natgillin/translations-raw huggingface dataset:
In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of etanercept and methotrexate did not result in unexpected safety findings, and the safety profile of etanercept when given in combination with methotrexate was similar to the profiles reported in studies of etanercept and methotrexate alone.
V dveletnem nadzorovanem kliničnem preskušanju pri bolnikih z revmatoidnim artritisom ni bilo pri kombiniranem zdravljenju z etanerceptom in metotreksatom nobenih nepričakovanih ugotovitev glede varnosti; varnostni profil etanercepta pri kombiniranem zdravljenju z metotreksatom je bil podoben varnostnemu profilu, ki je bil ugotovljen pri monoterapiji z etanerceptom oziroma metotreksatom.
Dimeric soluble receptors, such as etanercept, possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors.
Topni dimerni receptorji, kot je etanercept, imajo večjo afiniteto za TNF kot monomerni receptorji in so veliko bolj učinkoviti kompetitivni antagonisti vezave TNF na celične receptorje.
Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis
Psoriatični artritis, ankilozirajoči spondilitis in radiografsko nezaznavni aksialni spondilartritis
The recommended dose is 50 mg etanercept administered once weekly (see section 5.1).
Priporočeni odmerek je 50 mg etanercepta enkrat na teden (glejte poglavje 5.1).
• Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer.
• znaki rakavih obolenj: Rak lahko prizadene kateri koli del telesa, vključno s kožo in krvjo.
Do not recap the needle.
Pokrovčka ne natikajte nazaj na iglo.
Physicians should use caution when using Benepali in patients who also have moderate to severe alcoholic hepatitis.
Zdravniki naj bodo pazljivi, kadar uporabljajo zdravilo Benepali pri bolnikih, ki imajo tudi zmeren do hud alkoholni hepatitis.
A single 50 mg/ml injection of etanercept was found to be bioequivalent to two simultaneous injections of 25 mg/ml.
Ugotovili so, da je ena 50 mg/ml injekcija etanercepta bioekvivalentna dvema sočasnima injekcijama po 25 mg/ml.
In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with etanercept developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment.
V nadzorovanih preskušanjih bolnikov s psoriazo v plakih so se reakcije na mestu injiciranja v prvih 12 tednih zdravljenja pojavile pri približno 13,6 % bolnikov, zdravljenih z etanerceptom, in pri 3,4 % bolnikov, ki so dobivali placebo.
There were no differences in rates of infection among patients treated with etanercept and those treated with placebo for plaque psoriasis in placebo-controlled trials of up to 24 weeks duration.
V stopnjah pogostnosti okužb med bolniki, zdravljenimi z etanerceptom, in tistimi, ki so prejemali placebo za zdravljenje psoriaze v plakih, v preskušanjih, nadzorovanih s placebom, ki so trajala do 24 tednov, ni bilo razlik.
Benepali treatment may increase mortality in patients with established sepsis.
Zdravljenje z zdravilom Benepali lahko zveča smrtnost pri bolnikih z dokazano sepso.
The proportion of patients treated with etanercept who developed anticardiolipin antibodies was similarly increased compared to placebotreated patients.
Delež bolnikov, ki so razvili protitelesa proti kardiolipinu, je bil podobno povečan pri etanerceptu v primerjavi s placebom.
In plaque psoriasis, infiltration by inflammatory cells, including T-cells, leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Pri psoriazi v plakih se zaradi infiltracije vnetnih celic (vključno s celicami T) v psoriatičnih lezijah v primerjavi z neprizadeto kožo poveča koncentracija TNF.
Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo Benepali je mogoče uporabiti kot monoterapijo, kadar bolnik ne prenese metotreksata ali kadar trajno zdravljenje z metotreksatom ni primerno.
• Always keep the container out of the sight and reach of children.
• Vsebnik vedno shranjujte nedosegljivo otrokom.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov proizvajalca,
Serious infections affect fewer than 1 in 100 patients treated with etanercept.
Med zdravljenjem z etanerceptom so se resne okužbe pojavile pri manj kot 1 od 100 bolnikov.
