natgillin/translations-raw huggingface dataset:
Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State, consisting of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen/prefilled syringes and to inform them that the product is not for use in children and adolescents who weigh less than 62.5 kg, and a Patient Alert Card which is to be given to patients using Benepali. 
Pred prihodom na trg v vsaki državi članici se bo imetnik dovoljenja za promet s pristojnim organom v državi članici dogovoril glede končnega izobraževalnega gradivo, ki ga bodo sestavljale informacije za vse zdravstvene delavce, za katere se pričakuje, da bodo zdravilo predpisovali, glede pravilne in varne uporabe napolnjenih injekcijskih peresnikov in napolnjenih injekcijskih brizg, z obvestilom o neprimernosti zdravila za uporabo pri otrocih in mladostnikih s telesno maso manj kot 62,5 kg, in opozorilno kartico za bolnika, ki jo bo pred uporabo zdravila Benepali prejel bolnik.
The Patient Alert Card should contain the following key elements for patients treated with Benepali: 
Opozorilna kartica za bolnike naj vsebuje naslednje ključne elemente za bolnike, zdravljene z zdravilom Benepali:
• if you or the child have, or are at risk of developing a serious blood infection called sepsis. 
• če imate vi ali otrok resno okužbo krvi, imenovano sepso.
Some children and teenage patients who have received etanercept or other medicines that work the same way as etanercept have developed cancers, including unusual types, which sometimes resulted in death. 
Pri nekaterih otrocih in mladostnikih, ki so prejemali etanercept ali druga podobna zdravila z enakim načinom delovanja kot etanercept, se je razvil rak, vključno z neobičajnimi oblikami, ki se je včasih končal s smrtjo.
• Do not pinch the skin. 
• Kože ne ščipajte.
Two large clinical trials evaluating the use of etanercept in the treatment of CHF were terminated early due to lack of efficacy. 
Dve veliki klinični preskušanji za ovrednotenje uporabe etanercepta pri zdravljenju KSP sta bili predčasno prekinjeni zaradi slabe učinkovitosti zdravila.
It is important that you tell the baby's doctors and other healthcare professionals about the use of Benepali during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”). 
Pomembno je, da o uporabi zdravila Benepali med nosečnostjo obvestite dojenčkovega zdravnika in ostale zdravstvene delavce, preden dojenček prejme katero koli cepivo (za več informacij glejte poglavje 2 "Cepljenja").
Before starting treatment with Benepali, all patients must be evaluated for both active and inactive (‘latent') tuberculosis. 
Pred začetkom zdravljenja z zdravilom Benepali je treba vse bolnike pregledati tako glede aktivne kot tudi glede neaktivne ('latentne') tuberkuloze.
Treatment with etanercept 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5). 
25 mg etanercepta so dosegli bistveno izboljšanje pri 12 mesecih - približno 44 % bolnikov je doseglo normalen rezultat HAQ (manj kot 0,5).
Benepali should only be used during pregnancy if clearly needed. 
Zdravilo Benepali lahko med nosečnostjo uporabljamo le, če je to nujno potrebno.
Other medicines and Benepali 
Druga zdravila in zdravilo Benepali
In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life-threatening, or requiring hospitalisation or intravenous antibiotics) was observed. 
V preskušanjih, nadzorovanih s placebom, niso opazili zvečanja incidence resnih okužb (s smrtnim izidom, življenjsko ogrožajočih okužb ali takih, ki so zahtevale hospitalizacijo ali intravenske antibiotike).
- Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Benepali. 
- Zdravnik vam bo izročil tudi opozorilno kartico za bolnika, ki vsebuje pomembne podatke o varnosti, s katerimi morate biti seznanjeni pred zdravljenjem z zdravilom Benepali in med zdravljenjem z njim.
Allow the medicine to reach room temperature: 
Počakajte, da se zdravilo ogreje na sobno temperaturo:
• Instructional materials to share with patients. 
• Gradivo z navodili za bolnike.
Sharps disposal containers may be purchased at your local pharmacy. 
Vsebnik za ostre odpadke lahko kupite v lokalni lekarni.
Children and adults taking Benepali may have an increased risk of developing lymphoma or another cancer. 
