FrancophonIA/ELRC3.0 huggingface dataset:
English: Xgeva was compared with zoledronic acid (another medicine used to prevent bone complications) in four main studies in patients with different types of cancer which had spread to the bone.
Croatian: Xgeva je uspoređen sa zoledronskom kiselinom (drugim lijekom za sprječavanje koštanih komplikacija) u četirima glavnim ispitivanjima u bolesnika s različitim vrstama raka koji se proširio na kost.
English: Xgeva is a medicine used to prevent bone complications in adults with advanced cancer that has spread to the bone.
Croatian: Xgeva je lijek koji se primjenjuje za sprječavanje koštanih komplikacija u odraslih osoba s uznapredovalim rakom koji se proširio na kost.
English: How is Xgeva used?
Croatian: Kako se Xgeva koristi?
English: What benefits of Xgeva have been shown in studies?
Croatian: Koje su koristi od lijeka Xgeva utvrđene u ispitivanjima?
English: In these studies, Xgeva reduced the risk of developing a first skeletal-related event by 18% compared with zoledronic acid.
Croatian: U tim je ispitivanjima primjena lijeka Xgeva smanjila rizik od razvoja prvog koštanog događaja za 18 % u usporedbi sa zoledronskom kiselinom.
English: In this study, Xgeva reduced the risk of developing a first skeletal-related event by 16% compared with zoledronic acid.
Croatian: U tom je ispitivanju primjena lijeka Xgeva smanjila rizik od razvoja prvog koštanog događaja za 16 % u usporedbi sa zoledronskom kiselinom.
English: The European Medicines Agency decided that Xgeva's benefits are greater than its risks for patients with cancers that has spread to the bone, and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Xgeva nadmašuju s njim povezane rizike u bolesnika s rakom koji se proširio na kost, te da lijek može biti odobren za primjenu u Europskoj uniji.
English: The Agency considered that the benefits of Xgeva in giant cell tumour of bone were greater than the risks, and recommended that it be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi od lijeka Xgeva u liječenju gigantocelularnog tumora kosti nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: The cells in giant cell tumour of bone are also activated via RANKL, and treatment with denosumab prevents them from growing and breaking down bone, allowing normal bone to replace the tumour.
Croatian: RANKL-a, a liječenje denosumabom sprječava njihov rast i razgradnju kosti, čime se omogućuje normalnoj kosti da zamijeni tumor.
English: Patients should take calcium and vitamin D supplements while being treated with Xgeva.
Croatian: Za vrijeme terapije lijekom Xgeva, bolesnici trebaju uzimati nadomjestke kalcija i vitamina D.
English: For the full list of side effects and restrictions with Xgeva, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Xgeva potražite u uputi o lijeku.
English: Xgeva is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed.
Croatian: Xgeva se također primjenjuje u liječenju odraslih osoba i koštano sazrelih adolescenata s vrstom raka kosti koji se naziva gigantocelularni tumor kosti.
English: RP*>-1 (Relative potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep)
Croatian: *Relativna potentnost dobivena testiranjem na miševima u usporedbi s referentnim cjepivom koje se pokazalo djelotvornim kod ovaca.
English: Pharma ceutical Form
Croatian: Farmaceutski oblik
English: Further information on Extavia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/extavia.
Croatian: Više informacija o lijeku Extavia dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/extavia.
English: It is given by injection under the skin.
Croatian: Daje se kao injekcija pod kožu.
English: What is Extavia and what is it used for?
Croatian: Što je Extavia i za što se koristi?
English: Extavia is used in patients:
Croatian: Extavia se koristi u bolesnika:
English: In the second study, no delay in the time to disability progression was seen.
Croatian: U drugom ispitivanju nije utvrđena vremenska odgoda u pogledu napretka invalidnosti.
English: Other information about Extavia
Croatian: Ostale informacije o lijeku Extavia
English: What measures are being taken to ensure the safe and effective use of Extavia?
Croatian: Koje se mjere poduzimaju da bi se osigurala sigurna i učinkovita primjena lijeka Extavia?
