FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving AUBAGIO should be instructed to report symptoms of infections to a physician.
Slovenian: Bolnike, ki prejemajo zdravilo AUBAGIO, je treba poučiti, da zdravniku sporočajo simptome okužbe.
English: The minor metabolite TFMA (4-trifluoromethylaniline) caused mutagenicity and clastogenicity in vitro but not in vivo.
Slovenian: Manjši presnovek TFMA (4-trifluorometilanilin) je povzročil mutagenost in klastogenost in vitro, vendar ne in vivo.
English: Effect of teriflunomide on CYP1A2 substrate: caffeine
Slovenian: Učinek teriflunomida na substrat CYP1A2: kofein
English: If you suspect that you are pregnant while taking AUBAGIO or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Slovenian: Če posumite na nosečnost med jemanjem zdravila AUBAGIO ali v dveh letih po prenehanju zdravljenja, se morate nemudoma posvetovati s svojim zdravnikom zaradi preiskave za nosečnost.
English: An accelerated elimination procedure can be used at any time after discontinuation of teriflunomide (see sections 4.6 and 5.2 for procedural details).
Slovenian: Postopek pospešenega izločanja se lahko izvede kadar koli po prekinitvi jemanja teriflunomida (za podrobnosti postopka glejte poglavji 4.6 in 5.2).
English: Blood pressure elevation should be appropriately managed before and during treatment with teriflunomide.
Slovenian: Zvišanje krvnega tlaka je treba ustrezno obvladati pred in med zdravljenjem s teriflunomidom.
English: The mechanism is thought to be by interruption of enterohepatic recycling and/or gastrointestinal dialysis of teriflunomide.
Slovenian: Mehanizem naj bi bil prekinitev enterohepatične cirkulacije in/ali gastrointestinalne dialize teriflunomida.
English: Due to the prolonged half-life, accelerated elimination with cholestyramine or charcoal may be considered.
Slovenian: Zaradi podaljšane razpolovne dobe je treba preučiti možnost pospešenega izločanja s holestiraminom ali ogljem.
English: • To pay attention to certain signs and symptoms which might indicate liver disease or infection, and if any of these occur, to contact their doctor/HCP promptly
Slovenian: • da je pozoren na določene znake in simptome, ki lahko kažejo na bolezen jeter ali okužbo in če se kateri od njih pojavi, naj takoj obvestijo svojega zdravnika / zdravstvenega delavca;
English: The majority of effects reflect the basic mode of action of the compound (inhibition of dividing cells).
Slovenian: Glavnina učinkov odraža osnovno delovanje učinkovine (zaviranje delečih se celic).
English: Also contains: lactose.
Slovenian: Vsebuje tudi laktozo.
English: As a consequence teriflunomide reduces the proliferation of dividing cells that need de novo synthesis of pyrimidine to expand.
Slovenian: Posledično teriflunomid zmanjša proliferacijo delečih se celic, ki za rast potrebujejo sintezo pirimidinov de novo.
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where AUBAGIO is marketed, at launch and after launch, all healthcare professionals who are expected to use AUBAGIO are provided with the following items:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v dogovoru s pristojnimi nacionalnimi organi v vsaki državi članici, kjer se zdravilo AUBAGIO trži, ob in po prihodu zdravila na trg, vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali zdravilo AUBAGIO, prejeli naslednje:
English: In multiple sclerosis, inflammation destroys the protective sheath (called myelin) around the nerves in the CNS.
Slovenian: Pri multipli sklerozi vnetje uniči zaščitno ovojnico (imenovano mielin) okoli živcev v CŽS.
English: Both cholestyramine 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 accelerated elimination procedure with cholestyramine or activated powdered charcoal.
Slovenian: Holestiramin in aktivirano oglje v prahu lahko vplivata na absorpcijo estrogenov in progestogenov tako, da zanesljiva kontracepcija s peroralnimi kontracepcijskimi sredstvi med postopkom pospešenega izločanja s holestiraminom in aktiviranim ogljem v prahu, ni zajamčena.
