natgillin/translations-raw huggingface dataset:
• 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,
• bljedoće kože, umora ili pojave modrica, jer to može upućivati na krvne poremećaje uzrokovane poremećenom ravnotežom različitih vrsta krvnih stanica.
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.
Za ostale supstrate BCRP (npr. metotreksat, topotekan, sulfasalazin, daunorubicin, doksorubicin) i OATP porodice, osobito inhibitore HMG-CoA reduktaze (npr. simvastatin, atorvastatin, pravastatin, metotreksat, nateglinid, repaglinid, rifampicin), istodobna primjena se također mora provoditi uz oprez.
• if you are due to have a specific blood test (calcium level).
• ako morate napraviti određenu krvnu pretragu (utvrđivanje razine kalcija).
Effect of other medicinal products on leflunomide:
Utjecaj drugih lijekova na leflunomid:
• 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.
• unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
• neuobičajenih trnaca, slabosti li bolova u šakama ili stopalima, jer mogu upućivati na probleme sa živcima (periferna neuropatija).
severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis
teške anafilaktične/anafilaktoidne reakcije, vaskulitis, uključujući kožni nekrotizirajući vaskulitis
Leflunomide medac is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Leflunomid medac je kontraindiciran u bolesnika s teškom hipoproteinemijom ili oštećenom jetrenom funkcijom (vidjeti dio 4.3.).
• abnormal skin sensations like tingling (paraesthesia),
• nenormalni osjeti na koži poput trnaca (parestezije),
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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 (vidjeti nastavak teksta) kako bi se smanjila koncentracija A771726 u plazmi.
However, a 25 % decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Ipak, primjećeno je 25 %-tno smanjenje vršne vrijednosti internacionalnog normaliziranog omjera (INR) kod istodobne primjene A771726 s varfarinom, u usporedbi s monoterapijom varfarinom.
• severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• teške reakcije koje ponekad mogu biti opasne po život (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem).
elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
(transaminaze [osobito ALT], manje često gama-GT, alkalna fosfataza, bilirubin).
• eczema, dry skin, rash, itching,
• ekcem, suha koža, osip, svrbež,
Other medicines and Leflunomide medac
Drugi lijekovi i Leflunomid medac
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.
Nakon 12 mjeseci aktivnog liječenja stopa odgovora prema ACR-u u bolesnika koji su primali leflunomid bila je 52,3 % (studije MN301/303), 50,5 % (studija MN302) i 49,4 % (studija US301) u usporedbi s 53,8 % (studije MN301/303) u bolesnika koji su primali sulfasalazin te 64,8 % (studija MN302) i 43,9 % (studija US301) u bolesnika koji su primali metotreksat.
Most patients improved after discontinuation of Leflunomide medac.
Stanje se popravilo u većine bolesnika nakon prekida terapije lijekom Leflunomid medac.
• active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD).
• aktivnim reumatoidnim artritisom kao antireumatik koji modificira tijek bolesti (DMARD od engl. disease-modifying antirheumatic drug),
Leflunomide is metabolised to one primary (A771726) and many minor metabolites including TFMA (4-trifluoromethylaniline).
Leflunomid se metabolizira u jedan glavni (A771726) i više manjih metabolita, uključujući (4 trifluorometilanilin).
Tablet core: lactose monohydrate low-substituted hydroxypropyl cellulose tartaric acid sodium laurylsulfate magnesium stearate
Jezgra tablete: laktoza hidrat hidroksipropilceluloza, niskosupstituirana tartaratna kiselina natrijev laurilsulfat magnezijev stearat
What Leflunomide medac looks like and contents of the pack
Kako Leflunomid medac izgleda i sadržaj pakovanja
• an increase of certain enzymes in the blood (creatine phosphokinase),
• porast koncentracije određenih enzima u krvi (kreatin fosfokinaze),
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.
Čim se pojave reakcije na koži i/ili sluznici koje izazivaju sumnju na teške nuspojave, uzimanje Leflunomid medaca ili bilo kojeg dodatnog lijeka treba prekinuti i odmah započeti postupak ispiranja leflunomida.
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.
Following concomitant administration of a single dose of leflunomide to subjects receiving multiple doses of rifampicin (non-specific cytochrome P450 inducer) A771726 peak levels were increased by approximately 40 %, whereas the AUC was not significantly changed.
Nakon istodobne primjene pojedinačne doze leflunomida u osoba koje su primale višestruke doze rifampicina (nespecifičnog induktora citokroma P450), vršne koncentracije A771726 porasle su za 40 %, dok se vrijednost AUC nije značajno promijenila.
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.
U manjem ispitivanju (n = 30) istodobne primjene leflunomida (10 do 20 mg na dan) i metotreksata (10 do 25 mg na tjedan) opaženo je povišenje jetrenih enzima 2 do 3 puta u 5 od 30 bolesnika.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 July 2013
Datum prvog odobrenja: 25 srpanj 2013
• if you have moderate to severe kidney problems,
• ako imate umjerene do teške probleme s bubrezima,
• inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis),
• upala malih krvnih žila (vaskulitis, uključujući kožni nekrotizirajući vaskulitis),
Gidamed Medical Supplies Ltd. Τηλ:+ 357-257 510 30
Τηλ: +357-257 510 30
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 niže).
