FrancophonIA/ELRC3.0 huggingface dataset:
English: Each capsule contains 267 mg of pirfenidone.
Slovenian: Ena kapsula vsebuje 267 mg pirfenidona.
English: Pirfenidone should be used with caution in patients with moderate renal impairment.
Slovenian: Pri bolnikih z zmerno okvaro ledvic je treba pirfenidon uporabljati previdno.
English: ● skin reactions after going out in the sun or using sunlamps
Slovenian: • kožne reakcije po izpostavljenosti soncu ali uporabi ultravijoličnih svetilk, • siljenje na bruhanje (navzea),
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)
Slovenian: EU/1/11/667/013 42 tablet (2 × 21) EU/1/11/667/014 84 tablet (4 × 21)
English: 801 mg tablet
Slovenian: 801-mg tableta
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)
Slovenian: 1. teden - 21 kapsul (7 pretisnih omotov s po 3 kapsulami) 2. teden - 42 kapsul (7 pretisnih omotov s po 6 kapsulami)
English: 21 tablets 42 tablets) 90 tablets 180 tablets
Slovenian: 42 tablet 90 tablet
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)
Slovenian: • od 8. do 14. dneva vzemite 534-mg odmerek (dve rumeni tableti ali eno oranžno tableto) trikrat na dan skupaj s hrano (skupno 1602 mg/dan),
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.
Slovenian: Pri živalih pride do prenosa pirfenidona in/ali njegovih presnovkov prek placente, zato obstaja možnost kopičenja pirfenidona in/ali njegovih presnovkov v plodovnici.
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:
Slovenian: Pretisni omoti 801-mg tablet so za opomnik, da boste zdravilo vzeli trikrat na dan, označeni z naslednjimi simboli in okrajšavami imen dnevov v tednu:
English: At high doses (≥1,000 mg/kg/day) rats exhibited prolongation of gestation and reduction in foetal viability.
Slovenian: Pri velikih odmerkih (≥ 1000 mg/kg/dan) se je pri podganah čas brejosti podaljšal, sposobnost ploda za preživetje pa zmanjšala.
English: Table 4 Categorical assessment of change from Baseline to Week 52 in percent predicted FVC in study PIPF-016
Slovenian: Preglednica 4 Kategorična ocena sprememb do 52. tedna glede na izhodiščno vrednost v odstotkih predvidene forsirane vitalne kapacitete v študiji PIPF-016
English: Treatment with Esbriet also significantly reduced the decline of percent predicted FVC from Baseline at Weeks 13 (p<0.000001), 26 (p<0.000001), and 39
Slovenian: Zdravljenje z zdravilom Esbriet je tudi pomembno zmanjšalo padec v odstotkih predvidene forsirane vitalne kapacitete v 13. tednu (p < 0,000001), 26. tednu (p < 0,000001) in
English: b p-value versus Normal = 0.009 (pair-wise comparison with Bonferroni)
Slovenian: b p-vrednost glede na Normalno = 0,009 (parna primerjava po Bonferonniju)
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg hard capsules
Slovenian: IME ZDRAVILA Esbriet 267 mg trde kapsule
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.
Slovenian: Če ste vzeli več kapsul, kot bi smeli, takoj obiščite zdravnika, farmacevta ali oddelek prve pomoči najbližje bolnišnice in s seboj vzemite zdravilo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated tablets in Blisters 252 Multipack (INCLUDING BLUE BOX)
Slovenian: ŠKATLA - filmsko obložene tablete v pretisnih omotih v skupnem pakiranju z 252 tabletami(VKLJUČNO Z MODRIM OKENCEM)
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).
Slovenian: • od 15. dneva dalje (vzdrževalno zdravljenje) vzemite 801-mg odmerek (tri rumene tablete ali eno rjavo tableto) trikrat na dan skupaj s hrano (skupno 2403 mg/dan).
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).
Slovenian: Zdravljenje z zdravilom Esbriet je tudi pomembno zmanjšalo padec v odstotkih predvidene forsirane vitalne kapacitete v 24. tednu (p = 0,014), 36. tednu (p < 0,001), 48. tednu (p < 0,001) in 60. tednu (p < 0,001)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Roche Registration GmbH.
Slovenian: Roche Registration GmbH.
English: ● Severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.2 and 5.2).
Slovenian: • huda okvara ledvic (očistek kreatinina < 30 ml/min) ali končna odpoved ledvic, pri kateri je potrebna dializa (glejte poglavji 4.2 in 5.2).