From the start of part 2, the median time to flare was 116 days for patients who received etanercept and 28 days for patients who received placebo.
Od začetka drugega dela študije je bil mediani čas do ponovnega izbruha bolezni 116 dni pri bolnikih na etanerceptu in 28 dni pri bolnikih na placebu.
• Anti-diabetic medicines: Tell your doctor if you or the child have diabetes or are taking medicines to treat diabetes.
• Zdravila za zdravljenje sladkorne bolezni: Povejte zdravniku, če imate vi ali otrok sladkorno bolezen, ali če jemljete zdravila za zdravljenje sladkorne bolezni.
There have been reports of hypoglycaemia following initiation of etanercept in patients receiving medicinal products for diabetes, necessitating a reduction in anti-diabetic medicinal products in some of these patients.
Po uvedbi etanercepta so pri bolnikih, ki so prejemali zdravila za zdravljenje sladkorne bolezni, so poročali o hipoglikemiji, zaradi katere je bilo treba pri nekaterih od teh bolnikov zmanjšati odmerek zdravila za zdravljenje sladkorne bolezni.
Significant advantages for etanercept in combination with methotrexate compared with etanercept monotherapy and methotrexate monotherapy were also observed after 24 months.
Pomembne prednosti etanercepta v kombinaciji z metotreksatom pred monoterapijo z etanerceptom ali monoterapijo z metotreksatom so ugotovili tudi po 24 mesecih.
If any of the following happen, do not inject more Benepali.
Če se pojavi kar koli od naslednjega, si zdravila Benepali ne smete več injicirati.
There have been rare reports of CNS demyelinating disorders in patients treated with etanercept (see section 4.8).
Poročali so o redkih primerih demielinizirajočih obolenj centralnega živčnega sistema (CŽS) pri bolnikih, zdravljenih z etanerceptom (glejte poglavje 4.8).
• Signs of autoimmune reactions (where antibodies are made that may harm normal tissues in the body) such as pain, itching, weakness, and abnormal breathing, thinking, sensation, or vision;
• znaki avtoimunskih reakcij (reakcije, pri katerih se tvorijo protitelesa, ki lahko poškodujejo normalna telesna tkiva), kot so bolečina, srbenje, oslabelost, težave z dihanjem, motnje mišljenja, zaznavanja ali vida;
In studies when adult patients received concurrent treatment with etanercept plus anakinra, a higher rate of serious infections compared to etanercept alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count < 1,000/mm3).
V študijah, v katerih so odrasli bolniki sočasno prejemali etanercept in anakinro, so opažali večjo stopnjo resnih okužb v primerjavi s samim etanerceptom in pri 2 % bolnikov (3/139) se je pojavila nevtropenija (absolutna koncentracija nevtrofilcev < 1.000/mm3).
In part 2, 6 of 25 (24%) patients remaining on etanercept experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p = 0.007).
V drugem delu je 6 od 25 (24 %) bolnikov, ki so ostali na etanerceptu, doživelo ponoven izbruh bolezni, v primerjavi z 20 od 26 (77 %) bolnikov, ki so v drugem delu prejemali placebo (p = 0,007).
Women of childbearing potential should consider the use of appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy.
Ženske v rodni dobi morajo razmisliti o uporabi ustrezne kontracepcije za preprečitev nosečnosti med zdravljenjem z zdravilom Benepali in še tri tedne po prenehanju zdravljenja.
Etanercept has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Ugotovili so, etanercept izboljša telesno funkcijo pri bolnikih s psoriatičnim artritisom in upočasni hitrost napredovanja okvar perifernih sklepov, merjenih z rentgenskim slikanjem, pri bolnikih s poliartikularnimi simetričnimi podvrstami bolezni.
Hold the pre-filled syringe at 45 degrees to the skin.
Napolnjeno injekcijsko iglo nastavite na kožo pod kotom 45 stopinj.
These include rare reports of pancytopenia and very rare reports of aplastic anaemia.
Ti vključujejo tudi redke primere pancitopenije in zelo redke primere aplastične anemije.
