FrancophonIA/ELRC3.0 huggingface dataset:
English: Some vaccinations should not be given while taking Repso, and for a certain amount of time after stopping treatment.
Slovenian: Določenih cepiv se med uporabo zdravila Repso in določen čas po koncu tega zdravljenja ne sme uporabljati.
English: Titanium dioxide (E171) Hypromellose (E464) Macrogol 400
Slovenian: Titanov dioksid (E171) Hipromeloza (E464) Makrogol 400
English: A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs is only increased by 10 % to 50 %.
Slovenian: A771726 je izpodrinil ibuprofen, diklofenak in tolbutamid, vendar se je nevezana frakcija teh zdravil zvečala samo za 10 do 50 %.
English: - If you develop swollen spongy gums, ulcers, and loose teeth (an infectious mouth disease known as ulcerative stomatitis) then you should contact your doctor who may advise you to stop taking Repso.
Slovenian: - če se pri vas pojavijo gobaste dlesni, razjede in izguba zob (infekcijska ustna bolezen, znana kot ulcerativni stomatitis), obvestite svojega zdravnika, ki vam bo morda svetoval prenehanje jemanja zdravila Repso.
English: Repso is contraindicated in pregnancy (see section 4.3).
Slovenian: Zdravilo Repso je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
English: The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 pediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA) who ranged in age from 3 to 17 years.
Slovenian: Farmakokinetiko A771726 po peroralni uporabi leflunomida so raziskali pri 73 pediatričnih bolnikih, starih od 3 do 17 let, ki so imeli juvenilni revmatoidni artritis (JRA) s poliartikularnim potekom.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 March 2011
Slovenian: Datum pridobitve dovoljenja: 14. 3. 2011 Datum zadnjega podaljšanja:
English: The efficacy of leflunomide in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Slovenian: Učinkovitost leflunomida so pri zdravljenju revmatoidnega artritisa dokazali v 4 kontroliranih preskušanjih (1 v II.
English: If you suspect that you are pregnant while taking Repso or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Slovenian: Če med jemanjem zdravila Repso ali v dveh letih po koncu zdravljenja posumite, da ste zanosili, morate o tem nemudoma obvestiti svojega zdravnika in opraviti nosečnostni test.
English: If you or someone else swallows a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Repso, kot bi smeli Če ste vi ali kdo drug, pogoltnil več tablet naenkrat, ali če mislite, da je otrok pogoltnil tableto, se nemudoma obrnite na oddelek nujne pomoči najbližje bolnišnice ali obvestite svojega zdravnika.
English: Women of childbearing potential must not take Repso without using reliable contraceptive measures, and they must use reliable contraceptive measures up to 2 years after treatment.
Slovenian: Ženske v rodni dobi ne smejo jemati zdravila Repso, če ne uporabljajo zanesljive kontracepcijske zaščite in morajo uporabljati zanesljivo kontracepcijsko zaščito do 2 leti po zdravljenju.
English: In case you forget to take a dose, take it as soon as you remember.
Slovenian: Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, razen če ni že blizu čas za naslednjega.
English: Rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving leflunomide among other immunosuppressants.
Slovenian: Poročali so o redkih primerih progresivne multifokalne levkoencefalopatije (PML) bolnikih, ki so prejemali leflunomid poleg ostalih zdravil z imunosupresivnim delovanjem.
English: If both plasma concentrations are below 0.02 mg/l, and after a waiting period of at least 3 months, the risk of foetal toxicity is very low.
Slovenian: Če je ta koncentracija v obeh primerih manjša od 0,02 mg/l in po vsaj 3-mesečnem čakalnem obdobju, je tveganje toksičnosti za plod zelo majhno.
English: What Repso is and what it is used for What you need to know before you take Repso How to take Repso
Slovenian: Kaj je zdravilo Repso in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Repso Kako jemati zdravilo Repso Možni neželeni učinki
English: Colestyramine given orally at a dose of 8 g three times a day for 24 hours to three healthy volunteers decreased plasma levels of A771726 by approximately 40 % in 24 hours and by 49 % to 65 % in 48 hours.
Slovenian: Holestiramin, uporabljen peroralno v odmerku 8 g trikrat na dan 24 ur je pri treh zdravih prostovoljcih znižal plazemsko koncentracijo A771726 za približno 40 % v 24 urah in za 49 % do 65 % v 48 urah.
