FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with confirmed elevations in ALT, AST or bilirubin during treatment, the following dose adjustments may be necessary.
Slovenian: Pri bolnikih s potrjenimi zvišanji vrednosti ALT, AST ali bilirubina med zdravljenjem bo treba odmerke morda prilagoditi tako, kot je opisano v nadaljevanju.
English: Two percent of patients had percent predicted FVC below 50% and 21% of patients had a percent predicted DLCO below 35% at Baseline.
Slovenian: Dva odstotka bolnikov je imelo ob izhodišču odstotek predvidene FVC pod 50 %, 21 % bolnikov pa je imelo odstotek predvidene in difuzijsko kapaciteto za CO pod 35 %.
English: Driving and using machines Do not drive or use machines if you feel dizzy or tired after taking Esbriet.
Slovenian: Ne upravljajte vozil ali strojev, če ste po jemanju zdravila Esbriet omotični ali utrujeni.
English: ● If you experience swelling of the face, lips and/or tongue, itching, hives, difficulty breathing or wheezing, or feeling faint, which are signs of angioedema, a serious allergic reaction or anaphylaxis.
Slovenian: • Če se pojavi zatekanje obraza, ustnic in/ali jezika, srbenje, koprivnica, težave pri dihanju, sopenje ali omedlevica; to so znaki angioedema, ki je huda alergijska reakcija, ali anafilaksije.
English: ● There is a need to monitor liver function tests prior to initiation of treatment with Esbriet and at regular intervals thereafter.
Slovenian: • Pred začetkom zdravljenja z zdravilom Esbriet je treba preveriti delovanje jeter in ga nato redno spremljati.
English: ● Patients should be instructed to use a sunblock daily, to wear clothing that protects against sun exposure, and to avoid other medications known to cause photosensitivity.
Slovenian: • Bolnikom je treba naročiti, naj vsak dan uporabljajo kremo za sončenje, nosijo oblačila, ki ščitijo pred izpostavljenostjo soncu, in se izogibajo drugim zdravilom, za katera je znano, da povzročajo preobčutljivost na svetlobo.
English: Patients who miss 14 consecutive days or more of Esbriet treatment should re-initiate therapy by undergoing the initial 2-week titration regimen up to the recommended daily dose.
Slovenian: Bolniki, ki izpustijo 14 ali več zaporednih dni zdravljenja z zdravilom Esbriet, morajo terapijo ponovno začeti, tako da izvedejo dvotedenski režim titracije, dokler ne dosežejo priporočenega dnevnega odmerka.
English: If you forget to take Esbriet
Slovenian: Če ste pozabili vzeti zdravilo Esbriet
English: In subjects with moderate hepatic impairment (i.e. Child-Pugh Class B), pirfenidone exposure was increased by 60%.
Slovenian: Pri osebah z zmerno okvaro jeter (npr. razred B po lestvici Child-Pugh), je bila izpostavljenost pirfenidonu večja za 60 %.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev) zdravila, odgovornega (odgovornih) za sproščanje serij
English: Therefore, patients who develop signs or symptoms of angioedema or severe allergic reactions following administration of Esbriet should immediately discontinue treatment.
Slovenian: Zato je treba pri bolnikih, pri katerih se po uporabi zdravila Esbriet pojavijo znaki ali simptomi angioedema ali hudih alergijskih reakcij, zdravljenje takoj prekiniti.
English: Fluvoxamine and inhibitors of CYP1A2
Slovenian: Fluvoksamin in zaviralci CYP1A2
English: The 2-week treatment initiation pack contains a total of 63 capsules.
Slovenian: Pakiranje za dvotedenski začetek zdravljenja vsebuje skupaj 63 kapsul.
English: For treatment interruption of less than 14 consecutive days, the dose can be resumed at the previous recommended daily dose without titration.
Slovenian: Če je bilo zdravljenje prekinjeno manj kot 14 zaporednih dni, lahko bolnik nadaljuje z jemanjem predhodnega priporočenega dnevnega odmerka brez titracije.
English: ● amiodarone (used to treat some types of heart disease)
Slovenian: • amiodaron (uporablja se za zdravljenje nekaterih vrst bolezni srca),
English: ● You should not take other medicines, such as tetracycline antibiotics (such as doxycycline),
Slovenian: • Ne smete jemati drugih zdravil, na primer tetraciklinskih antibiotikov (kot je doksiciklin), zaradi katerih lahko postanete bolj občutljivi na sončno svetlobo.