Long-term safety of etanercept monotherapy (n = 103), etanercept plus methotrexate (n = 294), or methotrexate monotherapy (n = 197) were assessed for up to 3 years in a registry of 594 children aged 2 to 18 years with juvenile idiopathic arthritis, 39 of whom were 2 to 3 years of age.
Dolgoročno varnost zdravljenja z etanerceptom v monoterapiji (n = 103), zdravljenja z etanerceptom v kombinaciji z metotreksatom (n = 294) ali zdravljenja z metotreksatom v monoterapiji (n = 197) so ovrednotili za obdobje do 3 let na osnovi registra 594 otrok, starih od 2 do 18 let, z juvenilnim idiopatskim artritisom.
Serious allergic/anaphyla ctic reactions (including angioedema, bronchospasm), sarcoidosis
resne alergijske/anafilaktičn e reakcije (vključno z angioedemom in bronhospazmom),
In a study of 49 adult patients with rheumatoid arthritis treated with etanercept, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
Študija pri 49 odraslih bolnikih z revmatoidnim artritisom ni pokazala, da bi zdravljenje z etanerceptom zmanjšalo zapoznelo preobčutljivostno reakcijo, zmanjšalo raven imunoglobulinov ali spremenilo število efektorskih celic.
All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, and paleness) whilst on Benepali, they should seek immediate medical advice.
Vse bolnike in starše/skrbnike je treba opozoriti, da morajo pri bolniku v primeru pojava znakov ali simptomov, ki kažejo na krvno diskrazijo ali okužbo (npr. trdovratna zvišana telesna temperatura, vnetje žrela, podplutbe, krvavitve in bledica), med zdravljenjem z zdravilom Benepali takoj poiskati zdravniško pomoč.
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).
Nekatere okužbe so se pojavile nekaj tednov po začetku zdravljenja bolnikov z etanerceptom, 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).
Additionally, studies have not been conducted to assess the effects of discontinuing or reducing the recommended dose of etanercept following its long-term use in patients with JIA.
Pri bolnikih z JIA prav tako niso izvedli študij za ovrednotenje učinka prekinitve zdravljenja ali zmanjšanja priporočenega odmerka etanercepta po njegovi dolgotrajni uporabi.
If there is bleeding at the injection site, press a gauze pad over the injection site.
Če opazite krvavitev na mestu injiciranja, na mesto injiciranja pritisnite gazo.
Whether used alone or in combination with methotrexate, Benepali can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities.
Zdravilo Benepali samo ali v kombinaciji z metotreksatom lahko upočasni razvoj poškodb v sklepih zaradi revmatoidnega artritisa in izboljša sposobnost opravljanja vsakodnevnih opravil.
The dosage of etanercept is based on body weight for paediatric patients.
Odmerjanje etanercepta za pediatrične bolnike temelji na njihovi telesni masi.
• Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with etanercept.
• Kronična vnetna črevesna bolezen (KVČB): Pri bolnikih z juvenilnim idiopatskim artritisom (JIA), ki so se zdravili z etanerceptom, so poročali o primerih KVČB.
Benepali should be discarded if not used within four weeks after removal from the refrigerator.
Zdravilo Benepali zavrzite, če ga ne porabite v štirih tednih po odvzemu iz hladilnika.
In clinical studies, concurrent administration of abatacept and etanercept resulted in increased incidences of serious adverse events.
V kliničnih študijah je sočasna uporaba abatacepta in etanercepta zvečala incidenco resnih neželenih učinkov.
However, your doctor may determine an alternative frequency at which to inject Benepali.
Zdravnik vam lahko predpiše tudi drugačno pogostnost injiciranja zdravila Benepali.
Serious infections experienced by etanercept-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Med resnimi okužbami pri bolnikih, zdravljenih z etanerceptom, so bile celulitis, gastroenteritis, pljučnica, holecistitis, osteomielitis, gastritis, apendicitis, streptokokni fasciitis, miozitis, septični šok, divertikulitis in absces.
Your doctor may decide if you or the child need less anti-diabetic medicine while taking Benepali.
Zdravnik lahko odloči, da boste vi ali otrok med jemanjem zdravila Benepali potrebovali manj zdravila za zdravljenje sladkorne bolezni.
