FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Esbriet za vse podskupine pediatrične populacije za idiopatsko pljučno fibrozo.
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%).
Slovenian: Jemanje obeh farmacevtskih oblik s hrano je v primerjavi z jemanjem na tešče zmanjšalo Cmax pirfenidona; tableta zdravila Esbriet je zmanjšala Cmax nekoliko manj (za 40 %) kot kapsule zdravila Esbriet (za 50 %).
English: Medicines that may reduce how well Esbriet works:
Slovenian: Zdravila, ki lahko poslabšajo delovanje zdravila Esbriet:
English: 84 film-coated tablets.
Slovenian: 84 filmsko obloženih tablet
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.
Slovenian: Če simptomi ne popustijo, se lahko odmerek pirfenidona zmanjša na 1-2 kapsuli (267 mg-534 mg) dva do trikrat na dan skupaj s hrano, pri čemer naj se odmerek stopnjuje do priporočenega dnevnega odmerka, kakor dopušča preobčutljivost.
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).
Slovenian: ki so na voljo pri živalih, kažejo izločanje pirfenidona in/ali njegovih presnovkov v mleku, zato obstaja možnost kopičenja pirfenidona in/ali njegovih presnovkov v mleku (glejte poglavje 5.3).
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINOVITO UPORABO
English: ● Close monitoring is required of any patients who develop liver enzyme elevation with appropriate dose adjustment or discontinuation.
Slovenian: • Bolnike, pri katerih se je pojavilo povišanje jetrnih encimov, je treba pozorno spremljati in po potrebi prilagoditi odmerek ali prekiniti zdravljenje.
English: Weight loss has been reported in patients treated with Esbriet (see section 4.8).
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom Esbriet, so poročali o izgubi telesne mase (glejte poglavje 4.8).
English: If the rash persists after 7 days, Esbriet should be discontinued for 15 days, with re-escalation to the recommended daily dose in the same manner as the dose escalation period.
Slovenian: Če izpuščaj po sedmih dneh ne izgine, je treba zdravljenje z zdravilom Esbriet za 15 dni prekiniti, nato pa odmerek postopoma ponovno povečati do priporočenega dnevnega odmerka, tako kot v obdobju stopnjevanja odmerka.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL - INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Slovenian: NALEPKA - VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ MODREGA OKENCA)
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.
Slovenian: Pakiranja s plastenkami vsebujejo eno plastenko z 21 tabletami, dve plastenki, od katerih vsaka vsebuje 21 tablet (skupno 42 tablet), eno plastenko z 42 tabletami, eno plastenko z 90 tabletami, dve plastenki, od katerih vsaka vsebuje 90 tablet (skupno 180 tablet), ali eno plastenko s 180 tabletami.
English: Severe photosensitivity reactions are uncommon.
Slovenian: Hude reakcije preobčutljivosti na svetlobo so občasne.
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.
Slovenian: Pred jemanjem zdravila Esbriet morate opraviti preiskavo krvi, kar velja tudi za prvih šest mesecev jemanja, ko morate preiskavo krvi opraviti vsak mesec, nato pa vsake tri mesece.
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.
Slovenian: Čeprav med bolniki, ki so prejemali zdravilo Esbriet, in tistimi, ki so prejemali placebo, ni bilo razlik pri spremembi od izhodiščne vrednosti do 72. tedna glede prehojene razdalje v šestminutnem testu hoje (6MWT) s predhodno določenim rangom ANCOVA, se je v ad hoc analizi pri 37 % bolnikov, ki so prejemali zdravilo Esbriet, pri šestminutnem testu hoje pokazal padec razdalje ≥ 50 m v primerjavi s 47 % tistih, ki so prejemali placebo v študiji PIPF-004.
English: If you are breast-feeding or plan to breast-feed speak to your doctor or pharmacist before taking Esbriet.
Slovenian: Če dojite ali nameravate dojiti, se pred jemanjem zdravila Esbriet posvetujte z zdravnikom ali farmacevtom.
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.
Slovenian: Kapsule pogoltnite cele s kozarcem vode med jedjo ali po njej, da zmanjšate tveganje neželenih učinkov, kot sta navzea (občutek slabosti) in omotica.
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.