English: Treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 19 days to reach the recommended dose of 250 micrograms given every other day.
Croatian: Liječenje je potrebno započeti sa 62,5 mikrograma (četvrtinom doze) svaki drugi dan i postupno je povećavati tijekom 19 dana kako bi se dosegla preporučena doza od 250 mikrograma koja se daje svaki drugi dan.
English: • who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Croatian: • koji imaju sekundarno progresivni MS (vrstu MS-a koja slijedi nakon relapsno-remitirajućeg MS-a) i čija je bolest aktivna.
English: Extavia is a medicine used to treat adults who have multiple sclerosis (MS).
Croatian: Extavia je lijek koji se koristi za liječenje odraslih osoba s multiplom sklerozom (MS).
English: In both studies, Extavia showed a reduction in the number (30%) of clinical relapses.
Croatian: U oba ispitivanja lijeka Extavia utvrđeno je smanjenje broja (30 %) kliničkih relapsa.
English: Extavia received a marketing authorisation valid throughout the EU on 20 May 2008.
Croatian: Lijek Extavia dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 20. svibnja 2008.
English: Side effects reported with Extavia are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Extavia pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: • who have experienced the signs of MS for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines).
Croatian: • koji su prvi put osjetili znakove MS-a, a ti su znakovi dovoljno teški da se njima može opravdati terapija ubrizgavanjem kortikosteroida (protuupalnih lijekova).
English: Extavia must not be used in patients who have severe depression or have thoughts of suicide.
Croatian: Lijek Extavia ne smiju uzimati bolesnici koji imaju tešku depresiju ili razmišljaju o suicidu.
English: This medicine is the same as Betaferon, which is already authorised in the EU.
Croatian: Ovaj lijek isti je kao lijek Betaferon, koji je već odobren u EU-u.
English: The company that makes Betaferon has agreed that its scientific data can be used for Extavia.
Croatian: Tvrtka koja proizvodi lijek Betaferon pristala je da se njezini znanstveni podatci upotrijebe za lijek Extavia.
English: • who have MS of the type known as ‘relapsing-remitting', when the patient has attacks (relapses) between periods with no symptoms (remissions), and with at least two relapses within the last two years;
Croatian: • koji imaju vrstu MS-a poznatu pod nazivom relapsno-remitirajuća multipla skleroza kod koje bolesnik ima napadaje (relapse) između razdoblja bez simptoma (remisija) i imao je najmanje dva relapsa u posljednje dvije godine;
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Extavia 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 Extavia nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The most frequent side effects with Extavia are flu-like symptoms (including fever, chills, joint pain, malaise [feeling unwell], sweating, headache and muscle pain) and reactions at the site of injection.
Croatian: Najčešće su nuspojave lijeka Extavia simptomi slični gripi (uključujući vrućicu, zimicu, bol u zglobovima, malaksalost [opće loše osjećanje], znojenje, glavobolju i bol u mišićima) i reakcije na mjestu primjene injekcije.
English: The European Medicines Agency decided that Extavia's 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 Extavia nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Extavia must not be used in patients who have decompensated liver disease (when the liver is damaged and can no longer work adequately).
Croatian: Lijek Extavia ne smiju uzimati bolesnici s dekompenziranom bolešću jetre (kada je jetra oštećena i više ne radi ispravno).
English: As for all medicines, data on the use of Extavia are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Extavia kontinuirano se prate.
English: Extavia was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27 relapses.
Croatian: Lijek Extavia bio je učinkovitiji od placeba kada je riječ o smanjenju broja relapsa godišnje: bolesnici koji su primali lijek u prosjeku su imali 0,84 relapsa godišnje, dok su bolesnici koji su primali placebo imali 1.27 relapsa.
English: What are the risks associated with Extavia?
Croatian: Koji su rizici povezani s lijekom Extavia?
English: Extavia treatment should be stopped in patients whose condition does not improve.
Croatian: Terapiju lijekom Extavia potrebno je prekinuti u bolesnika čije se stanje ne poboljšava.