English: Tell your doctor if you plan to become pregnant after stopping treatment with Repso, as you need to ensure that all traces of Repso have left your body before trying to become pregnant.
Slovenian: Povejte svojemu zdravniku, če nameravate po prenehanju zdravljenja z zdravilom Repso zanositi, saj se morate, preden poskušate zanositi, prepričati, da v telesu ni več ostankov zdravila Repso.
English: - Severe infections (including sepsis), which may be fatal.
Slovenian: hude okužbe, vključno s sepso, ki je lahko usodna.
English: The results of a population pharmacokinetic analysis of these trials have demonstrated that pediatric patients with body weights ≤ 40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section 4.2).
Slovenian: Rezultati populacijske farmakokinetične analize teh preskušanj so pokazali, da je pri pediatričnih bolnikih s telesno maso ≤ 40 kg sistemska izpostavljenost A771726 (merjena s Css) manjša kot pri odraslih bolnikih z revmatoidnim artritisom (glejte poglavje 4.2).
English: If a patient taking Repso develops a peripheral neuropathy, consider discontinuing Repso therapy and performing the drug elimination procedure (see section 4.4).
Slovenian: Če bolnik med jemanjem zdravila Repso razvije periferno nevopatijo, je potrebno razmisliti o ukinitvi terapije z zdravilom Repso in o izvajanju postopka za eliminacijo zdravila (glejte poglavje 4.4).
English: Titanium dioxide (E171) Polydextrose (E1200) Hypromellose (E464) Triethyl citrate (E1505) Macrogol 8000
Slovenian: Titanov dioksid (E171) Polidekstroza (E1200) Hipromeloza (E464) Trietilcitrat (E1505) Makrogol 8000
English: Repso tablets should be swallowed whole with plenty of water.
Slovenian: Tablete zdravila Repso pogoltnite celo in z veliko vode.
English: Men wishing to father a child should contact their doctor who may advise them to stop taking Repso and take certain medicines to remove Repso rapidly and sufficiently from their body.
Slovenian: Moški, ki želijo zaploditi otroka, se morajo posvetovati z zdravnikom, ki jim bo morda svetoval, naj nehajo jemati zdravilo Repso in vzamejo določena zdravila za hitro in uspešno izločanje zdravila Repso iz telesa.
English: The use of leflunomide with antimalarials used in rheumatic diseases (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents including Tumour Necrosis Factor alpha-Inhibitors has not been adequately studied up to now in randomised trials (with the exception of methotrexate, see section 4.5).
Slovenian: Uporaba leflunomida z antimalariki, ki se uporabljajo pri revmatičnih boleznih (npr. s klorokinom ali hidroksiklorokinom), intramuskularnim ali peroralnim zlatom, D-penicilaminom, azatioprinom in drugimi imunosupresivnimi zdravili, vključno z zaviralci tumorje nekrotirajočih faktorjem alfa, doslej v randomiziranih preskušanjih ni bila raziskana (z izjemo metotreksata, glejte poglavje 4.5).
English: In responders, this response was maintained during 48 weeks.
Slovenian: Pri bolnikih, ki so se odzvali na zdravljenje, se je ta odziv ohranjal 48 tednov (glejte poglavje 4.2).
English: As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Repso and any other possibly associated treatment must be discontinued, and a leflunomide washout procedure initiated immediately.
Slovenian: Čim se na koži in/ali sluznici pojavijo reakcije, ki zbujajo sum na takšne hude reakcije, je treba prekiniti uporabo zdravila Repso in drugih zdravil, ki bi jih lahko povzročila, in takoj začeti postopek izpiranja.
English: Repso is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Slovenian: Zdravilo Repso je kontraindicirano pri bolnikih s hudo hipoproteinemijo ali okvarjenim delovanjem jeter (glejte poglavje 4.3).
English: The usual starting dose is 100 mg once a day for 3 days.
Slovenian: Običajni začetni odmerek zdravila Repso je 100 mg enkrat na dan prve tri dni.
English: In such cases re-exposure to leflunomide is contra-indicated (see section 4.3).
