natgillin/translations-raw huggingface dataset:
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).
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, doslej v randomiziranih preskušanjih ni bila zadosti raziskana (z izjemo metotreksata, glejte poglavje 4.5).
Uncommon: hypokalaemia, hyperlipidemia, hypophosphataemia Rare:
hipokaliemija, hiperlipidemija, hipofosfatemija
It has been shown in man that administration of an oral suspension of activated powdered charcoal or colestyramine leads to a rapid and significant increase in A771726 elimination rate and decline in plasma concentrations (see section 4.9).
Uporaba peroralne suspenzije aktivnega oglja v prahu ali holestiramina pri ljudeh vodi do hitrega in pomembnega povečanja hitrosti izločanja A771726 in zmanjša njegovo koncentracijo v plazmi (glejte poglavje 4.9).
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.
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.
Blood and lymphatic system disorders Common:
Bolezni krvi in limfatičnega sistema Pogosti:
Ask your pharmacist how to throw away medicines you no longer use.
O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
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:
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:
If you are already taking a nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide Zentiva.
Če že jemljete nesteroidna protivnetna zdravila (NSAID) ali kortikosteroide ali oboje, lahko z njimi nadaljujete tudi po začetku uporabe zdravila Leflunomid Zentiva.
It is recommended that patients receiving leflunomide are not treated with colestyramine or activated powdered charcoal because this leads to a rapid and significant decrease in plasma A771726 (the active metabolite of leflunomide; see also section 5) concentration.
Bolniki, ki dobivajo leflunomid, naj ne jemljejo holestiramina ali aktivnega oglja v prahu, ker hitro in pomembno znižata plazemsko koncentracijo A771726 (aktivnega presnovka leflunomida; glejte tudi poglavje 5).
Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects.
Nedavno ali sočasno zdravljenje s hepatotoksičnimi ali hematotoksičnimi imunomodulirajočimi protirevmatičnimi zdravili (npr. z metotreksatom) lahko poveča tveganje za resne neželene učinke; zato je treba pri uvedbi leflunomida skrbno pretehtati korist in tveganje tega zdravljenja.
These processes may be affected by hepatic dysfunction.
Jetrna disfunkcija lahko vpliva na ta dogajanja.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
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:
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:
Packs of 30 and 100 tablets are available.
Na voljo so pakiranja s 30 in 100 tabletami.
Not all pack size may be marketed.
Na trgu morda ni vseh navedenih pakiranj.
Without a loading dose, it is estimated that attainment of steady-state plasma concentrations would require nearly two months of dosing.
Ocenjujejo, da bi zdravilo brez udarnega odmerka doseglo koncentracijo v stanju dinamičnega ravnotežja v plazmi šele po skoraj dvomesečnem jemanju.
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.
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).
A pharmacokinetic interaction with oral contraceptives was observed with A771726 (see below).
Opazili so farmakokinetično interakcijo peroralnih kontraceptivov in A771726 (glejte spodaj).
Other medicines and Leflunomide Zentiva
Druga zdravila in zdravilo Leflunomid Zentiva
However there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
pri nekaterih bolnikih je nevropatija izginila, drugi pa so imeli stalne simptome.
The efficacy of Leflunomide Zentiva was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Učinkovitost zdravila Leflunomid Zentiva je dokazala kontrolirana, randomizirana dvojno slepa študija 3L01 pri 188 bolnikih s psoriatičnim artritisom.
Do not take Leflunomide Zentiva when you are breast-feeding, as leflunomide passes into the breast milk.
Ne jemljite zdravila Leflunomid Zentiva, če dojite, saj leflunomid lahko prehaja v mleko.
The extensive protein binding of A771726 could lead to displacement of other highly-bound drugs.
Izrazita vezava A771726 na beljakovine lahko povzroči izpodrinjenje drugih v veliki meri vezanih zdravil.
All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days.
Vsi bolniki, ki so dobivali leflunomid, so v preskušanjih III. faze dobivali začetni odmerek 100 mg 3 dni.
Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate
brezvodni koloidni silicijev dioksid magnezijev stearat (E470b) laktoza monohidrat
Together with ALT, a complete blood cell count, including differential white blood cell count and platelets, must be performed before start of leflunomide treatment as well as every 2 weeks for the first 6 months of treatment and every 8 weeks thereafter.
Pred začetkom zdravljenja z leflunomidom je treba hkrati z ALT določiti celotno krvno sliko, vključno z diferencialno belo krvno sliko in številom trombocitov; prvih 6 mesecev zdravljenja jo je treba ponavljati vsaka 2 tedna, potem pa vsakih 8 tednov.
Treatment duration was 12 months.
Zdravljenje je trajalo 12 mesecev.
Most patients improved after discontinuation of leflunomide.
