natgillin/translations-raw huggingface dataset:
The main measure of effectiveness was the time it took until a certain number of patients experienced a relapse. 
Glavno merilo učinkovitosti je bil čas, ki je pretekel, dokler pri določenem številu bolnikov ni prišlo do ponovitve bolezni.
A reduction in the score by 2 points indicates a clinically significant improvement of the patient's condition. 
Za 2 točki nižji rezultat kaže klinično pomembno izboljšanje bolnikovega stanja.
Soliris received a marketing authorisation valid throughout the EU on 20 June 2007. 
Za zdravilo Soliris je bilo 20. junija 2007 izdano dovoljenje za promet, veljavno po vsej EU.
In case of any infusion-related reactions, the doctor may slow down or stop the infusion. 
Če se pojavijo kakršne koli z infuzijo povezane reakcije, lahko zdravnik infuzijo upočasni ali zaustavi.
What measures are being taken to ensure the safe and effective use of Soliris? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Soliris?
The European Medicines Agency decided that Soliris' benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Soliris večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
It is used in patients who have an antibody called AQP4 and whose disease is relapsing (where the patient has attacks [relapses] between periods with no symptoms). 
Uporablja se pri bolnikih, ki imajo protitelo, imenovano AQP4, in katerih bolezen je recidivna (če ima bolnik napade [recidive] med obdobji brez simptomov).
Other information about Soliris 
Druge informacije o zdravilu Soliris
The most common side effect with Soliris (which may affect more than 1 in 10 people) is headache. 
Najpogostejši neželeni učinek zdravila Soliris (ki se lahko pojavi pri več kot 1 od 10 bolnikov) je glavobol.
In some patients who receive plasma exchange (the removal, treatment and return of their own blood plasma) or infusion of plasma, additional doses of Soliris are required. 
Pri nekaterih bolnikih, pri katerih poteka izmenjava plazme (odstranitev, zdravljenje in vrnitev njihove lastne krvne plazme) ali ki prejmejo infuzijo plazme, so potrebni dodatni odmerki zdravila Soliris.
Patients will also be given a special card that explains the symptoms of certain types of infection, instructing patients to seek medical care immediately if they experience them. 
Bolniki bodo dobili tudi posebno kartico, ki vsebuje razlago simptomov določenih vrst okužb, in navodilo, naj ob pojavu teh simptomov nemudoma poiščejo medicinsko pomoč.
What benefits of Soliris have been shown in studies? 
Kakšne koristi zdravila Soliris so se pokazale v študijah?
The most serious side effect, which may affect up to 1 in 100 people, is meningococcal sepsis (when bacteria and their toxins circulate in the blood and damage the organs). 
Najresnejši neželeni učinek, ki se lahko pojavi pri največ 1 od 100 bolnikov, je meningokokna sepsa (če bakterije in njihovi toksini krožijo v krvi in poškodujejo organe).
Soliris was shown to benefit patients with these rare diseases. 
Zdravilo Soliris se je izkazalo kot koristno pri bolnikih s temi redkimi boleznimi.
Why is Soliris authorised in the EU? 
Zakaj je bilo zdravilo Soliris odobreno v EU?
The main measures of effectiveness were the effect of Soliris on blood levels of haemoglobin and the need for transfusions. 
Glavni merili učinkovitosti sta bili učinek zdravila Soliris na ravni hemoglobina v krvi in potreba po transfuziji.
These diseases are rare, and Soliris was designated an ‘orphan medicine' (a medicine used in rare diseases). 
Te bolezni so redke, zato je bilo zdravilo Soliris določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
The medicine can only be obtained with a prescription and must be given under the supervision of a doctor who has experience in the management of patients with kidney disorders and disorders affecting the nervous system or the blood. 
Predpisovanje in izdaja zdravila je le na recept, daje pa se lahko le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem bolnikov z boleznimi ledvic in boleznimi, ki prizadenejo živčni sistem ali kri.
The company that markets Soliris will ensure that distribution of the medicine occurs only after checking that the patient has been vaccinated appropriately. 
Podjetje, ki trži zdravilo Soliris, bo zagotovilo, da se lahko zdravilo izda šele potem, ko se preveri, ali je bil bolnik ustrezno cepljen.
As for all medicines, data on the use of Soliris are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Soliris spremljajo.
Patients are monitored for any reactions during the infusion and for at least one hour afterwards. 
Pri bolnikih je treba preverjati, ali med infuzijo in še najmanj eno uro po njej ni prišlo do pojava kakršnih koli reakcij.
