FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Severe hepatic impairment or end stage liver disease (see sections 4.2 and 4.4).
Icelandic: Alvarlega skert lifrarstarfsemi eða lifrarsjúkdómur á lokastigi (sjá kafla 4.2 og 4.4),
English: The recommended maintenance daily dose of Esbriet is 3 capsules three times a day with food, for a total of 2403 mg/day.
Icelandic: Ráðlagður daglegur viðhaldsskammtur af Esbriet er 3 hylki þrisvar sinnum á dag með mat, samtals 2.403 mg/dag.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON Film-coated Tablets in Blisters
Icelandic: YTRI UMBÚÐUM ASKJA - Filmuhúðaðar töflur í þynnupakkningum
English: IPF is a chronic fibrotic and inflammatory pulmonary disease affected by the synthesis and release of pro-inflammatory cytokines including tumour necrosis factor-alpha (TNF-α) and interleukin-1-beta
Icelandic: Sjálfvakin lungnatrefjun (IPF) er langvinnur bandvefs- og bólgusjúkdómur í lungum sem verður fyrir áhrifum af nýmyndun og losun for-bólguónæmisboðefna, þ.m.t. TNF-α (tumour necrosis factor-alpha) og IL-1β (interleukin-1-beta) og pírfenidón hefur reynst draga úr uppsöfnun bólgufrumna sem svörun við ýmsum tegundum áreita.
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.
Icelandic: Ef hækkun amínótransferasa upp í ≤ 5 x eðlileg efri mörk kemur fram hjá sjúklingi ásamt einkennum eða of háu bilírúbíni í blóði skal hætta notkun Esbriet og ekki gefa sjúklingnum lyfið aftur.
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).
Icelandic: Ef ekki er hægt að komast hjá skammtagjöf cíprófloxacíns sem nemur 750 mg tvisvar á dag skal minnka skammtinn af pírfenidóni í 1.602 mg á dag (534 mg, þrisvar sinnum á dag).
English: ● stomach problems such as acid reflux, vomiting, feeling bloated, abdominal pain and discomfort, heart burn, feeling constipated and passing wind
Icelandic: magavandamál svo sem sýrubakflæði, uppköst, uppþemba, kviðverkur og vanlíðan, brjóstsviði,
English: Esbriet 801 mg film-coated tablets
Icelandic: Esbriet 801 mg filmuhúðaðar töflur
English: Patients should be instructed to report symptoms of photosensitivity reaction or rash to their physician.
Icelandic: Sjúklingum skal sagt að greina lækninum frá einkennum ljósnæmisviðbragða eða útbrotum.
English: General disorders and administration site conditions Very Common Fatigue Common
Icelandic: Almennar aukaverkanir og aukaverkanir á íkomustað Mjög algengar
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
Icelandic: Pakkning fyrir 2 vikna upphafsmeðferð: fjölpakkning með 63 filmuhúðuðum töflum (1 pakkning með 1 þynnu sem inniheldur 21 filmuhúðaða töflu og 1 pakkning með 2 þynnum sem innihalda 21 filmuhúðaða töflu)
English: Titanium dioxide (E171)
Icelandic: Títantvíoxíð (E171) Gelatín
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 to avoid exposure to the sun (see section 4.4).
Icelandic: Sjúklinga sem finna fyrir vægum til miðlungi alvarlegum ljósnæmisviðbrögðum eða útbrotum á að minna á daglega notkun sólvarnar og að forðast útsetningu fyrir sól (sjá kafla 4.4).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE 70 ML
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á INNRI UMBÚÐUM MIÐI - GLAS 70 ML
English: Microcrystalline cellulose Croscarmellose sodium Povidone
Icelandic: Örkristallaður sellulósi Natríumkroskarmellósi Póvídón
English: At high doses (≥450 mg/kg/day) rats exhibited a prolongation of oestrous cycle and a high incidence of irregular cycles.
Icelandic: Við háa skammta (≥ 450 mg/kg/dag) lengdist tímgunarhringur hjá rottum og tíðni óreglulegra hringja jókst.
