FrancophonIA/ELRC3.0 huggingface dataset:
English: If dizziness does not improve or if it worsens in severity, dose adjustment or even discontinuation of Esbriet may be warranted.
Croatian: Ako se omaglica ne poboljša ili ako se pogorša, možda će biti potrebno prilagoditi dozu ili čak prekinuti terapiju lijekom Esbriet.
English: In subjects with moderate hepatic impairment (i.e. Child-Pugh Class B), pirfenidone exposure was increased by 60%.
Croatian: U bolesnika s umjerenim oštećenjem funkcije jetre (tj. stadija B prema Child-Pugh klasifikaciji), izloženost pirfenidonu povećala se za 60%.
English: ● History of angioedema with pirfenidone (see section 4.4).
Croatian: ● Anamneza angioedema kod primjene pirfenidona (vidjeti dio 4.4).
English: Pirfenidone
Croatian: Pirfenidon
English: In the case of moderate inducers of CYP1A2 (e.g. omeprazole), concomitant use may theoretically result in a lowering of pirfenidone plasma levels.
Croatian: U slučaju umjerenih induktora CYP1A2 (npr. omeprazol), istodobna primjena može teoretski uzrokovati sniženje razine pirfenidona u plazmi.
English: 84 film-coated tablets.
Croatian: 84 filmom obložene tablete.
English: Patients should be monitored closely for signs of toxicity especially if they are concomitantly taking a known CYP1A2 inhibitor (see sections 4.5 and 5.2).
Croatian: Bolesnike treba pažljivo nadzirati zbog moguće pojave znakova toksičnosti, osobito ako istodobno uzimaju poznati inhibitor CYP1A2 (vidjeti dijelove 4.5 i 5.2).
English: It is unknown whether pirfenidone or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se pirfenidon ili njegovi metaboliti u majčino mlijeko u ljudi.
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.
Croatian: Bolesnike treba uputiti da svakodnevno koriste sredstva zaštitu od sunca, nose odjeću koja ih štiti od izloženosti suncu i izbjegavaju druge lijekove za koje se zna da uzrokuju fotoosjetljivost.
English: When tested under UV exposure pirfenidone was positive in a photoclastogenic assay in Chinese hamster lung cells.
Croatian: UV svjetlosti, pirfenidon je bio pozitivan u fotoklastogenom testu na kulturi plućnih stanica kineskog hrčka.
English: Pharmacotherapeutic group: Immunosuppressants, other immunosuppressants, ATC code: L04AX05 The mechanism of action of pirfenidone has not been fully established.
Croatian: Farmakoterapijska skupina: Imunosupresivi, ostali imunosupresivi, ATK oznaka: L04AX05
English: At high doses (≥450 mg/kg/day) rats exhibited a prolongation of oestrous cycle and a high incidence of irregular cycles.
Croatian: (≥450 mg/kg/dan) u štakora zabilježeni produženje estrusnog ciklusa i visoka incidencija nepravilnih ciklusa.
English: As it is unknown whether Esbriet passes into breast milk, your doctor will discuss the risks and benefits of taking this medicine while breast-feeding if you decide to do so.
Croatian: Budući da nije poznato izlučuje li se Esbriet u majčino mlijeko, ako odlučite dojiti, Vaš će liječnik s Vama razgovarati o rizicima i koristima uzimanja ovog lijeka tijekom dojenja.
English: ● enoxacin (a type of antibiotic)
Croatian: • enoksacin (vrsta antibiotika) • ciprofloksacin (vrsta antibiotika)
English: The 4-week treatment pack contains a total of 252 capsules.
Croatian: Pakiranje za 4-tjedno liječenje sadrži ukupno 252 kapsule.
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.
Croatian: Nakon peroralne primjene jednokratne doze od 801 mg u stanju sitosti u zdravih odraslih starijih dobrovoljaca (u dobi od 50-66 godina), brzina apsorpcije pirfenidona se smanjila, dok je vrijednost AUC-a u bolesnika s punim želucem iznosila približno 80-85% vrijednosti AUC-a opaženih u bolesnika koji su lijek uzeli natašte.
