FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of Kalydeco may increase systemic exposure of medicinal products that are sensitive substrates of P-gp, which may increase or prolong their therapeutic effect and adverse reactions.
Danish: Administration af Kalydeco kan forøge den systemiske eksponering af lægemidler, som er følsomme P-gp-substrater, hvilket kan forøge eller forlænge deres terapeutiske virkning og bivirkninger.
English: Results were consistent in both the 12 months to less than 24 months and 6 months to less than 12 months age cohorts.
Danish: Resultaterne var konsistente for både kohorten med patienter fra 12 måneder til under 24 måneder og kohorten med patienter fra 6 måneder til under 12 måneder.
English: The impact of severe hepatic impairment (Child Pugh Class C, score 10 to15) on the pharmacokinetics of ivacaftor monotherapy or in combination with tezacaftor/ivacaftor have not been studied.
Danish: Påvirkningen af svært nedsat leverfunktion (Child Pugh klasse C, score 10 til 15) på farmakokinetikken for ivacaftor-monoterapi eller i kombination med tezacaftor/ivacaftor er ikke undersøgt.
English: The mean (SD) sweat chloride at baseline (n = 25) was 97.88 mmol/L (14.00).
Danish: Gennemsnitlig (SD) sved-chlorid ved baseline (n=25) var 97,88 mmol/l (14,00).
English: In patients aged 2 to less than 6 years the most common adverse reactions were nasal congestion (26.5%), upper respiratory tract infection (23.5%), transaminase elevations (14.7%), rash (11.8%), and bacteria in sputum (11.8%).
Danish: Hos patienter i alderen 2 til under 6 år var de mest almindelige bivirkninger tilstoppet næse (26,5 %), infektion i de øvre luftveje (23,5 %), stigninger i aminotransferaser (14,7 %), udslæt (11,8 %) og bakterier i spyt (11,8 %).
English: Kalydeco tablets can also be used in combination with tezacaftor/ivacaftor tablets for the treatment of adults and adolescents aged 12 years and older with CF who have two F508del mutations in the CFTR gene (homozygous for the F508del mutation) or who have an F508del mutation and certain other second mutations (heterozygous for the F508del mutation).
Danish: Kalydeco tabletter kan også anvendes i kombination med tezacaftor/ivacaftor tabletter til behandling af voksne og unge i alderen 12 år og ældre med CF, som har to F508del-mutationer i CFTR-genet (homozygote for F508del-mutationen), eller som har en F508del-mutation og bestemte andre mutationer (heterozygote for F508del-mutationen).
English: One hundred and forty-four (144) patients from study 1 were rolled over in study 4, 67 in the placebo/ivacaftor group and 77 in the ivacaftor/ivacaftor group.
Danish: 144 patienter fra studie 1 indgik i studie 4, 67 i placebo/ivacaftor-gruppen og 77 i ivacaftor/ivacaftorgruppen.
English: No treatment differences for ivacaftor versus placebo were observed except for the respiratory domain of the CFQ-R (the treatment difference through 24 weeks of ivacaftor versus placebo was 8.4 [95% CI 2.2, 14.6] points) and for the mean change from baseline in sweat chloride (see Pharmacodynamic effects).
Danish: Der sås ingen forskelle i behandlingen med ivacaftor versus placebo med undtagelse af CFQ-R-score for respirationssymptomer (forskellen i behandlingen til og med uge 24 med ivacaftor versus placebo var 8,4 [95 % CI 2,2, 14,6] points), og for den gennemsnitlige ændring fra baseline i sved-chlorid (se Farmakodynamisk virkning).
English: 4 individual wallets with 14 sachets per wallet
Danish: 4 enkeltmapper med 14 breve i hver
English: Kalydeco in combination with tezacaftor/ivacaftor should not be prescribed in patients with CF who are heterozygous for the F508del mutation and have a second CFTR mutation not listed in section 4.1.
Danish: Kalydeco i kombination med tezacaftor/ivacaftor må ikke ordineres til patienter med CF, som er heterozygote for F508del-mutationen og har en anden CFTR-mutation, der ikke er anført i pkt.