Slovenian: Ponovna uporaba leflunomida je kontraindicirana (glejte poglavje 4.3).
English: Following concomitant administration of a single dose of leflunomide to subjects receiving multiple doses of rifampicin (non-specific cytochrome P450 inducer) A771726 peak levels were increased by approximately 40 %, whereas the AUC was not significantly changed.
Slovenian: Po sočasni aplikaciji enega samega odmerka leflunomida osebam, ki so prejemale ponavljajoče se odmerke rifampicina (nespecifičnega induktorja citokroma P450), so se najvišje koncentracije A771726 zvišale za približno 40 %, AUC pa se ni pomembno spremenila.
English: - If you are male and wish to father a child. As it cannot be excluded that Repso passes into semen, reliable contraception should be used during treatment with Repso.
Slovenian: - če ste moški in želite zaploditi otroka.Obstaja možnost, da se zdravilo Repso izloča v semensko tekočino, zato mora bolnik med zdravljenjem z zdravilom Repso uporabljati zanesljivo kontracepcijo.
English: Each film-coated tablet contains 97.25 mg of lactose monohydrate and 3.125 mg anhydrous lactose.
Slovenian: Ena filmsko obložena tableta vsebuje 97,25 mg laktoze monohidrata in 3,125 mg brezvodne laktoze.
English: • The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate).
Slovenian: • O ugotovljenem tveganju za sinergistično hepato ali hemato toksičnost v povezavi s kombinirano terapijo z drugimi imunomodulirajočimi protirevmatičnimi zdravili (diseasemodifying antirheumatic drug (DMARD) zdravili (na primer metotreksat).
English: Leflunomide 20 mg/day was significantly superior to placebo in reducing the symptoms of arthritis in patients with psoriatic arthritis: the PsARC (Psoriatic Arthritis treatment Response Criteria) responders were 59 % in the leflunomide group and 29.7 % in the placebo group by 6 months (p < 0.0001).
Slovenian: Leflunomid v odmerku 20 mg/dan je simptome artritisa pri bolnikih s psoriatičnim artritisom zmanjšal značilno bolj kot placebo: bolnikov, ki so se odzvali po merilih PsARC (Psoriatic Arthritis treatment Response Criteria; merila odziva na zdravljenje psoriatičnega artritisa), je bilo do 6. meseca med prejemniki leflunomida 59 % in med prejemniki placeba 29,7 % (p < 0,0001).
English: Each film-coated tablet contains 194.5 mg of lactose monohydrate and 6.25 mg anhydrous lactose.
Slovenian: Ena filmsko obložena tableta vsebuje 194,5 mg laktoze monohidrata in 6,25 mg brezvodne laktoze.
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.
Slovenian: Dokazano je, da uporaba aktivnega oglja (prašek, pripravljen v suspenziji) peroralno ali po nazogastrični sondi (50 g na 6 ur v 24 urah) zniža plazemsko koncentracijo aktivnega presnovka A771726 za 37 % v 24 urah in za 48 % v 48 urah.
English: interstitial lung disease (including interstitial pneumonitis), which may be fatal
Slovenian: intersticijska bolezen pljuč (vključno z intersticijsko pljučnico), ki je lahko usodna.
English: If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, these may be continued after starting leflunomide.
Slovenian: Če bolnik že prejema nesteroidna protivnetna zdravila (NSAIDs - nonsteroidal anti inflammatory drugs), kortikosteroide ali oboje, jih lahko po začetku jemanja leflunomida uporablja še naprej.
English: Haematological reactions
Slovenian: Hematološke reakcije
English: increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin
Slovenian: zvečano izpadanje las, ekcem, izpuščaji (vključno makulopapularni izpuščaji), pruritus, suha koža
English: This metabolite is responsible for essentially all the in vivo activity of leflunomide.
Slovenian: Ta je odgovoren za praktično vso aktivnost leflunomida in vivo.
English: If you are already taking non-steroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, you may continue to use these after starting Repso.
Slovenian: Če že jemljete nesteroidna protivnetna zdravila (NSAID) ali kortikosteroide ali oboje, lahko z njimi nadaljujete tudi po začetku uporabe zdravila Repso.
