FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER STRIPS BLISTER STRIPS - 4-WEEK TREATMENT PACK OF 252 CAPSULES
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER TRAKA BLISTER TRAKA - PAKIRANJE S 252 KAPSULE ZA 4-TJEDNU TERAPIJU ODRŽAVANJA
English: 60 (p<0.001).
Croatian: (p<0,001) i 60. tjednu (p<0,001).
English: ● Days 8 to 14: a dose of 534 mg administered three times a day (1602 mg/day)
Croatian: Od 8. do 14. dana: doza od 534 mg, primijenjena triput na dan (1602 mg/dan)
English: INFORMATION IN BRAILLE esbriet 267 mg tablets
Croatian: 16. PODACI NA BRAILLEOVOM PISMU esbriet 267 mg tablete
English: The recommended maintenance daily dose of Esbriet is 801 mg (3 yellow tablets or 1 brown tablet) three times a day with food, for a total of 2403 mg/day.
Croatian: Preporučena dnevna doza održavanja lijeka Esbriet je 801 mg (3 žute tablete ili 1 smeđa tableta) triput na dan s hranom, što čini ukupnu dozu od 2403 mg/dan.
English: Angioedema1
Croatian: Nepoznato anafilaksija1
English: Each capsule contains 267 mg of pirfenidone.
Croatian: Jedna kapsula sadrži 267 mg pirfenidona.
English: Esbriet 801 mg film-coated tablets
Croatian: Esbriet 801 mg filmom obložene tablete pirfenidon
English: Esbriet therapy should not be used in patients with severe hepatic impairment or end stage liver disease (see section 4.3, 4.4 and 5.2).
Croatian: Esbriet se ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije jetre ili u terminalnoj fazi jetrene bolesti (vidjeti dijelove 4.3, 4.4 i 5.2).
English: In study PIPF-006, treatment with Esbriet (N=171) did not reduce the decline of percent predicted FVC from Baseline at Week 72 compared with placebo (N=173; p=0.501).
Croatian: U ispitivanju PIPF-006, liječenje lijekom Esbriet (N=171) nije smanjilo pad postotka predviđenog FVC-a od početnih vrijednosti do onih izmjerenih u 72. tjednu liječenja u usporedbi s placebom (N=173, p=0,501).
English: Esbriet is contraindicated in severe hepatic impairment and end stage liver disease (see sections 4.2 and 4.3).
Croatian: Esbriet je kontraindiciran kod teškog oštećenja funkcije jetre i u bolesnika u terminalnoj fazi jetrene bolesti (vidjeti dijelove 4.2 i 4.3).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated Tablets in Blisters Multi Pack 63 - (INCLUDING BLUE BOX)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - filmom obložene tablete u blisterima; višestruko pakiranje od 63 (UKLJUČUJUĆI PLAVI OKVIR)
English: Titanium dioxide (E171)
Croatian: Ovojnica kapsule titanijev dioksid (E171) želatina
English: Immune system disorders Uncommon
Croatian: Poremećaji imunološkog sustava Manje često angioedem1
English: ● if you have severe or end stage kidney disease requiring dialysis.
Croatian: • ako bolujete od teške bolesti jetre ili bolesti jetre u završnoj fazi • ako bolujete od teške bolesti bubrega ili bolesti bubrega u završnoj fazi koja zahtijeva dijalizu
English: ● Days 1 to 7: a dose of 267 mg administered three times a day (801 mg/day)
Croatian: Od 1. do 7. dana: doza od 267 mg, primijenjena triput na dan (801 mg/dan)
English: Esbriet 534 mg film-coated tablets
Croatian: Esbriet 534 mg filmom obložene tablete pirfenidon
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg hard capsules Pirfenidone
Croatian: NAZIV LIJEKA Esbriet 267 mg tvrde kapsule pirfenidon
English: A reduced incidence of adverse events (nausea and dizziness) was observed in fed subjects when compared to the fasted group.
Croatian: Primijećena je niža incidencija nuspojava (mučnine i omaglice) u bolesnika s punim želucem u usporedbi sa skupinom koja je lijek uzela natašte.
English: ● Severe hepatic impairment or end stage liver disease (see sections 4.2 and 4.4).
