natgillin/translations-raw huggingface dataset:
The results of a population pharmacokinetic analysis of these trials have demonstrated that paediatric patients with body weights ≤40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section 
Rezultati populacijske farmakokinetičke analize tih ispitivanja pokazuju da su pedijatrijski bolesnici tjelesne težine ≤ 40 kg imali smanjenu sistemsku izloženost (mjerenu sa Css) A771726 u odnosu na odrasle bolesnike s reumatoidnim artritisom (vidjeti dio 4.2).
Skin reactions 
Kožne reakcije
• For rheumatoid arthritis: 10 or 20 mg Leflunomide Zentiva once daily, depending on the severity of the disease. 
• Za reumatoidni artritis: 10 mg ili 20 mg lijeka Leflunomide Zentiva jedanput na dan, ovisno o težini bolesti.
• colestyramine 8 g is administered 3 times daily for a period of 11 days, 
• kolestiramin 8 g tri puta na dan tijekom 11 dana
The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy. 
Sumnja se da aktivni metabolit leflunomida, A771726, uzrokuje teške defekte novorođenčeta kad se primjenjuje tijekom trudnoće.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BLISTER PACK 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE/BLISTER
Packs of 30 and 100 tablets are available. 
Dostupna su pakiranja od 30 i 100 tableta.
No data are available regarding treatment of patients with hepatic impairment. 
Nema raspoloživih podataka o liječenju bolesnika s oštećenom jetrenom funkcijom.
What you need to know before you take Leflunomide Zentiva Do not take Leflunomide Zentiva 
Što morate znati prije nego što počnete uzimati lijek Leflunomide Zentiva
toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme 
Vrlo rijetko: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, multiformni eritem Nepoznato:
Treatment duration was 12 months. 
Liječenje je trajalo 12 mjeseci.
A771726 plasma levels can be expected to be above 0.02 mg/L for a prolonged period. 
Očekuje se da će se koncentracija A771726 u plazmi viša od 0,02 mg/l zadržati duže vrijeme.
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. 
U ispitivanju u kojem se zdravim ženama leflunomid davao istodobno s trifaznim oralnim kontraceptivima koji su sadržavali 30 μg etiniloestradiola nije zabilježena smanjena kontracepcijska aktivnost pilule, dok je farmakokinetika A771726 bila u predviđenim rasponima.
A pharmacodynamics interaction with warfarin was observed with A771726 in a clinical pharmacology study (see below). 
Farmakodinamička interakcija s varfarinom primjećena je za A771726 u kliničkom farmakološkom ispitivanju (vidjeti ispod).
• Breast-feeding women (see section 4.6). 
• Dojilje (vidjeti dio 4.6).
Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats. 
Akutna toksičnost leflunomida, primijenjenog oralno i intraperitonealno, ispitivana je na miševima i štakorima.
Leflunomide is rapidly converted to the active metabolite, A771726, by first-pass metabolism (ring opening) in gut wall and liver. 
Leflunomid se brzo metabolizira u aktivni metabolit, A771726, prvim prolaskom kroz stijenku crijeva i jetru (otvaranje prstena).
ANNEX III LABELLING AND PACKAGE LEAFLET 
DODATAK III OZNAČIVANJE I UPUTA O LIJEKU
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BOTTLE PACK 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE/BOČICA
Talk to your doctor, pharmacist or nurse before taking Leflunomide Zentiva - if you have ever suffered from inflammation of the lung (interstitial lung disease). 
Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego što uzmete lijek Leflunomide Zentiva . - ako ste ikad imali upalu pluća (intersticijsku plućnu bolest) - ako ste ikad imali tuberkulozu ili ako ste bili u bliskom kontaktu s nekim tko ima ili je imao tuberkulozu.
100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30, 50 or 100 film-coated tablets. 
Bočica od polietilena visoke gustoće (HDPE) širokog grla, volumena 100 ml, sa zatvaračem s navojem s ugrađenim spremnikom za sredstvo za sušenje, koja sadrži 30, 50 ili 100 filmom obloženih tableta.
Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties. 
Leflunomid je antireumatik s antiproliferativnim svojstvima koji modificira tijek bolesti.
Alternatively, 50 g of activated powdered charcoal is administered 4 times daily. 
Alternativno, daje se 50 g aktivnog ugljena u prahu 4 puta na dan.
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. 
Kolestiramin u dozi od 8 g primijenjen oralno tri puta tijekom 24 sata u tri zdrava dobrovoljca smanjio je koncentraciju A771726 u plazmi za približno 40% u 24 sata te za 49% do 65% u 48 sati.
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- Ako imate dodatnih pitanja, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
Immune system disorders Common: 
Poremećaji imunološkog sustava Često:
severe increase in blood pressure Respiratory, thoracic and mediastinal disorders Rare: 
izraziti porast krvnog tlaka Poremećaji dišnog sustava, prsišta i sredoprsja Rijetko:
Leflunomide Zentiva contains lactose. 
