FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Populacijske farmakokinetičke analize podataka iz 4 ispitivanja provedena u zdravih osoba ili osoba s oštećenjem funkcije bubrega i jednog ispitivanja provedenog u bolesnika s IPF-om nisu pokazale klinički značajan utjecaj dobi, spola ni tjelesne veličine na farmakokinetiku pirfenidona.
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:
Croatian: Nositelj odobrenja mora osigurati da u vrijeme puštanja lijeka u promet svi liječnici za koje se očekuje da će propisivati Esbriet dobiju paket informacija za liječnike koji sadrži sljedeće:
English: IPF is a condition in which the tissues in your lungs become swollen and scarred over time, and as a result makes it difficult to breathe deeply.
Croatian: IPF je bolest kod koje tkivo u Vašim plućima otiče i s vremenom na njemu nastaju ožiljci, a posljedica toga je da ne možete duboko udahnuti.
English: Metabolism and nutrition disorders Very Common Anorexia Common
Croatian: Poremećaji metabolizma i prehrane Vrlo često anoreksija
English: ● You may become more sensitive to sunlight (photosensitivity reaction) when taking Esbriet.
Croatian: • Dok uzimate Esbriet možete postati osjetljiviji na sunčevu svjetlost (reakcija fotoosjetljivosti).
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.
Croatian: Ako iz bilo kojeg razloga morate prestati uzimati Esbriet na više od 14 uzastopnih dana, Vaš će liječnik ponovo započeti liječenje 1 kapsulom 3 puta na dan, postupno povećavajući dozu do 3 kapsule 3 puta na dan.
English: If any of the above affects you, do not take Esbriet.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas, nemojte uzimati Esbriet.
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.
Croatian: U ispitivanjima toksičnosti ponovljenih doza primijećena su povećanja težine jetre u miševa, štakora i pasa, koja su često bila praćena centrolobularnom hipertrofijom jetre.
English: As a precautionary measure, it is preferable to avoid the use of Esbriet during pregnancy.
Croatian: Kao mjera predostrožnosti savjetuje se izbjegavati primjenu lijeka Esbriet tijekom trudnoće.
English: Smoking has the potential to induce hepatic enzyme production and thus increase medicinal product clearance and decrease exposure.
Croatian: Pušenje može inducirati proizvodnju jetrenih enzima te tako povećati klirens lijeka i smanjiti izloženost lijeku.
English: Administration of Esbriet capsules with food results in a large reduction in Cmax (by 50%) and a smaller effect on AUC, compared to the fasted state.
Croatian: Primjena Esbriet kapsula s hranom rezultira velikim smanjenjem Cmax (za 50%) i manjim učinkom na AUC u usporedbi s primjenom natašte.
English: Median (25th-75th)
Croatian: Medijan (25.-75.)
English: Do not take more tablets each day than your prescribed daily dose.
Croatian: Nemojte uzeti više tableta u danu od propisane dnevne doze.
English: Liver function tests (ALT, AST and bilirubin) should be conducted prior to the initiation of treatment with Esbriet, and subsequently at monthly intervals for the first 6 months and then every 3 months thereafter (see section 4.8).
Croatian: Potrebno je provesti testove jetrene funkcije (ALT, AST i bilirubin) prije započinjanja liječenja lijekom Esbriet, svaki mjesec tijekom prvih 6 mjeseci liječenja, a zatim svaka 3 mjeseca (vidjeti dio 4.8).
English: Consumption of grapefruit juice is associated with inhibition of CYP1A2 and should be avoided during treatment with pirfenidone.
Croatian: Konzumiranje soka od grejpfruta povezano je s inhibicijom CYP1A2 i stoga ga treba izbjegavati tijekom liječenja pirfenidonom.
English: Each pack contains a total of 63 capsules.
Croatian: Jedno pakiranje sadrži sveukupno 63 kapsule.
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.
Croatian: Pirfenidon nije pokazao nikakvu mutagenu ni genotoksičnu aktivnost u standardnom nizu testova, a nije pokazao mutagenost ni kada se testirao uz izlaganje UV svjetlosti.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Esbriet in all subsets of the paediatric population in IPF (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Esbriet u svim podskupinama pedijatrijske populacije u indikaciji IPF-a (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Nervous system disorders Very Common Headache Common
Croatian: Poremećaji živčanog sustava Vrlo često glavobolja
English: Physicians should monitor patient's weight, and when appropriate encourage increased caloric intake if weight loss is considered to be of clinical significance.
