FrancophonIA/ELRC3.0 huggingface dataset:
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: • 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 (disease modifying antirheumatic drug (DMARD) zdravili (na primer metotreksat).
English: What Leflunomide ratiopharm is and what it is used for
Slovenian: Kaj je zdravilo Leflunomid ratiopharm in za kaj ga uporabljamo
English: Leflunomide ratiopharm is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Slovenian: Zdravilo Leflunomid ratiopharm je kontraindicirano pri bolnikih s hudo hipoproteinemijo ali okvarjenim delovanjem jeter (glejte poglavje 4.3).
English: This medicinal product contains lactose and soya lecithin.
Slovenian: To zdravilo vsebuje laktozo in sojin lecitin.
English: Leflunomide was studied in a single multicenter, randomized, double-blind, active-controlled trial in 94 patients (47 per arm) with polyarticular course juvenile rheumatoid arthritis.
Slovenian: Pediatrična populacija Leflunomid so raziskali v enem multicentričnem, randomiziranem, dvojno slepem preskušanju z aktivno kontrolo pri 94 bolnikih (47 na krak), ki so imeli juvenilni revmatoidni artritis s poliartikularnim potekom.
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 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: • For rheumatoid arthritis: 10 or 20 mg Leflunomide ratiopharm once daily, depending on the severity of the disease.
Slovenian: • za zdravljenje revmatoidnega artritisa: 10 ali 20 mg zdravila Leflunomid ratiopharm enkrat na dan, odvisno od resnosti obolenja.
English: • active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD).
Slovenian: • aktivnim revmatoidnim artritisom kot imunomodulirajoče antirevmatično zdravilo ("disease modifying antirheumatic drug" (DMARD))
English: Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide ratiopharm, as you need to ensure that all traces of Leflunomide ratiopharm have left your body before trying to become pregnant.
Slovenian: Povejte svojemu zdravniku, če nameravate po prenehanju zdravljenja z zdravilom Leflunomid ratiopharm zanositi, saj se morate, preden poskušate zanositi, prepričati, da v telesu ni več ostankov zdravila Leflunomid ratiopharm.
English: All elevations resolved, 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
Slovenian: V vseh primerih je zvišanje izginilo, pri 2 bolnikih ob nadaljevanju uporabe obeh zdravil in pri 3 po opustitvi leflunomida.
English: In case of severe haematological reactions, including pancytopenia, Leflunomide ratiopharm 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 ratiopharm in morebitnih drugih mielosupresivnih zdravil ter začeti postopek izpiranja leflunomida.
English: Haupt Pharma Münster GmbH Schleebrüggenkamp 15 48159 Münster
Slovenian: Haupt Pharma Münster GmbH Schleebrüggenkamp 15
English: • Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide, to 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 katero koli pomožno snov, navedeno v poglavju 6.1.
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 s substrati OAT3, kakršni so cefaklor, benzilpenicilin, ciprofloksacin, indometacin,
English: hypouricemia
Slovenian: hipourikemija
English: Reproductive system and breast disorders Not known:
Slovenian: Motnje reprodukcije in dojk Neznani:
English: Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable
Slovenian: Študije s hemodializo in kontinuirano ambulantno peritonealno dializo (CAPD) kažejo, da A771726, primarnega presnovka leflunomida, ni mogoče odstraniti z dializo.
English: • For psoriatic arthritis: 20 mg Leflunomide ratiopharm once daily.
Slovenian: • za zdravljenje aktivnega psoriatičnega artritisa: 20 mg zdravila Leflunomid ratiopharm enkrat na dan.
English: Each film-coated tablet contains 76 mg of lactose and 0.06 mg of soya lecithin.
Slovenian: Ena filmsko obložena tableta vsebuje 76 mg laktoze in 0,06 mg sojinega lecitina.
English: Contents of the pack and other information What Leflunomide ratiopharm contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Leflunomid ratiopharm
English: In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% vs. 28.6% (study MN301), and 49.4% vs. 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: If you take more Leflunomide ratiopharm than you should, contact your doctor or get other medical advice.