English: If you are breast-feeding or plan to breast-feed speak to your doctor or pharmacist before taking Esbriet.
Icelandic: Talaðu við lækninn eða lyfjafræðing áður en þú tekur Esbriet ef þú ert með barn á brjósti eða áætlar að hafa barn á brjósti.
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)
Icelandic: Gult járnoxíð (E172) Rautt járnoxíð (E172) 801 mg töflur
English: ● rifampicin (a type of antibiotic).
Icelandic: • rífampicín (sýklalyf).
English: A reduced incidence of adverse events (nausea and dizziness) was observed in fed subjects when compared to the fasted group.
Icelandic: Lægri tíðni aukaverkana (ógleði og sundls) kom fram við töku eftir máltíð samanborið við fastandi hópinn.
English: Table 1 Adverse reactions by SOC and MedDRA frequency Infections and infestations
Icelandic: Tafla 1 Aukaverkanir samkvæmt flokkun eftir líffærum og MeDRA tíðniflokkun Sýkingar af völdum sýkla og sníkjudýra
English: Iron oxide yellow (E172)
Icelandic: Gult járnoxíð (E172)
English: Decline of ≥10% or death or lung transplant
Icelandic: Skerðing ≥10% eða dauðsfall eða lungnaígræðsla 35 (20%)
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).
Icelandic: 52 marktækt minni hjá sjúklingum sem fengu Esbriet (N=278) samanborið við sjúklinga sem fengu lyfleysu (N=277, p<0,000001, rank ANCOVA).
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).
Icelandic: Ef ekki er hægt að komast hjá skammtagjöf cíprófloxacíns sem nemur 750 mg tvisvar sinnum á dag skal minnka skammtinn af pírfenidóni í 1602 mg á dag (tvö hylki, þrisvar á dag).
English: 2 bottles each containing 21 film-coated tablets (42 film-coated tablets in total) 1 bottle containing 42 film-coated tablets 1 bottle containing 90 film-coated tablets 2 bottles each containing 90 film-coated tablets (180 film-coated tablets in total) 1 bottle containing 180 film-coated tablets
Icelandic: 42 filmuhúðaðar töflur 1 glas sem inniheldur 90 filmuhúðaðar töflur 2 glös sem hvort inniheldur 90 töflur (alls 180 filmuhúðaðar töflur) 1 glas sem inniheldur 180 filmuhúðaðar töflur
English: Treatment with Esbriet should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF.
Icelandic: Sérfræðingar með reynslu í greiningu og meðferð á sjálfvakinni lungnatrefjun (IPF) skulu hefja meðferð með Esbriet og hafa eftirlit með henni.
English: In the case of moderate inducers of CYP1A2 (e.g. omeprazole), concomitant use may theoretically result in a lowering of pirfenidone plasma levels.
Icelandic: Ef um miðlungi öfluga CYP1A2 örva er að ræða (t.d. ómeprazól) getur samhliða notkun fræðilega valdið lækkun á þéttni pírfenidóns í plasma.
English: At high doses (≥1,000 mg/kg/day) rats exhibited prolongation of gestation and reduction in foetal viability.
Icelandic: Við háa skammta (≥ 1.000 mg/kg/dag) dróst meðgangan á langinn og lífslíkur fóstra minnkuðu hjá rottum.
English: ● muscle pain, aching joints/joint pains
Icelandic: vöðvaverkir, eymsli í liðum/liðverkir
English: ● omeprazole (used in the treatment of conditions such as indigestion, gastroesophageal reflux disease)
Icelandic: • ómeprazól (notað við t.d. meltingartruflunum, maga-vélindabakflæðissjúkdómi)
English: Table 4 Categorical assessment of change from Baseline to Week 52 in percent predicted FVC in study PIPF-016
Icelandic: 52 á hlutfalli áætlaðs FVC í rannsókninni PIPF-016
English: 801 mg film-coated tablets
Icelandic: 801 mg filmuhúðaðar töflur
English: Do not take more capsules each day than your prescribed daily dose.