Slovenian: Izgled zdravila Esbriet in vsebina pakiranja Trde kapsule Esbriet (kapsule) imajo bel do belkast neprozoren spodnji del in bel do belkast neprozoren zgornji del, na njih pa je z rjavim črnilom natisnjen napis „PFD 267 mg“.
English: General disorders and administration site conditions Very Common Fatigue Common
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti utrujenost
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4-WEEK TREATMENT MAINTENANCE PACK CONTAINING 252 CAPSULES (14 X 18 CAPSULES CONFIGURATION)
Slovenian: ŠKATLA - PAKIRANJE ZA ŠTIRITEDENSKO VZDRŽEVALNO ZDRAVLJENJE, KI VSEBUJE 252 KAPSUL (SESTAVLJA GA 14 X 18 KAPSUL)
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.
Slovenian: Tablete pogoltnite cele s kozarcem vode med jedjo ali po njej, da zmanjšate tveganje neželenih učinkov, kot sta navzea (občutek slabosti) in omotica.
English: ● enoxacin (a type of antibiotic)
Slovenian: • enoksacin (vrsta antibiotika),
English: The effect of food on pirfenidone oral AUC was consistent between the tablet and capsule formulations.
Slovenian: pirfenidona po peroralnem vnosu je bil med oblikama tablet in kapsul enakovreden.
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).
Slovenian: Po začetku zdravljenja je treba te teste prvih 6 mesecev izvajati v mesečnih razmakih, nato pa vsake tri mesece (glejte poglavje 4.8).
English: Gelatin
Slovenian: želatina
English: Esbriet must not be used in patients with a history of angioedema or hypersensitivity due to Esbriet (see section 4.3).
Slovenian: Zdravila Esbriet se ne sme uporabljati pri bolnikih z angioedemom ali preobčutljivostjo na zdravilo Esbriet v anamnezi (glejte poglavje 4.3).
English: Gastroesophageal reflux disease; vomiting; abdominal distension; abdominal discomfort; abdominal pain; abdominal pain upper; stomach discomfort; gastritis; constipation; flatulence
Slovenian: Pogosti gastroezofagealna refluksna bolezen, bruhanje, napetost trebušne stene, nelagodje v trebuhu, bolečine v trebuhu, bolečina v zgornjem delu trebuha, nelagodje v želodcu, gastritis, zaprtje, vetrovi Bolezni jeter, žolčnika in žolčevodov
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.
Slovenian: Če simptomi ne popustijo, se lahko odmerek pirfenidona zmanjša na 267 mg-534 mg dva do trikrat na dan skupaj s hrano, pri čemer naj se odmerek stopnjuje do priporočenega dnevnega odmerka, kakor dopušča preobčutljivost.
English: At high doses (≥450 mg/kg/day) rats exhibited a prolongation of oestrous cycle and a high incidence of irregular cycles.
Slovenian: Pri visokih odmerkih (≥ 450 mg/kg/dan) se je pri podganah ciklus estrusa podaljšal, nepravilnih ciklov pa je bilo več.
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.
Slovenian: Ko izpuščaj izgine, se lahko zdravilo Esbriet ponovno uvede, odmerek pa se do priporočenega dnevnega odmerka stopnjuje po zdravnikovi presoji.
English: ● Esbriet is contraindicated in patients with severe hepatic impairment or end stage liver disease.
Slovenian: Delovanje jeter • Zdravilo Esbriet je kontraindicirano pri bolnikih s hudo okvaro ali končno odpovedjo jeter.
English: ● if you have severe or end stage liver disease
Slovenian: • če imate hudo bolezen jeter ali končno odpoved jeter;
English: 4 blisters each containing 21 film-coated tablets (84 in total)
Slovenian: 4 pretisni omoti, od katerih vsak vsebuje 21 filmsko obloženih tablet (skupno 84)
English: 14 x PVC/PE/PCTFE aluminium foil blister strips each containing 18 capsules (2-day supply).
Slovenian: 14 x pretisni omoti iz PVC/PE/PCTFE in aluminijaste folije s po 18 kapsulami (dvodnevna zaloga).
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).
