natgillin/translations-raw huggingface dataset:
As soon as skin and/ or mucosal reactions are observed which raise the suspicion of such severe reactions, Arava and any other possibly associated medication must be discontinued, and a leflunomide washout procedure initiated immediately.
Čim se na koži in/ ali sluznici pojavijo reakcije, ki zbujajo sum na takšne hude reakcije, je treba prekiniti uporabo zdravila Arava in drugih zdravil, ki bi jih lahko povzročila, in takoj začeti postopek izpiranja.
In such cases re-exposure to leflunomide is contra-indicated (see section 4.3).
Ponovna uporaba leflunomida je kontraindicirana (glejte poglavje 4. 3).
It is known that medications with immunosuppressive properties - like leflunomide - may cause patients to be more susceptible to infections, including opportunistic infections.
Infekcijske in parazitske bolezni Znano je, da lahko zdravila z imunosupresivnim delovanjem, kakršno je leflunomid, zvečajo dovzetnost bolnikov za okužbe, vključno z oportunističnimi.
Patients with tuberculin reactivity must be carefully monitored because of the risk of tuberculosis reactivation.
Bolnike s tuberkulinsko reaktivnostjo je treba skrbno spremljati zaradi nevarnosti reaktiviranja tuberkuloze.
Interstitial Lung disease has been reported during treatment with leflunomide (see section 4.8).
Reakcije dihal Med zdravljenjem z leflunomidom je bila opisana intersticijska bolezen pljuč (glejte poglavje 4. 8).
Blood pressure must be checked before the start of leflunomide treatment and periodically thereafter.
Krvni tlak Krvni tlak je treba preveriti pred začetkom zdravljenja z leflunomidom in redno med zdravljenjem.
Male patients should be aware of the possible male-mediated foetal toxicity.
Zaploditev otroka (priporočila za moške) Moški bolniki se morajo zavedati možnih toksičnih učinkov za plod, ki jih lahko posreduje moški (glejte tudi poglavje 4. 4).
To minimise any possible risk, men wishing to father a child should consider discontinuing use of leflunomide and taking colestyramine 8 g 3 times daily for 11 days or 50 g of activated powdered charcoal 4 times daily for 11 days.
Da bi čim bolj zmanjšali morebitno tveganje, morajo moški, ki želijo zaploditi otroka, nehati uporabljati leflunomid in 11 dni jemati po 8 g holestiramina 3 - krat na dan ali 11 dni jemati po 50 g aktivnega oglja v prahu 4- krat na dan.
5 In either case the A771726 plasma concentration is then measured for the first time.
V obeh primerih se nato prvič izmeri plazemska koncentracija A771726.
If both plasma concentrations are below 0.02 mg/ l, and after a waiting period of at least 3 months, the risk of foetal toxicity is very low.
Če je ta koncentracija v obeh primerih manjša od 0, 02 mg/ l in po vsaj 3- mesečnem čakalnem obdobju, je tveganje toksičnosti za plod zelo majhno.
Colestyramine 8 g is administered 3 times daily.
Postopek izpiranja Trikrat na dan se daje po 8 g holestiramina.
Alternatively, 50 g of activated powdered charcoal is administered 4 times daily.
Druga možnost je uporaba 50 g aktivnega oglja v prahu, 4 - krat na dan.
Arava contains lactose.
Laktoza Zdravilo Arava vsebuje laktozo.
4.5 Interaction with other medicinal products and other forms of interaction
5 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Increased side effects may occur in case of recent or concomitant use of hepatotoxic or haematotoxic drugs or when leflunomide treatment is followed by such drugs 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).
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.
V majhni (n = 30) študiji sočasne uporabe leflunomida (10 do 20 mg na dan) in metotreksata (10 do 25 mg na teden) se je pri 5 od 30 bolnikov pojavilo 2 - do 3- kratno zvišanje jetrnih encimov.
A more than 3-fold increase was seen in another 5 patients.
Pri drugih 5 bolnikih se je pojavilo več kot 3- kratno zvišanje.
All of these also resolved,2 with continuation of both drugs and 3 after discontinuation of leflunomide.
Tudi pri teh je izginilo, pri 2 ob nadaljevanju uporabe obeh zdravil in pri 3 po opustitvi leflunomida.
The mechanism is thought to be by interruption of enterohepatic recycling and/ or gastrointestinal dialysis of A771726.
Domnevni mehanizem tega učinka je prekinitev enterohepatične recirkulacije in/ ali gastrointestinalna dializa A771726.
If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/ or corticosteroids, these may be continued after starting leflunomide.
Če bolnik že dobiva nesteroidne antirevmatike (NSAR), kortikosteroide ali oboje, jih lahko po začetku jemanja leflunomida uporablja še naprej.
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.