• severe and potentially severe allergic reactions,
• jake i potencijalno jake alergijske reakcije,
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
• repaglinid, pioglitazon, nateglinid ili roziglitazon za liječenje šećerne bolesti
• alosetron for the management of severe diarrhoea
• alosetron za liječenje teškog proljeva
• For rheumatoid arthritis: 10 to 20 mg Leflunomide medac once daily, depending on the severity of the disease.
• Za reumatoidni artritis: 10 mg do 20 mg lijeka Leflunomid medac jedanput na dan, ovisno o težini bolesti.
Do not take Leflunomide medac when you are breast-feeding, as leflunomide passes into the breast milk.
Nemojte uzimati Leflunomid medac dok dojite jer se leflunomid izlučuje u majčino mlijeko.
• inflammation of the lung (interstitial lung disease),
• upala pluća (intersticijska plućna bolest),
interstitial lung disease (including interstitial pneumonitis), which may be fatal Not known: pulmonary hypertension
intersticijska plućna bolest (uključujući intersticijski pneumonitis), koja može biti smrtonosna
• duloxetine for depression, urinary incontinence or in kidney disease in diabetics
• duloksetin za liječenje depresije, nesposobnosti zadržavanja mokraće ili bolesti bubrega u oboljelih od šećerne bolesti
After a 2-year waiting period, the A771726 plasma concentration is measured for the first time.
Nakon dvogodišnjeg čekanja koncentracija A771726 u plazmi mjeri se prvi put.
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).
Zabilježeno je da peroralna primjena suspenzije aktivnog ugljika ili kolestiramina u ljudi ubrzava i značajno povećava brzinu eliminacije A771726 i smanjuje njegovu koncentraciju u plazmi (vidjeti dio 4.9.).
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 trbuhu, pojačani gubitak kose, ekcem, osip (uključujući makulopapulozni osip), svrbež, 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).
agranulocytosis
agranulocitoza
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.
• Colestyramine 8 g is administered 3 times daily for a period of 11 days.
• Kolestiramin 8 g tri puta na dan tijekom 11 dana.
Therefore, when co-administered with substrates of OAT3, such as cefaclor, benzylpenicillin, ciprofloxacin, indomethacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is recommended.
Stoga se preporučuje oprez kod istodobne primjene leflunomida sa supstratima OAT3, kao što su cefaklor, benzilpenicilin, ciprofloksacin, indometacin, ketoprofen, furosemid, cimetidin, metotreksat, zidovudin.
• indomethacin, ketoprofen for pain or inflammation
• indometacin, ketoprofen za liječenje boli ili upale
Uncommon: hypokalaemia, hyperlipidemia, hypophosphataemia Rare:
hipokalijemija, hiperlipidemija, hipofosfatemija
• For psoriatic arthritis: 20 mg Leflunomide medac once daily.
Za psorijatični artritis: 20 mg lijeka Leflunomid medac jedanput na dan.
Symptoms of psoriatic arthritis include inflammation of joints, swelling, difficulty in moving, pain, and patches of red, scaly skin (skin lesions).
Simptomi aktivnog psorijatičnog artritisa uključuju upalu i oticanje zglobova, otežano kretanje, bol i područja crvene, ljuskaste kože (kožne lezije).
• 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,
• 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.
In case of severe haematological reactions, including pancytopenia, Leflunomide medac and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
U slučaju teških hematoloških reakcija, uključujući pancitopeniju, treba prekinuti liječenje lijekom Leflunomid medac i bilo kojim istodobno primijenjenim mijelosupresivnim lijekom te početi postupak ispiranja leflunomida.
If you forget to take Leflunomide medac
Ako ste zaboravili uzeti Leflunomid medac
• an increase in some liver test results,
• porast vrijednosti određenih jetrenih enzima,
• 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
• porast broja krvnih stanica zvanih eozinofili (eozinofilija), blagi pad broja bijelih krvnih stanica
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 odmah moraju obavijesti liječnika zbog provođenja testa na trudnoću.
• a marked decrease of some white blood cells (agranulocytosis),
• izrazitio smanjenje broja pojedinih bijelih krvnih stanica (agranulocitoza),
Patients were 317 years of age with active polyarticular course JRA regardless of onset type and naive to methotrexate or leflunomide.
Bolesnici su bili u dobi između 3 i 17 godina, imali su aktivni poliartikularni oblik juvenilnog reumatoidnog artritisa, bez obzira na tip nastupa bolesti i do tada nisu primali metotreksat ili leflunomid.
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 oko 40 % u 24 sata, te za 49 % do 65 % u 48 sati.
Germany medac
Njemačka medac
• 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.
• ako dobijete kožni osip ili ranice 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.
Human pharmacology Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties.
Farmakologija u ljudi Leflunomid je antireumatik s antiproliferativnim svojstvima koji modificira tijek bolesti.
