FrancophonIA/ELRC3.0 huggingface dataset:
English: Skilarence has not been studied in patients with pre-existing gastrointestinal disease.
Croatian: Skilarence nije ispitivan u bolesnika s prethodno prisutnom gastrointestinalnom bolešću.
English: However, if you become flushed and get any of the following signs: - wheezing, difficulty breathing or shortness of breath, - swelling of the face, lips, mouth or tongue stop taking Skilarence and call a doctor straight away.
Croatian: Međutim, ako dobijete navale crvenila i bilo koji od sljedećih znakova: - piskanje pri disanju, otežano disanje ili nedostatak zraka, - oticanje lica, usana, usta ili jezika odmah prestanite uzimati Skilarence i pozovite liječnika.
English: Patients should be made aware that they are likely to experience flushing in the first few weeks of taking Skilarence (see section 4.8).
Croatian: Bolesnici moraju biti svjesni da će vjerojatno imati navale crvenila u prvih nekoliko tjedana uzimanja lijeka Skilarence (vidjeti dio 4.8).
English: Risk factors can include previous immunosuppressive treatment and the existence of certain concomitant disorders (such as some autoimmune disorders or malignant haematological conditions).
Croatian: Rizični čimbenici mogu uključivati prethodno imunosupresivno liječenje te prisutnost pojedinih pridruženih poremećaja (kao što su neki autoimunosni poremećaji ili hematološki maligniteti).
English: Long-term efficacy data are currently not available for Skilarence, however, in the pharmacokinetic and clinical studies the systemic exposure, efficacy and safety of Skilarence were shown to be comparable to the active comparator containing dimethyl fumarate.
Croatian: Podaci o dugoročnoj djelotvornosti za Skilarence trenutno nisu dostupni, međutim u farmakokinetičkim i kliničkim ispitivanjima sistemske izloženosti pokazalo se da su djelotvornost i sigurnost lijeka Skilarence usporedive s aktivnim komparatorom koji sadrži dimetilfumarat.
English: It has not been studied in patients with pre-existing low leukocyte or lymphocyte counts.
Croatian: Nije ispitivan u bolesnika s već postojećim niskim brojem leukocita ili limfocita.
English: This could cause stomach and intestinal problems.
Croatian: To može uzrokovati želučane i crijevne probleme.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Exhalation of CO2 resulting from the metabolism of monomethyl fumarate is the primary route of elimination; only small amounts of intact monomethyl fumarate are excreted through urine or faeces.
Croatian: Izdisaj CO2 nastao metabolizmom monometilfumarata primarni je put eliminacije; samo mala količina intaktnog monometilfumarata izlučuje se putem urina ili fecesa.
English: There were no effects on foetal body weights or malformations attributed to maternal administration of dimethyl fumarate during the embryo-foetal development study in rats.
Croatian: Nije bilo učinaka na fetalnu tjelesnu težinu ili malformacija pripisanih primjeni dimetilfumarata u majke tijekom ispitivanja embriofetalnog razvoja u štakora.
English: For patients with pre-existing infections of clinical relevance, the physician should decide if treatment with Skilarence should only be initiated once the infection has resolved.
Croatian: Za bolesnike u kojih je prethodno prisutna klinički relevantna infekcija, liječnik treba odlučiti treba li započeti liječenje lijekom Skilarence jedino nakon što se infekcija izliječi.
English: No apparent dose relationship and no risk factors for the occurrence of these adverse reactions could be identified.
Croatian: Nema jasne povezanosti s dozom i nisu identificirani rizični čimbenici za ove nuspojave.
English: Patients who develop lymphopenia should be monitored for signs and symptoms of opportunistic infections, particularly for symptoms indicative of PML.
Croatian: Bolesnike koji razviju limfopeniju treba pratiti zbog znakova i simptoma oportunističkih infekcija, posebice zbog simptoma koji mogu upućivati na PML.
English: Prior and concomitant treatment with immunosuppressive or immunomodulating therapies Limited data are available on the efficacy and safety of Skilarence in patients who have been previously treated with other immunosuppressive or immunomodulating therapies.
