natgillin/translations-raw huggingface dataset:
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.
This can include medical history, possible previous contact with tuberculosis, and/or appropriate screening such as lung x-ray, tuberculin test and/or interferon-gamma release assay, as applicable.
To lahko obsega zdravstveno anamnezo, ugotavljanje možnih predhodnih stikov s tuberkulozo in/ali ustrezne presejalne postopke, npr. rentgensko slikanje pljuč, tuberkulinski test in/ali preskus sproščanja interferona gama, če pride v poštev.
Elimination of A771726 is slow and characterised by an apparent clearance of about 31 ml/hr.
Izločanje A771726 je počasno, z navideznim očistkom približno 31 ml/uro.
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.
Če se pojavi zamuda menstruacije ali obstaja kakšen drug razlog za sum, da je bolnica zanosila, mora o tem takoj obvestiti zdravnika in se z njim dogovoriti za nosečnostni test; če je nosečnostni test pozitiven, se morata zdravnik in bolnica pogovoriti o tveganjih v nosečnosti.
Leflunomide, administered orally and intraperitoneally, has been studied in acute toxicity studies in mice and rats.
Peroralno in intraperitonealno aplicirani leflunomid so proučili v študijah akutne toksičnosti pri miših in podganah.
severe infections, including sepsis which may be fatal.
hude okužbe, vključno s sepso, ki je lahko usodna.
This may be reduced to a few weeks by taking certain medicines which speed up removal of Leflunomide Zentiva from your body.
To obdobje je mogoče skrajšati na nekaj tednov z jemanjem določenih zdravil, ki pospešijo odstranjevanje zdravila Leflunomid Zentiva iz telesa.
Peripheral neuropathy
Periferna nevropatija
• Patients with severe hypoproteinaemia, e.g. in nephrotic syndrome.
• Bolniki s hudo hipoproteinemijo, npr. pri nefrotskem sindromu.
Leflunomide Zentiva belongs to a group of medicines called anti-rheumatic medicines.
Zdravilo Leflunomid Zentiva spada v skupino zdravil, ki jih imenujemo protirevmatična zdravila.
In vitro plasma protein binding interaction studies with warfarin at clinically relevant concentrations, however, showed no interaction.
Vendar študije interakcij plazemske beljakovinske vezave z varfarinom in vitro v klinično relevantnih koncentracijah niso pokazale nobenih interakcij.
anorexia, weight loss (usually insignificant), asthenia
anoreksija, izguba telesne mase (ponavadi nepomembno), astenija
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.
The active metabolite of leflunomide, A771726, has a long half-life, usually 1 to 4 weeks.
Aktivni presnovek leflunomida, A771726, ima dolg razpolovni čas, ponavadi od 1 do 4 tedne.
In a small prospective study in women (n=64) who became inadvertently pregnant while taking leflunomide for no more than three weeks after conception and followed by a drug elimination procedure, no significant differences (p=0.13) were observed in the overall rate of major structural defects (5.4%) compared to either of the comparison groups (4.2% in the disease matched group [n=108] and 4.2% in healthy pregnant women [n=78]).
V mali prospektivni študiji, ki je vključevala ženske (n=64), ki so nenačrtovano zanosile in prejemale leflunomid v obdobju, ki ni bil daljši od treh tednov po zanositvi in je vključeval tudi obdobje postopka eliminacije zdravila iz telesa, niso opazili statistično pomembnih razlik (p=0,13) v skupnem številu večjih strukturnih defektov (5,4%), v primerjavi z obema primerjanima skupinama (4,2% v skupini, ki je identična glede na bolezen [n=108] in 4,2% v skupini zdravih nosečnic [n=78]).
As similar drug-drug interactions cannot be excluded for leflunomide at recommended doses, the following study results and recommendations should be considered in patients treated with leflunomide:
Ker med uporabo leflunomida v priporočenih odmerkih ni mogoče izključiti podobnih medsebojnih delovanj, je treba med zdravljenjem z leflunomidom upoštevati naslednje rezultate študij in priporočila:
• The Summary of Product Characteristics
• Povzetek glavnih značilnosti zdravila
It is known that medicinal products with immunosuppressive properties - like leflunomide - may cause patients to be more susceptible to infections, including opportunistic infections.
