natgillin/translations-raw huggingface dataset:
All patients were also treated with a corticosteroid, which was stopped after reducing the dose gradually over 6 or 12 months. 
Vsi bolniki so prejeli tudi zdravljenje s kortikosteroidi, ki je bilo prekinjeno po postopnem zmanjševanju odmerka v 6 ali 12 mesecih.
RoActemra received a marketing authorisation valid throughout the EU on 16 January 2009. 
Za zdravilo RoActemra je bilo 16. januarja 2009 izdano dovoljenje za promet, veljavno po vsej EU.
The European Medicines Agency decided that RoActemra's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je menila, da so koristi zdravila RoActemra večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of RoActemra? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila RoActemra?
Cytokine release syndrome (CRS) 
Sindrom sproščanja citokinov (CRS)
RoActemra must not be used in patients who have an active, severe infection. 
Zdravilo RoActemra se ne sme uporabljati pri bolnikih z aktivnimi, resnimi okužbami.
As for all medicines, data on the use of RoActemra are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila RoActemra stalno spremljajo.
Tocilizumab attaches to the receptor for a messenger molecule or ‘cytokine' called interleukin-6. 
Tocilizumab se veže na receptor za sporočilno molekulo ali citokin, ki se imenuje interlevkin-6.
Other information about RoActemra: 
Druge informacije o zdravilu RoActemra:
Almost 4,000 patients from these 5 studies went on to enter studies looking at the long-term effects of RoActemra treatment and results showed that response to RoActemra is maintained for at least 2 years. 
Skoraj 4 000 bolnikov iz teh petih študij je nato sodelovalo v študijah, ki so proučevale dolgoročne učinke zdravljenja z zdravilom RoActemra, in rezultati so dokazali, da se odziv bolnikov na zdravilo RoActemra ohranja vsaj dve leti.
Why is RoActemra authorised in the EU? 
Zakaj je bilo zdravilo RoActemra odobreno v EU?
Doctors should monitor patients carefully for signs of infection during treatment, and should prescribe RoActemra with caution in patients who have had recurring or long-term infections, or diseases that could increase the risk of infections, such as diverticulitis or diabetes. 
Zdravniki morajo bolnike med zdravljenjem z zdravilom RoActemra pozorno spremljati zaradi znakov okužb in zdravilo predpisovati previdno pri bolnikih s ponavljajočimi ali dolgotrajnimi okužbami ali boleznimi, ki bi lahko povečale tveganje za pojav okužb, kakršni sta divertikulitis ali sladkorna bolezen.
Patients were allowed to continue treatment with methotrexate during the study. 
Med študijo so lahko bolniki še naprej prejemali metotreksat.
The most serious side effects are serious infections, complications of diverticulitis (a disease affecting the gut) and hypersensitivity (allergic) reactions. 
Najresnejši neželeni učinki so resne okužbe, zapleti divertikulitisa (bolezni, ki prizadene črevesje) in preobčutljivostne (alergijske) reakcije.
Side effects reported with RoActemra are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu RoActemra, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
RoActemra can also be used in adults and children from 2 years of age for the treatment of severe or life-threatening cytokine release syndrome (CRS, a condition that can cause nausea, vomiting, pain and low blood pressure). 
Zdravilo RoActemra se lahko prav tako uporablja pri odraslih in otrocih, starejših od dveh let, za zdravljenje hudega ali življenjsko nevarnega sindroma sproščanja citokinov (CRS, tj. bolezni, ki povzroča slabost, bruhanje, bolečine in nizek krvni tlak).
By preventing interleukin-6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of these diseases. 
Tocilizumab s preprečevanjem vezave interlevkina-6 na ustrezne receptorje zmanjša vnetje in druge simptome teh bolezni.
RoActemra is also used to treat adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen. 
Zdravilo RoActemra se uporablja tudi za zdravljenje odraslih z velikoceličnim arteritisom, boleznijo, pri kateri so običajno otečene arterije v glavi.
The main measure of effectiveness was based on the number of patients whose CRS resolved within 14 days of the first dose of RoActemra, and who needed no more than two doses of the medicine, and no additional treatment other than corticosteroid medicines. 
Glavno merilo učinkovitosti je temeljilo na številu bolnikov, pri katerih je bil sindrom CRS ozdravljen v 14 dneh od prejema prvega odmerka zdravila RoActemra in ki niso potrebovali več kot dveh odmerkov tega zdravila ter nobenega drugega zdravljenja razen kortikosteroidov.
