FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tablet core: lactose monohydrate, povidone, crospovidone type A, pregelatinized starch (maize), talc, anhydrous colloidal silica, lactose anhydrous and magnesium stearate.
Croatian: • Jezgra tablete: laktoza hidrat, povidon, krospovidon vrste A, prethodno geliran škrob (kukuruzni), talk, bezvodni koloidni silicijev dioksid, bezvodna laktoza i magnezijev stearat.
English: In case of severe haematological reactions, including pancytopenia, Leflunomide Teva and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
Croatian: U slučaju teških hematoloških reakcija, uključujući pancitopeniju, treba prekinuti liječenje Leflunomidom Teva i bilo kojim istodobno primijenjenim mijelosupresivnim lijekom te početi
English: What Leflunomide Teva looks like and contents of the pack Leflunomide Teva 20 mg film-coated tablets are dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Croatian: Kako Leflunomid Teva izgleda i sadržaj pakovanja Leflunomid Teva 20 mg filmom obložene tablete su tamno bež, filmom obložene tablete, trokutastog oblika, s utisnutom oznakom „20“ na jednoj strani i „L“ na drugoj.
English: - If you are allergic to leflunomide (especially a serious skin reaction, often with fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome) or any of the other ingredients of this
Croatian: Ako ste alergični na leflunomid (pogotovo ako imate teške kožne reakcije, često udružene s vrućicom, bolovima u zglobovima, crvenim kožnim mrljama ili mjehurićima, npr. Steven
English: severe infections, including sepsis which may be fatal 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: • Hypersensitivity to the active substance (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) or to any of the excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar (osobito u slučaju ranijeg Stevens-Johnsonovog sindroma, toksične epidermalne nekrolize, multiformnog eritema) ili neku od pomoćnih tvari navedenih u
English: Immune system disorders Common:
Croatian: Poremećaji probavnog sustava Često:
English: Teva Sweden AB Tel: +(46) 42 12 11 00
Croatian: Teva Sweden AB Tel: +(46) 42 12 11 00 United Kingdom Teva UK Limited
English: - Tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these may indicate serious conditions such as liver failure, which may be fatal.
Croatian: - Umora, boli u trbuhu ili žutice (žuta boja bjeloočnica ili kože) jer to može upućivati na teška stanja kao što je zatajenje jetre, koje može dovesti do smrtnog ishoda.
English: Since the active metabolite of leflunomide, A771726, is highly protein bound and cleared via hepatic metabolism and biliary secretion, plasma levels of A771726 are expected to be increased in patients with hypoproteinaemia.
Croatian: Kako se aktivni metabolit leflunomida, A771726, snažno veže za proteine plazme i uklanja metaboliziranjem u jetri i sekrecijom putem žuči, u bolesnika s hipoproteinemijom očekuje se povećanje koncentracije A771726 u plazmi.
English: Before and during treatment with Leflunomide Teva, your doctor will carry out blood tests at regular times.
Croatian: Prije i za vrijeme liječenja Leflunomidom Teva liječnik će Vas u redovitim razmacima slati na krvne pretrage zbog kontrole Vaših krvnih stanica i jetre.
English: The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases (especially ALT), less often gamma-GT, alkaline phosphatise, bilirubin))
Croatian: Najčešće zabilježene nuspojave tijekom primjene leflunomida su: blagi porast krvnog tlaka, leukopenija, parestezija, glavobolja, omaglica, proljev, mučnina, povraćanje, poremećaji sluznice usne šupljine (npr. aftozni stomatitis, ulceracije u ustima), bol u trbuhu, pojačani gubitak kose, ekcem, osip (uključujući makulopapulozni osip), svrbež, suha koža, tenosinovitis, povećanje CPK, anoreksija,
English: For tablets stored in blisters: Do not store above 25°C.
Croatian: Tablete u blisterima: Ne čuvati na temperaturi iznad 25°C.
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day vs. placebo were 54.6 % vs. 28.6 % (study MN301), and 49.4 % vs. 26.3 % (study US301).After 12 months with active treatment, the ACR response rates in leflunomide patients were 52.3 % (studies MN301/303), 50.5 % (study MN302) and 49.4 % (study US301), compared to 53.8 % (studies MN301/303) in sulphasalazine patients, 64.8 % (study MN302), and 43.9 % (study US301) in methotrexate patients.