Croatian: Prethodno i istodobno liječenje imunosupresivnim ili imunomodulacijskim lijekovima Dostupni su ograničeni podaci o sigurnosti i djelotvornosti lijeka Skilarence u bolesnika koji su prethodno liječeni drugim imunosupresivnim ili imunomodulacijskim lijekovima.
English: When switching patients from such therapies to Skilarence, the half-life and mode of action of the other therapy should be considered in order to avoid additive effects on the immune system.
Croatian: Pri prebacivanju bolesnika s takvih lijekova na Skilarence, treba uzeti u obzir poluvijek eliminacije i mehanizam djelovanja tog lijeka, kako bi se izbjegli aditivni učinci na imunosni sustav.
English: For the total leukocyte count, a decline became apparent at week 12 of treatment; it slowly increased again at week 16 (end of treatment); and 12 months after stopping treatment all patients had values above 3.0x10
Croatian: Za broj leukocita pad je postao uočljiv u 12. tjednu liječenja; polako je ponovno rastao u 16. tjednu (kraj liječenja) i 12 mjeseci nakon završetka liječenja svi su bolesnici imali vrijednosti iznad 3,0 x 10
English: What Skilarence is and what it is used for
Croatian: Što je Skilarence i za što se koristi
English: Pack sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets.
Croatian: Veličine pakiranja: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 i 400 želučanootpornih tableta.
English: Experience with related products containing dimethyl fumarate shows treatment benefit for at least up to 24 months.
Croatian: Iskustva sa sličnim lijekovima koji sadrže dimetilfumarat pokazuju korist liječenja tijekom najmanje 24 mjeseca.
English: Indigo carmine (E132)
Croatian: Indigo Carmine (E132) natrijev hidroksid
English: In vitro studies have shown that hydrolysis of dimethyl fumarate to monomethyl fumarate occurs rapidly at pH 8 (pH in the small intestine), but not at pH 1 (pH in the stomach).
Croatian: Ispitivanja in vitro pokazala su da se hidroliza dimetilfumarata u monometilfumarat događa brzo pri pH 8 (pH u tankom crijevu), ali ne pri pH 1 (pH u želucu).
English: Published clinical experience with dimethyl fumarate-containing products shows that individual episodes of flushing usually begin shortly after taking the tablets and resolve within a few hours.
Croatian: Objavljena klinička iskustva s lijekovima koji sadrže dimetilfumarat pokazuju da pojedine epizode navale crvenila počinju kratko nakon uzimanja tableta i prolaze unutar nekoliko sati.
English: The anti-inflammatory and immunomodulating effects of dimethyl fumarate and its metabolite monomethyl fumarate are not fully elucidated but are thought to be mainly due to the interaction with the intracellular reduced glutathione of cells directly involved in the pathogenesis of psoriasis.
Croatian: Protuupalno i imunomodulatorno djelovanje dimetilfumarata i njegovog metabolita monometilfumarata nisu u potpunosti razjašnjeni, ali se smatra da nastaju uglavnom zbog interakcije s intracelularnim reduciranim glutationom stanica koje su izravno uključene u patogenezu psorijaze.
English: Skilarence is not recommended in women of child-bearing potential not using appropriate contraception.
Croatian: Ne preporučuje se koristiti lijek Skilarence u žena reproduktivne dobi koje ne koriste odgovarajuću kontracepciju.
English: If you notice new or worsening weakness on one side of the body; clumsiness; changes in vision, thinking or memory; confusion; or personality changes lasting several days, stop taking Skilarence and talk to your doctor straight away.
Croatian: Ako primijetite novonastalu slabost jedne strane tijela ili njeno pogoršanje; nespretnost; promjene vida, razmišljanja ili pamćenja; smetenost; ili promjene osobnosti koje traju nekoliko dana, prestanite uzimati Skilarence i odmah se obratite liječniku.
English: However, there was an increased number of foetuses with the variations “supernumerary liver lobe” and “abnormal iliac alignment” at maternally toxic doses.