For more information about using RoActemra, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila RoActemra glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
An overview of RoActemra and why it is authorised in the EU 
Pregled zdravila RoActemra in zakaj je odobreno v EU
What are the risks associated with RoActemra? 
Kakšna tveganja so povezana z zdravilom RoActemra?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of RoActemra have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila RoActemra upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
What benefits of RoActemra have been shown in studies? 
Kakšne koristi je zdravilo RoActemra izkazalo v študijah?
The company that markets RoActemra must supply all doctors expected to prescribe the medicine with an educational pack containing important information on the safety and correct use of RoActemra. 
Družba, ki trži zdravilo RoActemra, mora vsem zdravnikom, ki naj bi predpisovali to zdravilo, zagotoviti izobraževalno gradivo s pomembnimi informacijami o varni in pravilni uporabi zdravila RoActemra.
One year after starting treatment, 56% of patients treated with RoActemra once a week did not have symptoms compared with 14% patients receiving placebo. 
Eno leto po začetku zdravljenja 56 % bolnikov, ki so se enkrat tedensko zdravili z zdravilom RoActemra, ni imelo simptomov bolezni v primerjavi s 14 % bolnikov, ki so prejemali placebo.
What is RoActemra and what is it used for? 
Kaj je zdravilo RoActemra in za kaj se uporablja?
RoActemra is a medicine used to treat: 
Zdravilo RoActemra se uporablja za zdravljenje:
CRS is a side effect of certain cancer treatments and RoActemra is used for CRS caused by chimeric antigen receptors (CAR) T-cell medicines. 
Sindrom CRS je stranski učinek nekaterih vrst zdravljenja raka, pri čemer se zdravilo RoActemra uporablja za zdravljenje sindroma CRS, ki ga povzročajo zdravila s himernimi receptorji antigenov (CAR) celic T.
RoActemra is used in combination with methotrexate for these conditions but it can be used on its own in patients for whom methotrexate is inappropriate. 
Zdravilo RoActemra se pri teh boleznih uporablja skupaj z metotreksatom, vendar se lahko pri bolnikih, za katere metotreksat ni primeren, uporablja samostojno.
The most common side effects (occurring in up to 1 patient in 10) with RoActemra are upper respiratory tract infections (nose and throat infection), nasopharyngitis (inflammation of the nose and throat), headache, hypertension (high blood pressure) and abnormal liver function tests. 
Najpogostejši neželeni učinki zdravila RoActemra (ki se pojavijo pri več kot 1 bolniku od 10) so okužbe zgornjih dihal (okužbe nosu in grla), nazofaringitis (vnetje nosu in grla), glavobol, hipertenzija (povišan krvni tlak) in neobičajni rezultati testov delovanja jeter.
The active substance in RoActemra, tocilizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target (called an antigen) in the body. 
Učinkovina v zdravilu RoActemra, tocilizumab, je monoklonsko protitelo, tj. vrsta beljakovine, ki je bila zasnovana tako, da prepozna specifično prijemališče (imenovano antigen) v telesu, in se veže nanj.
Studies show RoActemra is effective at reducing symptoms of several inflammatory conditions. 
V študijah so dokazali, da je zdravilo RoActemra učinkovito pri zmanjševanju simptomov različnih vnetnih bolezni.
This messenger is involved with inflammation and is found at high levels in patients with rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and CRS. 
Ta sporočilna molekula sodeluje pri povzročanju vnetja in je prisotna v visokih ravneh pri bolnikih z revmatoidnim artritisom, sistemskim juvenilnim idiopatskim artritisom, juvenilnim idiopatskim poliartritisom, velikoceličnim arteritisom in sindromom sproščanja citokinov.
RoActemra can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the relevant condition. 
Predpisovanje in izdaja zdravila RoActemra je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem zadevne bolezni.
The other study, which compared RoActemra injected under the skin with RoActemra given by infusion, showed that RoActemra injected under the skin was no less effective in achieving a response after 6 months. 
Druga študija, v kateri so primerjali injiciranje zdravila RoActemra pod kožo z dajanjem zdravila z infuzijo, je pokazala, da zdravilo, injicirano v podkožje, po šestih mesecih ni bilo nič manj učinkovito pri doseganju odziva.
• adults with moderate to severe active rheumatoid arthritis whose previous treatments with disease modifying antirheumatic drugs (DMARDs), such as methotrexate or medicines known as tumour necrosis factor (TNF) blockers, have not worked well or were not tolerated; 
• zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih, katerih predhodno zdravljenje z imunomodulirajočimi antirevmatičnimi zdravili (zdravili iz skupine DMARD), kot je metotreksat, ali zdravili, znanimi kot zaviralci tumorje nekrotizirajočega faktorja (TNF), ni bilo dovolj uspešno oziroma takšnega zdravljenja niso prenašali;
The fifth study involving 673 patients showed that patients receiving RoActemra on its own were more likely to respond than those taking methotrexate on its own. 