English: Extavia can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of MS.
Croatian: Extavia se izdaje samo na recept, a liječenje mora započeti liječnik s iskustvom u liječenju MS-a.
English: MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Croatian: MS je bolest kod koje upala oštećuje zaštitni sloj živaca (demijelinizacija), kao i same živce.
English: For more information about using Extavia, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Extavia pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: One of the two studies showed a significant delay in the time to disability progression (31% risk reduction due to Extavia) and in the time to becoming wheelchair bound (39%).
Croatian: U jednom od ta dva ispitivanja utvrđena je znatna vremenska odgoda kada je riječ o napretku invalidnosti (smanjenje rizika za 31 % zahvaljujući lijeku Extavia) i kada je riječ o vezanosti za invalidska kolica (39 %).
English: An overview of Extavia and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Extavia i zašto je odobren u EU-u
English: The active substance in Extavia is the protein interferon beta-1b, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Croatian: Djelatna tvar lijeka Extavia je protein interferon beta-1b, jedan iz skupine interferona koji tijelo prirodno proizvodi kako bi se lakše borilo protiv virusa i drugih napada.
English: In a study involving 487 patients with a single demyelinating event, treatment with Extavia for two years was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Extavia developed MS, compared with 45% of those who received placebo.
Croatian: U ispitivanju koje je obuhvatilo 487 bolesnika s jednokratnim događajem demijelinizacije, utvrđeno je da se uzimanjem lijeka Extavia tijekom dvije godine smanjuje rizik od razvijanja klinički jasnog MS-a: u 28 % bolesnika koji su primali lijek Extavia razvio se MS, u usporedbi s 45 % bolesnika koji su primali placebo.
English: Why is Extavia authorised in the EU?
Croatian: Zašto je lijek Extavia odobren u EU-u?
English: The exact way that Extavia works in MS is not yet known but the active substance, interferon beta-1b, seems to calm down the immune system, and prevents relapses of MS.
Croatian: Još uvijek nije potpuno poznato na koji način lijek Extavia djeluje kod MS-a, ali čini se da djelatna tvar interferon beta-1b smiruje imunosni sustavi i sprječava relapse MS-a.
English: In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Croatian: Kod MS-a imunosni sustav ne radi ispravno i napada dijelove središnjeg živčanog sustava (mozak, kralježničnu moždinu i optički živac [živac šalje signale iz oka u mozak]) te uzrokuje upalu koja oštećuje živce i njihov izolacijski sloj.
English: The patients can inject Extavia themselves once they have been trained.
Croatian: Bolesnici si mogu sami ubrizgavati lijek Extavia kada ih se osposobi za to.
English: Extavia is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms.
Croatian: Lijek Extavia dostupan je u obliku praška ili otapala za pripremu otopine koja je dovoljna za dozu lijeka od 250 mikrograma.
English: Extavia contains the active substance interferon beta-1b.
Croatian: Extavia sadrži djelatnu tvar interferon beta-1b.
English: Extavia was studied over a two-year period in 338 patients with relapsing remitting MS who were able to walk unaided, where its effectiveness was compared with placebo (a dummy treatment).
Croatian: Lijek Extavia ispitivan je tijekom razdoblja od dvije godine u 338 bolesnika s relapsno-remitirajućim MSom koji su se mogli kretati bez pomoći, a njegova je učinkovitost uspoređena s placebom (prividnim liječenjem).
English: Extavia has also been studied in 1,657 patients in two studies involving secondary progressive MS patients who were able to walk, where it was compared with placebo.
Croatian: Lijek Extavia ispitivan je i u dvama ispitivanjima na 1 657 bolesnika sa sekundarnim progresivnim MS-om koji su se mogli kretati i uspoređen je s placebom.
English: What benefits of Extavia have been shown in studies?
Croatian: Koje su koristi od lijeka Extavia utvrđene u ispitivanjima?