• 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,
druge lijekove za reumatoidni artritis poput antimalarika (primjerice, klorokina i hidroklorokina), intramuskularno ili kroz usta primijenjene soli zlata, D-penicilamin, azatioprin i druge imunosupresive (primjerice, metotreksat), jer se te kombinacije ne preporučuju,
severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
teško oštećenje jetre poput zatajenja jetre i akutne hepatičke nekroze¸ koja može završiti smrtnim ishodom
Do not take Leflunomide medac if you are, or think you may be pregnant.
Nemojte uzimati Leflunomid medac ako ste trudni ili mislite da biste mogli biti trudni.
Leflunomide medac 20 mg
Leflunomid medac 20 mg
3 days.
48 sati.
Leflunomide medac 15 mg
Leflunomid medac 15 mg
• inflammation of the mouth or mouth ulcers,
• upala sluznice usta ili ranice u ustima,
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.
• a slight decrease in the number of white blood cells (leucopenia),
• blagi pad broja bijelih krvnih stanica (leukopenija),
In either case it should be confirmed by a blood test that Leflunomide medac has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
U svakom slučaju, eliminaciju lijeka Leflunomid medac iz Vašeg organizma potrebno je potvrditi laboratorijskim pretragama krvi, a nakon toga trebate čekati još najmanje mjesec dana prije nego zatrudnite.
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 etinilestradiola nije zabilježena smanjena kontracepcijska aktivnost pilule, dok je farmakokinetika A771726 bila u predviđenim rasponima.Farmakokinetička interakcija s oralnim kontraceptivima primjećena je za A771726 (vidjeti niže).
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.
Do not take Leflunomide medac
Nemojte uzimati Leflunomid medac
Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide medac, to monitor your blood cells and liver.
Prije i za vrijeme liječenja lijekom Leflunomid medac liječnik će Vas u redovitim razmacima slati na krvne pretrage radi kontrole krvnih stanica i jetre.
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava Često:
• urticaria (nettle rash),
• urtikarija (koprivanjača),
What Leflunomide medac contains
Što Leflunomid medac sadrži
Each film-coated tablet contains 114 mg of lactose (as monohydrate) and 0.09 mg of soya lecithin.
Jedna filmom obložena tableta sadrži 114 mg laktoze (u obliku hidrata) i 0,09 mg sojinog lecitina.
• inflammation of the pancreas (pancreatitis),
• upala gušterače (pankreatitis),
The efficacy of leflunomide was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Djelotvornost leflunomida u liječenju psorijatičnog artritisa pokazala se u jednom kontroliranom, randomiziranom, dvostruko slijepom ispitivanju, 3L01 na 188 bolesnika s psorijatičnim artritisom.
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.
Također se mogu javiti druge nuspojave, poput zatajenje bubrega, smanjene koncentracije mokraćne kiseline u krvi, plućne hipertenzije, muške neplodnosti (koja se povlači nakon prestanka primjene ovoga lijeka), kožnog lupusa (karakteriziran osipom/crvenilom na područjima kože izloženima svjetlu), psorijaza (novonastala psorijaza ili pogoršanje psorijaze) i reakcije na lijek s eozinofilijom i sistemskim simptomima (DRESS), ali je njihova učestalost nepoznata.
diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis
proljev, mučnina, povraćanje, poremećaji sluznice usne šupljine (npr. aftozni stomatitis, ulceracije u ustima), bol u trbuhu, kolitis, uključujući mikroskopski kolitis poput limfocitnog kolitisa, kolagenog kolitisa
• headache, dizziness,
• glavobolja, omaglica,
• severe liver injury such as liver failure or necrosis which may be fatal,
• teško oštećenje jetre, poput zatajenja jetre ili nekroze, koje može biti opasno po život,
• anxiety,
• kolitis,
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 na odgovarajući način 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.).
Each film-coated tablet contains 76 mg of lactose (as monohydrate) and 0.06 mg of soya lecithin.
Jedna filmom obložena tableta sadrži 76 mg laktoze (u obliku hidrata) i 0,06 mg sojinog lecitina.
often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome), peanut or soya or to any of the other ingredients of this medicine (listed in section 6),
npr. Stevens-Johnsonov sindrom), kikiriki ili soju ili na neki drugi sastojak ovog lijeka (naveden u dijelu 6.),
In such cases re-exposure to leflunomide is contra-indicated (see section 4.3).
U tim je slučajevima neophodno potpuno ispiranje lijeka, a ponovno uzimanje leflunomida je kontraindicirano (vidjeti dio 4.3.).
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 studiji 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).
INFORMATION IN BRAILLE Leflunomide medac 10 mg
16. PODACI NA BRAILLEOVOM PISMU Leflunomid medac 10 mg
Uncommon: taste disturbances
poremećaji okusa
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, studije 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).
Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n = 182), methotrexate 7.5 mg/week increasing to 15 mg/week (n = 182), or placebo (n = 118).
U studiji US301, 482 randomizirana bolesnika s aktivnim reumatoidnim artritisom primala su leflunomid 20 mg/dan (n = 182), metotreksat 7,5 mg/tjedan, s povećanjem doze na 15 mg/tjedan (n = 182), ili placebo (n = 118).