FrancophonIA/ELRC3.0 huggingface dataset:
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:
Danish: Efter initiering af behandling bør dosis optitreres til den anbefalede daglige dosis på ni kapsler pr. dag over en 14-dages periode på følgende måde:
English: Decline of less than 10% No decline (FVC change >0%)
Danish: Fald på ≥10 % eller død Fald på mindre end 10 % Intet fald (FVC-ændring >0 %)
English: Concomitant use of strong inducers of CYP1A2 including smoking should be avoided during Esbriet therapy based on the observed relationship between cigarette smoking and its potential to induce CYP1A2.
Danish: Samtidig brug af stærke CYP1A2-induktorer, herunder rygning, bør ud fra det observerede forhold mellem rygning og dens potentielle CYP1A2-induktion undgås under behandling med Esbriet.
English: The overall mean binding ranged from 50% to 58% at concentrations observed in clinical studies (1 to 100 μg/ml).
Danish: Den samlede gennemsnitlige binding lå på 50 % til 58 % ved koncentrationer, som blev observeret i kliniske studier
English: Do not take more tablets each day than your prescribed daily dose.
Danish: Tag ikke flere tabletter per dag end lægen har ordineret til dig.
English: Treatment with Esbriet should be started and overseen by a specialist doctor experienced in the diagnosis and treatment of IPF.
Danish: Behandling med Esbriet bør opstartes og overvåges af en speciallæge med erfaring inden for diagnosen og behandling af IPF.
English: Your doctor may reduce your dose if you suffer from side effects such as, stomach problems, any skin reactions to sunlight or sun lamps, or significant changes to your liver enzymes.
Danish: Nedsættelse af dosis på grund af bivirkninger Din læge kan beslutte at sætte dosen ned, hvis du får bivirkninger såsom maveproblemer, hudreaktioner på sollys eller solarium eller betydelige leverenzymændringer.
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.
Danish: Der blev observeret en statistisk signifikant stigning i uterine tumorer hos hunrotter, som fik 1.500 mg/kg/dag, hvilket er 37 gange den humane dosis på 2.403 mg/dag.
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.
Danish: Esbriet bør anvendes med forsigtighed til patienter med eksisterende mildt til moderat nedsat leverfunktion (dvs. Child-Pugh Class A og B) i betragtning af risikoen for øget pirfenidon-eksponering.
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:
Danish: Blisterstrip i initieringspakningen til 2 ugers behandling og pakningen til 4 ugers vedligeholdelse af behandling er hver mærket med følgende symboler som en påmindelse om, at tage en dosis 3 gange dagligt:
English: Roche (Magyarország) Kft. Tel: +36 - 23 446 800
Danish: Magyarország Roche (Magyarország) Kft. Tel: +36 - 23 446 800
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsule
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Hård kapsel
English: The dose of pirfenidone may be reduced to 801 mg each day (267 mg three times a day).
Danish: Dosis af pirfenidon kan sættes ned til 801 mg om dagen (267 mg tre gange dagligt).
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.
Danish: Hvis du af en eller anden grund er nødt til at holde op med at tage Esbriet i mere end 14 dage efter hinanden, skal din læge starte behandlingen igen med en dosis på 267 mg tre gange dagligt og gradvist øge dosen til 801 mg tre gange dagligt.
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.
Danish: In vitro-data indikerer relevant farmakologisk aktivitet med hensyn til den primære metabolit (5-carboxy-pirfenidon) ved koncentrationer , som overstiger maksimale plasmakoncentrationer hos IPF patienter.
English: ● Periodic Safety Update Reports
Danish: · Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Approximately 70-80% of pirfenidone is metabolised via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6, and 2E1.
Danish: Pirfenidon metaboliseres ca. 70-80 % via CYP1A2 med mindre bidrag fra andre CYP-isoenzymer, herunder CYP2C9, 2C19, 2D6 og 2E1.
English: PIPF-004 and PIPF-006 compared treatment with Esbriet 2403 mg/day to placebo.
Danish: PIPF-004 og PIPF-006 sammenlignede behandling med Esbriet 2.403 mg/dag med placebo.