Croatian: Nakon 12 mjeseci aktivnog liječenja stopa odgovora prema ACR-u u bolesnika koji su primali leflunomid bila je 52,3% (studije MN301/303), 50,5% (studija MN302) i 49,4% (studija US301) u usporedbi sa 53,8% (studije MN301/303) u bolesnika koji su primali sulfasalazin te 64,8% (studija MN302) i 43,9% (studija
English: Due to a potential for additive hepatotoxic effects, it is recommended that alcohol consumption be avoided during treatment with leflunomide.
Croatian: Zbog mogućnosti dodatnog hepatotoksičnog učinka tijekom liječenja leflunomidom preporučuje se
English: 6.6 Special precautions for disposal No special requirements for disposal.
Croatian: 6.6 Posebne mjere za zbrinjavanje
English: If after stopping treatment with Leflunomide Teva you plan to become pregnant, you need to ensure that Leflunomide Teva has left your body before trying to become pregnant.
Croatian: Obavijestite svog liječnika ako planirate zatrudnjeti nakon prekida terapije Leflunomidom Teva jer je potrebno osigurati da se svi tragovi Leflunomida Teva uklone iz organizma prije nego što pokušate zatrudnjeti.
English: A randomised, double-blind, parallel-group non-inferiority study compared the relative efficacy of two different daily maintenance doses of leflunomide, 10 mg and 20 mg. From the results it can be concluded that efficacy results of the 20 mg maintenance dose were more favourable, on the other hand, the safety results favoured the 10 mg daily maintenance dose.
Croatian: Randomiziranom, dvostruko slijepom, neinferiornom studijom paralelnih grupa uspoređivala se relativna učinkovitost dviju različitih dnevnih doza održavanja leflunomida, odnosno 10 i 20 mg.
English: Leflunomide Teva stored in blisters are available in pack sizes of 28, 30 and 100 film-coated tablets.
Croatian: Leflunomid Teva u bočicama je dostupan u veličinama pakovanja od 28, 30 i 100 filmom obloženih
English: If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, these may be continued after starting leflunomide.
Croatian: Bolesnici koji već uzimaju nesteroidne protuupalne lijekove (NSAIL-e) i/ili kortikosteroide mogu ih nastaviti uzimati nakon uvođenja leflunomida u liječenje.
English: The extensive protein binding of A771726 could lead to displacement of other highly-bound drugs.
Croatian: Ekstenzivnim vezanjem za proteine A771726 može istisnuti ostale lijekove koji se snažno vežu za proteine plazme.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU NALJEPNICA NA BOČICI
English: Blisters: Do not store above 25°C.
Croatian: Blisteri: Ne čuvati na temperaturi iznad 25°C.
English: Study MN302 randomised 999 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=501) or methotrexate at 7.5 mg/week increasing to 15 mg/week (n=498).
Croatian: U studiji MN302 bilo je 999 randomiziranih bolesnika s aktivnim reumatoidnim artritisom koji su primali leflunomid 20 mg/dan (n=501) ili metotreksat 7,5 mg/tjedan, s povećanjem doze na 15 mg/tjedan (n=498).
English: Adverse events consistent with the safety profile for leflunomide were: abdominal pain, nausea, diarrhoea, elevated liver enzymes, anaemia, leucopenia, pruritus and rash.
Croatian: Nuspojave u skladu sa sigurnosnim profilom leflunomida bile su: bol u trbuhu, mučnina, proljev, povišene vrijednosti jetrenih enzima,
English: • Tablet coating: titanium dioxide, polydextrose, hypromellose, triethyl citrate and macrogol
Croatian: • Ovojnica tablete: titanijev dioksid, polidekstroza, hipromeloza, trietilcitrat i makrogol 8000.
English: Repeated oral administration of leflunomide to mice for up to 3 months, to rats and dogs for up to 6 months and to monkeys for up to 1 month's duration revealed that the major target organs for toxicity were bone marrow, blood, gastrointestinal tract, skin, spleen, thymus and lymph nodes.
Croatian: Ponavljana oralna primjena leflunomida na miševima do tri mjeseca, štakorima i psima do 6 mjeseci te majmunima do jednog mjeseca pokazala je da je toksičnost najočitija na koštanoj srži,
English: All of these also resolved, 2 with continuation of both drugs and 3 after discontinuation of leflunomide.
