FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Soliris will ensure that distribution of the medicine occurs only after checking that the patient has been vaccinated appropriately.
Croatian: Tvrtka koja lijek Soliris stavlja na tržište osigurat će distribuciju lijeka tek nakon što se provjeri je li bolesnik primio odgovarajuće cjepivo.
English: Side effects reported with Soliris are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Soliris pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The European Medicines Agency decided that Soliris' benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Soliris nadmašuju s njim povezane rizike te da može biti odobren za primjenu u EU-u.
English: Soliris should be given for life unless the patient develops serious side effects.
Croatian: Soliris se mora davati doživotno, osim ako bolesnik razvije ozbiljne nuspojave.
English: These are life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications.
Croatian: To su po život opasne genetske bolesti koje uzrokuju razgradnju crvenih krvnih stanica, što rezultira različitim zdravstvenim komplikacijama.
English: In a study in 7 children with PNH who had had at least one transfusion in the previous two years, all patients received Soliris.
Croatian: U ispitivanju provedenom na sedmero djece oboljele od PNH-a koja su u prethodne dvije godine primila barem jednu transfuziju, svi bolesnici primili su lijek Soliris.
English: In addition, 76% achieved haematological normalisation (levels of platelets and LDH within normal levels).
Croatian: Osim toga, 76 % bolesnika postiglo je hematološku normalizaciju (razine trombocita i LDH-a u granicama normalnih vrijednosti).
English: In comparison, none of the 44 patients receiving placebo had stable haemoglobin levels, and they needed an average of 10 transfusions.
Croatian: U usporedbi s time, nijedan od 44 bolesnika koji su primali placebo nije imao stabilne razine hemoglobina te su u prosjeku trebali deset transfuzija.
English: 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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Soliris također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of Soliris are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Soliris kontinuirano se prate.
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 any further vaccination is needed for patients taking Soliris.
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 Soliris potrebno ponovno cijepljenje.
English: 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.
Croatian: Liječenje lijekom Soliris tijekom 26 tjedana dovelo je do stabilnih razina hemoglobina u 49 % bolesnika (21 od 43), bez potrebe za transfuzijama crvenih krvnih stanica.
English: 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.
Croatian: PNH rezultira anemijom (malim brojem crvenih krvnih stanica), trombozom (krvnim ugrušcima u krvnim žilama), pancitopenijom (malim brojem krvnih stanica) i tamnim urinom, dok aHUS rezultira anemijom, trombocitopenijom (smanjenim brojem trombocita, komponenti koje pomažu pri zgrušavanju krvi) i zatajenjem bubrega.
English: The third study involved 30 patients with aHUS who had received at least one dose of Soliris.
Croatian: Treće je ispitivanje obuhvatilo 30 bolesnika oboljelih od aHUS-a koji su primili najmanje jednu dozu lijeka Soliris.
English: 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.
Croatian: Šest od sedam bolesnika nije trebalo transfuziju crvenih krvnih stanica te je došlo do poboljšanja razina hemoglobina tijekom 12 tjedana liječenja lijekom Soliris.
English: An overview of Soliris and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Soliris i zašto je odobren u EU-u
English: Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS).
Croatian: Soliris je lijek za liječenje odraslih i djece s paroksizmalnom noćnom hemoglobinurijom (PNH) i atipičnim hemolitičko-uremijskim sindromom (aHUS).
English: Haemoglobin is the protein in red blood cells that carries oxygen around the body.
Croatian: Hemoglobin je bjelančevina u crvenim krvnim stanicama koja prenosi kisik kroz tijelo.
English: What are the risks associated with Soliris?
Croatian: Koji su rizici povezani s lijekom Soliris?
English: 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.
Croatian: U drugom ispitivanju na 20 bolesnika s aHUS-om koji su već primali zamjenu plazme ili infuziju, 80 % bolesnika više nije trebalo zamjenu plazme, infuziju ni dijalizu, a u 90 % bolesnika postignuta je uravnotežena krvna slika nakon terapije lijekom Soliris.
English: 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).
Croatian: U ispitivanju koje se temelji na podatcima iz registra bolesnika oboljelih od PNH-a koji nikad nisu primili transfuziju krvi analizirane su razine enzima laktat dehidrogenaze (LDH).
English: 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.
Croatian: Ispitivanje je pokazalo da je terapija lijekom Soliris tijekom šest mjeseci dovela do klinički značajnog smanjenja razina LDH-a, ukazujući na smanjenje razgradnje crvenih krvnih stanica.
