FrancophonIA/ELRC3.0 huggingface dataset:
English: When tested under UV exposure pirfenidone was positive in a photoclastogenic assay in Chinese hamster lung cells.
Slovenian: Pri preskušanju pod ultravijolično svetlobo je bil pirfenidon pozitiven pri testu foto-klastogenosti v pljučnih celicah kitajskega hrčka.
English: Physicians should monitor patient's weight, and when appropriate encourage increased caloric intake if weight loss is considered to be of clinical significance.
Slovenian: Zdravniki naj spremljajo bolnikovo telesno maso in ga po potrebi vzpodbujajo k povečanju vnosa kalorij, kadar je izguba telesne mase klinično pomembna.
English: The dose of pirfenidone may be reduced to 3 capsules/day (1 capsule three times a day).
Slovenian: Odmerek pirfenidona se lahko zmanjša na 3 kapsule/dan (ena kapsula trikrat na dan).
English: If symptoms continue, see your doctor.
Slovenian: Če simptomi ne izginejo, obiščite zdravnika.
English: Esbriet may cause dizziness and fatigue, which could have a moderate influence on the ability to drive or use machines, therefore patients should exercise caution when driving or operating machinery if they experience these symptoms.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Esbriet lahko povzroči omotico in utrujenost, ki imata lahko zmeren vpliv na sposobnost vožnje in upravljanja strojev, zato morajo biti bolniki v primeru teh simptomov previdni, če vozijo ali upravljajo stroje.
English: The majority of pirfenidone is excreted as the 5-carboxy-pirfenidone metabolite (>95% of that recovered), with less than 1% of pirfenidone excreted unchanged in urine.
Slovenian: Večina pirfenidona se izloči kot presnovek 5-karboksi-pirfenidona (> 95 % izločenega), manj kot 1 % pirfenidona v seču pa se izloči nespremenjeno.
English: The results of mechanistic studies indicate that the occurrence of uterine tumours is probably related to a chronic dopamine-mediated sex hormone imbalance involving a species specific endocrine mechanism in the rat which is not present in humans.
Slovenian: Rezultati študij delovanja kažejo, da je pojavnost tumorjev na maternici verjetno povezana s kroničnim neravnovesjem spolnih hormonov, ki ga prenaša dopamin in pri podganah vključuje za to živalsko vrsto specifičen mehanizem endokrinega sistema, ki ga pri ljudeh ni.
English: In repeated dose toxicity studies increases in liver weight were observed in mice, rats and dogs; this was often accompanied by hepatic centrilobular hypertrophy.
Slovenian: V raziskavah toksičnosti pri ponavljajočih se odmerkih so pri miših, podganah in psih opazili povečanje jeter, ki ga je pogosto spremljala centrolobularna hipertrofija jeter.
English: ● Any other clinically significant ADRs based on the judgment of the prescriber
Slovenian: • katerekoli druge klinično pomembne neželene učinke po presoji zdravnika, ki predpiše zdravilo
English: However, existing data suggest that pirfenidone exerts both antifibrotic and anti-inflammatory properties in a variety of in vitro systems and animal models of pulmonary fibrosis (bleomycin- and transplant-induced fibrosis).
Slovenian: Vendar razpoložljivi podatki kažejo, da pirfenidon izraža protifibrotične in protivnetne lastnosti v različnih sistemih in vitro in živalskih modelih pljučne fibroze (fibroze, povzročene z bleomicinom in presadkom).
English: Esbriet helps to reduce scarring and swelling in the lungs, and helps you breathe better.
Slovenian: Zdravilo Esbriet pomaga zmanjševati število brazgotin in zatekanje v pljučih ter vam pomaga, da lažje dihate.
English: These are rare side effects.
Slovenian: Ti neželeni učinki so redki.
English: As a precautionary measure, it is preferable to avoid the use of Esbriet during pregnancy.
Slovenian: Kot varnostni ukrep je priporočljivo izogibanje zdravilu Esbriet med nosečnostjo.
English: The absolute bioavailability of pirfenidone has not been determined in humans.
Slovenian: Absolutna biološka uporabnost pirfenidona pri ljudeh ni bila ugotovljena.
