FrancophonIA/ELRC3.0 huggingface dataset:
English: This could be serious (see “If you stop taking Gilenya” in section 3, and also section 4, “Possible side effects”).
Croatian: To može biti ozbiljno (vidjeti „Ako prestanete uzimati Gilenyu“ u dijelu 3 i također dio 4 „Moguće nuspojave“).
English: • What GILENYA is and how it works;
Croatian: • Što je GILENYA i kako djeluje;
English: What is multiple sclerosis
Croatian: Što je multipla skleroza
English: Due to the long half-life of natalizumab, elimination usually takes up to 2-3 months following discontinuation.
Croatian: Zbog dugog poluvijeka natalizumaba, eliminacija obično traje do 2-3 mjeseca nakon prekida primjene.
English: • Medicines that slow the heartbeat (for example beta blockers, such as atenolol).
Croatian: • Lijekove koji usporavaju otkucaje srca (primjerice beta blokatori, poput atenolola).
English: Symptoms of PRES are usually reversible but may evolve into ischaemic stroke or cerebral haemorrhage.
Croatian: Simptomi PRES-a obično su reverzibilni ali mogu se razviti u ishemijski moždani udar ili moždano krvarenje.
English: While you are taking Gilenya (and for up to 2 months after you stop taking it), you may get infections more easily.
Croatian: Dok uzimate Gilenyu (i do 2 mjeseca nakon što je prestanete uzimati), mogli biste lakše dobiti neku infekciju.
English: Bradycardia Atrioventricular block
Croatian: Bradikardija Atrioventrikularni blok
English: The macula is a small area of the retina at the back of the eye which enables you to see shapes, colours, and details clearly and sharply.
Croatian: Makula („žuta pjega“) je malo područje mrežnice u stražnjem dijelu oka koje Vam omogućuje da jasno i oštro vidite oblike, boje i pojedinosti.
English: Do not use Gilenya during pregnancy, if you are trying to become pregnant or if you are a woman who could become pregnant and you are not using effective contraception.
Croatian: Nemojte koristiti Gilenyu tijekom trudnoće, ako pokušavate zatrudnjeti ili ako ste žena koja bi mogla zatrudnjeti i ne koristite učinkovitu kontracepciju.
English: Irregular heartbeat usually returns to normal in less than one day.
Croatian: Nepravilni otkucaji srca obično se vraćaju u normalu za manje od jednog dana.
English: • What multiple sclerosis is;
Croatian: • Što je multipla skleroza;
English: Other enzymes like CYP3A4 may also contribute to its metabolism, notably in the case of strong induction of CYP3A4.
Croatian: Drugi enzimi poput CYP3A4 također mogu doprinijeti njegovom metabolizmu, osobito u slučaju snažne indukcije CYP3A4.
English: Without an accelerated elimination procedure, clearance of teriflunomide from plasma can take from several months up to 2 years.
Croatian: Bez postupka ubrzane eliminacije, klirens teriflunomida iz plazme može trajati od nekoliko mjeseci do 2 godine.
English: Delay in diagnosis and treatment may lead to permanent neurological sequelae.
Croatian: Odgađanje dijagnoze i liječenja može dovesti do trajnih neuroloških posljedica.
English: • Importance of reporting adverse reactions;
Croatian: • Važnost prijavljivanja nuspojava;
English: - Immunodeficiency syndrome.
Croatian: - Sindrom imunodeficijencije.
English: Alemtuzumab has profound and prolonged immunosuppressive effects.
Croatian: Alemtuzumab ima snažne i produljene imunosupresivne učinke.
English: Gilenya helps to protect against attacks on the CNS by the immune system by reducing the ability of some white blood cells (lymphocytes) to move freely within the body and by stopping them from reaching the brain and spinal cord.
Croatian: Gilenya pomaže zaštititi SŽS od napada imunološkog sustava tako što smanjuje sposobnost nekih bijelih krvnih stanica (limfocita) da se slobodno kreću po tijelu i sprječava ih da dospiju do mozga i kralježnične moždine.
