FrancophonIA/ELRC3.0 huggingface dataset:
English: The confirmed R117H poly-T variant was 5T in 38 patients and 7T in 16 patients.
Danish: Den bekræftede R117H-poly-T-variant var 5T hos 38 patienter og 7T hos 16 patienter.
English: If a dose is missed within 6 hours of the time it is usually taken, the patient should be told to take it as soon as possible and then take the next dose at the regularly scheduled time.
Danish: Hvis en dosis glemmes inden for 6 timer fra det tidspunkt, den normalt tages på, skal patienten instrueres i at tage dosen så snart som muligt, og tage den næste dosis på det sædvanlige tidspunkt.
English: For patients with moderate hepatic impairment (Child-Pugh Class B), the dose should be reduced (see Table 2).
Danish: Til patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) skal dosis reduceres (se tabel 2).
English: Due to its high intrinsic permeability and low likelihood of being excreted intact, co-administration of BCRP inhibitors is not expected to alter exposure of ivacaftor and M1-IVA, while any potential changes in M6-IVA exposures are not expected to be clinically relevant.
Danish: Som følge af den høje intrinsiske permeabilitet og lave sandsynlighed for at blive udskilt intakt forventes samtidig administration af BCRP-hæmmere ikke at ændre eksponeringen for ivacaftor og M1-IVA, mens potentielle ændringer i M6-IVAeksponeringer ikke forventes at være klinisk relevante.
English: Patients received ivacaftor 25 mg, 50 mg or 75 mg according to their weight at each study visit (see section 4.2).
Danish: Patienterne fik ivacaftor 25 mg, 50 mg eller 75 mg i henhold til deres vægt ved hvert studiebesøg (se pkt.
English: The apparent terminal half-life was approximately 12 hours following a single dose in the fed state.
Danish: Den tilsyneladende terminale halveringstid var ca. 12 timer efter en enkeltdosis efter indtagelse af mad.
English: Swallow the tablet whole.
Danish: Slug tabletten hel.
English: Your child's doctor may perform some eye examinations prior to and during treatment with ivacaftor.
Danish: Dit barns læge kan udføre nogle øjenundersøgelser før og under behandling med ivacaftor.
English: Do not give your child a double dose to make up for a forgotten dose.
Danish: Du må ikke give dit barn en dobbeltdosis som erstatning for den glemte dosis.
English: Co-administration of ciprofloxacin with ivacaftor did not affect the exposure of ivacaftor.
Danish: Administration af ciprofloxacin sammen med ivacaftor påvirkede ikke eksponeringen for ivacaftor.
English: In vitro studies showed that ivacaftor is not a substrate for OATP1B1 or OATP1B3.
Danish: In vitro-studier har vist, at ivacaftor ikke er et substrat for OATP1B1 eller OATP1B3.
English: Nausea *
Danish: Kvalme*
English: • Increased liver enzymes in the blood have been seen in some people receiving Kalydeco.
Danish: • Forhøjede niveauer af leverenzymer i blodet er blevet observeret hos nogle personer, der fik Kalydeco.
English: The other ingredients are:
Danish: • Øvrige indholdsstoffer:
English: P value
Danish: P-værdi
English: Evening
Danish: Aften
English: Contact your doctor straight away if you get any of these.
Danish: Kontakt straks lægen, hvis du får en eller flere af disse.
English: No patients had elevations in total bilirubin.
Danish: Ingen patienter havde forhøjet total bilirubin.
English: In three of four patients the change in the sweat chloride test was < 5 mmol/L and this group did not demonstrate a clinically relevant improvement in FEV1 after 8 weeks of treatment.
Danish: Hos tre ud af fire patienter var ændringen i sved-chlorid-testen <5 mmol/l, og denne gruppe udviste ikke en klinisk relevant forbedring i FEV1 efter 8 ugers behandling.
English: In part B of study 8, the primary endpoint of safety was evaluated through 24 weeks (see section 4.8).
Danish: I del B af studie 8 blev det primære endepunkt, sikkerhed, evalueret i løbet af 24 uger (se pkt.
