natgillin/translations-raw huggingface dataset:
In a main study involving 169 children and adolescents with severe VKC, 55% of patients treated with Verkazia achieved CFS improvements of 50% or more, without the need of other medications, after 4 months, compared with around 28% of patients receiving a dummy treatment. 
V glavni študiji, ki je vključevala 169 otrok in mladostnikov s hudim VKC, je bilo pri 55 % bolnikov, zdravljenih z zdravilom Verkazia, po 4 mesecih doseženo izboljšanje CFS, ki je znašalo 50 % ali več, pri čemer ni bilo potrebe po drugih zdravilih, pri bolnikih, ki so prejemali placebo, pa jih je izboljšanje doseglo približno 28 %.
What benefits of Verkazia have been shown in studies? 
Kakšne koristi je zdravilo Verkazia izkazalo v študijah?
The European Medicines Agency therefore decided that Verkazia's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Verkazia večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
Verkazia must not be used in patients with active or suspected infections in or around the eye. 
Zdravilo Verkazia se ne sme uporabljati pri bolnikih z aktivnimi ali domnevnimi vnetji v očesu ali okoli njega.
The recommended dose is 1 drop 4 times a day in each affected eye, during VKC season. 
Priporočeni odmerek je ena kapljica štirikrat dnevno v sezoni VKC v vsako prizadeto oko.
If symptoms persist after the end of the season, Verkazia can continue to be used at the recommended dose until symptoms are under control and at a reduced dose (1 drop twice a day) thereafter. 
Če simptomi po sezoni ne izginejo, se lahko zdravilo Verkazia še naprej uporablja v priporočenem odmerku, dokler simptomi niso obvladani, in sicer v zmanjšanem odmerku (ena kapljica dvakrat dnevno).
Verkazia has been shown to be effective at improving the condition of the cornea and reducing the symptoms of the disease. 
Zdravilo Verkazia se je izkazalo za učinkovito pri izboljšanju stanja roženice in zmanjševanju simptomov bolezni.
The summary of the opinion of the Committee for Orphan Medicinal Products for Verkazia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Verkazia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
What are the risks associated with Verkazia? 
Kakšna tveganja so povezana z zdravilom Verkazia?
The most common side effects with Verkazia are eye pain and itching, which may affect around 1 in 10 people. 
Najpogostejši neželeni učinki zdravila Verkazia so bolečine v očeh in srbenje oči, ki lahko prizadenejo približno 1 osebo od 10.
Side effects are mostly mild and disappear shortly after application of the medicine. 
Neželeni učinki so večinoma blagi in kmalu po dajanju zdravila izginejo.
Because the number of patients with vernal keratoconjunctivitis is low, the disease is considered ‘rare', and Verkazia was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 April 2006. 
Ker je bolnikov s vernalnim keratokonjunktivitisom malo, velja ta bolezen za redko, zato je bilo zdravilo Verkazia 6. aprila 2006 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Applying it directly to the eye reduces eye inflammation but limits its effects elsewhere in the body. 
Nanos zdravila neposredno v oko zmanjša vnetje očesa, omeji pa učinke zdravila drugje v telesu.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Verkazia have 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 Verkazia upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The active substance in Verkazia, ciclosporin, blocks cells of the immune system (the body's natural defences) that are involved in the processes that cause the allergic reaction and inflammation in patients with VKC. 
Učinkovina v zdravilu Verkazia, ciklosporin, zavira celice imunskega sistema (naravnega obrambnega mehanizma telesa), ki sodelujejo pri procesih, ki pri bolnikih z VKC povzročajo alergijsko reakcijo in vnetje.
Verkazia is a medicine used to treat severe vernal keratoconjunctivitis (VKC), an allergic condition that affects the eye and mostly occurs seasonally, although in some patients symptoms can recur or persist all year round. 