English: Other medicines and AUBAGIO
Slovenian: Druga zdravila in zdravilo AUBAGIO
English: Teriflunomide is moderately metabolised and is the only component detected in plasma.
Slovenian: Teriflunomid se zmerno presnavlja in je edina komponenta, odkrita v plazmi.
English: If your test results show a problem with your liver, your doctor may stop your treatment with AUBAGIO.
Slovenian: Če preiskave pokažejo težavo z jetri, bo morda vaš zdravnik prekinil zdravljenje z zdravilom AUBAGIO.
English: Patients with severe active infection until resolution (see section 4.4).
Slovenian: Bolniki s hudo, aktivno okužbo do resolucije (glejte poglavje 4.4).
English: Following discontinuation of teriflunomide and the administration of cholestyramine 8 g three times a day, the plasma concentration of teriflunomide is reduced 52% at the end of day 1, 91% at the end of day 3, 99.2% at the end of day 7, and 99.9% at the completion of day 11.
Slovenian: Po prekinitvi jemanja teriflunomida in uporabi holestiramina 8 g trikrat na dan se plazemske koncentracije teriflunomida znižajo za 52 % na koncu 1. dne, za 91 % na koncu 3. dne, za 99,2 % na koncu 7. dne in 99,9 % na koncu 11. dne.
English: If discontinuation of the medicinal product is necessary, initiation of an accelerated elimination procedure should be considered.
Slovenian: Če je treba uporabo zdravila prekiniti, pride v poštev uvedba postopka za pospešeno eliminacijo.
English: Repeated doses of teriflunomide had no effect on the pharmacokinetics of S-warfarin, indicating that teriflunomide is not an inhibitor or an inducer of CYP2C9.
Slovenian: Ponavljajoči se odmerki teriflunomida niso imeli učinka na farmakokinetiko S-varfarina, kar kaže, da teriflunomid ni zaviralec ali induktor CYP2C9.
English: AUBAGIO contains the active substance teriflunomide which is an immunomodulatory agent and adjusts the immune system to limit its attack on the nervous system.
Slovenian: AUBAGIO vsebuje učinkovino teriflunomid, ki deluje imunomodulatorno in uravnava delovanje imunskega sistema tako, da zmanjša njegov napad na živčni sistem.
English: Effect of teriflunomide on warfarin
Slovenian: Učinek teriflunomida na varfarin
English: ILD and worsening of pre-existing ILD have been reported during treatment with leflunomide, the parent compound of teriflunomide.
Slovenian: O ILD in poslabšanju že obstoječe ILD so poročali med zdravljenjem z leflunomidom, starševsko spojino teriflunomida.
English: The estimated female plasma exposure via the semen of a treated patient is expected to be 100 times lower than the plasma exposure after 14 mg of oral teriflunomide.
Slovenian: Ocenjena plazemska izpostavljenost pri ženski preko sperme zdravljenega bolnika je 100-krat manjša od plazemske izpostavljenosti po 14 mg teriflunomida peroralno.
English: If you are affected, do not drive or use machines.
Slovenian: Če se ta učinek pojavi pri vas, ne smete voziti ali upravljati s stroji.
English: Results of studies in animals have not shown an effect on fertility (see section 5.3).
Slovenian: Rezultati študij na živalih niso pokazali učinka na plodnost (glejte poglavje 5.3).
English: Several sources of intrinsic variability were identified in healthy subjects and MS patients based on the PopPK analysis: age, body weight, gender, race, and albumin and bilirubin levels.
Slovenian: Na osnovi analize PopPK so pri zdravih osebah in bolnikih z MS odkrili več virov intrinzične variabilnosti: starost, telesna masa, spol, rasa in ravni albumina ter bilirubina.
English: Therefore, caution is required when switching patients from natalizumab to AUBAGIO.
Slovenian: Zato je potrebna previdnost pri prehajanju bolnikov z natalizumaba na zdravilo AUBAGIO.
English: It is possible that rapidly lowering the blood level of teriflunomide, by instituting the accelerated elimination procedure described below, at the first delay of menses, may decrease the risk to the foetus.