English: IPF is a condition in which the tissues in your lungs become swollen and scarred over time, and as a result makes it difficult to breathe deeply.
Slovenian: Idiopatska pljučna fibroza je stanje, pri katerem pljuča sčasoma zatečejo in se zabrazgotinijo, zato je globoko dihanje oteženo.
English: In vitro data indicate some pharmacologically relevant activity of the major metabolite (5-carboxy-pirfenidone) at concentrations in excess of peak plasma concentrations in IPF patients.
Slovenian: Podatki in vitro kažejo na določeno farmakološko pomembno aktivnost glavnega presnovka (5-karboksi-pirfenidona) pri koncentracijah, ki presegajo največje plazemske koncentracije pri bolnikih z idiopatsko pljučno fibrozo.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo peroralna uporaba
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 °C
English: ● if you are taking a medicine called fluvoxamine (used to treat depression and obsessive compulsive disorder [OCD])
Slovenian: • če jemljete zdravilo fluvoksamin (ki se uporablja za zdravljenje depresije in obsesivno kompulzivne motnje);
English: If you stop taking Esbriet
Slovenian: Če ste prenehali jemati zdravilo Esbriet
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.
Slovenian: Od skupaj 555 bolnikov je bila mediana predvidene forsirane vitalne kapacitete 68 % (razpon: 48-91 %) in difuzijska kapaciteta za CO (DLCO, - carbon monoxide diffusing capacity) 42 % (razpon: 27-170 %).
English: What Esbriet looks like and contents of the pack
Slovenian: Izgled zdravila Esbriet in vsebina pakiranja
English: ● fluvoxamine (used to treat depression and obsessive compulsive disorder (OCD)).
Slovenian: • fluvoksamin (uporablja se za zdravljenje depresije in obsesivno-kompulzivne motnje).
English: Patients should be encouraged to discontinue use of strong inducers of CYP1A2 and to stop smoking before and during treatment with pirfenidone.
Slovenian: Bolnike je treba vzpodbuditi, da pred zdravljenjem s pirfenidonom in med njim prenehajo uporabljati močne induktorje CYP1A2 in kaditi.
English: Agranulocytosis1
Slovenian: Redki agranulocitoza1
English: The primary endpoint in both studies was the change from Baseline to Week 72 in percent predicted Forced Vital Capacity (FVC).
Slovenian: Primarni cilj obeh študij je bila sprememba v 72. tednu glede na izhodiščno vrednost v odstotkih predvidene forsirane vitalne kapacitete (FVC).
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).
Slovenian: Reakcija preobčutljivosti na svetlobo ali izpuščaj: Bolnike, ki imajo blago do zmerno reakcijo preobčutljivosti na svetlobo ali izpuščaj, je treba opozoriti, naj vsak dan uporabljajo kremo za sončenje in naj se izogibajo izpostavljanju soncu (glejte poglavje 4.4).
English: ● If you have any further questions, ask your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: In the case of moderate inducers of CYP1A2 (e.g. omeprazole), concomitant use may theoretically result in a lowering of pirfenidone plasma levels.
Slovenian: Če so induktorji CYP1A2 zmerni (npr. omeprazol), lahko sočasna uporaba teoretično povzroči znižanje koncentracij pirfenidona v plazmi.
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Delovanje jeter
English: Discontinue Esbriet if necessary (see sections 4.2 and 4.4).
Slovenian: Prekinite zdravljenje z zdravilom Esbriet, če je to potrebno (glejte poglavji 4.2 in 4.4).
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).
Slovenian: Med zdravljenjem bolnikov je potrebna posebna pozornost glede znakov toksičnih učinkov, zlasti če hkrati jemljejo znan zaviralec CYP1A2 (glejte poglavji 4.5 in 5.2).
English: Total serum bilirubin increased in combination with increases of ALT and
Slovenian: Redki zvišana skupna vrednost bilirubina v serumu v kombinaciji z zvišanima vrednostma ALT in AST1
English: 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 3 capsules (for the Week 1 dosing), packaged together with 7 x PVC/PE/PCTFE aluminium foil blister strips, each containing 6 capsules (for the Week 2 dosing).