Icelandic: Ekki taka fleiri hylki á dag en læknirinn hefur ávísað.
English: Pirfenidone should be used with caution in patients with moderate renal impairment.
Icelandic: Gæta skal varúðar við notkun pírfenidóns hjá sjúklingum með miðlungi alvarlega skerðingu á nýrnastarfsemi.
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 (p=0.000002).
Icelandic: Meðferð með Esbriet minnkaði einnig marktækt skerðingu frá grunngildi á hlutfalli áætlaðs FVC í viku 13 (p<0,000001), 26 (p<0,000001) og 39 (p=0,000002).
English: ● tiredness
Icelandic: • lystarleysi
English: Esbriet contains the active substance pirfenidone and it is used for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adults.
Icelandic: Esbriet inniheldur virka efnið pírfenidón og er notað við meðferð á vægri til miðlungi alvarlegri sjálfvakinni lungnatrefjun hjá fullorðnum.
English: Wear sunblock daily and cover your arms, legs and head to reduce exposure to sunlight (see section 4: Possible side effects).
Icelandic: fótleggi og höfuð til að minnka útsetningu fyrir sólarljósi (sjá kafla 4:
English: ● dizziness
Icelandic: • niðurgangur
English: ● Capsule brown printing ink: shellac, iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), propylene glycol, ammonium hydroxide
Icelandic: Brúnt prentblek á hylki: gljálakk, svart járnoxíð (E172), rautt járnoxíð (E172), gult járnoxíð
English: INFORMATION IN BRAILLE esbriet 801 mg tablets
Icelandic: MEÐ BLINDRALETRI esbriet 801 mg töflur
English: Esbriet 534 mg film-coated tablets are orange, oval, approximately 1.6 x 0.8 cm biconvex film-coated tablets, debossed with “PFD”.
Icelandic: Esbriet 534 mg filmuhúðaðar töflur eru appelsínugular, sporöskjulaga, u.þ.b. 1,6 x 0,8 cm tvíkúptar, filmuhúðaðar töflur með ígreyptu „PFD“.
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).
Icelandic: Ekki skal nota Esbriet hjá sjúklingum með alvarlega skerta nýrnastarfsemi (CrCl < 30 ml/mín) eða nýrnasjúkdóm á lokastigi sem þarfnast skilunar (sjá kafla 4.3 og 5.2).
English: Esbriet 534 mg film-coated tablets are orange, oval, biconvex film-coated tablets, debossed with “PFD”.
Icelandic: Esbriet 534 mg filmuhúðaðar töflur eru appelsínugular, sporöskjulagaðar filmuhúðaðar töflur, kúptar báðum megin, með ígreyptu „PFD“.
English: Film-coated tablet 21 film-coated tablets.
Icelandic: 21 filmuhúðuð tafla.
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.
Icelandic: á Cmax (um 50%) og minni áhrifum á AUC, samanborið við gjöf á fastandi maga.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL - BOTTLE 200 ML
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á INNRI UMBÚÐUM MIÐI - GLAS 200 ML
English: Each capsule contains 267 mg of pirfenidone.
Icelandic: Hvert hylki inniheldur 267 mg af pírfenidóni.
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)
Icelandic: takið 534 mg skammt (2 gular töflur eða 1 appelsínugula töflu), 3 sinnum á dag (samtals 1.602 mg/dag) með mat daga 8 til 14
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).
Icelandic: Ekki má nota pírfenidón hjá sjúklingum með alvarlega skerðingu á nýrnastarfsemi (CrCl < 30 ml/mín) eða nýrnasjúkdóm á lokastigi sem þarfnast skilunar (sjá kafla 4.2 og 4.3).
English: Table 2 Categorical assessment of change from Baseline to Week 72 in percent predicted FVC in study PIPF-004
Icelandic: 72 á hlutfalli áætlaðs FVC í rannsókninni PIPF-004
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).