English: This makes it hard for your lungs to work properly.
Slovenian: Pljuča tako ne morejo pravilno delovati.
English: ● Concomitant use of fluvoxamine (see section 4.5).
Slovenian: • sočasna uporaba fluvoksamina (glejte poglavje 4.5),
English: Clinically relevant pharmacodynamic activity of the metabolite in patients with moderate renal impairment cannot be excluded.
Slovenian: Klinično pomembne farmakodinamične aktivnosti presnovka pri bolnikih z zmerno okvaro ledvic ni mogoče izključiti.
English: Your medicine is provided in either a 2-week treatment initiation pack, a 4-week treatment pack or in a bottle.
Slovenian: Zdravilo je na voljo v pakiranju za dvotedenski začetek zdravljenja, pakiranju za štiritedensko zdravljenje ali v plastenki.
English: Other medicines and Esbriet
Slovenian: Druga zdravila in zdravilo Esbriet
English: Approximately 80% of an orally administered dose of pirfenidone is cleared in the urine within 24 hours of dosing.
Slovenian: Približno 80 % peroralno zaužitega odmerka pirfenidona se odstrani s sečem v 24 urah od odmerjanja.
English: Do not take more tablets each day than your prescribed daily dose.
Slovenian: Ne vzemite večjega števila tablet na dan, kot je vaš predpisan dnevni odmerek.
English: Population pharmacokinetic analyses from 4 studies in healthy subjects or subjects with renal impairment and one study in patients with IPF showed no clinically relevant effect of age, gender or body size on the pharmacokinetics of pirfenidone.
Slovenian: Analiza populacijske farmakokinetike iz štirih študij z zdravimi osebami ali osebami z okvarjenim delovanjem ledvic in iz ene študije z bolniki, ki so imeli idiopatsko pljučno fibrozo, ni pokazala klinično pomembnega vpliva starosti, spola ali telesne velikosti na farmakokinetiko pirfenidona.
English: Mean apparent oral steady-state volume of distribution is approximately 70 l, indicating that pirfenidone distribution to tissues is modest.
Slovenian: Navidezni srednji volumen porazdelitve v stanju dinamičnega ravnovesja po peroralni uporabi je približno 70 l, kar kaže, da je porazdelitev pirfenidona v tkivih zmerna.
English: ● skin problems such as itchy skin, skin redness or red skin, dry skin, skin rash
Slovenian: • težave s kožo, kot so srbeča koža, rdečica na koži ali rdeča koža, suha koža, kožni izpuščaj,
English: Metabolism and nutrition disorders Very Common Anorexia Common
Slovenian: Presnovne in prehranske motnje Zelo pogosti anoreksija
English: However, since plasma levels of pirfenidone may be increased in some individuals with mild to moderate hepatic impairment, caution should be used with Esbriet treatment in this population.
Slovenian: Ker pa se koncentracije pirfenidona v plazmi pri nekaterih posameznikih z blago do zmerno okvaro jeter lahko zvišajo, je treba pri tej populaciji zdravilo Esbriet uporabljati previdno.
English: No adverse effects on fertility were observed in preclinical studies (see section 5.3).
Slovenian: V predkliničnih študijah niso opazili nobenih neželenih učinkov na plodnost (glejte poglavje 5.3).
English: Patients should be closely monitored for emergence of adverse reactions associated with Esbriet therapy.
Slovenian: Bolnike je potrebno skrbno spremljati zaradi pojava neželenih učinkov, povezanih s terapijo z zdravilom Esbriet.
English: Esbriet should be used with caution when ciprofloxacin is used at a dose of 250 mg or 500 mg once or two times a day.
Slovenian: Zdravilo Esbriet je treba ob uporabi ciprofloksacina v odmerkih 250 mg ali 500 mg enkrat ali dvakrat na dan uporabljati previdno.
English: Esbriet is for oral use.
Slovenian: Zdravilo Esbriet je za peroralno uporabo.
English: 2-week treatment initiation pack
Slovenian: Pakiranje za dvotedenski začetek zdravljenja
English: Patients should be instructed to report symptoms of photosensitivity reaction or rash to their physician.