Slovenian: 7 x pretisni omoti iz PVC/PE/PCTFE in aluminijaste folije s po 3 kapsulami (za enotedensko odmerjanje), pakirani skupaj s 7 x pretisnimi omoti iz PVC/PE/PCTFE in aluminijaste folije s po 6 kapsulami (za dvotedensko odmerjanje).
English: ● stomach problems such as acid reflux, vomiting, feeling bloated, abdominal pain and discomfort, heart burn, feeling constipated and passing wind
Slovenian: • težave z želodcem, kot so kisli refluks, bruhanje, občutek napihnjenosti, bolečine in nelagodje v trebuhu, zgaga, občutek zaprtja in vetrovi,
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).
Slovenian: Kapsule je treba pogoltniti cele z vodo in skupaj s hrano, s čimer se zmanjša možnost navzee in omotice (glejte poglavji 4.8 in 5.2).
English: 534 mg tablet 2 years.
Slovenian: 534-mg tablete 2 leti
English: The parent substance is predominantly metabolised to 5-carboxy-pirfenidone.
Slovenian: Izhodiščna spojina se v glavnem presnovi v 5-karboksi-pirfenidon.
English: If dizziness does not improve or if it worsens in severity, dose adjustment or even discontinuation of Esbriet may be warranted.
Slovenian: Če omotica ne poneha ali postane močnejša, bo morda treba prilagoditi odmerek ali celo prekiniti jemanje zdravila Esbriet.
English: ● omeprazole (used in the treatment of conditions such as indigestion, gastroesophageal reflux disease)
Slovenian: • omeprazol (uporablja se za zdravljenje stanj, kot so prebavne motnje in gastroezofagealna refluksna bolezen),
English: There are 14 x 2-day blister strips each containing 18 capsules (3 capsules per pocket).
Slovenian: V 14 x dvodnevnih pretisnih omotih je 18 kapsul (3 kapsule na žepek).
English: Upon initiating treatment, the dose should be titrated to the recommended daily dose of 2403 mg/day over a 14-day period as follows:
Slovenian: Na začetku zdravljenja je treba dnevni odmerek titrirati, dokler v 14 dneh ne dosežete priporočenega dnevnega odmerka 2403 mg/dan, kot je opisano spodaj:
English: ● propafenone (used to treat some types of heart disease)
Slovenian: • propafenon (uporablja se za zdravljenje nekaterih vrst bolezni srca),
English: The severity of phototoxic lesions was minimised by application of sunscreen.
Slovenian: Z uporabo kreme za sončenje se je resnost lezij zmanjšala.
English: Dizziness; somnolence; dysgeusia; lethargy
Slovenian: Pogosti omotica, zaspanost, disgevzija, letargičnost
English: The active substance is pirfenidone.
Slovenian: Učinkovina je pirfenidon.
English: The oral clearance of pirfenidone appears modestly saturable.
Slovenian: Kaže, da je peroralni očistek pirfenidona zmerno saturabilen.
English: PHARMACEUTICAL form
Slovenian: FARMACEVTSKA OBLIKA
English: Administration of Esbriet capsules with food results in a large reduction in Cmax (by 50%) and a smaller effect on AUC, compared to the fasted state.
Slovenian: Z jemanjem zdravila Esbriet v obliki kapsul skupaj s hrano se zelo zmanjša vrednost Cmax (za 50 %), učinek na vrednost AUC pa je manjši, kot če je zaužit na prazen želodec.
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:
Slovenian: Na začetku zdravljenja je treba dnevni odmerek titrirati, dokler v 14 dneh ne dosežete priporočenega dnevnega odmerka devetih kapsul na dan, kot je opisano spodaj:
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.
Slovenian: V študiji faze I je sočasna uporaba zdravila Esbriet in fluvoksamina (močnega zaviralca CYP1A2 z zaviralnim učinkom na druge izoencime CYP [CYP2C9, 2C19 in 2D6]) povzročila štirikratno povišanje izpostavljenosti pirfenidonu pri nekadilcih.
English: If for any reason you have to stop taking Esbriet for more than 14 consecutive days, your doctor will restart your treatment with a dose of 267 mg 3 times a day, gradually increasing this to a dose of 801 mg 3 times a day.
Slovenian: Če zdravila Esbriet iz kakršnega koli razloga ne boste jemali več kot 14 dni zapored, bo zdravnik ponovno začel zdravljenje z 267-mg odmerkom trikrat na dan in odmerek postopoma povečeval do 801-mg odmerka trikrat na dan.
