FrancophonIA/ELRC3.0 huggingface dataset:
English: Leflunomide Zentiva 100 mg film-coated tablets are white to almost white and round.
Slovenian: Leflunomid Zentiva 100 mg filmsko obložene tablete so bele do skoraj bele in okrogle oblike.
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).
Slovenian: faze, raziskave YU203, so 402 preiskovanca z aktivnim revmatoidnim artritisom randomizirano razvrstili na placebo (n = 102), leflunomid 5 mg (n = 95), 10 mg (n = 101) ali 25 mg/dan (n = 104).
English: Musculoskeletal and connective tissue disorders Common:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti:
English: In human plasma, A771726 is extensively bound to protein (albumin).
Slovenian: A771726 je v človeški plazmi izrazito vezan na beljakovine (albumin).
English: Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo.
Slovenian: Ponavljajoči se odmerki A771726 so zmanjšali povprečno Cmax kofeina (ki je substrat CYP1A2) za 18 % in njegovo povprečno AUC za 55 %; to kaže, da A771726 in vivo morda šibko inducira CYP1A2.
English: The tablets are packed in blisters.
Slovenian: Tablete so pakirane v pretisnih omotih.
English: In case of severe haematological reactions, including pancytopenia, Leflunomide Zentiva and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
Slovenian: V primeru hudih hematoloških neželenih učinkov, vključno s pancitopenijo, je treba prekiniti uporabo zdravila Leflunomid Zentiva in morebitnih drugih mielosupresivnih zdravil ter začeti postopek izpiranja leflunomida.
English: Interstitial lung disease, as well as rare cases of pulmonary hypertension have been reported during treatment with leflunomide (see section 4.8).
Slovenian: Med zdravljenjem z leflunomidom je bila opisana intersticijska bolezen pljuč, pa tudi redki primeri pljučne hipertenzije (glejte poglavje 4.8).
English: • For psoriatic arthritis: 20 mg Leflunomide Zentiva once daily.
Slovenian: • za zdravljenje aktivnega psoriatičnega artritisa: 20 mg zdravila Leflunomid Zentiva enkrat na dan.
English: Excipients with known effect Each tablet contains 138.42 mg of lactose monohydrate
Slovenian: Pomožne snovi z znanim učinkom Ena tableta vsebuje in 138,42 mg laktoze monohidrata.
English: White to almost white, round film-coated tablet, imprinted with ZBP on one side.
Slovenian: Bela do skoraj bela, okrogla filmsko obložena tableta, z napisom ZBP na eni strani.
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.
Slovenian: Aktivni presnovek leflunomida, A771726, je v veliki meri vezan na beljakovine in se odstranjuje z jetrno presnovo in biliarno sekrecijo, zato je mogoče pri bolnikih s hipoproteinemijo pričakovati zvišano koncentracijo A771726 v plazmi.
English: • In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days.
Slovenian: • Pri revmatoidnem artritisu: zdravljenje z leflunomidom se ponavadi začne z začetnim odmerkom 100 mg enkrat na dan 3 dni.
English: White to almost white, round film-coated tablet, imprinted with ZBN on one side.
Slovenian: Bela do skoraj bela, okrogla filmsko obložena tableta, z napisom ZBN na eni strani.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Slovenian: Pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta.
English: Leflunomide Zentiva 10 mg film-coated tablets are white to almost white and round.
Slovenian: Leflunomid Zentiva 10 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike.
English: Talk to your doctor, pharmacist or nurse before taking Leflunomide Zentiva - if you have ever suffered from inflammation of the lung (interstitial lung disease).
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Leflunomid Zentiva se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro: - če ste kdaj imeli vnetje pljuč (intersticijsko bolezen pljuč).
English: The pharmacokinetics of A771726 in CAPD subjects appeared to be similar to healthy volunteers.
