FrancophonIA/ELRC3.0 huggingface dataset:
English: Twenty-six patients out of the 34 enrolled (76.5%) had a CFTR genotype G551D/F508del with only 2 patients with a non-G551D mutation (S549N).
Danish: -Seksogtyve patienter ud af de 34, der indgik (76,5 %), havde en CFTR-genotype G551D/F508del, og kun 2 patienter havde en non-G551D-mutation (S549N).
English: Tinnitus common
Danish: Tinnitus almindelig
English: Indigo carmine aluminium lake (E132) Carnauba wax
Danish: Indigocarmin aluminium lake (E132) Carnaubavoks
English: Kalydeco can make you dizzy.
Danish: Kalydeco kan gøre dig svimmel.
English: In a human pharmacokinetic study, there was minimal elimination of ivacaftor and its metabolites in urine (only 6.6% of total radioactivity was recovered in the urine).
Danish: I et farmakokinetisk studie hos mennesker, var der minimal elimination af ivacaftor og metabolitter i urinen (kun 6,6 % af den totale radioaktivitet blev genfundet i urinen).
English: The results for clinically relevant secondary endpoints are shown in Table 3.
Danish: Resultaterne for klinisk relevante sekundære endepunkter er vist i tabel 3.
English: When they rolled over into study 4, the rate of annualised pulmonary exacerbations was 0.91 events/year across day 1 to week 48 and 0.77 events/year across weeks 48 to 96.
Danish: Når de blev overført til studie 4 var hyppigheden af annualiserede lungeeksacerbationer 0,91 hændelser/år over dag 1 til uge 48 og 0,77 hændelser/år over uge 48 til 96.
English: Do not give this medicine in combination with tezacaftor/ivacaftor to children under 12 years of age as it is not known if they are safe and effective for them.
Danish: Dette lægemiddel må ikke gives i kombination med tezacaftor/ivacaftor til børn under 12 år, da det er ukendt, om det er sikkert og effektivt til dem.
English: The exposure of ivacaftor increased approximately 2.5- to 4-fold when given with food containing fat.
Danish: Eksponeringen af ivacaftor øgedes ca. 2,5 til 4 gange, når det blev indtaget sammen med fedtholdig mad.
English: Ivacaftor granules (2 x 75 mg sachets) had similar bioavailability as the 150 mg tablet when given with fat-containing food to healthy adult subjects.
Danish: Ivacaftor-granulat (2 x 75 mg breve) havde en biotilgængelighed, som svarede til 150 mg-tabletten, når det blev givet sammen med fedtholdig mad til raske, voksne personer.
English: The pharmacokinetics of ivacaftor are generally linear with respect to time or dose ranging from 25 mg to 250 mg.
Danish: Ivacaftors farmakokinetik er generelt lineær med hensyn til tid eller et dosisinterval fra 25 mg til 250 mg.
English: Rhinitis common
Danish: Rhinitis almindelig
English: Predicted ivacaftor exposure based on observed ivacaftor concentrations in Phase 2 and 3 studies as determined using population PK analysis is presented by age group in Table 7.
Danish: Den forventede ivacaftor-eksponering, der er baseret på observerede ivacaftor-koncentrationer i fase 2- og 3-studier, bestemt ved hjælp af den populationsfarmakokinetiske analyse er vist pr. aldersgruppe i tabel 7.
English: Additional adverse reactions observed with ivacaftor in combination with tezacaftor/ivacaftor are also provided in Table 3.
Danish: Andre bivirkninger observeret med ivacaftor i kombination med tezacaftor/ivacaftor er også angivet i tabel 3.
English: Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for your child.
Danish: Læs denne indlægsseddel grundigt, inden dit barn begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: • Abnormality of the eye lens (cataract) without any effect on vision has been noted in some children and adolescents during treatment.
Danish: • En unormal linse i øjet (grå stær), der ikke påvirker synet, er blevet bemærket hos nogle børn og unge under behandlingen.
English: Pregnancy and fertility
Danish: Drægtighed og fertilitet
English: • Kalydeco (alone or in combination with tezacaftor/ivacaftor) is not recommended if you have undergone an organ transplant.
