FrancophonIA/ELRC3.0 huggingface dataset:
English: While this interaction of teriflunomide is not expected to adversely impact the efficacy of oral contraceptives, it should be considered when selecting or adjusting oral contraceptive treatment used in combination with teriflunomide.
Croatian: Iako se ne očekuje da bi ova interakcija s teriflunomidom mogla negativno utjecati na djelotvornost oralnih kontraceptiva, treba ju uzeti u obzir pri odabiru ili prilagodbi terapije oralnim kontraceptivima u kombinaciji s teriflunomidom.
English: As AUBAGIO decreases the number of white cells in the blood this may affect your ability to fight the infection.
Croatian: Budući da AUBAGIO smanjuje broj bijelih krvnih stanica u krvi, može utjecati na sposobnost organizma da se bori protiv infekcije.
English: If discontinuation of the medicinal product is necessary, initiation of an accelerated elimination procedure should be considered.
Croatian: Ako je nužan prekid liječenja, potrebno je razmotriti iniciranje postupka ubrzane eliminacije.
English: Teriflunomide is extensively bound to plasma protein (>99%), probably albumin and is mainly distributed in plasma.
Croatian: Teriflunomid se u viskom stupnju veže za proteine u plazmi (>99%), najvjerojatnije albumin, te se uglavnom raspodjeljuje u plazmi.
English: AUBAGIO helps to protect against attacks on the central nervous system by the immune system by limiting the increase of some white blood cells (lymphocytes).
Croatian: AUBAGIO pomaže zaštititi središnji živčani sustav od napada imunološkog sustava tako što ograničava povećanje broja nekih bijelih krvnih stanica (limfocita).
English: AUBAGIO is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
Croatian: AUBAGIO je indiciran za liječenje odraslih bolesnika s relapsno-remitirajućom multiplom sklerozom (MS) (molimo pogledajte dio 5.1 za važne informacije o populacijama u kojih je utvrđena djelotvornost lijeka).
English: Since AUBAGIO tablets contain lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product.
Croatian: Budući da AUBAGIO tablete sadrže laktozu, bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Two clinical studies have shown that vaccinations to inactivated neoantigen (first vaccination), or recall antigen (reexposure) were safe and effective during AUBAGIO treatment.
Croatian: Dva klinička ispitivanja su pokazala da su cijepljenje inaktiviranim neoantigenom (prvo cijepljenje), ili tzv. recall antigenom (ponovno izlaganje) sigurni i učinkoviti tijekom liječenja lijekom AUBAGIO.
English: Immune system
Croatian: Imunološki sustav
English: AUBAGIO is used in adults to treat relapsing remitting multiple sclerosis (MS).
Croatian: AUBAGIO se koristi u odraslih osoba za liječenje relapsno-remitirajuće multiple skleroze (MS).
English: Pregnancy must be excluded before start of treatment (see section 4.6).
Croatian: Prije početka liječenja mora se isključiti trudnoća (vidjeti dio 4.6).
English: • To remind patients to show the Patient Education Card to Doctors/HCPs involved with their medical care (especially in the event of medical emergencies and/or if new Doctors/HCPs are involved.)
Croatian: • podsjetnik za bolesnike da moraju pokazati Edukacijsku karticu za bolesnike liječnicima/zdravstvenim radnicima koji sudjeluju u njihovu liječenju (osobito u slučaju hitnih medicinskih stanja i/ili uključivanja novih liječnika/zdravstvenih radnika u liječenje)
English: The mean duration of disease, since first symptoms, was 8.0 years.
Croatian: Srednje trajanje bolesti od pojave prvih simptoma iznosilo je 8,0 godina.
English: TOWER-study
Croatian: Ispitivanje TOWER
English: The elimination of the active substance may take up to 2 years to occur naturally.
Croatian: Uklanjanje djelatne tvari iz tijela prirodnim putem može potrajati i do 2 godine.