V peti študiji, ki je zajela 673 bolnikov, so dokazali, da je obstajala pri bolnikih, ki so prejemali samo zdravilo RoActemra, večja verjetnost, da se bodo nanj odzvali, kot pri bolnikih, ki so jemali samo metotreksat.
In the fourth study, which included 498 patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around 9 times more likely to respond than those receiving placebo with methotrexate. 
V četrti študiji pri 498 bolnikih, ki se niso zadostno odzvali na zaviralce tumorje nekrotizirajočega faktorja, so se bolniki, ki so prejemali zdravilo RoActemra z metotreksatom, približno devetkrat pogosteje odzvali na zdravljenje kot bolniki, ki so prejemali placebo z metotreksatom.
In this study 85% (64 out of 75) patients treated with RoActemra responded to treatment and no longer had fever after 3 months, compared with 24% (9 out of 37) patients receiving placebo. 
V tej študiji se je 85 % (64 od 75) bolnikov, zdravljenih z zdravilom RoActemra, odzvalo na zdravljenje in po treh mesecih niso imeli več povišane telesne temperature v primerjavi s 24 % (9 od 37) bolnikov, ki so prejemali placebo.
In severe rheumatoid arthritis not previously treated with methotrexate, RoActemra given by infusion was investigated in one main study involving 1,162 patients. 
Pri hudem revmatoidnem artritisu, ki še ni bil zdravljen z metotreksatom, so zdravilo RoActemra, dano z infundiranjem, raziskovali v eni glavni študiji, v katero je bilo vključenih 1 162 bolnikov.
RoActemra is available as a solution to be injected under the skin and as a concentrate for making a solution for infusion (drip) into a vein. 
Zdravilo RoActemra je na voljo v obliki raztopine za injiciranje pod kožo in koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
• adults with severe rheumatoid arthritis that is getting worse in patients who have not been previously treated with a medicine called methotrexate; 
• hudega, slabšajočega se revmatoidnega artritisa pri odraslih bolnikih, ki se predhodno niso zdravili z metotreksatom;
RoActemra given by injection under the skin was investigated in two studies involving 1,918 patients with moderate to severe rheumatoid arthritis where previous treatment with DMARD had not worked well. 
Zdravilo RoActemra, ki se injicira pod kožo, so raziskovali tudi v dveh študijah, pri katerih je sodelovalo 1 918 bolnikov z zmernim ali hudim revmatoidnim artritisom, pri katerih predhodno zdravljenje z zdravilom is skupine DMARD ni bilo učinkovito.
How RoActemra is given, its dose and how often it is given depends on the condition it is used to treat. 
Način dajanja, odmerek in pogostost dajanja zdravila RoActemra so odvisni od bolezni, za katero se zdravilo uporablja.
In three of these studies, RoActemra was compared with placebo, as an add-on to failing treatment with conventional rheumatoid arthritis medicines in a total of over 3,000 patients. 
V treh od teh študij so zdravilo RoActemra primerjali s placebom pri več kot 3 000 bolnikih kot dodatek k neuspešnemu zdravljenju z običajnimi zdravili za zdravljenje revmatoidnega artritisa.
One of the studies, which involved 1,196 patients, also showed that the combination of RoActemra and methotrexate slowed down the damage to the joints and improved physical function after up to 2 years, when compared with the combination of placebo and methotrexate. 
Ena študija pri 1 196 bolnikih je dokazala, da je kombinacija zdravila RoActemra in metotreksata po največ dveh letih v primerjavi s kombinacijo placeba in metotreksata upočasnila tudi poškodbe sklepov in izboljšala funkcijsko zmogljivost.
Results showed that patients adding RoActemra were around 4 times more likely to respond to treatment than those adding placebo. 
Rezultati kažejo, da so se bolniki, ki so dodatno prejemali zdravilo RoActemra, štirikrat pogosteje odzvali na zdravljenje kot bolniki, ki so dodatno prejemali placebo.
Giant cell arteritis 
Velikocelični arteritis
Out of 51 patients who had CRS after being given the CAR-T cell medicine tisagenlecleucel, 39 responded to treatment with RoActemra (76.5%), while 8 out 15 patients (53.3%) who had CRS after being given axicabtagene ciloleucel responded. 