English: Mean absolute change from baseline in body weight (kg)
Danish: Gennemsnitlig absolut ændring fra baseline i kropsvægt (kg)
English: • Printing ink: shellac, iron oxide black (E172), propylene glycol (E1520) and ammonia solution, concentrated.
Danish: • Prægeblæk: shellac, jernoxid, sort (E172), propylenglycol (E1520) og ammoniakopløsning, koncentreret.
English: No dose adjustment of CYP3A substrates, such as midazolam, alprazolam, diazepam or triazolam, is required when these are coadministered with ivacaftor.
Danish: En dosisjustering af CYP3A-substrater, såsom midazolam, alprazolam, diazepam eller triazolam, er ikke nødvendig, når disse administreres sammen med ivacaftorregime.
English: Weight-for-age z-score Length-for-age z-score Weight-for-length z-score 28
Danish: z-score for vægt-for-alder z-score for længde-foralder z-score for vægt-forlængde
English: • Anticonvulsant medicines such as phenobarbital, carbamazepine and phenytoin, used for the treatment of epileptic seizures
Danish: • antikonvulsiva, såsom phenobarbital, carbamazepin og phenytoin, der anvendes til behandling af epileptiske krampeanfald.
English: In part 1, patients were randomised 1:1 to receive either 150 mg of ivacaftor or placebo every 12 hours with fat-containing food for 8 weeks in addition to their prescribed CF therapies and crossed over to the other treatment for the second 8 weeks after a 4- to 8-week washout period.
Danish: I del 1 blev patienterne randomiseret i forholdet 1:1 til at få enten 150 mg ivacaftor eller placebo hver 12 time sammen med fedtholdig mad i 8 uger i tillæg til deres ordinerede behandlinger mod CF, og de overkrydsede til den anden behandling i andre 8 uger efter en 4- til 8-ugers udvaskningsperiode.
English: The granules are supplied in sachets.
Danish: Granulatet leveres i breve.
English: Pharmacokinetic studies have not been performed with ivacaftor in patients with renal impairment.
Danish: Der er ikke udført farmakokinetiske studier med ivacaftor hos patienter med nedsat nyrefunktion.
English: In ivacaftor-treated patients, most transaminase elevations up to 5 x ULN resolved without treatment interruption.
Danish: Hos ivacaftor-behandlede patienter vendte de fleste aminotransferase-forhøjelser på op til 5 x ULN tilbage til normalen uden behandlingsafbrydelse.
English: Avoid giving your child food or drink containing grapefruit or Seville oranges during treatment with Kalydeco as they may increase the side effects of Kalydeco by increasing the amount of ivacaftor in your child's body.
Danish: Undgå at give dit barn mad eller drikke, der indeholder grapefrugt eller Sevilla-appelsiner, i løbet af behandlingen med Kalydeco, da det kan forøge bivirkningerne ved Kalydeco ved at øge mængden af ivacaftor i dit barns krop.
English: • Antifungal medicines such as ketoconazole, itraconazole, posaconazole, voriconazole and fluconazole, used for the treatment of fungal infections
Danish: • antimykotika, såsom ketoconazol, itraconazol, posaconazol, voriconazol og fluconazol, der anvendes til behandling af svampeinfektioner.
English: Table 1: Dosing recommendations for children aged 6 months and older Weight
Danish: Tabel 1: Doseringsanbefalinger til børn i alderen 6 måneder og derover Vægt
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.
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.
English: The estimated treatment difference for ivacaftor versus placebo was 1.7 percentage points (95% CI -0.6, 4.1); this difference was not statistically significant (P = 0.15).
Danish: Den estimerede behandlingsforskel for ivacaftor versus placebo var 1,7 procentpoints (95 % CI -0,6; 4,1), denne forskel var ikke statistisk signifikant (P=0,15).
English: Contact your child's doctor straight away if he/she gets any of these.
Danish: Kontakt straks dit barns læge, hvis barnet får et eller flere af disse.
English: Ivacaftor (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) has been studied with an oestrogen/progesterone oral contraceptive and was found to have no significant effect on the exposures of the oral contraceptive.