Croatian: Međutim, postojao je povećan broj fetusa s „prekobrojnim režnjem jetre“ i „abnormalnim ilijačnim poravnanjem“ pri dozama toksičnima za majku.
English: Skilarence may have a minor influence on the ability to drive and use machines.
Croatian: Skilarence može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: By contrast, unconjugated monomethyl fumarate is detectable in plasma.
Croatian: Nasuprot tome, nekonjugirani monometilfumarat može se otkriti u plazmi.
English: Rebound (defined as worsening of ≥125% of baseline PASI value) was assessed after 2 months off treatment and was shown not to be a clinical concern with fumaric acid esters, as it was documented in very few patients (Skilarence 1.1% and active comparator 2.2%, compared to 9.3% in the placebo group).
Croatian: Povratna pojava bolesti („rebound“) (definirano kao pogoršanje od ≤125 % u odnosu na početnu PASI vrijednost) procijenjena je 2 mjeseca nakon završetka liječenja i pokazalo se da uz estere fumaratne kiseline nije od kliničkog značaja s obzirom da je dokumentirana u vrlo malog broja bolesnika (Skilarence 1,1 % i aktivni komparator 2,2 %, u usporedbi s 9,3 % uz placebo).
English: Patients developing lymphopenia should be monitored after stopping treatment until their lymphocyte count has returned to the normal range (see section 4.8).
Croatian: Bolesnike koji razviju limfopeniju treba nadzirati nakon prekida liječenja sve dok im se broj limfocita ne vrati u normalan raspon. (vidjeti dio 4.8).
English: Skilarence 30 mg is available in packs containing 42, 70 and 210 gastro-resistant tablets.
Croatian: Skilarence 30 mg dostupan je u pakiranjima koji sadrže 42,70 i 210 želučanootporne tableta.
English: Swallow Skilarence tablets whole with liquid.
Croatian: Progutajte tablete Skilarence cijele, s tekućinom.
English: Leukopenia: If a marked decrease in the total number of white blood cells is found, the situation should be monitored carefully and treatment with Skilarence should be discontinued at levels below 3.0x10
Croatian: Ako se otkrije značajno smanjenje ukupnog broja bijelih krvnih stanica, situacija se mora pažljivo nadzirati, a liječenje lijekom Skilarence treba se prekinuti pri razinama ispod 3,0 x 10
English: 9/L or higher for two consecutive blood tests at which point monitoring can again be performed every 3 months.
Croatian: L ili više u dvije uzastopne pretrage krvi kada se opet može uvesti praćenje s učestalošću svaka 3 mjeseca.
English: No studies on the ability to drive and use machines have been conducted.
Croatian: Nisu provedena ispitivanja sposobnosti upravljanja vozilima i rada sa strojevima.
English: Treatment should not be initiated if leukopenia below 3.0x10
Croatian: Liječenje se ne smije započeti ako je u nalazu prisutna leukopenija ispod 3,0 x 10
English: Symptoms include fever, pain, aching muscles, headache, loss of appetite and a general feeling of weakness.
Croatian: Simptomi uključuju vrućicu, bolove, bolove u mišićima, glavobolju, gubitak apetita i opći osjećaj slabosti.
English: Allergic or hypersensitivity reactions
Croatian: Alergijske reakcije ili reakcije preosjetljivosti.
English: The most common adverse reactions observed with Skilarence in the Phase III clinical study (1102) in psoriasis patients were gastrointestinal events (62.7%), flushing (20.8%) and lymphopenia (10.0%).
Croatian: Najčešće nuspojave uočene uz Skilarence u III fazi kliničkog ispitivanja (1102) u bolesnika s psorijazom bile su gastrointestinalni događaji (62,7 %), navale crvenila (20,8 %) i limfopenija (10,0 %).
English: Patients began treatment with tablets containing 30 mg/day dimethyl fumarate or placebo, titrating up to a maximum of 720 mg/day in both active treatment arms as described in section 4.2.
Croatian: Bolesnici su započeli liječenje tabletama koje sadrže 30 mg/dan dimetilfumarata ili placebo, titrirajući do najviše 720 mg/dan u oba kraka s aktivnim liječenjem, kako je opisano u dijelu 4.2.