Slovenian: Če se ciprofloksacinu v odmerku 750 mg dvakrat na dan ni mogoče izogniti, je potrebno zmanjšati odmerek pirfenidona na 1602 mg na dan (534 mg trikrat na dan).
English: 534 mg tablet
Slovenian: 534-mg tableta
English: An increased incidence of liver tumours was observed in carcinogenicity studies conducted in rats and mice.
Slovenian: V študijah kancerogenosti pri podganah in miših so opazili povečano pojavnost tumorjev na jetrih.
English: Weight decreased; decreased appetite Psychiatric disorders Common
Slovenian: Pogosti zmanjšanje telesne mase, zmanjšan apetit
English: ● for the first 7 days take 1 capsule, 3 times a day with food (a total of 801 mg/day)
Slovenian: • prvih 7 dni vzemite eno kapsulo trikrat na dan skupaj s hrano (skupno 801 mg/dan),
English: How to store Esbriet
Slovenian: Kako jemati zdravilo Esbriet
English: Pirfenidone 2,403 mg/day (N = 278)
Slovenian: Pirfenidon 2403 mg/dan (n = 278)
English: Paediatric population There is no relevant use of Esbriet in the paediatric population for the indication of IPF.
Slovenian: Zdravilo Esbriet ni primerno za uporabo pri pediatrični populaciji za indikacijo idiopatske pljučne fibroze.
English: Upper respiratory tract infection; urinary tract infection Blood and lymphatic system disorders Rare
Slovenian: Infekcijske in parazitske bolezni Pogosti okužbe zgornjih dihal, okužbe sečil Bolezni krvi in limfatičnega sistema
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).
Slovenian: (VC) v 52. tednu (primarni cilj) v primerjavi s placebom (-0,09 ± 0,02 l v primerjavi z -0,16 ± 0,02 l,
English: INFORMATION IN BRAILLE esbriet 801 mg tablets
Slovenian: PODATKI V BRAILLOVI PISAVI esbriet 801 mg tablete
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).
Slovenian: Zdravljenje z zdravilom Esbriet se ne sme uporabljati pri bolnikih s hudo okvaro ali končno odpovedjo jeter (glejte poglavja 4.3, 4.4 in 5.2).
English: 42 film-coated tablets.
Slovenian: 42 filmsko obloženih tablet
English: ● Days 1 to 7: one capsule, three times a day (801 mg/day)
Slovenian: • 1.-7. dan: ena kapsula trikrat na dan (801 mg/dan)
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Slovenian: NAČIN IZDAJANJA ZDRAVILA Predpisovanje in izdaja zdravila je le na recept
English: Approximately 70-80% of pirfenidone is metabolised via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6, and 2E1.
Slovenian: Približno 70-80 % pirfenidona se presnavlja preko CYP1A2, medtem ko drugi izoencimi CYP, vključno s CYP2C9, 2C19, 2D6 in 2E1, k presnovi pirfenidona prispevajo manj.
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).
Slovenian: (kar je v okviru normalizirane porazdelitve telesne mase primerljivo z odmerkom 2403 mg/dan pri populacijah ZDA in Evrope, ki sta jih vključevali študiji PIPF-004/006) s placebom (n = 110 oz. n = 109).
English: ● infections of the throat or the airways going into the lungs and/or sinusitis
Slovenian: • okužbe žrela ali dihalnih poti, ki vodijo v pljuča, in/ali sinusitis, • okužbe mehurja,
English: The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, magnesium stearate
Slovenian: Pomožne snovi so: mikrokristalna celuloza, premreženi natrijev karmelozat, povidon K30, koloidni brezvodni silicijev dioksid, magnezijev stearat.
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).
Slovenian: Če se ciprofloksacinu v odmerku 750 mg dvakrat na dan ni mogoče izogniti, je potrebno zmanjšati odmerek pirfenidona na 1602 mg na dan (dve kapsuli trikrat na dan).
English: Esbriet should be used with caution in patients with moderate (CrCl 30-50 ml/min) renal impairment.
Slovenian: Pri bolnikih z zmerno okvaro ledvic (očistek kreatinina 30-50 ml/min) je treba zdravilo Esbriet uporabljati previdno.
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).
