FrancophonIA/ELRC3.0 huggingface dataset:
English: • Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide, peanut or soya or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost (posebno s predhodnim Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo, multiformnim eritemom) na zdravilno učinkovino, osnovni aktivni presnovek teriflunomid, zemeljske oreščke ali sojo ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: • indomethacin, ketoprofen for pain or inflammation
Slovenian: • indometacin, ketoprofen za bolečino ali vnetje,
English: Tablet core: lactose monohydrate low-substituted hydroxypropyl cellulose tartaric acid sodium laurylsulfate magnesium stearate
Slovenian: Jedro tablete: laktoza monohidrat hidroksipropil celuloza (nizko substituirana) vinska kislina natrijev lavrilsulfat magnezijev stearat
English: Patients were 317 years of age with active polyarticular course JRA regardless of onset type and naive to methotrexate or leflunomide.
Slovenian: Bolniki so bili stari od 3 do 17 let, imeli so aktiven JRA s poliartikularnim potekom, ne glede na način pojava, in še niso dobivali metotreksata ali leflunomida.
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: • zvečanje števila krvnih celic imenovanih eozinofilci (eozinofilija); blago zmanjšanje števila belih krvnih celic (levkopenija); zmanjšanje števila vseh krvnih celic (pancitopenija),
English: (pancytopenia),
Slovenian: (trombocitopenija),
English: • severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Slovenian: • hude, včasih življenje ogrožujoče reakcije (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem).
English: • cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension),
Slovenian: • kašelj ali oteženo dihanje, ki lahko nakazujeta težave s pljuči (intersticijska bolezen pljuč ali pljuèna hipertenzija),
English: • other medicines for rheumatoid arthritis such as antimalarials (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive drugs (e.g. methotrexate) as these combinations are not advisable,
Slovenian: • druga zdravila za zdravljenje revmatoidnega artritisa, kot so antimalariki (npr. klorokin in hidroksiklorokin), intramuskularno ali peroralno dano zlato, D-penicilamin, azatioprin in druga imunosupresivna zdravila (npr. metotreksat), saj te kombinacije niso priporočljive,
English: As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide medac 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 Leflunomid medac in drugih zdravil, ki bi jih lahko povzročila, in takoj začeti postopek izpiranja.
English: In a small (n = 30) study with co-administration of leflunomide (10 to 20 mg per day) with methotrexate (10 to 25 mg per week) a 2- to 3-fold elevation in liver enzymes was seen on 5 of 30 patients.
Slovenian: V majhni (n = 30) študiji sočasne uporabe leflunomida (10 do 20 mg na dan) in metotreksata (10 do 25 mg na teden) se je pri 5 od 30 bolnikov pojavilo 2- do 3-kratno zvišanje jetrnih encimov.
English: • warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce the risk of side effects of this medicine
Slovenian: • varfarin in druga peroralna zdravila, ki se uporabljajo za redčenje krvi, ker so potrebne kontrole,
English: At a dose level of 20 mg/day, average plasma concentration of A771726 at steady state is approximately 35 μg/ml.
Slovenian: Pri odmerku 20 mg/dan je bila povprečna plazemska koncentracija A771726 v stanju dinamičnega ravnotežja približno 35 µg/ml.
English: Absorption Excretion data from the
Slovenian: Podatki o ekskreciji iz študije
English: • an increase of certain enzymes in the blood (lactate dehydrogenase).
Slovenian: • zvišanje določenih encimov v krvi (laktat-dehidrogenaza).
English: Therefore, when co-administered with substrates of OAT3, such as cefaclor, benzylpenicillin, ciprofloxacin, indomethacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is recommended.
Slovenian: Zato je med sočasno uporabo substratov OAT3, kakršni so cefaklor, benzilpenicilin, ciprofloksacin, indometacin, ketoprofen, furosemid, cimetidin, metotreksat ali zidovudin, priporočljiva previdnost.
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: • problems in the nerves of the arms or legs (peripheral neuropathy).
Slovenian: • težave z živci rok ali nog (periferna nevropatija).
English: Most patients improved after discontinuation of Leflunomide medac.
Slovenian: Večini bolnikov se je po prenehanju jemanja zdravila Leflunomid medac stanje izboljšalo.
