FrancophonIA/ELRC3.0 huggingface dataset:
English: At high doses (≥1,000 mg/kg/day) rats exhibited a prolongation of gestation and reduction in fetal viability.
Croatian: Pri visokim je dozama (≥1000 mg/kg/dan) u štakora došlo do produženja gestacije i smanjenja sposobnosti preživljenja ploda.
English: No clinically relevant differences in the pharmacokinetics of pirfenidone were observed in subjects with mild to severe renal impairment compared with subjects with normal renal function.
Croatian: Nisu primijećene klinički značajne razlike u farmakokinetici pirfenidona u ispitanika s blagim do teškim oštećenjem funkcije bubrega u usporedbi s ispitanicima s normalnom bubrežnom funkcijom.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Funkcija jetre
English: Upper respiratory tract infection; urinary tract infection Blood and lymphatic system disorders Rare
Croatian: Često infekcija gornjih dišnih putova, infekcija mokraćnih putova Poremećaji krvi i limfnog sustava
English: Two percent of patients had percent predicted FVC below 50% and 21% of patients had a percent predicted DLCO below 35% at Baseline.
Croatian: Na početku ispitivanja, 2% bolesnika imalo je postotak predviđenog FVC-a manji od 50%, dok je 21% bolesnika imalo postotak predviđenog DLCO manji od 35%.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 267 mg pirfenidone.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna kapsula sadrži 267 mg pirfenidona.
English: The mean (SD) AUC0-∞ of 5carboxy-pirfenidone was significantly higher in the moderate (p = 0.009) and severe (p < 0.0001) renal impairment groups than in the group with normal renal function; 100 (26.3) mg•h/L and 168 (67.4)
Croatian: Srednje vrijednosti (standardno odstupanje, SD) AUC0-∞ za 5-karboksi-pirfenidon bile su značajno više u skupinama s umjerenim (p=0,009) i teškim (p<0,0001) oštećenjem funkcije bubrega nego u skupini s normalnom bubrežnom funkcijom; 100 (26,3) mg•h/l odnosno 168 (67,4) mg•h/l u usporedbi s 28,7 (4,99) mg•h/l.
English: Additionally, in an ad hoc analysis, 33% of patients receiving Esbriet showed a decline of ≥50 m in 6MWT distance, compared to 47% of patients receiving placebo in PIPF-006.
Croatian: Osim toga, ad hoc analiza pokazala je da se u 33% bolesnika koji su primali Esbriet udaljenost prijeđena tijekom 6MWT testa smanjila za ≥50 m, dok je isto primijećeno u 47% bolesnika koji su primali placebo u ispitivanju PIPF-006.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER STRIPS BLISTER STRIPS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER TRAKE
English: Agranulocytosis1
Croatian: Rijetko agranulocitoza1
English: 267 mg tablet Iron oxide yellow (E172) 534 mg tablet Iron oxide yellow (E172) Iron oxide red (E172) 801 mg tablet Iron oxide red (E172) Iron oxide black (E172)
Croatian: Tableta od 267 mg željezov oksid, žuti (E172) Tableta od 534 mg željezov oksid, žuti (E172) željezov oksid, crveni (E172) Tableta od 801 mg željezov oksid, crveni (E172) željezov oksid, crni (E172)
English: Approximately 70-80% of pirfenidone is metabolised via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6, and 2E1.
Croatian: Približno 70-80% pirfenidona metabolizira se uz pomoć CYP1A2, uz manji doprinos drugih CYP izoenzima, uključujući CYP2C9, 2C19, 2D6 i 2E1.
English: c p-value versus Normal < 0.0001 (pair-wise comparison with Bonferroni)
Croatian: c p-vrijednost naspram normalne funkcije < 0,0001 (usporedba parova uz Bonferronijevu korekciju)
English: The study (SP3) in Japanese patients compared pirfenidone 1800 mg/day (comparable to 2403 mg/day in the US and European populations of PIPF-004/006 on a weight-normalised basis) with placebo (N=110, N=109, respectively).
Croatian: U ispitivanju provedenom s japanskim bolesnicima (SP3) uspoređivali su se pirfenidon u dozi od 1800 mg/dan (koja je usporediva s dozom od 2403 mg/dan u američkoj [SAD] i europskoj populaciji iz ispitivanja PIPF-004/006 s obzirom na tjelesnu težinu ispitanika) i placebo (N=110 odnosno N=109).