English: In a multiple-dose, dose-ranging study in healthy older adults administered doses ranging from 267 mg to 1,335 mg three times a day, the mean clearance decreased by approximately 25% above a dose of 801 mg three times a day.
Croatian: U ispitivanju primjene višestrukih doza različitih jačina u zdravih starijih odraslih ispitanika, u kojem su se primjenjivale doze od 267 mg do 1335 mg triput na dan, srednja vrijednost klirensa smanjila se za približno 25% kod primjene doza većih od 801 mg triput na dan.
English: ● propafenone (used to treat some types of heart disease)
Croatian: • propafenon (koristi se za liječenje nekih srčanih bolesti)
English: Decline of less than 10% No decline (FVC change >0%)
Croatian: Pad manji od 10% Bez pada (promjena FVC >0%)
English: ● Capsule shell: gelatin, titanium dioxide (E171)
Croatian: • ovojnica kapsule: želatina, titanijev dioksid (E171)
English: If you forget to take Esbriet
Croatian: Ako ste zaboravili uzeti Esbriet
English: Patients should be closely monitored for emergence of adverse reactions associated with Esbriet therapy.
Croatian: Bolesnike treba pomno nadzirati zbog moguće pojave nuspojava povezanih s liječenjem lijekom Esbriet.
English: B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Multiple doses of pirfenidone up to a total dose of 4,806 mg/day were administered as six 267 mg capsules three times daily to healthy adult volunteers over a 12-day dose escalation period.
Croatian: Višestruke doze pirfenidona do ukupne doze od 4806 mg/dan primjenjivale su se u obliku 6 kapsula od 267 mg triput na dan zdravim odraslim dobrovoljcima tijekom 12-dnevnog razdoblja postupnog povećanja doze.
English: Angioedema/Anaphylaxis
Croatian: Angioedem/anafilaksija
English: For treatment interruption of less than 14 consecutive days, the dose can be resumed at the previous recommended daily dose without titration.
Croatian: Kod privremenog prekida liječenja kraćeg od 14 uzastopnih dana, liječenje se može nastaviti dotadašnjom preporučenom dnevnom dozom bez titracije.
English: Table 1 shows the adverse reactions reported at a frequency of ≥2% in 623 patients receiving Esbriet at the recommended dose of 2,403 mg/day in three pooled pivotal Phase 3 studies.
Croatian: Tablica 1 prikazuje nuspojave prijavljene s učestalošću od ≥2% u objedinjenim podacima prikupljenima u 623 bolesnika koji su primali Esbriet u preporučenoj dozi od 2403 mg/dan tijekom triju pivotalnih kliničkih ispitivanja faze 3.
English: Skin and subcutaneous tissue disorders Very Common Photosensitivity reaction; rash Common
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često reakcija fotoosjetljivosti, osip
English: Treatment with Esbriet should be started and overseen by a specialist doctor experienced in the diagnosis and treatment of IPF.
Croatian: Liječenje lijekom Esbriet treba započeti i nadgledati liječnik specijalist s iskustvom u dijagnosticiranju i liječenju IPF-a.
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.
Croatian: Farmakokinetika pirfenidona i metabolita 5-karboksi-pirfenidona uspoređivala se u ispitanika s umjerenim oštećenjem funkcije jetre (stadij B prema Child-Pugh klasifikaciji) i ispitanika s normalnom funkcijom jetre.
English: 2-week treatment initiation pack
Croatian: Pakiranje za 2-tjedni početak liječenja
English: The capsules are to be swallowed whole with water and taken with food to reduce the possibility of nausea and dizziness (see sections 4.8 and 5.2).
Croatian: Kapsula se mora progutati cijela s vodom i uzimati s hranom kako bi se smanjila mogućnost pojave mučnine i omaglice (vidjeti dijelove 4.8 i 5.2).
English: The 2-week treatment initiation pack contains a total of 63 capsules.
Croatian: Pakiranje za 2-tjedni početak liječenja sadrži ukupno 63 kapsule.
English: The severity of phototoxic lesions was minimised by application of sunscreen.
Croatian: Težina fototoksičnih lezija umanjena je primjenom krema za zaštitu od sunca.