English: The safety and efficacy of Skilarence was assessed in one double-blind, 3-arm, placebo- and active comparator-controlled Phase III study (1102) in patients with moderate to severe plaque psoriasis (Study 1102).
Croatian: Sigurnost i djelotvornost lijeka Skilarence procijenjena je u dvostruko slijepom, placebom i aktivnim komparatorom kontroliranom ispitivanju faze III (1102) s 3 kraka, kod bolesnika s umjerenom do teškom plak psorijazom (ispitivanje 1102).
English: Reproduction toxicity No fertility or pre- and post-natal development studies have been conducted with Skilarence.
Croatian: Reproduktivna toksičnost Nisu provedena ispitivanja plodnosti ni prenatalnog i postnatalnog razvoja za lijek Skilarence.
English: These adducts were detected in animal studies in the intestinal mucosa of rats and to a smaller extent in portal vein blood.
Croatian: Ti su spojevi otkriveni u ispitivanjima na životinjama u intestinalnoj sluznici štakora te u manjoj mjeri u krvi portalne vene.
English: Despite the high inter-subject variability, the exposure measured as AUC and Cmax was generally dose-proportional after single dose administration of 4 x 30 mg dimethyl fumarate tablets (total dose of 120 mg) and 2 x 120 mg dimethyl fumarate tablets (total dose of 240 mg).
Croatian: Usprkos velikoj varijabilnosti između ispitanika, izloženost mjerena kao AUC i Cmax općenito je bila proporcionalna dozi nakon primjene jedne doze od 4 x 30 mg dimetilfumarata u tabletama (ukupna doza od 120 mg) i 2 x 120 mg dimetilfumarata u tabletama (ukupna doza od 240 mg).
English: Renal findings in dogs included minimal to moderate tubular hypertrophy, increased incidence and severity of tubular vacuolation and minimal to slight tubular degeneration, which were considered toxicologically relevant.
Croatian: Nalazi bubrega u pasa uključivali su minimalnu do umjerenu tubularnu hipertrofiju, povećanu incidenciju i težinu tubularne vakuolizacije i minimalnu do slabu tubularnu degeneraciju, što se smatralo toksički relevantnim.
English: Proteinuria* Renal failure* Fanconi syndrome*
Croatian: Proteinurija Zatajenje bubrega* Fanconijev sindrom*
English: Caution should be exercised when prescribing medicinal products with a narrow therapeutic index that require absorption in the intestinal tract.
Croatian: Potreban je oprez kod propisivanja lijekova s uskim terapijskim indeksom koji zahtijevaju apsorpciju u probavnom traktu.
English: Skilarence is a medicine that contains the active substance dimethyl fumarate.
Croatian: Skilarence je lijek koji sadrži aktivnu tvar dimetilfumarat.
English: 9/L, lymphopenia below 1.0x10
Croatian: 9/ L, limfopenija ispod 1,0 x 10
English: Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Croatian: Skilarence je indiciran za liječenje umjerene do teške plak psorijaze u odraslih kojima je potrebna sistemska medikamentozna terapija.
English: Fanconi syndrome is a rare but serious kidney disorder which may occur with Skilarence.
Croatian: Fanconijev sindrom je rijedak, ali ozbiljan poremećaj bubrega koji se može pojaviti uz Skilarence.
English: There is no evidence for Skilarence interaction with cytochrome P450 and the most common efflux and uptake transporters, thus no interactions are expected with medicinal products metabolised or transported by these systems (see section 5.2).
Croatian: Nema dokaza interakcije lijeka Skilarence s citokromom P450 i najčešćim efluksnim i unosnim membranskim prijenosnicima, stoga se ne očekuju interakcije s lijekovima koji se metaboliziraju ili prenose tim sustavima (vidjeti dio 5.2).
English: The plasma protein binding of monomethyl fumarate is around 50%.
Croatian: Vezanje monometilfumarata za proteine u plazmi je oko 50 %.