English: Fingolimod highly distributes in red blood cells, with the fraction in blood cells of 86%.
Croatian: Fingolimod se velikim dijelom distribuira u crvene krvne stanice, s udjelom u krvnim stanicama od 86%.
English: During treatment, patients receiving Gilenya should be instructed to report promptly symptoms of infection to their physician.
Croatian: Za vrijeme liječenja, bolesnike koji primaju Gilenyu treba uputiti da odmah prijave simptome infekcije svome liječniku.
English: Fingolimod can induce bradycardia upon treatment initiation.
Croatian: Fingolimod može izazvati bradikardiju na početku liječenja.
English: • One case with very suggestive chronology of the event with compatible outcome then dechallenge and re-challenge positive
Croatian: • Jedan slučaj s vrlo sugestivnom kronologijom događaja s kompatibilnim ishodom i zatim pozitivnim dechallenge-om i rechallenge-om
English: Gilenya is used in adults and in children and adolescents (10 years of age and above) to treat relapsing-remitting multiple sclerosis (MS), more specifically in: - Patients who have failed to respond despite treatment with an MS treatment.
Croatian: Gilenya se koristi kod odraslih osoba i u djece i adolescenata (10 godina starosti i više) za liječenje relapsno-remitirajuće multiple skleroze (MS), odnosno kod: - Bolesnika kod kojih nije bilo odgovora usprkos liječenju terapijom za MS.
English: Macular oedema can cause some of the same vision symptoms as an MS attack (optic neuritis).
Croatian: Makularni edem može uzrokovati neke od istih simptoma s vidom kao i napadaj MS-a (optički neuritis).
English: - Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1).
Croatian: - Bolesnici s visoko aktivnom bolešću unatoč cjelovitom i odgovarajućem ciklusu liječenja barem jednom terapijom koja modificira tijek bolesti (za iznimke i informacije o razdobljima ispiranja vidjeti dijelove 4.4 i 5.1).
English: The swelling usually happens in the first 4 months of Gilenya treatment.
Croatian: Oticanje se obično događa u prva 4 mjeseca liječenja Gilenyom.
English: Low lymphocyte counts are maintained with chronic daily dosing.
Croatian: Niski broj limfocita održava se kroničnim dnevnim doziranjem.
English: - Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
Croatian: - Bolesnici s povećanim rizikom od oportunističkih infekcija, uključujući imunokompromitirane bolesnike (što uključuje one koji trenutno primaju imunosupresivnu terapiju ili one koji su imunokompromitirani zbog prethodne terapije).
English: Your doctor may want you to undergo an eye examination, especially if: - the centre of your vision gets blurry or has shadows; - you develop a blind spot in the centre of your vision; - you have problems seeing colours or fine detail.
Croatian: Liječnik će možda zatražiti da obavite očni pregled, osobito ako: - središte Vašeg vidnog polja postane mutno ili ima sjene, - razvijete slijepu pjegu u središtu vidnog polja, - imate poteškoća u razabiranju boja ili sitnijih detalja.
English: Before you start Gilenya, a skin examination is required to check whether you have any skin nodules.
Croatian: Prije nego počnete uzimati Gilenyu, morate obaviti pregled kože kako bi se provjerilo imate li bilo kakvih čvorića na koži.
English: Do not use any pack that is damaged or shows signs of tampering.
Croatian: Ne koristiti ako je pakiranje oštećeno ili su vidljivi znakovi otvaranja.
English: After oral administration, about 81% of the dose is slowly excreted in the urine as inactive metabolites.
Croatian: Nakon peroralne primjene, oko 81% doze polako se izlučuje u mokraći u obliku inaktivnih metabolita.
English: The pharmacologically active metabolite responsible for efficacy is fingolimod phosphate.
Croatian: Farmakološki aktivni metabolit odgovoran za djelotvornost je fingolimodfosfat.
English: Therefore, blood pressure should be regularly monitored during treatment with Gilenya.
Croatian: Stoga je potrebno redovito pratiti krvni tlak za vrijeme liječenja Gilenyom.