Po sočasni aplikaciji enega samega odmerka leflunomida osebam, ki so prejemale ponavljajoče se odmerke rifampicina (nespecifičnega induktorja citokroma P450), so se najvišje koncentracije A771726 zvišale za približno 40%, AUC pa se ni pomembno spremenila.
6 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.
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, farmakokinetika A771726 pa je bila v predvidenem območju.
No clinical data are available on the efficacy and safety of vaccinations under leflunomide treatment.
Cepljenja O učinkovitosti in varnosti cepljenj med zdravljenjem z leflunomidom ni kliničnih podatkov.
The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy.
Nosečnost Aktivni presnovek leflunomida, A771726, domnevno povzroča resne okvare ploda, če ga jemljejo nosečnice.
Arava is contraindicated in pregnancy (see section 4.3).
Zdravilo Arava je kontraindicirano med nosečnostjo (glejte poglavje 4. 3).
Women of childbearing potential have to use effective contraception during and up to 2 years after treatment (see “ waiting period” below) or up to 11 days after treatment (see abbreviated “ washout period” below).
6 prenehanju zdravljenja (glejte tudi “ čakalno obdobje ” spodaj), ali do 11 dni po prenehanju zdravljenja (glejte skrajšani “ postopek izpiranja ” spodaj).
For women receiving leflunomide treatment and who wish to become pregnant, one of the following procedures is recommended in order to ascertain that the foetus is not exposed to toxic concentrations of A771726 (target concentration below 0.02 mg/ l):
Pri ženskah, ki prejemajo leflunomid in želijo zanositi, je treba z enim od naslednjih postopkov zagotoviti, da plod ne bo izpostavljen toksični koncentraciji A771726 (ciljna koncentracija je pod 0, 02 mg/ l):
A771726 plasma levels can be expected to be above 0.02 mg/ l for a prolonged period.
Čakalno obdobje Pričakovati je mogoče, da bo plazemska koncentracija A771726 dolgo časa nad 0, 02 mg/ l.
The concentration may be expected to decrease below 0.02 mg/ l about 2 years after stopping the treatment with leflunomide.
Znižanje koncentracije pod 0, 02 mg/ l je mogoče pričakovati približno 2 leti po prenehanju zdravljenja z leflunomidom.
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.
If both plasma concentrations are below 0.02 mg/ l no teratogenic risk is to be expected.
Če je plazemska koncentracija v obeh primerih manjša od 0, 02 mg/ l, ni pričakovati tveganja za teratogenost.
Washout procedure
Postopek izpiranja Po prenehanju zdravljenja z leflunomidom:
• 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,
• 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.
7 However, also following either of the washout procedures, verification by 2 separate tests at an interval of at least 14 days and a waiting period of one-and-a-half months between the first occurrence of a plasma concentration below 0.02 mg/ l and fertilisation is required.
Vendar je tudi po kateremkoli od obeh postopkov izpiranja treba koncentracijo preveriti z 2 ločenima testoma v presledku vsaj 14 dni, z zanositvijo pa počakati še en mesec in pol po prvem znižanju plazemske koncentracije pod 0, 02 mg/ l.
Women of childbearing potential should be told that a waiting period of 2 years after treatment discontinuation is required before they may become pregnant.
Ženskam v rodni dobi je treba povedati, da morajo po koncu zdravljenja upoštevati 2- letno čakalno obdobje, preden smejo zanositi.
If a waiting period of up to approximately 2 years under reliable contraception is considered unpractical, prophylactic institution of a washout procedure may be advisable.
Če približno 2- letno čakalno obdobje, med katerim je treba zagotoviti zanesljivo kontracepcijo, za žensko ni primerno, je priporočljiva profilaktična izvedba izpiranja.
Animal studies indicate that leflunomide or its metabolites pass into breast milk.
Dojenje Študije na živalih so pokazale, da leflunomid ali njegovi presnovki prehajajo v mleko.
4.8 Undesirable effects
7 4. 8 Neželeni učinki
The most frequently adverse effects reported commonly (≥ 1/ 100 to < 1/ 10) 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))
Najpogostejši neželeni učinki povezani z leflunomidom, o katerih poročajo pogosto (≥ 1/ 100 do < 1/ 10) 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, anoreksija, izguba telesne mase (ponavadi nepomembno), astenija, blage alergijske reakcije in zvišanje jetrnih parametrov (transaminaze (zlasti ALT), manj pogosto gama- GT, alkalne fosfataze, bilirubina).