Od 51 bolnikov, ki so po prejemu CAR-T celične terapije z učinkovino tisagenlecleucel zboleli za sindromom CRS, se jih je na zdravljenje z zdravilom RoActemra odzvalo 39 (76,5 %), medtem ko se jih je v skupini bolnikov, ki je zbolela za sindromom CRS po prejemu terapije z učinkovino aksicabtagen ciloleucel, odzvalo 8 od 15 bolnikov (53,3 %).
In juvenile idiopathic polyarthritis, RoActemra given by infusion was compared with placebo in one main study involving 166 children from 2 years of age who could not take methotrexate or it did not work well enough. 
Pri juvenilnem idiopatskem poliartritisu so zdravilo RoActemra, ki je bilo dajano z infundiranjem, primerjali s placebom v eni glavni študiji, v kateri je sodelovalo 166 otrok, starih dve leti ali več, ki niso mogli jemati metotreksata ali pri katerih zdravljenje z njim ni bilo dovolj učinkovito.
• children from 2 years of age with juvenile idiopathic polyarthritis in whom treatment with methotrexate has not worked well enough. 
• juvenilnega idiopatskega poliartritisa pri otrocih, starejših od dveh let, pri katerih predhodno zdravljenje z metotreksatom ni bilo dovolj uspešno.
Another study involving 51 children from 1 year of age showed that RoActemra given by injection under the skin had a similar distribution in the body and effect on the disease to that previously seen with RoActemra given by infusion. 
Druga študija z 51 otroki, starejšimi od enega leta, je pokazala, da zdravilo RoActemra, dano z injiciranjem v podkožje, dosega podobno porazdelitev po telesu in učinek na bolezen kot zdravilo RoActemra, dano z infundiranjem.
How does RoActemra work? 
Kako zdravilo RoActemra deluje?
After 6 months of treatment, 45% of patients taking RoActemra in combination with methotrexate (130 out of 290) and 39% of patients taking RoActemra on its own (113 out of 292) achieved remission (did not show symptoms of the disease), compared with 15% of those taking placebo plus methotrexate (43 out of 287). 
Po šestmesečnem zdravljenju se je pri 45 % (130 od 290) bolnikov, ki so jemali zdravilo RoActemra v kombinaciji z metotreksatom, in 39 % (113 od 292) bolnikov, ki so jemali samo zdravilo RoActemra, pojavila remisija v primerjavi s 15 % (43 od 287) pri bolnikih, ki so jemali placebo z metotreksatom.
How is RoActemra used? 
Kako se zdravilo RoActemra uporablja?
In systemic juvenile idiopathic arthritis, RoActemra given by infusion was compared with placebo in one main study involving 112 children in whom treatment with NSAID and corticosteroids did not work well enough. 
Zdravilo RoActemra, ki je bilo dajano z infundiranjem, so pri sistemskem juvenilnem idiopatskem artritisu primerjali s placebom v eni glavni študiji, ki je vključevala 112 otrok, pri katerih zdravljenje z nesteroidnimi protivnetnimi zdravili (NSAID) in kortikosteroidi ni bilo dovolj učinkovito.
After 4 to 6 months of treatment, 26% of patients on RoActemra (21 out of 82) had a flare-up of symptoms during treatment, compared with 48% of patients taking placebo (39 out of 81). 
Po štirih do šestih mesecih zdravljenja so se simptomi ponovno pojavili pri 26 % (21 od 82) bolnikov, ki so jemali zdravilo RoActemra, v primerjavi z 48 % (39 od 81) bolnikov, ki so jemali placebo.
RoActemra, on its own or in combination with methotrexate, was compared with placebo (a dummy treatment) plus methotrexate. 
Zdravilo RoActemra, ki so ga bolniki prejemali samostojno ali v kombinaciji z metotreksatom, so primerjali s placebom (zdravilom brez učinkovine) ob sočasnem jemanju metotreksata.
In the first study, RoActemra was more effective than placebo in treating rheumatoid arthritis: after 6 months of treatment with RoActemra, 61% of patients responded to treatment compared with 32% on placebo. 
V prvi študiji je bilo zdravilo RoActemra učinkovitejše od placeba pri zdravljenju revmatoidnega artritisa: po šestmesečnem zdravljenju se je nanj odzvalo
RoActemra contains the active substance tocilizumab. 
Zdravilo RoActemra vsebuje učinkovino tocilizumab.