Zdravilo Verkazia se uporablja za zdravljenje hudega vernalnega keratokonjunktivitisa (VKC), alergijskega stanja, ki prizadene oči in se najpogosteje pojavlja sezonsko, čeprav se simptomi lahko pri nekaterih bolnikih ponovno pojavijo ali vztrajajo v katerem koli letnem času.
For more information about treatment with Verkazia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Verkazia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Why is Verkazia approved? 
Zakaj je bilo zdravilo Verkazia odobreno?
Verkazia is available as eye drops. 
Zdravilo Verkazia je na voljo v obliki kapljic za oči.
These symptoms usually occur when the drops are being put in the eyes and go away shortly after. 
Do teh simptomov običajno pride ob dajanju kapljic v oko in hitro po tem izginejo.
The full EPAR for Verkazia 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 Verkazia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
For the full list of all side effects and restrictions with Verkazia, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Verkazia glejte navodilo za uporabo.
Verkazia contains the active substance ciclosporin. 
Zdravilo Verkazia vsebuje učinkovino ciklosporin.
For practical information about using Verkazia, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Verkazia naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Verkazia can only be obtained with a prescription and treatment must be started by a healthcare professional qualified in ophthalmology (eye medicine). 
Predpisovanje in izdaja zdravila Verkazia je le na recept, zdravljenje z njim pa sme uvesti samo zdravstveni delavec, usposobljen na področju oftalmologije (očesne medicine).
Some of the patients were treated for an additional 8 months; this extension study showed that the benefits of Verkazia were maintained with continued use for up to 12 months. 
V tej podaljšani študiji je bilo dokazano, da so se koristi zdravila Verkazia ohranile tudi pri neprekinjeni uporabi v obdobju do 12 mesecev.
How is Verkazia used? 
Kako se zdravilo Verkazia uporablja?
How does Verkazia work? 
Kako zdravilo Verkazia deluje?
Verkazia reduces damage to the cornea (layer in the front of the eye) in most patients with VKC as shown by improvements in ‘corneal fluorescence staining' (CFS) scores (a standard measure of corneal health). 
Kot dokazujejo izboljšave rezultatov pri obarvanju roženice s fluorescentnim barvilom („corneal fluorescence staining“ (CFS)) (kar je standardno merilo zdravja roženice), zdravilo Verkazia pri večini bolnikov z VKC zmanjšuje poškodbe roženice (plasti na sprednjem delu očesa).
Symptoms such as itching, fluid or mucous discharge and light sensitivity also improved in patients treated with Verkazia to a greater extent than with the dummy treatment. 
Pri bolnikih, zdravljenih z zdravilom Verkazia, so se v primerjavi z bolniki, ki so prejemali placebo, bolj izboljšali simptomi, kot so srbenje, izcedek v obliki tekočine ali sluzi in občutljivost na svetlobo.
Starting doses are between 0.1 and 0.3 mg per kg bodyweight daily. 
Začetni odmerki znašajo od 0,1 do 0,3 mg na kilogram telesne mase na dan. Nato se
Tacforius should be taken once daily with water, on an empty stomach. 
Zdravilo Tacforius je treba jemati enkrat dnevno skupaj z vodo na prazen želodec.
What measures are being taken to ensure the safe and effective use of Tacforius? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tacforius?
The prolonged-release capsules allow tacrolimus to be released slowly from the capsule over several hours so that it needs to be taken only once a day. 
Kapsule s podaljšanim sproščanjem omogočajo, da se takrolimus več ur počasi sprošča iz kapsule, tako da jih je treba jemati le enkrat dnevno.
The full EPAR for Tacforius 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 Tacforius je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for Tacforius. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tacforius.
As for every medicine, the company provided studies on the quality of Tacforius. 
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Tacforius.
The Agency recommended that Tacforius be approved for use in the EU. 
Priporočila je, da se zdravilo Tacforius odobri za uporabo v EU.
Because Tacforius is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Tacforius generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
What are the benefits and risks of Tacforius? 
Kakšne so koristi in tveganja, povezani z zdravilom Tacforius?