English: Once liver function tests are within normal limits Esbriet may be re-escalated to the recommended daily dose if tolerated.
Croatian: Nakon što se nalazi testova jetrene funkcije vrate u normalu, Esbriet se može ponovno uvesti u liječenje, uz postupno povećavanje doze do preporučene dnevne doze, ako je bolesnik podnosi.
English: Clinical particulars
Croatian: KLINIČKI PODACI
English: What Esbriet looks like and contents of the pack Esbriet hard capsules (capsules) have a white to off-white opaque body and a white to off-white opaque cap with ‘PFD 267 mg' printed in brown ink.
Croatian: Esbriet tvrde kapsule (kapsule) imaju neprozirno tijelo bijele do bjelkaste boje i neprozirnu kapicu bijele do bjelkaste boje s oznakom 'PFD 267 mg' otisnutom smeđom tintom.
English: ● Concomitant use of fluvoxamine (see section 4.5).
Croatian: ● Istodobna primjena fluvoksamina (vidjeti dio 4.5).
English: EU/1/11/667/012 21 tablets EU/1/11/667/013 42 tablets (2 x 21) EU/1/11/667/014 84 tablets (4 x 21) EU/1/11/667/015 168 tablets (8 x 21)
Croatian: EU/1/11/667/012 21 tableta EU/1/11/667/013 42 tablete (2 x 21) EU/1/11/667/014 84 tablete (4 x 21) EU/1/11/667/015 168 tableta (8 x 21)
English: In a Phase 1 study, the co-administration of Esbriet and fluvoxamine (a strong inhibitor of CYP1A2 with inhibitory effects on other CYP isoenzymes [CYP2C9, 2C19, and 2D6]) resulted in a 4-fold increase in exposure to pirfenidone in non-smokers.
Croatian: U jednom ispitivanju faze 1 istodobna primjena lijeka Esbriet i fluvoksamina (snažnog inhibitora CYP1A2 koji ima inhibicijski učinak i na druge CYP izoenzime [CYP2C9, 2C19, i 2D6]) rezultirala je četverostrukim povećanjem izloženosti pirfenidonu u nepušača.
English: Myalgia; arthralgia
Croatian: Često mialgija, artralgija
English: 1 blister containing 21 film-coated tablets (21 in total) 2 blisters each containing 21 film-coated tablets (42 in total) 4 blisters each containing 21 film-coated tablets (84 in total) 8 blisters each containing 21 Film-coated tablets (168 in total)
Croatian: 1 blister koji sadrži 21 filmom obloženu tabletu (ukupno 21) 2 blistera, od kojih svaki sadrži 21 filmom obloženu tabletu (ukupno 42) 4 blistera, od kojih svaki sadrži 21 filmom obloženu tabletu (ukupno 84) 8 blistera, od kojih svaki sadrži 21 filmom obloženu tabletu (ukupno 168)
English: The primary endpoint in both studies was the change from Baseline to Week 72 in percent predicted Forced Vital Capacity (FVC).
Croatian: Primarna mjera ishoda u oba ispitivanja bila je promjena postotka predviđenog forsiranog vitalnog kapaciteta (engl. forced vital capacity, FVC) od početka ispitivanja do 72. tjedna liječenja.
English: Special care should also be exercised if CYP1A2 inhibitors are being used concomitantly with potent inhibitors of one or more other CYP isoenzymes involved in the metabolism of pirfenidone such as CYP2C9 (e.g. amiodarone, fluconazole), 2C19 (e.g. chloramphenicol) and 2D6 (e.g. fluoxetine, paroxetine).
Croatian: Poseban oprez potreban je i ako se istodobno s inhibitorima CYP1A2 primjenjuju snažni inhibitori jednog ili više drugih izoenzima CYP uključenih u metabolizam pirfenidona, kao što su CYP2C9 (npr. amiodaron, flukonazol), 2C19 (npr. kloramfenikol) i 2D6 (npr. fluoksetin, paroksetin).
English: ● You should tell your doctor if you suffer from kidney problems.
Croatian: • Recite svom liječniku ako imate tegobe s bubrezima.
English: Esbriet should be used with caution in patients with moderate (CrCl 30-50 ml/min) renal impairment.