Slovenian: Bolnikom je treba naročiti, naj o simptomih reakcije preobčutljivosti na svetlobo ali izpuščaja poročajo svojemu zdravniku.
English: A decision must be made whether to discontinue breast-feeding or to discontinue from Esbriet therapy, taking into account the benefit of breast-feeding for the child and the benefit of Esbriet therapy for the mother.
Slovenian: Pri odločitvi o prekinitvi dojenja ali prekinitvi zdravljenja z zdravilom Esbriet je treba upoštevati koristi dojenja za otroka in koristi zdravljenja z zdravilom Esbriet za mater.
English: Brown S-1-16530 or 03A2 inks containing:
Slovenian: Črnila rjavo črnilo S-1-16530 ali črnilo 03A2, ki vsebuje:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
English: ● Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,
English: ● You may become more sensitive to sunlight (photosensitivity reaction) when taking Esbriet.
Slovenian: • Pri jemanju zdravila Esbriet lahko postanete bolj občutljivi na sončno svetlobo (reakcija preobčutljivosti na svetlobo).
English: Grapefruit may prevent Esbriet from working properly.
Slovenian: Grenivka lahko prepreči, da bi zdravilo Esbriet delovalo pravilno.
English: Decline of less than 10% No decline (FVC change >0%)
Slovenian: Zmanjšanje za manj kot 10 % Ni zmanjšanja (sprememba forsirane vitalne kapacitete > 0 %)
English: These hepatic findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving Esbriet.
Slovenian: Ti izsledki v zvezi z jetri se skladajo z indukcijo jetrnih mikrosomskih encimov, česar pa pri bolnikih, ki so prejemali zdravilo Esbriet, niso opazili.
English: In vitro and in vivo extrapolations indicate that strong and selective inhibitors of CYP1A2 (e.g. enoxacin) have the potential to increase the exposure to pirfenidone by approximately 2 to 4-fold.
Slovenian: In vitro in in vivo ekstrapolacije kažejo, da imajo močni in selektivni zaviralci CYP1A2 (npr. enoksacin) potencial za povečanje izpostavljenosti pirfenidonu za približno 2 do 4-krat.
English: Wear sunblock daily and cover your arms, legs and head to reduce exposure to sunlight (see section 4: Possible side effects).
Slovenian: Zmanjšajte izpostavljenost sončni svetlobi; vsak dan uporabljajte kremo za sončenje in z oblačili pokrijte svoje roke, noge in glavo (glejte poglavje 4: Možni neželeni učinki).
English: This may become clinically relevant in patients with moderate renal impairment where plasma exposure to 5-carboxy-pirfenidone is increased.
Slovenian: To lahko postane klinično pomembno pri bolnikih z zmerno okvaro ledvic, kjer se izpostavljenost 5-karboksi-pirfenidonu v plazmi poveča.
English: België/Belgique/Belgien N.V. Roche S.A.
Slovenian: België/Belgique/Belgien N.V.
English: If you take more Esbriet than you should
Slovenian: Če ste vzeli večji odmerek zdravila Esbriet, kot bi smeli
English: ● Esbriet may cause dizziness and tiredness.
Slovenian: • Zdravilo Esbriet lahko povzroči omotico in utrujenost.
English: Consumption of grapefruit juice is associated with inhibition of CYP1A2 and should be avoided during treatment with pirfenidone.
Slovenian: Uživanje grenivkinega soka je povezano z zaviranjem CYP1A2 in se mu je treba med zdravljenjem s pirfenidonom izogibati.
English: In some situations, your doctor may advise you to stop taking Esbriet.
Slovenian: V določenih okoliščinah vam zdravnik lahko naroči, da zdravilo Esbriet prenehate jemati.
English: Pirfenidone attenuates fibroblast proliferation, production of fibrosis-associated proteins and cytokines, and the increased biosynthesis and accumulation of extracellular matrix in response to cytokine growth factors such as, transforming growth factor-beta (TGF-β) and platelet-derived growth factor (PDGF).
Slovenian: Pirfenidon zmanjšuje proliferacijo fibroblastov, tvorjenje s fibrozo povezanih beljakovin in citokinov ter povečano biosintezo in nastajanje ekstracelularnega prostora, ki sta odziv na rastne dejavnike citokinov, na primer na transformirajoči rastni dejavnik beta (TGF-β) in trombocitni rastni dejavnik (PDGF).