English: 1 bottle containing 21 film-coated tablets 1 bottle containing 90 film-coated tablets
Slovenian: 1 plastenka z 42 filmsko obloženimi tabletami 1 plastenka z 90 filmsko obloženimi tabletami
English: ● If you get any side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
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).
Slovenian: Vendar pa je zdravljenje z zdravilom Esbriet zmanjšalo padec v odstotkih predvidene forsirane vitalne kapacitete v 24. tednu (p < 0,001), 36. tednu (p = 0,011) in 48. tednu (p = 0,005) glede na izhodiščno vrednost.
English: ● Days 1 to 7: a dose of 267 mg administered three times a day (801 mg/day)
Slovenian: • 1.-7. dan: en 267-mg odmerek, vzet trikrat na dan (801 mg/dan)
English: Esbriet should be used with caution in patients with pre-existing mild to moderate hepatic impairment (i.e. Child-Pugh Class A and B) given the potential for increased pirfenidone exposure.
Slovenian: Pri bolnikih s predhodno blago do zmerno okvaro jeter (npr. razred A in B po lestvici Child-Pugh), je treba zdravilo Esbriet uporabljati previdno, saj obstaja možnost povečane izpostavljenosti pirfenidonu.
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.
Slovenian: Če ste vzeli več tablet, kot bi smeli, takoj obiščite zdravnika, farmacevta ali oddelek prve pomoči najbližje bolnišnice in s seboj vzemite zdravilo.
English: At Week 52, a decline from Baseline in percent predicted FVC of ≥10% or death was seen in 17% of patients receiving Esbriet compared to 32% receiving placebo (Table 4).
Slovenian: V 52. tednu so padec v odstotkih predvidene forsirane vitalne kapacitete glede na izhodiščno vrednost ≥ 10 % ali smrt opazili pri 17 % bolnikov, ki so prejemali zdravilo Esbriet, v primerjavi z 32 % pri tistih, ki so prejemali placebo (Preglednica 4).
English: Table 1 Adverse reactions by SOC and MedDRA frequency Infections and infestations
Slovenian: Preglednica 1 Neželeni učinki po organskih sistemih in pogostnosti MedDRA
English: 267 mg tablet
Slovenian: 267-mg tableta
English: Each film-coated tablet contains 267 mg pirfenidone.
Slovenian: Ena filmsko obložena tableta vsebuje 267 mg pirfenidona.
English: 267 mg film-coated tablets
Slovenian: 267-mg filmsko obložene tablete
English: c p-value versus Normal < 0.0001 (pair-wise comparison with Bonferroni)
Slovenian: c p-vrednost glede na Normalno < 0,0001 (parna primerjava po Bonferonniju)
English: No dose adjustment is required in patients with mild renal impairment who are receiving pirfenidone.
Slovenian: Pri bolnikih z blago okvaro ledvic, ki prejemajo pirfenidon, odmerka ni treba prilagajati.
English: ; 100 (26.3) mg•h/L and 168 (67.4)
Slovenian: 168 c (67,4)
English: ALT increased; AST increased; gamma glutamyl transferase increased
Slovenian: Pogosti zvišana vrednost ALT, zvišana vrednost AST, zvišana vrednost gamaglutamil-transferaze
English: Esbriet 801 mg film-coated tablets
Slovenian: Esbriet 801 mg filmsko obložene tablete pirfenidon
English: Each film-coated tablet contains 801 mg pirfenidone.
Slovenian: Ena filmsko obložena tableta vsebuje 801 mg pirfenidona.
English: A reduced incidence of adverse events (nausea and dizziness) was observed in fed subjects when compared to the fasted group.
Slovenian: Pri osebah, ki so imele poln želodec, je bila v primerjavi s skupino, ki je bila tešča, pojavnost neželenih učinkov (slabosti in omotice) manjša.
English: If a patient exhibits an aminotransferase elevation to >5 x ULN, Esbriet should be discontinued and the patient should not be rechallenged.
Slovenian: Če je pri bolniku zaznano zvišanje vrednosti aminotransferaze na vrednost, večjo od petkratne zgornje meje normalnega razpona, je treba jemanje zdravila Esbriet prekiniti, zdravila pa se ne sme ponovno uvesti.
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).
Slovenian: V študiji PIPF-016 je bil pri bolnikih, ki so prejemali zdravilo Esbriet (n = 278), padec v odstotkih predvidene forsirane vitalne kapacitete glede na izhodiščno vrednost v 52. tednu zdravljenja pomembno zmanjšan v primerjavi z bolniki, ki so prejemali placebo (n = 277; p < 0,000001, rang ANCOVA).
