natgillin/translations-raw huggingface dataset:
The Applicant committed to update the Summary of Product Characteristics and Package Leaflet in accordance to the outcome of the ongoing SPC harmonisation procedure under Article 30 of Directive 2001/83/EC with the reference product Protium and associated names. 
POGOJI V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA Predlagatelj se je zavezal, da bo v skladu s členom 30 Direktive 2001/83/ES in glede na rezultat postopka usklajevanja povzetka glavnih značilnosti zdravila, ki trenutno še poteka, posodobil povzetek glavnih značilnosti zdravila in navodilo za uporabo z referenčnim zdravilom Protium in povezanimi imeni.
LoOI-Q2: The Applicant was requested to state the batch size of the batch used for the new bioequivalence study for the test product. 
Seznam izrazitih zadržkov - V2: Predlagatelj je bil pozvan, naj navede velikost serije za serijo, uporabljeno v novi bioekvivalenčni študiji testnega zdravila.
During the DCP a CMS raised major objections concerning the bioequivalence with the originator under fed conditions. 
Med decentraliziranim postopkom je ena izmed zadevnih držav članic izrazila precejšnje zadržke glede bioekvivalence pri uporabi originatorskega zdravila po zaužitju hrane.
Standard criteria for bioequivalence were used i.e. the 90 % CI for the AUC and Cmax ratios must lie within the accepted range of 80.00-125.00. 
Uporabljena so bila standardna merila bioekvivalence tj. 90 % intervalov zaupanja za razmerja AUC in Cmaks mora biti v sprejemljivem razponu
Netherlands Bluefish Pharmaceuticals AB Torsgatan 11 
Holandsko Bluefish Pharmaceuticals AB Torsgatan 11
Germany Bluefish Pharmaceuticals AB Torsgatan 11 
Portugalska Bluefish Pharmaceuticals AB Torsgatan 11
Hungary 
Danska
MA (EU) number (Invented) name Strength Pharmaceutical form 
(Izmišljeno) ime Jakost Farmacevtska oblika
150 mg Powder for concentrate for solution for infusion 
150 mg prašek za koncentrat za raztopino za infundiranje intravenska uporaba
600 mg Solution for injection 
600 mg raztopina za injiciranje subkutana uporaba
Intravenous use Vial (glass) 
Pot uporabe Stična ovojnina
• At the request of the European Medicines Agency 
• na zahtevo Evropske Agencije za zdravila.
- If you have a serious infection. 
- če imate resno okužbo.
If this happens to you, do not drive or machines. 
Če se vam to zgodi, ne vozite oziroma ne upravljajte s stroji.
Folate supplementation was optional and only used in 10 % of patients. 
Dodajanje folata je bilo fakultativno in uporabljeno le pri 10% bolnikov.
• every two weeks during the first six months of treatment, and 
• (vsaka dva tedna) v prvih 6 mesecih zdravljenja in
In addition, an updated RMP should be submitted 
Poleg tega je treba posodobljeni RMP vložiti,
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.
This should be confirmed by a blood test. 
To potrdite s krvno preiskavo.
For more information on these, please read section 4 (Possible Side Effects). 
Za več informacij o tem, prosimo preberite poglavje 4 (Možni neželeni učinki).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 March 2011 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja: 10. 3. 2011
It may also cause some serious allergic reactions, or increase the chance of a severe infection. 
Prav tako lahko povzroči nekatere resne alergijske reakcije ali poveča možnost nastanka hudega vnetja.
The risk of tuberculosis should be considered. 
Potrebno je upoštevati tveganje za pojav tuberkuloze.
4.5 Interaction with other medicinal products and other forms of interaction Interactions studies have only been performed in adults. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študije medsebojnega delovanja so izvedli le pri odraslih.
- If you suffer from a severe condition that affects your immune system e.g. AIDS. 
- če trpite za resnim stanjem, ki vpliva na vaš imunski sistem (npr. AIDS).
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed. 
Vzemite to navodilo za uporabo, preostanek tablet in vsebnik s seboj v bolnišnico ali k zdravniku, da bodo vedeli, katere tablete ste pogoltnili.
No dosage adjustment is required in patients above 65 years of age. 
Prav tako odmerka ni treba prilagajati pri bolnikih, starejših od 65 let.
Pharmacokinetic data in elderly (> 65 years) are limited but consistent with pharmacokinetics in 
Farmakokinetični podatki pri starejših (> 65 let) so omejeni, vendar skladni s farmakokinetiko pri mlajših odraslih.
Leflunomide Teva is not recommended for use in children and adolescents below 18 years of age. 