In comparison, none of the 44 patients receiving placebo had stable haemoglobin levels, and they needed an average of 10 transfusions. 
V primerjavi s tem nobeden od 44 bolnikov, ki so prejemali placebo, ni imel stabilnih ravni hemoglobina, povprečno pa so potrebovali deset transfuzij.
An overview of Soliris and why it is authorised in the EU 
Pregled zdravila Soliris in zakaj je odobreno v EU
Side effects reported with Soliris are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Soliris, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Treatment with Soliris improved patients' symptoms and their ability to undertake daily activities based on a standard scoring system. 
Z zdravljenjem z zdravilom Soliris so se simptomi bolnikov izboljšali, izboljšala pa se je tudi njihova sposobnost za izvajanje vsakodnevnih opravil glede na standardni sistem točkovanja.
The company will also provide prescribers and patients with information on the safety of the medicine, and will send reminders to prescribers and pharmacists to check if any further vaccination is needed for patients taking Soliris. 
Zdravnikom, ki predpisujejo zdravilo, in bolnikom bo družba priskrbela tudi informacije o varnosti zdravila ter poslala opomnike zdravnikom, ki predpisujejo zdravilo, in farmacevtom, da preverijo, ali je za bolnike, ki prejemajo zdravilo Soliris, potrebno kakršno koli dodatno cepljenje.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Soliris 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 Soliris upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
In addition, 76% achieved haematological normalisation (levels of platelets and LDH within normal levels). 
Poleg tega je bila pri 76 % bolnikov dosežena hematološka normalizacija (ravni trombocitov in LDH znotraj običajnih ravni).
These are life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications. 
To sta življenjsko nevarni prirojeni bolezni, pri katerih se razgrajujejo rdeče krvne celice, kar povzroča različne zdravstvene težave.
Haemoglobin is the protein in red blood cells that carries oxygen around the body. 
Hemoglobin je beljakovina v rdečih krvnih celicah, ki prenaša kisik po telesu.
The study found that treatment with Soliris for 6 months led to clinically meaningful reductions in levels of LDH, indicating reduced breakdown of red blood cells. 
V študiji so odkrili, da je šestmesečno zdravljenje z zdravilom Soliris povzročilo klinično pomembna znižanja ravni LDH, kar kaže na upočasnitev razpadanja rdečih krvnih celic.
What are the risks associated with Soliris? 
Kakšna tveganja so povezana z zdravilom Soliris?
What is Soliris and what is it used for? 
Kaj je zdravilo Soliris in za kaj se uporablja?
The first study involved 17 patients with aHUS who did not respond to or could not be treated with plasma exchange or infusion. 
Prva študija je vključevala 17 bolnikov s to boleznijo, ki se niso odzvali na izmenjavo plazme ali infuzijo ali jih niso mogli zdraviti z njima.
By blocking the C5 complement protein, eculizumab prevents complement proteins from damaging cells, thereby helping to relieve the symptoms of these diseases. 
Ekulizumab z zaviranjem beljakovine komplementa C5 preprečuje, da bi njegova beljakovina poškodovala celice, kar pomaga lajšati simptome teh bolezni.
Soliris should be given for life unless the patient develops serious side effects. 
Zdravilo Soliris je treba dajati vse življenje, razen če se pri bolniku pojavijo resni neželeni učinki.
The second study, involving 20 patients with aHUS who were already receiving plasma exchange or infusion, resulted in 80% of the patients no longer requiring plasma exchange, infusion or dialysis and 90% of the patients achieving haematological normalisation after treatment with Soliris. 
V drugi študiji, v katero je bilo vključenih 20 bolnikov z atipičnim hemolitično-uremičnim sindromom, ki so že prejemali izmenjavo plazme ali infundiranje, 80 % bolnikov po zdravljenju z zdravilom Soliris ni več imelo potrebe po izmenjavi plazme, infuziji ali dializi, 90 % bolnikov pa je doseglo hematološko normalizacijo.
Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). 
Soliris je zdravilo, ki se uporablja za zdravljenje odraslih in otrok z paroksizmalno nočno hemoglobinurijo (PNH) in atipičnim hemolitično-uremičnim sindromom (aHUS).
The active substance in Soliris, eculizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the C5 complement protein, which is a part of the body's defence system called the ‘complement system'. 
Učinkovina zdravila Soliris, ekulizumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da se veže na beljakovino komplementa C5, ki je del obrambnega sistema telesa, imenovanega „sistem komplementa“.