Slovenian: Farmakokinetika A771726 je bila pri osebah na kontinuirani ambulantni peritonealni dializi podobna kot pri zdravih postovoljcih.
English: There are no specific data on the risk of male-mediated foetal toxicity.
Slovenian: Specifičnih podatkov o toksičnih učinkih za plod, ki jih lahko posreduje moški, ni.
English: Tell your doctor immediately if you experience: - pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood, - 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, - any symptoms of an infection such as fever, sore throat or cough, as this medicine may increase the chance of a severe infection which may be life-threatening, - cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension), - unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Slovenian: Nemudoma obvestite svojega zdravnika, če opazite: - bledico, utrujenost ali podplutbe, ki so lahko znak krvnih bolezni, ki jih povzroči neravnovesje različnih krvnih celic, ki sestavljajo kri, - utrujenost, bolečine v trebuhu ali zlatenico (porumenelost oči ali kože), ki so lahko znak resnih bolezni, kot je bolezen jeter, ki je lahko usodna, - simptome, kot so vročina, vneto grlo ali kašelj, ki nakazujejo okužbo, saj zdravilo Leflunomid Zentiva lahko poveča možnost nastanka hudih vnetij, ki so lahko usodna, - kašelj ali oteženo dihanje, ki lahko nakazujeta težave s pljuči (intersticijska bolezen pljuč ali pljučna hipertenzija), - nenavadno mravljinčenje, slabost ali bolečina v rokah in nogah.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IMETNIK DOVOLJENJA ZA PROMET
English: All elevations resolved 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
Slovenian: V vseh primerih je zvišanje izginilo, pri 2 bolnikih ob nadaljevanju uporabe obeh zdravil in pri 3 po opustitvi leflunomida.
English: It contains the active substance leflunomide.
Slovenian: Vsebuje zdravilno učinkovino leflunomid.
English: In patients with pre-existing anaemia, leucopenia, and/or thrombocytopenia as well as in patients with impaired bone marrow function or those at risk of bone marrow suppression, the risk of haematological disorders is increased.
Slovenian: Tveganje za pojav hematoloških motenj je večje pri bolnikih z obstoječo anemijo, levkopenijo in/ali trombocitopenijo, pri bolnikih z okvarjenim delovanjem kostnega mozga in tistih s tveganjem za supresijo kostnega mozga.
English: Immune system disorders Common:
Slovenian: Bolezni imunskega sistema Pogosti:
English: • In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days.
Slovenian: • Pri psoriatičnem artritisu: zdravljenje z leflunomidom se začne z začetnim odmerkom 100 mg enkrat na dan 3 dni.
English: Reproductive system and breast disorders Not known:
Slovenian: ledvična odpoved Motnje reprodukcije in dojk Neznani:
English: - zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide Zentiva which is absorbed by the body.
Slovenian: - indometacin, ketoprofen za bolečino ali vnetje, - furosemid za bolezni srca (diuretik, tableta za odvajanje vode), - zidovudin za HIV okužbe, - rosuvastatin, simvastatin, atorvastatin, pravastatin za hiperholesterolemijo (zvišane vrednosti holesterola), - sulfasalazin za vnetno bolezen črevesa ali revmatoidni artritis, - zdravilo imenovano holestiramin (uporablja se za zniževanje zvišanega holesterola) ali aktivno oglje, saj ti dve zdravili lahko znižata količino zdravila Leflunomid Zentiva, ki jo telo absorbira.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: How to take Leflunomide Zentiva
Slovenian: Kako jemati zdravilo Leflunomid Zentiva
English: This metabolite is responsible for essentially all the in vivo activity of Leflunomide Zentiva.
Slovenian: Ta je odgovoren za praktično vso aktivnost zdravila Leflunomid Zentiva in- vivo.
English: The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
Slovenian: Aktivni presnovek A771726 je izrazito vezan na beljakovine in se odstranjuje z jetrno presnovo in biliarno sekrecijo.