Icelandic: Meðferð með Esbriet dró hins vegar úr skerðingu á hlutfalli áætlaðs FVC frá grunngildi í viku 24 (p<0,001), 36 (p=0,011) og 48 (p=0,005).
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172) and iron oxide black (E172)
Icelandic: Í filmuhúðinni er: pólývínýl alkóhól, títantvíoxíð (E171), macrogol 3350, talkúm, rautt járnoxíð (E172) og svart járnoxíð (E172)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/011 90 tablets
Icelandic: MARKAÐSLEYFISNÚMER EU/1/11/667/011 90 töflur
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).
Icelandic: 72 var marktækt minni í rannsókn PIPF-006 (p<0,001, rank ANCOVA) samanborið við lyfleysu.
English: INFORMATION IN BRAILLE esbriet 267 mg tablets
Icelandic: MEÐ BLINDRALETRI esbriet 267 mg töflur
English: ● changes in taste
Icelandic: • breytt bragðskyn
English: Mutlipack: 63 (1 pack containing 1 blister of 21 and 1 pack containing 2 blisters of 21) filmcoated tablets
Icelandic: 63 filmuhúðaðar töflur (1 pakkning með 1 þynnu sem inniheldur 21 filmuhúðaða töflu og 1 pakkning með 2 þynnum sem hvor inniheldur 21 filmuhúðaða töflu)
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).
Icelandic: Meðferð með Esbriet dró einnig verulega úr skerðingu á hlutfalli áætlaðs FVC frá grunngildi í vikum 24 (p=0,014), 36 (p<0,001), 48 (p<0,001) og 60 (p<0,001).
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172)
Icelandic: Í filmuhúðinni er: pólývínýl alkóhól, títantvíoxíð (E171), macrogol 3350, talkúm, gult járnoxíð (E172)
English: The film coat consists of: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172) and iron oxide red (E172)
Icelandic: Í filmuhúðinni er: pólývínýl alkóhól, títantvíoxíð (E171), macrogol 3350, talkúm, gult járnoxíð (E172) og rautt járnoxíð (E172)
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.
Icelandic: 1.500 mg/kg/dag, 37faldan skammt handa mönnum 2.403 mg/dag.
English: When tested under UV exposure pirfenidone was positive in a photoclastogenic assay in Chinese hamster lung cells.
Icelandic: Pírfenidón reyndist jákvætt í ljósnæmislitningasundrunarprófi (photoclastogenic assay)
English: A decision must be made whether to discontinue breast-feeding or to discontinue from Esbriet therapy, taking into account the benefit of breast-feeding for the child and the benefit of Esbriet therapy for the mother.
Icelandic: Vega þarf og meta kosti brjóstagjafar fyrir barnið og ávinning meðferðar fyrir konuna og ákveða á grundvelli matsins hvort hætta eigi brjóstagjöf eða hætta/stöðva tímabundið meðferð með Esbriet.
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.
Icelandic: Dagar 15 og áfram: þrjú hylki, þrisvar á dag (2.403 mg/dag) Ráðlagður daglegur viðhaldsskammtur af Esbriet er þrjú 267 mg hylki þrisvar á dag með mat, samtals 2.403 mg/dag.
English: Table 3 Categorical assessment of change from Baseline to Week 72 in percent predicted FVC in study PIPF-006
Icelandic: 72 á hlutfalli áætlaðs FVC í rannsókninni PIPF-006
English: ● Days 1 to 7: a dose of 267 mg administered three times a day (801 mg/day)
Icelandic: 267 mg skammtur, gefinn þrisvar sinnum á dag (801 mg/dag)
English: Esbriet 267 mg film-coated tablets are yellow, oval, biconvex film-coated tablets, debossed with “PFD”.
Icelandic: Esbriet 267 mg filmuhúðaðar töflur eru gular, sporöskjulagaðar filmuhúðaðar töflur, kúptar báðum megin, með ígreyptu „PFD“.
English: ● headache.
Icelandic: • höfuðverkur.