Slovenian: Možno je, da lahko hiter upad ravni teriflunomida v krvi po uvedbi postopka pospešenega izločanja, ki je opisan v nadaljevanju, ob prvi zakasnjeni menstruaciji zniža tveganje za plod.
English: The following side effects may happen with this medicine.
Slovenian: Med zdravljenjem s tem zdravilom se lahko pojavijo naslednji neželeni učinki.
English: In the case of adverse reactions such as dizziness, which has been reported with leflunomide, the parent compound, the patient's ability to concentrate and to react properly may be impaired.
Slovenian: V primeru neželenih učinkov, kot je omotica, o kateri so poročali pri uporabi leflunomida, starševske spojine, je lahko bolnikova sposobnost koncentracije in ustrezne reakcije zmanjšana.
English: After stopping treatment with teriflunomide:
Slovenian: Po prekinitvi zdravljenja s teriflunomidom:
English: What you need to know before you take AUBAGIO 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo AUBAGIO 3.
English: The safety profile of leflunomide in patients suffering from rheumatoid arthritis or psoriatic arthritis may be pertinent when prescribing teriflunomide in MS patients.
Slovenian: Varnostni profil leflunomida pri bolnikih z revmatoidnim artritisom ali psoriatičnim artritisom je lahko pomemben pri predpisovanju teriflunomida bolnikom z MS.
English: Change in BOD week 108(1)
Slovenian: MRS končne točke niso merili sprememba BB v 108. tednu(1)
English: ALT increase (based on laboratory data) according to baseline status - Safety population in placebocontrolled studies
Slovenian: Zvišanje ravni ALT (na osnovi laboratorijskih podatkov) glede na izhodiščno raven - populacija za oceno varnosti v s placebom kontroliranih študijah placebo (N=997)
English: Patients with pre-existing liver disease and/or who consume substantial quantities of alcohol may be at increased risk of developing elevated liver enzymes when taking teriflunomide and should be closely monitored for signals of liver disease.
Slovenian: Bolniki z obstoječo boleznijo jeter ali/in tisti bolniki, ki uživajo pomembne količine alkohola imajo lahko večje tveganje za zvišane ravni jetrnih encimov, če jemljejo teriflunomid, zato jih je treba natančno spremljati glede znakov jetrne bolezni.
English: Fertility was unaffected in rats despite adverse effects of teriflunomide on male reproductive organs, including reduced sperm count.
Slovenian: Plodnost pri podganah ni bila prizadeta kljub neželenim učinkom teriflunomida na moške spolne organe, vključno z znižanim številom semenčic.
English: The effect on red blood cell (RBC) (<2%) and platelet counts (<10%) was less pronounced.
Slovenian: Učinek na eritrocite (< 2 %) in trombocite (< 10 %) je bil manj izrazit.
English: Teriflunomide may cause serious birth defects when administered during pregnancy.
Slovenian: Teriflunomid lahko povzroči resne prirojene okvare, če se jemlje med nosečnostjo.
English: Teriflunomide should not be used in patients with conditions of severe hypoproteinaemia.
Slovenian: Teriflunomid se ne sme uporabljati pri bolnikih s stanji hude hipoproteinemije.
English: Week 1 (wallets of 14 and 28) Week 2 (wallets of 14 and 28) Week 3 (wallets of 28) Week 4 (wallets of 28)
Slovenian: 1. teden (pretisne zgibanke po 14 in 28) 2. teden (pretisne zgibanke po 14 in 28) 3. teden (pretisne zgibanke po 28) 4. teden (pretisne zgibanke po 28)
English: Talk to your doctor or pharmacist before taking AUBAGIO if: - you have liver problems and/or if you drink large amounts of alcohol.
Slovenian: Pred začetkom jemanja zdravila AUBAGIO se posvetujte s svojim zdravnikom ali farmacevtom: - če imate težave z jetri ali/in če uživate večje količine alkohola.