Slovenian: Če se sočasni uporabi zdravila Esbriet ter močnega in selektivnega zaviralca CYP1A2 ni mogoče izogniti, je potrebno zmanjšati odmerek pirfenidona na 801 mg na dan (267 mg trikrat na dan).
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).
Slovenian: Če se sočasni uporabi pirfenidona ter močnega in selektivnega zaviralca CYP1A2 ni mogoče izogniti, je potrebno zmanjšati odmerek pirfenidona na 801 mg na dan (ena kapsula trikrat na dan).
English: If you are unsure ask your doctor or pharmacist.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
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.
Slovenian: Če je pri bolniku zaznano zvišanje vrednosti aminotransferaze na vrednost, manjšo ali enako petkratni zgornji meji normalnih vrednosti, ki ga spremljajo tudi simptomi ali hiperbilirubinemija, je treba jemanje zdravila Esbriet prekiniti, zdravila pa se ne sme ponovno uvesti.
English: ● ciprofloxacin (a type of antibiotic)
Slovenian: • ciprofloksacin (vrsta antibiotika),
English: ● Physician information (safety checklists)
Slovenian: • informacije za zdravnike (kontrolni seznami za zagotavljanje varne uporabe zdravila) • informacije za bolnike (navodilo za uporabo)
English: What Esbriet contains
Slovenian: Kaj vsebuje zdravilo Esbriet
English: Asthenia; non-cardiac chest pain Injury poisoning and procedural complications Common
Slovenian: Pogosti astenija, bolečine v prsnem košu, ki niso povezane s srcem Poškodbe in zastrupitve in zapleti pri posegih
English: Photosensitivity reaction and rash
Slovenian: Reakcija preobčutljivosti na svetlobo in izpuščaj
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).
Slovenian: V študiji PIPF-006 zdravljenje z zdravilom Esbriet (n = 171) ni zmanjšalo padca odstotka predvidene forsirane vitalne kapacitete v 72. tednu glede na izhodiščno vrednost v primerjavi s placebom (n = 173, p = 0,501).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER STRIPS BLISTER STRIPS - 4-WEEK TREATMENT PACK OF 252 CAPSULES
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU PRETISNI OMOTI - PAKIRANJE ZA ŠTIRITEDENSKO ZDRAVLJENJE Z 252 KAPSULAMI
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.
Slovenian: Študije doječih podgan kažejo, da se pirfenidon in/ali njegovi presnovki izločajo v mleku in da se lahko pirfenidon in/ali njegovi presnovki kopičijo v mleku.
English: 267 mg tablet and 801 mg tablet 3 years for blisters.
Slovenian: 267-mg tablete in 801-mg tablete 3 leta za pretisne omote 4 leta za plastenke
English: EU/1/11/667/010 90 tablets
Slovenian: EU/1/11/667/010 90 tablet
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Slovenian: Filmska obloga polivinilalkohol titanov dioksid (E171) makrogol 3350 smukec
English: Pirfenidone 2,403 mg/day (N = 171)
Slovenian: Pirfenidon 2403 mg/dan (n = 171)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - BOTTLE 250 ML
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - PLASTENKA 250 ml
English: 4-week treatment pack of 252 capsules
Slovenian: trda kapsula Pakiranje za štiritedensko zdravljenje z 252 kapsulami
English: Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
Slovenian: Zdravilo Esbriet je indicirano za zdravljenje blage do zmerne idiopatske pljučne fibroze pri odraslih.
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.
Slovenian: Priporočeni vzdrževalni dnevni odmerek zdravila Esbriet je 801 mg (tri rumene tablete ali ena rjava tableta) trikrat na dan, zaužit skupaj s hrano, tako da skupni dnevni odmerek znaša 2403 mg/dan.
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).
Slovenian: Zdravilo Esbriet ni bilo preučeno pri bolnikih s hudo okvaro jeter in se pri teh bolnikih ne sme uporabljati (glejte poglavje 4.3).
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.
Slovenian: Poleg tega se je v ad hoc analizi v študiji PIPF-006 razdalja pri šestminutnem testu hoje pri 33 % bolnikov, ki so prejemali zdravilo Esbriet, zmanjšala za ≥ 50 m v primerjavi s 47 % tistih, ki so prejemali placebo.
