah glede trajanja zdravljenja.
Patients in this study received a dose of 50 mg etanercept or placebo once weekly for 12 weeks and then all patients received open-label 50 mg etanercept once weekly for an additional 12 weeks.
Bolniki v tej študiji so dobivali odmerek 50 mg etanercepta ali placebo enkrat na teden 12 tednov, potem pa so vsi bolniki v odprtem delu dobivali 50 mg etanercepta enkrat na teden dodatnih 12 tednov.
Benepali is supplied as a solution for injection in a pre-filled pen (solution for injection).
Zdravilo Benepali je na voljo kot raztopina za injiciranje v napolnjenem injekcijskem peresniku (raztopina za injiciranje).
With twice-weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses.
Pričakovati je, da bodo koncentracije v stanju dinamičnega ravnovesja po odmerjanju 2-krat tedensko približno dvakrat večje od tistih, ki jih izmerimo po enkratnem odmerku.
Your doctor will determine if Benepali is an appropriate treatment.
Zdravnik bo presodil o primernosti zdravljenja z zdravilom Benepali.
At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebotreated patients.
V 24. tednu je 56 % bolnikov doseglo PASI 75 v skupini, zdravljeni z etanerceptom, v skupini s placebom pa 5 % bolnikov.
Pairwise comparison p-values: † = p < 0.05 for comparisons of etanercept + methotrexate vs. methotrexate and Φ = p < 0.05 for comparisons of etanercept + methotrexate vs. etanercept.
Vrednosti p za primerjavo po parih: † = p < 0,05 za primerjavo kombinacije etanercepta + metotreksata z metotreksatom in Φ = p < 0,05 za primerjavo kombinacije etanercepta + metotreksata z etanerceptom:
• Material to remind healthcare professionals that Benepali is not for use in children and adolescents who weigh less than 62.5 kg
• Gradivo, s katerim se zdravstvene delavce opominja, da zdravilo Benepali ni za uporabo pri otrocih in mladostnikih s telesno maso manj kot 62,5 kg.
- The other ingredients are sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate,
- Druge sestavine zdravila so saharoza, natrijev klorid, natrijev dihidrogenfosfat monohidrat,
Solution for injection
raztopina za injiciranje
Clear glass (type I) pre-filled syringe with stainless steel needle, rubber needle cover and rubber plunger containing 0.51 ml of solution.
Napolnjena injekcijska brizga iz prozornega stekla (tipa I) z iglo iz nerjavečega jekla, gumijastim pokrovčkom igle in gumijastim batom, ki vsebuje 0,51 ml raztopine.
• Vaccinations: Some vaccines, such as oral polio vaccine, should not be given during Benepali therapy.
• Cepljenja: Med zdravljenjem z zdravilom Benepali nekaterih cepiv, npr. peroralnega cepiva proti otroški paralizi, ni dovoljeno uporabljati.
At week 12, there was a statistically significant improvement in the SPARCC (Spondyloarthritis Research Consortium of Canada) score for the sacroiliac joint (SIJ) as measured by MRI for patients receiving etanercept.
Pri bolnikih, ki so prejemali etanercept, je po 12 tednih prišlo do statistično pomembnega izboljšanja rezultata SPARCC (SPARCC - Spondyloarthritis Research Consortium of Canada; Kanadski konzorcij za raziskovanje spondilartritisa) za sakroiliakalni sklep (SIJ - Sacroiliac Joint), ki so ga merili z magnetnoresonančnim slikanjem.
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).
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
A higher rate of major birth defects was observed in an 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).
V 1 opazovalni študiji, kjer so primerjali nosečnosti, izpostavljene etanerceptu (n = 370) v prvem trimesečju, z nosečnostmi, ki niso bile izpostavljene etanerceptu ali drugim antagonistom TNF (n = 164), so opazili večji delež resnih prirojenih napak (prilagojeno razmerje obetov 2,4, 95-% IZ: 1,0-5,5).
• Do not inject into areas that are red, hard, bruised, or tender.
• Ne injicirajte v predele, ki so pordeli, trdi, imajo modrico ali so občutljivi.