English: • daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
Slovenian: • daunorubicin, doksorubicin, paklitaksel, ali topotekan za zdravljenje raka,
English: In vitro inhibition studies in human liver microsomes suggest that cytochrome P450 (CYP) 1A2, 2C19 and 3A4 are involved in leflunomide metabolism.
Slovenian: Študije zaviranja in vitro z mikrosomi humanih jeter kažejo, da so v presnovo leflunomida vključeni citokromi P450 (CYP) 1A2, 2C19 in 3A4.
English: • inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis),
Slovenian: • vnetje majhnih žil (vaskulitis, vključno s kožnim nekrotizirajočim vaskulitisom),
English: • a marked decrease of some white blood cells (agranulocytosis),
Slovenian: • izrazito zmanjšanje nekaterih belih krvnih celic (agranulocitoza),
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 (DMARDdisease-modifying antirheumatic drug) zdravili (na primer metotreksat).
English: 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: 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: Symptoms of psoriatic arthritis include inflammation of joints, swelling, difficulty in 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: Leflunomide medac is contraindicated in pregnancy (see section 4.3).
Slovenian: Zdravilo Leflunomid medac je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
English: • an increase of certain enzymes in the blood (creatine phosphokinase),
Slovenian: • zvišanje določenih encimov v krvi (kreatin-fosfokinaza),
English: Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide medac, as you need to ensure that all traces of Leflunomide medac have left your body before trying to become pregnant.
Slovenian: Povejte svojemu zdravniku, če nameravate po prenehanju zdravljenja z zdravilom Leflunomid medac zanositi, saj se morate, preden poskušate zanositi prepričati, da v telesu ni več ostankov zdravila Leflunomid medac.
English: The usual starting dosage of Leflunomide medac is 100 mg once daily for the first three days.
Slovenian: Običajni začetni odmerek zdravila Leflunomid medac je ena 100-mg tableta enkrat na dan prve tri dni.
English: Leflunomide medac is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Slovenian: Zdravilo Leflunomid medac je kontraindicirano pri bolnikih s hudo hipoproteinemijo ali okvarjenim delovanjem jeter (glejte poglavje 4.3).
English: • a slight decrease in the number of white blood cells (leucopenia),
Slovenian: • rahlo zmanjšanje števila belih krvnih celic (levkopenija),
English: Human pharmacology Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties.
Slovenian: Farmakologija pri ljudeh Leflunomid je imunomodulirajoče antirevmatično zdravilo z antiproliferacijskimi lastnostmi.
English: If a patient taking Leflunomide medac develops a peripheral neuropathy, consider discontinuing Leflunomide medac therapy and performing the drug elimination procedure (see section 4.4).
Slovenian: Če bolnik med jemanjem zdravila Leflunomid medac razvije periferno nevopatijo, je potrebno razmisliti o ukinitvi terapije z zdravilom Leflunomid medac in o izvajanju postopka za eliminacijo zdravila (glejte poglavje 4.4).
English: • repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
Slovenian: • repaglinid, pioglitazon, nateglinid, ali rosiglitazon za zdravljenej sladkorne bolezni,
English: Adverse events consistent with the safety profile for leflunomide were: abdominal pain, nausea, diarrhoea, elevated liver enzymes, anaemia, leucopenia, pruritus and rash.
Slovenian: Neželeni učinki, skladni z varnostnim profilom leflunomida, so bili: bolečine v trebuhu, navzea, driska, zvišani jetrni encimi, anemija, levkopenija, srbenje in izpuščaj.
English: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD).
Slovenian: • aktivnim revmatoidnim artritisom kot imunomodulirajoče antirevmatično zdravilo (DMARD
English: Leflunomide medac can make you feel dizzy which may impair your ability to concentrate and react.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Leflunomid medac lahko povzroči omotičnost, kar lahko prizadene sposobnost za koncentracijo in reagiranje.
English: • eczema, dry skin, rash, itching,
Slovenian: • ekcem, suha koža, izpuščaj, srbenje,
English: If you are already taking a non-steroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide medac.
Slovenian: Če že jemljete nesteroidna protivnetna zdravila (NSAID) ali kortikosteroide ali oboje, lahko z njimi nadaljujete tudi po začetku uporabe zdravila Leflunomid medac.