English: Patients with severe lung problems or with smoker's cough may have a higher chance of developing side effects.
Croatian: Kod bolesnika koji imaju teške plućne probleme ili pušački kašalj mogla bi postojati veća vjerojatnost za razvoj nuspojava.
English: • Physicians should provide patients/parents/caregivers with the patient/parents/caregiver guide and with the pregnancy-specific patient reminder card.
Croatian: • Liječnici trebaju osigurati bolesnicima/roditeljima/skrbnicima vodič za bolesnike/roditelje/skrbnike i karticu za bolesnice s podsjetnikom specifičnu za pitanje trudnoće.
English: Your doctor will consider whether you need to have a vaccination against HPV before starting treatment.
Croatian: Vaš liječnik će razmotriti trebate li se cijepiti cjepivom protiv HPV-a prije započinjanja liječenja.
English: Nausea***
Croatian: Mučnina***
English: Gilenya can pass into breast milk and there is a risk of serious side effects for the baby.
Croatian: Gilenya može prijeći u majčino mlijeko i postoji rizik od ozbiljnih nuspojava za dijete.
English: Fingolimod and fingolimod phosphate are highly protein bound (>99%).
Croatian: Fingolimod i fingolimodfosfat u velikoj mjeri vežu se za proteine plazme (>99%).
English: Surveillance should include vigilance for both skin malignancies and mycosis fungoides.
Croatian: Nadzor treba uključivati oprez za oboje, i maligne bolesti kože i fungoidnu mikozu.
English: Eighteen percent of patients reached a minimal count below 200 cells/microlitre on at least one occasion.
Croatian: Osamnaest posto bolesnika postiglo je minimalan broj od manje od 200 stanica po mikrolitru barem u jednom navratu.
English: The maximal decline in heart rate is seen within 6 hours post dose, with 70% of the negative chronotropic effect achieved on the first day.
Croatian: Maksimalno sniženje srčane frekvencije vidi se unutar 6 sati nakon uzimanja doze, pri čemu se 70% negativnog kronotropnog učinka postiže prvog dana.
English: Gilenya is not intended for use in children below 10 years old as it has not been studied in MS patients in this age group.
Croatian: Gilenya nije namijenjena za upotrebu u djece mlađe od 10 godina, budući da nije bila ispitivana u bolesnika oboljelih od MS-a u ovoj dobnoj skupini.
English: Basal cell carcinoma
Croatian: Bazocelularni karcinom
English: Following single oral administration of [
Croatian: Nakon jednokratne peroralne primjene [
English: During and for up to two months after treatment with Gilenya vaccination may be less effective.
Croatian: Tijekom i do dva mjeseca nakon terapije Gilenyom cijepljenje bi moglo biti manje učinkovito.
English: o GILENYA must be stopped 2 months before planning a pregnancy.
Croatian: o Primjena GILENYE se mora prekinuti 2 mjeseca prije planiranja trudnoće.
English: Fingolimod was neither mutagenic nor clastogenic in animal studies.
Croatian: Fingolimod nije bio mutagen niti klastogen u ispitivanjima na životinjama.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for fingolimod, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za fingolimod, znanstveni zaključci CHMP-a su sljedeći:
English: Fingolimod and its metabolites crossed the placental barrier in pregnant rabbits.
Croatian: Fingolimod i njegovi metaboliti prešli su placentarnu barijeru u skotnih kunića.
English: It also explains what you should do to avoid becoming pregnant while you are taking Gilenya.
Croatian: Također je objašnjeno što trebate raditi kako biste izbjegli trudnoću dok uzimate Gilenyu.
English: Be sure to tell your doctor about any changes in your vision.
Croatian: Svakako obavijestite svog liječnika ako osjetite ikakve promjene u svom vidu.
English: This will usually go back to normal within 2 months of stopping treatment.
Croatian: On će se obično vratiti na normalu u roku od 2 mjeseca nakon prekida liječenja.