Danish: • Kalydeco (alene eller i kombination med tezacaftor/ivacaftor) bør ikke anvendes, hvis du har gennemgået en organtransplantation.
English: Exposure to ivacaftor may be reduced by the concomitant use of CYP3A inducers, potentially resulting in the loss of ivacaftor efficacy.
Danish: Eksponeringen for ivacaftor kan reduceres ved samtidig anvendelse af CYP3A-induktorer, hvilket muligvis resulterer i nedsat virkning af ivacaftor.
English: Ivacaftor is extensively metabolised in humans.
Danish: Ivacaftor metaboliseres i udtalt grad hos mennesker.
English: * Adverse reaction and frequency reported only in clinical studies with ivacaftor in combination with tezacaftor/ivacaftor.
Danish: * Bivirkning og hyppighed blev kun rapporteret i kliniske studier med ivacaftor i kombination med tezacaftor/ivacaftor.
English: The recommended dose of Kalydeco is one 150 mg tablet every 12 hours (in total 2 tablets: 300 mg per day).
Danish: Den anbefalede dosis af Kalydeco er en 150 mg tablet hver 12. time (i alt 2 tabletter: 300 mg pr. dag).
English: Ivacaftor dosing was interrupted in most patients with transaminase elevations > 5 x ULN.
Danish: Ivacaftor-doseringen blev afbrudt hos de fleste patienter med aminotransferase-forhøjelser >5 x ULN.
English: Kalydeco in a combination regimen with tezacaftor/ivacaftor in adults and adolescents aged 12 years and older
Danish: Kalydeco i et kombinationsregime med tezacaftor/ivacaftor til voksne og unge i alderen 12 år og ældre
English: A pre-planned subgroup analysis was conducted in patients 18 years and older (26 patients on placebo and 24 on ivacaftor).
Danish: Der blev udført en forud planlagt undergruppeanalyse af patienter i alderen 18 år og derover (26 patienter, der fik placebo, og 24, der fik ivacaftor).
English: Your child's doctor may decide to adjust your child's dose or if extra check-ups are needed.
Danish: Dit barns læge kan beslutte at justere dit barns dosis, eller om det er nødvendigt med ekstra kontroller.
English: Do not give this medicine to children under 6 months of age with gating mutations as it is not known if ivacaftor is safe and effective in these children, or in patients under 18 years of age with an R117H mutation as ivacaftor may not work in them.
Danish: Dette lægemiddel må ikke gives til børn under 6 måneder med gating-mutationer, da det er ukendt, om ivacaftor er sikkert og effektivt til disse børn, eller til patienter under 18 år med en R117H-mutation, da det kan være, at ivacaftor ikke virker hos dem.
English: Mean absolute change from baseline in CFQ-Rb respiratory domain score (points)c
Danish: P-værdi Gennemsnitlig absolut ændring fra baseline i CFQ-Rb respiratory domain score (points)c
English: No dose adjustment is required when Kalydeco is co-administered with ciprofloxacin.
Danish: Dosisjustering er ikke nødvendig, når Kalydeco administreres sammen med ciprofloxacin.
English: Study 7: study in paediatric patients with CF aged 2 to less than 6 years with G551D or another gating mutation
Danish: Studie 7: studie med pædiatriske patienter med CF i alderen 2 til under 6 år med G551D- eller en anden gating-mutation
English: No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A).
Danish: Ingen dosisjustering er nødvendig for patienter med let nedsat leverfunktion (Child-Pugh klasse A).
English: Available pharmacokinetic data in animals have shown excretion of ivacaftor into the milk of lactating female rats.
Danish: Tilgængelige farmakokinetiske data fra dyr har vist udskillelse af ivacaftor i mælken hos diegivende hunrotter.
English: Effect on liver function tests
Danish: Virkning på leverfunktionsprøver
English: Efficacy was not demonstrated in patients aged 6 to 11 years with CF who have an R117H mutation while only two adolescent patients were enrolled in study 6 (see section 5.1).