English: In the fed state, the 801 mg tablet met bioequivalence criteria based on the AUC measurements compared to the capsules, while the 90% confidence intervals for Cmax (108.26% - 125.60%) slightly exceeded the upper bound of standard bioequivalence limit (90% CI: 80.00% - 125.00%).
Slovenian: Na poln želodec so bile za 801-mg tableto v primerjavi s kapsulami na podlagi meritev AUC bioekvivalenčne zahteve izpolnjene, medtem ko so 90-% intervali zaupanja za Cmax (108,26-125,60 %) nekoliko presegli zgornjo standardno bioekvivalenčno mejo (90-% IZ: 80,00-125,00 %).
English: The dose of pirfenidone may be reduced to 801 mg each day (267 mg three times a day).
Slovenian: Odmerek pirfenidona se lahko zmanjša na 801 mg vsak dan (267 mg trikrat na dan).
English: ● if you have previously experienced angioedema with pirfenidone, including symptoms such as swelling of the face, lips and/or tongue which may be associated with difficulty breathing or wheezing
Slovenian: • če ste imeli v preteklosti pri uporabi pirfenidona angioedem, vključno s simptomi, kot so oteklost obraza, ustnic in/ali jezika, ki so lahko povezani s težkim dihanjem ali sopenjem;
English: 4-week treatment maintenance pack
Slovenian: Pakiranje za štiritedensko vzdrževalno zdravljenje
English: B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Exposure to 5-carboxy-pirfenidone increases 3.5 fold or more in patients with moderate renal impairment.
Slovenian: Izpostavljenost 5-karboksi-pirfenidonu se pri bolnikih z zmerno okvaro ledvic poveča 3,5-krat ali več.
English: Elderly No dose adjustment is necessary in patients 65 years and older (see section 5.2).
Slovenian: Starejši bolniki Pri bolnikih, ki so stari 65 let ali več, odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Cigarette smoking and inducers of CYP1A2
Slovenian: Kajenje in induktorji CYP1A2
English: IPF is a chronic fibrotic and inflammatory pulmonary disease affected by the synthesis and release of pro-inflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and interleukin-1-beta
Slovenian: Idiopatska pljučna fibroza je kronična fibrotična in vnetna pljučna bolezen, na katero vplivata sinteza in sproščanje provnetnih citokinov, vključno z dejavnikom tumorske nekroze alfa (TNF-α) in interlevkinom-1-beta (IL-1β).
English: Pirfenidone showed no indication of mutagenic or genotoxic activity in a standard battery of tests and when tested under UV exposure was not mutagenic.
Slovenian: Pri standardni seriji testov pirfenidon ni pokazal mutagene ali genotoksične aktivnosti in ob preskusu pod ultravijolično svetlobo ni bil mutagen.
English: ● rifampicin (a type of antibiotic).
Slovenian: • rifampicin (vrsta antibiotika).
English: 3 years for bottles.
Slovenian: 3 leta za plastenke.
English: Co-administration of Esbriet and 750 mg of ciprofloxacin (a moderate inhibitor of CYP1A2) increased the exposure to pirfenidone by 81%.
Slovenian: Sočasno dajanje zdravila Esbriet in 750 mg ciprofloksacina (zmernega inhibitorja CYP1A2) je povečalo izpostavljenost pirfenidonu za 81 %.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Roche Registration GmbH
English: Roche (Magyarország) Kft. Tel: +36 - 23 446 800
Slovenian: Magyarország Roche (Magyarország) Kft. Tel: +36 - 23 446 800
English: Hepatic function: In the event of significant elevation of alanine and/or aspartate aminotransferases (ALT/AST) with or without bilirubin elevation, the dose of pirfenidone should be adjusted or treatment discontinued according to the guidelines listed in section 4.4.
Slovenian: Delovanje jeter: Če se alanin- in/ali aspartat-aminotransferaza (ALT/AST) pomembno zvišata ne glede na to, ali se zviša tudi bilirubin, je treba prilagoditi odmerek pirfenidona ali pa prekiniti zdravljenje, kot določajo smernice, navedene v poglavju 4.4.
