FrancophonIA/ELRC3.0 huggingface dataset:
English: • Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/L (see section 4.6).
Slovenian: • Nosečnice in ženske v rodni dobi, ki med zdravljenjem z leflunomidom ne uporabljajo zanesljive kontracepcije; to velja tudi po zdravljenju, vse dokler je plazemska koncentracija aktivnega presnovka nad 0,02 mg/l (glejte poglavje 4.6).
English: Imprint on one side: ZBN.
Slovenian: Na eni strani imajo napis: ZBN.
English: If you suspect that you are pregnant while taking Leflunomide Zentiva or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test.
Slovenian: Če med jemanjem zdravila Leflunomid Zentiva ali v dveh letih po koncu zdravljenja posumite, da ste zanosili, morate o tem nemudoma obvestiti svojega zdravnika in opraviti nosečnostni test.
English: Adverse events consistent with the safety profile for leflunomide were: abdominal pain, nausea, diarrhoea, elevated liver enzymes, anaemia, leucopenia, pruritus and rash.
Slovenian: Neželeni učinki, skladni z varnostnim profilom leflunomida, so bili: bolečine v trebuhu, navzeja, driska, zvišani jetrni encimi, anemija, levkopenija, srbenje in izpuščaj.
English: Leflunomide 20 mg/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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: The metabolic biotransformation of leflunomide to A771726 and subsequent metabolism of A771726 is not controlled by a single enzyme and has been shown to occur in microsomal and cytosolic cellular fractions.
Slovenian: Presnovne biotransformacije leflunomida v A771726 in nadaljnje presnove A771726 ne uravnava en sam encim in dokazano je, da se pojavi v mikrosomski in citosolski celični frakciji.
English: All of these also resolved, 2 with continuation of both medicinal products and 3 after discontinuation of leflunomide.
Slovenian: Tudi pri teh je izginilo, pri 2 ob nadaljevanju uporabe obeh zdravil in pri 3 po opustitvi leflunomida.
English: Animal pharmacology
Slovenian: Farmakologija pri živalih
English: 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.
Slovenian: Študija interakcij z leflunomidom in cimetidinom (nespecifičnim šibkim zaviralcem citokroma P450) in vivo ni pokazala pomembnega vpliva na izpostavljenost A771726.
English: If a patient taking Leflunomide Zentiva develops a peripheral neuropathy, consider discontinuing Leflunomide Zentiva therapy and performing the drug elimination procedure (see section 4.4).
Slovenian: Če bolnik med jemanjem zdravila Leflunomid Zentiva razvije periferno nevropatijo, je potrebno razmisliti o ukinitvi terapije z zdravilom Leflunomid Zentiva in o izvajanju postopka za eliminacijo zdravila (glejte poglavje 4.4).
English: cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Slovenian: kožni eritematozni lupus, postulozna psoriaza ali njeno poslabšanje, neželena reakcija z eozinofilijo in sistemskimi simptomi (sindrom DRESS)
English: Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable.
Slovenian: Študije s hemodializo in kontinuirano ambulantno peritonealno dializo (CAPD) kažejo, da A771726, primarnega presnovka leflunomida, ni mogoče odstraniti z dializo.
English: If the patient is already receiving nonsteroidal anti-inflammatory drugs (NSAIDs) and/or corticosteroids, these may be continued after starting leflunomide.
Slovenian: Če bolnik že prejema nesteroidna protivnetna zdravila (NSAIDs - nonsteroidal anti-inflammatory drugs), kortikosteroide ali oboje, jih lahko po začetku jemanja leflunomida uporablja še naprej.
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Leflunomide Zentiva are provided with a physician educational pack containing the following:
Slovenian: Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo Leflunomid Zentiva dobili izobraževalno gradivo, ki vsebuje:
English: Concomitant administration of hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) is not advisable.
Slovenian: Sočasna uporaba hepatotoksičnih ali hematotoksičnih imunomodulirajočih protirevmatičnih zdravil (npr. metotreksata) ni priporočljiva.
English: Reliable contraception during treatment with leflunomide should also be guaranteed.
Slovenian: Zato je tudi med njihovim zdravljenjem z leflunomidom potrebna zanesljiva kontracepcija.