After the 12-week double-blind treatment period, all patients received etanercept 0.8 mg/kg (up to 50 mg) once weekly for additional 24 weeks.
Po 12-tedenskem obdobju dvojno slepega zdravljenja so vsi bolniki prejemali etanercept v odmerku 0,8 mg/kg (do 50 mg) enkrat na teden še dodatnih 24 tednov.
Approximately 15% of subjects who received etanercept achieved an ACR 70 response at month 3 and month 6 compared to fewer than 5% of subjects in the placebo arm.
Približno 15 % bolnikov, zdravljenih z etanerceptom, je do 3. in 6. meseca doseglo odziv ACR 70, v primerjavi z manj kot 5 % tistih, ki so prejemali placebo.
Opportunistic infections have been reported in association with etanercept, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
V povezavi z etanerceptom so poročali o oportunističnih okužbah, vključno z invazivnimi glivičnimi, parazitskimi (vključno s protozojskimi), virusnimi (vključno s herpesom zoster), bakterijskimi (vključno z bakterijama Listeria in Legionella) in atipičnimi mikobakterijskimi okužbami.
• Vaccinations: If possible, children should be up to date with all vaccinations before using Benepali.
• Cepljenja: Najbolje je, da otrok pred začetkom zdravljenja z zdravilom Benepali opravi vsa predvidena cepljenja.
• Signs of nerve disorders, such as numbness or tingling, changes in vision, eye pain, or onset of weakness in an arm or leg;
• znaki živčnih motenj, npr. omrtvelost ali mravljinčenje, spremembe vida, bolečina v očesu ali pojav šibkosti v roki ali nogi;
In this study, 53 patients received placebo, 214 patients received 50 mg etanercept once weekly and 153 patients received 25 mg etanercept twice weekly.
V tej študiji je 53 bolnikov dobivalo placebo, 214 bolnikov 50 mg etanercepta enkrat na teden in 153 bolnikov 25 mg etanercepta dvakrat na teden.
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including etanercept, in the postmarketing setting.
Pri otrocih, mladostnikih in mladih odraslih (do 22. leta starosti), ki so se zdravili z antagonisti TNF (začetek zdravljenja ≤ 18 let), vključno z etanerceptom, so v obdobju trženja poročali o malignostih, med katerimi so bile tudi smrtne.
If re-treatment with Benepali is indicated, the same guidance on treatment duration should be followed.
Če je indicirano ponovno zdravljenje z zdravilom Benepali, se moramo ravnati po istih smernicah glede trajanja zdravljenja.
 Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years and weighing 62.5 kg or more.
• poliartritisa (pozitivnega ali negativnega za revmatoidni faktor) in razširjenega oligoartritisa pri bolnikih, starejših od 2 let in s telesno maso 62,5 kg ali več.
• Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Benepali in case the infection worsens.
• Hepatitis C: Povejte zdravniku, če imate vi ali vaš otrok hepatitis C. Zdravnik bo morda želel spremljati zdravljenje z zdravilom Benepali za primer, če bi se okužba poslabšala.
Administration of Benepali should be discontinued if a patient develops a serious infection.
Zdravljenje z zdravilom Benepali je treba prekiniti, če pride do resne okužbe.
Dispose of the empty pen in an approved sharps container.
Prazen peresnik odstranite v odobren vsebnik za ostre odpadke.
Patients in the etanercept 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).
Pri bolnikih, ki so prejemali etanercept v kombinaciji z metotreksatom, so bili odzivi ACR 20, ACR 50 in ACR 70 ter izboljšanja na lestvicah ocene stopnje bolezni (DAS - Disease Activity Score) in HAQ tako po 24 kot po 52 tednih statistično pomembno večji kot pri bolnikih, ki so jih zdravili z enim samim zdravilom (izsledki so povzeti v spodnji preglednici).
In the toxicological studies with etanercept, no dose-limiting or target organ toxicity was evident.
V študijah toksičnosti etanercepta ni bilo opaziti toksičnosti, ki bi omejevala odmerjanje, niti toksičnosti za tarčne organe.