A registry study of patients with PNH who had never had a blood transfusion looked at the blood levels of the enzyme lactate dehydrogenase (LDH). 
V študiji registra bolnikov s paroksizmalno nočno hemoglobinurijo, ki nikoli niso prejeli transfuzije krvi, so preučevali ravni encima laktat dehidrogenaza (LDH) v krvi.
Soliris is given as an infusion (drip) into a vein and the recommended dose depends on what it is used for, and for patients under 18 years of age, on their bodyweight. 
Zdravilo Soliris se daje z infundiranjem (kapalno infuzijo) v veno, priporočeni odmerek pa je odvisen od tega, za kaj se zdravilo uporablja, pri bolnikih, mlajših od 18 let, pa tudi od njihove telesne mase.
PNH results in anaemia (low red blood cell counts), thrombosis (blood clots in the blood vessels), pancytopenia (low counts of blood cells) and dark urine, while aHUS results in anaemia, thrombocytopenia (a decrease in the number of platelets, components that help the blood to clot) and kidney failure. 
Posledice paroksizmalne nočne hemoglobinurije so slabokrvnost (nizko število rdečih krvnih celic), tromboza (nastajanje krvnih strdkov v ožilju), pancitopenija (nizko število krvnih celic) in temen urin, medtem ko so posledica atipičnega hemolitično-uremičnega sindroma slabokrvnost, trombocitopenija (zmanjšanje števila trombocitov, tj. krvnih ploščic, ki pomagajo pri strjevanju krvi) in odpoved ledvic.
The third study involved 30 patients with aHUS who had received at least one dose of Soliris. 
Tretja študija je vključevala 30 bolnikov z atipičnim hemolitično-uremičnim sindromom, ki so prejeli vsaj en odmerek zdravila Soliris.
Soliris is used to treat adults with myasthenia gravis (a disease where the immune system attacks and damages muscle cells causing muscle weakness), in whom other medicines do not work and who have a specific antibody in their body called AChR antibody. 
Zdravilo Soliris se uporablja za zdravljenje odraslih z miastenijo gravis (boleznijo, pri kateri imunski sistem napada in poškoduje mišične celice, kar povzroča mišično oslabelost), pri katerih druga zdravila ne delujejo in ki imajo v telesu specifično protitelo, imenovano protitelo AChR.
After around 22 months on average, 3% of patients treated with Soliris had had a relapse, whereas 43% of patients treated with placebo had already had a relapse after around 9 months on average. 
Po povprečno približno 22 mesecih je do ponovitve bolezni prišlo pri 3 % bolnikov, ki so prejemali zdravilo Soliris, medtem ko je pri 43 % bolnikov, ki so prejemali placebo, prišlo do ponovitve bolezni v povprečju po približno devetih mesecih.
Treatment with Soliris over 26 weeks led to stable haemoglobin levels in 49% of the patients (21 out of 43), without the need for transfusions of red blood cells. 
Zdravljenje z zdravilom Soliris je v 26 tednih stabiliziralo ravni hemoglobina pri 49 % (21 od 43) bolnikov, pri tem pa ni bilo potrebe po transfuziji rdečih krvnih celic.
In a study in 7 children with PNH who had had at least one transfusion in the previous two years, all patients received Soliris. 
V študiji pri sedmih otrocih s paroksizmalno nočno hemoglobinurijo, ki so v preteklih dveh letih prejeli vsaj eno transfuzijo, so zdravilo Soliris prejeli vsi bolniki.
For the full list of side effects and restrictions with Soliris, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Soliris glejte navodilo za uporabo.
For aHUS, Soliris was studied in three main studies involving 67 patients. 
Pri atipičnem hemolitično-uremičnem sindromu so zdravilo Soliris proučevali v treh glavnih študijah, ki so vključevale 67 bolnikov.
Soliris is also used to treat adults with neuromyelitis optica spectrum disorder (NMOSD), a disease where the immune system damages nerve cells causing problems mostly with the optic (eye) nerve and the spinal cord. 
Zdravilo Soliris se uporablja tudi za zdravljenje odraslih s specifično obliko nevromielitisa vidnega živca (NMOSD), tj. boleznijo, pri kateri imunski sistem poškoduje živčne celice, kar povzroča težave predvsem z vidnim (očesnim) živcem in hrbtenjačo.
