FrancophonIA/ELRC3.0 huggingface dataset:
English: However, animal studies to evaluate this specific risk have not been conducted.
Slovenian: Študije na živalih za oceno tega specifičnega tveganja ni bilo.
English: Fertility was not reduced.
Slovenian: Plodnost se ni zmanjšala.
English: The expiry date refers to the last day of that month.
Slovenian: Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: - if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Slovenian: - če ste kdaj imeli tuberkulozo ali če ste bili v tesnem stiku s kom, ki je imel ali ima tuberkulozo.
English: • every two weeks during the first six months of treatment, and
Slovenian: • vsaka dva tedna v prvih 6 mesecih zdravljenja in
English: Classification of expected frequencies:
Slovenian: Razvrstitev po pričakovani pogostnosti:
English: No special requirements for disposal.
Slovenian: Ni posebnih zahtev za odstranjevanje.
English: After this, most patients need a dose of:
Slovenian: Potem potrebuje večina bolnikov odmerek:
English: Folate supplementation was optional and only used in 10% of patients.
Slovenian: Dodajanje folata je bilo fakultativno in uporabljeno le pri 10 % bolnikov.
English: It is considered essential that monitoring recommendations are strictly adhered to.
Slovenian: Strogo upoštevanje priporočil za nadziranje je ključnega pomena.
English: These data do not allow an effective and safe dose recommendation.
Slovenian: Ti podatki ne dopuščajo priporočil o učinkovitem in varnem odmerku.
English: Before starting treatment, all patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.
Slovenian: Pred začetkom zdravljenja je treba vse bolnike oceniti glede aktivne in neaktivne ("latentne") tuberkuloze v skladu z lokalnimi priporočili.
English: If possible, take your tablets or the box with you to show the doctor.
Slovenian: Če je mogoče, vzemite tablete ali škatlico s seboj, da jih boste pokazali zdravniku.
English: There is no preferential uptake in erythrocytes.
Slovenian: Prioritetnega privzema v eritrocite ni.
English: Excretion data from the 14C study indicated that at least about 82 to 95% of the dose is absorbed.
Slovenian: Podatki o ekskreciji iz študije 14C so pokazali, da se absorbira vsaj 82 do 95 % odmerka.
English: • Additional risk minimisation measures
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj
English: Procreation (recommendations for men)
Slovenian: Zaploditev otroka (priporočila za moške)
English: For more information on these, please read section 4 (Possible side effects).
Slovenian: Za več informacij o tem, prosimo preberite poglavje 4 (Možni neželeni učinki).
English: There is no indication that these effects are of clinical relevance.
Slovenian: Ni znakov, da bi bili ti učinki klinično pomembni.
English: Your doctor may perform tests to see if you have tuberculosis.
Slovenian: Zdravnik lahko opravi preiskave, da bi ugotovil, ali imate tuberkulozo.
English: Waiting period
Slovenian: Čakalno obdobje
English: Duration of a complete washout is usually 11 days.
Slovenian: Popolno izpiranje ponavadi traja 11 dni.
English: A complete washout is essential in such cases.
Slovenian: V teh primerih je nujno popolno izpiranje.
English: Most of the cases occurred within the first 6 months of treatment.
Slovenian: Večina primerov se je pojavila v prvih 6 mesecih zdravljenja.
English: Your doctor may perform additional tests for differential diagnosis.
Slovenian: Zdravnik bo morda opravil dodatne preiskave za diferencialno diagnozo.
English: Pharmacokinetic data in elderly (>65 years) are limited but consistent with pharmacokinetics in younger adults.
Slovenian: Farmakokinetični podatki pri starejših (> 65 let) so omejeni, vendar skladni s farmakokinetiko pri mlajših odraslih.
English: The elimination half-life in patients is approximately 2 weeks.
Slovenian: Razpolovni čas izločanja pri bolnikih je približno 2 tedna.
English: Vaccination with live attenuated vaccines is, however, not recommended.
Slovenian: Vendar cepljenje z živim oslabljenim cepivom ni priporočljivo.
English: Use of alternative contraceptive methods is recommended.
Slovenian: Priporočljivo je uporabiti druge načine kontracepcije.
English: Keep the bottle tightly closed.
Slovenian: Plastenko shranjujte tesno zaprto.