Danish: Der blev ikke påvist en virkning hos patienter i alderen 6 til 11 år med CF, der har en R117H-mutation, mens kun to unge patienter indgik i studie 6 (se pkt.
English: Secondary endpoints were evaluation of pharmacokinetics and the absolute change from baseline in sweat chloride through 24 weeks of treatment (see Pharmacodynamic effects).
Danish: Sekundære endepunkter var evaluering af farmakokinetik og den absolutte ændring fra baseline i svedchlorid i løbet af 24 ugers behandling (se Farmakodynamiske virkninger).
English: • Kalydeco (alone or in combination with tezacaftor/ivacaftor) should only be used if you have one of the mutations in the CFTR gene indicated in section 1 (What Kalydeco is and what it is used for).
Danish: • Kalydeco (alene eller i kombination med tezacaftor/ivacaftor) må kun anvendes, hvis du har en af mutationerne i CFTR-genet, som er anført i punkt 1 (Virkning og anvendelse).
English: It is unknown whether ivacaftor is excreted in human milk.
Danish: Det er ukendt, om ivacaftor udskilles i human mælk.
English: Your doctor will do some blood tests to check your liver before and during treatment, particularly during the first year and especially if your blood tests showed high liver enzymes in the past.
Danish: • mørk urin Din læge vil tage nogle blodprøver for at kontrollere din lever før og under behandlingen, især i løbet af det første år, og især hvis dine blodprøver tidligere har vist høje leverenzymer.
English: Mean absolute change from baseline in BMI (kg/m2)
Danish: Gennemsnitlig absolut ændring fra baseline i BMI (kg/m2)
English: Weight-for-age z-score at week 48e
Danish: Vægt-for-alder z-score ved uge 48e
English: For patients in the placebo/ivacaftor group baseline percent predicted FEV1 is that of study 4 while for patients in the ivacaftor/ivacaftor group the baseline value is that of studies 1 and 2.
Danish: For patienter i placebo/ivacaftor-gruppen er procent af forventet FEV1 ved baseline værdien i studie 4, og for patienter i ivacaftor/ivacaftor-gruppen er værdien ved baseline værdien i studie 1 og 2.
English: Ivacaftor was administered orally every 12 hours with fat-containing food in addition to their prescribed CF therapies.
Danish: Ivacaftor blev administreret oralt hver 12. time sammen med fedtholdig mad i tillæg til deres ordinerede behandlinger for CF.
English: If possible, have your medicine and this leaflet with you.
Danish: Hvis det er muligt, skal du medbringe din medicin og denne indlægsseddel.
English: • Immunosuppressants such as ciclosporin, tacrolimus, everolimus and sirolimus used after an organ transplantation
Danish: • immunsupprimerende midler, såsom ciclosporin, tacrolimus, everolimus og sirolimus, der anvendes efter en organtransplantation.
English: This finding has not been observed in foetuses derived from rat dams treated with ivacaftor on gestation days 7 to 17, in rat pups exposed to ivacaftor through milk ingestion up to postnatal day 20, in 7-week old rats, nor in 3.5 to 5-month old dogs treated with ivacaftor.
Danish: Dette fund er ikke blevet observeret hos fostre fra rottekuld behandlet med ivacaftor på gestationsdag 7 til 17, hos rotteunger eksponeret for ivacaftor via mælkeindtagelse op til dag 20 efter fødslen, hos 7 uger gamle rotter eller hos 3,5-5 måneder gamle hunde behandlet med ivacaftor.
English: Table 7: Mean (SD) ivacaftor exposure by age group Age group
Danish: Tabel 7: Gennemsnitlig (SD) ivacaftor-eksponering pr. aldersgruppe Aldersgruppe
English: Tell your child's doctor right away if your child has any of these symptoms, which may be a sign of liver problems:
Danish: Fortæl det straks til dit barns læge, hvis dit barn har nogle af disse symptomer, da de kan være tegn på leverproblemer:
English: Mean change from baseline in z-scores
Danish: Gennemsnitlig ændring fra baseline i z-scores
English: The primary efficacy endpoint in both studies was the mean absolute change from baseline in percent predicted FEV1 through 24 weeks of treatment.