Znano je, da lahko zdravila z imunosupresivnim delovanjem, kakršno je leflunomid, zvečajo dovzetnost bolnikov za okužbe, vključno z oportunističnimi.
Leflunomide was administered as a single oral 100 mg dose to 3 haemodialysis patients and 3 patients on continuous peritoneal dialysis (CAPD).
Leflunomid so aplicirali v enkratnem peroralnem 100-mg odmerku 3 hemodializnim bolnikom in 3 bolnikom na kontinuirani ambulantni peritonealni dializi (CAPD).
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.
V randomizirani, dvojno slepi študiji na dveh paralelnih enakovrednih skupinah so primerjali relativno učinkovitost dveh različnih dnevnih vzdrževalnih odmerkov leflunomida, 10 mg in 20 mg. Na podlagi rezultatov lahko zaključimo, da je učinkovitost večja pri vzdrževalnem odmerku 20 mg, po drugi strani pa varnostni izid govori v prid vzdrževalnemu odmerku 10 mg.
Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide Zentiva, to monitor your blood cells and liver.
Vaš zdravnik vam bo pred in med zdravljenjem z zdravilom Leflunomid Zentiva v rednih presledkih opravljal preiskave krvi, da bo kontroliral vaše krvne celice in jetra.
Your doctor will also check your blood pressure regularly as Leflunomide Zentiva can cause an increase in blood pressure.
Prav tako vam bo vaš zdravnik redno meril krvni tlak, saj ga zdravilo Leflunomid Zentiva lahko zviša.
Leflunomide was not antigenic in animal models.
Leflunomid v živalskih modelih ni deloval antigeno.
Leflunomide Zentiva is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Zdravila Leflunomid Zentiva ni priporočljivo uporabljati za bolnike do 18. leta starosti, ker učinkovitost in varnost pri juvenilnem revmatoidnem artritisu (JRA) nista ugotovljeni (glejte poglavje 5.1 in 5.2).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je vaš zdravnik povedal, da ne prenašate določenih sladkorjev, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
The treatment should be initiated and supervised by specialists experienced in the treatment of rheumatoid arthritis and psoriatic arthritis.
Zdravljenje lahko prične in nadzira le specialist, ki ima izkušnje pri zdravljenju revmatoidnega artritisa in psoriatičnega artritisa.
A771726, the active metabolite of leflunomide, inhibits the human enzyme dihydroorotate dehydrogenase (DHODH) and exhibits antiproliferative activity.
A771726, aktivni presnovek leflunomida, zavira človeški encim dihidroorotat-dehidrogenazo (DHODH) in deluje antiproliferacijsko.
Binding of A771726 is linear in the therapeutic concentration range.
Vezava A771726 je v območju terapevtskih koncentracij linearna.
Both colestyramine and activated powdered charcoal may influence the absorption of oestrogens and progestogens such that reliable contraception with oral contraceptives may not be guaranteed during the washout procedure with colestyramine or activated powdered charcoal.
Tako holestiramin kot aktivno oglje v prahu lahko vplivata na absorpcijo estrogenov in progestagenov, tako da peroralni kontraceptivi med postopkom izpiranja s holestiraminom ali aktivnim ogljem v prahu ne zagotavljajo zanesljive kontracepcijske zaščite.
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.
Consistent with extensive protein binding A771726 has a low apparent volume of distribution (approximately 11 litres).
Skladno z izrazito vezavo na beljakovine ima A771726 majhen navidezni volumen porazdelitve (približno 11 litrov).
In the event that severe, uncontrolled infections occur, it may be necessary to interrupt leflunomide treatment and administer a washout procedure as described below.
Če se pojavijo hude, neobvladane okužbe, utegneta biti potrebna prekinitev zdravljenja z leflunomidom in postopek izpiranja, kot je opisano spodaj.
The main effects were anaemia, leucopenia, decreased platelet counts and panmyelopathy and reflect the basic mode of action of the compound (inhibition of DNA synthesis).
