natgillin/translations-raw huggingface dataset:
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
če se pridobijo novi podatki, ki lahko vplivajo na trenutne podatke o varnosti, načrt farmakovigilance ali aktivnosti za zmanjševanje tveganja.
Leflunomide ratiopharm is not recommended for use in children and adolescents below 18 years of age.
Uporaba zdravila Leflunomid ratiopharm ni priporočljiva pri otrocih in mladostnikih, ki so mlajši od 18 let.
Tablet 30 tablets 100 tablets
tableta 30 tablet 100 tablet
Leflunomide ratiopharm 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 ratiopharm 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).
3 days.
6 mesecev.
• Patients with moderate to severe renal insufficiency, because insufficient clinical experience is available in this patient group,
• Bolniki z zmerno do hudo ledvično insuficienco, ker v tej skupini ni dovolj kliničnih izkušenj,
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 prizadenejo celotno telo, vključujejo izgubo apetita, povišano telesno temperaturo, izgubo energije in anemijo (pomanjkanje rdečih krvnih celic).
If ALT (SGPT) elevations of more than 2-fold the upper limit of normal persist or if ALT elevations of more than 3fold the upper limit of normal are present, leflunomide must be discontinued and wash-out procedures initiated.
Če zvišanje ALT (SGPT) na več kot 2-kratno zgornjo mejo normalne vrednosti traja ali če presega 3-kratno zgornjo mejo normalne vrednosti, je uporabo leflunomida treba prekiniti in začeti postopke izpiranja.
Leflunomide ratiopharm with food, drink and alcohol
Zdravilo Leflunomid ratiopharm skupaj s hrano, pijačo in alkoholom
- if you are due to have a specific blood test (calcium level).
- če ste naročeni na specifično preiskavo krvi (raven kalcija).
In either case it should be confirmed by a blood test that Leflunomide ratiopharm has been sufficiently removed from your body and you should then wait for at least another month before you become pregnant.
V obeh primerih je treba s krvno preiskavo potrditi, da se je zdravilo Leflunomid ratiopharm dovolj odstranilo iz telesa, potem pa morate počakati vsaj še en mesec, preden zanosite.
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 ratiopharm from your body.
To obdobje je mogoče skrajšati na nekaj tednov z jemanjem določenih zdravil, ki pospešijo odstranjevanje zdravila Leflunomid ratiopharm iz telesa.
There have been reports of chronic overdose in patients taking Leflunomide ratiopharm 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 zdravilo Leflunomid ratiopharm v dnevnih odmerkih, do petkrat večjih od priporočenega dnevnega odmerka, in poročila o akutnem prevelikem odmerjanju pri odraslih in otrocih.
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 armakovigilančne aktivnosti, podrobno navedene v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2. dovoljenja za promet z zdravilom, in vseh nadaljnih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, dose reduction from 20 mg to 10 mg may be considered and monitoring must be performed weekly.
V primeru zvišanja ALT (SGPT) med 2- in 3-kratno zgornjo mejo normalne vrednosti je treba razmisliti o zmanjšanju odmerka z 20 mg na 10 mg in vsak teden opravljati kontrole.
Take the tablet with plenty of water.
Tablete vzemite z veliko količino vode.
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
v 60 dneh po pomembnem novem spoznanju (farmakovigilančnem ali povezanem z zmanjševanjem tveganja).
Results of animal fertility studies have shown no effect on male and female fertility, but adverse effects on male reproductive organs were observed in repeated dose toxicity studies (see section 5.3).
Rezultati študij plodnosti pri živalih ne kažejo učinkov na plodnost pri samcih ali samicah, vendar so v študijah toksičnosti pri ponavljajočih odmerkih opazili neželene učinke na moške reprodukcijske organe (glejte poglavje 5.3).
If you are pregnant or become pregnant while taking Leflunomide ratiopharm, the risk of having a baby with serious birth defects is increased.
Če ste noseči ali zanosite med jemanjem zdravila Leflunomid ratiopharm, je povečano tveganje, da se rodi otrok z resnimi prirojenimi okvarami.
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]).
Your doctor will carry out blood tests at regular intervals, before and during treatment with Leflunomide ratiopharm, to monitor your blood cells and liver.
Vaš zdravnik vam bo pred in med zdravljenjem z zdravilom Leflunomid ratiopharm v rednih presledkih opravljal preiskave krvi, da bo kontroliral vaše krvne celice in jetra.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst medicinal the product is on the market.
Imetnik dovoljenja za promet z zdravilom 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 čas trženja zdravila.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Leflunomide ratiopharm can make you feel dizzy which may impair your ability to concentrate and react.