English: The risk associated with combination therapy, in particular in long-term treatment, is unknown.
Slovenian: Nevarnosti, povezane s kombiniranim, zlasti dolgoročnim zdravljenjem, niso znane.
English: Infections may be more severe in nature and may, therefore, require early and vigorous treatment.
Slovenian: Okužbe so lahko hujše narave, zato utegne biti potrebno zgodnje in odločno zdravljenje.
English: Date of latest renewal: 08 January 2015
Slovenian: Datum zadnjega podaljšanja: 08 januar 2015
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/YYYY} Drugi viri informacij
English: Some patients may even still feel further improvements after 4 to 6 months of therapy.
Slovenian: Nekateri bolniki lahko nadaljnje izboljšanje občutijo celo še po 4 do 6 mesecih zdravljenja.
English: • Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group.
Slovenian: • Bolniki z zmerno do hudo ledvično insuficienco, ker v tej skupini ni dovolj kliničnih izkušenj.
English: NSAIDS/Corticosteroids
Slovenian: NSAIDs/kortikosteroidi
English: U kabelovny 130 102 37 Prague 10 Czech Republic
Slovenian: U kabelovny 130 102 37 Prague 10 Češka
English: If used together, the dose of rosuvastatin should not exceed 10 mg once daily.
Slovenian: Če sta uporabljena skupaj, odmerek rosuvastatina ne sme preseči 10 mg enkrat na dan.
English: Warfarin and other coumarine anticoagulants
Slovenian: Varfarin in drugi kumarinski antikoagulanti
English: This includes medicines obtained without a prescription.
Slovenian: To vključuje tudi zdravila brez recepta.
English: The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
Slovenian: Terapevtski učinek se ponavadi pojavi po 4 do 6 tednih in se lahko dodatno povečuje še do 4 do 6 mesecev.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Slovenian: Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne informacije!
English: The procedure may be repeated as clinically necessary.
Slovenian: Postopek se lahko ponavlja, v kolikor je to klinično potrebno.
English: Falsely low levels of calcium can be detected.
Slovenian: Možna je zaznava lažno nizkih ravni kalcija.
English: For washout procedures and other recommended actions in case of desired or unintended pregnancy, see section 4.6.
Slovenian: Za postopke izpiranja in druge priporočene ukrepe v primeru načrtovane ali nenačrtovane nosečnosti glejte poglavje 4.6.
English: No dose adjustment is required in patients above 65 years of age.
Slovenian: Prav tako odmerka ni treba prilagajati pri bolnikih, starejših od 65 let.
English: Zentiva Italia S.r.l.
Slovenian: Italia Zentiva Italia S.r.l.
English: Tell your doctor if you have unexplained chronic diarrhoea.
Slovenian: Obvestite svojega zdravnika, če imate nepojasnjeno kronično drisko.
English: Patients should be closely monitored for signs and symptoms of excessive exposure to the medicinal products and reduction of the dose of these medicinal products should be considered.
Slovenian: Bolnike je treba skrbno spremljati glede znakov in simptomov prekomerne izpostavljenosti zdravilom in v poštev pride zmanjšanje odmerka teh zdravil.
English: For further information on the laboratory testing please contact your doctor.
Slovenian: Za dodatne informacije o laboratorijskem testiranju se obrnite na svojega zdravnika.
English: Leflunomide Zentiva is not recommended for use in children and adolescents below 18 years of age.
Slovenian: Uporaba zdravila Leflunomid Zentiva ni priporočljiva pri otrocih in mladostnikih, ki so mlajši od 18 let.
English: mild allergic reactions
Slovenian: blage alergijske reakcije
English: Patients with a history of tuberculosis should be carefully monitored because of the possibility of reactivation of the infection.
Slovenian: Bolnike, ki imajo v anamnezi tuberkulozo, je treba skrbno kontrolirati, ker obstaja možnost za reaktiviranje okužbe.
English: The duration may be modified depending on clinical or laboratory variables.
Slovenian: Trajanje izpiranja se lahko prilagodi glede na klinične ali laboratorijske parametre.
English: Combinations with other treatments
Slovenian: Kombinacije z drugimi zdravili
English: A more than 3-fold increase was seen in another 5 patients.
