FrancophonIA/ELRC3.0 huggingface dataset:
English: Other effects found on heart, liver, cornea and respiratory tract could be explained as infections due to immunosuppression.
Croatian: Ostali učinci zabilježeni na srcu, jetri, rožnici i respiratornom sustavu mogu se objasniti pojavom infekcije povezane s imunosupresijom.
English: If you suspect that you are pregnant while taking Leflunomide Zentiva or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Croatian: Ako posumnjate da ste zatrudnjeli za vrijeme uzimanja lijeka Leflunomide Zentiva ili unutar dvije godine nakon prekida liječenja, morate se odmah obratiti svome liječniku radi testiranja na trudnoću.
English: Results of animal fertility studies have shown no effect on male and female fertility, but adverse effects on male reproductive organs were observed in repeated dose toxicity studies (see section 5.3).
Croatian: Rezultati ispitivanja plodnosti na životinjama nisu pokazali učinak na mušku i žensku plodnost, ali primjećeni su štetni učinci na reproduktivnim organima mužjaka u ispitivanjima toksičnosti ponovljenih doza (vidjeti dio 5.3).
English: Blood pressure
Croatian: Krvni tlak
English: The recommended maintenance dose is leflunomide 20 mg once daily (see section 5.1).
Croatian: Preporučena doza održavanja je 20 mg leflunomida jedanput na dan (vidjeti dio 5.1).
English: • That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
Croatian: • Budući da postoji rizik od teškog oštećenja jetre, važno je redovno kontrolirati razine ALT (SGPT) i na taj način pratiti funkciju jetre.
English: Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.
Croatian: Stoga se lijekovi koji se metaboliziraju uz CYP1A2 (kao što su duloksetin, alosetron, teofilin i tizanidin) moraju oprezno koristiti tijekom liječenja leflunomidom, budući da može doći do smanjenja djelotvornosti ovih lijekova.
English: No clinical data are available on the efficacy and safety of vaccinations under leflunomide treatment.
Croatian: Nema dostupnih kliničkih podataka o djelotvornosti i sigurnosti cijepljenja za vrijeme liječenja leflunomidom.
English: Cholestyramine or activated charcoal
Croatian: Kolestiramin ili aktivni ugljen
English: • That there is a risk of teratogenicity and so pregnancy must be avoided until leflunomide plasma levels are at an appropriate level.
Croatian: • Budući da postoji rizik od teratogenosti, trudnoću treba izbjegavati dok se ne postignu odgovarajuće razine leflunomida u plazmi.
English: Blood pressure must be checked before the start of leflunomide treatment and periodically thereafter.
Croatian: Krvni tlak mora se izmjeriti prije početka liječenja leflunomidom te periodički nakon toga.
English: Leflunomide exhibits the best protective effects on animal models of autoimmune diseases when administered in the early phase of the disease progression.
Croatian: Leflunomid pokazuje najbolje zaštitne učinke na životinjskim modelima u autoimunim bolestima kad se primjenjuje u ranoj fazi progresije bolesti.
English: Animal studies indicate that leflunomide or its metabolites pass into breast milk.
Croatian: Ispitivanja na životinjama pokazuju da se leflunomid i njegovi metaboliti izlučuju u majčino mlijeko.
English: The tablets are packed in blisters.
Croatian: Tablete su pakirane u blistere.
English: Symptoms
Croatian: Simptomi
English: Leflunomide was not antigenic in animal models.
Croatian: Leflunomid nije pokazao antigena svojstva na životinjskim modelima.
English: In case of doubtful measurements, it is recommended to determine the total albumin adjusted serum calcium concentration.
Croatian: U slučaju dvojbenih mjerenja preporučuje se utvrđivanje ukupne koncentracije kalcija u serumu korigiranog za albumin.
English: Respiratory reactions
Croatian: Respiratorne reakcije
English: It is not recommended to drink alcohol during treatment with Leflunomide Zentiva.
Croatian: Ne preporučuje se konzumacija alkohola tijekom liječenja lijekom Leflunomide Zentiva.
English: • Patients with impairment of liver function.
Croatian: • Bolesnici s oštećenom jetrenom funkcijom.
English: • Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost (osobito u slučaju ranijeg Stevens-Johnsonovog sindroma, toksične epidermalne nekrolize, multiformnog eritema) na djelatnu tvar, na glavni aktivni metabolit teriflunomid ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: In a study with radiolabelled 14C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
Croatian: U ispitivanjima radioaktivno obilježenog 14C-leflunomida u tri zdrava dobrovoljca nije otkriven nepromijenjeni leflunomid u plazmi, mokraći ni stolici.