Croatian: Esbriet je potrebno primjenjivati uz oprez kod bolesnika s umjerenim (klirens kreatinina 30-50 ml/min)
English: EU/1/11/667/005 21 tablets EU/1/11/667/006 42 tablets (2 x 21) EU/1/11/667/020 42 tablets EU/1/11/667/007 90 tablets EU/1/11/667/008 180 tablets (2 x 90) EU/1/11/667/021 180 tablets
Croatian: EU/1/11/667/005 21 tableta EU/1/11/667/006 42 tablete (2 x 21) EU/1/11/667/020 42 tablete EU/1/11/667/007 90 tableta EU/1/11/667/008 180 tableta (2 x 90) EU/1/11/667/021 180 tableta
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
Croatian: IPF je kronična fibrozirajuća i upalna plućna bolest na koju utječu sinteza i otpuštanje proupalnih citokina, uključujući faktor tumorske nekroze-alfa (engl. tumour necrosis factor-alpha, TNF-α) i interleukin-1-beta (IL-1β), a pokazalo se da pirfenidon smanjuje nakupljanje upalnih stanica kao odgovor na različite stimulanse.
English: ● Elevations of serum transaminases can occur during treatment with Esbriet.
Croatian: • Tijekom liječenja lijekom Esbriet može doći do porasta razine serumskih transaminaza.
English: Your doctor may reduce your dose if you suffer from side effects such as, stomach problems, any skin reactions to sunlight or sun lamps, or significant changes to your liver enzymes.
Croatian: Ako imate nuspojave poput želučanih tegoba, bilo kakve kožne reakcije na sunčevu svjetlost ili svjetlost lampe za sunčanje ili značajne promjene u razinama jetrenih enzima, liječnik će Vam možda smanjiti dozu.
English: 42 film-coated tablets.
Croatian: 42 filmom obložene tablete.
English: Treatment with pirfenidone significantly reduced mean decline in vital capacity (VC) at Week 52 (the primary endpoint) compared with placebo (-0.09±0.02 l versus -0.16±0.02 l respectively, p=0.042).
Croatian: Liječenje pirfenidonom značajno je smanjilo srednju vrijednost smanjenja vitalnog kapaciteta (engl. vital capacity, VC) u 52. tjednu (primarna mjera ishoda) u usporedbi s placebom (-0,09 ± 0,02 l naspram -0,16 ± 0,02 l, p=0,042).
English: In a pooled analysis of survival in PIPF-004 and PIPF-006 the mortality rate with Esbriet 2403 mg/day group was 7.8% compared with 9.8% with placebo (HR 0.77 [95% CI, 0.47-1.28]).
Croatian: U analizi objedinjenih podataka o preživljenju iz ispitivanja PIPF-004 i PIPF-006, stopa smrtnosti u skupini koja je primala Esbriet u dozi od 2403 mg/dan iznosila je 7,8%, dok je u skupini koja je primala placebo iznosila 9,8% (omjer hazarda HR 0,77 [95% CI, 0,47-1,28]).
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Roche Registration GmbH.
English: 14 x PVC/PE/PCTFE aluminium foil blister strips each containing 18 capsules (2-day supply).
Croatian: 14 x PVC/PE/PCTFE blister traka od aluminijske folije, od kojih svaka sadrži 18 kapsula (količina za 2 dana liječenja).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Roche Registration GmbH
English: PIPF-016 compared treatment with Esbriet 2,403 mg/day to placebo.
Croatian: U ispitivanju PIPF-016 uspoređivalo se liječenje lijekom Esbriet u dozi od 2403 mg/dan s placebom.
English: In animals placental transfer of pirfenidone and/or its metabolites occurs with the potential for accumulation of pirfenidone and/or its metabolites in amniotic fluid.
Croatian: U životinja, pirfenidon i/ili njegovi metaboliti prolaze kroz placentu i mogu se kumulirati u amnionskoj tekućini.
English: If a patient exhibits an aminotransferase elevation to ≤5 x ULN accompanied by symptoms or hyperbilirubinaemia, Esbriet should be discontinued and the patient should not be rechallenged.
Croatian: Ako u bolesnika dođe do porasta razine aminotransferaza ≤5 x GGN praćenog simptomima ili hiperbilirubinemijom, liječenje lijekom Esbriet mora se prekinuti i ne smije se ponovno uvoditi.
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.
Croatian: Međutim, budući da u nekih bolesnika s blagim do umjerenim oštećenjem funkcije jetre razine pirfenidona u plazmi mogu biti povišene, kod liječenja takvih bolesnika lijekom Esbriet potreban je oprez.