Danish: Det primære endepunkt for virkning i begge studier var den gennemsnitlige absolutte ændring fra baseline i procent af forventet FEV1 til og med 24 ugers behandling.
English: One patient (0.2%) on therapy and 2 patients (0.4%) on placebo permanently discontinued treatment for elevated transaminases.
Danish: Én patient (0,2 %) i behandling og 2 patienter (0,4 %), der fik placebo, seponerede behandlingen permanent på grund af forhøjede aminotransferaser.
English: Kalydeco contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Kalydeco indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: • Upper respiratory tract infection (the common cold), including sore throat and nasal congestion
Danish: • infektion i de øvre luftveje (forkølelse), herunder ondt i halsen og tilstoppet næse
English: If your child has liver problems, either moderate or severe, your child's doctor may need to reduce the dose of Kalydeco as your child's liver will not clear the medicine as fast as in children who have normal liver function.
Danish: Hvis dit barn har leverproblemer, enten moderate eller svære, kan det være nødvendigt, at dit barns læge reducerer dosis af Kalydeco, da dit barns lever ikke vil udskille lægemidlet lige så hurtigt som hos børn med normal leverfunktion.
English: • Herbal medicines such as St. John's wort (Hypericum perforatum)
Danish: • naturlægemidler, såsom prikbladet perikon (Hypericum perforatum)
English: In part 1 of study 5, the mean FEV1 percent predicted at baseline in placebo-treated patients was 79.3% while in ivacaftor-treated patients this value was 76.4%.
Danish: I del 1 af studie 5 var den gennemsnitlige FEV1 procent af forventet ved baseline hos placebobehandlede patienter 79,3 %, mens den var 76,4 % hos ivacaftor-behandlede patienter.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Kalydeco therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Kalydeco seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: In the cohort of patients aged 6 months to less than 12 months, one patient (9.1%) had elevated ALT of > 3 to ≤ 5 x ULN.
Danish: I kohorten af patienter i alderen 6 måneder til under 12 måneder havde én patient (9,1 %) forhøjet ALAT på >3 til ≤5 x ULN.
English: • Nuts, fat-containing nutritional bars or drinks
Danish: • nødder, fedtholdige energibarer eller -drikke
English: No safety data are available in infants aged 6 to less than 12 months of age who are treated with ivacaftor and moderate or strong CYP3A4 inhibitors.
Danish: Der foreligger ingen sikkerhedsdata for spædbørn i alderen fra 6 til under 12 måneder, der behandles med ivacaftor og moderate eller potente CYP3A4-hæmmere.
English: Following resolution of transaminase elevations, the benefits and risks of resuming treatment should be considered (see section 4.8).
Danish: Efter aminotransferaseforhøjelserne er vendt tilbage til normalen, bør fordele og risici ved at genoptage behandlingen overvejes (se pkt.
English: Long-term effectiveness study to compare disease progression among children with CF who have a specified CFTR gating mutation and are aged 2 through 5 years at the time of Kalydeco treatment initiation versus disease progression among concurrent matched cohort of children with CF who have never received Kalydeco treatment.
Danish: Langvarigt virkningsstudie til sammenligning af sygdomsprogression blandt børn med CF, der har en specificeret CFTR-gating-mutation og er i alderen 2 år til og med 5 år på tidspunktet for start på Kalydeco-behandling, versus sygdomsprogression i en parallelt matchet kohorte af børn med CF, der aldrig har fået Kalydeco-behandling.
English: Ensure that the mixture is completely and immediately consumed.
Danish: Sørg for, at barnet indtager hele blandingen straks.
English: Take the missed dose if less than 6 hours have passed since the time you missed the dose.
Danish: Tag den glemte dosis, hvis der er gået under 6 timer fra du skulle have taget en dosis.
English: • Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (PEG 3350), talc, indigo carmine aluminium lake (E132) and carnauba wax.
Danish: • Filmovertræk: polyvinylalkohol, titandioxid (E171), macrogol (PEG3350), talcum, indigocarmin aluminium lake (E132) og carnaubavoks.