English: What AUBAGIO looks like and contents of the pack
Croatian: Kako AUBAGIO izgleda i sadržaj pakiranja
English: It is possible that rapidly lowering the blood level of teriflunomide, by instituting the accelerated elimination procedure described below, at the first delay of menses, may decrease the risk to the foetus.
Croatian: Moguće je da se brzim snižavanjem razine teriflunomida u krvi primjenom postupka ubrzane eliminacije, opisanog u nastavku, pri prvom kašnjenju menstruacije može smanjiti rizik za plod.
English: An accelerated elimination procedure can be used at any time after discontinuation of teriflunomide (see sections 4.6 and 5.2 for procedural details).
Croatian: Postupak ubrzane eliminacije može se primijeniti u bilo kojem trenutku nakon prekida primjene teriflunomida (za pojedinosti o postupku vidjeti dijelove 4.6 i 5.2).
English: The mean duration of disease, since first symptoms, was 8.7 years.
Croatian: Srednje trajanje bolesti od pojave prvih simptoma iznosilo je 8,7 godina.
English: Due to the design of the study, high disease activity was defined as 2 or more relapses in one year, and with one or more Gd-enhancing lesion on brain MRI.
Croatian: Zbog dizajna ispitivanja visoka aktivnost bolesti definira se kao 2 ili više relapsa tijekom jedne godine, s jednom ili više lezija imbibiranih gadolinijem pri MRI oslikavanju mozga.
English: Effect of teriflunomide on warfarin
Croatian: Učinak teriflunomida na varfarin
English: Severe infections including sepsis, sometimes fatal have been reported postmarketing.
Croatian: Teške infekcije uključujući sepsu, ponekad sa smrtnim ishodom, prijavljene su nakon stavljanja lijeka u promet.
English: However, there was no apparent impact of this increase in plasma rosuvastatin exposure on the HMG-CoA reductase activity.
Croatian: Međutim, povećanje izloženosti rosuvastatinu u plazmi nije imalo vidljivog utjecaja na aktivnost HMG-CoA reduktaze.
English: In either case it should be confirmed by a blood test that the active substance has been sufficiently removed from your body and you need confirmation from your treating physician that the blood level of AUBAGIO is low enough to allow you to become pregnant.
Croatian: U oba slučaja treba krvnim pretragama potvrditi da je djelatna tvar u dovoljnoj mjeri uklonjena iz tijela, a nadležni liječnik mora potvrditi da su razine lijeka AUBAGIO u krvi dovoljno niske da biste zatrudnjeli.
English: Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: There were no external malformations in the offspring of male rats administered teriflunomide prior to mating with untreated female rats.
Croatian: Nije došlo do vanjskih malformacija u potomstvu mužjaka štakora koji su primali teriflunomid prije parenja s neliječenim ženkama štakora.
English: The effect on red blood cell (RBC) (<2%) and platelet counts (<10%) was less pronounced.
Croatian: Učinak na broj eritrocita (<2%) i trombocita (<10%) bio je manje izražen.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where AUBAGIO is marketed, at launch and after launch, all healthcare professionals who are expected to use AUBAGIO are provided with the following items:
Croatian: Nakon razgovora i dogovora s nadležnim nacionalnim tijelima u svakoj državi članici na čijem se tržištu AUBAGIO nalazi, nositelj odobrenja mora se pobrinuti da prilikom stavljanja lijeka u promet i po njegovu stavljanju u promet svi zdravstveni radnici za koje se očekuje da će primjenjivati AUBAGIO dobiju sljedeće materijale:
English: After the rapid elimination procedure with cholestyramine, an additional 23.1% was recovered (mostly in feces).
Croatian: Nakon postupka ubrzane eliminacije kolestiraminom pronađeno je dodatnih 23,1% (uglavnom u fecesu).
English: Teriflunomide is a substrate of the efflux transporter BCRP, which could be involved in direct secretion.