Danish: Ivacaftor (som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor) er blevet undersøgt sammen med oral kontraception indeholdende østrogen/progesteron, og der blev ikke fundet nogen signifikant indvirkning på eksponeringen for det orale kontraceptivum.
English: The most common adverse reactions experienced by patients aged 6 years and older who received ivacaftor in the pooled 48-week placebo-controlled Phase 3 studies that occurred with an incidence of at least 3% and up to 9% higher than in the placebo arm were headache (23.9%), oropharyngeal pain (22.0%), upper respiratory tract infection (22.0%), nasal congestion (20.2%), abdominal pain (15.6%), nasopharyngitis (14.7%), diarrhoea (12.8%), dizziness (9.2%), rash (12.8%) and bacteria in sputum (12.8%).
Danish: De hyppigste bivirkninger, som patienter i alderen 6 år og derover, der fik ivacaftor, oplevede i de samlede, 48-ugers, placebokontrollerede fase 3-studier, som opstod med en forekomst på mindst 3 % og op til 9 % højere end i placeboarmen, var hovedpine (23,9 %), orofaryngeale smerter (22,0 %), infektion i de øvre luftveje (22,0 %), tilstoppet næse (20,2 %), abdominalsmerter (15,6 %), nasofaryngitis (14,7 %), diarré (12,8 %), svimmelhed (9,2 %), udslæt (12,8 %) og bakterier i spyt (12,8 %).
English: Administration of ivacaftor may increase systemic exposure of medicinal products that are sensitive substrates of CYP2C9, and/or P-gp, and/or CYP3A which may increase or prolong their therapeutic effect and adverse reactions.
Danish: Administration af ivacaftor kan forøge den systemiske eksponering af lægemidler, som er følsomme CYP2C9- og/eller P-gp- og/eller CYP3A-substrater, hvilket kan forøge eller forlænge deres terapeutiske virkning og bivirkninger.
English: No safety data are available in infants aged 6 to less than 12 months of age with moderate or severe hepatic impairment treated with ivacaftor.
Danish: Der foreligger ingen sikkerhedsdata for spædbørn i alderen fra 6 til under 12 måneder med moderat til svært nedsat leverfunktion, der behandles med ivacaftor.
English: • Breast inflammation
Danish: • brystbetændelse
English: Package leaflet: Information for the patient Kalydeco 25 mg granules in sachet
Danish: Indlægsseddel: Information til patienten Kalydeco 25 mg granulat i brev
English: Once mixed, the mixture has been shown to be stable for one hour.
Danish: 3 år Det er blevet påvist, at blandingen er stabil i en time efter opblanding.
English: In patients with a confirmed R117H-7T genetic variant, the treatment difference between ivacaftor and placebo was 0.2% (95% CI -8.1, 8.5).
Danish: Hos patienter med en bekræftet R117H-7T-variant var behandlingsforskellen mellem ivacaftor og placebo 0,2 % (95 % CI -8,1, 8,5).
English: • Ear pain, ear discomfort
Danish: • øresmerter, øreproblemer
English: Table 3: Adverse reactions in patients treated with ivacaftor monotherapy or in combination with tezacaftor System organ class
Danish: Tabel 3: Bivirkninger hos patienter behandlet med ivacaftor-monoterapi eller i kombination med tezacaftor Systemorganklasse
English: Clinical efficacy in patients with the G970R mutation of the CFTR gene could not be established (see section 5.1).
Danish: Klinisk virkning hos patienter med G970R-mutationen i CFTR-genet kunne ikke klarlægges (se pkt.
English: Table 5 shows the results of the mean (SD) absolute change in percent predicted FEV1 for both groups of patients.
Danish: Tabel 5 viser den gennemsnitlige (SD) absolutte ændring i procent af forventet FEV1 for begge patientgrupper.
English: Administration of Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) may increase systemic exposure of medicinal products that are sensitive substrates of P-gp, which may increase or prolong their therapeutic effect and adverse reactions.
Danish: Administration af Kalydeco (som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor) kan forøge den systemiske eksponering af lægemidler, som er følsomme P-gp-substrater, hvilket kan forøge eller forlænge deres terapeutiske virkning og bivirkninger.