Because of the increased risk of developing meningococcal sepsis, Soliris must not be given to people who have an infection caused by Neisseria meningitides; it must also not be given to patients who have not been vaccinated against this bacterium, unless they have the vaccination and take appropriate antibiotics to reduce the risk of infection for two weeks after vaccination. 
Prav tako se ne sme dajati bolnikom, ki niso bili cepljeni proti tej bakteriji, razen če se cepijo in dva tedna po cepljenju jemljejo ustrezne antibiotike za znižanje tveganja okužbe.
Soliris led to a reduction of 4.7 points on the scale whereas placebo led to 2.8 point reduction after 26 weeks. 
Po 26 tednih je znižanje na lestvici pri zdravljenju z zdravilom Soliris znašalo 4,7 točke, s placebom pa 2,8 točke.
Six out of seven patients did not need any transfusion of red blood cells, and haemoglobin levels improved during 12 weeks of treatment with Soliris. 
Šest od sedmih bolnikov med 12-tedenskim zdravljenjem z zdravilom Soliris ni potrebovalo nobene transfuzije rdečih krvnih celic, raven hemoglobina pa se je izboljšala.
How is Soliris used? 
Kako se zdravilo Soliris uporablja?
In patients with PNH, aHUS, myasthenia gravis and NMOSD, the complement proteins are over-active and damage the patients' own cells. 
Pri bolnikih s paroksizmalno nočno hemoglobinurijo, atipičnim hemolitično-uremičnim sindromom, miastenijo gravis in specifično obliko nevromielitisa vidnega živca so beljakovine komplementa preveč dejavne, kar škoduje bolnikovim lastnim celicam.
For myasthenia gravis, Soliris was compared with placebo in one main study involving 126 adults with myasthenia gravis who had previously received standard treatment which had failed. 
Pri miasteniji gravis so zdravilo Soliris primerjali s placebom v eni glavni študiji, v katero je bilo vključenih 126 odraslih z miastenijo gravis, ki so bili prej zdravljeni standardno, a zdravljenje ni bilo uspešno.
For PNH, Soliris was compared with placebo (a dummy treatment) in one main study involving 87 adults with PNH who had had at least four blood transfusions for anaemia in the previous year. 
Pri paroksizmalni nočni hemoglobinuriji so zdravilo Soliris primerjali s placebom (zdravilom brez učinkovine) v eni glavni študiji, v katero je bilo vključenih 87 odraslih s paroksizmalno nočno hemoglobinurijo, ki so v preteklem letu zaradi slabokrvnosti prejeli najmanj štiri transfuzije krvi.
Treatment with Soliris increased platelet counts in 82% of the patients, and platelet counts rose to normal levels in 87% (13 out of 15 patients) who had low platelet counts at the start. 
Zaradi zdravljenja z zdravilom Soliris je število trombocitov naraslo pri 82 % bolnikov, na normalne ravni pa je naraslo pri 87 % (13 od 15 bolnikov) bolnikov, ki so imeli na začetku nizke ravni trombocitov.
Treatment increased platelet counts to normal levels in 83% of the patients, while the platelet count rose to normal levels in 77% (10 out of 13 patients) who initially had low platelet counts. 
Zaradi zdravljenja je število trombocitov naraslo na normalne ravni pri 83 % bolnikov, pri tistih, ki so imeli na začetku nizke ravni trombocitov, pa je na normalne ravni naraslo pri 77 % (10 od 13 bolnikov) bolnikov.
Soliris contains the active substance eculizumab. 
Zdravilo Soliris vsebuje učinkovino ekulizumab.
How does Soliris work? 
Kako zdravilo Soliris deluje?
For NMOSD, Soliris was compared with placebo in one main study involving 143 adults with NMOSD whose disease was relapsing. 
Pri specifični obliki nevromielitisa vidnega živca so zdravilo Soliris primerjali s placebom v eni glavni študiji, v katero je bilo vključenih 143 odraslih s specifično obliko nevromielitisa vidnega živca, pri katerih je bila bolezen recidivna.
In patients with PNH, the breakdown of red blood cells leads to a reduction in haemoglobin levels. 
Pri bolnikih s paroksizmalno nočno hemoglobinurijo se je z razgradnjo rdečih krvnih celic raven hemoglobina zmanjšala.
Levels of LDH rise as breakdown of red blood cells increases. 
Če rdeče krvne celice hitreje razpadajo, se ravni LDH zvišajo.
It is available in three forms: 
Na voljo je v treh oblikah:
This summary was last updated in 01-2016. 
Povzetek je bil nazadnje posodobljen 01-2016.