Croatian: Teriflunomid je supstrat efluksnog transportnog proteina BCRP, koji bi mogao sudjelovati u izravnoj sekreciji.
English: Teriflunomide 70 mg daily was administered up to 14 days in healthy subjects.
Croatian: Teriflunomid u dozi od 70 mg na dan primjenjivan je tijekom najviše 14 dana u zdravih ispitanika.
English: AUBAGIO contains lactose
Croatian: AUBAGIO sadrži laktozu
English: Teriflunomide may cause serious birth defects when administered during pregnancy.
Croatian: Teriflunomid može prouzročiti ozbiljne prirođene mane ako se primjenjuje tijekom trudnoće.
English: The educational material for HealthCare Professionals (HCP) will include the following key elements:
Croatian: Edukacijski materijali za zdravstvene radnike moraju sadržavati sljedeće ključne elemente:
English: Teriflunomide is the main metabolite of leflunomide.
Croatian: Teriflunomid je glavni metabolit leflunomida.
English: Gender, Elderly, Paediatric patients
Croatian: Spol, starije osobe i pedijatrijska populacija
English: Frequencies were defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja definirana je sljedećim kategorijama: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000),
English: For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, monitoring must be performed weekly.
Croatian: Ako ALT (SGPT) poraste 2 do 3 puta iznad gornje granice normale, razine enzima se moraju određivati svaki tjedan.
English: In placebo-controlled studies, peripheral neuropathy, including both polyneuropathy and mononeuropathy (e.g., carpal tunnel syndrome), was reported more frequently in patients taking teriflunomide than in patients taking placebo.
Croatian: U placebom kontroliranim ispitivanjima periferna neuropatija, uključujući polineuropatiju i mononeuropatiju (npr. sindrom karpalnog tunela), češće je primijećena u bolesnika koji su uzimali teriflunomid nego u bolesnika koji su primali placebo.
English: Tablet coating hypromellose titanium dioxide (E171) talc macrogol 8000 indigo carmine aluminum lake (E132)
Croatian: Ovojnica tablete hipromeloza titanijev dioksid (E171) talk makrogol 8000 boja indigo carmine aluminum lake (E132)
English: Over 21 days, 60.1% of the administered dose is excreted via feces (37.5%) and urine (22.6%).
Croatian: Tijekom 21 dana 60,1% primijenjene doze izluči se putem fecesa (37,5%) i mokraće (22,6%).
English: The mechanism is thought to be by interruption of enterohepatic recycling and/or gastrointestinal dialysis of teriflunomide.
Croatian: Smatra se da taj mehanizam djeluje prekidom enterohepatičkog kruženja i/ili gastrointestinalne dijalize teriflunomida.
English: These elevations in transaminase occurred mostly within the first 6 months of treatment and were reversible after treatment cessation.
Croatian: Ta povišenja razine transaminaze pojavila su se uglavnom unutar prvih 6 mjeseci liječenja te su se povukla nakon prekida liječenja.
English: Repeated doses of teriflunomide had no effect on the pharmacokinetics of S-warfarin, indicating that teriflunomide is not an inhibitor or an inducer of CYP2C9.
Croatian: Ponovljene doze teriflunomida nisu utjecale na farmakokinetiku S-varfarina, što upućuje na to da teriflunomid nije ni inhibitor ni induktor CYP2C9.
English: As a result, toxicity in animals was found at exposures equivalent or below human therapeutic levels.
Croatian: Iz tog je razloga toksičnost u životinja utvrđena pri izloženostima koje su jednake ili manje od razina izloženosti pri liječenju u ljudi.
English: Within this safety population, the most commonly reported adverse reactions in the teriflunomide treated patients were: headache, diarrhoea, increased ALT, nausea, and alopecia.
Croatian: Unutar te sigurnosne populacije najčešće prijavljene nuspojave u bolesnika liječenih teriflunomidom bile su sljedeće: glavobolja, proljev, povišene vrijednosti ALT-a, mučnina i alopecija.