English: 2-week treatment initiation pack (63 capsules): Week 1 - 21 capsules (7 blister strips, each with 3 capsules) Week 2 - 42 capsules (7 blister strips, each with 6 capsules)
Croatian: 1. tjedan - 21 kapsula (7 blister traka, svaka s 3 kapsule) 2. tjedan - 42 kapsule (7 blister traka, svaka sa 6 kapsula)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated tablets in Blisters
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - filmom obložene tablete u blisterima
English: 4 blisters each containing 21 film-coated tablets (84 in total)
Croatian: 4 blistera, od kojih svaki sadrži 21 filmom obloženu tabletu (ukupno 84)
English: ● Days 1 to 7: one capsule, three times a day (801 mg/day)
Croatian: • Od 1. do 7. dana: jedna kapsula, triput na dan (801 mg/dan)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4-WEEK TREATMENT MAINTENANCE PACK CONTAINING 252 CAPSULES (14 X 18 CAPSULES CONFIGURATION)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - PAKIRANJE S 252 KAPSULE ZA 4-TJEDNU TERAPIJU ODRŽAVANJA (OBLIK S 14 X 18 KAPSULA)
English: Although there was no difference between patients receiving Esbriet compared to placebo in change from Baseline to Week 72 of distance walked during a six minute walk test (6MWT) by the prespecified rank ANCOVA, in an ad hoc analysis, 37% of patients receiving Esbriet showed a decline of ≥50 m in 6MWT distance, compared to 47% of patients receiving placebo in PIPF-004.
Croatian: Iako nije bilo razlike između bolesnika koji su primali Esbriet u usporedbi s onima koji su primali placebo s obzirom na promjenu udaljenosti prijeđene tijekom 6-minutnog testa hodanja (engl. six minute walk test, 6MWT) od početnih vrijednosti do onih izmjerenih u 72. tjednu liječenja prema unaprijed definiranom rangu ANCOVA, ad hoc analiza pokazala je da se u 37% bolesnika koji su primali Esbriet udaljenost tijekom 6MWT testa smanjila za ≥50 m, dok je isto primijećeno u 47% bolesnika koji su primali placebo u ispitivanju PIPF-004.
English: Adults
Croatian: DJECE
English: Pirfenidone 2,403 mg/day (N = 278)
Croatian: Pirfenidon 2403 mg/dan (N = 278)
English: The 801 mg blisters strips 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 s filmom obloženim tabletama od 801 mg označena je sljedećim simbolima i skraćenicama imena dana u tjednu, kao podsjetnikom da dozu treba uzeti triput dnevno:
English: Once the rash has resolved, Esbriet may be re-introduced and re-escalated up to the recommended daily dose at the discretion of the physician.
Croatian: Nakon što se osip povuče, može se ponovno započeti liječenje lijekom Esbriet, uz postupno povećanje do preporučene dnevne doze, prema odluci liječnika.
English: The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, magnesium stearate
Croatian: Drugi sastojci su: mikrokristalična celuloza, umrežena karmelozanatrij, povidon K30, koloidni bezvodni silicijev dioksid, magnezijev stearat.
English: Total serum bilirubin increased in combination with increases of ALT and
Croatian: Rijetko povišene razine ukupnog serumskog bilirubina u kombinaciji s povišenim razinama ALT-a i AST-a1
English: ● Capsule brown printing ink: shellac, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), propylene glycol, ammonium hydroxide
Croatian: • smeđa tinta za označavanje na kapsuli: šelak, crni željezov oksid (E172), crveni željezov oksid (E172), žuti željezov oksid (E172), propilenglikol i amonijev hidroksid
English: In a pre-specified pooled analysis of studies PIPF-016, PIPF-004, and PIPF-006 at Month 12, all-cause mortality was significantly lower in Esbriet 2403 mg/day group (3.5%, 22 of 623 patients) compared with placebo (6.7%, 42 of 624 patients), resulting in a 48% reduction in the risk of all-cause mortality within the first 12 months (HR 0.52 [95% CI, 0.31-0.87], p=0.0107, log-rank test).