English: EU/1/11/667/010 90 tablets
Croatian: EU/1/11/667/010 90 tableta
English: ● If you have any further questions, ask your doctor or pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
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.
Croatian: Najveći dio pirfenidona izlučuje se u obliku metabolita 5-karboksi-pirfenidona (>95% izlučene doze), dok se manje od 1% izlučuje mokraćom u neizmijenjenom obliku.
English: The blisters pack contains 84 film-coated tablets and the multipack contains 252 (continuation pack 3x84) film-coated tablets.
Croatian: Pakiranja u blisteru sadrže 84 filmom obložene tablete, a višestruka pakiranja sadrže 252 (pakiranje za nastavak liječenja 3x84) filmom obložene tablete.
English: Esbriet contains the active substance pirfenidone and it is used for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adults.
Croatian: Esbriet sadrži djelatnu tvar pirfenidon i koristi se za liječenje blagih do umjerenih oblika idiopatske plućne fibroze (IPF) u odraslih.
English: Esbriet is for oral use.
Croatian: Esbriet se primjenjuje peroralno.
English: 534 mg tablet
Croatian: Tableta od 534 mg
English: If you are breast-feeding or plan to breast-feed speak to your doctor or pharmacist before taking Esbriet.
Croatian: Ako dojite ili planirate dojiti, razgovarajte sa svojim liječnikom ili ljekarnikom prije nego što počnete uzimati Esbriet.
English: This may become clinically relevant in patients with moderate renal impairment where plasma exposure to 5-carboxy-pirfenidone is increased.
Croatian: To može imati klinički značaj u bolesnika s umjerenim oštećenjem bubrežne funkcije u kojih je povećana izloženost 5-karboksi pirfenidonu u plazmi.
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.
Croatian: ako primijetite žutu boju očiju ili kože ili tamnu mokraću, koji mogu biti praćeni svrbežom kože, što su znakovi odstupanja u nalazima testova jetrene funkcije.
English: The studies were nearly identical in design, with few exceptions including an intermediate dose group (1,197 mg/day) in PIPF-004.
Croatian: Oba su ispitivanja bila gotovo identično dizajnirana, uz nekoliko iznimaka, uključujući skupinu ispitanika u ispitivanju PIPF-004 koja je primala srednju dozu lijeka (1197 mg/dan).
English: ● You should tell your doctor if you suffer from mild to moderate liver problems.
Croatian: • Recite svom liječniku ako imate blage do umjerene tegobe s jetrom.
English: Treatment with Esbriet should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF.
Croatian: Liječenje lijekom Esbriet treba započeti i nadgledati liječnik specijalist koji ima iskustva s dijagnosticiranjem i liječenjem IPF-a.
English: ● stomach problems such as acid reflux, vomiting, feeling bloated, abdominal pain and discomfort, heart burn, feeling constipated and passing wind
Croatian: • želučane tegobe kao što su povrat kiseline, povraćanje, osjećaj nadutosti, bol i nelagoda u trbuhu, žgaravica, osjećaj zatvora i puštanje vjetrova
English: At Week 72, a decline in FVC of ≥10% was seen in 23% of patients receiving Esbriet and 27% receiving placebo (Table 3).
Croatian: U 72. tjednu, pad FVC-a za ≥10% primijećen je u 23% bolesnika koji su primali Esbriet i 27% bolesnika koji su primali placebo (Tablica 3).
English: Gastroesophageal reflux disease; vomiting; abdominal distension; abdominal discomfort; abdominal pain; abdominal pain upper; stomach discomfort; gastritis; constipation; flatulence
Croatian: Često gastroezofagealna refluksna bolest, povraćanje, distenzija abdomena, nelagoda u abdomenu, bol u abdomenu, bol u gornjem dijelu abdomena, nelagoda u želucu, gastritis, konstipacija, flatulencija
English: INFORMATION IN BRAILLE Esbriet
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Esbriet
English: Compared to the fasted state, administration of either formulation with food reduced pirfenidone Cmax, with Esbriet tablet reducing the Cmax slightly less (by 40%) than Esbriet capsules (by 50%).