English: Blood levels of fingolimod and fingolimod phosphate decline in parallel in the terminal phase, leading to similar half-lives for both.
Croatian: Razine fingolimoda i fingolimodfosfata u krvi opadaju paralelno u terminalnoj fazi, što dovodi do sličnog poluvijeka za obje komponente.
English: Your doctor may have to do a blood test in order to exclude such abnormalities.
Croatian: Liječnik će možda morati obaviti krvnu pretragu da bi se isključili takvi poremećaji.
English: • Patients should read the package leaflet thoroughly before starting treatment and should keep it in case they need to refer to it again during treatment;
Croatian: • Bolesnici trebaju temeljito pročitati uputu o lijeku prije početka liječenja i trebaju je sačuvati u slučaju da je trebaju opet pročitati tijekom liječenja;
English: However, at initiation of treatment you will have to stay at the doctor's surgery or clinic for 6 hours after taking the first dose of Gilenya.
Croatian: Međutim, na početku liječenja morat ćete ostati u liječničkoj ambulanti ili klinici tijekom 6 sati nakon uzimanja prve doze Gilenye.
English: • Physicians should assess Tanner staging and measure height and weight as per standard of care;
Croatian: • Liječnik treba ocijeniti stupanj razvoja po Tanner-u i izmjeriti visinu i težinu prema standardu medicinske skrbi;
English: OUTER CARTON OF MULTIPACK CONTAINING WALLETS (WITH BLUE BOX)
Croatian: VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA KOJE SADRŽI OVITKE U OBLIKU NOVČANIKA (S PLAVIM OKVIROM)
English: If patients report visual disturbances at any time while on therapy, evaluation of the fundus, including the macula, should be carried out.
Croatian: Ako bolesnici prijave smetnje vida u bilo kojem trenutku dok primaju terapiju, treba učiniti pregled fundusa, uključujući makulu.
English: Caution patients against exposure to sunlight without protection.
Croatian: Upozorite bolesnike da se ne izlažu sunčevom svjetlu bez zaštite.
English: Caution is required in these subgroups due to very limited knowledge available from the clinical study.
Croatian: Potreban je oprez u ovim podskupinama zbog vrlo ograničenog znanja dostupnog iz kliničkih ispitivanja.
English: • Stopping GILENYA therapy may result in return of disease activity.
Croatian: • Prestanak liječenja GILENYOM može dovesti do povratka aktivnosti bolesti.
English: MS is a long-term condition that affects the central nervous system (CNS), comprised of the brain and spinal cord.
Croatian: MS je dugotrajno stanje koje pogađa središnji živčani sustav (SŽS), kojeg čine mozak i kralježnična moždina.
English: Single doses up to 80 times the recommended dose (0.5 mg) were well tolerated in healthy adult volunteers.
Croatian: Pojedinačne doze do 80 puta veće od preporučene doze (0,5 mg) zdravi odrasli dobrovoljci su dobro podnosili.
English: Before you start Gilenya, your doctor will confirm whether you have enough white blood cells in your blood and may want to repeat a check regularly.
Croatian: Prije nego što počnete liječenje Gilenyom, liječnik će potvrditi imate li dovoljno bijelih krvnih stanica u krvi i možda će htjeti to redovito provjeravati.
English: Prior to launch of GILENYA in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Croatian: Prije stavljanja u promet GILENYE u svakoj državi članici nositelj odobrenja mora se usuglasiti s nadležnim nacionalnim tijelom oko sadržaja i formata edukativnog programa, uključujući komunikacijske medije, načine distribucije i sve druge aspekte programa.
English: Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:
Croatian: Gilenya je indicirana kao monoterapija koja modificira tijek bolesti u visoko aktivne relapsnoremitirajuće multiple skleroze u sljedećim skupinama odraslih bolesnika i pedijatrijskih bolesnika u dobi od 10 i više godina:
English: Fingolimod phosphate Cmax was slightly decreased by 34% but AUC was unchanged.
Croatian: Cmax fingolimodfosfata bio je blago snižen za 34%, ali AUC je bio nepromijenjen.