Croatian: Sve su se te vrijednosti smanjile u 2 bolesnika koji su nastavili istodobno uzimati oba lijeka i u 3 bolesnika koji su prekinuli uzimati leflunomid.
English: Leflunomide Teva passes into breast milk.
Croatian: Leflunomid Teva sadrži laktozu.
English: 3542 DR Utrecht The Netherlands
Croatian: 2031 GA Haarlem Nizozemska
English: Recent, concomitant or consecutive use of potentially myelotoxic agents may be associated with a higher risk of haematological effects.
Croatian: Nedavno, istodobno ili naknadno uzimanje potencijalno mijelotoksičnih lijekova može povećati rizik
English: Teva Nederland B.V. Tel: +31 (0) 800 0228400
Croatian: Tel: +31 (0) 800 0228400 Norge
English: Administration of activated charcoal (powder made into a suspension) orally or via nasogastric tube (50 g every 6 hours for 24 hours) has been shown to reduce plasma concentrations of the active metabolite A771726 by 37 % in 24 hours and by 48 % in 48 hours.
Croatian: (50 g svakih 6 sati tijekom 24 sata) smanjila se koncentracija aktivnog metabolita A771726 za 37% u roku od 24 sata i za 48% u roku od 48 sati.
English: Study MN301 randomised 358 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=133), sulphasalazine 2 g/day (n=133), or placebo (n=92).
Croatian: U studiji MN301, 358 randomiziranih bolesnika s aktivnim reumatoidnim artritisom uzimalo je leflunomid 20 mg/dan (n=133), sulfasalazin 2 g/dan (n=133) ili placebo (n= 92).
English: For further information on the sample testing please contact the Marketing Authorisation Holder or its
Croatian: Za dodatne informacije o ispitivanju uzorka obratite se nositelju odobrenja za stavljanje gotovog lijeka u promet ili njegovom lokalnom predstavniku (vidjeti dio 7).
English: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/l), eosinophilia
Croatian: Manje često: anemija, blaga trombocitopenija (trombociti <100 g/l). pancitopenija (vjerojatno povezana s antiproliferativnim mehanizmom djelovanja), leukopenija (leukociti <2 g/l), eozinofilija
English: • Each Leflunomide Teva 20 mg film-coated tablet contains 20 mg of leflunomide.
Croatian: • Jedna Leflunomid Teva 20 mg filmom obložena tableta sadrži 20 mg leflunomida.
English: Since Leflunomide Teva can cause an increase in your blood pressure, your doctor will also check your blood pressure regularly.
Croatian: Liječnik će Vam također redovito kontrolirati krvni tlak jer Leflunomid Teva može uzrokovati njegovo povećanje.
English: • Each Leflunomide Teva 10 mg film-coated tablet contains 10 mg of leflunomide.
Croatian: • Jedna Leflunomid Teva 10 mg filmom obložena tableta sadrži 10 mg leflunomida.
English: EXPIRY DATE
Croatian: Razdoblje čekanja
English: - Reduction in the number of white blood cells, which makes infections more likely (leucopenia).
Croatian: - značajno smanjenje broja bijelih krvnih stanica, što može povećati sklonost infekcijama
English: The phase II trial, study YU203, randomised 402 subjects with active rheumatoid arthritis to placebo (n=102), leflunomide 5 mg (n=95), 10 mg (n=101) or 25 mg/day (n=104).
Croatian: U ispitivanju faze II, YU203, 402 randomizirana bolesnika s aktivnim reumatoidnim artritisom dobivala su placebo (n=102), leflunomid 5 mg/dan (n=95), 10 mg/dan
English: Tell your doctor immediately and stop taking Leflunomide Teva: - If you feel weak, light-headed or dizzy or have difficulty breathing, as these may be signs of a
Croatian: Ako osjetite slabost, ošamućenost ili omaglicu ili imate poteškoće s disanjem jer to mogu biti
English: - Severe liver damage (i.e. liver failure, liver necrosis), which may be fatal.
Croatian: - teško oštećena funkcija jetre (zatajenje jetre ili nekroza) koja može biti opasna po život.