English: AUBAGIO contains the active substance teriflunomide which is an immunomodulatory agent and adjusts the immune system to limit its attack on the nervous system.
Croatian: AUBAGIO sadrži djelatnu tvar teriflunomid koja je imunomodulator i prilagođava imunološki sustav kako bi ograničio napad na živčani sustav.
English: Results of studies in animals have not shown an effect on fertility (see section 5.3).
Croatian: Rezultati ispitivanja na životinjama nisu pokazali utjecaj na plodnost (vidjeti dio 5.3).
English: Hepatic effects During placebo-controlled studies the following was detected:
Croatian: Učinci na jetru Tijekom placebom kontroliranih ispitivanja otkriveno je sljedeće:
English: The volume of distribution is 11 l after a single intravenous (IV) administration.
Croatian: Volumen distribucije nakon jednokratne intravenske (i.v.) primjene iznosi 11 l.
English: • Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT)
Croatian: • alanin aminotransferazu/serumsku glutamat-piruvat transaminazu (ALT/SGPT)
English: If a decision is made to stop treatment with AUBAGIO, during the interval of 5 half-lives (approximately 3.5 months although may be longer in some patients), starting other therapies will result in concomitant exposure to AUBAGIO.
Croatian: Ako se liječenje lijekom AUBAGIO odluči prekinuti, uvođenje drugih lijekova tijekom razdoblja od 5 poluvjekova (približno 3,5 mjeseci, iako u nekih bolesnika može biti i dulje) dovest će do istodobne izloženosti lijeku AUBAGIO.
English: The recommended dose of teriflunomide is 14 mg once daily.
Croatian: Preporučena doza teriflunomida je 14 mg jedanput na dan.
English: Animal studies have shown excretion of teriflunomide in milk.
Croatian: Ispitivanja na životinjama pokazala su da se teriflunomid izlučuje u mlijeko.
English: The CNS is made up of the brain and spinal cord.
Croatian: SŽS tvore mozak i kralježnična moždina.
English: In multiple sclerosis, inflammation destroys the protective sheath (called myelin) around the nerves in the CNS.
Croatian: U multiploj sklerozi upala uništava zaštitnu ovojnicu (zvanu mijelin) oko živaca u SŽS-u.
English: Teriflunomide is moderately metabolised and is the only component detected in plasma.
Croatian: Teriflunomid se umjereno metabolizira te je jedina komponenta otkrivena u plazmi.
English: If a patient taking AUBAGIO develops a confirmed peripheral neuropathy, consider discontinuing AUBAGIO therapy and performing the accelerated elimination procedure.
Croatian: Ako bolesnik koji prima AUBAGIO razvije potvrđenu perifernu neuropatiju, mora se razmotriti prekid liječenja lijekom AUBAGIO i primjena postupka ubrzane eliminacije.
English: The estimated female plasma exposure via the semen of a treated patient is expected to be 100 times lower than the plasma exposure after 14 mg of oral teriflunomide.
Croatian: Očekivana procijenjena izloženost u plazmi žene putem sperme liječenog bolesnika je 100 puta niža od izloženosti u plazmi nakon peroralne primjene 14 mg teriflunomida.
English: Following discontinuation of teriflunomide and the administration of cholestyramine 8 g three times a day, the plasma concentration of teriflunomide is reduced 52% at the end of day 1, 91% at the end of day 3, 99.2% at the end of day 7, and 99.9% at the completion of day 11.
Croatian: Nakon prekida liječenja teriflunomidom i primjene kolestiramina u dozi od 8 g triput na dan koncentracija teriflunomida u plazmi smanjena je za 52% na kraju 1. dana, 91% na kraju 3. dana, 99,2% na kraju 7. dana i 99,9% na kraju 11. dana.
English: Tell your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, as you need to ensure that most of this medicine has left your body before trying to become pregnant.