Croatian: Teško oštećenje funkcije jetre ili terminalna faza jetrene bolesti (vidjeti dio 4.2 i 4.4).
English: ● from day 15 onwards (maintenance), take a dose of 801 mg (3 yellow tablets or 1 brown tablet), 3 times a day with food (a total of 2,403 mg/day).
Croatian: • od 15. dana nadalje (terapija održavanja) uzimajte dozu od 801 mg (3 žute tablete ili 1 smeđu tabletu), 3 puta na dan s hranom (ukupno 2403 mg/dan)
English: If a patient exhibits an aminotransferase elevation to >5 x ULN, Esbriet should be discontinued and the patient should not be rechallenged.
Croatian: Ako u bolesnika dođe do porasta razine aminotransferaza >5 x GGN, liječenje lijekom Esbriet mora se prekinuti i ne smije se ponovno uvoditi.
English: Concomitant use of strong inducers of CYP1A2 including smoking should be avoided during Esbriet therapy based on the observed relationship between cigarette smoking and its potential to induce CYP1A2.
Croatian: S obzirom na primijećenu povezanost između pušenja cigareta i njegove sposobnosti da inducira CYP1A2, tijekom liječenja lijekom Esbriet treba izbjegavati istodobnu primjenu snažnih induktora CYP1A2, uključujući pušenje.
English: Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Croatian: Pet. Sub.
English: ● bladder infections
Croatian: • infekcije mokraćnog mjehura
English: If a patient exhibits an aminotransferase elevation to >3 to ≤5 x ULN after starting Esbriet therapy, confounding medicinal products should be discontinued, other causes excluded, and the patient monitored closely.
Croatian: Ako nakon započinjanja terapije lijekom Esbriet u bolesnika dođe do porasta razine aminotransferaza na >3 do ≤5 x GGN, treba prekinuti primjenu svih istodobno primjenjivanih lijekova koji bi mogli uzrokovati taj porast, isključiti druge uzroke i pažljivo pratiti bolesnika.
English: Adverse reactions from post-marketing experience are also listed in Table 1.
Croatian: U Tablicu 1 uključene su i nuspojave prijavljene nakon stavljanja lijeka u promet.
English: ● from day 8 to 14 take 2 capsules, 3 times a day with food (a total of 1,602 mg/day)
Croatian: • od 8. do 14. dana uzimajte 2 kapsule 3 puta na dan s hranom (ukupno 1602 mg/dan)
English: Film-coated tablet 21 film-coated tablets.
Croatian: 21 filmom obložena tableta.
English: However, treatment with Esbriet reduced the decline of percent predicted FVC from Baseline at Weeks 24 (p<0.001), 36 (p=0.011), and 48 (p=0.005).
Croatian: Međutim, liječenje lijekom Esbriet smanjilo je pad postotka predviđenog FVC-a od početnih vrijednosti do onih izmjerenih u 24. tjednu (p<0,001), 36. tjednu (p=0,011) i 48. tjednu (p=0,005).
English: Esbriet has not been studied in individuals with severe hepatic impairment and Esbriet must not be used in patients with severe hepatic impairment (see section 4.3).
Croatian: Esbriet nije ispitivan u osoba s teškim oštećenjem funkcije jetre i stoga se ne smije primjenjivati u tih bolesnika (vidjeti dio 4.3).
English: In study PIPF-016, the decline of percent predicted FVC from Baseline at Week 52 of treatment was significantly reduced in patients receiving Esbriet (N=278) compared with patients receiving placebo (N=277; p<0.000001, rank ANCOVA).
Croatian: U ispitivanju PIPF-016, pad postotka predviđenog FVC-a od početka ispitivanja do 52. tjedna liječenja bio je značajno niži u bolesnika koji su primali Esbriet (N=278) u usporedbi s bolesnicima koji su primali placebo (N=277, p<0,000001, rang ANCOVA).
English: Each film-coated tablet contains 801 mg pirfenidone.
Croatian: Jedna filmom obložena tableta sadrži 801 mg pirfenidona.
English: ● Severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.2 and 5.2).