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥ 1/ 1. 000 do < 1/ 100); redki (≥ 1/ 10. 000 do < 1/ 1. 000); zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Cardiac disorders
Srčne bolezni Pogosti:
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema levkopenija (levkociti > 2 x 109/ l) Pogosti:
leucopenia (leucocytes > 2 G/ l)
anemija, blaga trombocitopenija (trombociti < 100 x 109/ l) Občasni:
Rare: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/ l), eosinophilia
pancitopenija (verjetno zaradi antiproliferacijskega mehanizma), levkopenija (levkociti < 2 x 109/ l), eozinofilija
Nervous system disorders
Bolezni živčevja Pogosti:
paraesthesia, headache, dizziness
parestezije, glavobol, omotica,
peripheral neuropathy
periferna nevropatija
Rare: interstitial lung disease (including interstitial pneumonitis), which may be fatal
intersticijska bolezen pljuč (vključno z intersticijsko pljučnico), ki je lahko usodna.
diarrhoea, nausea, vomiting, oral mucosal disorders (e. g., aphthous stomatitis, mouth ulceration), abdominal pain
driska, navzeja, bruhanje, bolezni ustne sluznice (npr. aftozni stomatitis, razjede v ustih), bolečine v trebuhu
renal failure
ledvična odpoved
Skin and subcutaneous tissue disorders
8 Bolezni kože in podkožja Pogosti:
toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
toksična epidermalna nekroliza, Stevens- Johnsonov sindrom, multiformni eritem
Musculoskeletal and connective tissue disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva Pogosti:
Metabolism and nutrition disorders
Presnovne in prehranske motnje Pogosti:
Infections and infestations
Infekcijske in parazitske bolezni Redki:
Rare: severe infections, including sepsis which may be fatal
hude okužbe, vključno s sepso, ki je lahko usodna.
9 Like other agents with immunosuppressive potential, leflunomide may increase susceptibility to infections, including opportunistic infections (see also section 4.4).
Tako kot druga zdravila z imunosupresivnim delovanjem lahko tudi leflunomid zveča dovzetnost za okužbe, vključno z oportunističnimi (glejte tudi poglavje 4. 4).
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije Pogosti:
severe anaphylactic/ anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis
hude anafilaktične/ anafilaktoidne reakcije, vaskulitis, vključno s kožnim nekrotizirajočim vaskulitisom
Hepatobiliary disorders
Bolezni jeter, žolčnika in žolčevodov Pogosti:
elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin)
zvišanje jetrnih parametrov (transaminaze [zlasti ALT], manj pogosto gama- GT, alkalne fosfataze, bilirubina)
hepatitis, jaundice/ cholestasis
hepatitis, zlatenica/ holestaza
Reproductive system and breast disorders
Motnje reprodukcije in dojk Neznani:
Psychiatric disorders
9 Psihiatrične motnje Občasni:
anxiety
tesnobnost
There have been reports of chronic overdose in patients taking Arava at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children.
Simptomi Obstajajo poročila o kroničnem prevelikem odmerjanju pri bolnikih, ki so jemali zdravilo Arava v dnevnih odmerkih, do petkrat večjih od priporočenega dnevnega odmerka, in poročila o akutnem prevelikem odmerjanju pri odraslih in otrocih.
In the event of an overdose or toxicity, colestyramine or charcoal is recommended to accelerate elimination.
Ukrepanje V primeru prevelikega odmerjanja ali toksičnih učinkov je treba za pospešitev izločanja uporabiti holestiramin ali oglje.
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.
Holestiramin, uporabljen peroralno v odmerku 8 g trikrat na dan 24 ur je pri treh zdravih prostovoljcih znižal plazemsko koncentracijo A771726 za približno 40% v 24 urah in za 49% do 65% v 48 urah.
10 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.
Dokazano je, da uporaba aktivnega oglja (prašek, pripravljen v suspenziji) peroralno ali po nazogastrični sondi (50 g na 6 ur v 24 urah) zniža plazemsko koncentracijo aktivnega presnovka A771726 za 37% v 24 urah in za 48% v 48 urah.
Pharmacotherapeutic group: selective immunosuppressive agents, ATC code:
Oznaka ATC:
Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties.
Farmakologija pri ljudeh Leflunomid je imunomodulirajoče antirevmatično zdravilo z antiproliferacijskimi lastnostmi.
Leflunomide is effective in animal models of arthritis and of other autoimmune diseases and transplantation, mainly if administered during the sensitisation phase.
Farmakologija pri živalih Leflunomid je učinkovit v živalskih modelih artritisa, drugih avtoimunskih bolezni in presaditev, predvsem če je uporabljen med senzibilizacijsko fazo.
It has immunomodulating/ immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties.
Učinkuje imunomodulacijsko/ imunosupresivno, deluje antiproliferacijsko in protivnetno.
A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity.
Način delovanja A771726, aktivni presnovek leflunomida, zavira človeški encim dihidroorotat- dehidrogenazo (DHODH) in deluje antiproliferacijsko.