Leflunomide Zentiva sadrži laktozu.
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. 
Vrlo rijetki slučajevi Stevens-Johnsonovog sindroma ili toksične epidermalne nekrolize i reakcije na lijek s eozinofilijom i sistemskim simptomima (engl.
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. 
Ponovljene doze A771726 smanjile su prosječnu Cmax i AUC kofeina (CYP1A2 supstrat) za 18%, odnosno za 55%, što ukazuje da bi A771726 mogao biti slabi induktor CYP1A2 in vivo.
Children and adolescents 
I DOHVATA DJECE
Pack sizes: 30 and 100 film-coated tablets. 
Veličine pakiranja: 30 i 100 filmom obloženih tableta.
Elderly 
Stariji
Interstitial lung disease, as well as rare cases of pulmonary hypertension have been reported during treatment with leflunomide (see section 4.8). 
Za vrijeme liječenja leflunomidom zabilježena je intersticijska plućna bolest, kao i rijetki slučajevi plućne hipertenzije (vidjeti dio 4.8).
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 
Odmah obavijestite svog liječnika i prestanite uzimati lijek Leflunomide Zentiva: - ako osjetite slabost, ošamućenost ili omaglicu ili imate poteškoće s disanjem, jer to mogu biti znaci ozbiljne alergijske reakcije, - ako dobijete kožni osip ili čireve u ustima, jer to može upućivati na teške reakcije, ponekad opasne po život (npr. Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem, reakcija na lijek s eozinofilijom i sistemskim simptomima, engl.
If such effects occur, a washout (see below) to reduce plasma levels of A771726 should be considered. 
Ako se ti učinci pojave, treba razmotriti postupak ispiranja („washout“) (vidjeti nastavak teksta) kako bi se smanjila koncentracija A771726 u plazmi.
An in vivo interaction study with leflunomide and cimetidine (non-specific weak cytochrome P450 (CYP) inhibitor) has demonstrated a lack of a significant impact on A771726 exposure. 
U in vivo ispitivanjima interakcija s leflunomidom i cimetidinom (nespecifičnim slabim inhibitorom citokroma P450 (CYP)) nije opažen značajan utjecaj na izloženost A771726.
Treatment duration was 6 months. 
Liječenje je trajalo 6 mjeseci.
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. 
Primjenom aktivnog ugljena (prašak pripravljen kao suspenzija) oralno ili putem nazogastrične sonde (50 g svakih 6 sati tijekom 24 sata) smanjila se koncentracija aktivnog metabolita A771726 za 37% u roku od 24 sata i za 48% u roku od 48 sati.
Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy. 
Intersticijska plućna bolest može imati smrtni ishod, a smrt može nastupiti iznenada tijekom liječenja leflunomidom.
Lactose 
Laktoza
There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of A771726. 
Zabilježeno je povećanje prosječne Cmax i AUC (2,65 odnosno 2,51 puta) za rosuvastatin, nakon ponovljenih doza A771726.
increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin Uncommon: urticaria 
pojačani gubitak kose, ekcem, osip (uključujući makulopapularni osip), pruritus, suha koža
Skin and subcutaneous tissue disorders Common: 
Poremećaji kože i potkožnog tkiva Često:
Without a loading dose, it is estimated that attainment of steady-state plasma concentrations would require nearly two months of dosing. 
Procjenjuje se da bi bez takve udarne doze lijek bilo potrebno uzimati skoro dva mjeseca kako bi se postiglo stanje dinamičke ravnoteže koncentracija lijeka u plazmi.
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). 
Odmah obavijestite svog liječnika u slučaju: - bljedoće kože, umora ili pojave modrica, jer to može upućivati na krvne poremećaje uzrokovane poremećenom ravnotežom različitih vrsta krvnih stanica, - umora, boli u trbuhu ili žutice (žuta boja bjeloočnica ili kože), jer to može upućivati na teška stanja kao što je zatajenje jetre, koje može dovesti do smrtnog ishoda, - bilo kojeg simptoma infekcije, kao što su vrućica, grlobolja ili kašalj, jer ovaj lijek može povećati rizik od teških infekcija koje mogu biti opasne po život, - kašlja ili problema s disanjem, jer to može upućivati na probleme s plućima (intersticijska plućna bolest ili plućna hipertenzija), - neuobičajenih trnaca, slabosti li bolova u šakama ili stopalima, jer mogu upućivati na probleme sa živcima (periferna neuropatija).
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). 