Croatian: ● Teško oštećenje funkcije bubrega (CrCl <30 ml/min ili terminalna faza bubrežne bolesti koja zahtijeva dijalizu (vidjeti dijelove 4.2 i 5.2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/011 90 tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/011 90 tableta
English: Each film-coated tablet contains 267 mg pirfenidone.
Croatian: Jedna filmom obložena tableta sadrži 267 mg pirfenidona.
English: Contact your doctor, pharmacist or nearest hospital casualty department immediately if you have taken more capsules than you should, and take your medicine with you.
Croatian: Ako ste uzeli više kapsula nego što ste trebali, odmah se javite svom liječniku, ljekarniku ili najbližoj hitnoj službi i ponesite lijek sa sobom.
English: Dizziness has been reported in patients taking Esbriet.
Croatian: U bolesnika koji uzimaju Esbriet prijavljena je omaglica.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON -2-WEEK TREATMENT INITIATION PACK (7 X 3 CAPSULES AND 7 X 6 CAPSULES CONFIGURATION)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - PAKIRANJE ZA 2-TJEDNI POČETAK LIJEČENJA (OBLIK SA 7 X 3 KAPSULE
English: Each film-coated tablet contains 534 mg pirfenidone.
Croatian: Jedna filmom obložena tableta sadrži 534 mg pirfenidona.
English: Esbriet should be used with caution in patients treated with other moderate inhibitors of CYP1A2 (e.g. amiodarone, propafenone).
Croatian: Esbriet treba primjenjivati uz oprez u bolesnika koji se liječe drugim umjerenim inhibitorima CYP1A2
English: No dose adjustment is necessary in patients with mild renal impairment.
Croatian: Nije potrebno prilagođavati dozu kod bolesnika s blagim oštećenjem funkcije bubrega.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/009 21 tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/009 21 tableta
English: In a total of 555 patients, the median baseline percent predicted FVC and %DLCO were 68% (range: 48-91%) and 42% (range: 27-170%), respectively.
Croatian: medijan početne vrijednosti postotka predviđenog FVC-a iznosio je 68% (raspon: 48-91%), a %DLCO
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg film-coated tablets Pirfenidone
Croatian: Esbriet 267 mg filmom obložene tablete pirfenidon
English: Mutlipack: 63 (1 pack containing 1 blister of 21 and 1 pack containing 2 blisters of 21) filmcoated tablets
Croatian: Višestruko pakiranje: 63 filmom obložene tablete (1 pakiranje koje sadrži 1 blister s 21 i 1 pakiranje koje sadrži 2 blistera s 21 filmom obloženom tabletom)
English: ● Any other clinically significant ADRs based on the judgment of the prescriber
Croatian: • svaku drugu nuspojavu koju liječnik koji je propisao lijek smatra klinički značajnom
English: Treatment with Esbriet also significantly reduced the decline of percent predicted FVC from Baseline at Weeks 24 (p=0.014), 36 (p<0.001), 48 (p<0.001), and 60 (p<0.001).
Croatian: Liječenje lijekom Esbriet značajno je smanjilo i pad postotka predviđenog FVC-a od početnih vrijednosti u 24. tjednu (p=0,014), 36. tjednu (p<0,001), 48. tjednu (p<0,001) i 60. tjednu (p<0,001).
English: ● headache.
Croatian: • glavobolja
English: High-Density Polyethylene (HDPE) bottle with a child-resistant and tamper-evident screw cap Pack sizes
Croatian: Boca od polietilena visoke gustoće (HDPE) zatvorena navojnim zatvaračem s evidencijom otvaranja sigurnim za djecu.
English: EU/1/11/667/005 EU/1/11/667/006 EU/1/11/667/007 EU/1/11/667/008 EU/1/11/667/009
Croatian: EU/1/11/667/005 EU/1/11/667/006 EU/1/11/667/007 EU/1/11/667/008 EU/1/11/667/009 EU/1/11/667/010 EU/1/11/667/011 EU/1/11/667/012 EU/1/11/667/013 EU/1/11/667/014 EU/1/11/667/015 EU/1/11/667/016 EU/1/11/667/017 EU/1/11/667/018 EU/1/11/667/019 EU/1/11/667/020 EU/1/11/667/021
English: Other therapies that are inhibitors of both CYP1A2 and one or more other CYP isoenzymes involved in the metabolism of pirfenidone (e.g. CYP2C9, 2C19, and 2D6) should be avoided during pirfenidone treatment.
