FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Verkazia are eye pain and itching, which may affect around 1 in 10 people.
Croatian: Najčešće nuspojave lijeka Verkazia jesu bol u oku i svrbež, koji se mogu javiti u otprilike 1 na 10 osoba.
English: 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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Verkazia nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: 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).
Croatian: Verkazia smanjuje oštećenje rožnice (prednji dio očne ovojnice) u većine bolesnika s VKC-om, što je utvrđeno poboljšanjima rezultata na testu „fluorescentnog bojenja rožnice” (CFS), standardne mjere zdravlja rožnice.
English: 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.
Croatian: Neki su bolesnici liječeni dodatnih 8 mjeseci te se ovim nastavkom ispitivanja pokazalo da su neprestanim liječenjem u trajanju od 12 mjeseci koristi lijeka Verkazia i dalje prisutne.
English: 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.
Croatian: Djelatna tvar u lijeku Verkazia, ciklosporin, inhibira stanice imunosnog sustava (prirodni obrambeni sustav tijela) koje su uključene u procese koji izazivaju alergijsku reakciju i upalu u bolesnika s VKCom.
English: Verkazia can only be obtained with a prescription and treatment must be started by a healthcare professional qualified in ophthalmology (eye medicine).
Croatian: Verkazia se izdaje samo na liječnički recept, a liječenje mora započeti specijalist oftalmolog (liječnik za bolesti oka).
English: For more information about treatment with Verkazia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Verkazia pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Verkazia is available as eye drops.
Croatian: Lijek Verkazia dostupan je u obliku kapi za oči.
English: For practical information about using Verkazia, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Verkazia bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: 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.
Croatian: Simptomi kao što su svrbež, tekući ili sluzavi iscjedak te osjetljivost na svjetlo također su se u bolesnika koji su primali lijek Verkazia smanjili više nego u bolesnika koji su primali placebo.
English: Verkazia must not be used in patients with active or suspected infections in or around the eye.
Croatian: Lijek Verkazia ne smiju uzimati bolesnici s aktivnim infekcijama oka ili područja oko oka ni bolesnici kod kojih postoji sumnja na takve infekcije.
English: What benefits of Verkazia have been shown in studies?
Croatian: Koje su koristi lijeka Verkazia utvrđene u ispitivanjima?
English: Verkazia contains the active substance ciclosporin.
Croatian: Lijek Verkazia sadržava djelatnu tvar ciklosporin.
English: How is Verkazia used?
Croatian: Kako se Verkazia koristi?
English: For the full list of all side effects and restrictions with Verkazia, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Verkazia potražite u uputi o lijeku.
English: How does Verkazia work?
Croatian: Kako djeluje Verkazia?
English: This summary was last updated in 07-2018.
Croatian: Verkazia EMA/467992/2018
English: Starting doses are between 0.1 and 0.3 mg per kg bodyweight daily.
Croatian: Početne doze iznose između 0,1 i 0,3 mg po kg tjelesne težine dnevno.
English: Tacforius should be taken once daily with water, on an empty stomach.
Croatian: Lijek Tacforius treba uzimati jedanput na dan s vodom na prazan želudac.
English: The full EPAR for Tacforius can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Tacforius nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 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.
Croatian: Kapsule s produljenim oslobađanjem omogućavaju polagano oslobađanje takrolimusa iz kapsule tijekom nekoliko sati, tako ih treba uzimati samo jedanput na dan.
English: As for every medicine, the company provided studies on the quality of Tacforius.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Tacforius.
English: This is a summary of the European public assessment report (EPAR) for Tacforius.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Tacforius.
English: What measures are being taken to ensure the safe and effective use of Tacforius?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tacforius?
English: 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.
Croatian: To znači da Tacforius sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Advagraf.
English: The doses are then adjusted according to the patient's response and the medicine's blood levels.
Croatian: se potom prilagođavaju u skladu s odgovorom bolesnika i razinama lijeka u krvi.
English: Doses of Tacforius are calculated on the basis of the patient's weight and the type of transplant the patient has had.
Croatian: Doze lijeka Tacforius izračunavaju se na temelju tjelesne težine bolesnika i vrste transplantacije kojoj je bolesnik bio podvrgnut.
English: What is Tacforius and what is it used for?
Croatian: Što je Tacforius i za što se koristi?