It is not intended to provide practical advice on how to use Tacforius. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Advagraf, and do not need to be repeated for Tacforius. 
Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Advagraf, zato jih ni treba ponoviti za zdravilo Tacforius.
Other information about Tacforius 
Druge informacije o zdravilu Tacforius
The European Medicines Agency concluded that, in accordance with EU requirements, Tacforius has been shown to have comparable quality and to be bioequivalent to Advagraf. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Tacforius primerljivo raven kakovosti kot referenčno zdravilo Advagraf ter da mu je biološko enakovredno.
This means that Tacforius contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Advagraf. 
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Advagraf, ki je že odobreno v Evropski uniji (EU).
For more information about treatment with Tacforius, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Tacforius preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The doses are then adjusted according to the patient's response and the medicine's blood levels. 
odmerki prilagodijo glede na bolnikov odziv in koncentracije zdravila v krvi.
What is Tacforius and what is it used for? 
Kaj je zdravilo Tacforius in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tacforius have 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 Tacforius upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Tacforius can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective. 
Zdravilo se lahko uporablja tudi za zdravljenje zavrnitve organa pri odraslih bolnikih, če druga imunosupresivna zdravila (zdravila, ki zavirajo delovanje imunskega sistema) niso učinkovita.
Only doctors experienced in immunosuppressive medicines and in the management of transplant patients should prescribe it and make changes to immunosuppressive treatment. 
Samo zdravniki, ki imajo izkušnje z imunosupresivnimi zdravili in vodenjem bolnikov po transplantaciji), lahko predpisujejo zdravilo in spreminjajo imunosupresivno zdravljenje.
Doses of Tacforius are calculated on the basis of the patient's weight and the type of transplant the patient has had. 
Odmerki zdravila Tacforius se izračunajo na podlagi bolnikove telesne mase in vrste bolnikovega presadka.
For practical information about using Tacforius, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Tacforius naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Tacforius is available as prolonged-release capsules containing tacrolimus. 
Zdravilo Tacforius je na voljo v obliki kapsul s podaljšanim sproščanjem, ki vsebujejo takrolimus.
Tacrolimus reduces the activity of cells in the immune system, called T-cells, that are primarily involved in attacking the transplanted organ (organ rejection). 
Takrolimus zavira delovanje celic imunskega sistema, imenovanih celice T, ki so zlasti vključene pri napadu na presajeni organ (pri zavrnitvi organa).
Tacforius contains the active substance tacrolimus and is a ‘generic medicine'. 
Zdravilo Tacforius vsebuje zdravilno učinkovino takrolimus in je „generično zdravilo“.
Tacforius is used for the long-term treatment of adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ). 
Zdravilo Tacforius se uporablja pri dolgotrajnem zdravljenju odraslih bolnikov s presajenimi ledvicami ali jetri za preprečevanje zavrnitve organa (pri kateri imunski sistem napade presajeni organ).
Therefore, the Agency's view was that, as for Advagraf, the benefit outweighs the identified risk. 
Zato je menila, da njegove koristi enako kot pri zdravilu Advagraf odtehtajo znana tveganja.
Why is Tacforius approved? 
Zakaj je bilo zdravilo Tacforius odobreno?
Tacforius can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila Tacforius je le na recept.
Tacrolimus, the active substance in Tacforius, is an immunosuppressive medicine. 
Zdravilna učinkovina v zdravilu Tacforius, takrolimus, je zdravilo za zaviranje imunske odzivnosti.
How has Tacforius been studied? 
Kako je bilo zdravilo Tacforius raziskano?
How does Tacforius work? 
Kako zdravilo Tacforius deluje?
How is Tacforius used? 
Kako se zdravilo Tacforius uporablja?
This is a life-long treatment. 
Zdravljenje je vseživljenjsko.
Further information on Ultomiris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ultomiris. 
Nadaljnje informacije za zdravilo Ultomiris so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Ultomiris.