English: Male patients should be aware of the possible male-mediated foetal toxicity.
Slovenian: Moški bolniki se morajo zavedati možnih toksičnih učinkov za plod, ki jih lahko posreduje moški.
English: Therefore, when warfarin is co-administered, close INR follow-up and monitoring is recommended.
Slovenian: Zato so med sočasno uporabo varfarina priporočljivi skrbno spremljanje in kontrole INR.
English: The extent of leflunomide absorption is not affected if it is taken with food.
Slovenian: Zaužitje leflunomida s hrano ne vpliva na obseg njegove absorpcije.
English: The principal faecal component was A771726.
Slovenian: Glavna sestavina blata je A771726.
English: Aluminium / Aluminium blister.
Slovenian: Pretisni omot: Aluminij/aluminij pretisni omot.
English: Therefore, closer monitoring of liver enzymes and haematological parameters is recommended in the initial phase after switching.
Slovenian: V začetnem obdobju po zamenjavi je zato priporočljivo natančnejše spremljanje jetrnih encimov in hematoloških parametrov.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite katerekoli neželene učinke, ki niso navedeni v tem navodilu.
English: 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.
Slovenian: 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.
English: Leflunomide Zentiva is contraindicated in patients with severe hypoproteinaemia or impairment of liver function (see section 4.3).
Slovenian: Zdravilo Leflunomid Zentiva je kontraindicirano pri bolnikih s hudo hipoproteinemijo ali okvarjenim delovanjem jeter (glejte poglavje 4.3).
English: A. LABELLING
Slovenian: OZNAČEVANJE
English: Infections and infestations Rare:
Slovenian: Infekcijske in parazitske bolezni Redki:
English: Pack sizes: 30 and 100 film-coated tablets.
Slovenian: Velikosti pakiranj: 30 in 100 filmsko obloženih tablet.
English: Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide Zentiva, as you need to ensure that all traces of Leflunomide Zentiva have left your body before trying to become pregnant.
Slovenian: Povejte svojemu zdravniku, če nameravate po prenehanju zdravljenja z zdravilom Leflunomid Zentiva zanositi, saj se morate, preden poskušate zanositi prepričati, da v telesu ni več ostankov zdravila Leflunomid Zentiva.
English: Thereafter, the A771726 plasma concentration must be determined again after an interval of at least 14 days.
Slovenian: Potem je treba koncentracijo A771726 v plazmi znova izmeriti po intervalu vsaj 14 dni.
English: The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy.
Slovenian: Aktivni presnovek leflunomida, A771726, domnevno povzroča resne okvare ploda, če ga jemljejo nosečnice.
English: Leflunomide Zentiva is contraindicated in pregnancy(see section 4.3).
Slovenian: Zdravilo Leflunomid Zentiva je kontraindicirano med nosečnostjo (glejte poglavje 4.3).
English: The use of leflunomide with antimalarials used in rheumatic diseases (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents including Tumour Necrosis Factor alpha-Inhibitors has not been adequately studied up to now in randomised trials (with the exception of methotrexate, see section 4.5).
Slovenian: Uporaba leflunomida z antimalariki, ki se uporabljajo pri revmatičnih boleznih (npr. s klorokinom ali hidroksiklorokinom), intramuskularnim ali peroralnim zlatom, D-penicilaminom, azatioprinom in drugimi imunosupresivnimi zdravili, vključno z zaviralci tumorje nekrotizirajočim faktorjem alfa, doslej v randomiziranih preskušanjih ni bila zadosti raziskana (z izjemo metotreksata, glejte poglavje 4.5).
English: Uncommon: hypokalaemia, hyperlipidemia, hypophosphataemia Rare:
Slovenian: hipokaliemija, hiperlipidemija, hipofosfatemija
English: It has been shown in man that administration of an oral suspension of activated powdered charcoal or colestyramine leads to a rapid and significant increase in A771726 elimination rate and decline in plasma concentrations (see section 4.9).
Slovenian: Uporaba peroralne suspenzije aktivnega oglja v prahu ali holestiramina pri ljudeh vodi do hitrega in pomembnega povečanja hitrosti izločanja A771726 in zmanjša njegovo koncentracijo v plazmi (glejte poglavje 4.9).