English: hepatitis, jaundice/cholestasis
Croatian: hepatitis, žutica/kolestaza
English: In a small prospective study in women (n=64) who became inadvertently pregnant while taking leflunomide for no more than three weeks after conception and followed by a drug elimination procedure, no significant differences (p=0.13) were observed in the overall rate of major structural defects (5.4%) compared to either of the comparison groups (4.2% in the disease matched group [n=108] and 4.2% in healthy pregnant women [n=78]).
Croatian: U manjem prospektivnom ispitivanju u žena (n=64) koje su neplanirano ostale u drugom stanju dok su uzimale leflunomid u trajanju od ne više od tri tjedna nakon začeća i nakon postupka eliminacije lijeka nisu zabilježene značajne razlike (p=0,13) u cjelokupnoj stopi većih strukturnih oštećenja (5,4%) u odnosu na bilo koju od komparativnih skupina (4,2% u bolesnih žena [n=108] i 4,2% u zdravih trudnica [n=78]).
English: Leflunomide Zentiva is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Croatian: Leflunomide Zentiva se ne preporučuje bolesnicima mlađima od 18 godina jer djelotvornost i sigurnost primjene kod juvenilnog reumatoidnog artritisa (JRA) nisu ustanovljene (vidjeti dijelove 5.1 i 5.2).
English: The only plasma-radiolabelled metabolite detected was A771726.
Croatian: Jedini otkriveni radioaktivno obilježeni metabolit u plazmi bio je A771726.
English: Binding of A771726 is linear in the therapeutic concentration range.
Croatian: Vezanje A771726 je linearno u rasponu terapijskih koncentracija.
English: The risk of their occurrence can be increased in patients with a history of interstitial lung disease.
Croatian: Rizik od njihove pojave može biti povećan u bolesnika s intersticijskom plućnom bolesti u anamnezi.
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures.
Croatian: Informacije navedene u Uputi za liječnika trebaju uključivati informacije o smanjenju doze, prekidu terapije i postupcima ispiranja lijeka („washout“).
English: A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these medicinal products is only increased by 10% to 50%.
Croatian: A771726 istiskuje ibuprofen, diklofenak i tolbutamid, ali se nevezana frakcija tih lijekova povećava za samo 10% do 50%.
English: Infections
Croatian: Infekcije
English: interstitial lung disease (including interstitial pneumonitis), which may be fatal
Croatian: intersticijska plućna bolest (uključujući intersticijski pneumonitis), koja može biti smrtonosna
English: The active metabolite of leflunomide, A771726, has a long half-life, usually 1 to 4 weeks.
Croatian: Aktivni metabolit leflunomida, A771726, ima dugi poluvijek, obično od 1 do 4 tjedna.
English: After administration of a radiolabelled dose of leflunomide, radioactivity was equally excreted in faeces, probably by biliary elimination, and in urine.
Croatian: Nakon primjene radioaktivno obilježenog leflunomida, radioaktivnost se u jednakoj mjeri pojavila u stolici, vjerojatno eliminacijom putem žuči, i u mokraći.
English: If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Croatian: Ako ste zaboravili uzeti lijek Leflunomide Zentiva Ako ste zaboravili uzeti dozu lijeka, uzmite je čim se sjetite, osim ako uskoro morate uzeti sljedeću dozu.
English: What Leflunomide Zentiva is and what it is used for What you need to know before you take Leflunomide Zentiva How to take Leflunomide Zentiva Possible side effects
Croatian: Što je Leflunomide Zentiva i za što se koristi Što morate znati prije nego što počnete uzimati lijek Leflunomide Zentiva Kako uzimati lijek Leflunomide Zentiva Moguće nuspojave
English: • Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Croatian: • Bolesnici s teškom hipoproteinemijom, npr. kod nefrotskog sindroma.
English: Leflunomide was embryotoxic and teratogenic in rats and rabbits at doses in the human therapeutic range and exerted adverse effects on male reproductive organs in repeated dose toxicity studies.
Croatian: Leflunomid je bio embriotoksičan i teratogen u štakora i kunića pri dozama u terapijskom rasponu za ljude te je izazvao štetne učinke na reproduktivnim organima mužjaka pri istraživanjima toksičnosti ponovljenih doza.
English: How to store Leflunomide Zentiva Contents of the pack and other information
Croatian: Kako čuvati lijek Leflunomide Zentiva Sadržaj pakiranja i druge informacije
English: Film-coated tablet.
