FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 100 mg hard capsules.}
Danish: Karton til blisterpakning (14, 21, 56, 60, 84, 90, 100 og 112) og perforeret enkeltdosisblisterpakning (100) til 100 mg hårde kapsler
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 50 mg hard capsules - PVC/Aluminium}
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Karton til blisterpakning (14, 21, 56, 60, 84, 90, 100 og 112) og perforeret enkeltdosisblisterpakning (100) til 50 mg hårde kapsler - PVC/aluminium
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 50 mg hard capsules.}
Danish: Karton til blisterpakning (14, 21, 56, 60, 84, 90, 100 og 112) og perforeret enkeltdosisblisterpakning (100) til 50 mg hårde kapsler
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 25mg hard capsules - PVC/Aluminium}
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Karton til blisterpakning (14, 21, 56, 60, 84, 90, 100 og 112) og perforeret enkeltdosisblisterpakning (100) til 25 mg hårde kapsler - PVC/aluminium
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack (14, 21, 56, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 150 mg hard capsules - PVC/Aluminium}
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Karton til blisterpakning (14, 21, 56, 60, 84, 90, 100 og 112) og perforeret enkeltdosisblisterpakning (100) til 150 mg hårde kapsler - PVC/aluminium
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 100 mg hard capsules- PVC/Aluminium}
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Karton til blisterpakning (14, 21, 56, 60, 84, 90, 100 og 112) og perforeret enkeltdosisblisterpakning (100) til 100 mg hårde kapsler - PVC/aluminium
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 200 mg hard capsules - PVC/Aluminium}
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Karton til blisterpakning (14, 21, 56, 60, 84, 90, 100 og 112) og perforeret enkeltdosisblisterpakning (100) til 200 mg hårde kapsler - PVC/aluminium
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 25 mg hard capsules}
Danish: Etiket til HDPE-beholderpakning (30, 200) til 25 mg hårde kapsler
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 200 mg hard capsules.}
Danish: Karton til blisterpakning (14, 21, 56, 60, 84, 90, 100 og 112) og perforeret enkeltdosisblisterpakning (100) til 200 mg hårde kapsler
English: 1 pre-filled syringe with safety device
Danish: 1 fyldt injektions-sprøjte med sikkerheds-anordning
English: 1 pre-filled syringe
Danish: 1 fyldt injektions-sprøjte
English: Content (concentration)
Danish: Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: Invented name Strength Pharmaceutical form
Danish: Særnavn Navn
English: OTHER Week 1, Week 2
Danish: Uge 1, Uge 2
English: These medicinal products should be avoided whenever possible.
Danish: Disse lægemidler bør så vidt muligt undgås.
English: These findings are not considered relevant to humans.
Danish: Disse resultater betragtes ikke som relevante for mennesker.
English: Children and adolescents Do not give Esbriet to children and adolescents under the age of 18.
Danish: Børn og unge Giv ikke Esbriet til børn og unge under 18 år.
English: More than 170 patients have been investigated in open studies for more than five years and some for up to 10 years.
Danish: Mere end 170 patienter er undersøgt i åbne studier i mere end fem år og nogle i op til 10 år.
English: ● Risk Management Plan (RMP)
Danish: · Risikostyringsplan (RMP)
English: Do not drink grapefruit juice whilst taking this medicine.
Danish: Du må ikke drikke grapefrugtjuice, når du tager dette lægemiddel.
English: In some situations, your doctor may advise you to stop taking Esbriet.
Danish: I nogle situationer, kan din læge råde dig til at stoppe med at tage Esbriet.
English: Component of a multipack, can't be sold separately
Danish: En del af en multipakning, som ikke sælges separat
English: Adverse reactions from post-marketing experience are also listed in Table 1.
Danish: Bivirkninger fra postmarketing-erfaringen er også angivet i tabel 1.
English: Be careful if you have to take part in activities where you have to be alert and co-ordinated.
Danish: Vær forsigtig, hvis du deltager i aktiviteter, hvor du skal være vågen og koordineret.
English: Esbriet with food and drink
Danish: Brug af Esbriet sammen med mad og drikke
English: Reversibility was observed after cessation of treatment.
Danish: Der sås reversibilitet efter ophør af behandling.
English: Esbriet is for oral use.
Danish: Esbriet er til oral brug.
English: A risk to the breastfed infant cannot be excluded.