Uporaba zdravila Leflunomid Teva ni priporočljiva pri otrocih in mladostnikih, ki so mlajši od 18 let.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske Agencije za zdravila http://www.ema.europa.eu/
Leflunomide Teva with food, drink and alcohol 
Zdravilo Leflunomid Teva skupaj s hrano, pijačo in alkoholom
Some people will notice further improvement after 4 to 6 months of treatment. 
Nekateri bolniki lahko nadaljnje izboljšanje občutijo po 4 do 6 mesecih zdravljenja.
- If you have ever had tuberculosis or interstitial lung disease (lung disease). 
- če ste kdaj imeli tuberkulozo ali intersticijsko bolezen pljuč (pljučna bolezen),
Not known side effects (frequency cannot be estimated from the available data): 
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being 
• v 60 dneh po pomembnem novem spoznanju (farmakovigilančnem ali povezanem z zmanjševanjem tveganja).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report 
V skladu s smernico CHMP o sistemih upravljanja s tveganji za zdravila za uporabo v humani medicini je treba posodobljeni RMP predložiti hkrati z naslednjim rednim dopolnjenim poročilom o varnosti zdravila (PSUR).
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch. 
V natisnjenem navodilu za uporabo mora biti navedeno ime in naslov izdelovalca odgovornega za sproščanje zadevne serije.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli zdravilo.
• Patients with moderate to severe renal insufficiency, because insufficient clinical experience is 
• Bolniki z zmerno do hudo ledvično insuficienco, ker v tej skupini ni dovolj kliničnih izkušenj.
Do not use this medicine after the expiry date that is stated on the outer carton or foil after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini poleg oznake EXP.
This leaflet was last revised in {MM/YYYY}. 
Navodilo je bilo nazadnje revidirano dne MM/YYYY.
- Severe allergic reaction. 
blage alergijske reakcije
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.
The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months. 
Terapevtski učinek se ponavadi pojavi po 4 do 6 tednih in se lahko dodatno povečuje še do 4 do 6
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). 
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in do dve leti po prenehanju zdravljenja (glejte tudi “čakalno obdobje” spodaj), ali do 11 dni po prenehanju zdravljenja
Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anemia (lack of red blood cells). 
Dodatni simptomi, ki prizadanejo celotno telo, vključujejo izgubo apetita, povišano telesno temperaturo, izgubo energije in anemijo (pomanjkanje rdečih krvnih celic).
If Leflunomide Teva has been sufficiently removed from your body, you should wait at least another 6 weeks before you become pregnant. 
Če se je zdravilo Leflunomid Teva dovolj odstranilo iz telesa, morate počakati vsaj še 6 tednov, preden zanosite.
The unbound fraction of A771726 is about 0.62 %. 
Nevezana frakcija A771726 je približno 0,62%.
For washout procedures and other recommended actions in case of desired or unintended pregnancy 
Za postopke izpiranja in druge priporočene ukrepe v primeru načrtovane ali nenačrtovane nosečnosti glejte poglavje 4.6.
Therefore, do not breast-feed during treatment. 
Zato med zdravljenjnem ne smete dojiti.
If you are pregnant, your doctor will discuss with you the risks to the pregnancy. 
Če test potrdi, da ste noseči, se bo zdravnik pogovoril z vami o tveganjih za nosečnost.
Discuss with your doctor to find out if any medicine you are taking is broken down by CYP2C9. 
Pogovorite se z vašim zdravnikom, da boste ugotovili ali že jemljete zdravila, ki se presnavljajo z encimom CYP2C9.
The risk of its occurrence is increased in patients with a history of interstitial lung disease. 
Tveganje za njen pojav je povečano pri bolnikih z anamnezo intersticijske bolezni pljuč.
- If you have very low levels of protein in your blood (hypoproteinaemia). 
- če imate zelo znižano število beljakovin v krvi (hipoproteinemija).
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare 
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).
• before initiation of leflunomide, 
• pred uvedbo leflunomida
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.
- An increase of lactate dehydrogenase (a blood enzyme). 
- zvišanje laktat-dehidrogenaze (encim v krvi),
Magyarország Teva Magyarország Zrt Tel.: +36 1 288 64 00 
Teva Magyarország Zrt Tel.: +36 1 288 64 00
There have been reports of chronic overdose in patients taking leflunomide at daily doses up to five times the recommended daily dose, and reports of acute overdose in adults and children. 
Obstajajo poročila o kroničnem prevelikem odmerjanju pri bolnikih, ki so jemali leflunomid v dnevnih odmerkih, do petkrat večjih od priporočenega dnevnega odmerka, in poročila o akutnem prevelikem odmerjanju pri odraslih in otrocih.
Pulmonary symptoms, such as cough and dyspnoea, may be a reason for discontinuation of the therapy and for further investigation, as appropriate. 