English: Adverse reactions are listed by System Organ Class (SOC) and within each frequency grouping [Very common (≥1/10), common (≥1/100 to
Slovenian: Neželeni učinki so navedeni po organskih sistemih, znotraj vsake od razvrstitev pogostnosti [zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do
English: Therefore, it is recommended that Esbriet be administered with food to reduce the incidence of nausea and dizziness.
Slovenian: Zato je priporočljivo, da se zdravilo Esbriet jemlje s hrano, saj to zmanjša pojavnost slabosti in omotice.
English: The clinical efficacy of Esbriet has been studied in four Phase 3, multicentre, randomised, double-blind, placebo-controlled studies in patients with IPF.
Slovenian: Klinično učinkovitost zdravila Esbriet pri bolnikih z idiopatsko pljučno fibrozo so preučevali v štirih multicentričnih, randomiziranih, dvojno slepih in s placebom nadzorovanih študijah faze III.
English: D-79639 Grenzach-Wyhlen Germany
Slovenian: 79639 Grenzach-Wyhlen Nemčija
English: ● Elevations of serum transaminases can occur during treatment with Esbriet.
Slovenian: • Med zdravljenjem z zdravilom Esbriet se lahko poviša raven transaminaz v serumu.
English: ● Photosensitivity reactions and skin rashes
Slovenian: • reakcije preobčutljivosti na svetlobo in kožne izpuščaje
English: ● indigestion or stomach upset
Slovenian: • prebavne ali želodčne motnje,
English: A Phase 1 interaction study evaluated the effect of cigarette smoking (CYP1A2 inducer) on the pharmacokinetics of pirfenidone.
Slovenian: Študija faze I medsebojnega delovanja je ovrednotila učinek kajenja cigaret (induktorja CYP1A2) na farmakokinetiko pirfenidona.
English: Esbriet should be used with caution in patients treated with other moderate inhibitors of CYP1A2 (e.g. amiodarone, propafenone).
Slovenian: Zdravilo Esbriet je treba uporabljati previdno pri bolnikih, ki se zdravijo z drugimi zmernimi zaviralci CYP1A2 (npr. amiodaronom, propafenonom).
English: Following oral administration of a single dose of 801 mg to healthy older adult volunteers (50-66 years of age) in the fed state, the rate of pirfenidone absorption slowed, while the AUC in the fed state was approximately 80-85% of the AUC observed in the fasted state.
Slovenian: Po peroralnem dajanju enkratnega 801-miligramskega odmerka zdravim starejšim odraslim prostovoljcem (50-66 let) na poln želodec se je absorpcija pirfenidona upočasnila, vrednost AUC na poln želodec pa je bila približno 80-85 % vrednosti AUC, opažene pri jemanju na prazen želodec.
English: ● If you experience yellowing of the eyes or skin, or dark urine, potentially accompanied by itching of the skin, which are signs of abnormal liver function tests.
Slovenian: • Če se pojavijo porumenele oči ali koža ali temen urin, kar lahko spremlja tudi srbenje kože; to so znaki nenormalnega delovanja jeter.
English: Each pack contains a total of 63 capsules.
Slovenian: Eno pakiranje vsebuje skupaj 63 kapsul.
English: Do not use this medicine after the expiry date which is stated on the bottle label, blister and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki plastenke, pretisnem omotu in škatli poleg oznak Uporabno do/EXP.
English: The bottle pack contains 270 capsules.
Slovenian: Plastenka vsebuje 270 kapsul.
English: The MAH must ensure that at launch all physicians who are expected to prescribe Esbriet are provided with a physician information pack containing the following:
Slovenian: Pred prihodom zdravila na trg mora imetnik dovoljenja za promet z zdravilom zagotoviti, da bodo vsi zdravniki, ki bodo predvidoma predpisovali zdravilo Esbriet, prejeli izobraževalno gradivo z informacijami za zdravnike, ki vsebuje:
English: 21 tablets
Slovenian: 21 tablet
English: If clinically appropriate the dose of Esbriet should be reduced or interrupted.