English: Peak LFT (ALT or AST) elevations were generally higher in paediatric patients than in older patients.
Danish: De maksimale stigninger i leverfunktionsprøverne (ALAT eller ASAT) var generelt højere hos pædiatriske patienter end hos ældre patienter.
English: There are no data available on the effect of ivacaftor on fertility in humans.
Danish: Der foreligger ingen data om ivacaftors mulige virkning på fertiliteten hos mennesker.
English: The median (range) tmax is approximately 4.0 (3.0; 6.0) hours in the fed state.
Danish: Median (interval) tmax er ca. 4,0 (3,0; 6,0) timer efter madindtagelse.
English: • Inner ear disorder (feeling dizzy or spinning)
Danish: • sygdom i det indre øre (følelse af at være svimmel eller dreje rundt)
English: Ivacaftor decreased survival and lactation indices and caused a reduction in pup body weights.
Danish: Ivacaftor nedsatte overlevelse og diegivning og forårsagede en reduktion af afkommets kropsvægt.
English: Other fat-containing foods are:
Danish: Andre fedtholdige madvarer er:
English: If you plan to breast-feed, ask your doctor for advice before taking Kalydeco.
Danish: Hvis du planlægger at amme, skal du spørge din læge til råds, før du tager Kalydeco.
English: • Hold sachet of granules with cut line on top.
Danish: • Hold brevet med granulat, så klippelinjen er øverst.
English: In vitro and in vivo data indicate that ivacaftor is primarily metabolised by CYP3A.
Danish: In vitro- og in vivo-data indikerer, at ivacaftor primært metaboliseres af CYP3A.
English: Exposures in 6- to 11-year-olds are predictions based on simulations from the population PK model using data obtained for this age group.
Danish: Eksponeringer hos 6- til 11-årige er projektioner baseret på simuleringer fra den populationsfarmakokinetiske model med data opnået for denne aldersgruppe.
English: Table 6: Effect of ivacaftor on growth parameters in patients aged 6 months to less than 24 months with baseline and week 24 values
Danish: Tabel 6: Ivacaftors virkning på vækstparametre hos patienter i alderen 6 måneder til under 24 måneder med værdier ved baseline og uge 24
English: • Anticoagulant medicines such as warfarin, used to prevent blood clots from forming or growing larger in blood and blood vessels
Danish: • antikoagulantia, såsom warfarin, der anvendes til at forhindre, at der dannes blodpropper, eller at de vokser sig større i blod og blodårer.
English: Your doctor will take into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Danish: Din læge vil tage højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for dig.
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is a weak inhibitor of CYP3A and P-gp and a potential inhibitor of CYP2C9.
Danish: Det er en svag hæmmer af CYP3A og P-gp og en potentiel hæmmer af CYP2C9.
English: Results shown as mean (minimum, maximum) change from baseline for ivacaftor-treated patients at week 8*:
Danish: Resultater vist som gennemsnitlig (minimum; maksimum) ændring fra baseline for ivacaftorbehandlede patienter ved uge 8*:
English: 12- to 17-year-olds
Danish: 12- til 17-årige
English: Bacteria in sputum very common
Danish: Bakterier i sputum meget almindelig
English: Titanium dioxide (E171) Macrogol (PEG 3350) Talc
Danish: Titandioxid (E171) Macrogol (PEG 3350) Talcum
English: Take Kalydeco tablets with food that contains fat.
Danish: Tag Kalydeco tabletterne sammen med mad, der indeholder fedt.
English: † Change from prior study baseline after 48 weeks of placebo treatment.
Danish: † Ændring fra baseline i tidligere studie efter 48 ugers placebobehandling.
English: It is unknown whether ivacaftor and/or its metabolites are excreted in human milk.
Danish: Det er ukendt, om ivacaftor og/eller dets metabolitter udskilles i human mælk.
English: Kalydeco can make your child dizzy.
Danish: Kalydeco kan gøre dit barn svimmel.
English: You must keep using all other medicines you use, unless your doctor tells you to stop using any.