• children from 1 year of age with active systemic juvenile idiopathic arthritis in whom other treatments (with anti-inflammatory medicines called NSAIDs and corticosteroids) have not worked well enough; 
• aktivnega sistemskega juvenilnega idiopatskega artritisa pri otrocih, starejših od enega leta, pri katerih predhodno zdravljenje z nesteroidnimi protivnetnimi zdravili (NSAIDs) ali sistemskimi kortikosteroidi ni bilo dovolj uspešno;
For the full list of side effects of RoActemra, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila RoActemra, glejte navodilo za uporabo.
In giant cell arteritis, RoActemra given by injection under the skin was found more effective than placebo in one main study involving 251 adults. 
Pri velikoceličnem arteritisu so v eni glavni študiji pri 251 odraslih ugotovili, da je zdravilo RoActemra, ki se daje z injiciranjem pod kožo, bolj učinkovito od placeba.
RoActemra given by infusion was considered to be effective at treating severe CRS based on a review of data from 66 patients who experienced this condition after they were given CAR-T cell medicines to treat a blood cancer. 
Na podlagi pregleda podatkov o 66 bolnikih, pri katerih se je po prejemu CAR-T celične terapije za zdravljenje krvnega raka pojavila huda oblika sindroma CRS, je bilo ugotovljeno, da je zdravilo RoActemra, dano v obliki infuzije, učinkovito pri zdravljenju tega sindroma.
For the treatment of moderate to severe rheumatoid arthritis where other medicines were unsuccessful, RoActemra given by infusion was studied in five main studies involving a total of over 4,000 adults. 
Zdravilo RoActemra, ki se daje z infundiranjem, so za zdravljenje zmernega do hudega revmatoidnega artritisa, pri katerem druga zdravila niso bila uspešna, raziskovali v petih glavnih študijah, ki so skupaj vključevale več kot 4 000 odraslih.
This summary was last updated in 12/2012. 
Povzetek je bil nazadnje posodobljen 12/2012.
A second application is not recommended. 
Drugi nanos se ne priporoča.
The European Commission granted a marketing authorisation valid throughout the European Union for NexoBrid on 18 December 2012. 
Evropska komisija je dovoljenje za promet z zdravilom NexoBrid, veljavno po vsej Evropski uniji, odobrila dne 18. decembra 2012.
Other information about NexoBrid 
Druge informacije o zdravilu NexoBrid
It is available as a powder and gel, which are mixed together to make a gel (2 g/22 g or 5 g/55 g). 
Na voljo je kot prašek in gel, ki se ju zmeša, da nastane gel (2 g/22 g ali 5 g/55 g).
In patients receiving NexoBrid, in around 15% (16 out of 106) of the wounds the eschar needed to be removed by surgery and around 18% (19 out of 106) required a skin graft, compared with around 63% (55 out of 88) and around 34% (30 out of 88) respectively in patients receiving standard debridement treatment. 
Pri bolnikih, ki so prejemali zdravilo NexoBrid, je bilo treba pri približno 15 % (16 od 106) ran eshare odstraniti s kirurškim posegom in pri približno 18 % (19 od 106) ran izvesti presaditev kože v primerjavi s približno 63 % (55 od 88) in 34 % (30 od 88) ran pri bolnikih, pri katerih so rane oskrbeli s standardnim čiščenjem.
What measures are being taken to ensure the safe use of NexoBrid? 
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila NexoBrid?
The effects of NexoBrid were first tested in experimental models before being studied in humans. 
Učinki zdravila NexoBrid so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
It should only be used in specialised burns centres, and should not be applied to more than 15% of the patient's total body surface area. 
Uporablja se samo v specializiranem centru za opekline, nanese pa se lahko na največ 15 % celotne površine telesa bolnika.
This is a summary of the European public assessment report (EPAR) for NexoBrid. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo NexoBrid.
What benefit has NexoBrid shown during the studies? 
Kakšne koristi je zdravilo NexoBrid izkazalo med študijami?
NexoBrid should be used within 15 minutes after mixing and should be left in contact with the skin for four hours. 
Zdravilo NexoBrid je treba uporabiti v 15 minutah po mešanju in ga v stiku s kožo pustiti štiri ure.
The company will also carry out a long-term study in adults and children comparing NexoBrid with standard debridement treatment to investigate the outcome of patients including cosmetic considerations. 
Družba bo prav tako izvedla dolgoročno študijo na odraslih in otrocih za primerjavo zdravila NexoBrid s standardnim čiščenjem, s katero bo proučila rezultate bolnikov, vključno s kozmetičnim vidikom.
The summary of the opinion of the Committee for Orphan Medicinal Products for NexoBrid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote za zdravilo NexoBrid je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
For more information about treatment with NexoBrid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom NexoBrid preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.