English: Contents of the pack and other information What Kalydeco contains
Danish: Pakningsstørrelser og yderligere oplysninger Kalydeco indeholder:
English: Your child's doctor may need to adjust your child's dose.
Danish: Dit barns læge kan finde det nødvendigt at justere dit barns dosis.
English: When the mean (SD) absolute change in percent predicted FEV1 is compared from study 4 baseline for patients in the ivacaftor/ivacaftor group (n = 72) who rolled over from study 1, the mean (SD) absolute change in percent predicted FEV1 was 0.0% (9.05), while for patients in the ivacaftor/ivacaftor group (n = 25) who rolled over from study 2 this figure was 0.6% (9.1).
Danish: Når den gennemsnitlige (SD) absolute ændring i procent af forventet FEV1 fra baseline i studie 4 sammenlignes for patienter i ivacaftor/ivacaftor-gruppen (n=72), som blev overført fra studie 1, var den gennemsnitlige (SD) absolutte ændring i procent af forventet FEV1 0,0 % (9,05), mens den var 0,6 % (9,1) for patienter i ivacaftor/ivacaftor-gruppen (n=25), som blev overført fra studie 2.
English: Table 2 reflects the adverse reactions observed with ivacaftor in clinical trials (placebo-controlled and uncontrolled studies) in which the length of exposure to ivacaftor ranged from 16 weeks to 144 weeks.
Danish: Tabel 2 angiver de bivirkninger, der sås med ivacaftor i kliniske studier (placebokontrollerede og ikke kontrollerede studier), hvori længden af eksponeringen for ivacaftor var fra 16 uger til 144 uger.
English: No patients had elevations in total bilirubin or discontinued ivacaftor treatment due to transaminase elevations in either cohort.
Danish: Ingen patienter havde forhøjet total bilirubin eller seponerede behandlingen med ivacaftor på grund af aminotransferaseforhøjelser i nogen af kohorterne.
English: Dosing intervals should be modified according to clinical response and tolerability (see sections 4.4 and 5.2).
Danish: Doseringsintervallerne bør modificeres i henhold til klinisk respons og tolerabilitet (se pkt.
English: What you need to know before your child takes Kalydeco Do not take Kalydeco
Danish: Det skal du vide, før dit barn begynder at tage Kalydeco Tag ikke Kalydeco
English: The recommended dose is one tezacaftor 100 mg/ivacaftor 150 mg tablet taken in the morning and one Kalydeco 150 mg tablet taken in the evening, approximately 12 hours apart with fat-containing food (see Method of administration).
Danish: Den anbefalede dosis er én tablet med tezacaftor 100 mg/ivacaftor 150 mg, der skal tages om morgenen, og én Kalydeco 150 mg tablet, der skal tages om aftenen, med ca. 12 timers mellemrum sammen med fedtholdig mad (se Administration).
English: Other forms of this medicine (granules in sachet) are more suitable for children under 6 years of age; ask your doctor or pharmacist.
Danish: Andre former af dette lægemiddel (granulat i brev) er mere egnet til børn under 6 år.
English: c Study 1 data were pooled from CFQ-R for adults/adolescents and CFQ-R for children 12 to 13 years of age; Study 2 data were obtained from CFQ-R for children 6 to 11 years of age.
Danish: Studie 1-data var samlet fra CFQ-R for voksne/unge og CFQ-R for børn fra 12 til 13 år.
English: Other medicines and Kalydeco
Danish: Brug af anden medicin sammen med Kalydeco
English: Co-administration of ivacaftor with rifampicin, a strong CYP3A inducer, decreased ivacaftor exposure (AUC) by 89% and decreased hydroxymethyl ivacaftor (M1) to a lesser extent than ivacaftor.
Danish: Administration af ivacaftor sammen med rifampicin, en potent CYP3A-induktor, nedsatte eksponeringen for ivacaftor (AUC) med 89 % og nedsatte hydroxymethyl-ivacaftor (M1) i mindre grad end ivacaftor.