Croatian: Liječnici trebaju pratiti tjelesnu težinu bolesnika i potaknuti ga na povećan unos kalorija ako je gubitak na težini klinički značajan.
English: Decline of ≥10% or death or lung transplant
Croatian: Pad za ≥10% ili smrt ili transplantacija pluća
English: Therefore, patients who develop signs or symptoms of angioedema or severe allergic reactions following administration of Esbriet should immediately discontinue treatment.
Croatian: Stoga bolesnici u kojih se pojave znakovi ili simptomi angioedema ili teških alergijskih reakcija nakon primjene lijeka Esbriet moraju odmah prekinuti liječenje.
English: Doses above 2403 mg/day are not recommended for any patient (see section 4.9).
Croatian: Ni za jednog se bolesnika ne preporučuju doze veće od 2403 mg/dan (vidjeti dio 4.9).
English: Do not use this medicine after the expiry date which is stated on the bottle label, blister and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici boce, blisteru i kutiji iza oznake „Rok valjanosti“ ili oznake „EXP“.
English: If you stop taking Esbriet
Croatian: Ako prestanete uzimati Esbriet
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.
Croatian: Ispitivanja mehanizma nastanka ovih tumora pokazala su da tumori uterusa vjerojatno nastaju zbog kronične neravnoteže spolnih hormona pod utjecajem dopamina, a koja u štakora uključuje endokrini mehanizam specifičan za vrstu koji ne postoji u ljudi.
English: The dose of pirfenidone may be reduced to 3 capsules/day (1 capsule three times a day).
Croatian: Doza pirfenidona može se smanjiti na 3 kapsule na dan (1 kapsula triput dnevno).
English: Therefore, it is recommended that Esbriet be administered with food to reduce the incidence of nausea and dizziness.
Croatian: Stoga se preporučuje Esbriet uzimati s hranom radi smanjenja incidencije mučnine i omaglice.
English: Talk to your doctor or pharmacist before taking Esbriet
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Esbriet.
English: In clinical studies, most patients who experienced dizziness had a single event, and most events resolved, with a median duration of 22 days.
Croatian: U većine bolesnika koji su u kliničkim ispitivanjima doživjeli omaglicu, ona se dogodila samo jednom te se u većini slučajeva povukla sama, uz medijan trajanja od 22 dana.
English: Esbriet helps to reduce scarring and swelling in the lungs, and helps you breathe better.
Croatian: Esbriet pomaže smanjiti nastanak ožiljaka i oticanje u plućima i tako olakšava disanje.
English: ● infections of the throat or the airways going into the lungs and/or sinusitis
Croatian: • infekcije grla ili dišnih putova koji vode u pluća i/ili sinusitis
English: Patients should be instructed to report symptoms of photosensitivity reaction or rash to their physician.
Croatian: Bolesnike treba uputiti da svom liječniku prijave simptome reakcije fotoosjetljivosti ili osipa.
English: ● Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The overall mean binding ranged from 50% to 58% at concentrations observed in clinical studies (1 to 100 μg/ml).
Croatian: Sveukupna srednja vrijednost vezivanja za proteine u plazmi kretala se u rasponu od 50% do 58% pri koncentracijama zabilježenima u kliničkim ispitivanjima (1 do 100 μg/ml).
English: ● amiodarone (used to treat some types of heart disease)
Croatian: • amiodaron (koristi se za liječenje nekih srčanih bolesti)
English: Cigarette smoking and inducers of CYP1A2
Croatian: Pušenje cigareta i induktori CYP1A2
English: Adverse reactions are listed by System Organ Class (SOC) and within each frequency grouping [Very common (≥1/10), common (≥1/100 to
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava, a unutar svake skupine učestalosti [vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100),
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.
Croatian: Funkcija jetre: U slučaju značajnog povišenja razina alanin i/ili aspartat aminotransferaza (ALT/AST), uz povišenje razine bilirubina ili bez njega, potrebno je prilagoditi dozu pirfenidona ili prekinuti liječenje sukladno smjernicama navedenima u dijelu 4.4.
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.
Croatian: Budući da Esbriet može izazvati omaglicu i umor, koji mogu umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima, bolesnici moraju biti oprezni dok upravljaju vozilima ili rade sa strojevima ako im se pojave ti simptomi.