Danish: En risiko for det ammede spædbarn kan ikke udelukkes.
English: There is limited clinical experience with overdose.
Danish: Der er begrænset erfaring med overdosering.
English: Your doctor will monitor your weight whilst you are taking this medicine.
Danish: Din læge skal holde øje med din vægt, mens du tager lægemidlet.
English: These are rare side effects.
Danish: Disse er sjældne bivirkninger.
English: This makes it hard for your lungs to work properly.
Danish: Dette gør, at det bliver svært for lungerne at fungere rigtigt.
English: This is especially important if you are taking the following medicines, as they may change the effect of Esbriet.
Danish: Det er især vigtigt, hvis du tager følgende lægemidler, da de kan påvirke Esbriets virkning.
English: The exposure to pirfenidone in smokers was 50% of that observed in non-smokers.
Danish: Eksponeringen for pirfenidon hos rygere var 50 % af den, der observeredes hos ikkerygere.
English: ● Additional risk minimisation measures
Danish: · Yderligere risikominimeringsforanstaltninger
English: Statistics
Danish: Statistik
English: There are no data from the use of Esbriet in pregnant women.
Danish: Der er ingen data fra anvendelse af Esbriet til gravide kvinder.
English: Rare side effects (may affect up to 1 in 1,000 people): ● blood tests may show decrease in white blood cells.
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer): · blodprøver kan vise nedsat antal hvide blodlegemer.
English: The safety of Esbriet has been evaluated in clinical studies including 1,650 volunteers and patients.
Danish: Esbriets sikkerhed er blevet vurderet i kliniske studier med 1.650 frivillige forsøgspersoner og patienter.
English: In both studies, treatment was administered three times daily for a minimum of 72 weeks.
Danish: I begge studier blev behandlingen administreret tre gange dagligt i minimum 72 uger.
English: Reports of anaphylactic reactions have also been received.
Danish: Der er også modtaget rapporter om anafylaktiske reaktioner.
English: Treatment was administered three times daily for 52 weeks.
Danish: Behandlingen blev givet tre gange dagligt i 52 uger.
English: Severe photosensitivity reactions are uncommon.
Danish: Alvorlige lysfølsomhedsreaktioner er ikke almindelige.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: · når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: It is important that you have these regular blood tests for as long as you are taking Esbriet.
Danish: Det er vigtigt, at du får taget blodprøver jævnligt, så længe du tager Esbriet.
English: 5-Carboxy-Pirfenidone
Danish: 5-carboxy-pirfenidon
English: The effect of food on pirfenidone oral AUC was consistent between the tablet and capsule formulations.
Danish: Effekten af føde på pirfenidon oral AUC var konsistent mellem tablet- og kapselformuleringerne.
English: Recommendations in case of ALT/AST elevations
Danish: Anbefalinger i tilfælde af forhøjet ALAT/ASAT
English: Sunburn Identified through post-marketing surveillance
Danish: Solskoldning Identificeret via overvågningen efter markedsføring
English: Rarely these have been associated with concomitant elevations in total serum bilirubin.
Danish: I sjældne tilfælde har disse været forbundet med samtidige stigninger i serum total bilirubin.
English: ● You should stop smoking before and during treatment with Esbriet.
Danish: · Hold op med at ryge før og under behandlingen med Esbriet.
English: Therefore, patients should know how they react to this medicinal product before they engage in activities requiring mental alertness or coordination (see section 4.7).
Danish: Derfor bør patienterne vide, hvordan de reagerer på dette lægemiddel, før de deltager i aktiviteter, som kræver mental opmærksomhed eller koordinering (se pkt.
English: Total serum bilirubin increased in combination with increases of ALT and
Danish: Serum total bilirubin forhøjet i kombination med stigninger i ALAT og
English: If symptoms continue, patients may be instructed to interrupt treatment for one to two weeks to allow symptoms to resolve.
Danish: Hvis symptomerne fortsætter, kan patienten tilrådes at afbryde behandlingen i en til to uger, således at symptomerne kan forsvinde.
English: In the event of a suspected overdose, supportive medical care should be provided including monitoring of vital signs and close observation of the clinical status of the patient.
Danish: I tilfælde af mistanke om overdosering iværksættes understøttende behandling, herunder monitorering af vitale tegn og nøje observation af patientens kliniske status.