English: Each film-coated tablet contains 267 mg of pirfenidone.
Icelandic: Hver filmuhúðuð tafla inniheldur 267 mg af pírfenidóni.
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).
Icelandic: 72 kom fram skerðing frá grunngildi á hlutfalli áætlaðs FVC ≥ 10% (þröskuldsgildi sem vísar til hættu á dauðsföllum vegna sjálfvakinnar lungnatrefjunar (IPF)) hjá 20% sjúklinga sem fengu
English: Esbriet 267 mg film-coated tablets are yellow, oval, approximately 1.3 x 0.6. cm biconvex film-coated tablets, debossed with “PFD”.
Icelandic: Esbriet 267 mg filmuhúðaðar töflur eru gular, sporöskjulaga, u.þ.b. 1,3 x 0,6 cm tvíkúptar, filmuhúðaðar töflur með ígreyptu „PFD“.
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
Icelandic: 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: Esbriet is contraindicated in patients with concomitant use of fluvoxamine (see section 4.3).
Icelandic: Ekki má nota Esbriet hjá sjúklingum sem nota flúvoxamín (sjá kafla 4.3).
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
Icelandic: Meðferð með Esbriet minnkaði einnig marktækt skerðingu frá grunngildi á hlutfalli áætlaðs FVC í viku 13 (p<0,000001), 26 (p<0,000001) og 39
English: 3 How to take Esbriet
Icelandic: Hvernig nota á Esbriet
English: Esbriet 801 mg film-coated tablets are brown, oval, approximately 2 x 0.9 cm biconvex film-coated tablets, debossed with “PFD”.
Icelandic: Esbriet 801 mg filmuhúðaðar töflur eru brúnar, sporöskjulaga, u.þ.b. 2 x 0,9 cm tvíkúptar, filmuhúðaðar töflur með ígreyptu „PFD“.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/016 63 tablets (21 + 42)
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/11/667/016 63 töflur (21 + 42)
English: Continuation pack: multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated tablets
Icelandic: Pakkning fyrir framhaldsmeðferð: fjölpakkning sem inniheldur 252 filmuhúðaðar töflur (3 pakkningar með 4 þynnum sem innihalda 21 filmuhúðaða töflu)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - BOTTLE 250 ML
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á INNRI UMBÚÐUM MIÐI - GLAS 250 ML
English: The oral clearance of pirfenidone appears modestly saturable.
Icelandic: Úthreinsun pírfenidóns eftir inntöku virðist geta mettast að hluta.
English: ANCOVA); 26% of patients receiving Esbriet showed a decline of ≥50 m in 6MWT distance compared to 36% of patients receiving placebo.
Icelandic: Esbriet samanborið við sjúklinga sem fengu lyfleysu; skerðing hjá 26% sjúklinga sem fengu Esbriet reyndist vera ≥50 m á 6MWT vegalengd, samanborið við 36% sjúklinga sem fengu lyfleysu.
English: ● chest pain
Icelandic: • brjóstverkur
English: Nervous system disorders Very Common Headache Common
Icelandic: Taugakerfi Mjög algengar
English: Film-coated tablet Multipack containing 252 (3 packs each containing 4 blisters of 21) film-coated Tablets
Icelandic: Fjölpakkning með 252 filmuhúðuðum töflum (3 pakkningar, hver með 4 þynnum sem innihalda 21 filmuhúðaða töflu)
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
Icelandic: Meðferð með Esbriet dró einnig verulega úr skerðingu á hlutfalli áætlaðs FVC frá grunngildi í vikum 24 (p=0,014), 36 (p<0,001), 48 (p<0,001) og 60
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.
Icelandic: Hjá dýrum kemur fram flutningur á pírfenidóni og/eða umbrotsefnum þess um fylgju og því er hugsanlegt að pírfenidón og/eða umbrotsefni þess safnist upp í legvatni.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 534 mg pirfenidone.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 534 mg af pírfenidóni.