Patients should take antibiotics for 2 weeks after they have been vaccinated. 
Bolniki morajo antibiotike jemati še dva tedna po cepljenju.
The Agency therefore decided that Ultomiris' benefits are greater than its risks and it can be authorised for use in the EU. 
Agencija je zato zaključila, da so koristi zdravila Ultomiris večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
It must also not be used in patients who have not been vaccinated against this infection unless they are taking antibiotics to reduce the risk of infection. 
Prav tako se ne sme uporabljati pri bolnikih, ki niso bili cepljeni proti tej okužbi, razen če jemljejo antibiotike za zmanjšanje tveganja okužbe.
The European Medicines Agency also noted that Ultomiris has a more convenient treatment schedule (with one infusion every 8 weeks instead of every 2 weeks). 
Evropska agencija za zdravila je tudi ugotovila, da ima zdravilo Ultomiris bolj primerno shemo zdravljenja (ena infuzija vsakih osem tednov namesto vsaka dva tedna).
The change in blood levels of LDH after 6 months of treatment was similar in the 2 groups. 
Sprememba ravni LDH v krvi po šestih mesecih zdravljenja je bila podobna v obeh skupinah.
What measures are being taken to ensure the safe and effective use of Ultomiris? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ultomiris?
In addition, around half of the patients in both groups had achieved normal blood levels of the enzyme LDH. 
Poleg tega so bile pri približno polovici bolnikov v obeh skupinah dosežene normalne ravni encima LDH v krvi.
As for all medicines, data on the use of Ultomiris are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ultomiris stalno spremljajo.
Patients receive an initial dose (called loading dose) and then a maintenance dose once every 8 weeks, starting 2 weeks after the loading dose. 
Bolniki prejmejo začetni odmerek (imenovan udarni ali polnilni odmerek) in nato vzdrževalni odmerek enkrat na osem tednov, s čimer se začne dva tedna po udarnem odmerku.
After 6 months of treatment, similar benefits were seen in both groups, with two-thirds or more of patients (74% given Ultomiris and 66% given eculizumab) not needing red blood cell transfusions. 
Po šestih mesecih zdravljenja so bile v obeh skupinah opažene podobne koristi, saj dve tretjini ali več bolnikov (74 %, ki so jemali zdravilo Ultomiris in 66 %, ki so prejemali ekulizumab), ni potrebovalo transfuzije rdečih krvnih celic.
It should be used after patients have been treated with eculizumab (another medicine for PNH) for at least the past 6 months. 
Uporabiti bi ga bilo treba po tem, ko je bolnik prejemal ekulizumab (drugo zdravilo za PNH) vsaj zadnjih šest mesecev.
Other information about Ultomiris 
Druge informacije o zdravilu Ultomiris
Why is Ultomiris authorised in the EU? 
Zakaj je bilo zdravilo Ultomiris odobreno v EU?
What benefits of Ultomiris have been shown in studies? 
Kakšne koristi je zdravilo Ultomiris izkazalo v študijah?
By attaching to the C5 protein, the medicine blocks its effect and thereby reduces the destruction of red blood cells. 
Z vezavo na beljakovino C5 zdravilo zavre njen učinek in s tem zmanjša uničenje rdečih krvnih celic.
Ultomiris is a medicine used to treat adults with paroxysmal nocturnal haemoglobinuria (PNH). 
Ultomiris je zdravilo, ki se uporablja za zdravljenje odraslih s paroksizmalno nočno hemoglobinurijo (PNH).
The most serious side effect is meningococcal infection, a bacterial infection caused by Neisseria meningitidis that can cause meningitis and blood poisoning. 
Najresnejši neželeni učinek je okužba z meningokoki, bakterijska okužba, ki jo povzroča bakterija Neisseria meningitidis, ki lahko povzroči meningitis in zastrupitev krvi.