Croatian: U unaprijed određenoj analizi objedinjenih podataka iz ispitivanja PIPF-016, PIPF-004 i PIPF-006 u 12. mjesecu, stopa smrtnosti zbog bilo kojeg uzroka bila je značajno niža u skupini koja je primala Esbriet u dozi od 2403 mg/dan (3,5%, 22 od 623 bolesnika) nego u onoj koja je primala placebo (6,7%, 42 od 624 bolesnika), što je rezultiralo smanjenjem rizika od smrti zbog bilo kojeg uzroka od 48% unutar prvih 12 mjeseci (HR 0,52 [95% CI, 0,31-0,87], p=0,0107, log-rang test).
English: There are 7 blister strips with 3 capsules per strip (1 capsule per pocket for Week 1) and 7 blister strips with 6 capsules per strip (2 capsules per pocket for Week 2).
Croatian: Sadrži 7 blister traka s 3 kapsule po traci (1 kapsula po odjeljku za 1. tjedan) i 7 blister traka sa 6 kapsula po traci (2 kapsule po odjeljku za 2. tjedan).
English: ● shortness of breath
Croatian: • nedostatak zraka • kašalj
English: INFORMATION IN BRAILLE esbriet 801 mg tablets
Croatian: 16. PODACI NA BRAILLEOVOM PISMU esbriet 801 mg tablete
English: ● Days 8 to 14: two capsules, three times a day (1602 mg/day)
Croatian: • Od 8. do 14. dana: dvije kapsule, triput na dan (1602 mg/dan)
English: ● for the first 7 days take 1 capsule, 3 times a day with food (a total of 801 mg/day)
Croatian: • prvih 7 dana uzimajte 1 kapsulu 3 puta na dan s hranom (ukupno 801 mg/dan)
English: ALT increased; AST increased; gamma glutamyl transferase increased
Croatian: Često povišene razine ALT-a, povišene razine AST-a, povišene razine gamaglutamil-transferaze
English: Weight decreased; decreased appetite Psychiatric disorders Common
Croatian: Često gubitak tjelesne težine, smanjen apetit
English: If clinically appropriate the dose of Esbriet should be reduced or interrupted.
Croatian: dozu lijeka Esbriet treba smanjiti ili prekinuti primjenu lijeka.
English: If ciprofloxacin at the dose of 750 mg two times a day cannot be avoided, the dose of pirfenidone should be reduced to 1602 mg daily (534 mg, three times a day).
Croatian: Ako je primjena ciprofloksacina u dozi od 750 mg dvaput na dan neizbježna, dozu pirfenidona treba smanjiti na 1602 mg na dan (534 mg, triput na dan).
English: Weight loss has been reported in patients treated with Esbriet (see section 4.8).
Croatian: U bolesnika liječenih lijekom Esbriet prijavljen je gubitak tjelesne težine (vidjeti dio 4.8).
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg hard capsules
Croatian: NAZIV LIJEKA Esbriet 267 mg tvrde kapsule
English: There are 14 x 18 capsules in PVC/PE/PCTFE aluminium foil perforated blister strips for a total of 252 capsules per pack.
Croatian: Perforirane PVC/PE/PCTFE blister trake od aluminijske folije sadrže 14 x 18 kapsula, što su sveukupno 252 kapsule po pakiranju.
English: ● Capsule filling: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate
Croatian: sadržaj kapsule: mikrokristalična celuloza, umrežena karmelozanatrij, povidon, magnezijev stearat
English: ● for the first 7 days take a dose of 267 mg (1 yellow tablet), 3 times a day with food (a total of 801 mg/day)
Croatian: • prvih 7 dana uzimajte dozu od 267 mg (1 žutu tabletu), 3 puta na dan s hranom (ukupno 801 mg/dan)
English: Package leaflet: Information for the user Esbriet 267 mg hard capsules Pirfenidone
Croatian: Uputa o lijeku: Informacije za korisnika Esbriet 267 mg tvrde kapsule pirfenidon
English: Pirfenidone 2,403 mg/day (N = 171)
Croatian: Pirfenidon 2403 mg/dan (N = 171)
English: If concomitant use of Esbriet with a strong and selective inhibitor of CYP1A2 cannot be avoided, the dose of pirfenidone should be reduced to 801 mg daily (one capsule, three times a day).
Croatian: Ako je istodobna primjena lijeka Esbriet sa snažnim i selektivnim inhibitorima CYP1A2 neizbježna, dozu pirfenidona treba smanjiti na 801 mg na dan (jedna kapsula, triput na dan).
English: The oral clearance of pirfenidone appears modestly saturable.