Pljučni simpotmi, npr. kašelj in dispneja, so lahko razlog za prekinitev terapije in nadaljnjo preiskavo, če je to potrebno.
Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma 
Zdravnike in bolnike je potrebno obvestiti, da je na razpolago za ta namen posvetovalna služba za posredovanje informacij o laboratorijskem testiranju plazemskih vrednosti leflunomida.
In vitro studies indicate that A771726 inhibits cytochrome P4502C9 (CYP2C9) activity. 
Študije in vitro kažejo, da A771726 zavira aktivnost citokroma P4502C9 (CYP2C9).
• The risk of infections, including opportunistic infections, and the contraindication for use in 
• O tveganju za infekcije, vključno z oportunističnimi infekcijami in kontraindikacijami za uporabo pri imunsko oslabelih bolnikih.
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP). 
Imetnik dovoljenja za promet bo izvedel farmakovigilančne aktivnosti, podrobno navedene v načrtu farmakovigilance, sprejetem v RMP predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh morebitnih poznejšimi posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Do not take Leflunomide Teva if you are pregnant, or think you may be pregnant. 
Ne jemljite zdravila Leflunomid Teva če ste ali mislite, da ste noseči.
If you take more Leflunomide Teva than you should If you or someone else swallows a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. 
Če ste vzeli večji odmerek zdravila Leflunomid Teva, kot bi smeli Če ste vi ali kdo drug, pogoltnil več tablet naenkrat, ali če mislite, da je otrok pogoltnil tableto, se nemudoma obrnite na oddelek nujne pomoči najbližje bolnišnice ali obvestite svojega zdravnika.
• Patients with significantly impaired bone marrow function or significant anaemia, leucopenia, 
• Bolniki z občutno okvarjenim delovanjem kostnega mozga ali izrazito anemijo, levkopenijo,
- If you suffer from moderate to severe kidney problems. 
- če imate zmerne do hude težave z ledvicami.
Leflunomide Teva tablets can be taken with or without food. 
Tablete zdravila Leflunomid Tevalahko vzamete z ali brez hrane.
A771726 displaced ibuprofen, diclofenac and tolbutamide but the unbound fraction of these drugs 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%.
If you are still able to have a child, you must not take Leflunomide Teva without using reliable contraception for at least 2 years after treatment. 
Če ste še vedno v rodni dobi ne smete jemati zdravila Leflunomid Teva najmanj 2 leti po koncu zdravljenja, če ne uporabljajo zanesljive kontracepcijske zaščite.
- If you are pregnant, think you may be pregnant, or are breast-feeding. 
- če ste noseči, mislite, da bi lahko bili noseči, ali dojite.
The MAH must ensure that the system of pharmacovigilance, as presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market. 
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, predložen v modulu 1.8.1 dovoljenja za promet z zdravilom, vzpostavljen in deluje preden da zdravilo v promet, in ves častrženja zdravila.
pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/l), eosinophilia 
pancitopenija (verjetno zaradi antiproliferacijskega mehanizma), levkopenija (levkociti < 2 x 109/l), eozinofilija
The enzymes involved in the metabolism of leflunomide and its metabolites are not exactly known. 
Encimi, vključeni v presnovo leflunomida in njegovih presnovkov, niso natančno znani.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
C. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
Interstitial lung disease is a potentially fatal disorder, which may occur acutely during therapy. 
Intersticijska bolezen pljuč je potencialno usodna bolezen, ki se med zdravljenjem lahko pojavi akutno.
The doctor that starts you on Leflunomide Teva and supervises you while you are on it should be experienced in the treatment of rheumatoid arthritis. 
Zdravnik, ki je pri vas začel zdravljenje z zdravilom Leflunomid Teva in vas spremlja med zdravljenjem, mora biti izkušen v zdravljenju revmatoidnega artritisa.
neutropenia or thrombocytopenia due to causes other than rheumatoid arthritis. 
nevtropenijo ali trombocitopenijo, katerih vzrok ni revmatoidni artritis.
ALT (SGPT) must be checked before initiation of leflunomide and at the same frequency as the complete blood cell count (every two weeks) during the first six months of treatment and every 
ALT (SGPT) je treba preveriti pred uvedbo leflunomida in z enako pogostnostjo kot celotno krvno sliko (vsaka dva tedna) v prvih 6 mesecih zdravljenja, potem pa vsakih 8 tednov.
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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product 
Če vam je vaš zdravnik povedal, da ne prenašate določenih sladkorjev, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
Leflunomide Teva tablets should be swallowed whole with sufficient amounts of liquid. 
Način uporabe Tablete Leflunomid Teva je treba pogoltniti cele, z zadostno količino tekočine.