English: The recommended maintenance daily dose of Esbriet is 3 capsules three times a day with food, for a total of 2403 mg/day.
Slovenian: Priporočeni vzdrževalni odmerek zdravila Esbriet so tri kapsule trikrat na dan, zaužite skupaj s hrano, tako da skupni dnevni odmerek znaša 2403 mg/dan.
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg hard capsules Pirfenidone
Slovenian: IME ZDRAVILA Esbriet 267 mg trde kapsule pirfenidon
English: PVC/Aclar (PCTFE) aluminium foil blister Pack sizes
Slovenian: 1 plastenka z 90 filmsko obloženimi tabletami Pretisni omoti iz PVC/Aclar (PCTFE) aluminijaste folije Velikosti pakiranj
English: Esbriet 534 mg film-coated tablets
Slovenian: Esbriet 534 mg filmsko obložene tablete pirfenidon
English: Each film-coated tablet contains 534 mg pirfenidone.
Slovenian: Ena filmsko obložena tableta vsebuje 534 mg pirfenidona.
English: Table 3 Categorical assessment of change from Baseline to Week 72 in percent predicted FVC in study PIPF-006
Slovenian: Preglednica 3 Kategorična ocena sprememb do 72. tedna glede na izhodiščno vrednost v odstotkih predvidene forsirane vitalne kapacitete v študiji PIPF-006
English: Phototoxicity and irritation were noted in guinea pigs after oral administration of pirfenidone and with exposure to UVA/UVB light.
Slovenian: Pri budrah sta bila po peroralnem zaužitju pirfenidona in po izpostavljenosti svetlobi UVA/UVB opažena fototoksičnost in draženje.
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).
Slovenian: V študiji PIPF-006 je bil padec razdalje pri šestminutnem testu hoje v 72. tednu glede na izhodiščno vrednost pomembno zmanjšan v primerjavi s placebom (p < 0,001, rang ANCOVA).
English: The blisters pack contains 84 film-coated tablets and the multipack contains 252 (continuation pack 3x84) film-coated tablets.
Slovenian: Pakiranja s pretisnimi omoti vsebujejo 84 filmsko obloženih tablet; skupna pakiranja vsebujejo 252
English: Dizziness has been reported in patients taking Esbriet.
Slovenian: Pri bolnikih, ki so jemali zdravilo Esbriet, so poročali o omotici.
English: Table 2 Categorical assessment of change from Baseline to Week 72 in percent predicted FVC in study PIPF-004
Slovenian: Preglednica 2 Kategorična ocena sprememb do 72. tedna glede na izhodiščno vrednost v odstotkih predvidene forsirane vitalne kapacitete v študiji PIPF-004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/011 90 tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/011 90 tablet
English: The recommended maintenance daily dose of Esbriet is three 267 mg capsules three times a day with food for a total of 2403 mg/day.
Slovenian: Priporočeni vzdrževalni dnevni odmerek zdravila Esbriet so tri 267-miligramske kapsule trikrat na dan, zaužite skupaj s hrano, tako da skupni dnevni odmerek znaša 2403 mg/dan.
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).
Slovenian: 624 bolnikov), kar je povzročilo 48-odstotno zmanjšanje tveganja smrtnosti zaradi vseh razlogov v prvih 12 mesecih (HR 0,52 [95-odstotni interval zaupanja, 0,31-0,87], p = 0,0107, test log-rang).
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.
Slovenian: (nekatera resna), kot so oteklost obraza, ustnic in/ali jezika, ki so lahko povezana s težkim dihanjem ali sopenjem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/009 21 tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/009 21 tablet
English: A statistically significant increase in uterine tumours was observed in female rats administered 1,500 mg/kg/day, 37 times the human dose of 2,403 mg/day.
Slovenian: Pri samicah podgan, ki so dobivale 1500 mg/kg/dan, kar je 37-kratnik odmerka 2403 mg/dan pri ljudeh, je bilo opaženo statistično pomembno povečanje števila tumorjev na maternici.
English: Esbriet 534 mg film-coated tablets are orange, oval, biconvex film-coated tablets, debossed with “PFD”.
Slovenian: Esbriet 534 mg filmsko obložene tablete so oranžne, ovalne, bikonveksne, filmsko obložene tablete z vtisnjenim napisom “PFD”.
English: AUC0-∞ = area under the concentration-time curve from time zero to infinity.
