FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on these results, a modified regimen for Kalydeco in a combination regimen with tezacaftor/ivacaftor is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Danish: Baseret på disse resultater anbefales et modificeret regime med Kalydeco i et kombinationsregime med tezacaftor/ivacaftor til patienter med moderat nedsat leverfunktion (se tabel 2 i pkt.
English: A reduction of the Kalydeco dose is recommended for co-administration with strong CYP3A inhibitors, such as ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin and clarithromycin (see sections 4.2 and 4.4).
Danish: Reduktion af Kalydeco-dosisanbefales ved administration sammen med potente CYP3A-hæmmere, såsom ketoconazol, itraconazol, posaconazol, voriconazol, telithromycin og clarithromycin (se pkt.
English: Co-administration with (oral) midazolam, a sensitive CYP3A substrate, increased midazolam exposure 1.5-fold, consistent with weak inhibition of CYP3A by ivacaftor.
Danish: Administration sammen med (oral) midazolam, et følsomt CYP3A-substrat, øger eksponeringen for midazolam 1,5 gange, i overensstemmelse med ivacaftors svage CYP3A-hæmning.
English: The pharmacokinetic profile, safety and efficacy of ivacaftor in 34 patients aged 2 to less than 6 years with CF who had a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutation in the CFTR gene were assessed in a 24-week uncontrolled study with ivacaftor (patients weighing less than 14 kg received ivacaftor 50 mg and patients weighing 14 kg or more received ivacaftor 75 mg).
Danish: Ivacaftors farmakokinetiske profil, sikkerhed og virkning hos 34 patienter i alderen 2 til under 6 år med CF, som havde en G551D-, G1244E-, G1349D-, G178R-, G551S-, S1251N-, S1255P-, S549Neller S549R-mutation i CFTR-genet, blev vurderet i et 24-ugers, ikke kontrolleret studie med ivacaftor (patienter, der vejede under 14 kg fik ivacaftor 50 mg, og patienter, der vejede 14 kg eller derover, fik ivacaftor 75 mg).
English: Each sachet contains 73.2 mg of lactose (as monohydrate) Kalydeco 75 mg granules in sachet Each sachet contains 75 mg of ivacaftor.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert brev indeholder 73,2 mg lactose (som monohydrat) Kalydeco 75 mg granulat i brev Hvert brev indeholder 75 mg ivacaftor.
English: Table 3: Effect of ivacaftor on other efficacy endpoints in studies 1 and 2
Danish: Tabel 3: Ivacaftors virkning på andre endepunkter for virkning i studie 1 og 2 Studie 1
English: Pharmacokinetic studies have not been performed with ivacaftor in patients with renal impairment, either as monotherapy or in a combination regimen with tezacaftor/ivacaftor.
Danish: Der er ikke udført farmakokinetiske studier med ivacaftor hos patienter med nedsat nyrefunktion, hverken som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor.
English: When co-administered with strong inhibitors of CYP3A, the Kalydeco dose should be reduced to 150 mg twice a week (see sections 4.4 and 4.5).
Danish: Ved administration sammen med potente CYP3A-hæmmere bør Kalydeco-dosen reduceres til 150 mg to gange ugentligt (se pkt.
English: Kalydeco 25 mg granules in sachet Kalydeco 50 mg granules in sachet Kalydeco 75 mg granules in sachet
Danish: Kalydeco 25 mg granulat i brev Kalydeco 50 mg granulat i brev Kalydeco 75 mg granulat i brev
English: In study 6 in patients aged 6 years or older with CF who had an R117H mutation in the CFTR gene, the treatment difference in mean change in sweat chloride from baseline through 24 weeks of treatment was -24 mmol/L (95% CI -28, -20).
Danish: I studie 6 hos patienter i alderen 6 år eller ældre med CF, som havde en R117H-mutation i CFTR-genet, var behandlingsforskellen i gennemsnitlig ændring i sved-chlorid fra baseline til og med uge 24 i behandlingsforløbet -24 mmol/l (95 % CI -28, -20).
English: Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor.
Danish: Tilfælde af ikke medfødte uigennemsigtigheder af linsen, der ikke påvirker synet, er blevet rapporteret hos pædiatriske patienter i behandling med ivacaftor enten som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor.
English: In all instances where dosing was interrupted for elevated transaminases and subsequently resumed, ivacaftor dosing was able to be resumed successfully (see section 4.4).
Danish: I alle de tilfælde, hvor doseringen blev afbrudt som følge af forhøjede aminotransferaser og efterfølgende genoptaget, kunne doseringen med ivacaftor genoptages med godt resultat (se pkt.
English: One tablet of ivacaftor 150 mg once daily
Danish: En tablet med ivacaftor 150 mg en gang dagligt
English: Therefore, use in transplanted patients is not recommended.
Danish: Derfor bør det ikke anvendes til patienter, der har gennemgået en transplantation.
English: In study 7 in patients aged 2 to less than 6 years with a gating mutation on at least 1 allele of the CFTR gene administered either 50 mg or 75 mg of ivacaftor twice daily, the mean absolute change from baseline in sweat chloride was -47 mmol/L (95% CI -58, -36) at week 24.
