FrancophonIA/ELRC3.0 huggingface dataset:
English: The symptoms of PML may be similar to an MS relapse.
Croatian: Simptomi PML-a mogu biti slični relapsu MS-a.
English: In two healthy volunteer studies, the occurrence and severity of flushing over the dosing period was reduced.
Croatian: U dva ispitivanja sa zdravim dobrovoljcima smanjila se pojava i težina navale crvenila u razdoblju doziranja.
English:  Taking your medicine with food can help to reduce the side effects above
Croatian: Uzimanje lijeka s hranom može pomoći u smanjenju gore opisanih nuspojava.
English: There is no relevant use of Tecfidera in children aged less than 10 years for the indication of relapsing remitting multiple sclerosis.
Croatian: Nema relevantne primjene Tecfidere u djece mlađe od 10 godina za indikaciju relapsnoremitirajuće multiple skleroze.
English: Symptoms may include dyspnoea, hypoxia, hypotension, angioedema, rash or urticaria.
Croatian: Simptomi mogu uključivati dispneju, hipoksiju, hipotenziju, angioedem, osip ili urtikariju.
English: MRI imaging may be considered as part of increased vigilance in patients considered at increased risk of PML.
Croatian: Snimanje MR-om može se smatrati dijelom pojačanog praćenja u bolesnika za koje se smatra da imaju povećan rizik od PML-a.
English: The adverse reactions described in the Toxicology and Reproduction toxicity sections below were not observed in clinical studies, but were seen in animals at exposure levels similar to clinical exposure levels.
Croatian: Nuspojave opisane u dijelovima Toksikologija i Reproduktivna toksičnost, u nastavku, nisu bile proučavane u kliničkim ispitivanjima, ali su viđene u životinja na razinama izloženosti sličnim kliničkim razinama izloženosti.
English: - swelling of the face, lips, mouth or tongue (angioedema) - wheezing, difficulty breathing or shortness of breath (dyspnoea, hypoxia) - dizziness or loss of consciousness (hypotension)
Croatian: - oticanje lica, usana, usta ili jezika (angioedem) - piskanje, otežano disanje ili nedostatak zraka (dispneja, hipoksija) - omaglica ili gubitak svijesti (hipotenzija)
English: Consumption of moderate amounts of alcohol did not alter exposure to dimethyl fumarate and was not associated with an increase in adverse reactions.
Croatian: Konzumiranje umjerenih količina alkohola nije imalo utjecaja na izloženost dimetilfumaratu i nije bilo povezano s povećanjem nuspojava.
English: Capsule print (black ink)
Croatian: Otisak na kapsuli (crna tinta)
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP”.
English: Magnetic Resonance imaging (MRI)
Croatian: Snimanje magnetskom rezonancijom (MR)
English: The forestomach of mice and rats does not have a human counterpart.
Croatian: Predželudac miševa i štakora nema ekvivalenta u ljudi.
English: Your doctor will advise whether other types of vaccines (non-live vaccines) should be given.
Croatian: Liječnik će Vam savjetovati smijete li primiti neke druge vrste cjepiva (neživa cjepiva).
English: - liver inflammation and increase in levels of liver enzymes (ALT or AST in combination with bilirubin)
Croatian: - upala jetre i povišenje razina jetrenih enzima (ALT ili AST u kombinaciji s bilirubinom)
English: Overall, Cmax and AUC increased approximately doseproportionally in the dose range studied (120 mg to 360 mg).
Croatian: Cmax i AUC općenito su se povećavali približno proporcionalno dozi u ispitivanom rasponu (120 mg do 360 mg).
English: Dimethyl fumarate demonstrated therapeutic activity in multiple models of inflammatory and neuroinflammatory injury.
Croatian: Dimetilfumarat je pokazao terapijsku aktivnost u višestrukim modelima inflamacijske i neuroinflamacijske ozljede.
English: The time to onset can be directly, several weeks or longer.
Croatian: Te promjene mogu nastupiti odmah, nakon nekoliko tjedana ili nakon duljeg vremena.