Croatian: U usporedbi s primjenom natašte, primjena bilo koje od formulacija s hranom smanjila je Cmax pirfenidona, s time da je Esbriet tableta smanjila Cmax nešto manje (za 40%)
English: The bottle packs contain one bottle containing 21 tablets, two bottles each containing 21 tablets (42 tablets in total), one bottle containing 42 tablets, one bottle containing 90 tablets, two bottles each containing 90 tablets (180 tablets in total) or one bottle containing 180 tablets.
Croatian: U pakiranju se nalazi jedna boca koja sadrži 21 tabletu, dvije boce od kojih svaka sadrži 21 tabletu (ukupno 42 tablete), jedna boca koja sadrži 42 tablete, jedna boca koja sadrži 90 tableta, dvije boce od kojih svaka sadrži 90 tableta (ukupno 180 tableta) ili jedna boca koja sadrži 180 tableta.
English: Dizziness; somnolence; dysgeusia; lethargy
Croatian: Često omaglica, somnolencija, disgeuzija, letargija
English: The blisters strips in the 2-week treatment initiation pack and 4-week treatment maintenance pack are each marked with the following symbols as a reminder to take a dose three times a day:
Croatian: Blister trake u pakiranju za 2-tjedni početak liječenja i pakiranju za 4-tjednu terapiju održavanja označene su sljedećim simbolima kao podsjetnik da dozu treba uzeti triput dnevno:
English: Mean apparent oral steady-state volume of distribution is approximately 70 l, indicating that pirfenidone distribution to tissues is modest.
Croatian: Nakon peroralne primjene, srednja vrijednost prividnog volumena distribucije u stanju dinamičke ravnoteže iznosi približno 70 l, što ukazuje na umjerenu distribuciju pirfenidona u tkiva.
English: The tablets are to be swallowed whole with water and taken with food to reduce the possibility of nausea and dizziness (see sections 4.8 and 5.2).
Croatian: Tablete se moraju progutati cijele s vodom i uzimati s hranom kako bi se smanjila mogućnost pojave mučnine i omaglice (vidjeti dijelove 4.8 i 5.2).
English: Clinically relevant pharmacodynamic activity of the metabolite in patients with moderate renal impairment cannot be excluded.
Croatian: Ne može se isključiti klinički značajna farmakodinamička aktivnost metabolita u bolesnika s umjerenim oštećenjem funkcije bubrega.
English: The bottle packs contain either one bottle containing 21 tablets or one bottle containing 90 tablets.
Croatian: U pakiranju se nalazi ili jedna boca koja sadrži 21 tabletu ili jedna boca koja sadrži 90 tableta.
English: The bottle pack contains one bottle containing 90 tablets.
Croatian: U pakiranju se nalazi jedna boca koja sadrži 90 tableta.
English: Patients who experience severe photosensitivity reaction or rash should be instructed to interrupt the dose and to seek medical advice (see section 4.4).
Croatian: Bolesnike koji razviju tešku reakciju fotoosjetljivosti ili težak osip treba uputiti da prestanu uzimati lijek i potraže savjet liječnika (vidjeti dio 4.4).
English: Photosensitivity reaction or rash: Patients who experience a mild to moderate photosensitivity reaction or rash should be reminded to use a sunblock daily and avoid exposure to the sun (see section 4.4).
Croatian: Reakcija fotoosjetljivosti ili osip: Bolesnike u kojih se pojave blaga do umjerena reakcija fotoosjetljivosti ili osip treba podsjetiti da svakodnevno koriste sredstva za zaštitu od sunca i izbjegavaju izlaganje suncu (vidjeti dio 4.4).
English: Asthenia; non-cardiac chest pain Injury poisoning and procedural complications Common
Croatian: Često astenija, bol u prsištu nevezana uz srce Ozljede, trovanja i proceduralne komplikacije
English: The most frequently reported adverse reactions during clinical study experience with Esbriet at a dose of 2,403 mg/day compared to placebo, respectively, were nausea (32.4% versus 12.2%), rash (26.2% versus 7.7%), diarrhoea (18.8% versus 14.4%), fatigue (18.5% versus 10.4%), dyspepsia (16.1% versus 5.0%), anorexia (11.4% versus 3.5%), headache (10.1% versus 7.7%), and photosensitivity reaction (9.3% versus 1.1%).