Pri otrocih in odraslih, ki prejemajo zdravilo Benepali, je morda tveganje za nastanek limfoma ali druge oblike raka večje.
Clinical improvement, including onset of action within 2 weeks with etanercept 25 mg, was similar to that seen in the previous trials and was maintained for up to 24 months. 
Klinično izboljšanje, vključno z nastopom delovanja zdravila v 2 tednih pri 25 mg etanercepta, je bilo podobno tistemu, ki so ga ugotavljali v prejšnjih preskušanjih, in se je ohranjalo do 24 mesecev.
Solution for injection (injection). 
raztopina za injiciranje (injekcija)
Component of a multipack, cannot be sold separately. 
Sestavni del večodmernega pakiranja, ni za posamično prodajo.
In this situation, the benefit/risk balance of Benepali therapy should be very carefully considered. 
V takem primeru je treba zelo skrbno pretehtati razmerje med koristmi in tveganji zdravljenja z zdravilom Benepali.
What you need to know before you use Benepali Do not use Benepali 
Kaj morate vedeti, preden boste uporabili zdravilo Benepali Ne uporabljajte zdravila Benepali
Etanercept did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2,000 mg/kg or a single intravenous dose of 1,000 mg/kg. 
Etanercept ni povzročilo smrtnosti ali pomembne toksičnosti pri miših ali podganah po enkratnem subkutanem odmerku 2.000 mg/kg ali enkratnem intravenskem odmerku 1.000 mg/kg.
This card contains important safety information that you need to be aware of before you are given Benepali and during treatment with Benepali. 
Ta kartica vsebuje pomembne informacije o varnosti, ki jih morate poznati, preden boste prejeli zdravilo Benepali in v času zdravljenja z zdravilom Benepali.
Check for the yellow plunger rod in the window to confirm that the full dose has been delivered. 
Preverite, ali je v okencu rumen bat, saj to potrjuje, da ste prejeli celotni odmerek.
Administration of live vaccines to infants for 16 weeks after the mother's last dose of Benepali is generally not recommended. 
Uporaba živih cepiv v prvih 16 tednih po tem, ko so matere dojenčkov prejele zadnji odmerek zdravila Benepali, pri dojenčkih običajno ni priporočljiva.
Toxic epidermal necrolysis 
toksična epidermalna nekroliza
There is no known antidote to etanercept. 
Znanega antidota za etanercept ni.
Treatment with Benepali should not be initiated in patients with active infections, including chronic or localised infections. 
Zdravljenja z zdravilom Benepali ne smete uvesti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi okužbami.
In addition, one study found more birth defects when the mother had received etanercept in pregnancy, compared with mothers who had not received etanercept or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported. 
Poleg tega so v eni študiji ugotovili več prirojenih napak, kadar je mati med nosečnostjo prejemala etanercept, v primerjavi z materami, ki niso prejemale etanercepta ali drugih podobnih zdravil (antagonistov TNF), vendar niso poročali o nobeni določeni vrsti prirojene okvare.
Etanercept has not been studied in children aged less than 2 years. 
Etanercepta niso preskušali pri otrocih, mlajših od 2 let.
The primary measure of efficacy (ASAS 40) was a 40% improvement in at least three of the four ASAS domains and absence of deterioration in the remaining domain. 
Primarno merilo za učinkovitost (ASAS 40) je bilo 40-% izboljšanje vsaj treh od štirih domen ASAS in odsotnost poslabšanja pri četrti domeni.
Contents of the pack and other information Instructions for use (see overleaf) 
Vsebina pakiranja in dodatne informacije Navodila za uporabo (glejte drugo stran navodila)
This may include a thorough medical history, a chest X-ray and a tuberculin test. 
To bo storil s temeljito medicinsko anamnezo, z rentgenskim slikanjem prsnega koša in s tuberkulinskim testom.
It should be injected into the thigh, abdomen, or back of the upper arm (see image on the left). 
Injicirati ga je treba v stegno, trebuh ali v hrbtno stran nadlakti (glejte levo sliko).
Percent of Patients Placebo n = 104 
Odstotek bolnikov Placebo n = 104
Benepali works by reducing the inflammation associated with certain diseases. 
Zdravilo Benepali deluje tako, da zmanjšuje vnetje, ki spremlja določene bolezni.
lymphoma, leukaemia 
limfom, levkemija karcinom
Etanercept was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy. 