The most common side effects with Ultomiris (which may affect more than 1 in 10 people) are upper respiratory tract infection (nose and throat infection), nasopharyngitis (inflammation of the nose and throat) and headache. 
Najpogostejši neželeni učinki zdravila Ultomiris (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so okužba zgornjih dihal (okužba nosu in grla), nazofaringitis (vnetje nosu in žrela) in glavobol.
An overview of Ultomiris and why it is authorised in the EU 
Pregled zdravila Ultomiris in zakaj je odobreno v EU
For more information about using Ultomiris, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Ultomiris glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Ultomiris are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Ultomiris, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Because patients treated with Ultomiris are more prone to infections, including severe meningococcal disease, Ultomiris must not be used in patients who have an ongoing meningococcal infection. 
Ker so bolniki, zdravljeni z zdravilom Ultomiris, bolj nagnjeni k okužbam, vključno s hudo meningokokno boleznijo, se zdravilo Ultomiris ne sme uporabljati pri bolnikih, ki imajo meningokokno okužbo.
In PNH, proteins known as the 'complement system', which is part of the immune system, become overactive because of a genetic mutation and start to attack the patients' own red blood cells. 
Pri PNH beljakovine, imenovane „sistem komplementa“, ki je del imunskega sistema, zaradi genske mutacije postanejo preveč aktivne in začnejo napadati bolnikove lastne rdeče krvne celice.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ultomiris have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ultomiris upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What are the risks associated with Ultomiris? 
Kakšna tveganja so povezana z zdravilom Ultomiris?
What is Ultomiris and what is it used for? 
Kaj je zdravilo Ultomiris in za kaj se uporablja?
The company that markets Ultomiris will ensure that the medicine is only made available to patients when healthcare professionals have made a written declaration that they have been vaccinated or are receiving antibiotic treatment to prevent meningococcal disease. 
Podjetje, ki trži zdravilo Ultomiris, bo zagotovilo, da je zdravilo bolnikom na voljo le, če zdravstveni delavci pisno izjavijo, da so bili cepljeni ali prejemajo zdravljenje z antibiotiki za preprečevanje meningokokne bolezni.
As for its safety, Ultomiris has similar side effects to eculizumab. 
Kar zadeva varnost, ima zdravilo Ultomiris podobne neželene učinke kot ekulizumab.
Patients will also be given a special card that explains the symptoms of meningococcal infection, instructing patients to seek medical care immediately if they experience them. 
Bolniki bodo prejeli tudi posebno kartico, v kateri so pojasnjeni simptomi meningokokne okužbe, in navodila, da takoj poiščejo zdravniško pomoč, če se pojavijo.
PNH is a potentially life-threatening disease in which there is excessive breakdown of red blood cells, leading to problems such as anaemia (low red blood cell counts), kidney problems and blood clots in the blood vessels. 
PNH je potencialno življenjsko nevarna bolezen, pri kateri prihaja do čezmerne razgradnje rdečih krvnih celic, kar povzroča težave, kot so anemija (nizko število rdečih krvnih celic), težave z ledvicami in krvni strdki v krvnih žilah.
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 re-vaccination is needed for patients taking Ultomiris. 
Zdravnikom, ki predpisujejo zdravilo, in bolnikom bo podjetje priskrbelo tudi informacije o varnosti zdravila ter poslala opomnike zdravnikom, ki predpisujejo zdravilo, in farmacevtom, da preverijo, ali je za bolnike, ki prejemajo zdravilo Ultomiris, potrebno kakršno koli ponovno cepljenje.
Ultomiris is used in patients who have symptoms of the disease as well as in patients who have stable blood levels of the enzyme lactate dehydrogenase (LDH), which gives an indication of how many red blood cells are being broken down. 
Zdravilo Ultomiris se uporablja pri bolnikih, ki imajo simptome bolezni, in pri bolnikih, ki imajo stabilne ravni encima laktat dehidrogenaze (LDH) v krvi, kar kaže, koliko rdečih krvnih celic je razgrajenih.