English: These diseases are rare, and Soliris was designated an ‘orphan medicine' (a medicine used in rare diseases).
Croatian: Te su bolesti rijetke, a Soliris je dobio status „lijeka za rijetku bolest”.
English: 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'.
Croatian: Djelatna tvar lijeka Soliris, ekulizumab, monoklonsko je protutijelo (vrsta bjelančevine) osmišljeno za vezivanje na komplementarnu bjelančevinu C5, koja je dio obrambenog sustava organizma naziva „sustav komplementa”.
English: 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.
Croatian: Soliris se također primjenjuje za liječenje odraslih s poremećajem iz spektra optičkog neuromijelitisa (NMOSD), bolesti pri kojoj imunosni sustav oštećuje stanice živaca, uzrokujući probleme uglavnom u očnom živcu i leđnoj moždini.
English: 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.
Croatian: Nakon prosječno 22 mjeseca, bolest se vratila kod 3 % bolesnika koji su primili Soliris, dok se kod 43 % bolesnika koji su primili placebo bolest u prosjeku vratila nakon 9 mjeseci.
English: By blocking the C5 complement protein, eculizumab prevents complement proteins from damaging cells, thereby helping to relieve the symptoms of these diseases.
Croatian: Inhibirajući komplementarnu bjelančevinu C5, ekulizumab je sprječava da oštećuje stanice, čime se ublažavaju simptomi tih bolesti.
English: In patients with PNH, aHUS, myasthenia gravis and NMOSD, the complement proteins are over-active and damage the patients' own cells.
Croatian: U bolesnika oboljelih od PNH-a i aHUS-a, mijastenije gravis i NMOSD-a komplementarne bjelančevine prekomjerno su aktivne te oštećuju krvne stanice bolesnika.
English: How is Soliris used?
Croatian: Kako se Soliris koristi?
English: In patients with PNH, the breakdown of red blood cells leads to a reduction in haemoglobin levels.
Croatian: U bolesnika s PNH-om razgradnja crvenih krvnih stanica uzrokuje smanjenu razinu hemoglobina.
English: 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.
Croatian: Lijek Soliris primjenjuje se intravenskom infuzijom (ukapavanjem), a preporučena doza ovisi o namjeni lijeka, te o tjelesnoj težini u bolesnika mlađih od 18 godina.
English: For aHUS, Soliris was studied in three main studies involving 67 patients.
Croatian: Liječenje aHUS-a lijekom Soliris ispitivano je u trima glavnim ispitivanjima koja su obuhvatila 67 bolesnika.
English: 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.
Croatian: Također se ne smije davati bolesnicima koji nisu cijepljeni protiv te bakterije, osim ako su cijepljeni i uzimaju odgovarajuće antibiotike radi smanjenja rizika od infekcije tijekom dva tjedna nakon cijepljenja.
English: 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.
Croatian: Za liječenje PNH-a, lijek Soliris uspoređen je s placebom (prividnim liječenjem) u jednom glavnom ispitivanju koje je obuhvatilo 87 odraslih osoba oboljelih od PNH-a koje su u prethodnoj godini primile barem četiri transfuzije krvi zbog anemije.
English: What benefits of Soliris have been shown in studies?
Croatian: Koje su koristi od lijeka Soliris utvrđene u ispitivanjima?
English: Soliris led to a reduction of 4.7 points on the scale whereas placebo led to 2.8 point reduction after 26 weeks.
Croatian: Nakon 26 tjedana, primjena lijeka Soliris dovela je do smanjenja od 4,7 bodova na ljestvici, dok je primjena placeba dovela do smanjenja od 2,8 bodova.
English: For NMOSD, Soliris was compared with placebo in one main study involving 143 adults with NMOSD whose disease was relapsing.
Croatian: Za liječenje NMOSD-a Soliris je uspoređen s placebom u jednom glavnom ispitivanju koje je uključivalo 143 odrasla bolesnika s NMOSD-om čija se bolest vratila.
English: 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.
Croatian: Dodatne doze lijeka Soliris potrebne su u nekih bolesnika koji primaju zamjenu plazme (uklanjanje, liječenje i vraćanje vlastite krvne plazme) ili infuziju plazme.
English: Levels of LDH rise as breakdown of red blood cells increases.
Croatian: Razine LDH-a rastu s povećanom razgradnjom crvenih krvnih stanica.
English: For the full list of side effects and restrictions with Soliris, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s lijekom Soliris potražite u uputi o lijeku.