Večini bolnikov se je po prenehanju jemanja zdravila Leflunomid Zentiva stanje izboljšalo.
Breast-feeding women must, therefore, not receive leflunomide.
Doječe ženske zato ne smejo jemati leflunomida.
• For rheumatoid arthritis: 10 or 20 mg Leflunomide Zentiva once daily, depending on the severity of the disease.
• za zdravljenje revmatoidnega artritisa: 10 ali 20 mg zdravila Leflunomid Zentiva enkrat na dan, odvisno od resnosti obolenja,
If you take more Leflunomide Zentiva than you should, contact your doctor or get other medical advice.
Če ste vzeli večji odmerek zdravila Leflunomid Zentiva, kot bi smeli Če vzamete več zdravila Leflunomid Zentiva, kot bi smeli, se posvetujte s svojim zdravnikom ali poiščite zdravniško pomoč.
In such cases re-exposure to leflunomide is contraindicated (see section 4.3).
Ponovna uporaba leflunomida je kontraindicirana (glejte poglavje 4.3).
severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal Skin and subcutaneous tissue disorders
huda okvara jeter, npr. odpoved jeter in akutna jetrna nekroza, ki sta lahko usodni Bolezni kože in podkožja
Leflunomide Zentiva can make you feel dizzy which may impair your ability to concentrate and react.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Leflunomid Zentiva lahko povzroči omotičnost, kar lahko prizadene sposobnost za koncentracijo in reagiranje.
Recent, concomitant or consecutive use of potentially myelotoxic agents may be associated with a higher risk of haematological effects.
Nedavno, sočasno ali navezujoče se zdravljenje s potencialno mielotoksičnimi zdravili poveča nevarnost za hematološke učinke.
A771726 plasma levels can be expected to be above 0.02 mg/L for a prolonged period.
Pričakovati je mogoče, da bo plazemska koncentracija A771726 dolgo časa nad 0,02 mg/l.
If such effects occur, a washout (see below) to reduce plasma levels of A771726 should be considered.
Če se pojavijo ti učinki, pride za znižanje koncentracije A771726 v plazmi v poštev postopek izpiranja (glejte spodaj).
After a 2-year waiting period, the A771726 plasma concentration is measured for the first time.
Po 2-letnem čakalnem obdobju se prvič izmeri plazemsko koncentracijo A771726.
Increased side effects may occur in case of recent or concomitant use of hepatotoxic or haematotoxic medicinal products or when leflunomide treatment is followed by such medicinal products without a washout period (see also guidance concerning combination with other treatments, section 4.4).
Če se leflunomid uporabi sočasno s hepatotoksičnimi ali hematotoksičnimi zdravili ali če zdravljenju z leflunomidom sledi zdravljenje s takšnimi zdravili brez obdobja izpiranja, se lahko neželeni učinki stopnjujejo (glejte tudi smernice glede kombiniranja z drugimi zdravili, poglavje 4.4).
This is thought to be achieved by a gastrointestinal dialysis mechanism and/or by interrupting enterohepatic recycling.
To je domnevno posledica mehanizma gastrointestinalne dialize, prekinitve enterohepatične recirkulacije ali obojega.
Imprint on one side: ZBP
Na eni strani imajo napis: ZBP.
If you have to be vaccinated, ask your doctor for advice.
Če se morate cepiti, se o tem posvetujte z zdravnikom.
Pack size: 3 film-coated tablets.
Velikost pakiranja: 3 filmsko obložene tablete.
In vitro inhibition studies in human liver microsomes suggest that cytochrome P450 (CYP) 1A2, 2C19 and 3A4 are involved in leflunomide metabolism.
Študije zavrtja in vitro z mikrosomi človeških jeter kažejo, da so v presnovo leflunomida vključeni 1A2, 2C19 in 3A4 citokroma P450 (CYP).
Uncommon: taste disturbances
motnje okusa
• alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period of 11 days.
• druga možnost je, da se v obdobju 11 dni uporabi po 50 g aktivnega oglja v prahu 4-krat na dan.
Treatment duration was 6 months.
Zdravljenje je trajalo 6 mesecev.
Pharmacotherapeutic group: selective immunosuppressants, ATC code: L04AA13.
Oznaka ATC: L04AA13.
Tell your doctor immediately and stop taking Leflunomide Zentiva: - 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
Nemudoma obvestite svojega zdravnika in prenehajte jemati zdravilo Leflunomid Zentiva: - če občutite slabost, vrtoglavost ali omotičnost ali težko dihate, saj so to lahko znaki resne alergijske reakcije, - če se vam razvijejo kožni izpuščaji ali razjede v ustih, je to lahko znak reakcij, ki so lahko usodne (npr. Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem, neželena reakcija z eozinofilijo in sistemskimi simptomi [sindrom DRESS]), glejte poglavje 2.