English: (sun; daytime dose) and (moon; evening dose).
Danish: (sol: middags dosis) og (måne: aften dosis).
English: Each dose should be separated by at least 3 hours.
Danish: Der skal være mindst 3 timer mellem hver dosis.
English: AUC0-∞ (mg•hr/L)
Danish: AUC0-∞ (mg•time/L)
English: No decline (FVC change >0%)
Danish: Intet fald (FVC-ændring > 0 %)
English: Cigarette smoking can reduce the effect of Esbriet.
Danish: Rygning kan mindske Esbriets virkning.
English: Ammonium hydroxide
Danish: Ammoniumhydroxid
English: Doses above 2403 mg/day are not recommended for any patient (see section 4.9).
Danish: Doser på over 2403 mg/dag anbefales ikke for nogen patienter (se pkt.
English: Following single dose administration of pirfenidone in healthy older adults, the mean apparent terminal elimination half-life was approximately 2.4 hours.
Danish: Efter administration af en enkelt dosis pirfenidon hos raske ældre var den tilsyneladende terminale eliminationshalveringstid omkring 2,4 timer.
English: Three of the Phase 3 studies (PIPF-004, PIPF-006, and PIPF-016) were multinational, and one (SP3) was conducted in Japan.
Danish: Tre af disse fase 3-studier (PIPF004, PIPF-006 og PIPF-016) var multinationale, mens et (SP3) blev udført i Japan.
English: Pirfenidone binds to human plasma proteins, primarily to serum albumin.
Danish: Pirfenidon binder sig til humane plasmaproteiner, primært til serumalbumin.
English: ● There is a need to monitor liver function tests prior to initiation of treatment with Esbriet and at regular intervals thereafter.
Danish: · Det er nødvendigt at overvåge leverfunktionstest inden initiering af behandling med Esbriet og med regelmæssige mellemrum derefter.
English: ● Patients are advised to avoid or reduce exposure to direct sunlight (including sunlamps).
Danish: · Patienter anbefales at undgå eller nedsætte eksponering for direkte sol (også solarier).
English: Grapefruit may prevent Esbriet from working properly.
Danish: Grapefrugt kan forhindre, at Esbriet virker rigtigt.
English: You will need a blood test before you start taking Esbriet and at monthly intervals for the first 6 months and then every 3 months thereafter whilst you are taking this medicine to check whether your liver is working properly.
Danish: Du skal have taget en blodprøve, før du begynder at tage Esbriet og hver måned i de første seks måneder og derefter hver tredje måned, mens du tager dette lægemiddel, for at kontrollere om leveren fungerer, som den skal.
English: The safety checklist about Esbriet should contain the following key elements related to liver function and photosensitivity:
Danish: Sikkerhedstjeklisten om Esbriet skal indeholde følgende nøgleelementer med hensyn til leverfunktion og lysfølsomhed:
English: Physicians should monitor patient's weight, and when appropriate encourage increased caloric intake if weight loss is considered to be of clinical significance.
Danish: Læger bør overvåge patientens vægt, og når det er relevant opfordre til øget kalorieindtag, hvis vægttabet betragtes som klinisk signifikant.
English: Exposure to direct sunlight (including sunlamps) should be avoided or minimised during treatment with Esbriet.
Danish: Eksponering for direkte sollys (herunder solarium) bør undgås eller minimeres under behandling med Esbriet.
English: Driving and using machines Do not drive or use machines if you feel dizzy or tired after taking Esbriet.
Danish: Du må ikke køre bil eller betjene maskiner, hvis du føler dig svimmel eller træt efter at have taget Esbriet.
English: Median (25th-75th)
Danish: Median (25.-75.)
English: ● Elevations of serum transaminases can occur during treatment with Esbriet.
Danish: · Der kan forekomme forhøjelser af serumtransaminaser under behandling med Esbriet.
English: Mean apparent oral steady-state volume of distribution is approximately 70 l, indicating that pirfenidone distribution to tissues is modest.
Danish: Det tilsyneladende orale gennemsnitlige steady-state-fordelingsvolumen er omkring 70 l, hvilket tyder på, at pirfenidons fordeling i vævene er beskeden.
English: (sunrise; morning dose)
Danish: (solopgang: dosis om morgenen)
English: The oral clearance of pirfenidone appears modestly saturable.