Glavni učinki so bili anemija, levkopenija, zmanjšanje števila trombocitov in panmielopatija; učinki odražajo temeljni način delovanja spojine (zaviranje sinteze DNA).
Effect of leflunomide on other medicinal products:
Vpliv leflunomida na druga zdravila:
What Leflunomide Zentiva is and what it is used for What you need to know before you take Leflunomide Zentiva How to take Leflunomide Zentiva Possible side effects
Kaj je zdravilo Leflunomid Zentiva in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Leflunomid Zentiva Kako jemati zdravilo Leflunomid Zentiva Možni neželeni učinki
Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex France
Sanofi Winthrop Industrie 56, Route de Choisy au Bac F-60205 Compiegne Cedex Francija
A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these medicinal products is only increased by 10% to 50%.
A771726 je izpodrinil ibuprofen, diklofenak in tolbutamid, vendar se je nevezana frakcija teh zdravil zvečala samo za 10 do 50 %.
Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.
Zato je treba med zdravljenjem previdno uporabljati zdravila, ki se presnavljajo s CYP1A2 (npr. duloksetin, alosetron, teofilin in tizanidin), ker lahko zmanjša učinkovitost teh zdravil.
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.
The Physician Leaflet should contain the following key messages:
Navodilo za zdravnika mora vsebovati naslednje informacije:
This medicinal product contains lactose (see leaflet for further information).
SEZNAM POMOŽNIH SNOVI To zdravilo vsebuje laktozo (za dodatne informacije glejte navodilo za uporabo).
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.
The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures.
Informacije v navodilu za zdravnika morajo vsebovati podatke o prilagajanju odmerka, prenehanju zdravljenja in postopkih za izplavljanje.
Repeated oral administration of leflunomide to mice for up to 3 months, to rats and dogs for up to 6 months and to monkeys for up to 1 month's duration revealed that the major target organs for toxicity were bone marrow, blood, gastrointestinal tract, skin, spleen, thymus and lymph nodes.
Ponavljajoče se peroralne aplikacije leflunomida mišim do 3 mesecev, podganam in psom do 6 mesecev in opicam do 1 meseca so pokazale, da so glavni tarčni organi toksičnosti kostni mozeg, kri, prebavila, koža, vranica, timus in bezgavke.
Men wishing to father a child should contact their doctor who may advise them to stop taking Leflunomide Zentiva and take certain medicines to remove Leflunomide Zentiva rapidly and sufficiently from their body.
Moški, ki želijo zaploditi otroka, se morajo posvetovati z zdravnikom, ki jim bo morda svetoval, da nehajo jemati zdravilo Leflunomid Zentiva in vzamejo določena zdravila za hitro in uspešno izločanje zdravila Leflunomid Zentiva iz telesa.
Leflunomide Zentiva tablets are for oral use.
Tablete Leflunomid Zentiva so za peroralno uporabo.
The principal urinary metabolites were glucuronide products derived from leflunomide (mainly in 0 to 24 hour samples) and an oxanilic acid derivative of A771726.
Glavni presnovki v urinu so bili glukuronidni derivati leflunomida (predvsem v vzorcih od 0 do 24 ur) in derivat oksanilne kisline A771726.
Effect on caffeine (CYP1A2 substrate)
Vpliv na kofein (substrat CYP1A2)
• Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia due to causes other than rheumatoid or psoriatic arthritis.
• Bolniki z občutno okvarjenim delovanjem kostnega mozga ali izrazito anemijo, levkopenijo, nevtropenijo ali trombocitopenijo, katerih vzrok ni revmatoidni ali psoriatični artritis.
It has immunomodulating/ immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties.
Učinkuje imunomodulacijsko/imunosupresivno, deluje antiproliferacijsko in protivnetno.
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).
However, in study US301 no significant differences were observed between leflunomide and methotrexate in the primary efficacy parameters.
V študiji US301 pa se parametri primarne učinkovitosti med leflunomidom in metotreksatom niso značilno razlikovali.
Women of childbearing potential must not take Leflunomide Zentiva without using reliable contraceptive measures.
Ženske v rodni dobi ne smejo jemati zdravila Leflunomid Zentiva, če ne uporabljajo zanesljive kontracepcijske zaščite.