English: Effect on organic anion transporter 3 (OAT3) substrates There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of OAT3 in vivo.
Slovenian: Vpliv na substrate prenašalca organskih anionov 3 (OAT3) Po večkratnih odmerkih A771726 so ugotovili povečanje povprečne Cmax cefaklorja za 1,43-krat in njegove povprečne AUC za 1,54-krat; to kaže, da A771726 in vivo zavira OAT3.
English: (pancytopenia), - severe increase in blood pressure, - inflammation of the lung (interstitial lung disease), - an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice, - severe infections called sepsis which may be fatal, - an increase of certain enzymes in the blood (lactate dehydrogenase).
Slovenian: resno zvišanje krvnega tlaka, vnetje pljuč (intersticijska bolezen pljuč), zvišanje nekaterih vrednosti jetrnih testov, kar se lahko razvije v resne bolezni, npr. hepatitis in zlatenico, hude okužbe, imenovane sepsa, ki so lahko usodne, zvišanje določenih encimov v krvi (laktat-dehidrogenaza).
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% versus 28.6% (study MN301), and 49.4% versus 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.
Slovenian: Po 12 mesecih aktivnega zdravljenja so bili deleži odzivov po ACR pri bolnikih na leflunomidu 52,3 % (študiji MN301/303), 50,5 % (študija MN302) in 49,4 % (študija US301) v primerjavi s 53,8 % (študiji MN301/303) pri bolnikih na sulfasalazinu ter 64,8 % (študija MN302) oz. 43,9 % (študija US301) pri bolnikih na metotreksatu.
English: For other substrates of BCRP (e.g., methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g., simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution.
Slovenian: Previdnost je potrebna tudi v primeru sočasne uporabe drugih substratov BCRP (npr. metotreksata, topotekana, sulfasalazina, daunorubicina, doksorubicina) in družine OATP, zlasti zaviralcev HMG-CoA-reduktaze (npr. simvastatina, atorvastatina, pravastatina, metotreksata, nateglinida, repaglinida, rifampicina).
English: Therefore, the plausibility of observed decreased ionised calcium levels needs to be questioned in patients under treatment with leflunomide or teriflunomide.
Slovenian: Zato je treba pri bolnikih, ki se zdravijo z leflunomidom ali teriflunomidom, podvomiti o verodostojnosti opaženih znižanih ravni ioniziranega kalcija.
English: What you need to know before you take Leflunomide Zentiva Do not take Leflunomide Zentiva
Slovenian: Kaj morate vedeti preden boste vzeli zdravilo Leflunomid Zentiva
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).
Slovenian: V študiji MN302 so 999 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/dan (n = 501) ali metotreksat 7,5 mg/teden z zvečanjem na 15 mg/teden (n = 498).
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).
Slovenian: V študiji US301 so 482 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/dan (n = 182), metotreksat 7,5 mg/teden z zvečanjem na 15 mg/teden (n = 182) ali placebo (n = 118).
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).
Slovenian: V študiji MN301 so 358 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/dan (n = 133), sulfasalazin 2 g/dan (n = 133) ali placebo (n = 92).
English: What Leflunomide Zentiva looks like and contents of the pack
Slovenian: Izgled zdravila Leflunomid Zentiva in vsebina pakiranja
English: Zentiva Portugal, Lda Tel: +351210601360
Slovenian: Zentiva Portugal, Lda Tel: +351210601360 PV-Portugal@zentiva.com
English: increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin Uncommon: urticaria
Slovenian: zvečano izpadanje las, ekcem, izpuščaji (vključno makulopapularni izpuščaji), pruritus, suha koža
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: 6.1 Seznam pomožnih snovi
English: Leflunomide Zentiva with food, drink and alcohol
Slovenian: Zdravilo Leflunomid Zentiva skupaj s hrano, pijačo in alkoholom Zdravilo Leflunomid Zentiva lahko jemljete s hrano ali brez nje.