English: It is used when the patient is considered to be at high risk of developing MS. Before using Extavia, doctors need to exclude other causes for the symptoms;
Croatian: Prije uporabe lijeka Extavia liječnik mora isključiti druge uzroke simptoma;
English: For the full list of side effects and restrictions with Extavia, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s lijekom Extavia potražite u uputi o lijeku.
English: How does Extavia work?
Croatian: Kako djeluje Extavia?
English: How is Extavia used?
Croatian: Kako se Extavia primjenjuje?
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 22 March 2017
Croatian: Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” prestale su 22. Ožujka 2017.
English: This summary was last updated in 03-2017.
Croatian: Ovaj sažetak je posljednji put ažuriran u 03-2017.
English: − familial mediterranean fever (FMF);
Croatian: − obiteljske mediteranske vrućice (FMF);
English: Ilaris was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Croatian: Lijek Ilaris prvobitno je odobren u „iznimnim okolnostima” zbog toga što su, iz znanstvenih razloga, u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije.
English: The full EPAR for Ilaris can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Ilaris nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Ilaris must not be used in patients with active or severe infection.
Croatian: Ilaris se ne smije koristiti u bolesnika s aktivnom ili teškom infekcijom.
English: The proportion of patients with no relapse was lower (around 57%) for children aged 2 to 4 years.
Croatian: Postotak bolesnika bez ponovne pojave bolesti bio je niži (oko 57 %) u djece u dobi od dvije do četiri godine.
English: Periodic fever syndromes
Croatian: Sindromi periodične vrućice
English: Some infections were unusual or opportunistic infections due to reduced white blood cell levels.
Croatian: Neke su infekcije bile atipične ili oportune, uslijed smanjenog broja bijelih krvnih stanica.
English: Ilaris is a medicine for treating the following inflammatory conditions:
Croatian: Ilaris je lijek koji se upotrebljava za liječenje sljedećih upalnih stanja:
English: This is a summary of the European public assessment report (EPAR) for Ilaris.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Ilaris.
English: Other information about Ilaris
Croatian: Ostale informacije o lijeku Ilaris
English: What measures are being taken to ensure the safe and effective use of Ilaris?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ilaris?
English: The most common infections were of the nose and throat.
Croatian: Najčešće su to bile infekcije nosa i grla.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ilaris on 23 October 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Ilaris u promet koje vrijedi na prostoru Europske unije od 23. listopada 2009.
English: What is Ilaris and what is it used for?
Croatian: Što je Ilaris i za što se koristi?
English: − hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD);
Croatian: − sindroma hiperimunoglobulina D (HIDS) / nedostatka mevalonat-kinaze (MKD);
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits seen with Ilaris outweigh its risks and recommended that it be authorised in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Ilaris nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The company that markets Ilaris will provide doctors who will use Ilaris with educational material containing the prescribing information, the patient reminder card and information for doctors containing important safety information about Ilaris, including precautions to be taken when using the medicine.
Croatian: Tvrtka koja stavlja na tržište lijek Ilaris dostavit će liječnicima koji će primjenjivati Ilaris edukativne materijale koji sadrže informacije o propisivanju lijeka, podsjetnik za bolesnike i informacije za liječnike koje sadrže važne sigurnosne informacije o lijeku Ilaris, uključujući i mjere opreza koje se moraju poduzeti prilikom primjene lijeka.
English: The main risk with this medicine is infection, mostly affecting the nose and throat.
Croatian: Glavni rizik primjene lijeka predstavlja pojava infekcija, i to uglavnom nosa i grla.
English: By attaching to interleukin-1 beta, canakinumab blocks its activity, helping to reduce inflammation thereby relieving the symptoms of the diseases.
Croatian: Vezivanjem na interleukin-1 beta canakinumab inhibira njegovo djelovanje te pomaže pri smanjenju upale i ublažavanju simptoma bolesti.
English: Ilaris treatment also allowed patients to reduce the amount of steroids they take to control inflammation.
Croatian: Terapija lijekom Ilaris također je omogućila bolesnicima da smanje količinu steroida koje uzimaju radi kontrole upalnog stanja.