English: Symptoms vary from patient to patient, but typically include walking difficulties, feeling off balance and visual difficulties (e.g. blurred or double vision).
Croatian: Simptomi variraju od bolesnika do bolesnika, ali obično uključuju teškoće pri hodanju, poremećaje ravnoteže i probleme s vidom (npr. zamućen vid ili dvoslike).
English: If you notice you are passing more urine, are more thirsty and drinking more than normal, your muscles seem weaker, you break a bone, or just have aches and pains, talk to your doctor as soon as possible so that this can be investigated further.
Croatian: Ako primijetite da mokrite više nego uobičajeno, da ste žedniji i pijete više tekućine nego inače, ako Vam se mišići čine slabijima, ako dođe do prijeloma kosti ili samo imate bolove, obratite se liječniku što prije kako bi se to dalje ispitalo.
English: The benefit/risk balance of the therapy should be reconsidered in discussion with the patient in the context of other therapeutic options available.
Croatian: Omjer koristi i rizika liječenja treba razmotriti u razgovoru s bolesnikom u kontekstu drugih raspoloživih terapijskih mogućnosti.
English: In placebo-controlled and uncontrolled clinical studies, a total of 2,468 patients have received Tecfidera and been followed for periods up to 4 years with an overall exposure equivalent to 3,588 person-years.
Croatian: U placebom kontroliranim i nekontroliranim kliničkim ispitivanjima, ukupno 2468 bolesnika primalo je Tecfideru i bili su praćeni tijekom razdoblja do 4 godine, s ukupnom izloženosti koja je ekvivalentna 3588 bolesnik-godina.
English: Importantly, Fanconi syndrome can occur without elevated creatinine levels or low glomerular filtration rate.
Croatian: Važno je imati na umu da se Fanconijev sindrom može pojaviti i bez povišenih razina kreatinina ili smanjene brzine glomerularne filtracije.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for dimethyl fumarate (multiple sclerosis), 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 dimetilfumarat (multipla skleroza), znanstveni zaključci CHMP-a su sljedeći:
English: Assessment of renal function (e.g. creatinine, blood urea nitrogen and urinalysis) is recommended prior to treatment initiation, after 3 and 6 months of treatment, every 6 to 12 months thereafter and as clinically indicated.
Croatian: Preporučene su procjene bubrežne funkcije (npr. kreatinin, ureja u krvi i pretraga urina) prije početka liječenja, nakon 3 i 6 mjeseci liječenja, zatim svakih 6 do 12 mjeseci te kako je klinički indicirano.
English: Potassium hydroxide Black iron oxide (E172)
Croatian: šelak kalijev hidroksid željezov oksid, crni (E172)
English: Based on data from placebo-controlled studies, the majority of patients with elevations had hepatic transaminases that were <3 times the upper limit of normal (ULN).
Croatian: Na temelju podataka iz placebom kontroliranih ispitivanja, većina bolesnika s povišenim jetrenim transaminazama imala je razine <3 puta iznad gornje granice normale (GGN).
English: Otherwise the patient should wait until the next scheduled dose.
Croatian: U suprotnom, bolesnik treba pričekati vrijeme kada prema rasporedu uzima sljedeću dozu.
English: Based on clinical pharmacology studies, no dose adjustments are needed (see section 5.2).
Croatian: Na temelju kliničkih farmakoloških ispitivanja, nije potrebna prilagodba doze (vidjeti dio 5.2).
English: In multiple sclerosis clinical studies, the concomitant treatment of relapses with a short course of intravenous corticosteroids was not associated with a clinically relevant increase of infection.
Croatian: U kliničkim ispitivanjima multiple skleroze, istodobno liječenje relapsa kratkotrajnom intravenskom primjenom kortikosteroida nije bilo povezano s klinički relevantnim porastom infekcije.
English: Patients receiving Tecfidera should be instructed to report symptoms of infections to a physician.
Croatian: Bolesnicima koji primaju Tecfideru treba savjetovati da simptome infekcije prijave liječniku.
English: No clinical data are available on the efficacy and safety of live attenuated vaccines in patients taking Tecfidera.