Do sada u randomiziranim ispitivanjima nije ispitivana primjena leflunomida s antimalaricima koji se koriste za reumatske bolesti (npr. klorokin i hidroksiklorokin), intramuskularno ili peroralno primijenjenim solima zlata, D-penicilaminom, azatioprinom te ostalim imunosupresivnim lijekovima uključujući inhibitore faktora nekroze tumora alfa (s izuzetkom metotreksata, vidjeti dio 4.5).
100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30 or 100 film-coated tablets. 
Bočica od polietilena visoke gustoće (HDPE) širokog grla, volumena 100 ml, sa zatvaračem s navojem s ugrađenim spremnikom za sredstvo za sušenje, koja sadrži 30 ili 100 filmom obloženih tableta.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOČICE
It contains the active substance leflunomide. 
Sadrži djelatnu tvar leflunomid.
Excipients with known effect Each tablet contains 138.42 mg of lactose monohydrate 
Pomoćne tvari s poznatim učinkom Jedna tableta sadrži 138,42 mg laktoze hidrata.
• alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period of 11 days. 
• alternativno, 50 g aktivnog ugljena u prahu 4 puta na dan tijekom 11 dana
All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days. 
Svi bolesnici koji su uzimali leflunomid u ispitivanjima faze III počeli su s dozom od 100 mg tijekom 3 dana.
Leflunomide Zentiva contains lactose 
Leflunomide Zentiva sadrži laktozu
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. 
Učinak na supstrate organskog anionskog transportera 3 (OAT 3) Zabilježeno je povećanje prosječne Cmax i AUC (1,43 odnosno 1,54 puta) za cefaklor, nakon ponovljenih doza A771726, što ukazuje da je A771726 inhibitor OAT3 in vivo.
Medicinal product subject to medical prescription. 
14. NAČIN IZDAVANJA LIJEKA Lijek se izdaje na recept.
Reproductive system and breast disorders Not known: 
Poremećaji bubrega i mokraćnog sustava Nepoznato:
Male patients should be aware of the possible male-mediated foetal toxicity. 
Bolesnici muškog spola moraju biti svjesni da mogu biti posrednici u pojavi fetalne toksičnosti.
White to almost white, round film-coated tablet, imprinted with ZBN on one side. 
Bijela do gotovo bijela, okrugla filmom obložena tableta s utisnutom oznakom ZBN na jednoj strani.
Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide Zentiva, to monitor your blood cells and liver. 
Prije i za vrijeme liječenja lijekom Leflunomide Zentiva liječnik će Vas u redovitim razmacima slati na krvne pretrage radi kontrole krvnih stanica i jetre.
If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, these may be continued after starting leflunomide. 
Bolesnici koji već uzimaju nesteroidne protuupalne lijekove (NSAIL) i/ili kortikosteroide mogu ih nastaviti uzimati nakon uvođenja leflunomida u liječenje.
Colestyramine 8 g is administered 3 times daily. 
Daje se 8 g kolestiramina 3 puta na dan.
The relevance of the findings in mice relative to the clinical use of leflunomide is uncertain. 
Nije sigurno jesu li ti nalazi u miševa značajni za kliničku primjenu leflunomida.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT 
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP
White to almost white, round film-coated tablet, imprinted with ZBP on one side. 
Bijela do gotovo bijela, okrugla filmom obložena tableta s utisnutom oznakom ZBP na jednoj strani.
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)). 
Najčešće zabilježene nuspojave tijekom primjene leflunomida su: blagi porast krvnog tlaka, leukopenija, parestezija, glavobolja, omaglica, proljev, mučnina, povraćanje, poremećaji sluznice usne šupljine (npr. aftozni stomatitis, ulceracije u ustima), bol u abdomenu, pojačani gubitak kose, ekcem, osip (uključujući makulopapularni osip), pruritus, suha koža, tenosinovitis, povećanje CPK, anoreksija, gubitak težine (obično beznačajan), astenija, blage alergijske reakcije i porast jetrenih parametara (transaminaze (osobito ALT), manje često gama-GT, alkalna fosfataza, bilirubin).
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. 
Djelotvornost lijeka Leflunomide Zentiva u liječenju psorijatičnog artritisa pokazala se u jednom kontroliranom, randomiziranom, dvostruko slijepom ispitivanju 3L01 na 188 bolesnika s psorijatičnim artritisom.
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. 
Uz određivanje vrijednosti ALT, prije početka liječenja leflunomidom valja načiniti kompletnu krvnu sliku s diferencijalnom bijelom krvnom slikom i trombocitima, a zatim to ponavljati svaka 2 tjedna u prvih 6 mjeseci liječenja i nakon toga svakih 8 tjedana.