Danish: Du skal blive ved med at bruge alle andre lægemidler, du bruger, medmindre lægen fortæller dig, at du skal holde op med at bruge et eller flere af dem.
English: Your child may experience side effects, including those mentioned in section 4 below.
Danish: Dit barn kan opleve bivirkninger, herunder bivirkninger, som nævnes i punkt 4 nedenfor.
English: Race had no clinically meaningful effect on the PK of ivacaftor in white (n = 379) and non-white (n = 29) patients based on a population PK analysis.
Danish: Racen havde ingen klinisk betydningsfuld virkning på farmakokinetikken af ivacaftor hos hvide (n=379) og ikke-hvide (n=29) patienter baseret på en populationsfarmakokinetisk analyse.
English: Lactose content
Danish: Lactose-indhold
English: M1 has approximately one-sixth the potency of ivacaftor and is considered pharmacologically active.
Danish: M1 har ca. en sjettedel af ivacaftors styrke og anses for at være farmakologisk aktivt.
English: Patients receiving Kalydeco in combination with tezacaftor/ivacaftor should be told not to take more than one dose of either tablet at the same time.
Danish: Patienter, der får Kalydeco i kombination med tezacaftor/ivacaftor, skal instrueres i ikke at tage mere end én dosis af hver tablet på samme tid.
English: Ivacaftor is a substrate of CYP3A4 and CYP3A5.
Danish: Ivacaftor er et substrat for CYP3A4 og CYP3A5.
English: Ivacaftor had an effect on fertility in rats (see section 5.3).
Danish: Ivacaftor havde en virkning på fertiliteten hos rotter (se pkt.
English: CI: confidence interval; NA: not analysed due to low incidence of events a Treatment difference = effect of ivacaftor - effect of placebo b CFQ-R: Cystic Fibrosis Questionnaire-Revised is a disease-specific, health-related quality-of-life measure for CF.
Danish: CI: konfidensinterval, NA: ikke analyseret på grund af en lav forekomst af hændelserne a Behandlingsforskel=ivacaftors virkning - placebos virkning b CFQ-R: Cystic Fibrosis Questionnaire-Revised er et sygdomsspecifikt, sundhedsrelateret mål for livskvalitet for CF.
English: Ivacaftor was associated with slight decreases of the seminal vesicle weights, a decrease of overall fertility index and number of pregnancies in females mated with treated males and significant reductions in number of corpora lutea and implantation sites with subsequent reductions in the average litter size and average number of viable embryos per litter in treated females.
Danish: Ivacaftor var forbundet med en let reduktion i sædblærevægten, en reduktion i det samlede fertilitetsindeks og antallet af drægtighedsperioder hos hunner, der blev parret med behandlede hanner, og med signifikante reduktioner i antallet af corpora lutea og implantationssteder med efterfølgende reduktioner i gennemsnitlig kuldstørrelse og det gennemsnitlige antal levedygtige embryoer pr. kuld hos behandlede hunner.
English: Interactions with medicinal products
Danish: Lægemiddelinteraktioner
English: Clinical studies of ivacaftor in combination regimen with tezacaftor did not include patients over 75 years of age.
Danish: Kliniske studier af ivacaftor i et kombinationsregime med tezacaftor inkluderede ikke patienter over 75 år.
English: Therefore, monitoring of the international normalised ratio (INR) is recommended during co-administration of warfarin with Kalydeco.
Danish: Derfor anbefales det, at den internationale, normaliserede ratio (INR) overvåges ved administration af warfarin sammen med Kalydeco.
English: Ivacaftor is a sensitive CYP3A substrate.
Danish: Ivacaftor er et følsomt CYP3A-substrat.
English: When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index, such as ciclosporin, everolimus, sirolimus or tacrolimus, caution and appropriate monitoring should be used.
Danish: Ved brug sammen med digoxin eller andre substrater for P-gp med et snævert terapeutisk indeks, såsom ciclosporin, everolimus, sirolimus eller tacrolimus, skal der udvises forsigtighed med passende overvågning.