Croatian: Nema kliničkih podataka o djelotvornosti i sigurnosti živih oslabljenih cjepiva u bolesnika koji uzimaju Tecfideru.
English: Tecfidera may affect your white blood cell counts, your kidneys and liver.
Croatian: Tecfidera može utjecati na broj bijelih krvnih stanica, na bubrege i jetru.
English: - medicines that affect the kidneys including some antibiotics (used to treat infections), “water tablets” (diuretics), certain types of painkillers (such as ibuprofen and other similar antiinflammatories and medicines purchased without a doctor's prescription) and medicines that contain lithium - Taking Tecfidera with certain types of vaccines (live vaccines) may cause you to get an infection and should, therefore, be avoided.
Croatian: lijekove koji utječu na bubrege uključujući i neke antibiotike (koji se koriste za liječenje infekcija), “tablete za mokrenje” (diuretici), određene tablete protiv bolova (kao što je ibuprofen i slični protuupalni lijekovi i lijekovi koji se izdaju bez liječničkog recepta) i lijekove koji sadržavaju litij Uzimanje Tecfidere s nekim vrstama cjepiva (živa cjepiva) može uzrokovati da dobijete infekciju te se stoga treba izbjegavati.
English: The terminal half-life of monomethyl fumarate is short (approximately 1 hour) and no circulating monomethyl fumarate is present at 24 hours in the majority of individuals.
Croatian: Terminalno poluvrijeme monometilfumarata je kratko (oko 1 sat), tako da nakon 24 sata u većine osoba nema cirkulirajućeg monometilfumarata.
English: Moderately low to very low lymphocyte counts - Lymphocyte counts (a type of white blood cell) may be decreased for a long period of time.
Croatian: Umjereno nizak do vrlo nizak broj limfocita - broj limfocita (vrsta bijelih krvnih stanica) može biti smanjen tijekom dugog vremenskog razdoblja.
English: Titanium dioxide (E171) Brilliant Blue FCF (E133) Yellow iron oxide (E172)
Croatian: Ovojnica kapsule želatina titanijev dioksid (E171) brilliant blue FCF (E133) željezov oksid, žuti (E172)
English: In the placebo-controlled studies most patients (>98%) had normal lymphocyte values prior to initiating treatment.
Croatian: Većina je bolesnika u placebom kontroliranim ispitivanjima (>98%) imala normalne vrijednosti limfocita prije početka liječenja.
English: 1171 LP Badhoevedorp The Netherlands
Croatian: Prins Mauritslaan 13 1171 LP Badhoevedorp
English: However, should flushing be accompanied by a red rash or hives and you get any of these symptoms:
Croatian: Međutim, ako imate navalu crvenila praćenu crvenim osipom ili koprivnjačom i jave se bilo koji od sljedećih simptoma:
English: In vitro CYP induction studies did not demonstrate an interaction between Tecfidera and oral contraceptives.
Croatian: In vitro ispitivanja indukcije CYP-a nisu pokazala interakciju između Tecfidere i oralnih kontraceptiva.
English: Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Croatian: Tipični simptomi povezani s PML-om su raznovrsni, razvijaju se danima do tjednima, a uključuju progresivnu slabost na jednoj strani tijela ili nespretnost udova, smetnje vida i promjene u razmišljanju, pamćenju i orijentaciji što dovodi do smetenosti i promjene osobnosti.
English: Cases of overdose with Tecfidera have been reported.
Croatian: Prijavljeni su slučajevi predoziranja s Tecfiderom.
English: Tecfidera is not recommended for use in children and adolescents because there is limited experience in the use of Tecfidera in this population.
Croatian: Tecfidera se ne preporučuje za primjenu u djece i adolescenata jer su iskustva njezine primjene u tim skupinama bolesnika ograničena.
English: Placebo Tecfidera 240 mg twice a day
Croatian: Placebo Tecfidera 240 mg dvaput na dan
English: Tecfidera is not recommended during pregnancy and in women of childbearing potential not using appropriate contraception (see section 4.5).