Slovenian: Če ste vzeli večji odmerek zdravila Leflunomid ratiopharm, kot bi smeli Če vzamete več zdravila Leflunomid ratiopharm, kot bi smeli, se posvetujte s svojim zdravnikom ali poiščite zdravniško pomoč.
English: Peripheral neuropathy
Slovenian: (periferna nevropatija).
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: BCRP (npr. metotreksata, topotekana, sulfasalazina, daunorubicina, doksorubicina) in družine OATP, zlasti zaviralcev HMG-CoA-reduktaze (npr. simvastatina, atorvastatina, pravastatina, metotreksata, nateglinida, repaglinida, rifampicina).
English: Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
Slovenian: Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren
English: Each film-coated tablet contains 152 mg of lactose and 0.12 mg of soya lecithin.
Slovenian: Ena filmsko obložena tableta vsebuje 152 mg laktoze in 0,12 mg sojinega lecitina.
English: Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.
Slovenian: (npr. duloksetin, alosetron, teofilin in tizanidin), ker lahko zmanjša učinkovitost teh zdravil.
English: Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Slovenian: Imetnik dovoljenja za promet ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm
English: Leflunomide ratiopharm is contraindicated in pregnancy (see section
Slovenian: Zdravilo Leflunomid ratiopharm je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
English: Leflunomide ratiopharm 10 mg film-coated tablets are white to almost white and round with a diameter of about 6 mm.
Slovenian: Leflunomid ratiopharm 10 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike s premerom približno 6 mm.
English: Do not take Leflunomide ratiopharm if you are, or think you may be pregnant.
Slovenian: Ne jemljite zdravila Leflunomid ratiopharm, če ste ali mislite, da ste noseči.
English: Titanium dioxide (E171) Xanthan gum
Slovenian: Filmska obloga lecitin (sojina zrna) polivinil alkohol smukec titanov dioksid (E171) ksantan gumi
English: EU/1/10/654/003 30 film-coated tablets EU/1/10/654/004 100 film-coated tablets
Slovenian: EU/1/10/654/003 30 filmsko obloženih tablet EU/1/10/654/004 100 filmsko obloženih tablet
English: anaemia, mild thrombocytopenia (platelets <100 G/L)
Slovenian: anemija, blaga trombocitopenija (trombociti < 100 x 109/l)
English: EU/1/10/654/001 30 film-coated tablets EU/1/10/654/002 100 film-coated tablets
Slovenian: EU/1/10/654/001 30 filmsko obloženih tablet EU/1/10/654/002 100 filmsko obloženih tablet
English: Most patients improved after discontinuation of leflunomide.
Slovenian: Večini bolnikov se je po prenehanju jemanja zdravila Leflunomid ratiopharm stanje izboljšalo.
English: This metabolite is responsible for essentially all the in-vivo activity of Leflunomide ratiopharm.
Slovenian: Ta je odgovoren za praktično vso aktivnost zdravila Leflunomid ratiopharm in vivo.
English: Lactose monohydrate Low-substituted hydroxypropyl cellulose Tartaric acid
Slovenian: Jedro tablete laktoza monohidrat hidroksipropil celuloza (nizko substituirana) vinska kislina natrijev lavrilsulfat magnezijev stearat
English: A771726 plasma levels can be expected to be above 0.02 mg/L for a prolonged period.
Slovenian: Čakalno obdobje Pričakovati je mogoče, da bo plazemska koncentracija A771726 dolgo časa nad 0,02 mg/l.
English: Leflunomide ratiopharm 20 mg
Slovenian: Leflunomid ratiopharm 20 mg
English: At a dose level of 20 mg/day, average plasma concentration of A771726 at steady state is approximately
Slovenian: Pri odmerku 20 mg/dan je bila povprečna plazemska koncentracija A771726 v stanju dinamičnega ravnotežja približno 35 µg/ml.
English: severe increase in blood pressure Respiratory, thoracic and mediastinal disorders Rare:
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Redki:
English: In a study in which leflunomide was given concomitantly with a triphasic oral contraceptive pill containing 30 μg ethinyloestradiol to healthy female volunteers, there was no reduction in contraceptive activity of the pill, and A771726 pharmacokinetics were within predicted ranges.