English: There was negligible urinary excretion of ivacaftor as unchanged parent.
Danish: Der var en ubetydelig udskillelse af ivacaftor i urinen, som det uændrede udgangsstof.
English: Nasopharyngitis very common
Danish: Nasofaryngitis meget almindelig
English: No ivacaftor-treated patients experienced a transaminase elevation > 3 x ULN associated with elevated total bilirubin > 1.5 x ULN.
Danish: Ingen ivacaftorbehandlede patienter oplevede en aminotransferase-forhøjelse >3 x ULN forbundet med forhøjet total bilirubin >1,5 x ULN.
English: Absolute change in percent predicted FEV1 (percentage points)
Danish: Absolut ændring i procent af forventet FEV1 (procentpoints)
English: Ivacaftor was administered orally every 12 hours with fat-containing food.
Danish: Ivacaftor blev administreret oralt hver 12. time sammen med fedtholdig mad.
English: Kalydeco 150 mg film-coated tablets are light blue, capsule-shaped, 16.5 mm x 8.4 mm, and printed with “V 150” in black ink on one side and plain on the other.
Danish: Kalydeco 150 mg filmovertrukne tabletter er lyseblå, kapselformede, 16,5 mm x 8,4 mm og præget med “V 150” i sort blæk på den ene side og glat på den anden side.
English: Co-administration of ivacaftor with grapefruit juice, which contains one or more components that moderately inhibit CYP3A, may increase exposure to ivacaftor.
Danish: Administration af ivacaftor sammen med grapefrugtjuice, der indeholder et eller flere stoffer, som hæmmer CYP3A moderat, kan øge eksponeringen for ivacaftor.
English: • Medicines for diabetes such as glimepiride and glipizide, used to lower sugar blood levels.
Danish: • lægemidler mod diabetes, såsom glimepirid og glipizid, der anvendes til at sænke sukkerniveauet i blodet.
English: After steady-state dosing of ivacaftor in combination with tezacaftor in CF patients, the mean (SD) terminal half-life of ivacaftor was approximately 9.3 (1.7) hours.
Danish: Efter steady-state-dosering af ivacaftor i kombination med tezacaftor hos CF-patienter var den gennemsnitlige (SD) terminale halveringstid for ivacaftor ca. 9,3 (1,7) timer.
English: The film-coated tablets are packed in a thermoform (PolyChloroTriFluoroEthylene [PCTFE]/foil) blister or a High-Density PolyEthylene (HDPE) bottle with a polypropylene child-resistant closure, foil-lined induction seal and molecular sieve desiccant.
Danish: De filmovertrukne tabletter er pakket i en thermoform (polychlortrifluorethylen [PCTFE]/folie) blister eller en højdensitets polyethylen (HDPE) beholder med en børnesikret lukke af polypropylen, foliebeklædt induktionsforsegling og tørremiddel med molekylær si.
English: This shows that patients in the ivacaftor/ivacaftor group maintained the improvement seen at week 48 of the initial study (day 0 through week 48) in percent predicted FEV1 through week 144.
Danish: Dette viser, at patienter i ivacaftor/ivacaftor-gruppen opretholdt den forbedring, der blev observeret ved uge 48 i det indledende studie (dag 0 til og med uge 48) i procent af forventet FEV1 til og med uge 144.
English: Simulations for predicting the steady-state exposure of ivacaftor showed that by reducing the dosage from 150 mg q12h to 150 mg once daily, adults with moderate hepatic impairment would have comparable steady-state Cmin values as those obtained with a dose of 150 mg q12h in adults without hepatic impairment.
Danish: Simuleringer for forudsigelse af steady-state-eksponeringen af ivacaftor viste, at ved at reducere dosis fra 150 mg hver 12. time til 150 mg én gang dagligt, ville voksne personer med moderat nedsat leverfunktion have steady-state Cmin-værdier, som var sammenlignelige med de værdier, der blev opnået med en dosis på 150 mg hver 12. time hos voksne uden nedsat leverfunktion.
English: Granules in sachet White to off-white granules approximately 2 mm in diameter.
Danish: Granulat i brev Hvidt til off-white granulat med en diameter på ca. 2 mm.