Croatian: Ne preporučuje se koristiti Tecfideru za vrijeme trudnoće niti u žena reproduktivne dobi koje ne koriste odgovarajuću kontracepciju (vidjeti dio 4.5).
English: - herpes zoster (shingles) with symptoms such as blisters, burning, itching or pain of the skin, typically on one side of the upper body or the face, and other symptoms, like fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
Croatian: - herpes zoster sa simptomima kao što su mjehurići, osjećaj pečenja, svrbež ili bol kože, obično na jednoj strani gornjeg dijela tijela ili lica, te drugim simptomima kao što su vrućica i slabost u ranim stadijima infekcije, nakon čega slijede utrnulost, svrbež ili crvene mrlje popraćene jakom boli
English: What Tecfidera is and what it is used for What Tecfidera is
Croatian: Što je Tecfidera i za što se koristi Što je Tecfidera
English: If lymphocyte count is found to be below the normal range, thorough assessment of possible causes should be completed prior to initiation of treatment with Tecfidera.
Croatian: Ako se utvrdi da je broj limfocita ispod normalnog raspona, treba se obaviti temeljita procjena mogućih uzroka prije početka liječenja Tecfiderom.
English: The increased incidence of elevations of hepatic transaminases in patients treated with Tecfidera relative to placebo was primarily seen during the first 6 months of treatment.
Croatian: Povećana incidencija povišenja razina jetrenih transaminaza u bolesnika liječenih Tecfiderom u odnosu na placebo primijećena je uglavnom tijekom prvih 6 mjeseci liječenja.
English: Resolution of the adverse reactions has been observed after treatment was discontinued.
Croatian: Nestanak nuspojava opažen je nakon prekida liječenja.
English: Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions.
Croatian: Privremeno smanjenje doze na 120 mg dvaput na dan može smanjiti pojavu navala crvenila i nuspojave probavnog sustava.
English: The contribution of prior immunosuppressive therapy to the development of PML in dimethyl fumarate treated patients is unknown.
Croatian: Doprinos prethodne imunosupresivne terapije za razvoj PML-a u bolesnika liječenih dimetilfumaratom nije poznat.
English: Prescribers and patients should be alert to this possibility in the event of severe flushing reactions (see sections 4.2, 4.5 and 4.8).
Croatian: Propisivači i bolesnici trebaju obratiti pozornost na tu mogućnost u slučaju pojave teških reakcija navala crvenila (vidjeti dijelove 4.2, 4.5 i 4.8).
English: The patient may take the missed dose only if they leave 4 hours between doses.
Croatian: Bolesnik smije uzeti propuštenu dozu samo ako je između doza proteklo 4 sata.
English: Patients should be instructed to discontinue Tecfidera and seek immediate medical care if they experience signs or symptoms of anaphylaxis.
Croatian: Bolesnicima se mora savjetovati da prekinu uzimati Tecfideru i potraže hitnu medicinsku pomoć ako osjete znakove ili simptome anafilaksije.
English: Other circulating metabolites included fumaric acid, citric acid and monomethyl fumarate.
Croatian: Drugi cirkulirajući metaboliti uključuju fumaratnu kiselinu, citratnu kiselinu i monometilfumarat.
English: How Tecfidera works
Croatian: Kako Tecfidera radi
English: However, due to Tecfidera immunomodulatory properties (see section 5.1), if a patient develops a serious infection, suspending treatment with Tecfidera should be considered and the benefits and risks should be reassessed prior to re-initiation of therapy.
Croatian: zbog imunomodulatornih svojstava Tecfidere (vidjeti dio 5.1), ako bolesnik razvije ozbiljnu infekciju potrebno je razmotriti privremeni prekid liječenja Tecfiderom i ponovno procijeniti omjer koristi i rizika prije ponovnog uvođenja terapije.
English: Dimethyl fumarate has been shown to cross the placental membrane into fetal blood in rats and rabbits, with ratios of fetal to maternal plasma concentrations of 0.48 to 0.64 and 0.1 respectively.
Croatian: Prikazano je da dimetilfumarat prelazi kroz membranu placente u krv fetusa u štakora i kunića, s omjerima plazmatske koncentracije u fetusu prema majci 0,48 do 0,64 odnosno 0,1.