Slovenian: AUC0-∞ = površina pod krivuljo koncentracija-čas od časa nič do neskončnosti a p-vrednost glede na Normalno = 1,00 (parna primerjava po Bonferonniju)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER STRIPS BLISTER STRIPS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU PRETISNI OMOT
English: ● from day 8 to 14 take 2 capsules, 3 times a day with food (a total of 1,602 mg/day)
Slovenian: • od 8. do 14. dneva vzemite dve kapsuli trikrat na dan skupaj s hrano (skupno 1602 mg/dan),
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.
Slovenian: Med zdravljenjem s pirfenidonom se je treba izogibati drugim zdravljenjem, ki zavirajo CYP1A2 in enega ali več izoencimov CYP, ki so vključeni v presnovo pirfenidona (npr. CYP2C9, 2C19 in 2D6).
English: Nervous system disorders Very Common Headache Common
Slovenian: Žilne bolezni Pogosti vročinski oblivi
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).
Slovenian: V študiji PIPF-004 je bil pri bolnikih, ki so prejemali zdravilo Esbriet (n = 174), padec v odstotkih predvidene forsirane vitalne kapacitete glede na izhodiščno vrednost v 72. tednu pomembno zmanjšan v primerjavi z bolniki, ki so prejemali placebo (n = 174, p = 0,001, rang ANCOVA).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE 70 ML
Slovenian: PODATKI NA STIČNI OVOJNINI NALEPKA - PLASTENKA 70 ml
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Navodilo je bilo nazadnje revidirano dne Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg film-coated tablets Pirfenidone
Slovenian: Esbriet 267 mg filmsko obložene tablete pirfenidon
English: Hepatic impairment
Slovenian: Pogosti nespečnost
English: Esbriet 267 mg film-coated tablets are yellow, oval, biconvex film-coated tablets, debossed with “PFD”.
Slovenian: Esbriet 267 mg filmsko obložene tablete so rumene, ovalne, bikonveksne, filmsko obložene tablete z vtisnjenim napisom “PFD”.
English: As a precautionary measure, it is preferable to avoid the use of Esbriet if you are pregnant, planning to become pregnant, or think you might be pregnant as the potential risks to the unborn child are unknown.
Slovenian: Če ste noseči, če načrtujete nosečnost ali če mislite, da ste noseči, se je jemanju zdravila Esbriet iz previdnosti bolje izogniti.
English: Multiple doses of pirfenidone up to a total dose of 4,806 mg/day were administered as six 267 mg capsules three times daily to healthy adult volunteers over a 12-day dose escalation period.
Slovenian: Zdravi odrasli prostovoljci so v 12-dnevnem obdobju stopnjevanja odmerka prejemali več odmerkov pirfenidona dnevno, pri čemer je celotni odmerek znašal 4806 mg/dan v obliki šestih 267-miligramskih kapsul trikrat na dan. Neželeni učinki so bili blagi, prehodni in skladni z najpogosteje navedenimi neželenimi učinki pirfenidona.
English: Esbriet 534 mg film-coated tablets are orange, oval, approximately 1.6 x 0.8 cm biconvex film-coated tablets, debossed with “PFD”.
Slovenian: Esbriet 534 mg filmsko obložene tablete so oranžne, ovalne, velike približno 1,6 x 0,8 cm, bikonveksne, filmsko obložene tablete z vtisnjenim napisom “PFD”.
English: Renal Impairment Group
Slovenian: Okvara ledvic (skupine)
English: 2-week treatment initiation pack: multipack containing 63 (1 pack containing 1 blister of 21 and 1 pack containing 2 blisters of 21) film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA filmsko obložena tableta skupno pakiranje, ki vsebuje 63 (1 pakiranje z 1 pretisnim omotom po 21 in 1 pakiranje z 2 pretisnima omotoma po 21) filmsko obloženih tablet
English: At Week 72, a decline in FVC of ≥10% was seen in 23% of patients receiving Esbriet and 27% receiving placebo (Table 3).
Slovenian: V 72. tednu je bil zaznan padec v odstotkih predvidene forsirane vitalne kapacitete ≥ 10 % pri 23 % bolnikov, ki so prejemali zdravilo Esbriet, in pri 27 %
English: ● Capsule brown printing ink: shellac, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), propylene glycol, ammonium hydroxide
Slovenian: • Rjavo črnilo za tiskanje na kapsulo: šelak, črni železov oksid (E172), rdeči železov oksid
English: Esbriet 801 mg film-coated tablets are brown, oval, biconvex film-coated tablets, debossed with “PFD”.