English: 4-week treatment maintenance pack
Croatian: Pakiranje za 4-tjednu terapiju održavanja
English: A Phase 1 interaction study evaluated the effect of cigarette smoking (CYP1A2 inducer) on the pharmacokinetics of pirfenidone.
Croatian: U ispitivanju interakcija faze 1 ocjenjivao se učinak pušenja cigareta (induktor CYP1A2) na farmakokinetiku pirfenidona.
English: Patients who miss 14 consecutive days or more of Esbriet treatment should re-initiate therapy by undergoing the initial 2-week titration regimen up to the recommended daily dose.
Croatian: Bolesnici koji propuste 14 ili više uzastopnih dana liječenja lijekom Esbriet trebaju ponovno započeti terapiju primjenom početnog režima 2-tjedne titracije do preporučene dnevne doze.
English: You will need a blood test before you start taking Esbriet and at monthly intervals for the first 6 months and then every 3 months thereafter whilst you are taking this medicine to check whether your liver is working properly.
Croatian: Morat ćete raditi krvne pretrage prije početka liječenja lijekom Esbriet, jednom mjesečno tijekom prvih 6 mjeseci i zatim svaka 3 mjeseca tijekom liječenja, kako bi se utvrdilo radi li Vam jetra ispravno.
English: Approximately 80% of an orally administered dose of pirfenidone is cleared in the urine within 24 hours of dosing.
Croatian: Oko 80% peroralno primijenjene doze pirfenidona izlučuje se mokraćom unutar 24 sata od primjene.
English: (sun; daytime dose) and (moon; evening dose).
Croatian: (mjesec; večernja doza).
English: The absolute bioavailability of pirfenidone has not been determined in humans.
Croatian: Nije utvrđena apsolutna bioraspoloživost pirfenidona u ljudi.
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).
Croatian: Pirfenidon smanjuje proliferaciju fibroblasta, stvaranje proteina povezanih s fibrozom, stvaranje citokina te povećanu biosintezu i kumulaciju izvanstaničnog matriksa kao odgovor na citokine/faktore rasta, kao što su transformirajući faktor rasta beta (engl. transforming growth factor-beta, TGF-β) i trombocitni faktor rasta (engl. platelet-derived growth factor, PDGF).
English: No adverse effects on fertility were observed in preclinical studies (see section 5.3).
Croatian: U pretkliničkim ispitivanjima nisu primijećeni štetni učinci na plodnost (vidjeti dio 5.3).
English: Do not take more capsules each day than your prescribed daily dose.
Croatian: Nemojte uzeti više kapsula u danu od propisane dnevne doze.
English: 267 mg tablet and 801 mg tablet 3 years for blisters.
Croatian: Tablete od 267 mg i tablete od 801 mg 3 godine za blistere.
English: Dose reduction due to side effects
Croatian: Smanjenje doze zbog nuspojava
English: ● if you are taking a medicine called fluvoxamine (used to treat depression and obsessive compulsive disorder [OCD])
Croatian: • ako uzimate lijek koji se naziva fluvoksamin (koristi se u liječenju depresije i opsesivno-kompulzivnog poremećaja [OKP])
English: If you are unsure ask your doctor or pharmacist.
Croatian: Ako niste sigurni, pitajte svog liječnika ili ljekarnika.
English: 534 mg tablet 2 years.
Croatian: Tablete od 534 mg 2 godine.
English: Patients should be encouraged to discontinue use of strong inducers of CYP1A2 and to stop smoking before and during treatment with pirfenidone.
Croatian: Bolesnike treba potaknuti da prestanu primjenjivati jake induktore CYP1A2 te da prestanu pušiti prije i za vrijeme liječenja pirfenidonom.
English: Photosensitivity reaction and rash
Croatian: Reakcija fotoosjetljivosti i osip
English: The active substance is pirfenidone.
Croatian: Djelatna tvar je pirfenidon.
English: Driving and using machines Do not drive or use machines if you feel dizzy or tired after taking Esbriet.
Croatian: Nemojte upravljati vozilima ni rukovati strojevima ako osjećate omaglicu ili umor nakon što uzmete
English: These hepatic findings are consistent with an induction of hepatic microsomal enzymes, an effect which has not been observed in patients receiving Esbriet.
Croatian: Ti nalazi na jetri u skladu su s indukcijom jetrenih mikrosomskih enzima, ali taj učinak nije primijećen u bolesnika koji primaju Esbriet.
English: Grapefruit may prevent Esbriet from working properly.