English: The downstream metabolism of fumaric acid occurs through the tricarboxylic acid cycle, with exhalation of CO2 serving as a primary route of elimination.
Croatian: Nizvodni metabolizam fumaratne kiseline se zbiva kroz ciklus trikarboksilatne kiseline, tako da je izdisanje CO2 glavni put eliminacije.
English: Reddening of the face or body (flushing) is a very common side effect.
Croatian: Crvenjenje lica ili tijela (navala crvenila) vrlo je česta nuspojava.
English: Dimethyl fumarate was administered orally at doses of 25, 75, 200 and 400 mg/kg/day in mice, and at doses of 25, 50, 100, and 150 mg/kg/day in rats.
Croatian: Dimetilfumarat je primijenjen peroralno u dozama u od 25, 75, 200 i 400 mg/kg/dan u miševa, a pri dozama od 25, 50, 100 i 150 mg/kg/dan u štakora.
English: - Very rare (<1/10,000) - Not known (frequency cannot be estimated from the available data)
Croatian: - rijetko (≥1/10 000 i <1/1000) - vrlo rijetko (<1/10 000) - nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)
English: A single 240 mg 14C-dimethyl fumarate dose study identified glucose as the predominant metabolite in human plasma.
Croatian: Ispitivanje jednokratnom dozom od 240 mg 14C-dimetilfumarata je pokazalo da je glukoza predominantni metabolit u ljudskoj plazmi.
English: The frequencies described in the table below are based on 769 patients treated with Tecfidera 240 mg twice a day and 771 patients treated with placebo
Croatian: Učestalosti opisane u tablici u nastavku temelje se na 769 bolesnika liječenih Tecfiderom 240 mg dva puta dnevno i 771 bolesnika koji su dobivali placebo.
English: The relevance of these findings to human risk is unknown.
Croatian: Nije poznata relevantnost ovih nalaza za rizik u ljudi.
English: The pharmacokinetics of Tecfidera in these adolescent patients was consistent with that previously observed in adult patients (Cmax: 2.00±1.29 mg/l; AUC0-12hr: 3.62±1.16 h.mg/l, which corresponds to an overall daily AUC of 7.24 h.mg/l).
Croatian: Farmakokinetika Tecfidere u ovih adolescentnih bolesnika bila je sukladna onoj prethodno opaženoj u odraslih bolesnika (Cmax: 2,00±1,29 mg/l; AUC0-12hr: 3,62±1,16 h.mg/l, što odgovara ukupnom dnevnom AUC-u od 7,24 h.mg/l).
English: Flushing is usually described as flushing or hot flush, but can include other events (e.g. warmth, redness, itching, and burning sensation).
Croatian: Navala crvenila je obično opisana kao navala crvenila ili navala vrućine, ali može uključiti druge promjene (npr. toplinu, crvenilo, svrbež i osjećaj žarenja).
English: 120 mg capsules: 14 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Croatian: Kapsule od 120 mg: 14 kapsula u PVC/PE/PVDC-PVC aluminijskim blister pakiranjima.
English: Therefore, all pharmacokinetic analyses related to dimethyl fumarate were performed with plasma monomethyl fumarate concentrations.
Croatian: Prema tome, sve farmakokinetičke analize u odnosu na dimetilfumarat su obavljene s koncentracijama monometilfumarata u plazmi.
English: Before initiating treatment with Tecfidera, a baseline MRI should be available (usually within 3 months) as a reference.
Croatian: Prije početka liječenja Tecfiderom, treba biti na raspolaganju početni MR nalaz (napravljen obično unutar 3 mjeseca), kao referentni nalaz.
English: Mean and median lymphocyte counts remained within normal limits.
Croatian: Srednja vrijednost broja limfocita i medijan ostali su u granicama normale.
English: Subjects received Tecfidera 120 mg twice a day for 7 days followed by 240 mg twice a day for 24 weeks.