English: The efficacy of leflunomide was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Slovenian: Učinkovitost leflunomida je dokazala kontrolirana, randomizirana dvojno slepa študija 3L01 pri 188 bolnikih s psoriatičnim artritisom.
English: Effect of leflunomide on other medicinal products
Slovenian: Vpliv leflunomida na druga zdravila:
English: The ACR (American College of Rheumatology) response rates in study YU203 were 27.7 % for placebo, 31.9 % for 5 mg, 50.5 % for 10 mg and 54.5 % for 25 mg/day.
Slovenian: Deleži odziva po ACR (American College of Rheumatology) so bili v študiji YU203 27,7 % na placebo, 31,9 % na leflunomid 5 mg, 50,5 % na leflunomid 10 mg in 54,5 % na leflunomid 25 mg/dan.
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: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD),
Slovenian: ("disease-modifying antirheumatic drug" (DMARD)),
English: Therefore, it is not recommended to drink alcohol during treatment.
Slovenian: Med zdravljenjem z zdravilom Repso zato ni priporočljivo pitje alkohola.
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
Slovenian: Občasni neželeni učinki (prizadanejo lahko največ 1 od 100 ljudi) - zmanjšanje števila rdečih krvnih celic, kar lahko povzroči bledico kože in slabotnost ali zasoplost (anemija)
English: Do not take Repso when you are breast-feeding, as leflunomide passes into the breast milk.
Slovenian: Ne jemljite zdravila Repso, če dojite, saj leflunomid lahko prehaja v mleko.
English: UAB “Sicor Biotech” Eesti filiaal Tel: +372 661 0801
Slovenian: UAB “Sicor Biotechˮ Eesti filiaal Tel: +372 661 0801
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 so poročali o intersticijski bolezni pljuč, pa tudi o redkih primerih pljučne hipertenzije (glejte poglavje 4.8).
English: Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.
Slovenian: Sočasna uporaba hepatotoksičnih ali hematotoksičnih imunomodulirajočih antirevmatičnih zdravil (npr. metotreksata) ni priporočljiva.
English: Effect of other medicinal products on leflunomide
Slovenian: Vpliv drugih zdravil na leflunomid:
English: severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous
Slovenian: hude anafilaktične/anafilaktoidne reakcije, vaskulitis, vključno s kožnim nekrotizirajočim vaskulitisom
English: The doctor that starts you on Repso and supervises you while you are on it should be experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
Slovenian: Zdravnik, ki je pri vas začel zdravljenje z zdravilom Repso in vas spremlja med zdravljenjem, mora biti izkušen v zdravljenju revmatoidnega in psoriatričnega artritisa.
English: The symptoms include inflammation of joints, swelling, difficulty moving, pain and patches of red, scaly skin (skin lesions).
Slovenian: Simptomi aktivnega psoriatičnega artritisa vključujejo vnetje sklepov, zatekanje, težko premikanje, bolečine in rdeče, luskaste površine na koži (lezije kože).
English: taste disturbances
Slovenian: motnje okusa
English: • Physician Leaflet The Physician Leaflet should contain the following key messages:
Slovenian: Navodilo za zdravnika mora vsebovati naslednje informacije:
English: - For psoriatic arthritis: 20 mg once daily.
Slovenian: • za zdravljenje aktivnega psoriatičnega artritisa: 20 mg zdravila Repso enkrat na dan.
English: In case of severe haematological reactions, including pancytopenia, Repso and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
Slovenian: V primeru hudih hematoloških reakcij, vključno s pancitopenijo, je treba prekiniti uporabo zdravila Repso in morebitnih drugih mielosupresivnih zdravil ter začeti postopek izpiranja leflunomida.
English: Swallow tablets whole.
Slovenian: Pogoltnite celo tableto.
English: Psoriatic arthritis
Slovenian: Psoriatrični artritis
English: Do not use this medicine after the expiry date that is stated on the outer carton, blister or tablet container after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini, pretisnem omotu ali vsebniku za tablete poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: It will take 4 to 6 weeks before you feel an improvement in your condition.
Slovenian: Do opaznega izboljšanja stanja lahko mine 4-6 tednov.
English: HDPE tablet container with polypropylene screw cap.
Slovenian: HDPE vsebnik za tablete s polipropilensko zaporko na navoj.