Croatian: Filmom obložena tableta.
English: The mechanism is thought to be by interruption of enterohepatic recycling and/or gastrointestinal dialysis of A771726.
Croatian: Pretpostavlja se da se taj mehanizam zasniva na prekidu enterohepatičke recirkulacije i/ili gastrointestinalne dijalize A771726.
English: For women receiving leflunomide treatment and who wish to become pregnant, one of the following procedures is recommended in order to ascertain that the foetus is not exposed to toxic concentrations of A771726 (target concentration below 0.02 mg/L):
Croatian: Za žene koje se liječe leflunomidom, a planiraju trudnoću, preporučuje se jedan od sljedećih postupaka kako bi se osiguralo da fetus ne bude izložen toksičnim koncentracijama A771726 (ciljna koncentracija niža od 0,02 mg/l):
English: This metabolite is responsible for essentially all the in vivo activity of Leflunomide Zentiva.
Croatian: Taj je metabolit odgovoran za gotovo svu in vivo aktivnost lijeka Leflunomide Zentiva.
English: The main effects were anaemia, leucopenia, decreased platelet counts and panmyelopathy and reflect the basic mode of action of the compound (inhibition of DNA synthesis).
Croatian: Glavni učinci bili su anemija, leukopenija, smanjen broj trombocita i panmijelopatija i oni pokazuju osnovni način djelovanja tog spoja (inhibicija sinteze DNK).
English: Pulmonary symptoms, such as cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.
Croatian: Plućni simptomi, kao što su kašalj i dispneja, mogu biti razlogom za prekid liječenja i provođenje odgovarajućih daljnjih pretraga.
English: Omission of the loading dose may decrease the risk of adverse events (see section 5.1).
Croatian: Izostanak udarne doze može smanjiti rizik od nuspojava (vidjeti dio 5.1).
English: If both plasma concentrations are below 0.02 mg/L no teratogenic risk is to be expected.
Croatian: Ako su obje koncentracije niže od 0,02 mg/l, ne očekuje se teratogeni rizik.
English: A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity.
Croatian: A771726, aktivni metabolit leflunomida, inhibira humani enzim dihidroorotat dehidrogenazu (DHODH) i djeluje antiproliferativno.
English: Drinking alcohol while taking Leflunomide Zentiva may increase the chance of liver damage.
Croatian: Konzumacija alkohola za vrijeme liječenja lijekom Leflunomide Zentiva može povećati mogućnost oštećenja jetre.
English: severe infections, including sepsis which may be fatal
Croatian: teške infekcije, uključujući sepsu, koja može biti smrtonosna
English: Men wishing to father a child should contact their doctor who may advise them to stop taking Leflunomide Zentiva and take certain medicines to remove Leflunomide Zentiva rapidly and sufficiently from their body.
Croatian: Muškarci koji žele postati roditelji trebaju se obratiti svom liječniku koji će im možda savjetovati da prestanu uzimati lijek Leflunomide Zentiva i uzmu određene lijekove koji će brzo i u dovoljnoj mjeri ukloniti lijek Leflunomide Zentiva iz tijela.
English: If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Leflunomide Zentiva rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Croatian: Ako test potvrdi trudnoću, liječnik može preporučiti liječenje određenim lijekovima kojima se Leflunomide Zentiva brzo i u dovoljnoj mjeri izlučuje iz organizma, jer se time može smanjiti opasnost za Vaše dijete.
English: Leflunomide at a daily dose of at least 10 mg (10 to 25 mg in study YU203, 20 mg in studies MN301 and US301) was statistically significantly superior to placebo in reducing the signs and symptoms of rheumatoid arthritis in all 3 placebo-controlled trials.
Croatian: Leflunomid u dozi od najmanje 10 mg na dan (10 do 25 mg u ispitivanju YU203, 20 mg u ispitivanjima MN301 i US301) bio je statistički značajno bolji u odnosu na placebo u smanjivanju znakova i simptoma reumatoidnog artritisa u sva 3 placebom kontrolirana ispitivanja.
English: Do not take Leflunomide Zentiva if you are, or think you may be pregnant.
Croatian: Nemojte uzimati lijek Leflunomide Zentiva ako ste trudni ili mislite da biste mogli biti trudni.
English: In vivo, it is rapidly and almost completely metabolised to A771726 which is active in vitro, and is presumed to be responsible for the therapeutic effect.