The efficacy of Arava in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Revmatoidni artritis Učinkovitost zdravila Arava so pri zdravljenju revmatoidnega artritisa dokazali v 4 kontroliranih preskušanjih (1 v II. fazi in 3 v III. fazi).
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).
V preskušanju II. 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).
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).
Zdravljenje je trajalo
Treatment duration was 6 months.
10 6 mesecev.
Study MN303 was an optional 6-month blinded continuation of MN301 without the placebo arm, resulting in a 12-month comparison of leflunomide and sulphasalazine.
Študija MN303 je bila fakultativno 6- mesečno slepo nadaljevanje MN301 brez skupine s placebom in je omogočila 12- mesečno primerjavo leflunomida in sulfasalazina.
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).
V študiji MN302 so 999 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/ dan (n = 501) ali metotreksat 7, 5 mg/ teden z zvečanjem na 15 mg/ teden (n = 498).
Folate supplementation was optional and only used in 10% of patients.
Dodajanje folata je bilo fakultativno in uporabljeno le pri 10% bolnikov.
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).
V študiji US301 so 482 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/ dan (n = 182), metotreksat 7, 5 mg/ teden z zvečanjem na 15 mg/ teden (n = 182) ali placebo (n = 118).
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% 11 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.
28.6% (study MN301), and 49.4% vs.
V preskušanjih III. faze je bil delež odziva po ACR na leflunomid 20 mg/ dan v primerjavi s placebom 54, 6% proti 28, 6% (študija MN301) in 49, 4% proti 26, 3% (študija US301).
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.
43, 9% (študija US301) pri bolnikih na metotreksatu.
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.
Pediatrična uporaba 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.
Patients were 3– 17 years of age with active polyarticular course JRA regardless of onset type and naive to methotrexate or leflunomide.
Bolniki so bili stari od 3 do 17 let, imeli so aktiven JRA s poliartikularnim potekom, ne glede na način pojava, in še niso dobivali metotreksata ali leflunomida.
In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories :< 20kg, 20-40 kg, and > 40kg.
V tem preskušanju sta polnilni in vzdrževalni odmerek leflunomida temeljila na treh kategorijah telesne mase: < 20 kg, od 20 do 40 kg in > 40 kg.
After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥ 30% (p=0.02).
Po 16 tednih zdravljenja je bila razlika v deležu odziva statistično značilna v prid metotreksata po opredelitvi izboljšanja (DOI - Definition of Improvement) za JRA ≥ 30% (p = 0, 02).
(see section 4.2).
Pri bolnikih, ki so se odzvali na zdravljenje, se je ta odziv ohranjal 48 tednov (glejte poglavje 4. 2).
The pattern of adverse events of leflunomide and methotrexate seems to be similar, but the dose used in lighter subjects resulted in a relatively low exposure (see section 5.2).
Vzorec neželenih učinkov leflunomida in metotreksata je podoben, vendar je bila izpostavljenost lažjih bolnikov zaradi uporabljenega odmerka relativno nizka (glejte poglavje 5. 2).
The efficacy of Arava was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20mg/ day.
Psoriatični artritis Učinkovitost zdravila Arava je dokazala kontrolirana, randomizirana dvojno slepa študija 3L01 pri 188 bolnikih s psoriatičnim artritisom.
Leflunomide 20mg/ 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).
Leflunomid v odmerku 20 mg/ dan je simptome artritisa pri bolnikih s psoriatičnim artritisom zmanjšal značilno bolj kot placebo: bolnikov, ki so se odzvali po merilih PsARC (Psoriatic Arthritis treatment Response Criteria; merila odziva na zdravljenje psoriatičnega artritisa), je bilo do 6. meseca med prejemniki leflunomida 59% in med prejemniki placeba 29, 7% (p < 0, 0001).
5.2 Pharmacokinetic properties
11 5. 2 Farmakokinetične lastnosti
In a study with radiolabelled 14C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
V študiji z radioaktivno označenim 14C- leflunomidom pri 3 zdravih prostovoljcih v plazmi, urinu ali blatu niso našli nespremenjenega leflunomida.
In other studies, unchanged leflunomide levels in plasma have rarely been detected, however, at ng/ ml plasma levels.
V drugih študijah so koncentracije nespremenjenega leflunomida v plazmi zaznali le redko, v plazemskih koncentracijah reda velikosti ng/ ml.
This metabolite is responsible for essentially all the in-vivo activity of Arava.
Ta je odgovoren za praktično vso aktivnost zdravila Arava in vivo.
Excretion data from the 14C study indicated that at least about 82 to 95% of the dose is absorbed.
Absorpcija Podatki o ekskreciji iz študije 14C so pokazali, da se absorbira vsaj 82 do 95% odmerka.