English: 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.
Croatian: Budući da je Tacforius generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: 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.
Croatian: Lijek Tacforius također se može primjenjivati za liječenje odbacivanja organa u odraslih bolesnika kada drugi imunosupresivni lijekovi (lijekovi koji smanjuju aktivnost imunosnog sustava) nisu učinkoviti.
English: What are the benefits and risks of Tacforius?
Croatian: Koje su koristi i rizici lijeka Tacforius?
English: 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.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, lijek Tacforius dokazao usporedivu kakvoću te da je bioekvivalentan lijeku Advagraf.
English: Other information about Tacforius
Croatian: Ostale informacije o lijeku Tacforius
English: Tacrolimus reduces the activity of cells in the immune system, called T-cells, that are primarily involved in attacking the transplanted organ (organ rejection).
Croatian: Takrolimus smanjuje aktivnost stanica imunosnog sustava naziva T-stanice, koje su primarno uključene u napadanje presađenog organa (odbacivanje organa).
English: It is not intended to provide practical advice on how to use Tacforius.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Tacforius.
English: 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.
Croatian: Ispitivanja omjera koristi i rizika djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Advagraf i ne treba ih ponavljati za lijek Tacforius.
English: 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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Tacforius nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Tacforius tacrolimus
Croatian: Tacforius takrolimus
English: The Agency recommended that Tacforius be approved for use in the EU.
Croatian: Agencija je preporučila davanje odobrenja za stavljanje lijeka Tacforius u promet u EU-u.
English: For more information about treatment with Tacforius, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Tacforius pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: 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).
Croatian: Lijek Tacforius primjenjuje se za dugoročno liječenje odraslih bolesnika koji su bili podvrgnuti transplantaciji bubrega ili jetre kako bi se spriječilo odbacivanje (kada imunosni sustav napadne transplantirani organ).
English: Why is Tacforius approved?
Croatian: Zašto je Tacforius odobren?
English: Therefore, the Agency's view was that, as for Advagraf, the benefit outweighs the identified risk.
Croatian: Stoga je stav Agencije da korist nadmašuje identificirani rizik, kao i za lijek Advagraf.
English: Tacforius is available as prolonged-release capsules containing tacrolimus.
Croatian: Lijek Tacforius dostupan je u obliku kapsula s produljenim oslobađanjem koje sadržavaju takrolimus.
English: For practical information about using Tacforius, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Tacforius bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Tacforius contains the active substance tacrolimus and is a ‘generic medicine'.
Croatian: Tacforius sadržava djelatnu tvar takrolimus te je „generički lijek”.
English: Tacforius can only be obtained with a prescription.
Croatian: Lijek Tacforius izdaje se samo na liječnički recept.
English: Tacrolimus, the active substance in Tacforius, is an immunosuppressive medicine.
Croatian: Djelatna tvar lijeka Tacforius, takrolimus, jest imunosupresiv.
English: Only doctors experienced in immunosuppressive medicines and in the management of transplant patients should prescribe it and make changes to immunosuppressive treatment.
Croatian: Lijek smiju propisivati te mijenjati terapiju imunosupresiva samo liječnici s iskustvom u primjeni imunosupresivnih lijekova i liječenju transplantiranih bolesnika.
English: How does Tacforius work?
Croatian: Kako djeluje Tacforius?
English: How is Tacforius used?
Croatian: Kako se Tacforius koristi?
English: How has Tacforius been studied?
Croatian: Kako je Tacforius ispitivan?
English: This is a life-long treatment.
Croatian: Terapija je doživotna.
English: Further information on Ultomiris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ultomiris.
Croatian: Više informacija o lijeku Ultomiris nalazi se na internetskim stranicama Agencije:ema.europa.eu/medicines/human/EPAR/Ultomiris.
English: 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).
Croatian: Europska agencija za lijekove također je zamijetila da Ultomiris ima praktičniji raspored liječenja (jednom infuzijom svakih osam tjedana umjesto svaka dva tjedna).
English: 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.
Croatian: Također se ne smije primjenjivati u bolesnika koji protiv te infekcije nisu cijepljeni, osim ako uzimaju antibiotike za smanjenje rizika od infekcije.
English: The change in blood levels of LDH after 6 months of treatment was similar in the 2 groups.