English: severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
Slovenian: huda okvara jeter, npr. odpoved jeter in akutna jetrna nekroza, ki sta lahko usodni
English: Date of first authorisation: 08 January 2010 Date of latest renewal: 08 January 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve registracije: 02 januar 2010
English: Leflunomide Zentiva can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Slovenian: Občasno lahko zdravilo Leflunomid Zentiva povzroči nekatere krvne, jetrne, pljučne težave ali težave z živci v rokah in nogah.
English: PHARMACEUTICAL FORM
Slovenian: FARMAKOLOŠKE LASTNOSTI
English: Excipients with known effect Each tablet contains 78 mg of lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom Ena tableta vsebuje 78 mg laktoze monohidrata.
English: renal failure
Slovenian: Okvara ledvic
English: Leflunomide Zentiva can occasionally cause some problems with your blood, liver, lungs, or nerves in your arms or legs.
Slovenian: Občasno lahko zdravilo Leflunomid Zentiva povzroči nekatere krvne, jetrne,pljučne težave ali težave z živci v rokah in nogah .
English: Excipients with known effect Each tablet contains 72 mg of lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom Ena tableta vsebuje 72 mg laktoze monohidrata.
English: Leflunomide Zentiva contains lactose.
Slovenian: Zdravilo Leflunomid Zentiva vsebuje laktozo.
English: Talc (E553b) Hypromellose (E464) Titanium dioxide (E171) Macrogol 8000
Slovenian: Filmska obloga: smukec (E553b) hipromeloza (E464) titanov dioksid (E171) makrogol 8000
English: Crospovidone (E1202) Talc (E553b)
Slovenian: Jedro tablete: koruzni škrob povidon (E1201) krospovidon (E1202) smukec (553b)
English: 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 50 filmsko obloženih tablet 100 filmsko obloženih tablet
English: often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome) or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to teriflunomide (used to treat multiple sclerosis), - if you have any liver problems, - if you have moderate to severe kidney problems, - if you have severely low numbers of proteins in your blood (hypoproteinaemia), - if you suffer from any problem which affects your immune system (e.g. AIDS), - if you have any problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets, - if you are suffering from a serious infection, - if you are pregnant, think you may be pregnant, or are breast-feeding.
Slovenian: 6) ali ste alergični na teriflunomid (ki se uporablja za zdravljenje multiple skleroze), - če imate kakršnekoli težave z jetri, - če imate zmerne do hude težave z ledvicami, - če imate zelo znižano število beljakovin v krvi (hipoproteinemija), - če kakršnakoli težava vpliva na vaš imunski sistem (npr. AIDS), - če imate kakršnekoli težave z vašim kostnim mozgom ali imate v krvi zmanjšano število rdečih krvnih celic, belih krvnih celic ali krvnih ploščic, - če imate kakšno resno okužbo, - če ste noseči, mislite, da bi lahko bili noseči, ali dojite.
English: Tél: +33 (0) 800 089 219 PV-France@zentiva.com
Slovenian: Zentiva France Tél: +33 (0) 800 089 219 PV-France@zentiva.com
English: colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g., aphthous stomatitis, mouth ulceration), abdominal pain
Slovenian: kolitis, vključno z mikroskopskim kolitisom, kot je na primer limfocitni kolitis, kolagenski kolitis, driska, navzeja, bruhanje, bolezni ustne sluznice (npr. aftozni stomatitis, razjede v ustih), bolečine v trebuhu
English: Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary hypertension, male infertility (which is reversible once treatment with this medicine is stopped), cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis (new or worsening) and DRESS may also occur with an unknown frequency.
Slovenian: Pojavijo se lahko tudi drugi neželeni učinki, katerih pogostnost ni znana, kot so ledvična odpoved, zmanjšana koncentracija sečne kisline v krvi, pljučna hipertenzija, neplodnost pri moških (izgine po prenehanju uporabe tega zdravila), kožni lupus (značilen izpuščaj/eritem na predelih kože, ki so izpostavljeni svetlobi), luskavica (ki se pojavi na novo ali poslabšanje le te) in sindrom DRESS.