English: Immune system disorders severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous hypokalaemia, hyperlipidemia, hypophosphataemia paraesthesia, headache, dizziness, peripheral neuropathy
Croatian: Manje često: hipokalijemija, hiperlipidemija, hipofosfatemija parestezija, glavobolja, omaglica, periferna neuropatija
English: Both colestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the washout procedure with colestyramine or activated powdered charcoal.
Croatian: Stoga se kontracepcija oralnim kontraceptivima ne može smatrati pouzdanom tijekom postupka eliminacije u kojima se primjenjuje kolestiramin ili aktivni ugljen u prahu.
English: Absorption
Croatian: Eliminacija
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 00 7
Croatian: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
English: Human pharmacology
Croatian: Pedijatrijska populacija
English: - If you get any side effects , talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Croatian: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex
English: Some vaccinations should not be given while taking Leflunomide Teva, and for a certain amount of time after stopping treatment.
Croatian: Za vrijeme uzimanja Leflunomida Teva kao i određeno vrijeme nakon prekida liječenja ne smije se provoditi cijepljenje određenim cjepivima.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C
Croatian: Ne čuvati na temperaturi iznad 25°C
English: All elevations resolved, 2 with continuation of both drugs and 3 after discontinuation of leflunomide.
Croatian: Sve su se povišene vrijednosti smanjile u 2 bolesnika koji su nastavili istodobno uzimati oba lijeka i u 3
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: 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: Dark beige, triangle shaped, film-coated tablets, engraved with ”20” on one side and “L” on the other.
Croatian: Tamnobež, filmom obložene tablete, u obliku trokuta, s oznakom „20“ utisnutom na jednoj strani i „L“
English: In such cases re-exposure to leflunomide is contra-indicated (see
Croatian: U tim je slučajevima neophodna potpuna eliminacija lijeka, a ponovno uzimanje leflunomida je kontraindicirano (vidjeti dio 4.3.).
English: - unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Croatian: - Neuobičajenih trnaca, slabosti li bolova u šakama ili stopalima jer mogu upućivati na probleme sa
English: Leflunomide Teva 20 mg film-coated tablets
Croatian: Leflunomid Teva 20 mg filmom obložene tablete
English: 4.4 Special warnings and precautions for use Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.
Croatian: Ne preporučuje se istodobna primjena hepatotoksičnih ili hematotoksičnih DMARD-a (npr.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of leflunomide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 10 mg leflunomida.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of leflunomide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 20 mg leflunomida.
English: - Vomiting.
Croatian: - mučnina; - povraćanje;
English: - Hedache.
Croatian: - proljev;
English: NAME OF THE MEDICINAL PRODUCT Leflunomide Teva 20 mg film-coated tablets
Croatian: NAZIV GOTOVOG LIJEKA Leflunomid Teva 20 mg filmom obložene tablete
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C
Croatian: Ne čuvati na temperaturi iznad 30°C
English: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Croatian: Vrlo rijetko: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, multiformni eritem kožni eritemski lupus, pustularna psorijaza ili pogoršanje psorijaze
English: Uncommon side effects (may affect up to 1 in 100 people) - Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness - Mild reduction in blood platelets, which increases the risk of bleeding or bruising.
Croatian: Manje česte nuspojave (mogu se javiti u 1 od 100 ljudi): - smanjeni broj crvenih krvnih stanica što može uzrokovati bljedoću kože te slabost i otežano
English: NAME OF THE MEDICINAL PRODUCT Leflunomide Teva 10 mg film-coated tablets
Croatian: NAZIV GOTOVOG LIJEKA Leflunomid Teva 10 mg filmom obložene tablete
English: Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable.
Croatian: Studije s hemodijalizom i kroničnom ambulantnom peritonealnom dijalizom upućuju da se A771726,
English: Your doctor may recommend a treatment to remove Leflunomide Teva rapidly and sufficiently from your body.
Croatian: Ako liječnik potvrdi trudnoću, može preporučiti liječenje određenim lijekovima za brzo i djelotvorno izlučivanje Leflunomida Teva iz organizma, što može
English: Especially if you are taking any of the following: - Any other medicine used to treat rheumatoid arthritis, e.g. methotrexate and azathioprine (immunosuppressants), chloroquine and hydroxychloroquine (antimalarials), gold (by mouth or injection), and D-penicillamine.
Croatian: (imunosupresivni lijekovi), klorokin i hidroksiklorokin (antimalarici), zlato (kroz usta ili injekcijom) i D-penicilamin.
