FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Days 8 to 14: a dose of 534 mg administered three times a day (1602 mg/day)
Danish: · Dag 8-14: en dosis på 534 mg administreret tre gange dagligt (1602 mg/dag)
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.
Danish: Hvis symptomerne varer ved, kan dosis af pirfenidon reduceres til 1-2 kapsler (267 mg-534 mg) to til tre gange dagligt sammen med føde og derefter forhøjes til den anbefalede daglige dosis, som tåles.
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.
Danish: Esbriet hårde kapsler (kapsler) har en hvid til off-white uigennemsigtig ”krop” og en hvid til off-white uigennemsigtig hætte med "PFD 267 mg" påtrykt med brun farve.
English: Immune system disorders Uncommon
Danish: Immunsystemet Ikke almindelig Angioødem1
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).
Danish: Der bør også udvises særlig forsigtighed, hvis der anvendes CYP1A2-hæmmere samtidig med potente hæmmere af et eller flere andre CYP-isoenzymer, som er involveret i pirfenidons metabolisme, såsom CYP2C9 (f.eks. amiodaron, fluconazol), 2C19 (f.eks. chloramphenicol) og 2D6 (f.eks. fluoxetin, paroxetin).
English: ● Esbriet is contraindicated in patients with severe hepatic impairment or end stage liver disease.
Danish: Leverfunktion · Esbriet er kontraindiceret hos patienter med svært nedsat leverfunktion eller leversygdom i sidste stadie.
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.
Danish: Hvis en patient har en aminotransferaseforhøjelse på ≤5 x ULN ledsaget af symptomer eller hyperbilirubinæmi, bør Esbriet seponeres, og patienten bør ikke optitreres med lægemidlet igen.
English: ● from day 15 onwards (maintenance), take 3 capsules, 3 times a day with food (a total of 2,403 mg/day).
Danish: · fra dag 15 og fremefter (vedligeholdelse) tager du tre kapsler tre gange om dagen sammen med mad (i alt 2.403 mg/dag).
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).
Danish: Pirfenidon bør anvendes med forsigtighed hos patienter med mildt til moderat nedsat leverfunktion, og patienter bør overvåges nøje for tegn på toksicitet, især hvis de samtidig tager en kendt CYP1A2-hæmmer (se pkt.
English: As a precautionary measure, it is preferable to avoid the use of Esbriet during pregnancy.
Danish: For en sikkerheds skyld bør Esbriet undgås under graviditet.
English: 4 years for bottles.
Danish: 4 år for beholdere.
English: ● Days 1 to 7: a dose of 267 mg administered three times a day (801 mg/day)
Danish: · Dag 1-7: en dosis på 267 mg administreret tre gange dagligt (801 mg/dag)
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)
Danish: Det gennemsnitlige (standardafvigelse) AUC0-∞ for 5-carboxy-pirfenidon var signifikant højere i grupperne med moderat (p = 0,009) og svært (p < 0,0001) nedsat nyrefunktion end i gruppen med normal nyrefunktion, henholdsvis 100 (26,3) mg•time/l og 168 (67,4) mg•time/l sammenlignet med 28,7 (4,99) mg•time/l.
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)
Danish: EU/1/11/667/012 21 tabletter EU/1/11/667/013 42 tabletter (2 x 21) EU/1/11/667/014 84 tabletter (4 x 21) EU/1/11/667/015 168 tabletter (8 x 21)
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).
Danish: I en forudspecificeret poolet analyse af studierne PIPF-016, PIPF-004 og PIPF-006 ved måned 12 var dødeligheden, uanset årsag, signifikant lavere hos gruppen, der fik Esbriet 2403 mg/dag (3,5 %, 22 ud af 623 patienter), sammenlignet med den gruppe, der fik placebo (6,7 %, 42 ud af 624 patienter), hvilket resulterede i en reduktion på 48 % i risikoen for død uanset årsag inden for de første 12 måneder (HR 0,52 [95 % CI 0,31-0,87]; p=0,0107, log-rank-test).
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.
Danish: I en ad hoc-analyse viste 33 % af de patienter, som fik Esbriet, et fald på ≥50 m i 6MWT-distancen, sammenlignet med 47 % af de patienter, som fik placebo i PIPF-006.
English: If a patient exhibits an aminotransferase elevation to >5 x ULN, Esbriet should be discontinued and the patient should not be rechallenged.
Danish: Hvis en patients aminotransferaseværdier stiger til >5 x ULN, bør Esbriet seponeres, og patienten bør ikke få lægemidlet igen.
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).
Danish: Esbriet er ikke undersøgt hos patienter med svært nedsat leverfunktion, og Esbriet må ikke anvendes hos patienter med svært nedsat leverfunktion (se pkt.