English: Propylene glycol
Icelandic: Lifur og gall Algengar
English: Photosensitivity reaction and rash
Icelandic: Ljósnæmisviðbrögð og útbrot
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/018 84 tablets (4x21)
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/11/667/018 84 töflur (4 x 21)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 801 mg pirfenidone.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 801 mg af pírfenidóni.
English: Biotransformation
Icelandic: Tölfræðibreytur
English: NAME OF THE MEDICINAL PRODUCT Esbriet 801 mg film-coated tablets Pirfenidone
Icelandic: Esbriet 801 mg filmuhúðaðar töflur Pírfenidón
English: Esbriet is contraindicated in severe hepatic impairment and end stage liver disease (see sections 4.2 and 4.3).
Icelandic: Esbriet má ekki nota hjá sjúklingum með alvarlega skerta lifrarstarfsemi eða lifrarsjúkdóm á lokastigi (sjá kafla 4.2 og 4.3).
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg film-coated tablets Pirfenidone
Icelandic: Esbriet 267 mg filmuhúðaðar töflur Pírfenidón
English: NAME OF THE MEDICINAL PRODUCT Esbriet 534 mg film-coated tablets Pirfenidone
Icelandic: Esbriet 534 mg filmuhúðaðar töflur Pírfenidón
English: Esbriet 801 mg film-coated tablets are brown, oval, biconvex film-coated tablets, debossed with “PFD”.
Icelandic: Esbriet 801 mg filmuhúðaðar töflur eru brúnar, sporöskjulagaðar filmuhúðaðar töflur, kúptar báðum megin, með ígreyptu „PFD“.
English: Decline of ≥10% or death or lung transplant Decline of less than 10%
Icelandic: Skerðing ≥10% eða dauðsfall eða lungnaígræðsla 39 (23%)
English: Pruritus; erythema; dry skin; rash erythematous; rash macular; rash pruritic Musculoskeletal and connective tissue disorders Common
Icelandic: Kláði; roðaþot; þurr húð; roðaþotsútbrot; dröfnuútbrot; útbrot með kláða Stoðkerfi og stoðvefur
English: Paediatric population There is no relevant use of Esbriet in the paediatric population for the indication of IPF.
Icelandic: Börn Notkun Esbriet á ekki við hjá börnum við ábendingunni sjálfvakin lungnatrefjun (IPF).
English: Tablet core
Icelandic: Þynnupakkning inniheldur
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/019 252 tablets (3x84)
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/11/667/019 252 töflur (3x84)
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg film-coated tablets
Icelandic: Upplýsingar fyrir notanda lyfsins Esbriet 267 mg filmuhúðaðar töflur
English: Printing Inks
Icelandic: Innihald hylkis
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).
Icelandic: takið 801 mg skammt (3 gular töflur eða 1 brúna töflu), 3 sinnum á dag (samtals 2.403 mg/dag) með mat frá og með degi 15 (viðhaldsmeðferð).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/017 252 tablets (3 x 84)
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/11/667/017 252 töflur (3 x 84)
English: Oral use.
Icelandic: talið í sömu röð.
English: ● feeling sleepy
Icelandic: B. FYLGISEÐILL
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.
Icelandic: Sjúklinga sem þola illa meðferðina vegna aukaverkana frá meltingarfærum á að minna á að taka lyfið með mat.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/020
Icelandic: MARKAÐSLEYFISNÚMER EU/1/11/667/020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/019 252 tablets (3 x 84)
Icelandic: 12. MARKAÐSLEYFISNÚMER EU/1/11/667/019 252 töflur (3 x 84)
English: 1 bottle containing 21 film-coated tablets 1 bottle containing 90 film-coated tablets
Icelandic: 534 mg filmuhúðaðar töflur 1 glas sem inniheldur 21 filmuhúðaða töflu 1 glas sem inniheldur 90 filmuhúðaðar töflur
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg hard capsules Pirfenidone
Icelandic: Upplýsingar fyrir notanda lyfsins Esbriet 267 mg hörð hylki Pírfenidón