English: CYP2C9 substrates
Danish: CYP2C9-substrater
English: Following multiple oral dose administrations of ivacaftor, the exposure of ivacaftor generally increased with dose from 25 mg every 12 hours to 450 mg every 12 hours.
Danish: Efter flere orale dosisadministrationer af ivacaftor øgedes eksponeringen af ivacaftor generelt med dosis fra 25 mg hver 12. time til 450 mg hver 12. time.
English: In vitro responses seen in single channel patch clamp experiments using membrane patches from rodent cells expressing mutant CFTR forms do not necessarily correspond to in vivo pharmacodynamic response (e.g., sweat chloride) or clinical benefit.
Danish: In vitro-respons set i patch clamp-eksperimenter med en enkelt kanal, der anvender membranudsnit fra gnaverceller, der udtrykker muterede CFTR-former, stemmer ikke nødvendigvis overens med in vivo farmakodynamisk respons (f.eks. sved-chlorid) eller klinisk fordel.
English: Tell your doctor right away if you have any of these symptoms, which may be a sign of liver problems:
Danish: Fortæl det straks til lægen, hvis du har nogle af disse symptomer, da de kan være tegn på leverproblemer:
English: The granules are packed in a Biaxially Oriented Polyethylene Terephthalate/Polyethylene/Foil/Polyethylene (BOPET/PE/Foil/PE) sachet.
Danish: Granulatet er pakket i et brev af biaksialt orienteret polyethylenterephthalat/polyethylen/folie/polyethylen (BOPET/PE/folie/PE).
English: Due to mutations in the CFTR gene (see below), chloride movement is reduced in those with cystic fibrosis (CF).
Danish: På grund af mutationer i CFTR-genet (se nedenfor) er chloridoverførslen nedsat hos personer med cystisk fibrose (CF).
English: BMI-for-age z-score at week 48e
Danish: BMI-for-alder z-score ved uge 48e
English: • A fat-containing meal or snack should be given to your child just before or just after dosing (some examples are provided below).
Danish: • Barnet skal have et fedtholdigt måltid eller mellemmåltid lige før eller lige efter indtagelse af medicinen (se eksempler nedenfor).
English: The effect of the potentially reduced activity of CYP3A4 in patients carrying the CYP3A4*22 variant on ivacaftor exposure is not known.
Danish: Virkningen af den potentielt reducerede aktivitet af CYP3A4 på ivacaftor-eksponering er ukendt hos patienter, der er bærere af CYP3A4*22-varianten.
English: The tablets should not be chewed, crushed, or broken before swallowing.
Danish: Tabletterne må ikke tygges, knuses eller deles, før de sluges.
English: 7 tablets
Danish: 7 tabletter
English: CFQ-R respiratory domain score (points)
Danish: CFQ-R-score for respirationssymptomer (points)
English: If you have liver problems, either moderate or severe, your doctor may need to reduce the dose of your tablets, because your liver will not clear the medicine as fast as in people who have normal liver function.
Danish: Hvis du har leverproblemer, enten moderate eller svære, kan det være nødvendigt, at din læge reducerer dosis af dine tabletter, da din lever ikke vil udskille lægemidlet lige så hurtigt som hos personer med normal leverfunktion.
English: In vitro studies showed that ivacaftor is not a substrate for P-gp.
Danish: In vitro-studier har vist, at ivacaftor ikke er et substrat for P-gp.
English: The pharmacokinetics of ivacaftor are similar between healthy adult volunteers and patients with CF.
Danish: Ivacaftors farmakokinetik er sammenlignelig for raske voksne frivillige og for patienter med CF.
English: Absolute change in sweat chloride (mmol/L)
Danish: Absolut ændring i sved-chlorid (mmol/l)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Kalydeco in one or more subsets of the paediatric population in cystic fibrosis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Kalydeco i en eller flere undergrupper af den pædiatriske population med cystisk fibrose (se pkt.
English: Transaminase elevations occurred in 12.8% of ivacaftor-treated patients versus 11.5% of placebo-treated patients.