Croatian: In vivo se brzo i gotovo potpuno metabolizira u A771726, koji je aktivan in vitro te se smatra odgovornim za terapijski učinak.
English: Leflunomide was not mutagenic.
Croatian: Leflunomid nije pokazao mutageno djelovanje.
English: Therefore, when warfarin or another coumarin anticoagulant is co-administered, close international normalised ratio (INR) follow-up and monitoring is recommended.
Croatian: Stoga, kada se varfarin i drugi kumarinski antikoagulansi primjenjuju istodobno s leflunomidom, preporučuje se pomno praćenje i nadzor internacionalnog normaliziranog omjera (engl. international normalised ratio, INR).
English: Like other agents with immunosuppressive potential, leflunomide may increase susceptibility to infections, including opportunistic infections (see also section 4.4).
Croatian: Kao i druge tvari s imunosupresivnim potencijalom, leflunomid može povećati osjetljivost na infekcije, uključujući i oportunističke infekcije (vidjeti dio 4.4).
English: There have been case reports of increased prothrombin time, when leflunomide and warfarin were co-administered.
Croatian: Prijavljeni su slučajevi povećanog protrombinskog vremena, kada su se istodobno primjenjivali leflunomid i varfarin.
English: In patients on leflunomide treatment presenting unexplained chronic diarrhoea appropriate diagnostic procedures should be performed.
Croatian: U bolesnika koji primaju terapiju leflunomidom, a u kojih je prisutan neobjašnjiv kronični proljev potrebno je provesti odgovarajuće dijagnostičke postupke.
English: Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex France
Croatian: Sanofi Winthrop Industrie 56, route de Choisy au bac F-60205 Compiegne Cedex Francuska
English: • before initiation of leflunomide,
Croatian: • prije početka liječenja leflunomidom,
English: In case of ulcerative stomatitis, leflunomide administration should be discontinued.
Croatian: U slučaju pojave ulceroznog stomatitisa primjenu leflunomida treba prekinuti.
English: ALT (SGPT) must be checked before initiation of leflunomide and at the same frequency as the complete blood cell count (every two weeks) during the first six months of treatment and every 8 weeks thereafter.
Croatian: ALT (SGPT) se mora provjeriti prije početka liječenja leflunomidom te u jednakim razmacima kao i kompletnu krvnu sliku, odnosno, svaka dva tjedna tijekom prvih 6 mjeseci liječenja i nakon toga svakih 8 tjedana.
English: Women of childbearing potential must not take Leflunomide Zentiva without using reliable contraceptive measures.
Croatian: Žene reproduktivne dobi ne smiju uzimati lijek Leflunomide Zentiva ako ne koriste učinkovitu kontracepciju.
English: Leflunomide Zentiva is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Croatian: Leflunomide Zentiva se primjenjuje za liječenje odraslih bolesnika s aktivnim oblikom reumatoidnog artritisa ili aktivnim oblikom psorijatičnog artritisa.
English: Rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving leflunomide among other immunosuppressants.
Croatian: Rijetki slučajevi progresivne multifokalne leukoencefalopatije (PML) zabilježeni su u bolesnika koji su dobivali leflunomid uz druge imunosupresive.
English: Effect of leflunomide on other medicinal products:
Croatian: Učinak leflunomida na druge lijekove:
English: For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, dose reduction from 20 mg to 10 mg may be considered and monitoring must be performed weekly.
Croatian: Kad se ALT (SGPT) poveća 2 do 3 puta u odnosu na gornju granicu normale, može se razmotriti smanjenje doze s 20 mg na 10 mg, a vrijednosti se moraju kontrolirati jednom na tjedan.
English: It is known that medicinal products with immunosuppressive properties - like leflunomide - may cause patients to be more susceptible to infections, including opportunistic infections.
Croatian: Poznato je da lijekovi s imunosupresivnim svojstvima, poput leflunomida, mogu povećati osjetljivost bolesnika na infekcije, uključujući oportunističke infekcije.
English: There were no adverse events reported in the majority of case reports of overdose.
Croatian: U većini prijavljenih slučajeva predoziranja nije bilo nuspojava.
English: Women of childbearing potential should be told that a waiting period of 2 years after treatment discontinuation is required before they may become pregnant.
Croatian: Ženama reproduktivne dobi treba reći da moraju proći 2 godine od prekida liječenja do moguće trudnoće.
English: Not known:
Croatian: Nepoznato:
English: Date of first authorisation: 08 January 2010
Croatian: Datum prvog odobrenja: 08. siječnja 2010.