English: The 4-week treatment pack contains a total of 252 capsules.
Danish: Pakningen til 4 ugers behandling indeholder i alt 252 kapsler.
English: Treatment with Esbriet should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of IPF.
Danish: Behandling med Esbriet bør iværksættes og overvåges af speciallæger med erfaring inden for diagnose og behandling af IPF.
English: PIPF-016 compared treatment with Esbriet 2,403 mg/day to placebo.
Danish: PIPF-016 sammenlignede behandling med Esbriet 2.403 mg/dag og placebo.
English: Patients should be instructed to use a sunblock daily, to wear clothing that protects against sun exposure, and to avoid other medicinal products known to cause photosensitivity.
Danish: Patienterne bør instrueres om at anvende solcreme med høj faktor dagligt, klæde sig i tøj, som beskytter mod solen, og undgå andre lægemidler, som vides at forårsage lysfølsomhed.
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.
Danish: I et multidosisdoseringsstudie hos raske ældre blev der administreret doser fra 267 mg til 1.335 mg tre gange dagligt, oggennemsnitlig clearance faldt med omkring 25 % over en dosis på 801 mg tre gange dagligt.
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.
Danish: · Patienter skal informeres om at anvende solcreme hver dag, at bruge tøj, der beskytter mod soleksponering, og at undgå andre lægemidler, som forårsager lysfølsomhed.
English: a p-value versus Normal = 1.00 (pair-wise comparison with Bonferroni) b p-value versus Normal = 0.009 (pair-wise comparison with Bonferroni) c p-value versus Normal < 0.0001 (pair-wise comparison with Bonferroni)
Danish: p-værdi versus normal = 1,00 (parvis sammenligning med Bonferroni) p-værdi versus normal = 0,009 (parvis sammenligning med Bonferroni) p-værdi versus normal < 0,0001 (parvis sammenligning med Bonferroni)
English: Roche Slovensko, s.r.o.
Danish: Slovenská republika Roche Slovensko, s.r.o.
English: The studies were nearly identical in design, with few exceptions including an intermediate dose group (1,197 mg/day) in PIPF-004.
Danish: Der var dog nogle få undtagelser, herunder en mellemdosisgruppe (1.197 mg/dag) i PIPF-004.
English: Wear sunblock daily and cover your arms, legs and head to reduce exposure to sunlight (see section 4: Possible side effects).
Danish: Brug solcreme med høj faktor hver dag, og tildæk arme, ben og hoved for at mindske udsættelsen for sollys (se pkt.
English: If any of the above affects you, do not take Esbriet.
Danish: Hvis noget af ovennævnte gælder for dig, må du ikke tage Esbriet.
English: 42 tablets
Danish: 42 tabletter
English: Two piece capsules with a white to off-white opaque body and white to off-white opaque cap imprinted with “PFD 267 mg” in brown ink and containing a white to pale yellow powder.
Danish: Todelte kapsler med en hvid til off-white uigennemsigtig krop og hvid til off-white uigennemsigtig hætte med "PFD 267 mg" påtrykt med brun farve og indeholdende et hvidt til svagt lysegult pulver.
English: Fluvoxamine and inhibitors of CYP1A2
Danish: Fluvoxamin og CYP1A2-hæmmere
English: Pirfenidone
Danish: Pirfenidon
English: INFORMATION IN BRAILLE Esbriet
Danish: INFORMATION I BRAILLESKRIFT Esbriet
English: At high doses (≥450 mg/kg/day) rats exhibited a prolongation of oestrous cycle and a high incidence of irregular cycles.
Danish: Ved høje doser (≥450 mg/kg/dag) udviste rotter en forlænget østralperiode og høj forekomst af irregulære perioder.
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.
Danish: Der blev administreret flere doser af pirfenidon op til en samlet dosis på 4.806 mg/dag i form af seks kapsler 267 mg tre gange dagligt til raske frivillige forsøgspersoner over en 12-dages dosistitreringsperiode.
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.
Danish: Der blev ikke observeret nogen klinisk relevante forskelle i pirfenidons farmakokinetik hos forsøgspersoner med mildt til svært nedsat nyrefunktion sammenlignet med forsøgspersoner med normal nyrefunktion.