English: 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.
Croatian: Lijek Soliris primjenjuje se za liječenje mijastenije gravis (bolesti pri kojoj imunosni sustav napada i oštećuje stanice mišića te uzrokuje slabost mišića) u odraslih osoba koje nisu reagirale na druge lijekove te koji imaju specifična protutijela naziva protutijela na acetilkolinske receptore (AChR).
English: The first study involved 17 patients with aHUS who did not respond to or could not be treated with plasma exchange or infusion.
Croatian: Prvo je ispitivanje obuhvatilo 17 bolesnika oboljelih od aHUS-a koji nisu reagirali na terapiju zamjenom plazme ili infuzijom, odnosno za koje ta terapija nije bila prikladna.
English: 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.
Croatian: Za liječenje mijastenije gravis lijek Soliris uspoređen je s placebom u jednom glavnom ispitivanju koje je obuhvatilo 126 odraslih osoba oboljelih od mijastenije gravis kod kojih prethodna standardna terapija nije bila uspješna.
English: Patients are monitored for any reactions during the infusion and for at least one hour afterwards.
Croatian: Tijekom infuzije i najmanje jedan sat nakon nje bolesnici su pod nadzorom radi utvrđivanja mogućih reakcija.
English: How does Soliris work?
Croatian: Kako djeluje Soliris?
English: 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.
Croatian: Terapija lijekom Soliris dovela je do povećanja broja trombocita u 82 % bolesnika te do normalnih razina trombocita u 87 % bolesnika (13 od 15 bolesnika) koji su na početku terapije imali niski broj trombocita.
English: 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.
Croatian: Liječenje je dovelo do povećanja broja trombocita na normalne razine u 83 % bolesnika, dok je u bolesnika s početnim malim brojem trombocita dovelo do normalnih razina trombocita u 77 % bolesnika (10 od 13 bolesnika).
English: Soliris contains the active substance eculizumab.
Croatian: Lijek Soliris sadrži djelatnu tvar ekulizumab.
English: It is available in three forms:
Croatian: Dostupno je u tri oblika:
English: PCV-1 is not known to cause any disease.
Croatian: Koliko je poznato, PCV-1 ne uzrokuje nikakvu bolest.
English: This summary was last updated in 01-2016.
Croatian: Ovaj sažetak je posljednji put ažuriran u siječnju 2016.
English: The full EPAR for Rotarix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Rotarix nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: 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.
Croatian: Virus je živ, no oslabljen je kako ne bi uzrokovao bolest, što ga čini prikladnim za uporabu u cjepivu.
English: Rotarix should never be injected under any circumstances.
Croatian: Rotarix se ni pod kojim okolnostima ne smije injicirati.
English: Rotarix is given according to official recommendations.
Croatian: Rotarix se primjenjuje u skladu sa službenim preporukama.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rotarix on 21 February 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Rotarix na snazi u Europskoj uniji od 21. veljače 2006.
English: 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.
Croatian: Osim toga, tvrtka koja Rotarix stavlja u promet razvija cjepivo bez svinjskog cirkovirusa tipa 1 (PCV-1) nakon što je u cjepivu pronađena vrlo mala količina virusnih čestica 2010. godine.
English: Rotarix is given as two doses, at least four weeks apart.
Croatian: Rotarix se primjenjuje u dvije doze s razmakom od najmanje četiri tjedna.
English: Other information about Rotarix:
Croatian: Ostale informacije o lijeku Rotarix:
English: Ideally, both doses should be given before the baby is aged 16 weeks and they must be given by the time the baby is 24 weeks old.
Croatian: Idealno bi bilo da se obje doze daju prije nego što dojenče navrši 16 tjedana života, a doze se moraju dati do dobi od 24 tjedna.
English: The same vaccination course can be used in babies born up to 13 weeks prematurely (from 27 weeks gestational age).
Croatian: Isti ciklus cijepljenja može se primjenjivati u dojenčadi rođene do 13 tjedana prijevremeno (od 27. tjedna gestacijske dobi).
English: Rotarix can be given at the same time as other vaccines.
Croatian: Rotarix se može primjenjivati u isto vrijeme kao i druga cjepiva.
English: Rotarix contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain).
Croatian: Rotarix sadrži živi atenuirani (oslabljeni) oblik ljudskog rotavirusa (soj RIX4414).
English: 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.