Croatian: Recite svome liječniku ako planirate zatrudnjeti nakon prekida liječenja lijekom AUBAGIO jer prije nego što pokušate ostati trudni morate biti sigurni da je najveći dio ovog lijeka uklonjen iz tijela.
English: During this period women should discuss any plans to stop or change contraception with the treating physician.
Croatian: Tijekom tog razdoblja žena treba s nadležnim liječnikom razgovarati o planovima za prekid kontracepcije ili promjenu metode kontracepcije.
English: No evidence of carcinogenicity was observed in rats and mice.
Croatian: U štakora i miševa nisu uočeni dokazi kancerogenosti.
English: If your test results show a problem with your liver, your doctor may stop your treatment with AUBAGIO.
Croatian: Ako rezultati pretraga upućuju na tegobe s jetrom, liječnik će možda prekinuti liječenje lijekom AUBAGIO.
English: The results from the TOPIC study confirmed the efficacy of teriflunomide in RRMS (including early RRMS with first clinical demyelinating event and MRI lesions disseminated in time and space).
Croatian: Rezultati iz TOPIC ispitivanja potvrdili su djelotvornost teriflunomida kod relapsno-remitirajuće multiple skleroze (RRMS) (uključujući ranu RRMS s prvim kliničkim demijelinizirajućim događajem i MRI lezijama diseminiranim u vremenu i prostoru).
English: If you take more AUBAGIO than you should
Croatian: Ako uzmete više lijeka AUBAGIO nego što ste trebali
English: However, this is most likely an underestimation since extensive organ distribution was observed in rats.
Croatian: Međutim, ta je procjena vjerojatno manja od prave vrijednosti jer je u štakora primijećena opsežna raspodjela u organe.
English: • Summary of Product Characteristics (SmPC)
Croatian: • Sažetak opisa svojstava lijeka (SmPC)
English: The safety profile of leflunomide in patients suffering from rheumatoid arthritis or psoriatic arthritis may be pertinent when prescribing teriflunomide in MS patients.
Croatian: Sigurnosni profil leflunomida u bolesnika koji boluju od reumatoidnog artritisa ili psorijatičnog artritisa može biti relevantan kada se teriflunomid propisuje oboljelima od multiple skleroze.
English: New onset or worsening pulmonary symptoms, such as persistent cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.
Croatian: Novi nastup ili pogoršanje plućnih simptoma, poput kašlja koji ne prolazi i dispneje, mogu biti razlogom za prekid liječenja i daljnje pretrage po potrebi.
English: Cases of severe skin reactions have been reported postmarketing (including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi teških kožnih reakcija (uključujući StevensJohnsonov sindrom i toksičnu epidermalnu nekrolizu).
English: ILD may occur acutely at any time during therapy with a variable clinical presentation.
Croatian: Intersticijska plućna bolest može se pojaviti akutno u bilo koje doba tijekom liječenja s varijabilnom kliničkom slikom.
English: After stopping treatment with teriflunomide:
Croatian: Nakon prekida liječenja teriflunomidom:
English: Patients with severe immunodeficiency states, e.g. acquired immunodeficiency syndrome (AIDS).
Croatian: Bolesnici s teškim imunodeficijentnim stanjima, npr. sindromom stečene imunodeficijencije (AIDS).
English: Based on the clinical data related to concomitant administration of teriflunomide with interferon beta or with glatiramer acetate, no waiting period is required when initiating teriflunomide after interferon beta or glatiramer acetate or when starting interferon beta or glatiramer acetate, after teriflunomide.
Croatian: Na temelju kliničkih podataka koji se odnose na istodobnu primjenu teriflunomida s interferonom beta ili s glatiramer acetatom nije potrebno razdoblje čekanja kada se liječenje teriflunomidom započinje nakon liječenja interferonom beta ili glatiramer acetatom, kao ni kada se primjena interferona beta ili glatiramer acetata započinje nakon liječenja teriflunomidom.