Croatian: Ispitanici su primali Tecfideru u dozi od 120 mg dvaput na dan tijekom 7 dana te potom 240 mg dvaput na dan tijekom 24 tjedna.
English: On average, lymphocyte counts decreased by approximately 30% of baseline value.
Croatian: U prosjeku se broj limfocita smanjio otprilike za 30% od početne vrijednosti.
English: DK-3400 Hillerod
Croatian: DK-3400 Hillerød
English: At the first sign or symptom suggestive of PML, Tecfidera should be withheld and appropriate diagnostic evaluations need to be performed.
Croatian: Kod prvog znaka ili simptoma koji ukazuje na PML, primjenu Tecfidere treba prekinuti te provesti odgovarajuće dijagnostičke procjene.
English: Commonly used medicinal products in patients with multiple sclerosis, intramuscular interferon beta-1a and glatiramer acetate, were clinically tested for potential interactions with dimethyl fumarate and did not alter the pharmacokinetic profile of dimethyl fumarate.
Croatian: Uobičajeno korišteni lijekovi u bolesnika s multiplom sklerozom, intramuskularni interferon beta-1a i glatirameracetat, klinički su ispitani na potencijalne interakcije s dimetilfumaratom i pokazalo se da nisu promijenili farmakokinetički profil dimetilfumarata.
English: A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.
Croatian: Prolazno povišenje srednje vrijednosti broja eozinofila zabilježeno je tijekom prva 2 mjeseca terapije.
English: Orally administered dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases and is converted to its primary metabolite, monomethyl fumarate, which is also active.
Croatian: Peroralno primijenjeni dimetilfumarat prolazi brzu predsistemsku hidrolizu pomoću esteraza i pretvara se u svoj primarni metabolit, monometilfumarat, koji je također aktivan.
English: 240 mg capsules: 56 or 168 capsules in PVC/PE/PVDC-PVC aluminium blister packs.
Croatian: Kapsule od 240 mg: 56 ili 168 kapsula u PVC/PE/PVDC-PVC aluminijskim blister pakiranjima.
English: These data should be considered cautiously regarding limitations of the study design (no control arm, pre- versus post-dose comparison) (see section 4.2).
Croatian: Ove je podatke potrebno oprezno razmotriti s obzirom na ograničenja dizajna ispitivanja (nije bilo kontrolne skupine ni usporedbe prije naspram poslije doze) (vidjeti dio 4.2).
English: In clinical trials, 3 patients out of a total of 2,560 patients treated with dimethyl fumarate experienced serious flushing symptoms that were probable hypersensitivity or anaphylactoid reactions.
Croatian: U kliničkim ispitivanjima 3 od ukupno 2560 bolesnika liječenih dimetilfumaratom imala su ozbiljne simptome navale crvenila, koje su vjerojatno bile reakcije preosjetljivosti ili anafilaktoidne reakcije.
English: Tecfidera seems to work by stopping the body's defence system from damaging your brain and spinal cord.
Croatian: Čini se da Tecfidera djeluje zaustavljajući oštećenja mozga i leđne moždine izazvana djelovanjem obrambenog sustava tijela.
English: When switching patients from another disease modifying therapy to Tecfidera, the half-life and mode of action of the other therapy should be considered in order to avoid an additive immune effect while at the same time, reducing the risk of reactivation of MS.
Croatian: Kod prelaska bolesnika s druge terapije koja modificira tijek bolesti na Tecfideru, treba uzeti u obzir poluvijek i način djelovanja druge terapije kako bi se izbjegao aditivni imunološki učinak uz istovremeno smanjenje rizika od reaktivacije MS-a.
English: If JCV testing is undertaken, it should be considered that the influence of lymphopenia on the accuracy of anti-JCV antibody test has not been studied in dimethyl fumarate treated patients.
Croatian: Ako je provedeno JCV testiranje, treba uzeti u obzir da utjecaj limfopenije na točnost testa na anti-JCV protutijela nije ispitana u bolesnika koji se liječe dimetilfumaratom.
English: Capsule contents (enteric-coated microtablets)
Croatian: Sadržaj kapsule (acidorezistentne mikrotablete)