Croatian: Najčešće prijavljene nuspojave tijekom kliničkih ispitivanja primjene lijeka Esbriet u dozi od 2403 mg/dan u usporedbi s placebom bile su mučnina (32,4% naspram 12,2%), osip (26,2% naspram 7,7%), proljev (18,8% naspram 14,4%), umor (18,5% naspram 10,4%), dispepsija (16,1% naspram 5,0%), anoreksija (11,4% naspram 3,5%), glavobolja (10,1% naspram 7,7%) i reakcija fotoosjetljivosti (9,3% naspram 1,1%).
English: Available pharmacokinetic data in animals have shown excretion of pirfenidone and/or its metabolites in milk with the potential for accumulation of pirfenidone and/or its metabolites in milk (see section 5.3).
Croatian: Dostupni podaci iz ispitivanja farmakokinetike na životinjama pokazuju da se pirfenidon i/ili njegovi metaboliti izlučuju u mlijeko i da se u njemu kumuliraju (vidjeti dio 5.3).
English: Esbriet should be used with caution in patients with pre-existing mild to moderate hepatic impairment (i.e. Child-Pugh Class A and B) given the potential for increased pirfenidone exposure.
Croatian: Esbriet treba primjenjivati uz oprez u bolesnika s postojećim blagim do umjerenim oštećenjem funkcije jetre (tj. stadija A i B prema Child-Pugh klasifikaciji) jer postoji mogućnost povećane izloženosti pirfenidonu.
English: Esbriet is contraindicated in patients with concomitant use of fluvoxamine (see section 4.3).
Croatian: Esbriet je kontraindiciran u bolesnika koji istodobno uzimaju fluvoksamin (vidjeti dio 4.3).
English: Film-coated tablet (tablet).
Croatian: Filmom obložena tableta (tableta)
English: Studies in lactating rats indicate that pirfenidone and/or its metabolites are excreted in milk with the potential for accumulation of pirfenidone and/or its metabolites in milk.
Croatian: Ispitivanja na ženkama štakora u laktaciji pokazuju da se pirfenidon i/ili njegovi metaboliti izlučuju u mlijeku, pri čemu može doći do kumulacije pirfenidona i/ili njegovih metabolita u mlijeku.
English: ● indigestion or stomach upset
Croatian: • probavne tegobe ili nadražen želudac
English: ● weight loss
Croatian: • gubitak tjelesne težine
English: Paediatric population There is no relevant use of Esbriet in the paediatric population for the indication of IPF.
Croatian: Pedijatrijska populacija Nema relevantne primjene lijeka Esbriet u pedijatrijskoj populaciji za liječenje IPF-a.
English: Pirfenidone should be used with caution in patients with mild to moderate hepatic impairment and patients should be monitored closely for signs of toxicity especially if they are concomitantly taking a known CYP1A2 inhibitor (see sections 4.2 and 4.4).
Croatian: Pirfenidon stoga treba primjenjivati uz oprez u bolesnika s blagim do umjerenim oštećenjem funkcije jetre i takve bolesnike treba pažljivo nadzirati zbog moguće pojave znakova toksičnosti, osobito ako istodobno uzimaju poznati inhibitor CYP1A2 (vidjeti dijelove 4.2 i 4.4).
English: Exposure to direct sunlight (including sunlamps) should be avoided or minimised during treatment with Esbriet.
Croatian: Tijekom liječenja lijekom Esbriet, izlaganje izravnoj sunčevoj svjetlosti (uključujući lampe za sunčanje) treba izbjegavati ili svesti na najmanju moguću mjeru.
English: ● Close monitoring is required of any patients who develop liver enzyme elevation with appropriate dose adjustment or discontinuation.
Croatian: • Potrebno je pažljivo pratiti bolesnike u kojih dođe do porasta razine jetrenih enzima te prilagoditi dozu na odgovarajući način ili potpuno prekinuti terapiju.