English: The active substance in Ilaris, canakinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a messenger molecule or ‘cytokine' in the body called interleukin-1 beta.
Croatian: Djelatna tvar u lijeku Ilaris je canakinumab, monoklonsko protutijelo (vrsta bjelančevine) dizajnirano na način da prepoznaje i veže se na glasničku molekulu u tijelu ili „citokin” naziva interleukin-1 beta.
English: − cryopyrin-associated periodic syndromes (CAPS);
Croatian: − periodičnih sindroma povezanih s kriopirinom (CAPS);
English: Ilaris can only be obtained with a prescription.
Croatian: Ilaris se izdaje samo na recept.
English: After proper training, patients or their caregivers may inject Ilaris themselves if the doctor deems it appropriate (for gouty arthritis the medicine should always be given by a healthcare professional).
Croatian: Nakon odgovarajuće obuke oboljele osobe ili njihovi njegovatelji mogu sami davati injekcije lijeka Ilaris ako liječnik to smatra primjerenim (u slučaju uričnog artritisa lijek uvijek mora davati zdravstveni radnik).
English: Ilaris is given as a single injection under the skin every 8 weeks for CAPs and every 4 weeks for the other periodic fever syndromes (TRAPS, HIDS/MKD and FMF) and Still's disease.
Croatian: Za liječenje CAPS-a Ilaris se daje kao jednokratna injekcija pod kožu svakih osam tjedana, a svaka četiri tjedna za liječenje sindroma periodične vrućice (TRAPS, HIDS/MKD i FMF) te Stillove bolesti.
English: Injections are usually given in the upper thigh, upper arm, abdomen or buttocks.
Croatian: Injekcije se obično daju u gornji dio bedra, nadlakticu, trbuh ili stražnjicu.
English: In patients with gouty arthritis, a single injection is given on-demand to treat gouty arthritis attacks.
Croatian: U pacijenata s uričnim artritisom jednokratna injekcija daje se po potrebi za liječenje napadaja uričnog artritisa.
English: In patients taking Ilaris, after 3 days, the pain level was reduced from 74 to 25 (on a standard rating scale from 0 to 100), whereas in patients taking the comparator the pain level was reduced from 74 to 35.
Croatian: U bolesnika koji su uzimali lijek Ilaris, nakon tri dana razina boli smanjena je sa 74 na 25 (na standardnoj ljestvici od 0 do 100), dok je kod bolesnika koji su uzimali usporedni lijek razina boli smanjena sa 74 na 35.
English: The risk of developing a new gouty arthritis attack was also reduced with Ilaris (17% with Ilaris versus 37% with triamcinolone acetonide).
Croatian: Rizik od nastupa novog napadaja uričnog artritisa također je smanjen s lijekom Ilaris (17 % s lijekom Ilaris u odnosu na 37 % s triamcinolon acetonidom).
English: It is not intended to provide practical advice on how to use Ilaris.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Ilaris.
English: • 4 types of periodic fever syndromes (diseases marked by recurring inflammation and fever) in adults and children aged 2 and above:
Croatian: • četiriju vrsta sindroma periodične vrućice (bolesti za koje su karakteristične ponavljajuća upala i vrućica) u odraslih osoba i djece u dobi od dvije godine i starije:
English: • Gouty arthritis, painful inflammation of the joints caused by deposit of urate crystals (in adults).
Croatian: • uričnog artritisa, bolne upale zglobova uzrokovane taloženjem kristala urata (u odraslih osoba).
English: Because of the similarities between childhood Still's disease and the adult form (adult-onset Still's disease, AOSD), Ilaris is expected to have similar benefits in adults.
Croatian: Zbog sličnosti između Stillove bolesti dječje dobi i Stillove bolesti odrasle dobi (AOSD), očekuje se da će lijek Ilaris imati slične koriste i u odraslih osoba.
English: Why is Ilaris approved?
Croatian: Zašto je lijek Ilaris odobren?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ilaris 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 Ilaris nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.