In the case of side effects such as dizziness the patient's ability to concentrate and to react properly may be impaired.
V primeru neželenih učinkov, npr. omotice, je lahko prizadeta bolnikova sposobnost koncentracije in ustreznega reagiranja.
Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy.
Intersticijska bolezen pljuč je potencialno smrtna bolezen, ki se med zdravljenjem lahko pojavi akutno.
Leflunomide was not mutagenic.
Leflunomid ni bil mutagen.
In multiple dose studies in patients with rheumatoid arthritis, the pharmacokinetic parameters of A771726 were linear over the dose range of 5 to 25 mg.
V študijah z več odmerki pri bolnikih z revmatoidnim artritisom so bili farmakokinetični parametri A771726 v območju odmerkov od 5 do 25 mg linearni.
As leflunomide has a long persistence in the body, a switching to another DMARD (e.g. methotrexate) without performing the washout procedure (see below) may raise the possibility of additive risks even for a long time after the switching (i.e. kinetic interaction, organ toxicity).
Ker leflunomid ostane dolgo v telesu, lahko prehod na drugo imunomodulirajoče protirevmatično zdravilo (npr. metotreksat) brez postopka izpiranja (glejte spodaj) celo dolgo časa po prehodu povzroči dodatna tveganja (tj. kinetične interakcije, organotoksične učinke).
Leflunomide was embryotoxic and teratogenic in rats and rabbits at doses in the human therapeutic range and exerted adverse effects on male reproductive organs in repeated dose toxicity studies.
Leflunomid je bil pri podganah in kuncih embriotoksičen in teratogen v odmerkih, ki so bili v terapevtskem območju za ljudi, in je imel v študijah toksičnosti ponavljajočih se odmerkov neželene učinke na moške reproduktivne organe.
Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anaemia (lack of red blood cells).
Dodatni simptomi, ki prizadenejo celotno telo, vključujejo izgubo apetita, povišano telesno temperaturo, izgubo energije in anemijo (pomanjkanje rdečih krvnih celic).
The pharmacokinetics of A771726 following oral administration of leflunomide have been investigated in 73 paediatric patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA) who ranged in age from 3 to 17 years.
Farmakokinetiko A771726 po peroralni uporabi leflunomida so raziskali pri 73 pediatričnih bolnikih, starih od 3 do 17 let, ki so imeli juvenilni revmatoidni artritis (JRA) s poliartikularnim potekom.
Rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported in patients receiving leflunomide among other immunosuppressants.
Poročali so o redkih primerih progresivne multifokalne levkoencefalopatije (PML) pri pacientih, ki so prejemali leflunomid poleg ostalih zdravil z imunosupresivnim delovanjem.
In these studies, the clinical effect was closely related to the plasma concentration of A771726 and to the daily dose of leflunomide.
V teh študijah je bil klinični učinek tesno povezan s plazemsko koncentracijo A771726 in z dnevnim odmerkom leflunomida.
In case of ulcerative stomatitis, leflunomide administration should be discontinued.
V primeru ulcerativnega stomatitisa je treba zdravljenje z leflunomidom prekiniti.
Leflunomide at a daily dose of at least 10 mg (10 to 25 mg in study YU203, 20 mg in studies MN301 and US301) was statistically significantly superior to placebo in reducing the signs and symptoms of rheumatoid arthritis in all 3 placebo-controlled trials.
Leflunomid v dnevnem odmerku vsaj 10 mg (10 do 25 mg v študiji YU203, 20 mg v študijah MN301 in US301) je znake in simptome revmatoidnega artritisa v vseh 3 s placebom kontroliranih preskušanjih zmanjšal statistično značilno bolj kot placebo.
The tablets are packed in blisters or bottles.
Tablete so pakirane v pretisnih omotih ali plastenkah.
In patients with rheumatoid arthritis, no pharmacokinetic interaction between the leflunomide (10 to 20 mg per day) and methotrexate (10 to 25 mg per week) was demonstrated.
Pri bolnikih z revmatoidnim artritisom ni bilo ugotovljenih farmakokinetičnih interakcij med leflunomidom (10 do 20 mg na dan) in metotreksatom (10 do 25 mg na teden).