Slovenian: Esbriet 801 mg filmsko obložene tablete so rjave, ovalne, bikonveksne, filmsko obložene tablete z vtisnjenim napisom “PFD”.
English: At high doses (≥1,000 mg/kg/day) rats exhibited a prolongation of gestation and reduction in fetal viability.
Slovenian: Pri podganah se je pri velikih odmerkih (≥ 1000 mg/kg/dan) čas brejosti podaljšal, sposobnost ploda za preživetje pa zmanjšala.
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
Slovenian: 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: Photosensitivity
Slovenian: Preobčutljivost na svetlobo
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment (i.e. Child-Pugh Class A and B).
Slovenian: Pri bolnikih z blago do zmerno okvaro jeter (npr. razreda A in B po lestvici Child-Pugh) odmerka ni treba prilagajati.
English: ● diarrhoea
Slovenian: • zaspanost,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/016 63 tablets (21+42)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/667/016 63 tablet (21 + 42)
English: Fluvoxamine should be discontinued prior to the initiation of Esbriet therapy and avoided during Esbriet therapy due to the reduced clearance of pirfenidone.
Slovenian: med zdravljenjem s tem zdravilom pa se mu je treba izogibati, saj zmanjšuje očistek pirfenidona.
English: Exposure to direct sunlight (including sunlamps) should be avoided or minimised during treatment with Esbriet.
Slovenian: Med jemanjem zdravila Esbriet se izogibajte soncu (vključno z ultravijoličnimi svetilkami).
English: There are 14 x 18 capsules in PVC/PE/PCTFE aluminium foil perforated blister strips for a total of 252 capsules per pack.
Slovenian: perforiranih pretisnih omotih iz PVC/PE/PCTFE in aluminijaste folije je 14 x 18 kapsul, kar je skupaj
English: ● weight loss
Slovenian: Izguba telesne mase
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172) and iron oxide black (E172)
Slovenian: Filmsko oblogo sestavljajo: polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec, rdeči železov oksid (E172) in črni železov oksid (E172).
English: What Esbriet is and what it is used for What you need to know before you take Esbriet How to take Esbriet
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Esbriet Kako jemati zdravilo Esbriet
English: Esbriet 267 mg film-coated tablets are yellow, oval, approximately 1.3 x 0.6. cm biconvex film-coated tablets, debossed with “PFD”.
Slovenian: Esbriet 267 mg filmsko obložene tablete so rumene, ovalne, velike približno 1,3 x 0,6 cm, bikonveksne, filmsko obložene tablete z vtisnjenim napisom “PFD”.
English: ● Product information (SPC)
Slovenian: Blago srednja vrednost (SD)
English: Other side effects may include Talk to your doctor if you get any side effects.
Slovenian: Drugi možni neželeni učinki Če opazite kateri koli neželeni učinek, o tem obvestite zdravnika.
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172) and iron oxide red (E172)
Slovenian: Filmsko oblogo sestavljajo: polivinilalkohol, titanov dioksid (E171), makrogol 3350, smukec, rumeni železov oksid (E172) in rdeči železov oksid (E172).
English: 801 mg film-coated tablets
Slovenian: 801-mg filmsko obložene tablete
English: Microcrystalline cellulose Croscarmellose sodium Povidone K30
Slovenian: Jedro tablete mikrokristalna celuloza premreženi natrijev karmelozat providon K30 koloidni brezvodni silicijev dioksid magnezijev stearat
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).
Slovenian: Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali končno odpovedjo ledvic, pri kateri je potrebna dializa, je uporaba pirfenidona kontraindicirana (glejte poglavji 4.2 in 4.3).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE 200 ML
Slovenian: PODATKI NA STIČNI OVOJNINI NALEPKA - PLASTENKA 200 ml
English: ● Day 15 onward: three capsules, three times a day (2403 mg/day)
Slovenian: • Od 15. dne dalje: en 801-mg odmerek, vzet trikrat na dan (2403 mg/dan)
English: Fatigue has been reported in patients taking Esbriet.
Slovenian: Pri bolnikih, ki so jemali zdravilo Esbriet, so poročali o utrujenosti.
English: ● from day 15 onwards (maintenance), take 3 capsules, 3 times a day with food (a total of 2,403 mg/day).
Slovenian: • od 15. dneva dalje (vzdrževalno zdravljenje)vzemite tri kapsule trikrat na dan skupaj s hrano
English: PHARMACOLOGICAL PROPERTIES
Slovenian: Farmakokinetični podatki,
English: INFORMATION IN BRAILLE esbriet 267 mg tablets
Slovenian: esbriet 267 mg tablete