English: The 267 mg blisters strips containing 63 film-coated tablets are each marked with the following symbols and abbreviated names of the day as a reminder to take a dose three times a day:
Croatian: Svaka blister traka sa 63 filmom obložene tablete od 267 mg označena je sljedećim simbolima i skraćenicama imena dana u tjednu, kao podsjetnik da dozu treba uzeti triput dnevno:
English: Dose adjustments and other considerations for safe use Gastrointestinal events: In patients who experience intolerance to therapy due to gastrointestinal undesirable effects, patients should be reminded to take the medicinal product with food.
Croatian: Probavne smetnje: Bolesnike koji ne podnose terapiju zbog gastrointestinalnih nuspojava treba podsjetiti da lijek uzimaju s hranom.
English: Two piece capsules with a white to off-white opaque body and white to off-white opaque cap imprinted with “PFD 267 mg” in brown ink and containing a white to pale yellow powder.
Croatian: Dvodijelne kapsule s neprozirnim tijelom bijele do bjelkaste boje i neprozirnom kapicom bijele do bjelkaste boje na kojoj je smeđom tintom otisnuto 'PFD 267 mg' i koje sadrže bijeli do blijedožuti prašak.
English: PIPF-004 and PIPF-006 compared treatment with Esbriet 2403 mg/day to placebo.
Croatian: U ispitivanjima PIPF-004 i PIPF-006 uspoređivalo se liječenje lijekom Esbriet u dozi od 2403 mg/dan s placebom.
English: Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
Croatian: Esbriet je indiciran u odraslih osoba za liječenje blagih do umjereno teških oblika idiopatske plućne fibroze (IPF).
English: Photosensitivity
Croatian: Fotoosjetljivost
English: Esbriet must not be used in patients with a history of angioedema or hypersensitivity due to Esbriet (see section 4.3).
Croatian: Esbriet se ne smije koristiti u bolesnika s anamnezom angioedema ili preosjetljivosti zbog primjene lijeka Esbriet (vidjeti dio 4.3).
English: Discontinue Esbriet if necessary (see sections 4.2 and 4.4).
Croatian: Ako je potrebno, primjenu lijeka Esbriet treba prekinuti (vidjeti dijelove 4.2 i 4.4).
English: There are 14 x 2-day blister strips each containing 18 capsules (3 capsules per pocket).
Croatian: Sveukupno ima 14 blister traka za 2-dnevno liječenje, od kojih svaka sadrži 18 kapsula (3 kapsule po odjeljku).
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment (i.e. Child-Pugh Class A and B).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim do umjerenim oštećenjem funkcije jetre (tj. stadija A i B prema Child-Pugh klasifikaciji).
English: Fluvoxamine should be discontinued prior to the initiation of Esbriet therapy and avoided during Esbriet therapy due to the reduced clearance of pirfenidone.
Croatian: Zbog smanjenog klirensa pirfenidona, primjenu fluvoksamina treba prekinuti prije započinjanja terapije lijekom Esbriet i izbjegavati tijekom terapije lijekom Esbriet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL - INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA - UNUTARNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: 267 mg tablet
Croatian: Tableta od 267 mg
English: 801 mg tablet
Croatian: Tableta od 801 mg
English: How to store Esbriet
Croatian: Kako čuvati Esbriet
English: If symptoms persist, the dose of pirfenidone may be reduced to 267 mg - 534 mg, two to three times a day with food with re-escalation to the recommended daily dose as tolerated.
Croatian: Ako simptomi potraju, doza pirfenidona može se smanjiti na 267 mg - 534 mg dva do tri puta na dan s hranom, uz postupno povećavanje do preporučene dnevne doze prema podnošljivosti.
English: If symptoms persist, the dose of pirfenidone may be reduced to 1-2 capsules (267 mg - 534 mg) two to three times/day with food with re-escalation to the recommended daily dose as tolerated.
Croatian: Ako simptomi potraju, doza pirfenidona može se smanjiti na 1-2 kapsule (267 mg - 534 mg) dva do tri puta na dan s hranom, uz postupno povećavanje do preporučene dnevne doze prema podnošljivosti.