English: Silica, colloidal anhydrous Croscarmellose sodium Hypromellose acetate succinate Lactose monohydrate Magnesium stearate Mannitol
Danish: Silica, kolloid vandfri Croscarmellosenatrium Hypromelloseacetatsuccinat Lactosemonohydrat Magnesiumstearat Mannitol
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BREVE
English: • Mix the entire content of a sachet with 5 mL of age-appropriate soft food or liquid.
Danish: • Bland hele brevets indhold med 5 ml ”alderssvarende” mosede fødevarer eller væske.
English: The other ingredients are: silica, colloidal anhydrous , croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sucralose and sodium laurilsulfate (E487).
Danish: Øvrige indholdsstoffer: Silica, kolloid vandfri, croscarmellosenatrium, hypromelloseacetatsuccinat, lactosemonohydrat, magnesiumsterat, mannitol, sucralose og natriumlaurilsulfat (E487).
English: 2- to 5-year-olds (< 14 kg)
Danish: 2- til 5-årige (<14 kg)
English: Therefore, co-administration of Kalydeco with strong CYP3A inducers is not recommended (see section 4.5).
Danish: Derfor kan administration af Kalydeco sammen med potente CYP3A-induktorer ikke anbefales (se pkt.
English: Food or drink containing grapefruit or Seville oranges should be avoided during treatment with Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor, see section 4.2).
Danish: Mad eller drikke, der indeholder grapefrugt eller Sevilla-appelsiner, bør undgås under behandling med Kalydeco (som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor, se pkt.
English: If you stop taking Kalydeco
Danish: Hvis du holder op med at tage Kalydeco
English: Table 6 shows the results of the mean (SD) absolute change in percent predicted FEV1 for both groups of patients.
Danish: Tabel 6 viser den gennemsnitlige (SD) absolutte ændring i procent af forventet FEV1 for begge patientgrupper.
English: • Antibacterial agents such as telithromycin, clarithromycin, erythromycin, rifampicin and rifabutin, used for the treatment of bacterial infections
Danish: • antibakterielle midler, såsom telithromycin, clarithromycin, erythromycin, rifampicin og rifabutin, der anvendes til behandling af bakterieinfektioner.
English: Table 1: Dosing recommendations for patients aged 6 months and older Weight
Danish: Tabel 1: Doseringsanbefalinger til patienter i alderen 6 måneder og derover Vægt
English: The AUC of ivacaftor when given in combination with tezacaftor increased approximately 3-fold when given with fat containing food.
Danish: AUC for ivacaftor blev ca. tredoblet, når det blev givet i kombination med tezacaftor, og når det blev givet sammen med fedtholdig mad.
English: Table 3 reflects the adverse reactions observed with ivacaftor monotherapy in clinical trials (placebocontrolled and uncontrolled studies) in which the length of exposure to ivacaftor ranged from 16 weeks to 144 weeks.
Danish: Tabel 3 angiver de bivirkninger, der sås med ivacaftor-monoterapi i kliniske studier (placebokontrollerede og ikke kontrollerede studier), hvori længden af eksponeringen for ivacaftor var fra 16 uger til 144 uger.
English: Through week 24
Danish: Til og med uge 24
English: The duration of continuous ivacaftor treatment was 24 weeks for patients randomised to the part 1 placebo/ivacaftor treatment sequence and 16 weeks for patients randomised to part 1 ivacaftor/placebo treatment sequence.
Danish: Varigheden af kontinuerlig ivacaftor-behandling var 24 uger for patienter, der var randomiseret til placebo/ivacaftor-behandlingssekvens i del 1, og 16 uger for patienter, der var randomiseret til ivacaftor/placebo-behandlingssekvens i del 1.
English: Kalydeco contains lactose.
Danish: Kalydeco indeholder lactose.
English: Ivacaftor Mean (SD)
Danish: Ivacaftor gennemsnit (SD)
English: Secondary efficacy variables included absolute change from baseline in sweat chloride through 24 weeks of treatment, absolute change from baseline in BMI at 24 weeks of treatment, absolute change in the CFQ-R respiratory domain score through 24 weeks of treatment and time to first pulmonary exacerbation.