How to store Leflunomide Zentiva Contents of the pack and other information
Shranjevanje zdravila Leflunomid Zentiva Vsebina pakiranja in dodatne informacije
Postmarketing studies
Študije izvedene po prihodu zdravila na trg
paraesthesia, headache, dizziness, peripheral neuropathy Cardiac disorders
parestezije, glavobol, omotica, periferna nevropatija
100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30 or 100 film-coated tablets.
100-ml plastenka iz polietilena visoke gostote s širokim vratom in navojno zaporko z integriranim vsebnikom za sušilno sredstvo, ki vsebuje bodisi 30 ali 100 filmsko obloženih tablet.
There is no dose adjustment recommended in patients with mild renal insufficiency.
Pri bolnikih z blago ledvično insuficienco odmerka ni treba prilagajati.
100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30, 50 or 100 film-coated tablets.
100-ml plastenka iz polietilena visoke gostote s širokim vratom in navojno zaporko z integriranim vsebnikom za sušilno sredstvo, ki vsebuje bodisi 30, ali 50 in 100 filmsko obloženih tablet.
• colestyramine 8 g is administered 3 times daily for a period of 11 days,
• se v obdobju 11 dni uporabi po 8 g holestiramina 3-krat na dan,
Leflunomide Zentiva 100 mg film-coated tablets are white to almost white and round.
Leflunomid Zentiva 100 mg filmsko obložene tablete so bele do skoraj bele in okrogle oblike.
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).
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).
Musculoskeletal and connective tissue disorders Common:
Bolezni mišično-skeletnega sistema in vezivnega tkiva Pogosti:
In human plasma, A771726 is extensively bound to protein (albumin).
A771726 je v človeški plazmi izrazito vezan na beljakovine (albumin).
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.
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.
The tablets are packed in blisters.
Tablete so pakirane v pretisnih omotih.
In case of severe haematological reactions, including pancytopenia, Leflunomide Zentiva and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
V primeru hudih hematoloških neželenih učinkov, vključno s pancitopenijo, je treba prekiniti uporabo zdravila Leflunomid Zentiva in morebitnih drugih mielosupresivnih zdravil ter začeti postopek izpiranja leflunomida.
Interstitial lung disease, as well as rare cases of pulmonary hypertension have been reported during treatment with leflunomide (see section 4.8).
Med zdravljenjem z leflunomidom je bila opisana intersticijska bolezen pljuč, pa tudi redki primeri pljučne hipertenzije (glejte poglavje 4.8).
• For psoriatic arthritis: 20 mg Leflunomide Zentiva once daily.
• za zdravljenje aktivnega psoriatičnega artritisa: 20 mg zdravila Leflunomid Zentiva enkrat na dan.
Excipients with known effect Each tablet contains 138.42 mg of lactose monohydrate
Pomožne snovi z znanim učinkom Ena tableta vsebuje in 138,42 mg laktoze monohidrata.
White to almost white, round film-coated tablet, imprinted with ZBP on one side.
Bela do skoraj bela, okrogla filmsko obložena tableta, z napisom ZBP na eni strani.
Since the active metabolite of leflunomide, A771726, is highly protein bound and cleared via hepatic metabolism and biliary secretion, plasma levels of A771726 are expected to be increased in patients with hypoproteinaemia.
Aktivni presnovek leflunomida, A771726, je v veliki meri vezan na beljakovine in se odstranjuje z jetrno presnovo in biliarno sekrecijo, zato je mogoče pri bolnikih s hipoproteinemijo pričakovati zvišano koncentracijo A771726 v plazmi.
• In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days.
• Pri revmatoidnem artritisu: zdravljenje z leflunomidom se ponavadi začne z začetnim odmerkom 100 mg enkrat na dan 3 dni.
White to almost white, round film-coated tablet, imprinted with ZBN on one side.
Bela do skoraj bela, okrogla filmsko obložena tableta, z napisom ZBN na eni strani.
Always take this medicine exactly as your doctor or pharmacist has told you.
Pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta.
Leflunomide Zentiva 10 mg film-coated tablets are white to almost white and round.
Leflunomid Zentiva 10 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike.
Talk to your doctor, pharmacist or nurse before taking Leflunomide Zentiva - if you have ever suffered from inflammation of the lung (interstitial lung disease).
Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Leflunomid Zentiva se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro: - če ste kdaj imeli vnetje pljuč (intersticijsko bolezen pljuč).
The pharmacokinetics of A771726 in CAPD subjects appeared to be similar to healthy volunteers.
Farmakokinetika A771726 je bila pri osebah na kontinuirani ambulantni peritonealni dializi podobna kot pri zdravih postovoljcih.