Croatian: Čini se da je klirens pirfenidona nakon peroralne primjene umjereno saturabilan.
English: If concomitant use of Esbriet with a strong and selective inhibitor of CYP1A2 cannot be avoided, the dose of pirfenidone should be reduced to 801 mg daily (267 mg, three times a day).
Croatian: Ako je istodobna primjena lijeka Esbriet sa snažnim i selektivnim inhibitorima CYP1A2 neizbježna, dozu pirfenidona treba smanjiti na 801 mg na dan (267 mg, triput na dan).
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Croatian: 14. NAČIN IZDAVANJA LIJEKA Lijek se izdaje na recept
English: 801 mg film-coated tablets 1 bottle containing 90 film-coated tablets
Croatian: Filmom obložene tablete od 801 mg 1 boca koja sadrži 90 filmom obloženih tableta
English: Swallow the capsules whole with a drink of water, during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness.
Croatian: Kapsule progutajte cijele s vodom, a uzmite ih tijekom ili nakon obroka kako biste smanjili rizik od nuspojava poput mučnine i omaglice.
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Croatian: Film ovojnica poli(vinilni) alkohol titanijev dioksid (E171) makrogol 3350 talk
English: Pirfenidone should be used with caution in patients with moderate renal impairment.
Croatian: Pirfenidon je potrebno primjenjivati uz oprez kod bolesnika s umjerenim oštećenjem funkcije bubrega.
English: Swallow the tablets whole with a drink of water, during or after a meal to reduce the risk of side effects such as nausea (feeling sick) and dizziness.
Croatian: Tablete progutajte cijele s vodom, a uzmite ih tijekom ili nakon obroka kako biste smanjili rizik od nuspojava poput mučnine i omaglice.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku
English: ● dizziness
Croatian: • pospanost
English: 3 How to take Esbriet
Croatian: Kako uzimati Esbriet
English: Bioequivalence was demonstrated in the fasted state when comparing the 801 mg tablet to three 267 mg capsules.
Croatian: Dokazana je bioekvivalentnost između tablete od 801 mg i tri kapsule od 267 mg nakon primjene natašte.
English: ● from day 8 to 14 take a dose of 534 mg (2 yellow tablets or 1 orange tablet), 3 times a day with food (a total of 1,602 mg/day)
Croatian: • od 8. do 14. dana uzimajte dozu od 534 mg (2 žute tablete ili 1 narančastu tabletu), 3 puta na dan s hranom (ukupno 1602 mg/dan)
English: a p-value versus Normal = 1.00 (pair-wise comparison with Bonferroni) b p-value versus Normal = 0.009 (pair-wise comparison with Bonferroni) c p-value versus Normal < 0.0001 (pair-wise comparison with Bonferroni)
Croatian: AUC0-∞ = površina ispod krivulje koncentracija-vrijeme od nulte točke do beskonačnosti a p-vrijednost naspram normalne funkcije = 1,00 (usporedba parova uz Bonferronijevu korekciju) b p-vrijednost naspram normalne funkcije = 0,009 (usporedba parova uz Bonferronijevu korekciju)
English: Pirfenidone 2,403 mg/day (N = 174)
Croatian: Pirfenidon 2403 mg/dan (N = 174)
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.
Croatian: Uzimajući u obzir korist dojenja za dijete i korist liječenja lijekom Esbriet za majku, nužno je odlučiti hoće li se prekinuti dojenje ili terapija lijekom Esbriet.
English: 4-week treatment pack of 252 capsules
Croatian: Pakiranje s 252 kapsule za 4-tjedno liječenje
English: If ciprofloxacin at the dose of 750 mg two times a day cannot be avoided, the dose of pirfenidone should be reduced to 1602 mg daily (two capsules, three times a day).
Croatian: Ako je primjena ciprofloksacina u dozi od 750 mg dvaput na dan neizbježna, dozu pirfenidona treba smanjiti na 1602 mg na dan (dvije kapsule, triput na dan).
English: INFORMATION IN BRAILLE esbriet 534 mg tablets
Croatian: 16. PODACI NA BRAILLEOVOM PISMU esbriet 534 mg tablete
English: The recommended maintenance daily dose of Esbriet is 3 capsules three times a day with food, for a total of 2403 mg/day.
Croatian: Preporučena dnevna doza održavanja lijeka Esbriet je 3 kapsule triput na dan s hranom, što čini ukupnu dozu od 2403 mg/dan.