Soluble TNFRs are thought to regulate TNF biological activity.
Topni receptorji TNF verjetno uravnavajo biološko aktivnost TNF.
Etanercept showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
Pokazali so, da je etanercept od izhodišča do 12 tednov statistično pomembno izboljšalo večino ocen z zdravjem povezane kakovosti življenja in telesne funkcije, vključno z BASFI (BASFI - Bath Ankylosing Spondylitis Functional Index; indeks Bath za ocenjevanje aktivnosti ankilizirajočega spondilitisa), rezultatom splošnega zdravstvenega stanja EuroQol 5D in rezultatom telesne komponente SF-36, v primerjavi s placebom.
Instead, the safety and efficacy of etanercept were assessed in four randomised, double-blind, placebo-controlled studies.
Namesto tega so varnost in učinkovitost etanercepta ocenili v štirih randomiziranih, dvojno slepih, s placebom nadzorovanih študijah.
Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Zdravilo Benepali 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.
• Swelling of the face, throat, hands, or feet
• otekanje obraza, žrela, rok ali nog;
The double-blind period was followed by an open-label period during which all patients receive etanercept 50 mg weekly for up to an additional 92 weeks.
Dvojno slepemu obdobju je sledilo odprto obdobje, med katerim so vsi bolniki prejemali etanercept v odmerku 50 mg na teden, kar je trajajo do 92 dodatnih tednov.
70b a 25 mg etanercept SC twice weekly b p < 0.001, etanercept vs. placebo c p < 0.01, etanercept vs. placebo
70b a 25 mg etanercepta subkutano dvakrat na teden b p < 0,001, etanercept v primerjavi s placebom c p < 0,01, etanercept v primerjavi s placebom
Etanercept 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Učinek 25 mg odmerka etanercepta je bil pomembno boljši kot pri metotreksatu glede ocene erozije sklepov, tako po 12 kot po 24 mesecih.
One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with etanercept for up to approximately 6 years, including 231 patients treated with etanercept in combination with methotrexate in the 2-year activecontrolled study.
Sto devetindvajset (129) novih malignih obolenj različnih tipov so ugotovili pri 4.114 bolnikih z revmatoidnim artritisom, zdravljenih v kliničnih preskušanjih z etanerceptom do približno 6 let,
• The risk of Congestive Heart Failure (CHF)
• Tveganje za kongestivno srčno odpoved
Do not use this medicine after the expiry date which is stated on the carton and the label of the prefilled syringe after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki napolnjene injekcijske brizge poleg oznake "EXP".
All subdomains of the HAQ were improved in patients treated with etanercept compared to controls at 3 and 6 months.
Po vseh kriterijih vprašalnika HAQ je bilo vidno izboljšanje pri bolnikih na etanerceptu v 3. in 6. mesecu zdravljenja v primerjavi s kontrolno skupino.
In an open-label, safety extension study, 58 paediatric patients from the above study (from the age of 4 years at time of enrolment) continued to receive etanercept for up to 10 years.
Varnost uporabe zdravila so spremljali v odprtem podaljšku študije, v katerem se je 58 otrok iz zgoraj omenjene študije (v času vključitve so bili stari 4 leta ali več) z etanerceptom zdravilo do 10 let.
If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately.
Če se pri vas ali otroku razvijejo simptomi okužbe, na primer vročina, mrzlica ali kašelj, nemudoma obvestite zdravnika.
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).
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).
Gently stretch the skin at the cleaned injection site.
Nežno napnite kožo na očiščenem mestu injiciranja.
The solution is clear to slightly opalescent, colourless or pale yellow, and is formulated at pH 6.2 ± 0.3.
Raztopina je bistra do nekoliko opalescentna, brezbarvna ali bledorumena in ima pH 6,2 ± 0,3.
Do not use this medicine after the expiry date which is stated on the carton and the label of the prefilled pen after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki napolnjenega injekcijskega peresnika poleg oznake "EXP".
• Do not throw the sharps container in household bin.
• Vsebnika za ostre odpadke ne mečite med gospodinjske odpadke.