Danish: I studie 7 hos patienter i alderen 2 til under 6 år med en gating-mutation på mindst 1 allel i CFTRgenet, der enten fik administreret 50 mg eller 75 mg ivacaftor to gange dagligt, var den gennemsnitlige absolutte ændring fra baseline i sved-chlorid -47 mmol/l (95 % CI -58; -36) ved uge 24.
English: The safety and efficacy of Kalydeco in children aged less than 6 months have not been established.
Danish: Pædiatrisk population Kalydecos sikkerhed og virkning hos børn under 6 måneder er ikke klarlagt.
English: Table 4: Effect of ivacaftor on other efficacy endpoints in studies 1 and 2
Danish: Tabel 4: Ivacaftors virkning på andre endepunkter for virkning i studie 1 og 2 Studie 1
English: Granules in sachet 14 sachets
Danish: Granulat i brev 14 breve
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS - 56-TABLET PACK
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER - PAKNING MED 56 TABLETTER
English: Co-administration of Kalydeco with strong CYP3A inducers, such as rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John's wort (Hypericum perforatum), is not recommended (see section 4.4).
Danish: Administration af Kalydeco sammen med potente CYP3A-induktorer, såsom rifampicin, rifabutin, phenobarbital, carbamazepin, phenytoin og perikon (Hypericum perforatum), bør undgås (se pkt.
English: Do not break, chew or dissolve the tablets.
Danish: Tabletterne må ikke knækkes, tygges eller opløses.
English: How to store Kalydeco 6.
Danish: Sådan skal du tage Kalydeco 4.
English: No dose adjustment is recommended when Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) is used with moderate or weak CYP3A inducers.
Danish: Ingen dosisjustering er nødvendig, når Kalydeco (som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor) anvendes sammen med moderate eller svage CYP3A-induktorer.
English: In a subgroup analysis in patients 6 to 11 years of age (8 patients on placebo and 9 patients on ivacaftor), the placebo group showed an improvement in mean percent predicted FEV1 from 94.0% at baseline to 98.4% post-baseline; the ivacaftor group showed a slight decline in mean FEV1 from 97.5% at baseline to 96.2% overall post-baseline.
Danish: I en underguppeanalyse af patienter i alderen 6 til 11 år (8 patienter, der fik placebo, og 9, der fik ivacaftor) var der en forbedring i placebogruppen i gennemsnitlig procent forventet FEV1 fra 94,0 % ved baseline til 98,4 % efter baseline.
English: Starting dose: One tablet of ivacaftor 150 mg every other day.
Danish: Startdosis: En tablet med ivacaftor 150 mg hver anden dag.
English: Through week 48
Danish: Til og med uge 48
English: Co-administration of Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) with strong CYP3A inducers, such as rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John's wort (Hypericum perforatum), is not recommended (see section 4.4).
Danish: Administration af Kalydeco (som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor) sammen med potente CYP3A-induktorer, såsom rifampicin, rifabutin, phenobarbital, carbamazepin, phenytoin og perikon (Hypericum perforatum), bør undgås (se pkt.
English: Therefore, co-administration of Kalydeco (monotherapy or in combination with tezacaftor/ivacaftor) with strong CYP3A inducers is not recommended (see section 4.5).
Danish: Derfor kan administration af Kalydeco (monoterapi eller i kombinationregime med tezacaftor/ivacaftor) sammen med potente CYP3A-induktorer ikke anbefales (se pkt.
English: Study 5: study in patients with CF with non-G551D gating mutations Study 5 was a Phase 3, two-part, randomised, double-blind, placebo-controlled, crossover study (part 1) followed by a 16-week open-label extension period (part 2) to evaluate the efficacy and safety of ivacaftor in patients with CF aged 6 years and older who have a G970R or non-G551D gating mutation in the CFTR gene (G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P or G1349D).
Danish: Studie 5: studie hos patienter med CF med non-G551D gating-mutationer Studie 5 var et fase 3, todelt, randomiseret, dobbeltblindet, placebokontrolleret overkrydsningsstudie (del 1), efterfulgt af en 16-ugers åben forlængelsesperiode (del 2), til at evaluere ivacaftors virkning og sikkerhed hos CF-patienter i alderen 6 år og derover, som har en G970R eller non-G551D gatingmutation i CFTR-genet (G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P eller G1349D).
English: Use of ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor, is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks (see sections 4.2 and 5.2).
Danish: Ivacaftor, enten som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor, bør ikke anvendes til patienter med svært nedsat leverfunktion, medmindre fordelene forventes at opveje risici (se pkt.
English: Co-administration with fluconazole, a moderate inhibitor of CYP3A, increased ivacaftor exposure by 3-fold and increased M1 to a lesser extent than ivacaftor.
Danish: Administration sammen med fluconazol, en moderat CYP3A-hæmmer, øgede eksponeringen for ivacaftor 3 gange og øgede M1 i mindre grad end ivacaftor.