Danish: Den orale clearance af pirfenidon synes moderat mætbar.
English: Reproductive toxicology studies demonstrated no adverse effects on male and female fertility or postnatal development of offspring in rats and there was no evidence of teratogenicity in rats (1,000 mg/kg/day) or rabbits (300 mg/kg/day).
Danish: Reproduktionstoksicitetsstudier viste ingen skadelige virkninger på hanners og hunners fertilitet og postnatale udvikling hos afkommet hos rotter, og der var ingen evidens for teratogenicitet hos rotter (1.000 mg/kg/dag) eller kaniner (300 mg/kg/dag).
English: Pirfenidone showed no indication of mutagenic or genotoxic activity in a standard battery of tests and when tested under UV exposure was not mutagenic.
Danish: Pirfenidon viste ingen indikation af mutagen eller genotoksisk aktivitet i en række standardforsøg, og når det blev testet under UV-eksponering, var det ikke mutagent.
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.
Danish: Som en sikkerhedsforanstaltning, foretrækkes det at undgå brugen af Esbriet, hvis du er gravid, har planer om at blive gravid eller tror, at du kan være gravid, da de potentielle risici for det ufødte barn ikke er kendte.
English: Smoking has the potential to induce hepatic enzyme production and thus increase medicinal product clearance and decrease exposure.
Danish: Rygning kan potentielt inducere leverenzymproduktion og dermed øge lægemidlets clearance og mindske eksponeringen.
English: For patients with confirmed elevations in ALT, AST or bilirubin during treatment, the following dose adjustments may be necessary.
Danish: For patienter med bekræftede forhøjelser af ALAT, ASAT eller bilirubin under behandling kan følgende dosisjusteringer være nødvendige.
English: An increased incidence of liver tumours was observed in carcinogenicity studies conducted in rats and mice.
Danish: Der blev observeret en stigning i incidensen af levertumorer i karcinogenicitetsstudier på rotter og mus.
English: As it is unknown whether Esbriet passes into breast milk, your doctor will discuss the risks and benefits of taking this medicine while breast-feeding if you decide to do so.
Danish: Da det ikke vides, om Esbriet udskilles i human mælk, vil lægen tale med dig om risici og fordele ved at tage medicinen, mens du ammer, hvis du beslutter dig for det.
English: (IL-1β) and pirfenidone has been shown to reduce the accumulation of inflammatory cells in response to various stimuli.
Danish: 1β), og pirfenidon er vist at reducere akkumulation af inflammatoriske celler som reaktion på forskellige stimuli.
English: Adverse reactions were mild, transient, and consistent with the most frequently reported adverse reactions for pirfenidone.
Danish: Bivirkningerne var lette, forbigående og overensstemmende med de hyppigst indberettede bivirkninger for pirfenidon.
English: The results of mechanistic studies indicate that the occurrence of uterine tumours is probably related to a chronic dopamine-mediated sex hormone imbalance involving a species specific endocrine mechanism in the rat which is not present in humans.
Danish: Resultaterne af mekanistiske studier tyder på, at forekomsten af uterine tumorer sandsynligvis er relateret til en kronisk dopaminmedieret ubalance i kønshormonerne, som involverer en artsspecifik endokrin mekanisme hos rotter, der ikke er til stede hos mennesker.
English: Initiation Pack
Danish: Initieringspakning
English: This medicine does not require any special storage conditions.
Danish: Denne medicin kræver ikke specielle opbevaringsbetingelser.
English: Therefore, it is recommended that Esbriet be administered with food to reduce the incidence of nausea and dizziness.
Danish: Derfor anbefales det, at Esbriet administreres med føde for at mindske incidensen af kvalme og svimmelhed.
English: AUC0-∞ = area under the concentration-time curve from time zero to infinity.
Danish: AUC0-∞ = arealet under koncentration-tid-kurven fra tid nul til uendelig.
English: The severity of phototoxic lesions was minimised by application of sunscreen.
Danish: Graden af fototoksiske læsioner blev minimeret ved anvendelse af solcreme med høj faktor.
English: <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data)] the adverse reactions are presented in order of decreasing seriousness.
Danish: <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), ikke kendt (kan ikke estimeres ud fra tilgængelig data), og de er anført med de alvorligste bivirkninger først.
English: Other side effects may include Talk to your doctor if you get any side effects.