English: Systemic exposure increases in a dose proportional manner after oral administration teriflunomide from 7 to 14 mg.
Croatian: Sistemska izloženost povećava se proporcionalno dozi nakon peroralne primjene teriflunomida u dozi od 7 do 14 mg.
English: Blood pressure elevation should be appropriately managed before and during treatment with teriflunomide.
Croatian: Povišen krvni tlak treba liječiti na odgovarajući način prije i tijekom liječenja teriflunomidom.
English: AUBAGIO is available in cardboard cartons containing: - 14, 28, 84 and 98 tablets in wallet packs with integrated aluminium blisters; - 10x1 tablet in all aluminium perforated unit-dose blisters.
Croatian: AUBAGIO je dostupan u kartonskim kutijama koje sadrže: - 14, 28, 84 i 98 tableta u kartonskim ovicima s integriranim aluminijskim blisterima; - 10x1 tabletu u perforiranim aluminijskim blisterima s jediničnim dozama.
English: Anemia, decreased platelet counts and effects on the immune system, including leukopenia, lymphopenia and secondary infections, were related to the effects on the bone marrow and/or lymphoid organs.
Croatian: Anemija, smanjen broj trombocita i učinci na imunološki sustav, uključujući leukopeniju, limfopeniju i sekundarne infekcije, povezane su s učincima na koštanu srž i/ili limfoidne organe.
English: If skin and /or mucosal reactions are observed which raise the suspicion of severe generalised major skin reactions (Stevens-Johnson syndrome, or toxic epidermal necrolysis-Lyell's syndrome), teriflunomide and any other possibly associated treatment must be discontinued, and an accelerated procedure initiated immediately.
Croatian: Ako se primijete reakcije na koži/sluznici zbog kojih se sumnja na teške generalizirane ozbiljne kožne reakcije (Stevens-Johnsonov sindrom ili toksičnu epidermalnu nekrolizu - Lyellov sindrom), mora se prekinuti primjena teriflunomida i bilo koje druge terapije koja bi mogla biti povezana s time te odmah započeti postupak ubrzane eliminacije.
English: Your doctor will check your blood pressure before the start of treatment and regularly thereafter.
Croatian: Liječnik će Vam provjeriti krvni tlak prije početka liječenja i redovito ga kontrolirati nakon toga.
English: As a consequence teriflunomide reduces the proliferation of dividing cells that need de novo synthesis of pyrimidine to expand.
Croatian: Time teriflunomid smanjuje proliferaciju stanica koje se dijele i kojima je de novo sinteza pirimidina potrebna za širenje.
English: Pancreatitis, Stomatitis
Croatian: zubobolja pankreatitis, stomatitis
English: • Affects liver function
Croatian: • utječe na funkciju jetre
English: Patients with pre-existing liver disease and/or who consume substantial quantities of alcohol may be at increased risk of developing elevated liver enzymes when taking teriflunomide and should be closely monitored for signals of liver disease.
Croatian: U bolesnika s postojećom bolešću jetre i / ili bolesnika koji konzumiraju znatne količine alkohola može postojati povećan rizik od povišenja jetrenih enzima tijekom primjene teriflunomida pa te bolesnike treba pomno motriti kako bi se uočili mogući znakovi bolesti jetre.
English: What you need to know before you take AUBAGIO 3.
Croatian: Što morate znati prije nego počnete uzimati AUBAGIO
English: The minor metabolite TFMA (4-trifluoromethylaniline) caused mutagenicity and clastogenicity in vitro but not in vivo.
Croatian: Sporedni metabolit TFMA (4-trifluorometilanilin) uzrokovao je mutagenosti i klastogenost in vitro, ali ne i in vivo.
English: In the event of relevant overdose or toxicity, cholestyramine or activated charcoal is recommended to accelerate elimination.
Croatian: U slučaju značajnog predoziranja ili toksičnosti, preporučuje se primjena kolestiramina ili aktivnog ugljena za ubrzavanje eliminacije.