Etanercept je bil pomembno boljši kot placebo po vseh kriterijih aktivnosti bolezni (p < 0,001) in odzivi so bili podobni, ne glede na sočasno zdravljenje z metotreksatom.
Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with etanercept for up to 48 months. 
Resne okužbe so se pojavile pri 6,3 % bolnikov z revmatoidnim artritisom, ki so prejemali etanercept do 48 mesecev.
Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-α) inhibitors, ATC code: L04AB01 
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB01
196 n = 46 n = 
n = 196 n = 46 n = 96 n = 90
Treatment with Benepali should continue until remission is achieved, for up to 24 weeks. 
Zdravljenje z zdravilom Benepali je treba nadaljevati, dokler ne dosežemo remisije, vendar največ 24 tednov.
Hypoglycaemia in patients treated for diabetes 
Hipoglikemija pri bolnikih, ki se zdravijo zaradi sladkorne bolezni
If you have used more Benepali than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately. 
Če ste uporabili večji odmerek zdravila Benepali, kot bi smeli Če ste uporabili večji odmerek zdravila Benepali, kot bi smeli (bodisi ste ga naenkrat injicirali preveč bodisi prepogosto), se nemudoma posvetujte z zdravnikom ali farmacevtom.
Clinical responses were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC). 
Klinični odzivi so bili izraženi v odstotkih bolnikov, ki so dosegli odziv ACR 20, 50 in 70 in v odstotkih bolnikov z izboljšanjem ocene po kriterijih PsARC (Psoriatic Arthritis Response Criteria).
• Alcohol abuse: Benepali should not be used for the treatment of hepatitis related to alcohol abuse. 
• Zloraba alkohola: Zdravila Benepali ne smete uporabljati za zdravljenje hepatitisa, povezanega z zlorabo alkohola.
Doctor's name: 
Zdravnikovo ime:
See ‘Choose an injection site' for guidance with choosing an injection site. 
Glejte "Izbira mesta injiciranja" za navodila o izbiri mesta injiciranja.
System Organ 
Organski sistem
Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Benepali. 
Pediatrični bolniki, ki potrebujejo odmerek, drugačen kot polnih 25 mg ali 50 mg, zdravila Benepali ne smejo prejeti.
During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three etanercept doses. 
V prvih 12 tednih dvojno slepega obdobja zdravljenja so bolniki dobivali placebo ali enega od navedenih odmerkov etanercepta.
Within the System Organ Class, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 
Znotraj organskih sistemov so neželeni učinki navedeni po pogostnosti (število bolnikov, pri katerih se pričakuje pojav učinka), z uporabo naslednjih kategorij: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
• Teaching guide to facilitate training of the patients in the safe use of the pre-filled pen/prefilled syringes 
• Učni vodnik, s pomočjo katerega bo bolnikom lažje razložiti varno uporabo napolnjenega injekcijskega peresnika/napolnjenih injekcijskih brizg
Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to etanercept treatment. 
Izsledki sicer še niso dokončni, vendar podatki iz enega od teh preskušanj kažejo na morebitno tendenco k poslabšanju KSP pri bolnikih, zdravljenih z etanerceptom.
It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating etanercept therapy (see Vaccinations, above). 
Za pediatrične bolnike priporočamo, da pred začetkom zdravljenja z etanerceptom, če je le mogoče, opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje (glejte Cepljenja zgoraj).
Choose an injection site: 
Izberite mesto injiciranja:
For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), Benepali can slow down the structural damage to those joints caused by the disease. 
Pri bolnikih z več simetrično prizadetimi bolečimi ali oteklimi sklepi (npr. dlanmi, zapestji ali stopali) lahko zdravilo Benepali upočasni razvoj strukturnih okvar teh sklepov, ki jih povzroča bolezen.
Other etanercept products with appropriate dosage forms for children are available. 
Na voljo so druga zdravila etanercepta z odmerki, primernimi za otroke.
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. 