PCV-1 is not known to cause any disease. 
Za PCV-1 ni znano, da bi povzročal bolezen.
The European Commission granted a marketing authorisation valid throughout the European Union for Rotarix on 21 February 2006. 
Evropska komisija je dovoljenje za promet z zdravilom Rotarix, veljavno po vsej Evropski uniji, izdala 21. februarja 2006.
The virus is alive, but it has been weakened so that it does not cause the disease, which makes it suitable for use in a vaccine. 
Virus je živ, vendar oslabljen, tako da ne povzroči bolezni, zato je primeren za uporabo v cepivu.
The full EPAR for Rotarix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Rotarix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This document is a summary of the European Public Assessment Report (EPAR) for Rotarix. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rotarix.
What measures are being taken to ensure the safe and effective use of Rotarix? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rotarix?
• an oral suspension in a squeezable tube. 
• kot peroralna suspenzija v iztisljivi tubi.
Other information about Rotarix: 
Druge informacije o zdravilu Rotarix:
Rotarix should never be injected under any circumstances. 
Cepivo Rotarix se pod nobenim pogojem ne sme injicirati.
Rotarix can be given at the same time as other vaccines. 
Cepivo Rotarix se lahko daje sočasno z drugimi cepivi.
In addition, the company that markets Rotarix is developing a vaccine free of porcine circovirus type 1 (PCV-1) after a very small amount of viral particles was found in the vaccine in 2010. 
Poleg tega družba, ki trži cepivo Rotarix, razvija cepivo, ki ne bo vsebovalo prašičjega cirkovirusa tipa 1 (PCV-1), po tem ko je bila v cepivu iz leta 2010 najdena zelo mala količina virusnih delcev.
For more information about treatment with Rotarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Rotarix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The vaccine can only be obtained with a prescription. 
Izdaja cepiva je le na recept.
Rotarix contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain). 
Cepivo Rotarix vsebuje živo atenuirano (oslabljeno) obliko humanega rotavirusa (sev RIX4414).
Overall, the clinical studies of Rotarix involved over 75,000 babies and took place in various countries worldwide. 
Klinične študije cepiva Rotarix so skupaj zajele prek 75 000 dojenčkov in so potekale v različnih državah po vsem svetu.
A risk management plan has been developed to ensure that Rotarix is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Rotarix je bil pripravljen načrt obvladovanja tveganj.
The same vaccination course can be used in babies born up to 13 weeks prematurely (from 27 weeks gestational age). 
Enaka shema se lahko uporabi pri dojenčkih, ki so se rodili največ 13 tednov prezgodaj (po 27. tednu gestacijske starosti).
The most common side effects with Rotarix (seen in between 1 and 10 patients in 100) are diarrhoea and irritability. 
Najpogostejša neželena učinka cepiva Rotarix (opažena pri 1 do 10 bolnikih od 100) sta driska in razdražljivost.
Rotarix rotavirus vaccine, live 
Rotarix cepivo proti rotavirusu, živo
It must also not be given to patients who have disorders that cause severe abnormalities of the immune system called ‘severe combined immunodeficiency', who have had intussusception in the past, or who have problems with their bowel that could put them at risk of intussusception. 
Ne sme se uporabljati pri bolnikih z obolenji, ki povzročajo resne nepravilnosti imunskega sistema, imenovane „huda kombinirana imunodeficienca“, ki so v preteklosti imeli invaginacijo ali ki imajo težave s črevesjem, zaradi česar obstaja nevarnost za invaginacijo.
The first dose is given when the baby is older than six weeks. 
Prvi odmerek dojenček prejme po šestem tednu starosti.
This helps to protect against gastroenteritis caused by rotavirus. 
To pomaga pri zaščiti pred gastroenteritisom, ki ga povzroča rotavirus.
What benefit has Rotarix shown during the studies? 
Kakšne koristi je zdravilo Rotarix izkazalo med študijami?
These results were compared with the findings of a study in babies born at full term who were vaccinated with Rotarix. 
Te rezultate so primerjali z ugotovitvami študije pri polno donošenih dojenčkih, ki so bili cepljeni s cepivom Rotarix.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rotarix. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Rotarix is used in babies aged from 6 to 24 weeks to protect against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections. 
Cepivo Rotarix se uporablja pri dojenčkih, starih od 6 do 24 tednov, za zaščito pred gastroenteritisom (drisko in bruhanjem), ki ga povzroča okužba z rotavirusi.