English: A majority of patients (73%) had not received disease-modifying therapy during the 2 years before study entry.
Slovenian: Večina bolnikov (73 %) ni prejemala imunomodulirajočih zdravil 2 leti pred vključitvijo v raziskavo.
English: The recommended dose of teriflunomide is 14 mg once daily.
Slovenian: Priporočeni odmerek teriflunomida je 14 mg enkrat na dan.
English: Safety studies, in which teriflunomide was concomitantly administered with interferon beta or with glatiramer acetate for up to one year did not reveal any specific safety concerns, but a higher adverse reaction rate as compared to teriflunomide monotherapy was observed.
Slovenian: Varnostne študije, v katerih je bil teriflunomid sočasno uporabljen z interferonom beta ali glatiramer acetatom do enega leta, niso pokazale posebnih varnostnih zadržkov, vendar se je pokazala višja stopnja neželenih učinkov v primerjavi z monoterapijo s teriflunomidom.
English: Accelerated Elimination Procedure: Cholestyramine and activated charcoal
Slovenian: Postopek pospešenega izločanja: Holestiramin ali aktivirano oglje
English: This loss of myelin is called demyelination.
Slovenian: Izgubi mielina pravimo demielinizacija.
English: The elimination of teriflunomide from the circulation can be accelerated by administration of cholestyramine or activated charcoal, presumably by interrupting the reabsorption processes at the intestinal level.
Slovenian: Izločanje teriflunomida iz krvnega obtoka lahko pospešimo z dajanjem holestiramina ali aktiviranega oglja, domnevno zaradi prekinitve procesov reabsorpcije na ravni črevesja.
English: If such effects occur, the accelerated elimination procedure (see above) to reduce plasma levels of teriflunomide should be considered.
Slovenian: Če se ti učinki pojavijo, je treba preučiti možnost uporabe postopka pospešenega izločanja (glejte predhodno besedilo), da se znižajo plazemske ravni teriflunomida.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se posvetujte s svojim zdravnikom glede jemanja tega zdravila.
English: Secondary pathways involve oxidation, N-acetylation and sulfate conjugation.
Slovenian: Sekundarne poti vključujejo oksidacijo, Nacetilacijo in sulfatno konjugacijo.
English: However, also following either of the accelerated elimination procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/l and fertilisation is required.
Slovenian: Vendar je tudi po opravljenem katerem koli postopku pospešenega izločanja potrebno preverjanje z 2 ločenima preiskavama s presledkom vsaj 14 dni in čakalna doba enega in pol meseca od prve določitve plazemske koncentracije pod 0,02 mg/l in zanositvijo.
English: Patients with severe immunodeficiency states, e.g. acquired immunodeficiency syndrome (AIDS).
Slovenian: Bolniki s stanji hude imunske pomanjkljivosti, npr. sindrom pridobljene imunske pomanjkljivosti (acquired immunodeficiency syndrome AIDS).
English: New onset or worsening pulmonary symptoms, such as persistent cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate.
Slovenian: Novo nastali pljučni simptomi, kot je dalj časa trajajoče kašljanje in dispneja, ali poslabšanje pljučnih simptomov so lahko razlog za prekinitev zdravljenja in nadaljnje preiskave, če je primerno.
English: • Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) o Liver enzymes should be assessed every two weeks during the first 6 months of treatment, and every 8 weeks thereafter or as indicated by clinical signs and symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
Slovenian: • raven alanin-aminotransferaze/serumske glutamat piruvat transaminaze (ALT/SGPT) o Jetrne encime je treba določiti pred začetkom zdravljenja s teriflunomidom, in sicer vsaka 2 tedna v prvih šestih mesecih zdravljenja in nato vsakih 8 tednov ali ob pojavu kliničnih znakov in simptomov, kot so nepojasnjena navzea, bruhanje, trebušne bolečine, utrujenost, anoreksija ali zlatenica in/ali temno obarvan urin.
English: The risk of failure (confirmed relapse or permanent treatment discontinuation whichever came first) was the primary endpoint.