Slovenian: V študiji, v kateri so zdravim prostovoljkam dajali leflunomid sočasno s trifaznimi kontracepcijskimi tabletami, ki so vsebovale 30 µg etinilestradiola, se kontracepcijsko delovanje tablet ni zmanjšalo,
English: Musculoskeletal and connective tissue disorders Common:
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti: tenosinovitis
English: Leflunomide ratiopharm 10 mg
Slovenian: Leflunomid ratiopharm 10 mg
English: Leflunomide ratiopharm 20 mg film-coated tablets are white to almost white and round with a diameter of about 8 mm and a break-mark on one side of the tablet.
Slovenian: Leflunomid ratiopharm 20 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike s premerom približno 8 mm ter zarezo za prelom na eni strani.
English: - The other ingredients are lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric acid, sodium laurylsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans), poly(vinyl alcohol), talc, titanium dioxide (E171) and xanthan gum in the film-coating
Slovenian: • Pomožne snovi so: laktoza monohidrat, nizko substituirana hidroksipropil celuloza, vinska kislina, natrijev lavrilsulfat in magnezijev stearat v jedru tablete ter lecitin (sojina zrna), poli(vinil alkohol), smukec, titanov dioksid (E171) in ksantan gumi v filmski oblogi.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: • Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: 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 a not known 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: Very rare side effects (may affect up to 1 in 10,000 people)
Slovenian: Zelo redki neželeni učinki (prizadenejo lahko največ 1 od 10.000 bolnikov)
English: Leflunomide ratiopharm is for oral use.
Slovenian: Tablete Leflunomid ratiopharm so za peroralno uporabo.
English: Leflunomide ratiopharm contains lactose.
Slovenian: Zdravilo Leflunomid ratiopharm vsebuje laktozo.
English: - a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide ratiopharm which is absorbed by the body.
Slovenian: - zdravilo imenovano holestiramin (uporablja se za zniževanje zvišanega holesterola) ali aktivno oglje, saj ti dve zdravili lahko znižata količino zdravila Leflunomid ratiopharm, ki jo telo absorbira, Če že jemljete nesteroidna protivnetna zdravila (NSAID) ali kortikosteroide ali oboje, lahko z njimi nadaljujete tudi po začetku uporabe zdravila Leflunomid ratiopharm.
English: Other medicines and Leflunomide ratiopharm
Slovenian: Druga zdravila in zdravilo Leflunomid ratiopharm
English: Certain vaccinations should not be given while taking Leflunomide ratiopharm, and for a certain amount of time after stopping treatment.
Slovenian: Leflunomid ratiopharm in določen čas po koncu tega zdravljenja ne sme uporabljati.
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 nekrotizirajočim faktorjem alfa,
English: Leflunomide is metabolised to one primary (A771726) and many minor metabolites including TFMA (4-trifluoromethylaniline).
Slovenian: Leflunomid se presnovi v en glavni (A771726) in več stranskih presnovkov, med katerimi je tudi
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: It is recommended that monitoring of liver enzymes be maintained after discontinuation of leflunomide treatment, until liver enzyme levels have normalised.
Slovenian: Nadziranje jetrnih encimov je priporočljivo nadaljevati tudi po prekinitvi zdravljenja z leflunomidom,
English: Rare side effects (may affect up to 1 in 1,000 people)
Slovenian: Redki neželeni učinki (prizadenejo lahko največ 1 od 1.000 bolnikov))
English: How to store Leflunomide ratiopharm Contents of the pack and other information
Slovenian: Shranjevanje zdravila Leflunomid ratiopharm Vsebina pakiranja in dodatne informacije
English: Postmarketing studies
Slovenian: Študije, izvedene po prihodu zdravila na trg
English: As soon as skin and/or mucosal reactions are observed which raise the suspicion of such severe reactions, Leflunomide ratiopharm 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
English: You will normally take Leflunomide ratiopharm over long periods of time.
Slovenian: Običajno boste zdravilo Leflunomid ratiopharm jemali dolgo časa.