English: Esbriet is contraindicated in patients with concomitant use of fluvoxamine (see section 4.3).
Danish: Esbriet er kontraindiceret til patienter ved samtidig brug af fluvoxamin (se pkt.
English: ● Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: · Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: In a pooled analysis of survival in PIPF-004 and PIPF-006 the mortality rate with Esbriet 2403 mg/day group was 7.8% compared with 9.8% with placebo (HR 0.77 [95% CI, 0.47-1.28]).
Danish: I en poolet analyse af overlevelsen i PIPF-004 og PIPF-006 var mortalitetsraten i gruppen med Esbriet 2403 mg/dag 7,8 % sammenlignet med 9,8 % med placebo (HR 0,77 [95 % CI, 0,47-1,28]).
English: No dose adjustment is required in patients with mild renal impairment who are receiving pirfenidone.
Danish: Dosisjustering er ikke nødvendig hos patienter med mildt nedsat nyrefunktion, som får pirfenidon.
English: Once liver function tests are within normal limits Esbriet may be re-escalated to the recommended daily dose if tolerated.
Danish: Når leverfunktionstestene er inden for normalværdierne, kan Esbriet optitreres til den anbefalede daglige dosis, hvis dette tolereres.
English: Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).
Danish: Esbriet er indiceret til voksne til behandling af mild til moderat idiopatisk pulmonal fibrose (IPF).
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).
Danish: Lysfølsomhedsreaktion eller udslæt: Patienter, som oplever en mild til moderat lysfølsomhedsreaktion eller udslæt, skal mindes om, at de skal bruge solcreme med høj faktor dagligt og undgå udsættelse for sol (se pkt.
English: At high doses (≥1,000 mg/kg/day) rats exhibited a prolongation of gestation and reduction in fetal viability.
Danish: Ved høje doser (≥1.000 mg/kg/dag) udviste rotter forlænget drægtighedsperiode og nedsat levedygtighed hos fostre.
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%).
Danish: De hyppigst indberettede bivirkninger under kliniske studier af Esbriet ved en dosis på 2.403 mg/dag sammenlignet med placebo var kvalme (32,4 % kontra 12,2 %), udslæt (26,2 % kontra 7,7 %), diarré (18,8 % kontra 14,4 %), træthed (18,5 % kontra 10,4 %), dyspepsi (16,1 % kontra 5,0 %), anoreksi (11,4 % kontra 3,5 %), hovedpine (10,1 % kontra 7,7 %) og lysfølsomhedsreaktion (9,3 % kontra
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Filmovertrukket tablet
English: Patients should be closely monitored for emergence of adverse reactions associated with Esbriet therapy.
Danish: Patienterne skal overvåges nøje for bivirkninger, der er forbundet med Esbriet-behandlingen.
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Danish: Polyvinyl alkohol Titandioxid (E171) Makrogol 3350
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.
Danish: Samtidig administration af lægemidler, der fungerer som potente induktorer af både CYP1A2 og de øvrige CYP-isoenzymer, som er involveret i pirfenidons metabolisme (f.eks. rifampicin), kan resultere i en signifikant sænkning af pirfenidons plasmakoncentration.
English: Treatment with pirfenidone significantly reduced mean decline in vital capacity (VC) at Week 52 (the primary endpoint) compared with placebo (-0.09±0.02 l versus -0.16±0.02 l respectively, p=0.042).
Danish: Behandling med pirfenidon reducerede signifikant det gennemsnitlige fald i vital kapacitet (VC) ved uge 52 (det primære effektmål) sammenlignet med placebo (henholdsvis -0,09±0,02 l kontra -0,16±0,02 l, p=0,042).
English: Gastroesophageal reflux disease; vomiting; abdominal distension; abdominal discomfort; abdominal pain; abdominal pain upper; stomach discomfort; gastritis; constipation; flatulence
Danish: Gastroøsofageal reflukssygdom, opkastning, udspiling af maven, abdominalt ubehag, abdominalsmerter, smerter i øverste del af abdomen, gastrisk ubehag, gastrit, obstipation, flatulens
English: Esbriet should be used with caution in patients treated with other moderate inhibitors of CYP1A2 (e.g. amiodarone, propafenone).