Slovenian: Primarna končna točka je bilo tveganje neuspeha (potrjen recidiv ali trajna prekinitev zdravljenja, kar koli se je zgodilo prej).
English: The mean number of relapses within the year before study inclusion was 1.4 with 36.2% of patients having gadolinium-enhancing lesions at baseline.
Slovenian: Povprečno število zagonov v letu pred vključitvijo v raziskavo je bilo 1,4; v izhodišču je 36,2 % bolnikov imelo lezije, povzročene z gadolinijem.
English: For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with AUBAGIO.
Slovenian: Če je pri bolnikih presejalni test za tuberkulozo pozitiven, jih zdravite po standardni medicinski praksi pred zdravljenjem z zdravilom AUBAGIO.
English: For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).
Slovenian: Za vse morebitne nadaljnje informacije o preskušanju vzorcev se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom (glejte poglavje 7).
English: Teriflunomide remains in your blood for a long time after you stop taking it. Continue to use effective contraception after you stop treatment.
Slovenian: Teriflunomid ostane v vaši krvi še dolgo potem, ko ga prenehate jemati.
English: In a placebo-controlled thorough QT study performed in healthy subjects, teriflunomide at mean steady-state concentrations did not show any potential for prolonging the QTcF interval compared with placebo: the largest time matched mean difference between teriflunomide and placebo was 3.45 ms with the upper bound of the 90% CI being 6.45 ms.
Slovenian: V s placebo kontrolirani študiji QT, opravljeni pri zdravih osebah, teriflunomid pri povprečnih koncentracijah v stanju dinamičnega ravnovesja ni pokazal potenciala za podaljšanje intervala QTcF v primerjavi s placebom: najdaljši čas ujemajoče se povprečne razlike med teriflunomidom in placebom je bil 3,45 ms z zgornjo mejo 90-odstotnega intervala zaupanja 6,45 ms.
English: • Risk of infections/serious infections o To discuss the need to contact the doctor in the event of signs/symptoms of infection, or if the patient takes other medicines that affect the immune system 2.
Slovenian: • tveganje za okužbe / resne okužbe o bolnike je treba poučiti, da zdravniku sporočijo znake / simptome okužbe ali če jemljejo druga zdravila, ki vplivajo na imunski sistem.
English: The treatment should be initiated and supervised by a physician experienced in the management of multiple sclerosis.
Slovenian: Zdravljenje mora uvesti in nadzorovati zdravnik z izkušnjami pri obravnavi multiple skleroze.
English: • To remind patients to show the Patient Education Card to Doctors/HCPs involved with their medical care (especially in the event of medical emergencies and/or if new Doctors/HCPs are involved.)
Slovenian: • opomniti bolnike, da zdravnikom / zdravstvenim delavcem, ki so vključeni v njihovo zdravljenje (zlasti v nujnih primerih in /ali kadar so vključeni novi zdravniki / zdravstveni delavci) pokažejo Opozorilno kartico za bolnika.
English: - you are lactose intolerant.
Slovenian: - če ne prenašate laktoze.
English: Due to the design of the study, high disease activity was defined as 2 or more relapses in one year, and with one or more Gd-enhancing lesion on brain MRI.
Slovenian: Zaradi zasnove študije, je bila zelo aktivna bolezen opredeljena kot 2 ali več zagonov v enem letu in ena ali več lezij po gadolinijevem kontrastiranju možganov z MRS.
English: What AUBAGIO is and what it is used for 2.
Slovenian: Kaj je zdravilo AUBAGIO in za kaj ga uporabljamo 2.
English: A reminder to provide patients with a Patient Education Card, including filling-in their contact details, and to provide replacement Patient Education Cards as necessary; 3.
Slovenian: Opomnik, da bolnikom izročijo Opozorilno kartico za bolnika, v kateri so njihovi kontaktni podatki, in jim, po potrebi, zagotovijo nadomestne Opozorilne kartice za bolnika; 3.