There are no specific data on the risk of male-mediated foetal toxicity.
Specifičnih podatkov o toksičnih učinkih za plod, ki jih lahko posreduje moški, ni.
Tell your doctor immediately if you experience: - pale skin, tiredness, or bruising, as these may indicate blood disorders caused by an imbalance in the different types of blood cells which make up blood, - 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, - 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, - cough or breathing problems as these may indicate problems of the lung (interstitial lung disease or pulmonary hypertension), - unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Nemudoma obvestite svojega zdravnika, če opazite: - bledico, utrujenost ali podplutbe, ki so lahko znak krvnih bolezni, ki jih povzroči neravnovesje različnih krvnih celic, ki sestavljajo kri, - utrujenost, bolečine v trebuhu ali zlatenico (porumenelost oči ali kože), ki so lahko znak resnih bolezni, kot je bolezen jeter, ki je lahko usodna, - simptome, kot so vročina, vneto grlo ali kašelj, ki nakazujejo okužbo, saj zdravilo Leflunomid Zentiva lahko poveča možnost nastanka hudih vnetij, ki so lahko usodna, - kašelj ali oteženo dihanje, ki lahko nakazujeta težave s pljuči (intersticijska bolezen pljuč ali pljučna hipertenzija), - nenavadno mravljinčenje, slabost ali bolečina v rokah in nogah.
NAME OF THE MARKETING AUTHORISATION HOLDER
IMETNIK DOVOLJENJA ZA PROMET
All elevations resolved 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
V vseh primerih je zvišanje izginilo, pri 2 bolnikih ob nadaljevanju uporabe obeh zdravil in pri 3 po opustitvi leflunomida.
It contains the active substance leflunomide.
Vsebuje zdravilno učinkovino leflunomid.
In patients with pre-existing anaemia, leucopenia, and/or thrombocytopenia as well as in patients with impaired bone marrow function or those at risk of bone marrow suppression, the risk of haematological disorders is increased.
Tveganje za pojav hematoloških motenj je večje pri bolnikih z obstoječo anemijo, levkopenijo in/ali trombocitopenijo, pri bolnikih z okvarjenim delovanjem kostnega mozga in tistih s tveganjem za supresijo kostnega mozga.
Immune system disorders Common:
Bolezni imunskega sistema Pogosti:
• In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for 3 days.
• Pri psoriatičnem artritisu: zdravljenje z leflunomidom se začne z začetnim odmerkom 100 mg enkrat na dan 3 dni.
Reproductive system and breast disorders Not known:
ledvična odpoved Motnje reprodukcije in dojk Neznani:
- zidovudine for HIV infection - rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol) - sulfasalazine for inflammatory bowel disease or rheumatoid arthritis - a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal as these medicines can reduce the amount of Leflunomide Zentiva which is absorbed by the body.
- indometacin, ketoprofen za bolečino ali vnetje, - furosemid za bolezni srca (diuretik, tableta za odvajanje vode), - zidovudin za HIV okužbe, - rosuvastatin, simvastatin, atorvastatin, pravastatin za hiperholesterolemijo (zvišane vrednosti holesterola), - sulfasalazin za vnetno bolezen črevesa ali revmatoidni artritis, - zdravilo imenovano holestiramin (uporablja se za zniževanje zvišanega holesterola) ali aktivno oglje, saj ti dve zdravili lahko znižata količino zdravila Leflunomid Zentiva, ki jo telo absorbira.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
How to take Leflunomide Zentiva
Kako jemati zdravilo Leflunomid Zentiva
This metabolite is responsible for essentially all the in vivo activity of Leflunomide Zentiva.
Ta je odgovoren za praktično vso aktivnost zdravila Leflunomid Zentiva in- vivo.
The active metabolite A771726 is extensively protein bound and cleared via hepatic metabolism and biliary secretion.
Aktivni presnovek A771726 je izrazito vezan na beljakovine in se odstranjuje z jetrno presnovo in biliarno sekrecijo.
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.
Vpliv na substrate prenašalca organskih anionov 3 (OAT3) 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.
(pancytopenia), - severe increase in blood pressure, - inflammation of the lung (interstitial lung disease), - an increase in some liver results which may develop into serious conditions such as hepatitis and jaundice, - severe infections called sepsis which may be fatal, - an increase of certain enzymes in the blood (lactate dehydrogenase).
resno zvišanje krvnega tlaka, vnetje pljuč (intersticijska bolezen pljuč), zvišanje nekaterih vrednosti jetrnih testov, kar se lahko razvije v resne bolezni, npr. hepatitis in zlatenico, hude okužbe, imenovane sepsa, ki so lahko usodne, zvišanje določenih encimov v krvi (laktat-dehidrogenaza).
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.
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.