Danish: Esbriet bør anvendes med forsigtighed til patienter, som er i behandling med andre moderate CYP1A2-hæmmere (f.eks. amiodaron og propafenon).
English: 3 years for bottles.
Danish: 3 år for beholdere.
English: In the case of moderate inducers of CYP1A2 (e.g. omeprazole), concomitant use may theoretically result in a lowering of pirfenidone plasma levels.
Danish: Samtidig brug af moderate CYP1A2-induktorer (f.eks. omeprazol) kan teoretisk medføre nedsat plasmakoncentration af pirfenidon.
English: ● Esbriet can cause weight loss.
Danish: · Esbriet kan give vægttab.
English: The bottle pack contains 270 capsules.
Danish: Beholderen indeholder 270 kapsler.
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.
Danish: Blisterpakningerne indeholder 21, 42, 84 eller 168 filmovertrukne tabletter og multipakningerne indeholder 63 (2-ugers pakning til initiering af behandling 21+42) eller 252 (vedligeholdelsespakning 3x84) filmovertrukne tabletter.
English: If a patient exhibits an aminotransferase elevation to >3 to ≤5 x ULN after starting Esbriet therapy, confounding medicinal products should be discontinued, other causes excluded, and the patient monitored closely.
Danish: Hvis patienten har en aminotransferaseforhøjelse på >3 til ≤5 x ULN efter initiering af Esbrietbehandling, bør andre lægemidler med en mulig levertoksisk virkning seponeres, andre årsager udelukkes, og patienten overvåges nøje
English: The bottle packs contain either one bottle containing 21 tablets or one bottle containing 90 tablets.
Danish: Beholderemballagen indeholder enten en beholder indeholdende 21 tabletter eller en beholder indeholdende 90 tabletter.
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:
Danish: Hver 801 mg blisterstrip er markeret med følgende symboler og forkortelser for ugedagene, som en påmindelse om at tage en dosis tre gange om dagen:
English: 21 tablets
Danish: 21 tabletter
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.
Danish: Kontakt straks din læge, apoteket eller nærmeste skadestue, hvis du har taget flere kapsler, end du skal.
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:
Danish: Hver 267 mg blisterstrip indeholdende 63 filmovertrukne tabletter er markeret med følgende symboler og forkortelser for ugedagene, som en påmindelse om at tage en dosis tre gange om dagen:
English: Table 1 Adverse reactions by SOC and MedDRA frequency Infections and infestations
Danish: Tabel 1 Bivirkninger efter systemorganklasse og hyppighed ifølge MedDRA Infektioner og parasitære sygdomme
English: The blisters pack contains 84 film-coated tablets and the multipack contains 252 (continuation pack 3x84) film-coated tablets.
Danish: Blisterpakningerne indeholder 84 filmovertrukne tabletter og multipakken indeholder 252 (vedligeholdelsespakning 3x84) filmovertrukne tabletter.
English: The bottle pack contains one bottle containing 90 tablets.
Danish: Beholderemballagen indeholder en beholder indeholdende 90 tabletter.
English: The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30, colloidal anhydrous silica, magnesium stearate
Danish: Øvrige indholdsstoffer: Mikrokrystallinsk cellulose, croscarmellosenatrium, povidon K30, kolloid vandfri silica, magnesiumstearat
English: Studies in lactating rats indicate that pirfenidone and/or its metabolites are excreted in milk with the potential for accumulation of pirfenidone and/or its metabolites in milk.
Danish: Studier af diegivende rotter tyder på, at pirfenidon og/eller dets metabolitter udskilles i mælken med potentiale for akkumulation af pirfenidon og/eller dets metabolitter i mælken.
English: 60 (p<0.001).
Danish: og 48 (p=0,005).
English: Patients should be instructed to report symptoms of photosensitivity reaction or rash to their physician.
Danish: Patienterne bør instrueres i at fortælle deres læge om symptomer på lysfølsomhed eller udslæt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER STRIPS BLISTER STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERSTRIP BLISTERSTRIP
English: Do not take more capsules each day than your prescribed daily dose.