Croatian: Grejpfrut može spriječiti pravilno djelovanje lijeka Esbriet.
English: Reversibility was observed after cessation of treatment.
Croatian: Primijećeno je da se te promjene povlače nakon prekida liječenja.
English: ● If you experience swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or wheezing, or feeling faint, which are signs of angioedema, a serious allergic reaction or anaphylaxis.
Croatian: • ako primijetite oticanje lica, usana i/ili jezika, svrbež, koprivnjaču, otežano disanje ili piskanje pri disanju ili ako se osjećate kao da ćete se onesvijestiti, što su znakovi angioedema, ozbiljne alergijske reakcije ili anafilaksije.
English: Co-administration of Esbriet and 750 mg of ciprofloxacin (a moderate inhibitor of CYP1A2) increased the exposure to pirfenidone by 81%.
Croatian: Istodobna primjena lijeka Esbriet i 750 mg ciprofloksacina (umjerenog inhibitora CYP1A2) povećala je izloženost pirfenidonu za 81%.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30°C
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%).
Croatian: Nakon primjene u stanju sitosti, tableta od 801 mg ispunjavala je kriterije za bioekvivalentnost u odnosu na kapsulu s obzirom na vrijednosti AUC-a, dok su intervali pouzdanosti od 90% za Cmax (108,26%125,60%) bili malo iznad gornje granice standardnog praga za bioekvivalentnost (90% CI: 80,00%
English: Roche (Magyarország) Kft. Tel: +36 - 23 446 800
Croatian: Magyarország Roche (Magyarország) Kft. Tel: +36 - 23 446 800
English: D-79639 Grenzach-Wyhlen Germany
Croatian: 79639 Grenzach-Wyhlen
English: ● Esbriet may cause dizziness and tiredness.
Croatian: • Esbriet može izazvati omaglicu i umor.
English: An increased incidence of liver tumours was observed in carcinogenicity studies conducted in rats and mice.
Croatian: U ispitivanjima kancerogenosti primijećena je povećana incidencija tumora jetre u štakora i miševa.
English: The parent substance is predominantly metabolised to 5-carboxy-pirfenidone.
Croatian: Ishodišni spoj se prvenstveno metabolizira u 5-karboksi-pirfenidon.
English: ● Esbriet is contraindicated in patients with severe hepatic impairment or end stage liver disease.
Croatian: • Esbriet je kontraindiciran u bolesnika s teškim oštećenjem funkcije jetre ili u terminalnoj fazi jetrene bolesti.
English: The clinical efficacy of Esbriet has been studied in four Phase 3, multicentre, randomised, double-blind, placebo-controlled studies in patients with IPF.
Croatian: Klinička djelotvornost lijeka Esbriet ispitivana je u četirima multicentričnim, randomiziranim, dvostruko slijepim, placebom kontroliranim ispitivanjima faze 3 u bolesnika s IPF-om.
English: For patients with confirmed elevations in ALT, AST or bilirubin during treatment, the following dose adjustments may be necessary.
Croatian: U bolesnika s potvrđenim porastom razine ALT-a, AST-a ili bilirubina tijekom liječenja možda će biti potrebne sljedeće prilagodbe doze.
English: In vitro data indicate some pharmacologically relevant activity of the major metabolite (5-carboxy-pirfenidone) at concentrations in excess of peak plasma concentrations in IPF patients.
Croatian: Podaci dobiveni in vitro ukazuju na određenu farmakološki značajnu aktivnost glavnog metabolita (5-karboksi-pirfenidona) pri koncentracijama višima od vršnih koncentracija u plazmi bolesnika s IPF-om.
English: Exposure to 5-carboxy-pirfenidone increases 3.5 fold or more in patients with moderate renal impairment.
Croatian: Izloženost 5-karboksi-pirfenidonu povećava se 3,5 puta ili više u bolesnika s umjerenim oštećenjem funkcije bubrega.
English: ● if you are allergic to pirfenidone or any of the other ingredients of this medicine (listed in section 6)
Croatian: Nemojte uzimati Esbriet • ako ste alergični na pirfenidon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: ● fluvoxamine (used to treat depression and obsessive compulsive disorder (OCD)).
Croatian: • fluvoksamin (koristi se za liječenje depresije i opsesivno kompulzivnog poremećaja (OKP))
English: 250 ml white HDPE bottle with child-resistant closure containing 270 capsules.
Croatian: Bijela boca od polietilena visoke gustoće (HDPE) volumena 250 ml sa sigurnosnim zatvaračem za djecu, koja sadrži 270 kapsula.