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)
Danish: 2-ugers pakning til initiering af behandling (63 kapsler): Uge 1 - 21 kapsler (7 blisterstrip med hver 3 kapsler) Uge 2 - 42 kapsler (7 blisterstrip med hver 6 kapsler)
English: Anaphylaxis1
Danish: Anafylaksi1
English: 42 film-coated tablets.
Danish: 42 filmovertrukne tabletter.
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).
Danish: 7 x PVC/PE/PCTFE-aluminiumsblisterstrip med hver 3 kapsler (til dosering i uge 1) pakket sammen med 7 x PVC/PE/PCTFE-aluminiumsblisterstrip med hver 6 kapsler (til dosering i uge 2).Hver pakke indeholder i alt 63 kapsler.
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.
Danish: Hold op med at tage Esbriet, og kontakt straks din læge · Hvis du oplever hævelse i ansigt, læber og/eller tunge, kløe, nældefeber, har vejrtrækningsproblemer eller hvæser, eller føler dig mat, hvilket er tegn på angioødem, som er en alvorlig form for allergisk reaktion eller anafylaksi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4-WEEK TREATMENT MAINTENANCE PACK CONTAINING 252 CAPSULES (14 X 18 CAPSULES CONFIGURATION)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE - 4-UGERS PAKNING TIL VEDLIGEHOLDELSE AF BEHANDLING MED 252 KAPSLER (INDHOLD: 14 X 18 KAPSLER)
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.
Danish: · Dag 15 og fremefter: en dosis på 801 mg administreret tre gange dagligt (2403 mg/dag) Den anbefalede daglige vedligeholdelsesdosis af Esbriet er 801 mg tre gange dagligt med føde, i alt 2403 mg/dag.
English: Microcrystalline cellulose Croscarmellose sodium Povidone K30
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Povidon K30
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.
Danish: Hvis symptomerne varer ved, kan dosis af pirfenidon reduceres til 267 mg-534 mg to til tre gange dagligt sammen med føde og derefter forhøjes til den anbefalede daglige dosis, som tåles.
English: Microcrystalline cellulose Croscarmellose sodium Povidone
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium
English: ● At the request of the European Medicines Agency;
Danish: En opdateret RMP skal fremsendes: · på anmodning fra Det Europæiske Lægemiddelagentur.
English: 14 x PVC/PE/PCTFE aluminium foil blister strips each containing 18 capsules (2-day supply).
Danish: 14 x PVC/PE/PCTFE-aluminiumsblisterstrip med hver 18 kapsler (behandling i 2 dages).
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.
Danish: Efter markedsføringen er der rapporteret om angioødem (herunder alvorlige tilfælde) såsom hævelse af ansigt, læber og/eller tunge, som kan være forbundet med åndedrætsbesvær eller hvæsende vejrtrækning, i forbindelse med brug af Esbriet.
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.
Danish: Tabletterne sluges hele med et glas vand under eller efter et måltid for at mindske risikoen for bivirkninger som kvalme og svimmelhed.
English: INFORMATION IN BRAILLE esbriet 801 mg tablets
Danish: INFORMATION I BRAILLESKRIFT esbriet 801 mg tabletter
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.
Danish: Kapslerne sluges hele med et glas vand under eller efter et måltid for at mindske risikoen for bivirkninger som kvalme og svimmelhed.
English: ● Severe renal impairment (CrCl <30 ml/min) or end stage renal disease requiring dialysis (see sections 4.2 and 5.2).
Danish: · Svært nedsat nyrefunktion (CrCl <30 ml/min) eller nyresygdom i sidste stadie, som kræver dialyse (se pkt.
English: Median (25th-75th) AUC0-∞ = area under the concentration-time curve from time zero to infinity.
Danish: AUC0-∞ = arealet under koncentration-tid-kurven fra tid nul til uendelighed.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 267 mg pirfenidone.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En kapsel indeholder 267 mg pirfenidon.
English: Pirfenidone 2,403 mg/day (N = 278)
Danish: Pirfenidon 2.403 mg/dag (N = 278)
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).
Danish: De foreliggende data for farmakokinetikken hos dyr har vist, at pirfenidon og/eller dets metabolitter udskilles i mælk, og der er potentiale for akkumulation af pirfenidon og/eller dets metabolitter i mælken (se pkt.
English: 1 bottle containing 21 film-coated tablets 1 bottle containing 90 film-coated tablets
Danish: 1 beholder indeholdende 21 filmovertrukne tabletter 1 beholder indeholdende 90 filmovertrukne tabletter
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)
Danish: 1 blister indeholdende 21 filmovertrukne tabletter (21 i alt) 2 blister hver indeholdende 21 filmovertrukne tabletter (42 i alt) 4 blister hver indeholdende 21 filmovertrukne tabletter (84 i alt) 8 blister hver indeholdende 21 filmovertrukne tabletter (168 i alt)
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).