Danish: De sekundære virkningsvariabler omfattede absolut ændring fra baseline i sved-chlorid til og med behandlingsuge 24, absolut ændring fra baseline i BMI efter 24 ugers behandling, absolut ændring i CFQ-R-score for respirationssymptomer til og med behandlingsuge 24 og tid til første lungeforværring.
English: Kalydeco monotherapy
Danish: Kalydeco-monoterapi
English: No patients treated with tezacaftor/ivacaftor discontinued treatment for elevated transaminases.
Danish: Ingen patienter behandlet med tezacaftor/ivacaftor seponerede behandlingen på grund af forhøjede aminotransferaser.
English: In study 4, patients who completed treatment in studies 1 and 2 with placebo were switched to ivacaftor while patients on ivacaftor continued to receive it for a minimum of 96 weeks, i.e., the length of treatment with ivacaftor was at least 96 weeks for patients in the placebo/ivacaftor group and at least 144 weeks for patients in the ivacaftor/ivacaftor group.
Danish: I studie 4 blev patienter, der gennemførte behandlingen i studie 1 og 2 med placebo, skiftet til ivacaftor, mens patienterne, der fik ivacaftor, fortsatte med at få det i mindst 96 uger, dvs. behandlingsvarigheden med ivacaftor var mindst 96 uger for patienter i placebo/ivacaftor-gruppen, og mindst 144 uger for patienter i ivacaftor/ivacaftor-gruppen.
English: Kalydeco in a combination regimen with tezacaftor/ivacaftor The efficacy and safety of Kalydeco in a combination regimen with tezacaftor/ivacaftor in patients with CF was assessed in two clinical studies; a 24 week, randomized, double-blind, placebo-controlled study with 504 patients aged 12 years and older who were homozygous for the F508del mutation; and a randomized, double-blind, placebo-controlled and ivacaftor controlled, 2 period, 3 treatment, 8-week crossover study with 244 patients aged 12 years and older who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity.
Danish: Kalydeco i et kombinationsregime med tezacaftor/ivacaftor Kalydecos virkning og sikkerhed i et kombinationsregime med tezacaftor/ivacaftor hos patienter med CF blev vurderet i 2 kliniske studier; et 24-ugers, randomiseret, dobbeltblindet, placebokontrolleret studie med 504 patienter i alderen 12 år og ældre, som var homozygote for F508del-mutationen, og et randomiseret, dobbeltblindet, placebokontrolleret og ivacaftor-kontrolleret 8-ugers overkrydsningsstudie med 2 perioder og 3 behandlinger med 244 patienter i alderen 12 år og ældre, som var heterozygote for F508del-mutationen og en anden mutation forbundet med residuel CFTRaktivitet.
English: Mix the entire content of a sachet with 5 mL of age-appropriate soft food or liquid that is at or below room temperature and consume it completely.
Danish: Bland hele indholdet af et brev med 5 ml ”alderssvarende” mosede fødevarer eller 5 ml væske, der er ved eller under stuetemperatur, og indtag det hele.
English: Co-administration with digoxin, a sensitive P-gp substrate, increased digoxin exposure by 1.3-fold, consistent with weak inhibition of P-gp by ivacaftor.
Danish: Administration sammen med digoxin, et følsomt P-gp-substrat, øgede eksponeringen for digoxin 1,3 gange, i overensstemmelse med ivacaftors svage P-gp-hæmning.
English: Avoid food or drink containing grapefruit or Seville oranges during treatment with Kalydeco as they may increase the side effects of Kalydeco by increasing the amount of ivacaftor in your body.
Danish: Undgå mad og drikke, der indeholder grapefrugt eller Sevilla-appelsiner, i løbet af behandlingen med Kalydeco, da det kan forøge bivirkningerne ved Kalydeco ved at øge mængden af ivacaftor i din krop.
English: Medicinal products affecting the pharmacokinetics of ivacaftor
Danish: Lægemidler, der påvirker ivacaftors farmakokinetik
English: Table 5: Effect of ivacaftor on percent predicted FEV1 in study 4 Original study and treatment group
Danish: Tabel 5: Ivacaftors virkning på procent af forventet FEV1 i studie 4 Oprindeligt studie og behandlingsgruppe