Danish: Stigninger i aminotransferaser opstod hos 12,8 % af de ivacaftor-behandlede patienter versus 11,5 % af de placebobehandlede patienter.
English: Food or liquid should be at room temperature or below.
Danish: Fødevarernes eller væskens temperatur skal svare til stuetemperatur eller derunder.
English: Whenever possible the phase of the poly-T variant identified with the R117H mutation should be determined as this may be informative in considering treatment of patients with an R117H mutation (see section 4.2).
Danish: Når det er muligt, skal fasen af den poly-T-variant, der er identificeret sammen med R117H-mutationen, bestemmes, da oplysning om fasen af poly-T-varianten kan være nyttig ved overvejelse af behandling af patienter med en R117H-mutation (se pkt.
English: M6 has less than one-fiftieth the potency of ivacaftor and is not considered pharmacologically active.
Danish: M6 har under 1/50 af ivacaftors styrke og anses ikke for at være farmakologisk aktivt.
English: You may experience side effects, including those mentioned in section 4 below.
Danish: Du kan opleve bivirkninger, herunder bivirkninger, som nævnes i punkt 4 nedenfor.
English: These medications included dornase alfa (73.1% versus 65.1%), salbutamol (53.8% versus 42.2%), tobramycin (44.9% versus 33.7%) and salmeterol/fluticasone (41.0% versus 27.7%).
Danish: Disse lægemidler omfattede dornase alfa (73,1 % versus 65,1 %), salbutamol (53,8 % versus 42,2 %), tobramycin (44,9 % versus 33,7 %) og salmeterol/fluticason (41,0 % versus 27,7 %).
English: Refer to the Summary of Product Characteristics of tezacaftor/ivacaftor for additional data.
Danish: Se produktresuméet for tezacaftor/ivacaftor for yderligere data.
English: Clinical studies of ivacaftor monotherapy did not include sufficient numbers of patients age 65 years and older to determine whether pharmacokinetic parameters are similar or not to those in younger adults.
Danish: Kliniske studier af ivacaftor-monoterapi omfattede ikke et tilstrækkeligt antal patienter i alderen 65 år og ældre til at bestemme, om de farmakokinetiske parametre svarer til dem for yngre voksne.
English: Data on percent predicted FEV1 (exploratory endpoint) were available for 3 patients in the ivacaftor 50 mg group and 17 patients in the 75 mg dosing group.
Danish: Data for procent forventet FEV1 (eksploratorisk endepunkt) var tilgængelige for 3 patienter i gruppen med ivacaftor 50 mg og 17 patienter i doseringsgruppen med 75 mg.
English: Ivacaftor also potentiated the channel-open probability of R117H-CFTR, which has both low channel-open probability (gating) and reduced channel current amplitude (conductance).
Danish: Ivacaftor potenserede desuden sandsynligheden for åbning af kanalen ved R177H-CFTR, som både medfører lav sandsynlighed for åbning af kanalen (gating) og nedsat amplitude i den aktuelle kanal (ledeevne).
English: The results for clinically relevant secondary endpoints are shown in Table 4.
Danish: Resultaterne for klinisk relevante sekundære endepunkter er vist i tabel 4.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: The G970R mutation causes a splicing defect resulting in little-to-no CFTR protein at the cell surface which may explain the results observed in subjects with this mutation in study 5 (see Pharmacodynamic effects and Clinical efficacy data).
Danish: G970R-mutationen forårsager en splicing-defekt, der fører til kun lidt eller intet CFTR-protein på celleoverfladen, hvilket kan forklare de observerede resultater hos personer med denne mutation i studie 5 (se Farmakodynamisk virkning og Klinisk virkning og sikkerhed).
English: The mean (SD) overall change in stature-for-age z-score was -0.01 (0.33).
Danish: Den gennemsnitlige (SD) samlede ændring i staturfor-alder z-score var -0,01 (0,33).
English: • Redness in the throat
Danish: • rødmen i halsen
English: As a precautionary measure, it is preferable avoid the use of Kalydeco during pregnancy.