English: After oral administration, dimethyl fumarate is not detected in plasma because it is rapidly hydrolysed by esterases to its active metabolite monomethyl fumarate.
Croatian: Nakon peroralne primjene, dimetilfumarat nije otkriven u plazmi jer što se brzo hidrolizira esterazama u svoj aktivni metabolit monometilfumarat.
English: The inflammatory cytokine production is reduced with induction of proapoptotic events, inhibition of keratinocyte proliferation, reduced expression of adhesion molecules, and diminished inflammatory infiltrate within psoriatic plaques.
Croatian: Smanjeno je stvaranje upalnih citokina s indukcijom proapoptotičnih događaja, inhibicijom proliferacije keratinocita, smanjenom ekspresijom adhezijskih molekula i smanjenim upalnim infiltratom unutar psorijatičnih plakova.
English: The main activity of dimethyl fumarate and monomethyl fumarate is considered to be immunomodulatory, resulting in a shift in T helper cells (Th) from the Th1 and Th17 profile to a Th2 phenotype.
Croatian: Smatra se da je glavna aktivnost dimetilfumarata i monometilfumarata imunomodulatorna, dovodeći do pomaka T-pomoćnih stanica (Th) iz profila Th1 i Th17 u Th2 fenotip.
English: The objectives of the educational programme are to inform health care professionals about the risk of serious infections, mainly opportunistic infections such as progressive multifocal leukoencephalopathy (PML), and to provide guidance on the monitoring of lymphocyte and leukocyte count abnormalities.
Croatian: Ciljevi edukacijskog programa su obavijestiti zdravstvene radnike o riziku nastanka ozbiljnih, uglavnom oportunih infekcija poput progresivne multifokalne leukoencefalopatije (PML) i dati smjernice o praćenju poremećaja broja limfocita i leukocita.
English: If you get severe or prolonged diarrhoea with Skilarence, other medicines may not work as well as they should.
Croatian: Ako uz Skilarence dobijete teški ili produljeni proljev, drugi lijekovi možda neće djelovati onako dobro kako bi trebali.
English: A part of the total dimethyl fumarate is hydrolysed by esterases and the alkaline milieu of the small intestine, while the remainder enters the portal vein blood.
Croatian: Dio ukupnog dimetilfumarata hidrolizira se esterazama i alkalnim okolišem u tankom crijevu, dok ostatak ulazi u portalni krvotok.
English: In rare cases hypophosphataemic osteomalacia with non-localised bone pain, elevated alkaline phosphatase in serum and stress fractures may occur.
Croatian: U rijetkim slučajevima hipofosfatemične osteomalacije s nelokaliziranim koštanim bolovima mogu se pojaviti povišena alkalna fosfataza u serumu i stres frakture.
English: In the clinical study a total of 20.8% of patients receiving Skilarence experienced flushing, which was mild in the majority of cases (see section 4.4).
Croatian: U kliničkom ispitivanju ukupno je 20,8 % bolesnika koji su primali Skilarence doživjelo navale crvenila, koje su u većini slučajeva bile blage (vidjeti dio 4.4).
English: What Skilarence is
Croatian: Što je Skilarence
English: At week 16, patients treated with Skilarence had a lower mean DLQI compared to placebo (5.4 vs 8.8).
Croatian: U 16. tjednu bolesnici liječeni lijekom Skilarence imali su nižu srednju vrijednost DLQI-a u usporedbi s onima koji su primali placebo (5,4 naprama 8,8).
English: The most serious side effects that may occur with Skilarence are allergic or hypersensitivity reactions; kidney failure or a kidney disease called Fanconi syndrome; or a severe brain infection called progressive multifocal leukoencephalopathy (PML).
Croatian: Najozbiljnije nuspojave koje se mogu javiti uz Skilarence su alergijske reakcije ili reakcije preosjetljivosti, zatajenje bubrega ili bolest bubrega koja se zove Fanconijev sindrom ili teška infekcija mozga koja se zove progresivna multifokalna leukoencefalopatija (engl. progressive multifocal leukoencephalopathy, PML).
English: Skilarence may decrease leukocyte and lymphocyte counts (see section 4.8).