English: Leflunomide Teva contains lactose.
Croatian: Sadrži djelatnu tvar leflunomid.
English: Discuss with your doctor to find out if any medicine you are taking is broken down by CYP2C9.
Croatian: Upitajte svog liječnika razgrađuje li se neki od lijekova koji uzimate putem enzima
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet:
English: Rare side effects (may affect up to 1 in 1,000 people) - Severe reduction in blood cells which can cause weakness, bruising or make infections more - Severe reduction in the number of white blood cells, which makes infections more likely
Croatian: Rijetke nuspojave (mogu se javiti u 1 od 1000 ljudi): - značajno smanjenje broja svih krvnih stanica, što može uzrokovati slabost, nastajanje modrica ili
English: Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=182), methotrexate 7.5 mg/week increasing to 15 mg/week (n=182), or placebo (n=118).
Croatian: U studiji US301, 482 randomizirana bolesnika s aktivnim reumatoidnim artritisom primala su leflunomid 20 mg/dan (n=182), metotreksat 7,5 mg/tjedan, s povećanjem doze na 15 mg/tjedan (n=
English: - Abdominal pain.
Croatian: - pojačan gubitak kose;
English: Leflunomide Teva 10 mg film-coated tablets
Croatian: Leflunomid Teva 10 mg filmom obložene tablete
English: In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: < 20 kg, 20-40 kg, and > 40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥ 30 % (p = 0.02).
Croatian: U ovom su se ispitivanju udarna doza i doza održavanja leflunomida zasnivale na 3 kategorije tjelesne težine: <20 kg, 20-40 kg i >40 kg.
English: The concentration may be expected to decrease below 0.02 mg/l about 2 years after stopping the treatment
Croatian: Smanjenje koncentracije A771726 u plazmi na razinu nižu od 0,02 mg/l očekuje se za oko dvije godine nakon prekida liječenja leflunomidom.
English: The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
Croatian: A771726 ekstenzivno se veže za proteine plazme i uklanja jetrenim metabolizmom te izlučuje putem žuči.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Croatian: IME NOSITELJA
English: Pharmacovigilance system
Croatian: Postmarketinške studije
English: hepatitis, jaundice/cholestasis
Croatian: anemija, leukopenija, svrbež i osip.
English: Deutschland Teva GmbH Tel: (49) 731 402 08
Croatian: Teva Italia S.r.l. Tel: +(39) 028917981
English: Pack sizes of 30 and 100 film-coated tablets.
Croatian: Veličine pakovanja od 30 i 100
English: Common side effects (may affect up to 1 in 10 people) - Mild increase in blood pressure.
Croatian: Česte nuspojave (mogu se javiti u 1 od 10 ljudi):
English: Very rare side effects (may affect up to 1 in 10,000 people) - An infection characterised by high fever, sore throat, skin lesions and an extreme reduction of white blood cells (agranulocytosis).
Croatian: Česte nuspojave (mogu se javiti u 1 od 10 ljudi): - smanjeni broj bijelih krvnih stanica, što povećava sklonost razvoju infekcija (leukopenija); - kožne reakcije, npr. osjećaj pečenja i bockanja, svrbež ili trnci (parestezija);
English: Leflunomide Teva tablets
Croatian: filmom obloženih tableta.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: Medicinal product subject to medical prescription.
Croatian: NAZIV GOTOVOG LIJEKA
English: - If you are male and wish to father a child. As it cannot be excluded that Leflunomide Teva passes into semen, reliable contraception should be used during treatment with Leflunomide Teva.
Croatian: Teva u sjeme, tijekom terapije Leflunomidom Teva treba primjenjivati učinkovitu kontracepciju.
English: EU/1/11/675/007 100 film-coated tablets
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/11/675/006 30 filmom obloženih tableta EU/1/11/675/007 100 filmom obloženih tableta
English: Male patients should be aware of the possible male-mediated foetal toxicity.
Croatian: Planiranje obitelji (preporuke za muškarce) Muški bolesnici moraju biti svjesni da mogu biti posrednici u pojavi fetalne toksičnosti.
English: Norge
Croatian: Hrvatska
English: The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after
Croatian: Kad se razmišlja o primjeni živih atenuiranih cjepiva nakon prekida liječenja Leflunomidom Teva, treba uzeti u obzir