Zdravilo Leflunomid ratiopharm lahko povzroči omotičnost, kar lahko prizadene sposobnost za koncentracijo in reagiranje.
Leflunomide ratiopharm can occasionally cause some problems with your blood, liver, lungs or nerves in your arms or legs.
Občasno lahko zdravilo Leflunomid ratiopharm povzroči nekatere krvne, jetrne, pljučne težave ali težave z živci v rokah in nogah.
Leflunomide ratiopharm is used to treat adult patients with active rheumatoid arthritis or with active psoriatic arthritis.
Zdravilo Leflunomid ratiopharm se uporablja za zdravljenje odraslih bolnikov z aktivnim revmatoidnim artritisom ali aktivnim psoriatičnim artritisom.
The tablets must be swallowed with sufficient amounts of liquid.
Pogoltniti jih je treba z zadostno količino tekočine.
Leflunomide ratiopharm may be taken with or without food.
Zdravilo Leflunomid ratiopharm lahko jemljete s hrano ali brez nje.
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 ratiopharm.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vse spremembe varnostnega profila referenčnega zdravila, zaradi katerih je treba spremeniti načrt za obvladovanje tveganja ali navodilo za uporabnika za zdravilo Leflunomid ratiopharm, takoj uvedene.
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 forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Če ste pozabili vzeti zdravilo Leflunomid ratiopharm Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, razen če ni že blizu čas za naslednjega.
Your doctor will also check your blood pressure regularly as Leflunomide ratiopharm can cause an increase in blood pressure.
Prav tako vam bo vaš zdravnik redno meril krvni tlak, saj ga zdravilo Leflunomid ratiopharm lahko zviša.
Omission of the loading dose may decrease the risk of adverse events (see section 5.1).
Izpustitev začetnaga odmerka lahko zmanjša tveganje za neželene učinke (glejte poglavje 5.1).
Men wishing to father a child should contact their doctor who may advise them to stop taking Leflunomide ratiopharm and take certain medicines to remove Leflunomide ratiopharm 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 ratiopharm in vzamejo določena zdravila za hitro in uspešno izločanje zdravila Leflunomid ratiopharm iz telesa.
Women of childbearing potential must not take Leflunomide ratiopharm without using reliable contraceptive measures.
Ženske v rodni dobi ne smejo jemati zdravila Leflunomid ratiopharm, če ne uporabljajo zanesljive kontracepcijske zaščite.
If you suspect that you are pregnant while taking Leflunomide ratiopharm or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Če med jemanjem zdravila Leflunomid ratiopharm ali v dveh letih po koncu zdravljenja posumite, da ste zanosili, morate o tem nemudoma obvestiti svojega zdravnika in opraviti nosečnostni test.
What Leflunomide ratiopharm is and what it is used for What you need to know before you take Leflunomide ratiopharm How to take Leflunomide ratiopharm Possible side effects
Kaj je zdravilo Leflunomid ratiopharm in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Leflunomid ratiopharm Kako jemati zdravilo Leflunomid ratiopharm
The efficacy of Leflunomide ratiopharm in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Učinkovitost zdravila Leflunomid ratiopharm so pri zdravljenju revmatoidnega artritisa dokazali v 4 kontroliranih preskušanjih (1 v II.
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
Drinking alcohol while taking Leflunomide ratiopharm may increase the chance of liver damage.
Pitje alkohola med jemanjem zdravila Leflunomid ratiopharm lahko poveča možnost poškodbe jeter.
The tablets must be swallowed whole with sufficient amounts of liquid.
Pogoltniti jih je treba cele, z zadostno količino tekočine.
- sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
- sulfasalazin za vnetno bolezen črevesa ali revmatoidni artritis,
The usual starting dosage of Leflunomide ratiopharm is 100 mg once daily for the first three days.
Običajni začetni odmerek zdravila Leflunomid ratiopharm je ena 100-mg tableta enkrat na dan prve tri dni.
40 ml HDPE-wide-necked bottle, with polypropylene screw cap with integrated desiccant container (white silica gel), containing either 30 or 100 film-coated tablets.
40-ml plastenka s širokim vratom in navojno zaporko z integriranim vsebnikom za sušilno sredstvo (beli silikagel), ki vsebuje bodisi 30 ali 100 filmsko obloženih tablet na vsebnik.
If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove Leflunomide ratiopharm rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Če test potrdi, da ste noseči, vam bo zdravnik morda predlagal zdravljenje z določenimi zdravili, ki hitro in uspešno odstranijo zdravilo Leflunomid ratiopharm iz vašega telesa, ker to lahko zmanjša tveganje za otroka.