Danish: Tag ikke flere kapsler per dag end lægen har ordineret til dig.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER STRIPS BLISTER STRIPS - 4-WEEK TREATMENT PACK OF 252 CAPSULES
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERSTRIP BLISTERSTRIP - 4-UGERS PAKNING TIL BEHANDLING MED 252 KAPSLER
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.
Danish: I et fase I-studie resulterede samtidig administration af Esbriet og fluvoxamin (en stærk CYP1A2hæmmer med hæmmende virkning på andre CYP-isoenzymer [CYP2C9, 2C19 og 2D6]) i en 4-folds stigning i eksponeringen for pirfenidon hos ikke-rygere.
English: B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
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.
Danish: Patienter, som glemmer eller af anden årsag afbryder behandlingen med Esbriet i 14 eller flere fortløbende dage, bør reinitiere behandlingen med et indledende 2-ugers titreringsregime op til den anbefalede daglige dosis.
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)
Danish: Talkum267 mg tablet Gul jernoxid (E172) 534 mg tablet Gul jernoxid (E172) Rød jernoxid (E172) 801 mg tablet Rød jernoxid (E172) Sort jernoxid (E172)
English: Upper respiratory tract infection; urinary tract infection Blood and lymphatic system disorders Rare
Danish: Infektion i de øvre luftveje, urinvejsinfektion Blod og lymfesystem
English: 4 blisters each containing 21 film-coated tablets (84 in total)
Danish: 4 blister hver indeholdende 21 filmovertrukne tabletter (84 i alt)
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).
Danish: Patienter skal overvåges nøje for tegn på toksicitet, især hvis de samtidig tager en kendt CYP1A2-inhibitor (se pkt.
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).
Danish: Faldet i 6MWT-distance fra udgangspunktet til uge 72 var signifikant reduceret i forhold til placebo i studiet PIPF-006 (p<0,001, rank ANCOVA).
English: Do not store this medicine above 30ºC.
Danish: Denne medicin må ikke opbevares ved temperaturer over 30 °C.
English: Esbriet contains the active substance pirfenidone and it is used for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF) in adults.
Danish: Esbriet indeholder det aktive stof pirfenidon og bruges til behandling af mild til moderat idiopatisk pulmonal fibrose (IPF) hos voksne.
English: Other medicines and Esbriet
Danish: Brug af anden medicin sammen med Esbriet
English: 2 What you need to know before you take Esbriet
Danish: Det skal du vide, før du begynder at tage Esbriet
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.
Danish: Kontakt straks din læge, apotekspersonalet eller nærmeste skadestue, hvis du har taget flere tabletter, end du skal.
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.
Danish: Andre behandlinger, som hæmmer både CYP1A2 og et eller flere andre CYP-isoenzymer, som er involveret i pirfenidons metabolisme (f.eks. CYP2C9, 2C19 og 2D6), bør undgås under behandling med pirfenidon.
English: PHARMACEUTICAL form
Danish: LÆGEMIDDELFORM
English: Esbriet may cause dizziness and fatigue, which could have a moderate influence on the ability to drive or use machines, therefore patients should exercise caution when driving or operating machinery if they experience these symptoms.
Danish: Esbriet kan forårsage svimmelhed og træthed, som kan have en moderat påvirkning på evnen til at føre motorkøretøj og betjene maskiner.
English: Colloidal anhydrous silica Magnesium stearate
Danish: Kolloid vandfri silica Magnesiumstearat
English: General disorders and administration site conditions Very Common Fatigue Common
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig Træthed
English: If the rash persists after 7 days, Esbriet should be discontinued for 15 days, with re-escalation to the recommended daily dose in the same manner as the dose escalation period.
Danish: Hvis udslættet varer ved efter syv dage, bør Esbriet afbrydes i 15 dage og derefter optitreres til den anbefalede daglige dosis på samme måde som den indledende dosistitrering.
English: ● You should tell your doctor if you suffer from kidney problems.
Danish: · Fortæl det til lægen, hvis du lider af nyreproblemer.