Danish: Andre bivirkninger kan være Tal med lægen, hvis du får bivirkninger.
English: In clinical studies, most patients who experienced dizziness had a single event, and most events resolved, with a median duration of 22 days.
Danish: I kliniske studier havde de fleste patienter, som oplevede svimmelhed, en enkelt bivirkning, og de fleste forsvandt inden for en medianvarighed af 22 dage.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: It is unknown whether pirfenidone or its metabolites are excreted in human milk.
Danish: Det vides ikke, om pirfenidon eller dets metabolitter udskilles i human mælk.
English: Metabolism and nutrition disorders Very Common Anorexia Common
Danish: Metabolisme og ernæring Meget almindelig Anoreksi Almindelig
English: This medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ikke specielle opbevaringsbetingelser.
English: Your medicine is provided in either a 2-week treatment initiation pack, a 4-week treatment pack or in a bottle.
Danish: Lægemidlet leveres enten i en initieringspakning til 2 ugers behandling, i en pakning til 4 ugers behandling eller i en beholder.
English: Approximately 80% of an orally administered dose of pirfenidone is cleared in the urine within 24 hours of dosing.
Danish: Omkring 80 % af en oralt administreret dosis pirfenidon udskilles i urinen senest 24 timer efter dosering.
English: Paediatric population There is no relevant use of Esbriet in the paediatric population for the indication of IPF.
Danish: Pædiatrisk population Der er ingen relevant anvendelse af Esbriet i den pædiatriske population til indikationen IPF.
English: Therefore, patients who develop signs or symptoms of angioedema or severe allergic reactions following administration of Esbriet should immediately discontinue treatment.
Danish: Derfor skal patienter, der udvikler tegn eller symptomer på angioødem eller allergiske reaktioner af svær grad efter administration af Esbriet, ophøre med behandlingen omgående.
English: The absolute bioavailability of pirfenidone has not been determined in humans.
Danish: Pirfenidons absolutte biotilgængelighed er endnu ikke klarlagt hos mennesker.
English: IPF is a condition in which the tissues in your lungs become swollen and scarred over time, and as a result makes it difficult to breathe deeply.
Danish: IPF er en sygdom, hvor vævet i lungerne hæver og bliver arret over tid, og det gør det svært at trække vejret dybt.
English: ● Close monitoring is required of any patients who develop liver enzyme elevation with appropriate dose adjustment or discontinuation.
Danish: · Nøje overvågning er påkrævet af enhver patient, som udvikler leverenzymforhøjelse, med passende dosisjustering eller seponering.
English: 534 mg tablet 2 years.
Danish: 534 mg tablet 2 år.
English: Phototoxicity and irritation were noted in guinea pigs after oral administration of pirfenidone and with exposure to UVA/UVB light.
Danish: Der blev observeret fototoksicitet og irritation hos marsvin efter oral administration af pirfenidon og med eksponering for UVA/UVB-lys.
English: 267 mg tablet and 801 mg tablet 3 years for blisters.
Danish: 267 mg tablet og 801 mg tablet 3 år for blister.
English: Agranulocytosis1
Danish: Agranulocytose1
English: However, existing data suggest that pirfenidone exerts both antifibrotic and anti-inflammatory properties in a variety of in vitro systems and animal models of pulmonary fibrosis (bleomycin- and transplant-induced fibrosis).
Danish: Eksisterende data tyder dog på, at pirfenidon har både antifibrotiske og antiinflammatoriske egenskaber i forskellige in vitro-systemer og dyremodeller med lungefibrose (bleomycin- og transplantationsinduceret fibrose).
English: The physician information should encourage the prescribers to report serious adverse reactions and clinically significant ADRs of special interest including:
Danish: Lægeinformationen skal opfordre de ordinerende læger til at rapportere alvorlige bivirkninger og klinisk signifikante uønskede bivirkninger af særlig interesse, herunder:
English: Decline of ≥10% or death or lung transplant Decline of less than 10%
Danish: Fald på ≥ 10 % eller død eller lungetransplantation Fald på mindre end 10 %
English: Adverse reactions are listed by System Organ Class (SOC) and within each frequency grouping [Very common (≥1/10), common (≥1/100 to
Danish: Bivirkningerne er anført efter systemorganklasse og grupperet efter hyppighed [meget almindelig (≥1/10), almindelig (≥1/100 til