English: Leflunomide is indicated for the treatment of adult patients with
Slovenian: KLINIČNI PODATKI 4.1 Terapevtske indikacije Leflunomid je indiciran za zdravljenje odraslih bolnikov z
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Repso are provided with a physician educational pack containing the following:
Slovenian: Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Repso - If you already have low red or white blood cells (anaemia or leucopenia), low blood platelets, which may increase your bleeding or bruising (thrombocytopenia), low bone marrow function or if you are at risk of your bone marrow not working properly your doctor may advise you to take certain medicines to speed up the removal of Repso from your body.
Slovenian: Pred začetkom uporabe zdravila Repso se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro: - če že imate zmanjšano število rdečih ali belih krvnih celic (anemija ali levkopeniija), zmanjšano število krvnih ploščic, kar bi lahko povečalo krvavitve ali pojav modric (trombocitopenija), zmanjšano funkcijo kostnega mozga ali če obstaja tveganje za nepravilno delovanje vašega kostnega mozga, vam bo zdravnik morda predlagal, da vzamete zdravila, ki bodo pospešila izločanje zdravilo Repso iz vašega telesa.
English: • The Summary of Product Characteristics
Slovenian: • Povzetek glavnih značilnosti zdravila • Navodilo za zdravnika
English: Silica, colloidal anhydrous Lactose anhydrous Magnesium stearate
Slovenian: Brezvodni koloidni silicijev dioksid Brezvodna laktoza Magnezijev stearat
English: For tablets stored in tablet containers: Do not store above 30°C.
Slovenian: Tablete, shranjene v vsebnikih za tablete: Shranjujte pri temperaturi do 30°C.
English: • Tablet coating: titanium dioxide, hypromellose, macrogol 400, iron oxide yellow, polysorbate, quinoline yellow aluminium lake and indigo carmine aluminium lake.
Slovenian: • Obloga tablete: titanov dioksid, hipromeloza, makrogol 400, rumeni železov oksid, polisorbat, kinolinsko rumeno barvilo in indigotin.
English: 2031GA Haarlem
Slovenian: 2031GA Haarlem Nizozemska
English: This medicinal product contains lactose (see leaflet for further information).
Slovenian: To zdravilo vsebuje laktozo (za dodatne informacije glejte Navodilo za uporabo).
English: Before and during treatment with Repso, your doctor will carry out blood tests at regular times.
Slovenian: Vaš zdravnik vam bo pred in med zdravljenjem z zdravilom Repso v rednih presledkih opravljal preiskave krvi, da bo kontroliral vaše krvne celice in jetra.
English: - Problems in the nerves of the arms or legs (peripheral neuropathy).
Slovenian: To kaže na težave z živci (periferna nevropatija).
English: • Tablet core: lactose monohydrate, povidone, crospovidone type A, pregelatinized starch (maize), talc, anhydrous colloidal silica, lactose anhydrous and magnesium stearate.
Slovenian: • Jedro tablete: laktoza monohidrat, povidon, krospovidon vrste A, predgelirani koruzni škrob, smukec, brezvodni koloidni silicijev dioksid, brezvodna laktoza, magnezijev stearat.
English: Cases of peripheral neuropathy have been reported in patients receiving Repso.
Slovenian: Pri bolnikih, ki so jemali zdravilo Repso, so poročali o primerih periferne nevropatije.
English: 28 film-coated tablets 30 film-coated tablets 100 film-coated tablets
Slovenian: 28 filmsko obloženih tablet 30 filmsko obloženih tablet 100 filmsko obloženih tablet
English: Liver reactions
Slovenian: Jetrne reakcije
English: How to store Repso
Slovenian: Kako jemati zdravilo Repso
English: For tablets stored in blisters: Do not store above 25°C.
Slovenian: Tablete, shranjene v pretisnih omotih: Shranjujte pri temperaturi do 25°C.
English: Since Repso can cause an increase in your blood pressure, your doctor will also check your blood pressure regularly.
Slovenian: Prav tako vam bo vaš zdravnik redno meril krvni tlak, saj ga zdravilo Repso lahko zviša.
English: Pack sizes of 28, 30 and 100 film-coated tablets.
Slovenian: Pakiranja po 28, 30 in 100 filmsko obloženih tablet.