Slovenian: Če je klinično primerno, je treba zmanjšati odmerek zdravila Esbriet ali pa prekiniti njegovo jemanje.
English: Do not take more capsules each day than your prescribed daily dose.
Slovenian: Ne vzemite večjega števila kapsul na dan, kot je vaš predpisan dnevni odmerek.
English: In the event of significant elevation of liver aminotransferases the dose of Esbriet should be adjusted or treatment discontinued according to the guidelines listed below.
Slovenian: Če se vrednosti jetrnih aminotransferaz pomembno zvišajo, je treba prilagoditi odmerek zdravila Esbriet ali pa prekiniti zdravljenje, kot določajo spodnje smernice.
English: ● if you have severe or end stage kidney disease requiring dialysis.
Slovenian: • če imate hudo bolezen ledvic ali končno odpoved ledvic, pri kateri je potrebna dializa.
English: ● Patients should be informed that Esbriet is known to be associated with photosensitivity reactions and that preventative measures have to be taken.
Slovenian: • Bolnike je treba obvestiti, da se pri jemanju zdravila Esbriet lahko pojavljajo reakcije preobčutljivosti na svetlobo in da je treba izvesti ustrezne zaščitne ukrepe.
English: 6.5 Nature and contents of container
Slovenian: 6.5 Vrsta ovojnine in vsebina Velikosti pakiranj
English: The capsules contain a white to pale yellow powder.
Slovenian: Kapsule vsebujejo bel do bledorumen prašek.
English: (IL-1β) and pirfenidone has been shown to reduce the accumulation of inflammatory cells in response to various stimuli.
Slovenian: Dokazano je, da pirfenidon zmanjšuje kopičenje vnetnih celic, nastalih kot odgovor na različne stimuluse.
English: Your doctor will monitor your weight whilst you are taking this medicine.
Slovenian: Med jemanjem tega zdravila bo zdravnik spremljal vašo maso.
English: ● Capsule shell: gelatin, titanium dioxide (E171)
Slovenian: • Ovojnica kapsule: želatina, titanov dioksid (E171)
English: Reversibility was observed after cessation of treatment.
Slovenian: Po prekinitvi zdravljena so opazili reverzibilnost.
English: If for any reason you have to stop taking Esbriet for more than 14 consecutive days, your doctor will restart your treatment with 1 capsule 3 times a day, gradually increasing this to 3 capsules 3 times a day.
Slovenian: Če zdravila Esbriet iz kakršnegakoli razloga ne boste jemali več kot 14 dni zapored, bo zdravnik ponovno začel zdravljenje z eno kapsulo trikrat na dan in odmerek postopoma povečeval do treh kapsul trikrat na dan.
English: Patients should be instructed to use a sunblock daily, to wear clothing that protects against sun exposure, and to avoid other medicinal products known to cause photosensitivity.
Slovenian: Bolnikom je treba naročiti, naj vsak dan uporabljajo kremo za sončenje, nosijo oblačila, ki ščitijo pred izpostavljenostjo soncu in se izogibajo drugim zdravilom, za katera je znano, da povzročajo preobčutljivost na svetlobo.
English: There is limited clinical experience with overdose.
Slovenian: Kliničnih izkušenj s prevelikim odmerjanjem je malo.
English: ● History of angioedema with pirfenidone (see section 4.4).
Slovenian: • angioedem zaradi pirfenidona v anamnezi (glejte poglavje 4.4),
English: Pharmacotherapeutic group: Immunosuppressants, other immunosuppressants, ATC code: L04AX05 The mechanism of action of pirfenidone has not been fully established.
Slovenian: Farmakoterapevtska skupina: imunosupresivi, drugi imunosupresivi, oznaka ATC: L04AX05
English: The pharmacokinetics of pirfenidone and the 5-carboxy-pirfenidone metabolite were compared in subjects with moderate hepatic impairment (Child-Pugh Class B) and in subjects with normal hepatic function.
Slovenian: Narejena je bila primerjava farmakokinetike pirfenidona in presnovka 5-karboksi-pirfenidona pri osebah z zmerno okvaro jeter (razred B po lestvici Child-Pugh) in pri osebah z normalnim delovanjem jeter.
English: Pirfenidone
Slovenian: Pirfenidon