English: • Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet)
Danish: • Pakningsstørrelse på 56 breve (indeholder 4 enkeltmapper med 14 breve i hver).
English: For patients randomised to the placebo/ivacaftor treatment sequence in part 1 there was a further mean (SD) change of 3.3% (9.3%) in percent predicted FEV1 after the additional 16 weeks of treatment with ivacaftor.
Danish: For patienter randomiseret til placebo/ivacaftor-behandlingssekvensen i del 1 var der en yderligere gennemsnitlig (SD) ændring på 3,3 % (9,3 %) i procent forventet FEV1 efter de yderligere 16 ugers behandling med ivacaftor.
English: Your doctor will decide whether to recommend that you stop breast-feeding or for you to stop ivacaftor therapy.
Danish: Din læge vil beslutte, om det er bedst, at du stopper amningen eller behandlingen med ivacaftor.
English: Medicinal products affected by ivacaftor
Danish: Lægemidler, der påvirkes af ivacaftor
English: The mean (SD) Faecal Elastase-1 value at baseline (n = 27) was 28 µg/g (95).
Danish: Gennemsnitlig (SD) fækal elastase-1-værdi ved baseline (n=27) var 28 µg/g (95).
English: Other medicinal products for which exposure may be increased include glimepiride and glipizide; these medicinal products should be used with caution.
Danish: Andre lægemidler, hvor eksponeringen kan være øget, omfatter glimepirid og glipizid.
English: The geometric least squares mean ratio (90% CI) for the granules relative to tablets was 0.951 (0.839, 1.08) for AUC0-∞ and 0.918 (0.750, 1.12) for Cmax.
Danish: Det geometrisk mindste kvadraters gennemsnitsforhold (90 % CI) for granulat i forhold til tabletter var 0,951 (0,839; 1.08) for AUC0-∞ og 0,918 (0,750; 1,12) for Cmax.
English: In a human pharmacokinetic study with ivacaftor monotherapy, there was minimal elimination of ivacaftor and its metabolites in urine (only 6.6% of total radioactivity was recovered in the urine).
Danish: I et farmakokinetisk studie hos mennesker med ivacaftor-monoterapi, var der minimal elimination af ivacaftor og metabolitter i urinen (kun 6,6 % af den totale radioaktivitet blev genfundet i urinen).
English: Light blue, capsule-shaped film-coated tablets, printed with “V 150” in black ink on one side and plain on the other (16.5 mm x 8.4 mm in modified tablet shape).
Danish: Lyseblå, kapselformede filmovertrukne tabletter, præget med “V 150” i sort blæk på den ene side og glat på den anden side (16,5 mm x 8,4 mm i en modificeret tabletform).
English: Ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Danish: Ivacaftor er ikke blevet undersøgt hos patienter med CF, som har gennemgået organtransplantation.
English: Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with ivacaftor.
Danish: Tilfælde af ikke medfødte uigennemsigtigheder af linsen, der ikke påvirker synet, er blevet rapporteret hos pædiatriske patienter i behandling med ivacaftor.
English: Less evidence of a positive effect of ivacaftor has been shown for patients with an R117H-7T mutation associated with less severe disease (see section 5.1).
Danish: Evidensen for en positiv virkning af ivacaftor har vist sig at være mindre hos patienter med en R117H-7T-mutation, som er forbundet med sygdom af lavere sværhedsgrad (se pkt.
English: Thirty-nine patients (mean age 23 years) with baseline FEV1 ≥ 40% predicted (mean FEV1 78% predicted [range: 43% to 119%]) were enrolled.
Danish: 39 patienter (gennemsnitsalder 23 år) med baseline-FEV1 ≥40 % forventet (gennemsnitlig FEV1 78 % forventet [interval: 43 % til 119 %]) indgik.
English: Placebo Study 2
Danish: Ivacaftor Placebo Studie 2
English: In particular, tell your child's doctor if your child is taking any of the medicines listed below.
Danish: Du skal især fortælle det til dit barns læge, hvis dit barn tager et eller flere af lægemidlerne angivet nedenfor.