Danish: I studie PIPF-006 reducerede behandling med Esbriet (N=171) ikke faldet i procent forventet FVC fra udgangspunktet til uge 72 sammenlignet med placebo (N=173, p=0,501).
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.
Danish: Den anbefalede daglige vedligeholdelsesdosis af Esbriet er 801 mg (3 gule tabletter eller 1 brun tablet) tre gange om dagen med mad, i alt 2403 mg/dag.
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.
Danish: Beholderemballagen indeholder en beholder indeholdende 21 tabletter, to beholdere indeholdende hver 21 tabletter (42 tabletter i alt), en beholder indeholdende 42 tabletter, en beholder indeholdende 90 tabletter, to beholdere indeholdende hver 90 tabletter (180 tabletter i alt) eller en beholder indeholdende 180 tabletter.
English: Package leaflet: Information for the user Esbriet 267 mg hard capsules Pirfenidone
Danish: Indlægsseddel: Information til brugeren Esbriet 267 mg hårde kapsler Pirfenidon
English: At Week 72, a decline in FVC of ≥10% was seen in 23% of patients receiving Esbriet and 27% receiving placebo (Table 3).
Danish: I uge 72 sås der et fald i FVC på ≥10 % hos 23 % af de patienter, som fik Esbriet, og 27 % af de patienter, som fik placebo (tabel 3).
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.
Danish: Når udslættet er forsvundet, kan behandlingen med Esbriet fortsætte og dosen forhøjes til den anbefalede daglige dosis efter lægens skøn.
English: If symptoms continue, see your doctor.
Danish: Kontakt din læge, hvis symptomerne varer ved.
English: Weight loss has been reported in patients treated with Esbriet (see section 4.8).
Danish: Der er indberetninger om vægttab hos patienter, som er i behandling med Esbriet (se pkt.
English: AST1
Danish: ASAT1
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 February 2011
Danish: Dato for første markedsføringstilladelse: 28. februar 2011 Dato for seneste fornyelse: 8. september 2015
English: INFORMATION IN BRAILLE esbriet 267 mg tablets
Danish: INFORMATION I BRAILLESKRIFT esbriet 267 mg tabletter
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).
Danish: I uge 72 sås der et fald fra udgangspunktet i procent forventet FVC på ≥10 % (en tærskel, der indikerer risiko for mortalitet ved IPF) hos 20 % af patienterne, som fik Esbriet, sammenlignet med 35 % af dem, som fik placebo (tabel 2).
English: Esbriet must not be used in patients with a history of angioedema or hypersensitivity due to Esbriet (see section 4.3).
Danish: Esbriet må ikke anvendes hos patienter med Esbriet-forårsaget angioødem eller overfølsomhed i anamnesen (se pkt.
English: INFORMATION IN BRAILLE esbriet 534 mg tablets
Danish: INFORMATION I BRAILLESKRIFT esbriet 534 mg tabletter
English: 801 mg film-coated tablets 1 bottle containing 90 film-coated tablets
Danish: 801 mg filmovertrukne tabletter 1 beholder indeholdende 90 filmovertrukne tabletter
English: Pirfenidone 2,403 mg/day (N = 171)
Danish: Pirfenidon 2.403 mg/dag (N = 171)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL - INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET - MELLEMLIGGENDE ÆSKE AF MULTIPAKNING (UDEN BLÅ BOKS)
English: The recommended maintenance daily dose of Esbriet is 3 capsules three times a day with food, for a total of 2403 mg/day.
Danish: Den anbefalede daglige vedligeholdelsesdosis af Esbriet er 3 kapsler tre gange om dagen med mad, i alt 2403 mg/dag.
English: 267 mg film-coated tablets
Danish: 267 mg filmovertrukne tabletter
English: EU/1/11/667/010 90 tablets
Danish: EU/1/11/667/010 90 tabletter
English: Pirfenidone 2,403 mg/day (N = 174)
Danish: Pirfenidon 2.403 mg/dag (N = 174)
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.
Danish: Hos dyr passerer pirfenidon og/eller dets metabolitter placenta, og der er potentiale for akkumulation af pirfenidon og/eller dets metabolitter i fostervandet.
English: No dose adjustment is necessary in patients with mild renal impairment.
Danish: Det er ikke nødvendigt at tilpasse dosis hos patienter med mildt nedsat nyrefunktion.
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).
Danish: Esbriet-behandling bør ikke anvendes hos patienter med svært nedsat nyrefunktion (kreatininclearance (CrCl) <30 ml/min) eller nyresygdom i sidste stadie, som kræver dialyse (se pkt.