English: The treatment should be initiated and supervised by specialists experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
Croatian: Liječenje mora započeti i nadzirati liječnik specijalist s iskustvom u liječenju reumatoidnog i psorijatičnog artritisa.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: Bottle:
Croatian: Bočica:
English: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD),
Croatian: • aktivnim reumatoidnim artritisom kao antireumatik koji modificira tijek bolesti (DMARD od engl. disease-modifying antirheumatic drug),
English: Increased side effects may occur in case of recent or concomitant use of hepatotoxic or haematotoxic medicinal products or when leflunomide treatment is followed by such medicinal products without a washout period (see also guidance concerning combination with other treatments, section 4.4).
Croatian: Više nuspojava može se pojaviti u slučaju nedavne ili istodobne primjene hepatotoksičnih ili hematotoksičnih lijekova ili kad se nakon primjene takvih lijekova leflunomid primjenjuje bez perioda ispiranja (vidjeti upute o kombinaciji s ostalim lijekovima, dio 4.4).
English: Since such therapy can lead to additive or even synergistic toxicity (e.g. hepato- or haematotoxicity), combination with another DMARD (e.g. methotrexate) is not advisable.
Croatian: Kako takvo liječenje može uzrokovati dodatnu, pa čak i sinergističku toksičnost (npr. hepatotoksičnost ili hematotoksičnost), ne preporučuje se kombinacija s drugim DMARD-ima (npr. metotreksatom).
English: Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide Zentiva, as you need to ensure that all traces of Leflunomide Zentiva have left your body before trying to become pregnant.
Croatian: Obavijestite svog liječnika ako planirate zatrudnjeti nakon prekida liječenja lijekom Leflunomide Zentiva, jer je potrebno osigurati da se svi tragovi lijeka Leflunomide Zentiva uklone iz organizma prije nego što pokušate zatrudnjeti.
English: A pack of 3 tablets is available
Croatian: Dostupno je pakiranje od 3 tablete.
English: If you are already taking a nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide Zentiva.
Croatian: Ako već uzimate nesteroidne protuupalne lijekove (NSAIL) i/ili kortikosteroide, možete ih nastaviti uzimati nakon što počnete uzimati lijek Leflunomide Zentiva.
English: You will normally take Leflunomide Zentiva over long periods of time.
Croatian: Leflunomide Zentiva se obično uzima tijekom duljeg vremenskog razdoblja.
English: At steady state plasma levels accumulate about 33- to 35-fold compared with single dose.
Croatian: Koncentracija u plazmi u stanju dinamičke ravnoteže kumulira se oko 33 do 35 puta više nego kod primjene jedne doze.
English: No incremental overall benefit was observed in the studied population with the use of a loading dose regimen.
Croatian: Nije zabilježen porast cjelokupne koristi u ispitivanoj populaciji koja je dobivala udarnu dozu.
English: If both plasma concentrations are below 0.02 mg/L, and after a waiting period of at least 3 months, the risk of foetal toxicity is very low.
Croatian: Ako je u oba slučaja koncentracija u plazmi manja od 0,02 mg/l, a nakon stanke od najmanje 3 mjeseca, rizik od fetalne toksičnosti vrlo je malen.
English: In vitro inhibition studies in human liver microsomes suggest that cytochrome P450 (CYP) 1A2, 2C19 and 3A4 are involved in leflunomide metabolism.
Croatian: In vitro ispitivanja inhibicije u ljudskim jetrenim mikrosomima ukazuju da su citokromi P450 (CYP) 1A2, 2C19 i 3A4 uključeni u metabolizam leflunomida.
English: In female mice an increased incidence, dose-dependent, of bronchiolo-alveolar adenomas and carcinomas of the lung was noted.
Croatian: U ženki miševa zabilježena je povećana incidencija (ovisna o dozi) bronhioloalveolarnih adenoma i karcinoma pluća.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, posavjetujte se sa svojim liječnikom prije nego što počnete uzimati ovaj lijek.
English: Other medicines and Leflunomide Zentiva
Croatian: Drugi lijekovi i Leflunomide Zentiva
English: If a patient taking Leflunomide Zentiva develops a peripheral neuropathy, consider discontinuing Leflunomide Zentiva therapy and performing the drug elimination procedure (see section 4.4).
Croatian: Ako se u bolesnika koji uzima lijek Leflunomide Zentiva pojavi periferna neuropatija, treba razmotriti prestanak terapije lijekom Leflunomide Zentiva i provođenje postupka eliminacije lijeka (vidjeti dio 4.4).