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.
The Marketing Authorisation Holder (MAH) shall ensure that any changes to the safety profile of the reference medicinal product requiring changes to the Risk Management Plan or Product Information are immediately implemented for Leflunomide Zentiva.
Imetnik dovoljenja za promet mora zagotoviti, da so vse spremembe ki se nanašajo na varnostni profil referenčnega zdravila in zadevajo spremembe Načrta za obvladovanje tveganja (RMP) ali informacije o zdravilu takoj usklajene z zdravilom Leflunomid Zentiva.
Leflunomide can be administered with food, since the extent of absorption is comparable in the fed and fasting state.
Leflunomid se lahko jemlje s hrano, ker je obseg absorpcije na poln in prazen želodec primerljiv.
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.
However, the minor metabolite TFMA (4-trifluoromethylaniline) caused clastogenicity and point mutations in vitro, whilst insufficient information was available on its potential to exert this effect in vivo.
Toda eden od stranskih presnovkov, TFMA (4-trifluorometilanilin) je in vitro povzročil klastogenost in točkaste mutacije; za oceno možnosti za pojav tega učinka in vivo pa ni na voljo dovolj informacij.
Co-administration of teriflunomide with leflunomide is not recommended, as leflunomide is the parent compound of teriflunomide.
Teriflunomida in leflunomida ni priporočljivo uporabljati hkrati, ker je leflunomid matična spojina teriflunomida.
The only plasma-radiolabelled metabolite detected was A771726.
Edini radioaktivno označeni presnovek, ki so ga zaznali v plazmi, je bil A771726.
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).
• Patients with impairment of liver function.
• Bolniki z okvarjenim delovanjem jeter.
It is possible that rapidly lowering the blood level of the active metabolite, by instituting the drug elimination procedure described below, at the first delay of menses may decrease the risk to the foetus from leflunomide.
Hitro zmanjšanje krvne koncentracije aktivnega presnovka s postopkom za eliminacijo zdravila (opisanim spodaj) takoj ob zamudi menstruacije morda lahko zmanjša tveganje leflunomida za plod.
At steady state plasma levels accumulate about 33- to 35-fold compared with single dose.
V stanju dinamičnega ravnotežja se plazemske koncentracije v primerjavi z enim samim odmerkom akumulirajo okrog 33- do 35-krat.
The recommended maintenance dose is leflunomide 10 mg to 20 mg once daily depending on the severity (activity) of the disease.
Priporočeni vzdrževalni odmerek je 10 do 20 mg leflunomida enkrat na dan, odvisno od resnosti (aktivnosti) obolenja.
No data are available regarding treatment of patients with hepatic impairment.
O zdravljenju bolnikov z okvaro jeter ni podatkov.
In vivo, it is rapidly and almost completely metabolised to A771726 which is active in vitro, and is presumed to be responsible for the therapeutic effect.
In vivo se leflunomid hitro in skoraj popolnoma presnovi v A771726, ki je aktiven in vitro in je domnevno odgovoren za terapevtski učinek.
In female mice an increased incidence, dose-dependent, of bronchiolo-alveolar adenomas and carcinomas of the lung was noted.
Pri mišjih samicah je bilo ugotovljeno od odmerka odvisno zvečanje pogostnosti bronhioloalveolarnih adenomov in karcinomov pljuč.
Not known:
Neznani:
Serious undesirable effects might occur (e.g. hepatotoxicity, haematotoxicity or allergic reactions, see below), even if the treatment with leflunomide has been stopped.
Resni neželeni učinki (npr. hepatotoksični in hematotoksični učinki ali alergijske reakcije, glejte spodaj) se lahko pojavijo tudi po prekinitvi zdravljenja z leflunomidom.
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.
Leflunomide exhibits the best protective effects on animal models of autoimmune diseases when administered in the early phase of the disease progression.
Zaščitni učinek leflunomida je v živalskih modelih avtoimunskih bolezni najboljši, če je zdravilo uporabljeno v zgodnjem obdobju napredovanja bolezni.
Effect on repaglinide (CYP2C8 substrate)
Vpliv na repaglinid (substrat CYP2C8)