Croatian: Skilarence može smanjiti broj leukocita i limfocita (vidjeti dio 4.8).
English: Opportunistic infections/progressive multifocal leukoencephalopathy (PML) Cases of opportunistic infections, particularly of progressive multifocal leukoencephalopathy (PML) have been reported with other dimethyl fumarate-containing products (see section 4.8).
Croatian: Oportunističke infekcije / progresivna multifokalna leukoencefalopatija (PML) Pri primjeni drugih lijekova koji sadrže dimetilfumarat zabilježeni su slučajevi oportunističkih infekcija, posebice progresivne multifokalne leukoencefalopatije (PML) (vidjeti dio 4.8).
English: No data are available on the efficacy and safety of Skilarence when taken concomitantly with other immunosuppressive or immunomodulating therapies (see section 4.5).
Croatian: Nema dostupnih podataka o djelotvornosti i sigurnosti primjene lijeka Skilarence istodobno s drugim imunosupresivnim ili imunomodulacijskim lijekovima (vidjeti dio 4.5).
English: Renal function (e.g. creatinine, blood urea nitrogen and urinalysis) should be checked prior to initiation of treatment and every 3 months thereafter.
Croatian: Potrebno je provjeriti bubrežnu funkciju (npr. kreatinin, ureu u krvi i analizu urina) prije uvođenja liječenja i svaka 3 mjeseca nakon toga.
English: Acute lymphatic leukaemia* Irreversible pancytopenia*
Croatian: Akutna limfatična leukemija* Ireverzibilna pancitopenija*
English: Based on available data suggesting that fumaric acid esters may activate cellular pathways related to the development of renal tumours, a potential tumorigenic activity of exogenously administered dimethyl fumarate on the kidneys cannot be excluded.
Croatian: Temeljem dostupnih podataka koji upućuju na to da esteri fumaratne kiseline mogu aktivirati stanične puteve povezane s razvojem tumora bubrega, mogućnost tumorogenog djelovanja egzogeno primijenjenog dimetilfumarata na bubrege ne može se isključiti.
English: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Croatian: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 i 400 želučanootporne tablete u PVC/PVDC aluminijskim blisterima.
English: Unconjugated dimethyl fumarate, however, cannot be detected in the plasma of animals or psoriatic patients following oral administration.
Croatian: Nekonjugirani se dimetilfumarat, međutim, ne može otkriti u plazmi životinja ili bolesnika s psorijazom nakon peroralne primjene.
English: Do not breast-feed during treatment with Skilarence.
Croatian: Nemojte dojiti tijekom liječenja lijekom Skilarence.
English: Treatment week
Croatian: Tjedan liječenja
English: Skilarence is contraindicated during pregnancy (see section 4.3).
Croatian: Skilarence je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
English: Superiority testing vs placebo PASI 75, n (%) p-value a a
Croatian: Test superiornosti lijeka u odnosu na placebo PASI 75, n (%) p-vrijednost
English: In particular, in the clinical study there was a slight decrease in mean lymphocyte counts starting between weeks 3 and 5 and reaching a maximum in week 12 where approximately one third of patients had lymphocyte values below 1.0x10
Croatian: Nadalje, u kliničkom ispitivanju došlo je do blagog smanjenja srednjih vrijednosti broja limfocita s početkom između 3. i 5. tjedna koje je doseglo maksimum u 12. tjednu kada je približno jedna trećina bolesnika imala vrijednosti broja limfocita ispod 1,0 x 10
English: Fumaderm = Active comparator, a combination product with the same content of dimethyl fumarate plus 3 monoethyl hydrogen fumarate salts; n=number of patients with available data; N=number of patients in population; PASI=Psoriasis Area Severity Index; PGA=Physician's Global Assessment; a Superiority of Skilarence vs.
Croatian: = aktivni komparator, kombinacija lijeka s istim sadržajem dimetilfumarata i 3 monoetilfumaratnim solima, n = broj bolesnika s dostupnim podacima; N = broj bolesnika u populaciji; PASI=Psoriasis Area Severity Index;