English: Not all pack sizes may be marketed.
Slovenian: Na trgu ni vseh navedenih pakiranj.
English: Pustular psoriasis and worsening of psoriasis have been reported after the use of leflunomide.
Slovenian: Po jemanju leflunomida so poročali o posturalni psoriazi in njenem poslabšanju.
English: Povidone (E1201) Crospovidone (E1202) Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate
Slovenian: Jedro tablete: koruzni škrob povidon (E1201) krospovidon (E1202) brezvodni koloidni silicijev dioksid magnezijev stearat (E470b) laktoza monohidrat
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: Yellowish to ochre and triangular film-coated tablet, imprinted with ZBO on one side.
Slovenian: Rumenkasta do okrasta, trikotna filmsko obložena tableta, z napisom ZBO na eni strani.
English: Blister:
Slovenian: Plastenka:
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Leflunomide is rapidly converted to the active metabolite, A771726, by first-pass metabolism (ring opening) in gut wall and liver.
Slovenian: Leflunomid se že med presnovo prvega prehoda v črevesni steni in jetrih hitro pretvori (z odprtjem obroča) v aktivni presnovek A771726.
English: Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the switching.
Slovenian: Tveganje za resne neželene učinke lahko poleg tega poveča tudi prehod z leflunomida na drugo imunomodulirajoče protirevmatično zdravilo brez postopka izpiranja (glejte poglavje 4.4), in to celo dalj časa po prehodu.
English: It is not recommended to drink alcohol during treatment with Leflunomide Zentiva.
Slovenian: Med zdravljenjem z zdravilom Leflunomid Zentiva ni priporočljivo pitje alkohola.
English: cysts and polyps) The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Uporaba nekaterih imunosupresivnih zdravil poveča nevarnost malignomov, zlasti limfoproliferativnih bolezni.
English: Uncommon: anaemia, mild thrombocytopenia (platelets <100 G/L) Rare:
Slovenian: anemija, blaga trombocitopenija (trombociti < 100 x 109/l)
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali s farmacevtom.
English: - an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the number of white blood cells (leucopenia); decrease in the number of all blood cells
Slovenian: Redki neželeni učinki (prizadenejo lahko največ 1 od 1.000 bolnikov) zvečanje števila krvnih celic imenovanih eozinofilci (eozinofilija), blago zmanjšanje števila belih krvnih celic (levkopenija); izmanjšanje števila vseh krvnih celic (pancitopenija).
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).
Slovenian: Po 16 tednih zdravljenja je bila razlika v deležu odziva statistično značilna v prid metotreksata po opredelitvi izboljšanja (DOI - Definition of Improvement) za JRA ≥ 30 % (p = 0,02).
English: In a study with radiolabelled 14C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
Slovenian: zdravih prostovoljcih v plazmi, urinu ali blatu niso našli nespremenjenega leflunomida.
English: Medicinal product subject to medical prescription.
Slovenian: NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept.
English: Film-coated tablet.
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta
English: Human pharmacology
Slovenian: Farmakologija pri ljudeh
English: In either case the A771726 plasma concentration is then measured for the first time.
Slovenian: V obeh primerih se nato prvič izmeri plazemska koncentracija A771726.
English: Rare cases of severe liver injury, including cases with fatal outcome, have been reported during treatment with leflunomide.
Slovenian: Med zdravljenjem z leflunomidom so opisani redki primeri hude okvare jeter, tudi s smrtnim izidom.
English: There have been case reports of increased prothrombin time, when leflunomide and warfarin were co-administered.
Slovenian: Med sočasno uporabo leflunomida in varfarina so opisani primeri podaljšanja protrombinskega časa.