English: 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% for 25 mg/day.
Slovenian: 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.
English: Blood and lymphatic system disorders Common:
Slovenian: Bolezni krvi in limfatičnega sistema Pogosti:
English: Ask your pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne potrebujete več, se posvetujte s farmacevtom.
English: Alanine Aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency:
Slovenian: Alanin-aminotransferazo (ALT) oz. serumsko glutamat-piruvat-transferazo (SGPT) in celotno krvno sliko, vključno z diferencialno belo krvno sliko in številom trombocitov, je treba preveriti sočasno in z enako pogostnostjo:
English: pancreatitis
Slovenian: pankreatitis
English: If you are already taking a nonsteroidal anti-inflammatory drug (NSAID) and/or corticosteroids, you may continue to take them after starting Leflunomide Zentiva.
Slovenian: Če že jemljete nesteroidna protivnetna zdravila (NSAID) ali kortikosteroide ali oboje, lahko z njimi nadaljujete tudi po začetku uporabe zdravila Leflunomid Zentiva.
English: It is recommended that patients receiving leflunomide are not treated with colestyramine or activated powdered charcoal because this leads to a rapid and significant decrease in plasma A771726 (the active metabolite of leflunomide; see also section 5) concentration.
Slovenian: Bolniki, ki dobivajo leflunomid, naj ne jemljejo holestiramina ali aktivnega oglja v prahu, ker hitro in pomembno znižata plazemsko koncentracijo A771726 (aktivnega presnovka leflunomida; glejte tudi poglavje 5).
English: Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects.
Slovenian: Nedavno ali sočasno zdravljenje s hepatotoksičnimi ali hematotoksičnimi imunomodulirajočimi protirevmatičnimi zdravili (npr. z metotreksatom) lahko poveča tveganje za resne neželene učinke; zato je treba pri uvedbi leflunomida skrbno pretehtati korist in tveganje tega zdravljenja.
English: These processes may be affected by hepatic dysfunction.
Slovenian: Jetrna disfunkcija lahko vpliva na ta dogajanja.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Alanine aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency:
Slovenian: Alanin-aminotransferazo (ALT) (oz. serumsko glutamat-piruvat-transferazo SGPT) in celotno krvno sliko, vključno z diferencialno belo krvno sliko in številom trombocitov, je treba preveriti sočasno in z enako pogostnostjo:
English: Packs of 30 and 100 tablets are available.
Slovenian: Na voljo so pakiranja s 30 in 100 tabletami.
English: Not all pack size may be marketed.
Slovenian: Na trgu morda ni vseh navedenih pakiranj.
English: Without a loading dose, it is estimated that attainment of steady-state plasma concentrations would require nearly two months of dosing.
Slovenian: Ocenjujejo, da bi zdravilo brez udarnega odmerka doseglo koncentracijo v stanju dinamičnega ravnotežja v plazmi šele po skoraj dvomesečnem jemanju.
English: Very rare cases of Stevens Johnson syndrome or toxic epidermal necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients treated with leflunomide.
Slovenian: Zelo redko so pri bolnikih, zdravljenih z leflunomidom, opisani Stevens-Johnsonov sindrom ali toksična epidermalna nekroliza in neželene reakcije z eozinofilijo in sistemskimi simptomi (sindrom DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms).
English: A pharmacokinetic interaction with oral contraceptives was observed with A771726 (see below).
Slovenian: Opazili so farmakokinetično interakcijo peroralnih kontraceptivov in A771726 (glejte spodaj).
English: Other medicines and Leflunomide Zentiva
Slovenian: Druga zdravila in zdravilo Leflunomid Zentiva
English: However there was a wide variability in final outcome, i.e. in some patients the neuropathy resolved and some patients had persistent symptoms.
Slovenian: pri nekaterih bolnikih je nevropatija izginila, drugi pa so imeli stalne simptome.
English: The efficacy of Leflunomide Zentiva was demonstrated in one controlled, randomised, double blind study 3L01 in 188 patients with psoriatic arthritis, treated at 20 mg/day.
Slovenian: Učinkovitost zdravila Leflunomid Zentiva je dokazala kontrolirana, randomizirana dvojno slepa študija 3L01 pri 188 bolnikih s psoriatičnim artritisom.