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)
Slovenian: 1 pretisni omot z 21 filmsko obloženimi tabletami (skupno 21) 2 pretisna omota, od katerih vsak vsebuje 21 filmsko obloženih tablet (skupno 42) 4 pretisni omoti, od katerih vsak vsebuje 21 filmsko obloženih tablet (skupno 84) 8 pretisnih omotov, od katerih vsak vsebuje 21 filmsko obloženih tablet (skupno 168)
English: Esbriet is contraindicated in severe hepatic impairment and end stage liver disease (see sections 4.2 and 4.3).
Slovenian: Zdravilo Esbriet je kontraindicirano pri hudi okvari ali končni odpovedi jeter (glejte poglavji 4.2 in 4.3).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON -2-WEEK TREATMENT INITIATION PACK (7 X 3 CAPSULES AND 7 X 6 CAPSULES CONFIGURATION)
Slovenian: ŠKATLA - PAKIRANJE ZA DVOTEDENSKI ZAČETEK ZDRAVLJENJA (SESTAVLJAJO GA 7 X 3 KAPSULE IN 7 X 6 KAPSUL)
English: Pirfenidone 2,403 mg/day (N = 174)
Slovenian: Pirfenidon 2403 mg/dan (n = 174)
English: mg•h/L compared to 28.7 (4.99) mg•h/L respectively.
Slovenian: p < 0,0001) okvaro ledvic kot v skupini z normalnim delovanjem ledvic (28,7 (4,99) mg•h/l).
English: Mean (SD)
Slovenian: Hudo srednja vrednost (SD)
English: ● Days 8 to 14: a dose of 534 mg administered three times a day (1602 mg/day)
Slovenian: • 8.-14. dan: en 534-mg odmerek, vzet trikrat na dan (1602 mg/dan)
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.
Slovenian: Med zdravljenjem z zdravilom Esbriet se je zaradi opažene povezave med kajenjem in možnostjo, da kajenje sproži CYP1A2, treba izogibati sočasni uporabi močnih induktorjev CYP1A2, vključno s kajenjem.
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.
Slovenian: trda kapsula (kapsula) Dvodelne kapsule z belim do belkastim neprozornim spodnjim delom in belim do belkastim neprozornim zgornjim delom, na katerem je z rjavim črnilom natisnjen napis „PFD 267 mg“,
English: 267 mg film-coated tablets 1 bottle containing 21 film-coated tablets
Slovenian: 267-mg filmsko obložene tablete 1 plastenka z 21 filmsko obloženimi tabletami
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).
Slovenian: V 72. tednu so padec v odstotkih predvidene forsirane vitalne kapacitete glede na izhodiščno vrednost ≥ 10 % (prag, ki kaže tveganje umrljivosti pri idiopatski pljučni fibrozi) opazili pri 20 % bolnikov, ki so prejemali zdravilo Esbriet, v primerjavi s 35 % pri tistih, ki so prejemali placebo (preglednica 2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated Tablets in Blisters Multi Pack 63 - (INCLUDING BLUE BOX)
Slovenian: ŠKATLA - filmsko obložene tablete v pretisnih omotih v skupnem pakiranju s 63 tabletami(VKLJUČNO Z MODRIM OKENCEM)
English: ● Severe hepatic impairment or end stage liver disease (see sections 4.2 and 4.4).
Slovenian: • huda okvara ali končna odpoved jeter (glejte poglavji 4.2 in 4.4),
English: Clinical particulars
Slovenian: KLINIČNI PODATKI
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]).
Slovenian: V združeni analizi preživetja je bila v študijah PIPF-004 in PIPF-006 stopnja umrljivosti v skupini, ki je prejemala zdravilo Esbriet v odmerku 2403 mg/dan, enaka 7,8 %, pri tisti s placebom pa 9,8 % (HR
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.
Slovenian: Če je po začetku zdravljenja z zdravilom Esbriet pri bolniku zaznano zvišanje vrednosti aminotransferaze na vrednost, večjo od trikratne zgornje meje normalnih vrednosti in manjšo ali enako petkratni zgornji meji normalnih vrednosti, je treba prekiniti jemanje zdravil z istim učinkom in izključiti druge vzroke, bolnika pa skrbno spremljati.