English: The patient was excluded from the full analysis and safety set.
Croatian: Bolesnik je isključen iz potpunog skupa podataka za analizu i skupa za sigurnosnu analizu.
English: Your doctor may switch you directly from beta interferon, glatiramer acetate or dimethyl fumarate to Gilenya if there are no signs of abnormalities caused by your previous treatment.
Croatian: Liječnik će Vas možda odmah prebaciti s liječenja beta interferonom, glatirameracetatom ili dimetilfumaratom na liječenje Gilenyom ako nema znakova poremećaja uzrokovanih Vašim prethodnim liječenjem.
English: • Patients should ensure medication compliance and avoid misuse, especially treatment interruption, and repeat cardiac monitoring;
Croatian: • Bolesnici trebaju osigurati suradljivost u uzimanju terapije te izbjegavati pogrešnu primjenu lijeka, naročito prekid liječenja i ponavljati praćenje srca;
English: These patients should not receive concomitant phototherapy with UV-B-radiation or PUVA-photochemotherapy.
Croatian: Ovi bolesnici ne smiju primiti istodobnu fototerapiju s UV-B zračenjem ili PUVA-fotokemoterapiju.
English: Drug exposure in rats at this dose was similar to that in patients at the therapeutic dose (0.5 mg).
Croatian: Izloženost lijeku u toj dozi u štakora bila je slična onoj u bolesnika na terapijskoj dozi (0,5 mg).
English: You will probably not notice any symptoms but if you notice yellowing of your skin or the whites of your eyes, abnormally dark urine or unexplained nausea and vomiting, tell your doctor straight away.
Croatian: Vjerojatno nećete osjetiti nikakve simptome, ali ako primijetite žutilo kože ili bjeloočnica, neuobičajeno tamnu mokraću ili neobjašnjivu mučninu i povraćanje, odmah o tome obavijestite svoga liječnika.
English: You must use effective contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).
Croatian: Morate koristiti učinkovitu kontracepciju tijekom liječenja i tijekom 2 mjeseca nakon prekida liječenja (vidjeti dio „Trudnoća i dojenje“).
English: Your chance of developing macular oedema is higher if you have diabetes or have had an inflammation of the eye called uveitis.
Croatian: Mogućnost da će se kod Vas razviti makularni edem veća je ako imate šećernu bolest ili ste imali upalu oka koja se zove uveitis.
English: Gilenya is not expected to have an influence on your ability to drive and use machines.
Croatian: Ne očekuje se da bi Gilenya mogla utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: Adverse reactions reported with Gilenya 0.5 mg in Studies D2301 (FREEDOMS) and D2309 (FREEDOMS II) are shown below.
Croatian: Nuspojave prijavljene za Gilenyu od 0,5 mg u ispitivanjima D2301 (FREEDOMS) i D2309 (FREEDOMS II) prikazane su u nastavku.
English: Regarding the signal ‘autoimmune haemolytic anaemia (AIHA)', the PRAC concluded that the cumulative review provided by the MAH as well as the plausible theoretical mechanism support a causal relationship between therapy with fingolimod and occurrence of AIHA:
Croatian: U vezi sa signalom „autoimune hemolitičke anemije (AIHA; od engl. autoimmune haemolytic anaemia)“, PRAC je zaključio da kumulativni pregled kojeg je dao nositelj odobrenja kao i vjerojatni teorijski mehanizam podržavaju uzročno-posljedičnu vezu između terapije fingolimodom i pojave AIHA-e:
English: Within 4-6 hours after the first dose of fingolimod 0.5 mg, the lymphocyte count decreases to approximately 75% of baseline in peripheral blood.
Croatian: U roku od 4 do 6 sati nakon prve doze fingolimoda od 0,5 mg, broj limfocita se smanjuje na približno 75% od početne vrijednosti u perifernoj krvi.
English: Pooled results of Studies D2301 and D2302 showed a consistent and statistically significant reduction in annualised relapse rate compared to comparator in subgroups defined by gender, age, prior multiple sclerosis therapy, disease activity or disability levels at baseline.