English: Do not take Leflunomide Zentiva when you are breast-feeding, as leflunomide passes into the breast milk.
Slovenian: Ne jemljite zdravila Leflunomid Zentiva, če dojite, saj leflunomid lahko prehaja v mleko.
English: The extensive protein binding of A771726 could lead to displacement of other highly-bound drugs.
Slovenian: Izrazita vezava A771726 na beljakovine lahko povzroči izpodrinjenje drugih v veliki meri vezanih zdravil.
English: All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days.
Slovenian: Vsi bolniki, ki so dobivali leflunomid, so v preskušanjih III. faze dobivali začetni odmerek 100 mg 3 dni.
English: Rare:
Slovenian: Redki:
English: Silica colloidal anhydrous Magnesium stearate (E470b) Lactose monohydrate
Slovenian: brezvodni koloidni silicijev dioksid magnezijev stearat (E470b) laktoza monohidrat
English: Together with ALT, a complete blood cell count, including differential white blood cell count and platelets, must be performed before start of leflunomide treatment as well as every 2 weeks for the first 6 months of treatment and every 8 weeks thereafter.
Slovenian: Pred začetkom zdravljenja z leflunomidom je treba hkrati z ALT določiti celotno krvno sliko, vključno z diferencialno belo krvno sliko in številom trombocitov; prvih 6 mesecev zdravljenja jo je treba ponavljati vsaka 2 tedna, potem pa vsakih 8 tednov.
English: Treatment duration was 12 months.
Slovenian: Zdravljenje je trajalo 12 mesecev.
English: Most patients improved after discontinuation of leflunomide.
Slovenian: Večini bolnikov se je po prenehanju jemanja zdravila Leflunomid Zentiva stanje izboljšalo.
English: Breast-feeding women must, therefore, not receive leflunomide.
Slovenian: Doječe ženske zato ne smejo jemati leflunomida.
English: • For rheumatoid arthritis: 10 or 20 mg Leflunomide Zentiva once daily, depending on the severity of the disease.
Slovenian: • za zdravljenje revmatoidnega artritisa: 10 ali 20 mg zdravila Leflunomid Zentiva enkrat na dan, odvisno od resnosti obolenja,
English: agranulocytosis
Slovenian: agranulocitoza
English: If you take more Leflunomide Zentiva than you should, contact your doctor or get other medical advice.
Slovenian: Če ste vzeli večji odmerek zdravila Leflunomid Zentiva, kot bi smeli Če vzamete več zdravila Leflunomid Zentiva, kot bi smeli, se posvetujte s svojim zdravnikom ali poiščite zdravniško pomoč.
English: In such cases re-exposure to leflunomide is contraindicated (see section 4.3).
Slovenian: Ponovna uporaba leflunomida je kontraindicirana (glejte poglavje 4.3).
English: severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal Skin and subcutaneous tissue disorders
Slovenian: huda okvara jeter, npr. odpoved jeter in akutna jetrna nekroza, ki sta lahko usodni Bolezni kože in podkožja
English: Leflunomide Zentiva can make you feel dizzy which may impair your ability to concentrate and react.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Leflunomid Zentiva lahko povzroči omotičnost, kar lahko prizadene sposobnost za koncentracijo in reagiranje.
English: Recent, concomitant or consecutive use of potentially myelotoxic agents may be associated with a higher risk of haematological effects.
Slovenian: Nedavno, sočasno ali navezujoče se zdravljenje s potencialno mielotoksičnimi zdravili poveča nevarnost za hematološke učinke.
English: A771726 plasma levels can be expected to be above 0.02 mg/L for a prolonged period.
Slovenian: Pričakovati je mogoče, da bo plazemska koncentracija A771726 dolgo časa nad 0,02 mg/l.
English: If such effects occur, a washout (see below) to reduce plasma levels of A771726 should be considered.
Slovenian: Če se pojavijo ti učinki, pride za znižanje koncentracije A771726 v plazmi v poštev postopek izpiranja (glejte spodaj).
English: After a 2-year waiting period, the A771726 plasma concentration is measured for the first time.