English: ● Esbriet can cause weight loss.
Slovenian: • Zdravilo Esbriet lahko povzroči izgubo telesne mase.
English: It is unknown whether pirfenidone or its metabolites are excreted in human milk.
Slovenian: Dojenje Ni znano, ali se pirfenidon oz. njegovi presnovki izločajo v materino mleko.
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.
Slovenian: V preglednici 1 so prikazani neželeni učinki, ki so bili v združenih podatkih iz treh ključnih študij faze III poročani s pogostnostjo ≥ 2 % pri 623 bolnikih, ki so prejemali zdravilo Esbriet v priporočenem odmerku 2403 mg/dan.
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:
Slovenian: Pretisni omoti v pakiranju za dvotedenski začetek zdravljenja in štiritedensko nadaljevanje zdravljenja so za opomnik, da boste zdravilo vzeli trikrat na dan, označeni z naslednjimi simboli:
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).
Slovenian: Bolnikom z močno reakcijo preobčutljivosti na svetlobo ali izpuščajem je treba naročiti, naj prekinejo z jemanjem odmerkov in poiščejo zdravniško pomoč (glejte poglavje 4.4).
English: ● Capsule filling: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate
Slovenian: • Vsebina kapsule: mikrokristalna celuloza, premreženi natrijev karmelozat, povidon, magnezijev stearat
English: ● You should stop smoking before and during treatment with Esbriet.
Slovenian: • Pred zdravljenjem z zdravilom Esbriet in med njim morate prenehati kaditi.
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.
Slovenian: Pakiranja s pretisnimi omoti vsebujejo 21, 42, 84 ali 168 filmsko obloženih tablet; skupna pakiranja vsebujejo 63 (pakiranje 21 + 42 za dvotedenski začetek zdravljenja) ali 252 (nadaljevalno pakiranje
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.
Slovenian: Sočasna uporaba zdravil, ki delujejo kot močni induktorji CYP1A2 in drugih izoencimov CYP, vključenih v presnovo pirfenidona (npr. rifampicina), lahko pomembno zniža koncentracije pirfenidona v plazmi.
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.
Slovenian: Učinki na prebavila: Bolnike, ki so zaradi neželenih učinkov na prebavila preobčutljivi na zdravljenje, je treba opozoriti, naj zdravilo jemljejo skupaj s hrano.
English: Treatment with Esbriet should be started and overseen by a specialist doctor experienced in the diagnosis and treatment of IPF.
Slovenian: Zdravljenje z zdravilom Esbriet lahko uvede in nadzoruje le zdravnik specialist z izkušnjami pri diagnosticiranju in zdravljenju idiopatske pljučne fibroze.
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%).
Slovenian: (26,2 % v primerjavi s 7,7 %), driski (18,8 % v primerjavi s 14,4 %), utrujenosti (18,5 % v primerjavi z 10,4 %), dispepsiji (16,1 % v primerjavi s 5,0 %), anoreksiji (11,4 % v primerjavi s 3,5 %), glavobolu (10,1 % v primerjavi s 7,7 %), in reakciji preobčutljivosti na svetlobo (9,3 % v primerjavi z
English: PIPF-016 compared treatment with Esbriet 2,403 mg/day to placebo.
Slovenian: V študiji PIPF-016 so primerjali zdravljenje z zdravilom Esbriet 2403 mg/dan s placebom.
English: Sunburn Identified through post-marketing surveillance
Slovenian: 1 opredeljeno med spremljanjem v obdobju trženja
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.
Slovenian: V študiji z več različnimi odmerki pri zdravih starejših odraslih, pri katerih so uporabljeni odmerki znašali od 267 mg do 1335 mg trikrat na dan, se je srednja vrednost očistka pri odmerkih, višjih od 801 mg trikrat na dan, znižala za približno 25 %.
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).
Slovenian: Tablete je treba pogoltniti cele z vodo in skupaj s hrano, s čimer se zmanjša možnost navzee in omotice (glejte poglavji 4.8 in 5.2).
English: ● This medicine has been prescribed for you only.