English: The safety checklist about Esbriet should contain the following key elements related to liver function and photosensitivity:
Croatian: • Informacije za bolesnike (Uputa o lijeku) Kontrolni popis za provjeru sigurnosti primjene lijeka Esbriet mora sadržavati sljedeće ključne elemente koji se odnose na funkciju jetre i fotoosjetljivost:
English: ● skin problems such as itchy skin, skin redness or red skin, dry skin, skin rash
Croatian: • kožne tegobe kao što su svrbež, crvenilo, suha koža, kožni osip
English: If for any reason you have to stop taking Esbriet for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg 3 times a day, gradually increasing this to a dose of 801 mg 3 times a day.
Croatian: Ako iz bilo kojeg razloga morate prestati uzimati Esbriet na više od 14 uzastopnih dana, Vaš će liječnik ponovo započeti liječenje dozom od 267 mg 3 puta na dan, postupno povećavajući dozu do 801 mg 3 puta 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
Croatian: • ako ste tijekom prethodne primjene pirfenidona imali angioedem, uključujući simptome poput oticanja lica, usana i/ili jezika, koji mogu biti povezani s otežanim disanjem ili piskanjem pri disanju
English: Fluvoxamine and inhibitors of CYP1A2
Croatian: Fluvoksamin i inhibitori CYP1A2
English: Results showed that there was a mean increase of 60% in pirfenidone exposure after a single dose of 801 mg pirfenidone (3 x 267 mg capsule) in patients with moderate hepatic impairment.
Croatian: Rezultati su ukazali na srednje povećanje izloženosti pirfenidonu od 60% nakon primjene jednokratne doze pirfenidona od 801 mg (3 x 1 kapsula od 267 mg) u bolesnika s umjerenim oštećenjem funkcije jetre.
English: The dose of pirfenidone may be reduced to 801 mg each day (267 mg three times a day).
Croatian: Doza pirfenidona može se smanjiti na 801 mg svaki dan (267 mg triput na dan).
English: A statistically significant increase in uterine tumours was observed in female rats administered 1,500 mg/kg/day, 37 times the human dose of 2,403 mg/day.
Croatian: Statistički značajan porast tumora uterusa primijećen je u ženki štakora kojima je primjenjivana doza od 1500 mg/kg/dan, koja je 37 puta veća od doze za ljude od 2403 mg/dan.
English: 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 3 capsules (for the Week 1 dosing), packaged together with 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 6 capsules (for the Week 2 dosing).
Croatian: 7 x PVC/PE/PCTFE blister traka od aluminijske folije, od kojih svaka sadrži 3 kapsule (za 1. tjedan primjene), pakiranih zajedno sa 7 x PVC/PE/PCTFE blister traka od aluminijske folije, od kojih svaka sadrži 6 kapsula (za 2. tjedan primjene).
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.
Croatian: U slučaju značajnog porasta razine jetrenih aminotransferaza, potrebno je prilagoditi dozu lijeka Esbriet ili prekinuti liječenje sukladno smjernicama navedenima u nastavku.
English: Upon initiating treatment, the dose should be titrated to the recommended daily dose of 2403 mg/day over a 14-day period as follows:
Croatian: Na početku liječenja dozu treba titrirati tijekom razdoblja od 14 dana do preporučene dnevne doze od 2403 mg/dan na sljedeći način:
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.
Croatian: In vitro i in vivo ekstrapolacije ukazuju na to da snažni i selektivni inhibitori CYP1A2 (npr. enoksacin) mogu povećati izloženost pirfenidonu približno 2 do 4 puta.
English: ● Patients should be instructed to use a sunblock daily, to wear clothing that protects against sun exposure, and to avoid other medications known to cause photosensitivity.
Croatian: • Bolesnike treba uputiti da svakodnevno koriste sredstva sa zaštitu od sunca, da nose odjeću koja ih štiti od izloženosti suncu i da izbjegavaju druge lijekove za koje se zna da uzrokuju fotoosjetljivost.
English: Medicines that may increase side effects of Esbriet:
Croatian: Lijekovi koji mogu pojačati nuspojave lijeka Esbriet:
English: The effect of food on pirfenidone oral AUC was consistent between the tablet and capsule formulations.
Croatian: Učinak hrane na AUC pirfenidona nakon peroralne primjene bio je podudaran kod primjene tableta i kapsula.