Danish: For en sikkerheds skyld bør Kalydeco undgås under graviditeten.
English: Ivacaftor may inhibit CYP2C9.
Danish: Ivacaftor kan hæmme CYP2C9.
English: Ivacaftor acts at the level of the cystic fibrosis transmembrane conductance regulator (CFTR), a protein that forms a channel at the cell surface that allows the movement of particles such as chloride in and out of the cell.
Danish: Ivacaftor virker på niveauet for cystisk fibrose transmembran konduktansregulatoren (CFTR), et protein, der danner en kanal ved celleoverfladen, så partikler som chlorid kan føres ind og ud af cellen.
English: Some examples of age-appropriate soft foods or liquids include puréed fruits or vegetables, yogurt, applesauce, water, milk, breast milk, infant formula, or juice.
Danish: Eksempler på alderssvarende mosede fødevarer eller væske er pureret frugt eller grøntsager, yoghurt, æblegrød, vand, mælk, brystmælk, modermælkserstatning eller juice.
English: In the event of significant elevations of transaminases (e.g., patients with ALT or AST > 5 x the upper limit of normal (ULN), or ALT or AST > 3 x ULN with bilirubin > 2 x ULN), dosing should be interrupted and laboratory tests closely followed until the abnormalities resolve.
Danish: I tilfælde af signifikante forhøjelser af aminotransferaser (f.eks. patienter med ALAT eller ASAT >5 x den øvre normalgrænse (ULN) eller ALAT eller ASAT >3 x ULN med bilirubin >2 x ULN) bør doseringen afbrydes, og laboratorieprøver skal følges nøje, indtil anomalierne har fortaget sig.
English: Morning
Danish: Morgen
English: • Kalydeco is not recommended for patients who have undergone an organ transplant.
Danish: • Kalydeco bør ikke anvendes til patienter, som har gennemgået en organtransplantation.
English: • This medicine has been prescribed for your child only.
Danish: • Lægen har ordineret dette lægemiddel til dit barn.
English: In particular, tell your doctor if you are taking any of the medicines listed below.
Danish: Du skal især fortælle det til lægen, hvis du tager et eller flere af lægemidlerne angivet nedenfor.
English: Your child must keep using all other medicines, unless your child's doctor tells him/her to stop using any.
Danish: Dit barn skal blive ved med at bruge alle andre lægemidler, medmindre lægen fortæller dit barn, at han/hun skal holde op med at bruge et eller flere af dem.
English: Serious side effects include stomach (abdominal) ache and increased liver enzymes in the blood.
Danish: Alvorlige bivirkninger omfatter mavesmerter og forhøjede niveauer af leverenzymer i blodet.
English: At the 4-week follow-up visit (4 weeks after dosing with ivacaftor ended), mean sweat chloride values for each group were trending to pre-treatment levels.
Danish: Ved 4-ugers-opfølgningsbesøget (4 uger efter afslutning af dosering med ivacaftor) bevægede middelværdierne for sved-chlorid for hver gruppe sig mod niveauerne før behandling.
English: Kalydeco contains the active ingredient ivacaftor.
Danish: Kalydeco indeholder det aktive indholdsstof ivacaftor.
English: If you have been prescribed Kalydeco to be taken with tezacaftor/ivacaftor, read the tezacaftor/ivacaftor package leaflet.
Danish: Hvis du har fået ordineret Kalydeco, som skal tages sammen med tezacaftor/ivacaftor, skal du læse indlægssedlen for tezacaftor/ivacaftor.
English: The safety data of ivacaftor in combination with tezacaftor/ivacaftor was evaluated in 98 patients between 12 to less than 18 years of age.
Danish: Sikkerhedsdata for ivacaftor i kombination med tezacaftor/ivacaftor er evalueret for 98 patienter i alderen 12 til under 18 år.
English: Your doctor may decide to adjust your dose or that you need extra check-ups.
Danish: Lægen kan beslutte at justere din dosis, eller at du har behov for ekstra kontroller.