V tem poglavju so prikazani podatki iz štirih randomiziranih nadzorovanih preskušanj pri odraslih z revmatoidnim artritisom, ene študije pri odraslih s psoriatičnim artritisom, ene študije pri odraslih z ankilozirajočim spondilitisom, ene študije pri odraslih z radiografsko nezaznavnim aksialnim spondilartritisom, štirih študij pri odraslih s psoriazo v plakih, treh študij pri bolnikih z juvenilnim idiopatskim artritisom in ene študije pri pediatričnih bolnikih s psoriazo v plakih.
The impact of long-term treatment with etanercept on the development of autoimmune diseases is unknown. 
Vpliv dolgotrajnega zdravljenja z etanerceptom na razvoj avtoimunskih bolezni ni znan.
If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Benepali, and in accordance with local recommendations. 
Če se ugotovi neaktivna ('latentna') tuberkuloza, je treba pred uvedbo zdravila Benepali in v skladu z nacionalnimi priporočili začeti zdravljenje latentne tuberkuloze s tuberkulostatiki.
• Tuberculosis: As cases of tuberculosis have been reported in patients treated with Benepali, your doctor will check for signs and symptoms of tuberculosis before starting Benepali. 
• Tuberkuloza: Ker so pri bolnikih, ki so se zdravili z zdravilom Benepali, poročali o primerih tuberkuloze, se bo vaš zdravnik prepričal, da nimate znakov ali simptomov tuberkuloze, preden se boste začeli zdraviti z zdravilom Benepali.
B. Injection steps Step 1: 
B. Koraki injiciranja 1. korak:
Patients should be evaluated for infections before, during, and after treatment with Benepali, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours). 
Pred zdravljenjem z zdravilom Benepali, med njim in po njem je treba bolnike pregledati glede okužb in pri tem upoštevati, da je povprečni razpolovni čas izločanja etanercepta iz telesa približno 70 ur (razpon 7 do 300 ur).
You should consult your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby. 
Če zanosite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom.
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. 
Bolnike v ciljni populaciji, ki ''se niso odzvali'', opredeljuje nezadosten odziv (PASI < 50 ali PGA [PGA - Physician Global Assessment] manj kot dober) ali poslabšanje bolezni med zdravljenjem, ko je bolnik prejemal najmanj vsako od treh glavnih razpoložljivih sistemskih zdravljenj v zadostnem odmerku in dovolj časa, da je bilo mogoče oceniti odziv.
*Some patients did not provide complete data for each endpoint **ASAS=Assessments in Spondyloarthritis International Society ***Bath Ankylosing Spondylitis Disease Activity Index a: p < 0.001, b: < 0.01 and c: < 0.05, respectively between etanercept and placebo 
*Nekateri bolniki niso predložili popolnih podatkov za vsak opazovani dogodek **ASAS = Mednarodno združenje za ocenjevanje spondilartritisa ***Indeks Bath za ocenjevanje aktivnosti ankilizirajočega spondilitisa a: p < 0,001, b: < 0.01 oziroma c: < 0,05 med etanerceptom in placebom
You or the child should not use Benepali with medicines that contain the active substance anakinra or abatacept. 
Zdravila Benepali vi ali otrok ne smete uporabljati skupaj z zdravili, ki vsebujejo učinkovino anakinro ali abatacept.
If any of the above occurs, tell your doctor immediately, or visit the casualty department at your nearest hospital. 
Če se pojavi kar koli od zgoraj navedenega, se nemudoma posvetujte z zdravnikom ali pojdite v ambulanto za nujno pomoč najbližje bolnišnice.
• If you have psoriasis, do not inject into any raised, thick, red, or scaly skin patches, or lesions. 
• Če imate luskavico, ne injicirajte v privzdignjena, zadebeljena, rdeča ali luskava območja kože ali v lezije.
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p < 0.001). 
Rezultat indeksa invalidnosti je bil bistveno boljši v vseh časovnih točkah pri bolnikih s psoriatičnim artritisom, zdravljenih z etanerceptom, v primerjavi s placebom (p < 0,001).
2 weeks 
2 tedna
Significant improvement was also observed for the ASAS partial remission and BASDAI 50. 
Pomembno izboljšanje so opazili tudi pri delni remisiji ASAS in
The 10 mg etanercept dose had consistently less effect on structural damage than the 25 mg dose. 
10 mg odmerek etanercepta je imel ves čas manjši učinek na strukturno poškodbo sklepov kot 25 mg odmerek.