Slovenian: Pri drugih 5 bolnikih se je pojavilo več kot 3-kratno zvišanje.
English: The effect of leflunomide on improvement of function and on reduction of skin lesions was modest.
Slovenian: Učinek leflunomida na izboljšanje funkcije in zmanjšanje kožnih sprememb je bil zmeren.
English: Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy.
Slovenian: Starost nad 60 let, sočasna uporaba nevrotoksičnih zdravil in sladkorna bolezen lahko povečajo tveganje za periferno nevropatijo.
English: For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7).
Slovenian: Za dodatne informacije o testiranju vzorca se obrnite na imetnika dovoljenja za promet z zdravilom ali njegovega lokalnega predstavnika (glejte poglavje 7).
English: The tablets should be swallowed whole with sufficient amounts of liquid.
Slovenian: Tablete je treba pogoltniti cele, z zadostno količino tekočine.
English: The leflunomide treatment effect was evident by 1 month, stabilised by 3 to 6 months and continued throughout the course of treatment.
Slovenian: Učinek zdravljenja z leflunomidom je bil očiten po 1 mesecu, ustalil se je v obdobju od 3 do 6 mesecev in je trajal ves čas zdravljenja.
English: • every 8 weeks thereafter (see section 4.4).
Slovenian: • potem vsakih 8 tednov (glejte poglavje 4.4).
English: This may take up to 2 years.
Slovenian: Ti lahko ostanejo v telesu do 2 leti.
English: Leflunomide is indicated for the treatment of adult patients with:
Slovenian: Leflunomid je indiciran za zdravljenje odraslih bolnikov z:
English: Swallow the tablet whole and with plenty of water.
Slovenian: Tableto pogoltnite celo in z veliko vode.
English: These washout procedures may be repeated if clinically necessary.
Slovenian: Te postopke izpiranja je mogoče ponavljati, če je klinično potrebno.
English: mild increase in blood pressure
Slovenian: blago zvišanje krvnega tlaka
English: In rats and dogs, Heinz bodies and/or Howell-Jolly bodies were found.
Slovenian: Pri podganah in psih so našli Heinzova telesca, Howell-Jollyjeva telesca ali oboja.
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing.
Slovenian: Zdravnike in bolnike je potrebno obvestiti, da je na razpolago za ta namen posvetovalna služba za posredovanje informacij o laboratorijskem testiranju plazemskih vrednosti leflunomida.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Women of childbearing potential have to use effective contraception during and up to 2 years after treatment (see “waiting period” below) or up to 11 days after treatment (see abbreviated “washout period” below).
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do dve leti po prenehanju zdravljenja (glejte tudi “čakalno obdobje” spodaj), ali do 11 dni po prenehanju zdravljenja (glejte skrajšani “postopek izpiranja” spodaj).
English: No difference was observed between leflunomide and sulphasalazine (study MN301).
Slovenian: Med leflunomidom in sulfasalazinom niso ugotovili razlike (študija MN301).
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: • The risk of infections, including opportunistic infections, and the contraindication for use in immuno-compromised patients.
Slovenian: • O tveganju za infekcije, vključno z oportunističnimi infekcijami in kontraindikacijami za uporabo pri imunsko oslabelih bolnikih.
English: Toxicity in animals was found at doses equivalent to human therapeutic doses.
Slovenian: Toksičnost pri živalih je bila ugotovljena v odmerkih, ekvivalentnih terapevtskim odmerkom pri ljudeh.
English: • before initiation of leflunomide
Slovenian: • pred uvedbo leflunomida
English: In a carcinogenicity study in rats, leflunomide did not show carcinogenic potential.
Slovenian: V študiji kancerogenosti pri podganah leflunomid ni pokazal kancerogenega potenciala.
English: In responders, this response was maintained during 48 weeks (see section 4.2).
Slovenian: Pri bolnikih, ki so se odzvali na zdravljenje, se je ta odziv ohranjal 48 tednov (glejte poglavje 4.2).
English: Effect on oral contraceptive (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel)
Slovenian: Vpliv na peroralne kontraceptive (0,03 mg etinilestradiola in 0,15 mg levonorgestrela)
English: The initial period was followed by an open label maintenance period of three months, during which both groups received leflunomide 20 mg daily.