English: Teriflunomide concentrations measured during an 11-day procedure to accelerate teriflunomide elimination with either 8 g cholestyramine three times a day, 4 g cholestyramine three times a day or 50 g activated charcoal twice a day following cessation of teriflunomide treatment have shown that these regimens were effective in accelerating teriflunomide elimination, leading to more than 98% decrease in teriflunomide plasma concentrations, with cholestyramine being faster than charcoal.
Slovenian: Koncentracije teriflunomida, izmerjene med 11-dnevnim postopkom za pospešitev izločanja teriflunomida bodisi z 8 g holestiramina trikrat na dan, 4 g holestiramina trikrat na dan ali 50 g aktiviranega oglja dvakrat na dan po prekinitvi zdravljenja s teriflunomidom, so pokazale, da te sheme učinkovito pospešijo izločanje teriflunomida, kar privede do več kot 98-odstotnega znižanja plazemske koncentracije teriflunomida, pri čemer holestiramin deluje hitreje kot oglje.
English: No evidence of carcinogenicity was observed in rats and mice.
Slovenian: Pri podganah in miših niso našli dokazov karcinogenosti.
English: There are limited amount of data from the use of teriflunomide in pregnant women.
Slovenian: Podatki o uporabi teriflunomida pri nosečnicah so omejeni.
English: AUBAGIO is available in cardboard cartons containing: - 14, 28, 84 and 98 tablets in wallet packs with integrated aluminium blisters; - 10x1 tablet in all aluminium perforated unit-dose blisters.
Slovenian: Zdravilo AUBAGIO je na voljo v kartonskih škatlah, ki vsebujejo: - 14, 28, 84 in 98 tablet v pretisnih zgibankah z aluminijastimi pretisnimi omoti; - 10 x 1 tableto v enoodmernih perforiranih pretisnih omotih v celoti iz aluminija.
English: If you are pregnant or become pregnant while taking AUBAGIO, the risk of having a baby with birth defects is increased.
Slovenian: Če ste noseči ali zanosite med jemanjem zdravila AUBAGIO, se poveča tveganje prirojenih okvar pri otroku.
English: The risk of a second clinical attack over 2 years was 35.9% in the placebo group and 24.0% in the teriflunomide 14 mg treatment group (hazard ratio: 0.57, 95% confidence interval: 0.38 to 0.87, p=0.0087).
Slovenian: Tveganje za drugi klinični napad je bilo v 2letnem obdobju v skupini s placebom 35,9 % in v skupini s 14 mg teriflunomida 24,0 % (razmerje ogroženosti: 0,57, 95 % interval zaupanja: od 0,38 do 0,87, p = 0,0087).
English: Effects on immune cell numbers in the blood: In the placebo-controlled studies, teriflunomide 14 mg once a day led to a mild mean reduction in lymphocyte count, of less than 0.3 x 109/l, which occurred over the first 3 months of treatment and levels were maintained until the end of the treatment.
Slovenian: Učinki na število imunskih celic v krvi: V s placebo kontroliranih študijah je jemanje 14 mg teriflunomida enkrat na dan privedlo do blagega povprečnega znižanja števila limfocitov (manj od 0,3 x 10 9/l), do katerega je prišlo v prvih 3 mesecih zdravljenja, nato pa so se ravni ohranile do konca zdravljenja.
English: Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Slovenian: Bolniki s hudo hipoproteinemijo, npr. nefrotskim sindromom.
English: The measurement of ionised calcium levels might show falsely decreased values under treatment with leflunomide and/or teriflunomide (the active metabolite of leflunomide) depending on the type of ionised calcium analyser used (e.g. blood gas analyser).
Slovenian: Med zdravljenjem z leflunomidom in/ali teriflunomidom (aktivnim presnovkom leflunomida) se lahko pojavijo lažno nizke vrednosti meritev koncentracije ioniziranega kalcija, odvisno od vrste analizatorja, uporabljenega za določanje ioniziranega kalcija (npr. analizator krvnih plinov).
English: AUBAGIO contains lactose (a type of sugar).
Slovenian: Zdravilo AUBAGIO vsebuje laktozo (vrsto sladkorja).