The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Leflunomide ratiopharm are provided with a physician educational pack containing the following:
Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo Leflunomid ratiopharm dobili izobraževalno gradivo, ki vsebuje:
Film-coated tablet 30 film-coated tablets 100 film-coated tablets
filmsko obložena tableta 30 filmsko obloženih tablet 100 filmsko obloženih tablet
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE
The results of a population pharmacokinetic analysis of these trials have demonstrated that pediatric patients with body weights ≤40 kg have a reduced systemic exposure (measured by Css) of A771726 relative to adult rheumatoid arthritis patients (see section
Rezultati populacijske farmakokinetične analize teh preskušanj so pokazali, da je pri pediatričnih bolnikih s telesno maso 40 kg sistemska izpostavljenost A771726 (merjena s Css) manjša kot pri odraslih bolnikih z revmatoidnim artritisom (glejte poglavje 4.2).
Leflunomide ratiopharm contains the active substance leflunomide which belongs to a group of medicines called anti-rheumatic medicines.
Zdravilo Leflunomid ratiopharm vsebuje zdravilno učinkovino leflunomid, ki spada v skupino zdravil, ki jih imenujemo antirevmatična zdravila.
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.
Študija interakcij z leflunomidom in cimetidinom (nespecifičnim šibkim zaviralcem citokroma P450 (CYP)) in vivo ni pokazala pomembnega vpliva na izpostavljenost A771726.
severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• hude, včasih življenje ogrožujoče reakcije (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem).
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.
MN301 brez skupine s placebom in je omogočila 12-mesečno primerjavo leflunomida in sulfasalazina.
Do not take Leflunomide ratiopharm when you are breast-feeding, as leflunomide passes into the breast milk.
Ne jemljite zdravila Leflunomid ratiopharm, če dojite, saj leflunomid lahko prehaja v mleko.
Thereafter, the A771726 plasma concentration must be determined again after an interval of at least 14 days.
Potem je treba plazemsko koncentracijo A771726 znova izmeriti po intervalu vsaj 14 dni.
- 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
• zvečanje števila krvnih celic imenovanih eozinofilci (eozinofilija); blago zmanjšanje števila belih krvnih celic (levkopenija); zmanjšanje števila vseh krvnih celic (pancitopenija),
• The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
• O ugotovljenem tveganju za sinergistično hepato ali hemato toksičnost v povezavi s kombinirano terapijo z drugimi imunomodulirajočimi protirevmatičnimi zdravili (disease modifying antirheumatic drug (DMARD) zdravili (na primer metotreksat).
What Leflunomide ratiopharm is and what it is used for
Kaj je zdravilo Leflunomid ratiopharm in za kaj ga uporabljamo
Leflunomide ratiopharm is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Zdravilo Leflunomid ratiopharm je kontraindicirano pri bolnikih s hudo hipoproteinemijo ali okvarjenim delovanjem jeter (glejte poglavje 4.3).
This medicinal product contains lactose and soya lecithin.
To zdravilo vsebuje laktozo in sojin lecitin.
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 populacija 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.
A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n = 121) with early RA, who received either 20 mg or 100 mg of leflunomide in two parallel groups during the initial three day double blind period.
Randomizirana študija je ocenila delež odzivnosti pri bolnikih (n = 121), ki še niso bili zdravljeni z imunomodulirajočimi protirevmatičnimi zdravili, so imeli zgoden RA in so med uvodnim tridnevnim dvojno slepim obdobjem prejemali bodisi 20 mg bodisi 100 mg leflunomida v dveh vzporednih skupinah.
• For rheumatoid arthritis: 10 or 20 mg Leflunomide ratiopharm once daily, depending on the severity of the disease.
• za zdravljenje revmatoidnega artritisa: 10 ali 20 mg zdravila Leflunomid ratiopharm enkrat na dan, odvisno od resnosti obolenja.
• active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD).
• aktivnim revmatoidnim artritisom kot imunomodulirajoče antirevmatično zdravilo ("disease modifying antirheumatic drug" (DMARD))
Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide ratiopharm, as you need to ensure that all traces of Leflunomide ratiopharm have left your body before trying to become pregnant.
Povejte svojemu zdravniku, če nameravate po prenehanju zdravljenja z zdravilom Leflunomid ratiopharm zanositi, saj se morate, preden poskušate zanositi, prepričati, da v telesu ni več ostankov zdravila Leflunomid ratiopharm.