English: How to take Leflunomide ratiopharm
Slovenian: Kako jemati zdravilo Leflunomid ratiopharm
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA /PLASTENKA ŠKATLA
English: The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide ratiopharm.
Slovenian: Pri odločanju za uporabo živega oslabljenega cepiva po koncu zdravljenja z zdravilom Leflunomid ratiopharm je treba upoštevati dolg razpolovni čas leflunomida.
English: Name and address of the manufacturers responsible for batch release
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE Ime in naslov izdelovalcev, odgovornih za sproščanje serije
English: Male patients should be aware of the possible male-mediated foetal toxicity.
Slovenian: Zaploditev otroka (priporočila za moške) Moški bolniki se morajo zavedati možnih toksičnih učinkov za plod, ki jih lahko posreduje moški.
English: Teva Nederland B.V. Tel: +31 (0)800 0228 400
Slovenian: Tel: +31 (0)800 0228 400
English: Cases of peripheral neuropathy have been reported in patients receiving leflunomide.
Slovenian: Periferna nevropatija Pri bolnikih, ki so jemali zdravilo Leflunomid ratiopharm, so poročali o primerih periferne nevropatije.
English: Tell your doctor immediately and stop taking Leflunomide ratiopharm: if you experience weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic reaction, 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: Effect on organic anion transporter 3 (OAT3) substrates There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of OAT3 in vivo.
Slovenian: Po večkratnih odmerkih A771726 so ugotovili povečanje povprečne Cmax cefaklorja za 1,43-krat in njegove povprečne AUC za 1,54-krat; to kaže, da A771726 in vivo zavira OAT3.
English: Effect on oral contraceptive (0.03 mg ethinylestradiol and 0.15 mg levonorgestrel) There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of A771726.
Slovenian: Po ponavljajočih se odmerkih A771726 se je povprečna Cmax etinilestradiola povečala za 1,58-krat in njegova povprečna AUC0-24 za 1,54-krat; povprečna Cmax levonorgestrela se je povečala za 1,33-krat in povprečna AUC0-24 za 1,41-krat.
English: - The active substance is leflunomide.
Slovenian: • Zdravilna učinkovina je leflunomid.
English: The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 pediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA)
Slovenian: Pediatrična populacija Farmakokinetiko A771726 po peroralni uporabi leflunomida so raziskali pri 73 pediatričnih bolnikih,
English: See sextion 4.
Slovenian: V preskušanju II.
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: • Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: It is not recommended to drink alcohol during treatment with Leflunomide ratiopharm.
Slovenian: Med zdravljenjem z zdravilom Leflunomid ratiopharm ni priporočljivo pitje alkohola.
English: Psychiatric disorders Uncommon:
Slovenian: Bolezni sečil neznana:
English: One film-coated tablet contains 20 mg of leflunomide.
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg leflunomida.
English: If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila Leflunomid ratiopharm, se posvetujte z zdravnikom, s farmacevtom ali z medicinsko sestro.
English: What Leflunomide ratiopharm looks like and contents of the pack
Slovenian: Izgled zdravila Leflunomid ratiopharm in vsebina pakiranja
English: Leflunomide ratiopharm 10 mg tablets Leflunomide
Slovenian: Leflunomid ratiopharm 10 mg tablete leflunomid
English: Leflunomide ratiopharm 20 mg tablets Leflunomide
Slovenian: Leflunomid ratiopharm 20 mg tablete leflunomid
English: Alanine aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency: before initiation of leflunomide, every two weeks during the first six months of treatment, and every 8 weeks thereafter (see section 4.4).
Slovenian: Alanin-aminotransferazo (ALT) (oz. serumsko glutamat-piruvat-transferazo (SGPT)) in celotno krvno sliko, vključno z diferencialno belo krvno sliko in številom trombocitov, je treba preveriti sočasno in z enako pogostnostjo:
English: Each tablet contains 20 mg of leflunomide.
Slovenian: Ena tableta vsebuje 20 mg leflunomida.
English: • Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis,
Slovenian: • Bolniki z občutno okvarjenim delovanjem kostnega mozga ali izrazito anemijo, levkopenijo,