Croatian: Tijekom liječenja pirfenidonom treba izbjegavati i druge lijekove koji inhibiraju CYP1A2 i jedan ili više drugih izoenzima CYP uključenih u metabolizam pirfenidona (npr. CYP2C9, 2C19 i 2D6).
English: The primary endpoint was the change from Baseline to Week 52 in percent predicted FVC.
Croatian: Primarna mjera ishoda bila je promjena postotka predviđenog FVC-a od početka ispitivanja do 52. tjedna liječenja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - BOTTLE 250 ML
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - BOCA OD 250 ML
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE 70 ML
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA - BOCA OD 70 ML
English: The use of pirfenidone is contraindicated in patients with severe renal impairment (CrCl <30ml/min) or end stage renal disease requiring dialysis (see sections 4.2 and 4.3).
Croatian: Primjena pirfenidona kontraindicirana je u bolesnika s teškim oštećenjem funkcije bubrega (CrCl <30ml/min) ili bolesnika u terminalnoj fazi bubrežne bolesti koja zahtijeva dijalizu (vidjeti dijelove 4.2 i 4.3).
English: Contact your doctor, pharmacist or nearest hospital casualty department immediately if you have taken more tablets than you should, and take your medicine with you.
Croatian: Ako ste uzeli više tableta nego što ste trebali, odmah se javite svom liječniku, ljekarniku ili najbližoj hitnoj službi i ponesite lijek sa sobom.
English: Film-coated tablet Multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated Tablets
Croatian: Višestruko pakiranje: 252 filmom obložene tablete (3 pakiranja, od kojih svako sadrži 4 blistera s 21 filmom obloženom tabletom)
English: Dose adjustments or temporary treatment discontinuation may be necessary in mild to severe cases of photosensitivity reaction or rash (see section 4.2).
Croatian: U slučaju blagih do teških slučajeva reakcije fotoosjetljivosti ili osipa možda će biti potrebno prilagoditi dozu ili privremeno prekinuti liječenje (vidjeti dio 4.2).
English: Esbriet 267 mg film-coated tablets are yellow, oval, approximately 1.3 x 0.6. cm biconvex film-coated tablets, debossed with “PFD”.
Croatian: Esbriet 267 mg filmom obložene tablete su žute, ovalne, bikonveksne filmom obložene tablete, dimenzija približno 1,3 x 0,6 cm, s utisnutom oznakom 'PFD'.
English: Reports of angioedema (some serious) such as swelling of the face, lips and/or tongue which may be associated with difficulty breathing or wheezing have been received in association with use of Esbriet in the post-marketing setting.
Croatian: Kod primjene lijeka Esbriet nakon njegova stavljanja u promet prijavljeni su slučajevi angioedema (ponekad ozbiljni) poput oticanja lica, usana i/ili jezika, koji mogu biti praćeni otežanim disanjem ili piskanjem pri disanju.
English: Manufacturer
Croatian: Njemačka Proizvođač
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172) and iron oxide black (E172)
Croatian: Film ovojnica sadrži: polivinilni alkohol, titanijev dioksid (E171), makrogol 3350, talk, crveni željezov oksid (E172) i crni željezov oksid (E172).
English: Co-administration of medicinal products that act as potent inducers of both CYP1A2 and the other CYP isoenzymes involved in the metabolism of pirfenidone (e.g. rifampicin) may result in significant lowering of pirfenidone plasma levels.
Croatian: CYP uključenih u metabolizam pirfenidona (npr. rifampicina) može uzrokovati značajno sniženje razine pirfenidona u plazmi.
English: Esbriet 267 mg film-coated tablets are yellow, oval, biconvex film-coated tablets, debossed with “PFD”.
Croatian: Esbriet 267 mg filmom obložene tablete su žute, ovalne, bikonveksne filmom obložene tablete s utisnutom oznakom 'PFD'.
English: Table 4 Categorical assessment of change from Baseline to Week 52 in percent predicted FVC in study PIPF-016
Croatian: Tablica 4: Kategorijska ocjena promjene postotka predviđenog FVC-a od početka ispitivanja do 52. tjedna liječenja u ispitivanju PIPF-016
English: Esbriet therapy should not be used in patients with severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.3 and 5.2).