English: If you are unsure ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER STRIPS BLISTER STRIPS - 2-WEEK TREATMENT INITIATION PACK (7 X 3 CAPSULES AND 7 X 6 CAPSULES CONFIGURATION)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERSTRIP BLISTERSTRIP - 2-UGERS PAKNING TIL INITIERING AF BEHANDLING (INDHOLD: 7 X 3 KAPSLER OG 7 X 6 KAPSLER)
English: Nervous system disorders Very Common Headache Common
Danish: Meget almindelig Hovedpine Almindelig
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis du er i tvivl.
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.
Danish: Den anbefalede daglige vedligeholdelsesdosis af Esbriet er tre 267 mg kapsler tre gange dagligt med føde, i alt 2403 mg/dag.
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).
Danish: Ved uge 52 blev der observeret et fald i forhold til udgangspunktet i procent forventet FVC på ≥10 % eller død hos 17 % af de patienter, som fik Esbriet, sammenlignet med hos 32 % af dem, som fik placebo (tabel 4).
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).
Danish: Hvis det ikke kan undgås at anvende ciprofloxacin i doseringen 750 mg to gange om dagen, skal pirfenidon-dosis reduceres til 1602 mg dagligt (534 mg tre gange dagligt).
English: High-Density Polyethylene (HDPE) bottle with a child-resistant and tamper-evident screw cap Pack sizes
Danish: Højdensitetspolyethylen (HDPE)-beholder med et børnesikret og brudsikret skruelåg Pakningsstørrelser
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
Danish: 1 beholder indeholdende 21 filmovertrukne tabletter 2 beholdere hver indeholdende 21 filmovertrukne tabletter (42 filmovertrukne tabletter i alt) 1 beholder indeholdende 42 filmovertrukket tabletter 1 beholder indeholdende 90 filmovertrukne tabletter 2 beholdere hver indeholdende 90 filmovertrukne tabletter (180 filmovertrukne tabletter i alt) 1 beholder indeholdende 180 filmovertrukket tabletter
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).
Danish: Hvis samtidig brug af Esbriet og en potent, selektiv CYP1A2-hæmmer ikke kan undgås, skal pirfenidon-dosis reduceres til 801 mg dagligt (267 mg tre gange dagligt).
English: NAME OF THE MEDICINAL PRODUCT Esbriet 267 mg hard capsules
Danish: LÆGEMIDLETS NAVN Esbriet 267 mg hårde kapsler
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).
Danish: Hvis samtidig brug af Esbriet og en potent, selektiv CYP1A2-hæmmer ikke kan undgås, skal pirfenidon-dosis reduceres til 801 mg dagligt (én kapsel tre gange dagligt).
English: 534 mg film-coated tablets
Danish: 534 mg filmovertrukne tabletter
English: Table 2 Categorical assessment of change from Baseline to Week 72 in percent predicted FVC in study PIPF-004
Danish: Tabel 2 Kategorisk vurdering af ændring fra udgangspunktet til uge 72 i procent forventet FVC i studie PIPF-004
English: Table 3 Categorical assessment of change from Baseline to Week 72 in percent predicted FVC in study PIPF-006
Danish: Tabel 3 Kategorisk vurdering af ændring fra udgangspunktet til uge 72 i procent forventet FVC i studie PIPF-006
English: Each capsule contains 267 mg of pirfenidone.
Danish: En kapsel indeholder 267 mg pirfenidon.
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).
Danish: Hvis det ikke kan undgås at anvende ciprofloxacin i doseringen 750 mg to gange om dagen, skal pirfenidon-dosis reduceres til 1602 mg dagligt (to kapsler tre gange dagligt).
English: Esbriet is contraindicated in severe hepatic impairment and end stage liver disease (see sections 4.2 and 4.3).
Danish: Esbriet er kontraindiceret ved svært nedsat leverfunktion og leversygdom i sidste stadie (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON -2-WEEK TREATMENT INITIATION PACK (7 X 3 CAPSULES AND 7 X 6 CAPSULES CONFIGURATION)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - 2-UGERS PAKNING TIL INITIERING AF BEHANDLING (INDHOLD: 7 X 3 KAPSLER OG 7 X 6 KAPSLER)
English: Photosensitivity reaction and rash
Danish: Lysfølsomhedsreaktion og udslæt
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé pkt.
English: The primary endpoint was the change from Baseline to Week 52 in percent predicted FVC.
Danish: Det primære effektmål var ændring i procent forventet FVC fra udgangspunktet til uge 52.
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
Danish: 2-ugers pakning til initiering af behandling: multipakning indeholdende 63 filmovertrukne tabletter (1 pakning indeholdende 1 blister a 21 og 1 pakning indeholdende 2 blister a 21)
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).
Danish: I studiet PIPF-016 var faldet i procent forventet FVC fra udgangspunktet til behandlingsuge 52 signifikant reduceret hos patienter, som fik Esbriet (N=278), sammenlignet med patienter, som fik placebo (N=277, p<0,000001, rank ANCOVA).