Slovenian: Po 2-letnem čakalnem obdobju se prvič izmeri plazemsko koncentracijo A771726.
English: Increased side effects may occur in case of recent or concomitant use of hepatotoxic or haematotoxic medicinal products or when leflunomide treatment is followed by such medicinal products without a washout period (see also guidance concerning combination with other treatments, section 4.4).
Slovenian: 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).
English: This is thought to be achieved by a gastrointestinal dialysis mechanism and/or by interrupting enterohepatic recycling.
Slovenian: To je domnevno posledica mehanizma gastrointestinalne dialize, prekinitve enterohepatične recirkulacije ali obojega.
English: Imprint on one side: ZBP
Slovenian: Na eni strani imajo napis: ZBP.
English: If you have to be vaccinated, ask your doctor for advice.
Slovenian: Če se morate cepiti, se o tem posvetujte z zdravnikom.
English: Pack size: 3 film-coated tablets.
Slovenian: Velikost pakiranja: 3 filmsko obložene tablete.
English: In vitro inhibition studies in human liver microsomes suggest that cytochrome P450 (CYP) 1A2, 2C19 and 3A4 are involved in leflunomide metabolism.
Slovenian: Študije zavrtja in vitro z mikrosomi človeških jeter kažejo, da so v presnovo leflunomida vključeni 1A2, 2C19 in 3A4 citokroma P450 (CYP).
English: Uncommon: taste disturbances
Slovenian: motnje okusa
English: • alternatively, 50 g of activated powdered charcoal is administered 4 times daily for a period of 11 days.
Slovenian: • druga možnost je, da se v obdobju 11 dni uporabi po 50 g aktivnega oglja v prahu 4-krat na dan.
English: Treatment duration was 6 months.
Slovenian: Zdravljenje je trajalo 6 mesecev.
English: Pharmacotherapeutic group: selective immunosuppressants, ATC code: L04AA13.
Slovenian: Oznaka ATC: L04AA13.
English: Tell your doctor immediately and stop taking Leflunomide Zentiva: - if you experience weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic reaction, - if you develop a skin rash or ulcers in your mouth, as these may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section
Slovenian: Nemudoma obvestite svojega zdravnika in prenehajte jemati zdravilo Leflunomid Zentiva: - če občutite slabost, vrtoglavost ali omotičnost ali težko dihate, saj so to lahko znaki resne alergijske reakcije, - če se vam razvijejo kožni izpuščaji ali razjede v ustih, je to lahko znak reakcij, ki so lahko usodne (npr. Stevens-Johnsonov sindrom, toksična epidermalna nekroliza, multiformni eritem, neželena reakcija z eozinofilijo in sistemskimi simptomi [sindrom DRESS]), glejte poglavje 2.
English: Lactose
Slovenian: Laktoza
English: How to store Leflunomide Zentiva Contents of the pack and other information
Slovenian: Shranjevanje zdravila Leflunomid Zentiva Vsebina pakiranja in dodatne informacije
English: Postmarketing studies
Slovenian: Študije izvedene po prihodu zdravila na trg
English: paraesthesia, headache, dizziness, peripheral neuropathy Cardiac disorders
Slovenian: parestezije, glavobol, omotica, periferna nevropatija
English: 100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30 or 100 film-coated tablets.
Slovenian: 100-ml plastenka iz polietilena visoke gostote s širokim vratom in navojno zaporko z integriranim vsebnikom za sušilno sredstvo, ki vsebuje bodisi 30 ali 100 filmsko obloženih tablet.
English: There is no dose adjustment recommended in patients with mild renal insufficiency.
Slovenian: Pri bolnikih z blago ledvično insuficienco odmerka ni treba prilagajati.
English: 100 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container, containing either 30, 50 or 100 film-coated tablets.
Slovenian: 100-ml plastenka iz polietilena visoke gostote s širokim vratom in navojno zaporko z integriranim vsebnikom za sušilno sredstvo, ki vsebuje bodisi 30, ali 50 in 100 filmsko obloženih tablet.
English: • colestyramine 8 g is administered 3 times daily for a period of 11 days,
Slovenian: • se v obdobju 11 dni uporabi po 8 g holestiramina 3-krat na dan,