Slovenian: Uvodnemu obdobju je sledilo odprto trimesečno vzdrževalno obdobje, med katerim sta obe skupini prejemali 20 mg leflunomida dnevno.
English: However, there was no apparent impact of this increase in plasma rosuvastatin exposure on the HMG-CoA reductase activity.
Slovenian: Vendar to povečanje izpostavljenosti rovastatinu v plazmi ni opazno vplivalo na aktivnost HMG-CoA-reduktaze.
English: Effect on BCRP (Breast Cancer Resistance Protein) and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
Slovenian: Vpliv na substrate BCRP (Breast Cancer Resistance Protein) in/ali transportne polipeptide organskih anionov B1 in B3 (OATP1B1/B3)
English: Interference with determination of ionised calcium levels
Slovenian: Vpliv na določanje ravni ioniziranega kalcija
English: LDH increased
Slovenian: zvišan LDH
English: Zentiva Pharma UK Limited Tel: +44 (0) 845 372 7101
Slovenian: United Kingdom Zentiva Pharma UK Limited Tel: +44 (0) 845 372 7101
English: Other effects found on heart, liver, cornea and respiratory tract could be explained as infections due to immunosuppression.
Slovenian: Druge učinke, ugotovljene na srcu, jetrih, roženici in dihalih, je mogoče razložiti kot okužbe zaradi imunosupresije.
English: • That there is a risk of teratogenicity and so pregnancy must be avoided until leflunomide plasma levels are at an appropriate level.
Slovenian: • Da obstaja tveganje za teratogenost, zato se je potrebno izogniti nosečnosti dokler niso dosežene primerne plazemske vrednosti leflunomida.
English: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Slovenian: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, multiformni eritem
English: To minimise any possible risk, men wishing to father a child should consider discontinuing use of leflunomide and taking colestyramine 8 g 3 times daily for 11 days or 50 g of activated powdered charcoal 4 times daily for 11 days.
Slovenian: Da bi čim bolj zmanjšali morebitno tveganje, morajo moški, ki želijo zaploditi otroka, nehati uporabljati leflunomid in 11 dni jemati po 8 g holestiramina 3krat na dan ali 11 dni jemati po 50 g aktivnega oglja v prahu 4-krat na dan.
English: • active psoriatic arthritis.
Slovenian: • aktivnim psoriatičnim artritisom.
English: elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
Slovenian: zvišanje jetrnih parametrov (transaminaze [zlasti ALT], manj pogosto gama-GT, alkalne fosfataze, bilirubina)
English: • The need to counsel patients on important risks associated with leflunomide therapy and appropriate precautions when using the medicine.
Slovenian: • O potrebi po svetovanju bolnikom o pomembnih tveganjih povezanih z zdravljenjem z leflunomidom in o primernih varnostnih ukrepih med uporabo zdravila.
English: In case of doubtful measurements, it is recommended to determine the total albumin adjusted serum calcium concentration.
Slovenian: V primeru dvomljivih meritev je priporočljivo določiti koncentracijo kalcija v serumu, korigirano glede na skupni albumin.
English: hepatitis, jaundice/cholestasis
Slovenian: hepatitis, zlatenica/holestaza
English: Do not use this medicine after the expiry date which is stated on the packaging.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
English: marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility
Slovenian: mejno (reverzibilno) znižanje koncentracije semenčic, celotnega števila semenčic in hitre progresivne gibljivosti
English: While this interaction is not expected to adversely impact the efficacy of oral contraceptives, consideration should be given to the type of oral contraceptive treatment.
Slovenian: Sicer ni pričakovati, da bi to medsebojno delovanje poslabšalo učinkovitost peroralnih kontraceptivov, razmisliti pa je treba o vrsti peroralne kontracepcije.
English: The unbound fraction of A771726 is about 0.62%.
Slovenian: Nevezana frakcija A771726 je približno 0,62 %.
English: If you are affected, do not drive, or use machines.
Slovenian: Če čutite vplive zdravila, ne vozite oziroma ne upravljajte s stroji.
English: Thus, the overall incidence of infections can increase (in particular of rhinitis, bronchitis and pneumonia).
Slovenian: Zaradi tega se lahko zveča celotna pogostnost okužb (zlasti rinitisa, bronhitisa in pljučnice).