All elevations resolved, 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
V vseh primerih je zvišanje izginilo, pri 2 bolnikih ob nadaljevanju uporabe obeh zdravil in pri 3 po opustitvi leflunomida.
In case of severe haematological reactions, including pancytopenia, Leflunomide ratiopharm and any concomitant myelosuppressive treatment must be discontinued and a leflunomide washout procedure initiated.
V primeru hudih hematoloških reakcij, vključno s pancitopenijo, je treba prekiniti uporabo zdravila Leflunomid ratiopharm in morebitnih drugih mielosupresivnih zdravil ter začeti postopek izpiranja leflunomida.
Haupt Pharma Münster GmbH Schleebrüggenkamp 15 48159 Münster
Haupt Pharma Münster GmbH Schleebrüggenkamp 15
• Hypersensitivity (especially previous Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) to the active substance, to the principal active metabolite teriflunomide, to peanut or soya or to any of the excipients listed in section 6.1.
• Preobčutljivost (posebno s predhodnim Stevens-Johnsonovim sindromom, toksično epidermalno nekrolizo, multiformnim eritemom) na zdravilno učinkovino, osnovni aktivni presnovek teriflunomid, zemeljske oreščke ali sojo ali katero koli pomožno snov, navedeno v poglavju 6.1.
Therefore, when co-administered with substrates of OAT3, such as cefaclor, benzylpenicillin, ciprofloxacin, indomethacin, ketoprofen, furosemide, cimetidine, methotrexate, zidovudine, caution is recommended.
Zato je med sočasno uporabo s substrati OAT3, kakršni so cefaklor, benzilpenicilin, ciprofloksacin, indometacin,
hypouricemia
hipourikemija
Reproductive system and breast disorders Not known:
Motnje reprodukcije in dojk Neznani:
Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable
Študije s hemodializo in kontinuirano ambulantno peritonealno dializo (CAPD) kažejo, da A771726, primarnega presnovka leflunomida, ni mogoče odstraniti z dializo.
• For psoriatic arthritis: 20 mg Leflunomide ratiopharm once daily.
• za zdravljenje aktivnega psoriatičnega artritisa: 20 mg zdravila Leflunomid ratiopharm enkrat na dan.
Each film-coated tablet contains 76 mg of lactose and 0.06 mg of soya lecithin.
Ena filmsko obložena tableta vsebuje 76 mg laktoze in 0,06 mg sojinega lecitina.
Contents of the pack and other information What Leflunomide ratiopharm contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Leflunomid ratiopharm
In the phase III trials, the ACR response rates for leflunomide 20 mg/day versus placebo were 54.6% vs. 28.6% (study MN301), and 49.4% vs. 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.
Po 12 mesecih aktivnega zdravljenja so bili deleži odzivov po ACR pri bolnikih na leflunomidu 52,3 % (študiji MN301/303), 50,5 % (študija MN302) in 49,4 % (študija US301) v primerjavi s 53,8 % (študiji MN301/303) pri bolnikih na sulfasalazinu ter 64,8 % (študija MN302) oz. 43,9 % (študija US301) pri bolnikih na metotreksatu.
If you take more Leflunomide ratiopharm than you should, contact your doctor or get other medical advice.
Če ste vzeli večji odmerek zdravila Leflunomid ratiopharm, kot bi smeli Če vzamete več zdravila Leflunomid ratiopharm, kot bi smeli, se posvetujte s svojim zdravnikom ali poiščite zdravniško pomoč.
Peripheral neuropathy
(periferna nevropatija).
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.
BCRP (npr. metotreksata, topotekana, sulfasalazina, daunorubicina, doksorubicina) in družine OATP, zlasti zaviralcev HMG-CoA-reduktaze (npr. simvastatina, atorvastatina, pravastatina, metotreksata, nateglinida, repaglinida, rifampicina).
Each film-coated tablet contains 152 mg of lactose and 0.12 mg of soya lecithin.
Ena filmsko obložena tableta vsebuje 152 mg laktoze in 0,12 mg sojinega lecitina.
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.
(npr. duloksetin, alosetron, teofilin in tizanidin), ker lahko zmanjša učinkovitost teh zdravil.
Marketing Authorisation Holder ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Imetnik dovoljenja za promet ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm
Leflunomide ratiopharm is contraindicated in pregnancy (see section
Zdravilo Leflunomid ratiopharm je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
Leflunomide ratiopharm 10 mg film-coated tablets are white to almost white and round with a diameter of about 6 mm.
Leflunomid ratiopharm 10 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike s premerom približno 6 mm.