Compared to placebo, treatment with etanercept resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6. 
Zdravljenje z etanerceptom je v primerjavi s placebom povzročilo statistično pomembno izboljšanje ASAS 40, ASAS 20 in ASAS 5/6.
Evidence of efficacy for the once-weekly dosing regimen in this patient population has been based on data from the study in patients with ankylosing spondylitis. 
Pri tej skupini bolnikov dokaz učinkovitosti režima odmerjanja enkrat na teden temelji na podatkih iz študije pri bolnikih z ankilozirajočim spondilitisom.
Abbreviation: sPGA-static Physician Global Assessment a p < 0.0001 compared with placebo 
Okrajšava: sPGA-statična zdravnikova splošna ocena a p < 0,0001 v primerjavi s placebom
Another study found no increased risk of birth defects when the mother had received etanercept in pregnancy. 
V drugi študiji niso ugotovili povečanega tveganja za prirojene napake, kadar je mati med nosečnostjo prejemala etanercept.
If active tuberculosis is diagnosed, Benepali therapy must not be initiated. 
Če je postavljena diagnoza aktivne tuberkuloze, se zdravljenja z zdravilom Benepali ne sme uvesti.
Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Benepali. 
Ti simptomi namreč lahko kažejo na pojav življenjsko ogrožajoče bolezni krvi, pri kateri bo zdravljenje z zdravilom Benepali morda treba prekiniti.
No data are available on the secondary transmission of infection by live vaccines in patients receiving etanercept. 
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, ki prejemajo etanercept, ni na voljo.
The difference between etanercept alone and methotrexate alone was also significant (p < 0.05). 
Pomembna je bila tudi razlika med monoterapijo z etanerceptom in monoterapijo z metotreksatom (p < 0,05).
ASAS 50 and 70 responses used the same criteria with a 50% improvement or a 70% improvement, respectively. 
Odziva ASAS 50 in 70 sta bila definirana po istih kriterijih, le da je šlo za 50-% oziroma
The efficacy of etanercept versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing etanercept with other systemic therapies. 
Učinkovitosti etanercepta v primerjavi z drugimi sistemskimi zdravljenji pri bolnikih z zmerno do hudo psoriazo (ki se odziva na druga sistemska zdravljenja) niso ovrednotili s študijami, v katerih bi neposredno primerjali etanercept z drugimi sistemskimi terapijami.
Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1). 
Alternativno se je pokazalo, da je varen in učinkovit odmerek 50 mg enkrat na teden (glejte poglavje 5.1).
Consequently, Benepali should not be used in patients for the treatment of alcoholic hepatitis. 
Zato zdravila Benepali ne smemo uporabljati pri bolnikih za zdravljenje alkoholnega hepatitisa.
A placebo-controlled trial, in which 89 adult patients were treated with etanercept in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown etanercept to be an effective treatment for Wegener's granulomatosis. 
S placebom nadzorovano preskušanje, v katerem je 89 odraslih bolnikov poleg standardnega zdravljenja (vključno s ciklofosfamidom ali metotreksatom in glukokortikoidi) jemalo etanercept z medianim časom zdravljenja 25 mesecev, ni pokazalo učinkovitosti etanercepta za zdravljenje Wegenerjeve granulomatoze.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'. 
Zdravilo Benepali vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with etanercept than in the control group. 
Incidenca nekožnih malignih obolenj različnih tipov je bila pomembno večja pri bolnikih, zdravljenih z etanerceptom, kot pri tistih v kontrolni skupini.
Wipe the skin at the injection site with an alcohol swab. 
Očistite kožo na mestu injiciranja z alkoholnim zložencem.
If any serious allergic or anaphylactic reaction occurs, Benepali therapy should be discontinued immediately and appropriate therapy initiated. 
Če se pojavi kakršna koli resna alergijska ali anafilaktična reakcija, je treba zdravljenje z zdravilom Benepali takoj prekiniti in uvesti ustrezno zdravljenje.
There was some evidence to support a benefit of re-treatment with etanercept in patients initially responding to treatment. 
Nekaj podatkov kaže na ugoden odziv na ponovno zdravljenje z etanerceptom pri bolnikih, ki so se prvotno odzvali na zdravljenje.