English: • 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,
Slovenian: • simptome, kot so vročina, vneto grlo ali kašelj, ki nakazujejo okužbo, saj to zdravilo lahko poveča možnost nastanka hudih vnetij, ki so lahko usodna,
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in plastenki poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: • tiredness, abdominal pain, or jaundice (yellow discolouration of the eyes or skin), as these may indicate serious conditions such as liver failure, which may be fatal,
Slovenian: • utrujenost, bolečine v trebuhu ali zlatenico (porumenelost oči ali kože), ki so lahko znak resnih bolezni, kot je bolezen jeter, ki je lahko smrtna,
English: This metabolite is responsible for essentially all the in-vivo activity of Leflunomide medac.
Slovenian: Ta je odgovoren za praktično vso aktivnost zdravila Leflunomid medac in vivo.
English: C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
Slovenian: 3 zdravih prostovoljcih v plazmi, urinu ali blatu niso našli nespremenjenega leflunomida.
English: • if you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section 2.
Slovenian: • če se vam razvijejo kožni izpuščaji ali razjede v ustih, je to lahko znak smrtno nevarnih reakcij (npr. Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem, neželena reakcija z eozinofilijo in sistemskimi simptomi [sindrom DRESS]), glejte poglavje 2.
English: • inflammation of the mouth or mouth ulcers,
Slovenian: • vnetje v ustih ali razjede v ustih,
English: • sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
Slovenian: • sulfasalazin za zdravljenej vnetne bolezeni črevesa ali revmatoidnega artritisa,
English: How to store Leflunomide medac Contents of the pack and other information
Slovenian: Shranjevanje zdravila Leflunomid medac Vsebina pakiranja in dodatne informacije
English: A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n = 121) with early RA, who received either 20 mg or 100 mg of leflunomide with matching placebo in two parallel groups during the initial three day double blind period.
Slovenian: Randomizirana študija je ocenila delež odzivnosti pri bolnikih (n = 121), ki še niso bili zdravljeni z imunomodulirajočimi protirevmatičnimi zdravili, so imeli zgoden RA in so med uvodnim tridnevnim dvojno slepim obdobjem prejemali bodisi 20 mg bodisi 100 mg leflunomida v dveh vzporednih skupinah.
English: • Colestyramine 8 g is administered 3 times daily for a period of 11 days.
Slovenian: • Se v obdobju 11 dni uporabi po 8 g holestiramina 3-krat na dan.
English: In case of severe haematological reactions, including pancytopenia, Leflunomide medac 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 Leflunomid medac in morebitnih drugih mielosupresivnih zdravil ter začeti postopek izpiranja leflunomida.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Leflunomide medac
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Leflunomid medac se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro:
English: Do not take Leflunomide medac when you are breast-feeding, as leflunomide passes into the breast milk.
Slovenian: Ne jemljite zdravila Leflunomid medac, če dojite, saj leflunomid lahko prehaja v mleko.
English: • inflammation of the lung (interstitial lung disease),
Slovenian: • vnetje pljuč (intersticijska bolezen pljuč),
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 o redkih primerih pljučne hipertenzije (glejte poglavje 4.8).
English: • taste disturbances,
Slovenian: • motnje okusa,
English: Leflunomide medac 20 mg
Slovenian: Leflunomid medac 20 mg
English: Leflunomide medac 15 mg
Slovenian: Leflunomid medac 15 mg
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day vs. placebo were 54.6 % vs. 28.6 % (study MN301), and 49.4 % vs. 26.3 % (study US301).
Slovenian: V preskušanjih III. faze je bil delež odziva po ACR na leflunomid 20 mg/dan v primerjavi s placebom 54,6 % proti 28,6 % (študija MN301) in 49,4 % proti 26,3 % (študija US301).
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.> UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
English: • Alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period of 11 days.
Slovenian: • Druga možnost je, da se v obdobju 11 dni uporabi po 50 g aktivnega oglja v prahu 4-krat na dan.
English: Very rare cases of Stevens-Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients treated with leflunomide.
Slovenian: Zelo redko so pri bolnikih, zdravljenih z leflunomidom, opisani Stevens-Johnsonov sindrom ali toksična epidermalna nekroliza in neželene reakcije z eozinofilijo in sistemskimi simptomi (sindrom DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms).