Croatian: Ne smije se također primjenjivati u bolesnika koji imaju poremećaje koji uzrokuju teške abnormalnosti imunosnog sustava, stanja koje se naziva „teška kombinirana imunodeficijencija”, koji su imali intususcepciju u prošlosti ili koji imaju problema s crijevima zbog kojih mogu biti podložni riziku od intususcepcije.
English: What measures are being taken to ensure the safe and effective use of Rotarix?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Rotarix?
English: Rotarix contains small amounts of rotavirus, a virus that causes gastroenteritis.
Croatian: Rotarix sadrži male količine rotavirusa, virusa koji uzrokuje gastroenteritis.
English: This document is a summary of the European Public Assessment Report (EPAR) for Rotarix.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Rotarix.
English: 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.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Rotarix.
English: For more information about treatment with Rotarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Rotarix pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: Overall, the clinical studies of Rotarix involved over 75,000 babies and took place in various countries worldwide.
Croatian: Ukupno gledajući, klinička ispitivanja lijeka Rotarix provedena su na više od 75 000 dojenčadi u raznim zemljama diljem svijeta.
English: If the ready-made oral suspension is used, the contents of the prefilled oral applicator or tube should be given into the mouth of the baby.
Croatian: Ako se koristi gotova oralna suspenzija, sadržaj napunjenog oralnog aplikatora ili tube potrebno je primijeniti kroz usta dojenčeta.
English: In the main study, the number of cases of severe rotavirus gastroenteritis was lower following vaccination with Rotarix: 0.1% of the babies vaccinated with Rotarix in whom effectiveness was assessed developed severe rotavirus gastroenteritis (12 out of over 9,000) compared with 0.9% of the babies who received placebo (77 out of almost 9,000).
Croatian: U glavnom provedenom ispitivanju broj slučajeva teškog gastroenteritisa uzrokovanog rotavirusom bio je manji nakon cijepljenja lijekom Rotarix: teški gastroenteritis uzrokovan rotavirusom razvio se u 0,1 % djece cijepljene Rotarixom u koje se ocjenjivala djelotvornost lijeka (12 od više od 9 000) u usporedbi s 0,9 % djece koja su primila placebo (77 od gotovo 9 000).
English: • an oral suspension in a squeezable tube.
Croatian: • kao oralna suspenzija u tubi za istiskivanje.
English: Rotarix rotavirus vaccine, live
Croatian: Rotarix cjepivo protiv rotavirusa, živo
English: Four additional studies were carried out in over 3,000 infants, to confirm that the ready-for-use forms of the vaccine were as safe and as effective as the powder and solvent formulation in stimulating the production of antibodies against rotavirus.
Croatian: Provedena su i četiri dodatna ispitivanja na više od 3 000 dojenčadi, kako bi se potvrdilo da su gotovi oblici cjepiva sigurni i djelotvorni kao formulacija u obliku praška i otapala u poticanju proizvodnje antitijela protiv rotavirusa.
English: Rotarix is used in babies aged from 6 to 24 weeks to protect against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Croatian: Rotarix se primjenjuje u dojenčadi u dobi od 6 do 24 tjedna za prevenciju gastroenteritisa (proljeva i povraćanja) izazvanog infekcijom rotavirusom.
English: If the powder and solvent are used, they should be mixed together just before the vaccine is given, and the resulting suspension given directly into the mouth of the baby using the oral applicator provided.
Croatian: Ako se koriste prašak i otapalo, potrebno ih je pomiješati netom prije primjene cjepiva, a nastalu suspenziju potrebno je izravno primijeniti kroz usta dojenčeta uz pomoć oralnog aplikatora namijenjenog za tu svrhu.
English: The first dose is given when the baby is older than six weeks.
Croatian: Prva se doza daje nakon što dojenče navrši šest tjedana života.
English: Rotarix must not be used in babies who are hypersensitive (allergic) to any of the ingredients of the vaccine or those who showed signs of allergy after receiving a dose of rotavirus vaccine in the past.
Croatian: Rotarix se ne smije primjenjivati u djece koja su preosjetljiva (alergična) na bilo koji od sastojaka cjepiva ili u djece koja su pokazivala znakove alergije nakon primanja doze cjepiva protiv rotavirusa u prošlosti.
English: The most common side effects with Rotarix (seen in between 1 and 10 patients in 100) are diarrhoea and irritability.
Croatian: Najčešće nuspojave Rotarixa (utvrđene kod 1 do 10 na 100 bolesnika) su proljev i razdražljivost.
English: A risk management plan has been developed to ensure that Rotarix is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Rotarix.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rotarix, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za Rotarix nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.