Croatian: Objedinjeni rezultati ispitivanja D2301 i D2302 pokazali su dosljedno i statistički značajno smanjenje godišnje stope relapsa u usporedbi s lijekom usporedbe u podskupinama definiranima prema spolu, dobi, prethodnoj terapiji za multiplu sklerozu, aktivnosti bolesti ili razinama onesposobljenosti na početku.
English: MRI analyses used evaluable dataset.
Croatian: Analize MRI koristile su podatke koji su se mogli ocjenjivati.
English: During and for up to 2 months after treatment with Gilenya, you should not receive certain types of vaccine (live attenuated vaccines) as they could trigger the infection that they were supposed to prevent.
Croatian: Za vrijeme i do 2 mjeseca nakon liječenja Gilenyom ne smijete primiti određene vrste cjepiva (živa oslabljena cjepiva) jer bi ona mogla potaknuti infekciju koju bi inače trebala sprječiti.
English: There are no data on the effects of fingolimod on labour and delivery.
Croatian: Nema podataka o učincima fingolimoda na trudove i porod.
English: Malignant melanoma****
Croatian: Maligni melanom****
English: Gilenya can generally be started immediately after discontinuation of interferon or glatiramer acetate.
Croatian: Liječenje Gilenyom općenito se može započeti odmah nakon prekida uzimanja interferona ili glatirameracetata.
English: Patients with symptoms and signs consistent with cryptococcal meningitis (e.g. headache accompanied by mental changes such as confusion, hallucinations, and/or personality changes) should undergo prompt diagnostic evaluation.
Croatian: Bolesnike sa simptomima i znakovima koji odgovaraju kriptokoknom meningitisu (npr. glavobolja popraćena mentalnim promjenama kao što su konfuzija, halucinacije i/ili promjene osobnosti) potrebno je odmah dijagnostički ocijeniti.
English: If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor is required to decide if Gilenya is appropriate for you.
Croatian: Ako ste se liječili alemtuzumabom, potrebna je temeljita procjena i razgovor s Vašim liječnikom da bi se odlučilo je li Gilenya primjerena za Vas.
English: If you have severe liver problems, you should not take Gilenya.
Croatian: Ako imate teške probleme s jetrom, ne smijete uzimati Gilenyu.
English: Hepatic enzyme increased (increased ALT, Gamma glutamyltransferase, Aspartate transaminase)
Croatian: Povišenje jetrenih enzima (povišeni ALT, gama glutamil transferaza, aspartat transaminaza)
English: A study in four healthy subjects who received a single intravenous dose of a radioiodolabelled analogue of fingolimod demonstrated that fingolimod penetrates into the brain.
Croatian: Ispitivanje provedeno na četiri zdrava ispitanika koji su primili jednokratnu intravensku dozu radiooznačenog analoga fingolimoda pokazalo je da fingolimod prodire u mozak.
English: Fingolimod is a sphingosine 1-phosphate receptor modulator.
Croatian: Fingolimod je modulator sfingozin 1-fosfat receptora.
English: - There are very limited data available in children between 10-12 years old, less than 40 kg or at Tanner stage <2 (see sections 4.8 and 5.1).
Croatian: Dostupni su vrlo ograničeni podaci u djece između 10-12 godina, težine manje od 40 kg ili stupanja razvoja po Tanner-u <2 (vidjeti dijelove 4.8 i 5.1).
English: What Gilenya is and what it is used for What you need to know before you take Gilenya How to take Gilenya
Croatian: Što je Gilenya i za što se koristi Što morate znati prije nego počnete uzimati Gilenyu Kako uzimati Gilenyu
English: Since there is a potential risk of malignant skin growths, patients treated with fingolimod should be cautioned against exposure to sunlight without protection.
Croatian: Budući da postoji potencijalni rizik od malignih izraslina kože, bolesnike liječene fingolimodom potrebno je upozoriti da se ne izlažu sunčevoj svjetlosti bez zaštite.