Croatian: Esbriet se ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina <30 ml/min) ili u terminalnoj fazi bubrežne bolesti koja zahtijeva primjenu dijalize (vidjeti dijelove 4.3 i 5.2).
English: Upon initiating treatment, the dose should be titrated to the recommended daily dose of nine capsules per 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
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172) and iron oxide red (E172)
Croatian: Film ovojnica sadrži: polivinilni alkohol, titanijev dioksid (E171), makrogol 3350, talk, žuti željezov oksid (E172) i crveni željezov oksid (E172).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER STRIPS BLISTER STRIPS - 2-WEEK TREATMENT INITIATION PACK (7 X 3 CAPSULES AND 7 X 6 CAPSULES CONFIGURATION)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER TRAKA BLISTER TRAKA - PAKIRANJE ZA 2-TJEDNI POČETAK LIJEČENJA (OBLIK SA 7 X 3 KAPSULE
English: Esbriet 534 mg film-coated tablets are orange, oval, biconvex film-coated tablets, debossed with “PFD”.
Croatian: Esbriet 534 mg filmom obložene tablete su narančaste, ovalne, bikonveksne filmom obložene tablete s utisnutom oznakom 'PFD'.
English: At Week 72, a decline from baseline in percent predicted FVC of ≥10% (a threshold indicative of the risk of mortality in IPF) was seen in 20% of patients receiving Esbriet compared to 35% receiving placebo (Table 2).
Croatian: U 72. tjednu, pad postotka predviđenog FVC-a za ≥10% u odnosu na početne vrijednosti (granična vrijednost koja ukazuje na rizik od smrti zbog IPF-a) primijećen je u
English: Printing Inks
Croatian: Prijavljivanje nuspojava
English: In study PIPF-004, the decline of percent predicted FVC from Baseline at Week 72 of treatment was significantly reduced in patients receiving Esbriet (N=174) compared with patients receiving placebo (N=174; p=0.001, rank ANCOVA).
Croatian: U ispitivanju PIPF-004, pad postotka predviđenog FVC-a od početka ispitivanja do 72. tjedna liječenja bio je značajno manji u bolesnika koji su primali Esbriet (N=174) nego u onih koji su primali placebo (N=174, p=0,001, rang ANCOVA).
English: However, treatment with Esbriet reduced the decline of percent predicted FVC from Baseline at Weeks 24 (p<0.001),
Croatian: Liječenje lijekom Esbriet značajno je smanjilo i pad postotka predviđenog FVC-a od početnih vrijednosti u 13. tjednu (p=0,000001),
English: Esbriet 801 mg film-coated tablets are brown, oval, biconvex film-coated tablets, debossed with “PFD”.
Croatian: Esbriet 801 mg filmom obložene tablete su smeđe, ovalne, bikonveksne filmom obložene tablete s utisnutom oznakom 'PFD'.
English: 36 (p=0.011), and 48 (p=0.005).
Croatian: (N=173, p=0,501).
English: Table 3 Categorical assessment of change from Baseline to Week 72 in percent predicted FVC in study PIPF-006
Croatian: Tablica 3: Kategorijska ocjena promjene postotka predviđenog FVC-a od početka ispitivanja do 72. tjedna liječenja u ispitivanju PIPF-006
English: 1 bottle containing 21 film-coated tablets 1 bottle containing 90 film-coated tablets
Croatian: 1 boca koja sadrži 21 filmom obloženu tabletu
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Roche Pharma AG
English: 267 mg film-coated tablets
Croatian: Filmom obložene tablete od 267 mg
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE 200 ML
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA - BOCA OD 200 ML
English: Table 2 Categorical assessment of change from Baseline to Week 72 in percent predicted FVC in study PIPF-004
Croatian: Tablica 2: Kategorijska ocjena promjene postotka predviđenog FVC-a od početka ispitivanja do 72. tjedna liječenja u ispitivanju PIPF-004
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172)
Croatian: Film ovojnica sadrži: polivinilni alkohol, titanijev dioksid (E171), makrogol 3350, talk i žuti željezov oksid (E172).