- 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 liječenje boli ili upale - furosemid za liječenje bolesti srca (diuretik, tableta za vodu) - zidovudin za liječenje HIV infekcije - rozuvastatin, simvastatin, atorvastatin, pravastatin za liječenje hiperkolesterolemije (povišeni kolesterol) - sulfasalazin za liječenje upalne bolesti crijeva ili reumatoidnog artritisa - lijek koji se zove kolestiramin (primjenjuje se za snižavanje visoke razine kolesterola) ili aktivni ugljen, jer ti lijekovi mogu smanjiti količinu lijeka Leflunomide Zentiva koju Vaše tijelo apsorbira.
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 
Zabilježeno je povećanje prosječne Cmax i AUC0-24 (1,58 odnosno 1,54 puta) za etinilestradiol i povećanje prosječne Cmax i AUC0-24 (1,33 odnosno 1,41 puta) za levonorgestrel, nakon ponovljenih doza A771726.
There was an increase in mean repaglinide Cmax and AUC (1.7- and 2.4-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of CYP2C8 in vivo. 
Zabilježeno je povećanje prosječne Cmax i AUC (1,7 odnosno 2,4 puta) za repaglinid, nakon ponovljenih doza A771726, što ukazuje da je A771726 inhibitor CYP2C8 in vivo.
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. 
Kako se aktivni metabolit leflunomida, A771726, snažno veže za proteine u plazmi i uklanja metaboliziranjem u jetri i sekrecijom putem žuči, u bolesnika s hipoproteinemijom očekuje se povećanje koncentracije A771726 u plazmi.
The procedure may be repeated as clinically necessary. 
Ako je klinički neophodno, postupak se može ponoviti.
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). 
Psoriatic Arthritis Treatment Response Criteria, PsARC) na liječenje odgovorilo 59% bolesnika u skupini liječenoj leflunomidom i 29,7% bolesnika u skupini koja je primala placebo (p< 0,0001).
Study MN301 randomised 358 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n=133), sulphasalazine 2 g/day (n=133), or placebo (n=92). 
U ispitivanju MN301, 358 randomiziranih bolesnika s aktivnim reumatoidnim artritisom uzimalo je leflunomid 20 mg/dan (n=133), sulfasalazin 2 g/dan (n=133) ili placebo (n=92).
Age older than 60 years, concomitant neurotoxic medications, and diabetes may increase the risk for peripheral neuropathy. 
Rizik od periferne neuropatije može biti povećan u bolesnika starijih od 60 godina, onih koji istodobno uzimaju neurotoksične lijekove ili u bolesnika s dijabetesom.
A randomised, double-blind, parallel-group non-inferiority study compared the relative efficacy of two different daily maintenance doses of leflunomide, 10 mg and 20 mg. From the results it can be concluded that efficacy results of the 20 mg maintenance dose were more favourable, on the other hand, the safety results favoured the 10 mg daily maintenance dose. 
Randomiziranim, dvostruko slijepim, neinferiornim ispitivanjem paralelnih skupina uspoređivala se relativna djelotvornost dviju različitih dnevnih doza održavanja leflunomida, odnosno 10 i 20 mg.
Washout procedure 
Postupak ispiranja („washout“)
There are no specific data on the risk of male-mediated foetal toxicity. 
Nema specifičnih podataka da bi liječenje muškaraca moglo uzrokovati pojavu fetalne toksičnosti.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
Imprint on one side: ZBP 
Utisnuta oznaka na jednoj strani: ZBP.
All patients received folate 1 mg bid. 
Svi bolesnici primali su 1 mg folata dvaput na dan.
The patient must be advised that if there is any delay in onset of menses or any other reason to suspect pregnancy, they must notify the physician immediately for pregnancy testing, and if positive, the physician and patient must discuss the risk to the pregnancy. 
Bolesnice treba savjetovati da u slučaju kašnjenja menstruacije ili sumnje na trudnoću obavezno odmah obavijeste liječnika zbog provođenja testa na trudnoću.
• Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/L (see section 4.6). 
• Trudnice i žene reproduktivne dobi koje ne koriste učinkovitu kontracepciju tijekom liječenja leflunomidom i nakon njega, sve dok je koncentracija aktivnog metabolita u plazmi veća od
In such cases re-exposure to leflunomide is contraindicated (see section 4.3). 
U tim je slučajevima neophodno potpuno ispiranje lijeka, a ponovno uzimanje leflunomida je kontraindicirano (vidjeti dio 4.3).
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). 
U ispitivanju MN302 bilo je 999 randomiziranih bolesnika s aktivnim reumatoidnim artritisom koji su primali leflunomid 20 mg/dan (n=501) ili metotreksat 7,5 mg/tjedan, s povećanjem doze na 15 mg/tjedan (n=498).
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). 
U ispitivanju faze II, YU203, 402 randomizirana bolesnika s aktivnim reumatoidnim artritisom dobivala su placebo (n=102), leflunomid 5 mg/dan (n=95), 10 mg/dan (n=101) ili 25 mg/dan (n=104).