Croatian: Promjena razine LDH-a u krvi nakon šest mjeseci terapije bila je slična u obje skupine.
English: Patients should take antibiotics for 2 weeks after they have been vaccinated.
Croatian: Bolesnici bi trebali uzimati antibiotike tijekom dva tjedna nakon cijepljenja.
English: What measures are being taken to ensure the safe and effective use of Ultomiris?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ultomiris?
English: Patients receive an initial dose (called loading dose) and then a maintenance dose once every 8 weeks, starting 2 weeks after the loading dose.
Croatian: Bolesnici primaju početnu (udarnu) dozu te zatim doze održavanja jednom svakih osam tjedana, s početkom dva tjedna nakon udarne doze.
English: 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.
Croatian: Nakon šest mjeseci terapije uočene su slične koristi u obje skupine, pri čemu dvije trećine ili više bolesnika (74 % onih koji su primili Ultomiris i 66 % onih koji su primili ekulizumab) nisu trebali transfuziju crvenih krvnih stanica.
English: In addition, around half of the patients in both groups had achieved normal blood levels of the enzyme LDH.
Croatian: Nadalje, oko polovice bolesnika u obje skupine postiglo je normalne razine enzima LDH u krvi.
English: The Agency therefore decided that Ultomiris' benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Ultomiris nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: As for its safety, Ultomiris has similar side effects to eculizumab.
Croatian: U pogledu sigurnosti, Ultomiris ima slične nuspojave kao i ekulizumab.
English: Other information about Ultomiris
Croatian: Ostale informacije o lijeku Ultomiris
English: 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.
Croatian: Najčešće nuspojave lijeka Ultomiris (koje se mogu javiti u više od 1 na 10 osoba) su infekcije gornjih dišnih puteva (infekcije nosa i grla), nazofaringitis (upala nosa i grla) te glavobolja.
English: Side effects reported with Ultomiris are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ultomiris pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Ultomiris is given as an infusion (drip) into a vein and the recommended dose depends on the patient's bodyweight.
Croatian: Ultomiris se primjenjuje infuzijom (ukapavanjem) u venu, a preporučena doza ovisi o tjelesnoj težini bolesnika.
English: What is Ultomiris and what is it used for?
Croatian: Što je Ultomiris i za što se primjenjuje?
English: As for all medicines, data on the use of Ultomiris are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Ultomiris kontinuirano se prate.
English: 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 blood disorders.
Croatian: Lijek se izdaje samo na liječnički recept i treba ga primjenjivati pod nadzorom liječnika s iskustvom u liječenju bolesnika s poremećajima krvi.
English: It should be used after patients have been treated with eculizumab (another medicine for PNH) for at least the past 6 months.
Croatian: Trebao bi se primjenjivati nakon liječenja bolesnika ekulizumabom (drugim lijekom za PNH) u razdoblju od najmanje šest prethodnih mjeseci.
English: In addition, none of the patients treated with Ultomiris had a flare-up of symptoms during this time, in comparison to 5 of those continuing with eculizumab.
Croatian: Nadalje, nijedan od bolesnika liječenih Ultomirisom nije iskusio naglo pogoršanje simptoma tijekom tog razdoblja, u usporedbi s pet bolesnika koji su nastavili primati ekulizumab.
English: 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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ultomiris također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: By attaching to the C5 protein, the medicine blocks its effect and thereby reduces the destruction of red blood cells.
Croatian: Vezivanjem na bjelančevinu C5 lijek blokira njezino djelovanje, čime smanjuje uništavanje crvenih krvnih stanica.
English: 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.
Croatian: Zbog toga što su bolesnici na terapiji lijekom Ultomiris skloniji infekcijama, uključujući ozbiljnu meningokoknu infekciju, Ultomiris se ne smije primjenjivati u bolesnika s postojećom meningokoknom infekcijom.
English: 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.
Croatian: PNH je bolest potencijalno opasna po život u kojoj dolazi do prekomjerne razgradnje crvenih krvnih stanica, što uzrokuje probleme poput anemije (niskih razina crvenih krvnih stanica), problema s bubrezima i krvnih ugrušaka u krvnim žilama.
English: An overview of Ultomiris and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ultomiris i zašto je odobren u EU-u
English: Why is Ultomiris authorised in the EU?
Croatian: Zašto je lijek Ultomiris odobren u EU-u?