English: Animal studies indicate that leflunomide or its metabolites pass into breast milk.
Slovenian: Študije na živalih so pokazale, da leflunomid ali njegovi presnovki prehajajo v mleko.
English: In such cases patients should refrain from driving cars and using machines.
Slovenian: V takšnih primerih naj bolnik ne vozi in ne upravlja s stroji.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Slovenian: Zdravniki se morajo zavedati tveganja za lažno negativne izvide tuberkulinskega kožnega testa, zlasti pri hudo bolnih ali imunsko oslabelih bolnikih.
English: In either case it should be confirmed by a blood test that Leflunomide Zentiva has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
Slovenian: V obeh primerih je treba s krvno preiskavo potrditi, da se je zdravilo Leflunomid Zentiva dovolj odstranilo iz telesa, potem pa morate počakati vsaj še en mesec, preden zanosite.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu/
English: If ALT (SGPT) elevations of more than 2-fold the upper limit of normal persist or if ALT elevations of more than 3-fold the upper limit of normal are present, leflunomide must be discontinued and wash-out procedures initiated.
Slovenian: Če zvišanje ALT (SGPT) na več kot 2-kratno zgornjo mejo normalne vrednosti traja ali če presega 3-kratno zgornjo mejo normalne vrednosti, je uporabo leflunomida treba prekiniti in začeti postopke izpiranja.
English: Study MN303 was an optional 6-month blinded continuation of MN301 without the placebo arm, resulting in a 12-month comparison of leflunomide and sulphasalazine.
Slovenian: Študija MN303 je bila fakultativno 6-mesečno slepo nadaljevanje MN301 brez skupine s placebom in je omogočila 12-mesečno primerjavo leflunomida in sulfasalazina.
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).
Slovenian: Rezultati študije plodnosti na živalih niso pokazali vpliva na plodnost moških in žensk, vendar so neželene učinke na moške reproduktivne organe opazili v študijah toksičnosti s ponavljajočimi se odmerki (glejte poglavje 5.3).
English: Omission of the loading dose may decrease the risk of adverse events (see section 5.1).
Slovenian: Izpustitev začetnega odmerka lahko zmanjša tveganje za neželene učinke (glejte poglavje 5.1).
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.
Slovenian: ALT (SGPT) je treba preveriti pred uvedbo leflunomida in z enako pogostnostjo kot celotno krvno sliko (vsaka dva tedna) v prvih 6 mesecih zdravljenja, potem pa vsakih 8 tednov.
English: In study MN302 leflunomide was significantly less effective than methotrexate.
Slovenian: V študiji MN302 je bil leflunomid statistično značilno manj učinkovit kot metotreksat.
English: CPK increased
Slovenian: zvišan CPK
English: Leflunomide is effective in animal models of arthritis and of other autoimmune diseases and transplantation, mainly if administered during the sensitisation phase.
Slovenian: Leflunomid je učinkovit v živalskih modelih artritisa, drugih avtoimunskih bolezni in presaditev, predvsem če je uporabljen med senzibilizacijsko fazo.
English: • That there is a risk of severe liver injury and so regular measurement of ALT (SGPT) levels to monitor liver function is important.
Slovenian: • Da obstaja tveganje za hudo jetrno poškodbo in zato je pomembno redno spremljanje jetrne funkcije z meritvami vrednosti ALT (SGPT).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V razvrstitvi pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli zdravilo.
English: • Patients with serious infections (see section 4.4).
Slovenian: • Bolniki z resnimi okužbami (glejte poglavje 4.4).
English: The recommended maintenance dose is leflunomide 20 mg once daily (see section 5.1).
Slovenian: Priporočeni vzdrževalni odmerek je 20 mg leflunomida enkrat na dan (glejte poglavje 5.1).
English: Blood pressure must be checked before the start of leflunomide treatment and periodically thereafter.
Slovenian: Krvni tlak je treba preveriti pred začetkom zdravljenja z leflunomidom in redno med zdravljenjem.
English: If you are pregnant or become pregnant while taking Leflunomide Zentiva, the risk of having a baby with serious birth defects is increased.
Slovenian: Če ste noseči ali zanosite med jemanjem zdravila Leflunomid Zentiva, je povečano tveganje, da se rodi otrok z resnimi prirojenimi okvarami.