Slovenian: • Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
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)
Slovenian: Srednja vrednost (SD) AUC0-∞ 5-karboksi-pirfenidona je bila značilno večja v skupinah z zmerno (100 (26,3) mg•h/l; p = 0,009) in hudo (168 (67,4) mg•h/l;
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:
Slovenian: Pretisni omoti 267-mg tablet, ki vsebujejo 63 filmsko obloženih tablet, so za opomnik, da boste zdravilo vzeli trikrat na dan, označeni z naslednjimi simboli in okrajšavami imen dnevov v tednu:
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).
Slovenian: Pirfenidon je treba pri bolnikih z blago do zmerno okvaro jeter uporabljati previdno, med njihovim zdravljenjem pa je potrebna posebna pozornost glede znakov toksičnih učinkov, zlasti če hkrati jemljejo znan zaviralec CYP1A2 (glejte poglavji 4.2 in 4.4).
English: Bioequivalence was demonstrated in the fasted state when comparing the 801 mg tablet to three 267 mg capsules.
Slovenian: Bioekvivalenca je bila dokazana na tešče, primerjali pa so 801-mg tableto s tremi 267-mg kapsulami.
English: The 4-week treatment pack contains a total of 252 capsules.
Slovenian: Pakiranje za štiritedensko zdravljenje vsebuje skupaj 252 kapsul.
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)
Slovenian: 267-mg tableta rumeni železov oksid (E172) 534-mg tableta rumeni železov oksid (E172) rdeči železov oksid (E172) 801-mg tableta rdeči železov oksid (E172) črni železov oksid (E172)
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: Esbriet contains the active substance pirfenidone and it is used for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adults.
Slovenian: Zdravilo Esbriet vsebuje učinkovino pirfenidon in se uporablja za zdravljenje blage do zmerne idiopatske pljučne fibroze pri odraslih.
English: The bottle pack contains one bottle containing 90 tablets.
Slovenian: Pakiranja s plastenkami vsebujejo eno plastenko z 90 tabletami.
English: Once liver function tests are within normal limits Esbriet may be re-escalated to the recommended daily dose if tolerated.
Slovenian: Ko so testi delovanja jeter spet v okviru normalnih vrednosti, se lahko odmerek zdravila Esbriet začne ponovno stopnjevati do priporočenega dnevnega odmerka, kakor dopušča preobčutljivost.
English: PIPF-004 and PIPF-006 compared treatment with Esbriet 2403 mg/day to placebo.
Slovenian: V študijah PIPF-004 in PIPF-006 so primerjali zdravljenje z zdravilom Esbriet v odmerku 2403 mg/dan s placebom.
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).
Slovenian: Posebna previdnost je potrebna tudi, če se zaviralci CYP1A2 uporabljajo sočasno z močnimi zaviralci enega ali več drugih izoencimov, vključenih v presnovo pirfenidona, na primer CYP2C9 (npr. amiodaron, flukonazol), 2C19 (npr. kloramfenikol) in 2D6 (npr. fluoksetin, paroksetin).
English: The bottle packs contain either one bottle containing 21 tablets or one bottle containing 90 tablets.
Slovenian: Pakiranja s plastenkami vsebujejo eno plastenko z 21 tabletami ali eno plastenko z 90 tabletami.
English: Roche Pharma AG Emil-Barell-Str. 1
Slovenian: Emil-Barell-Strasse 1
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).
Slovenian: V 7 pretisnih omotih so 3 kapsule na pretisni omot (1 kapsula v žepku za 1. teden) in v 7 pretisnih omotih je 6 kapsul na pretisni omot (2 kapsuli v žepku za 2. teden).
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.
Slovenian: Pri bolnikih z blago do hudo okvaro ledvic ni bilo opaženih klinično pomembnih razlik v farmakokinetiki pirfenidona v primerjavi z osebami z normalnim delovanjem ledvic.
English: Medicines that may increase side effects of Esbriet:
Slovenian: Zdravila, ki lahko okrepijo neželene učinke zdravila Esbriet:
English: Results showed that there was a mean increase of 60% in pirfenidone exposure after a single dose of 801 mg pirfenidone (3 x 267 mg capsule) in patients with moderate hepatic impairment.
Slovenian: Rezultati so pokazali, da se je pri bolnikih z zmerno okvaro jeter po enem odmerku pirfenidona, ki je znašal 801 mg (3 kapsule po 267 mg), izpostavljenost pirfenidonu povprečno zvišala za 60 %.