English: Treatment with Esbriet also significantly reduced the decline of percent predicted FVC from Baseline at Weeks 24 (p=0.014), 36 (p<0.001), 48 (p<0.001), and
Croatian: Liječenje lijekom Esbriet značajno je smanjilo i pad postotka predviđenog FVC-a od početnih vrijednosti u 24. tjednu (p=0,014), 36. tjednu (p<0,001), 48. tjednu
English: The blister packs contain 21, 42, 84 or 168 film-coated tablets and the multipacks contain 63 (2-week treatment initiation pack 21+42) or 252 (continuation pack 3x84) film-coated tablets.
Croatian: 63 (pakiranje za 2-tjedni početak liječenja 21+42) ili 252 (pakiranje za nastavak liječenja 3x84)
English: ● from day 15 onwards (maintenance), take 3 capsules, 3 times a day with food (a total of 2,403 mg/day).
Croatian: • od 15. dana nadalje (terapija održavanja) uzimajte 3 kapsule 3 puta na dan s hranom
English: ● feeling weak or feeling low in energy
Croatian: • bol u mišićima, bolovi u zglobovima • osjećaj slabosti ili nedostatka energije
English: Elevations in ALT and AST >3 × upper limit of normal (ULN) have been reported in patients receiving therapy with Esbriet.
Croatian: U bolesnika koji su primali Esbriet primijećeno je povišenje razine ALT-a i AST-a >3 x iznad gornje granice normale (GGN).
English: The decline in 6MWT distance from Baseline to Week 72 was significantly reduced compared with placebo in study PIPF-006 (p<0.001, rank ANCOVA).
Croatian: U ispitivanju PIPF-006, smanjenje udaljenosti prijeđene tijekom 6MWT testa od početnih vrijednosti do onih izmjerenih u 72. tjednu bilo je značajno manje u odnosu na placebo (p<0,001, rang ANCOVA).
English: ● omeprazole (used in the treatment of conditions such as indigestion, gastroesophageal reflux disease)
Croatian: Lijekovi koji smanjuju učinak lijeka Esbriet: • omeprazol (koristi se za liječenje stanja poput probavnih tegoba i gastroezofagealne refluksne bolesti) • rifampicin (vrsta antibiotika)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 267 mg pirfenidone.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 267 mg pirfenidona.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE 250 ML
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA - BOCA OD 250 ML
English: ● Day 15 onward: a dose of 801 mg administered three times a day (2403 mg/day) The recommended maintenance daily dose of Esbriet is 801 mg three times a day with food for a total of 2403 mg/day.
Croatian: • Od 15. dana nadalje: tri kapsule, triput na dan (2403 mg/dan) Preporučena dnevna doza održavanja lijeka Esbriet je tri kapsule od 267 mg triput na dan s hranom, što čini ukupnu dozu od 2403 mg/dan.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/016 63 tablets (21 + 42)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/016 63 tablete (21+42)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated tablets in Blisters 252 Multipack (INCLUDING BLUE BOX)
Croatian: KUTIJA - filmom obložene tablete u blisterima; višestruko pakiranje od 252 (UKLJUČUJUĆI
English: Other side effects may include Talk to your doctor if you get any side effects.
Croatian: Obratite se svom liječniku ako se pojavi bilo koja nuspojava.
English: Sunburn Identified through post-marketing surveillance
Croatian: Često sunčane opekline Utvrđeno tijekom praćenja nakon stavljanja lijeka u promet
English: ● Photosensitivity reactions and skin rashes
Croatian: • reakcije fotoosjetljivosti i kožne osipe • odstupanja u nalazima testova jetrene funkcije
English: Respiratory, thoracic and mediastinal disorders Common
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: The decline in distance walked during a 6MWT from Baseline to Week 52 was significantly reduced in patients receiving Esbriet compared with patients receiving placebo in PIPF-016 (p=0.036, rank
Croatian: U ispitivanju PIPF-016, smanjenje udaljenosti prijeđene tijekom 6MWT testa od početnih vrijednosti do onih izmjerenih u 52. tjednu bilo je značajno manje u bolesnika koji su primali Esbriet u usporedbi s bolesnicima koji su primali placebo (p=0,036, rang ANCOVA); u 26% bolesnika koji su primali