English: Other medicines and Leflunomide medac
Slovenian: Druga zdravila in zdravilo Leflunomid medac
English: The most frequently reported adverse effects with leflunomide are: mild increase in blood pressure, leucopenia, paraesthesia, headache, dizziness, diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, increased hair loss, eczema, rash (including maculo-papular rash), pruritus, dry skin, tenosynovitis, CPK increased, anorexia, weight loss (usually insignificant), asthenia, mild allergic reactions and elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatise, bilirubin).
Slovenian: Najpogostejši neželeni učinki, o katerih poročajo in so povezani z leflunomidom, so: blago zvišanje krvnega tlaka, levkopenija, parestezija, glavobol, omotica, driska, navzea, bruhanje, bolezni ustne sluznice (npr. aftozni stomatitis, razjede v ustih), bolečine v trebuhu, zvečano izpadanje las, ekcem, izpuščaji (vključno makulopapularni izpuščaji), pruritus, suha koža, tendosinovitis, zvišan CPK,
English: • a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia),
Slovenian: • zmanjšanje števila rdečih krvnih celic (anemija) in zmanjšanje števila krvnih ploščic
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: Z neznano pogostnostjo se lahko pojavijo neželeni učinki, kot je 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: leucopenia (leucocytes > 2 G/l)
Slovenian: 9/l) levkopenija (levkociti > 2 x 10
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 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: • increased hair loss,
Slovenian: • zvečano izpadanje las,
English: • severe liver injury such as liver failure or necrosis which may be fatal,
Slovenian: • resne poškodbe jeter, kot sta odpoved jeter ali nekroza, ki sta lahko usodni,
English: • headache, dizziness,
Slovenian: • glavobol, omotica,
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: Each film-coated tablet contains 114 mg of lactose (as monohydrate) and 0.09 mg of soya lecithin.
Slovenian: Ena filmsko obložena tableta vsebuje 114 mg laktoze (v obliki monohidrata) in 0,09 mg sojinega lecitina.
English: Leflunomide medac 10 mg film-coated tablets are white to almost white and round with a diameter of about 6 mm.
Slovenian: Leflunomid medac 10 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike s premerom približno 6 mm.
English: • severe increase in blood pressure,
Slovenian: • resno zvišanje krvnega tlaka,
English: White to almost white, round film-coated tablet with a diameter of about 6 mm.
Slovenian: Bela do skoraj bela, okrogla filmsko obložena tableta s premerom približno 6 mm.
English: Each film-coated tablet contains 76 mg of lactose (as monohydrate) and 0.06 mg of soya lecithin.
Slovenian: Ena filmsko obložena tableta vsebuje 76 mg laktoze (v obliki monohidrata) in 0,06 mg sojinega lecitina.
English: INFORMATION IN BRAILLE Leflunomide medac 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Leflunomid medac 10 mg
English: Leflunomide medac contains lactose.
Slovenian: Zdravilo Leflunomid medac vsebuje laktozo.
English: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/l), eosinophilia
Slovenian: pancitopenija (verjetno zaradi antiproliferacijskega mehanizma), levkopenija
English: interstitial lung disease (including interstitial pneumonitis), which may be fatal Not known: pulmonary hypertension
Slovenian: intersticijska bolezen pljuč (vključno z intersticijsko pljučnico), ki je lahko usodna.
English: • abnormal skin sensations like tingling (paraesthesia),
Slovenian: • nenormalne kožne zaznave, npr. mravljinčenje (parestezije),
English: with continuation of both drugs and 3 after discontinuation of leflunomide.
Slovenian: Tudi pri teh je izginilo, pri 2 ob nadaljevanju uporabe obeh zdravil in pri 3 po opustitvi leflunomida.
English: • For psoriatic arthritis: 20 mg Leflunomide medac once daily.
Slovenian: • za zdravljenje aktivnega psoriatičnega artritisa: 20 mg zdravila Leflunomide medac enkrat na dan.
English: Do not take Leflunomide medac
Slovenian: Ne jemljite zdravila Leflunomid medac
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: • inflammation of the pancreas (pancreatitis),
Slovenian: • vnetje trebušne slinavke (pankreatitis),
English: • The active substance is leflunomide.
Slovenian: • Zdravilna učinkovina je leflunomid.