The PSUR cycle of Leflunomide Teva will correspond to the one attributed to the reference medicinal product, Arava, until otherwise specified. 
Cikel PSUR za zdravilo Leflunomid Teva bo enak tistem za referenčno zdravilo Arava, dokler ne bo določeno drugače.
Drinking alcohol while taking Leflunomide Teva may increase the chance of liver damage. 
Pitje alkohola med jemanjem zdravila Leflunomid Teva lahko poveča možnost poškodbe jeter.
Respiratory reactions 
Jetrne reakcije
- If you have bone marrow problems, or if you have low numbers of red or white blood cells or a reduced number of blood platelets, due to causes other than rheumatoid or psoriatic arthritis. 
- če imate kakršnekoli težave z vašim kostnim mozgom ali imate v krvi zmanjšano število rdečih ali belih krvnih celic ali zmanjšano število krvnih ploščic, zaradi drugih razlogov kot sta revmatoidni ali psoriatični artritis.
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.
- Yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice). 
- porumenelost kože ali beločnic zaradi težav z jetri ali krvjo (zlatenica).
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 antirevmatično zdravilo (npr. metotreksat) brez postopka izpiranja (glejte spodaj) celo dolgo časa po prehodu povzroči dodatna tveganja (tj. kinetične interakcije, organotoksične učinke).
Leflunomide Teva 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). 
Pediatrična populacija Zdravila Leflunomid Teva ni priporočljivo uporabljati za bolnike do 18. leta starosti, ker učinkovitost in varnost pri juvenilnem revmatoidnem artritisu (JRA) nista ugotovljeni (glejte poglavji 5.1 in 5.2).
The efficacy of leflunomide in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III). 
Učinkovitost zdravila Leflunomid Teva so pri zdravljenju revmatoidnega artritisa dokazali v 4 kontroliranih preskušanjih (1 v II.
The concentration may be expected to decrease below 0.02 mg/l about 2 years after stopping the treatment 
Znižanje koncentracije pod 0,02 mg/l je mogoče pričakovati približno 2 leti po prenehanju zdravljenja z leflunomidom.
A more rapid elimination of A771726 was observed in haemodialysis subjects which was not due to extraction of drug in the dialysate. 
Hitrejša eliminacija A771726 je bila opažena pri osebah na hemodializi, kar pa ni bila posledica izločanja zdravila v dializat.
- If you switch to another medicine to treat your rheumatoid arthritis or if you have recently taken medicines that may be harmful to your liver or blood, your doctor may advise you to take certain medicines to speed up the removal of Leflunomide Teva from your body or may closely monitor you when you start taking Leflunomide Teva. 
- če ste prej jemali druga zdravila za zdravljenje revmatoidnega artritisa ali če ste pred kratkim jemali zdravila, ki lahko škodujejo vašim jetrom ali krvi, vam bo zdravnik morda predlagal, da vzamete zdravila, ki bodo pospešila izločanje zdravilo Leflunomid Teva iz vašega telesa ali vas bo natančno spremljal ob začetku jemanja zdravila Leflunomid Teva.
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.
What Leflunoamide Teva is and what it is used for Leflunomide Teva belongs to a group of medicines called anti-rheumatic medicines. 
Kaj je zdravilo Leflunomid Teva in za kaj ga uporabljamo Zdravilo Leflunomid Teva spada v skupino zdravil, ki jih imenujemo antirevmatična zdravila.
Read all of this leaflet carefully before you start taking this medicine because it contains 
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne informacije!
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
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.
Each tablet contains 194.5 mg of lactose monohydrate and 6.25 mg anhydrous lactose. 
Ena tableta vsebuje 194,5 mg laktoze monohidrata in 6,25 mg brezvodne laktoze.
Some vaccinations should not be given while taking Leflunomide Teva, and for a certain amount of time after stopping treatment. 
Določenih cepiv se med uporabo zdravila Leflunomid Teva in določen čas po koncu tega zdravljenja ne sme uporabljati.
Each tablet contains 97.25 mg of lactose monohydrate and 3.125 mg anhydrous lactose. 
Ena tableta vsebuje 97,25 mg laktoze monohidrata in 3,125 mg brezvodne laktoze.
leucopenia (leucocytes > 2 G/l) 
levkopenija (levkociti > 2 x 109/l)
6.6 Special precautions for disposal No special requirements for disposal. 
Ni posebnih zahtev za odstranjevanje.
It has immunomodulating/immunosuppressive characteristics, acts as an antiproliferative agent, and displays anti-inflammatory properties. 
Učinkuje imunomodulacijsko/imunosupresivno, deluje antiproliferacijsko in protivnetno.