English: 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.
Croatian: Bolesnici će također dobiti posebnu karticu koja sadrži pojašnjenja simptoma meningokokne infekcije, te ih upućuje da odmah potraže medicinsku pomoć ako uoče znakove te infekcije.
English: 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.
Croatian: Također, tvrtka će propisivačima lijeka i bolesnicima osigurati informacije o sigurnoj primjeni lijeka, a propisivačima lijeka i ljekarnicima poslat će podsjetnike da provjere je li za bolesnike koji primaju lijek Ultomiris potrebno ponovno cijepljenje.
English: Ultomiris is a medicine used to treat adults with paroxysmal nocturnal haemoglobinuria (PNH).
Croatian: Ultomiris se primjenjuje za liječenje odraslih bolesnika s paroksizmalnom noćnom hemoglobinurijom (PNH).
English: In the first study, 246 patients with PNH who previously had not been treated with a medicine blocking the complement system, such as eculizumab, received either Ultomiris or eculizumab.
Croatian: U prvom ispitivanju, 246 bolesnika s PNH-om koji prethodno nisu bili na terapiji lijekovima koji blokiraju sustav komplementa poput ekulizumaba primili su ili Ultomiris ili ekulizumab.
English: In the second study in 195 patients with PNH who did not have symptoms after at least 6 months of treatment with eculizumab, patients either continued treatment with eculizumab or switched to Ultomiris.
Croatian: U drugom ispitivanju na 195 bolesnika s PNH-om koji nisu imali simptome nakon barem šest mjeseci terapije ekulizumabom, bolesnici su ili nastavili s terapijom ekulizumabom ili su prešli na Ultomiris.
English: What are the risks associated with Ultomiris?
Croatian: Koji su rizici povezani s lijekom Ultomiris?
English: 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.
Croatian: Tvrtka koja lijek Ultomiris stavlja u promet mora osigurati dostupnost lijeka samo onim bolesnicima čiji su liječnici dali pisanu izjavu da su bolesnici cijepljeni ili da uzimaju antibiotsku terapiju za sprječavanje meningokokne bolesti.
English: For more information about using Ultomiris, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Ultomiris pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: How does Ultomiris work?
Croatian: Kako djeluje Ultomiris?
English: 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.
Croatian: Kod PNH-a bjelančevine naziva „sustav komplementa” koje su dio imunosnog sustava postaju preaktivne zbog genetske mutacije te počinju napadati vlastite crvene krvne stanice u organizmu.
English: 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.
Croatian: Ultomiris se primjenjuje u bolesnika sa simptomima bolesti kao i u bolesnika sa stabilnim razinama enzima laktat dehidrogenaze (LDH) u krvi, koji ukazuje na količinu crvenih krvnih stanica koja se razgrađuje.
English: What benefits of Ultomiris have been shown in studies?
Croatian: Koje su koristi od lijeka Ultomiris utvrđene u ispitivanjima?
English: The active substance contained in Ultomiris, ravulizumab, is a monoclonal antibody (a type of protein) designed to attach to the C5 protein, which is part of the complement system.
Croatian: Djelatna tvar lijeka Ultomiris, ravulizumab, monoklonsko je protutijelo (vrsta bjelančevine) osmišljeno za vezivanje na bjelančevinu C5 koja je dio sustava komplementa.
English: Ultomiris is as effective as eculizumab in treating patients with PNH, reducing the breakdown of red blood cells and avoiding the need for transfusions.
Croatian: Ultomiris je jednako učinkovit kao i ekulizumab u liječenju bolesnika s PNH-om u smanjenju razgradnje crvenih krvnih stanica i izbjegavanju potrebe za transfuzijom.
English: The most serious side effect is meningococcal infection, a bacterial infection caused by Neisseria meningitidis that can cause meningitis and blood poisoning.
Croatian: Neisseria meningitidis koja može uzrokovati meningitis i otrovanje krvi.
English: Ultomiris was shown in 2 studies to be as effective as eculizumab in reducing the breakdown of red blood cells and avoiding the need for transfusions in patients with PNH.
Croatian: Ultomiris se pokazao jednako učinkovit kao ekulizumab u smanjenju razgradnje crvenih krvnih stanica i izbjegavanju potrebe za transfuzijama u bolesnika s PNH-om.