English: The use of Kalydeco monotherapy or in combination with tezacaftor/ivacaftor in patients with severe hepatic impairment is therefore not recommended unless the benefits outweigh the risks (see Table 2 in section 4.2 and section 4.4).
Danish: Kalydeco som monoterapi eller i kombination med tezacaftor/ivacaftor anbefales derfor ikke til patienter med svært nedsat leverfunktion, medmindre fordelene opvejer risiciene (se tabel 2 i pkt.
English: Kalydeco 150 mg tablets
Danish: Kalydeco 150 mg tabletter
English: Please refer to Kalydeco tablets Package Leaflet
Danish: Se indlægssedlen for Kalydeco tabletter
English: Through week 24 Through week 48
Danish: Til og med uge 24 Til og med uge 48
English: After oral administration of ivacaftor 150 mg every 12 hours in combination with tezacaftor 100 mg once daily in patients with CF in the fed state, the mean (± SD) for apparent volume of distribution of ivacaftor was 206 (82.9) L.
Danish: Efter oral administration af ivacaftor 150 mg hver 12. time i kombination med tezacaftor 100 mg én gang dagligt til patienter med CF efter indtagelse af mad var gennemsnittet (±SD) for det tilsyneladende fordelingsvolumen af ivacaftor 206 (82,9) l.
English: • Tablet core: cellulose microcrystalline, lactose monohydrate, hypromellose acetate succinate, croscarmellose sodium, sodium laurilsulfate (E487), silica, colloidal anhydrous, and magnesium stearate.
Danish: • Tabletkerne: cellulose, mikrokrystallinsk, lactosemonohydrat, hypromelloseacetatsuccinat, croscarmellosenatrium, natriumlaurilsulfat (E487), silica, kolloid vandfri, og magnesiumsterat.
English: A reduction of the Kalydeco dose (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) is recommended for patients taking concomitant moderate CYP3A inhibitors, such as fluconazole and erythromycin (see sections 4.2 and 4.4).
Danish: Reduktion af Kalydeco-dosis (som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor) anbefales til patienter, der samtidig behandles med moderate CYP3A-hæmmere såsom fluconazol og erythromycin (se pkt.
English: CYP3A inducers
Danish: CYP3A-induktorer
English: Ivacaftor may cause dizziness (see section 4.8) and, therefore, patients experiencing dizziness should be advised not to drive or use machines until symptoms abate.
Danish: 4.8), og patienter, der oplever svimmelhed, bør rådes til ikke at føre motorkøretøj eller betjene maskiner, før symptomerne aftager.
English: No patients discontinued ivacaftor treatment due to transaminase elevations.
Danish: Ingen patienter seponerede behandlingen med ivacaftor på grund af aminotransferaseforhøjelser.
English: The estimated treatment difference for ivacaftor versus placebo was 2.1 percentage points (95% CI -1.1, 5.4).
Danish: Den estimerede forskel i behandlingen med ivacaftor versus placebo var 2,1 procentpoint (95 % CI -1,1, 5,4).
English: When co-administered with moderate inhibitors of CYP3A, the Kalydeco dose should be reduced to 150 mg once daily (see sections 4.4 and 4.5).
Danish: Ved administration sammen med moderate CYP3A-hæmmere bør Kalydeco-dosen reduceres til 150 mg en gang dagligt (se pkt.
English: Cellulose, microcrystalline Lactose monohydrate Hypromellose acetate succinate Croscarmellose sodium Sodium laurilsulfate (E487) Silica, colloidal anhydrous Magnesium stearate
Danish: Cellulose, mikrokrystallinsk Lactosemonohydrat Hypromelloseacetatsuccinat Croscarmellosenatrium Natriumlaurilsulfat (E487) Silica, kolloid vandfri Magnesiumstearat
English: • Talk to your child's doctor if you have been told your child has kidney problems, or has previously had them.
Danish: • Kontakt dit barns læge, hvis du har fået at vide, at dit barn har nyreproblemer eller har haft det tidligere.
English: Each film-coated tablet contains 150 mg of ivacaftor.
Danish: Hver filmovertrukket tablet indeholder 150 mg ivacaftor.
English: After oral administration of ivacaftor 150 mg every 12 hours in combination with tezacaftor 100 mg once daily in patients with CF in the fed state, the mean (± SD) for apparent clearance of ivacaftor was 15.7 (6.38) L/h.
Danish: Efter oral administration af ivacaftor 150 mg hver 12. time i kombination med tezacaftor 100 mg én gang dagligt til patienter med CF efter indtagelse af mad var gennemsnittet (±SD) for den tilsyneladende clearance af ivacaftor 15,7 (6,38) l/t.
English: • Talk to your child's doctor if your child has liver problems, or has had them previously.
Danish: • Kontakt dit barns læge, hvis dit barn har leverproblemer eller har haft det tidligere.
English: Kalydeco tablets are also indicated for the treatment of adults aged 18 years and older with cystic fibrosis (CF) who have an R117H mutation in the CFTR gene (see sections 4.4 and 5.1).
Danish: Kalydeco tabletter er også indiceret til behandling af voksne i alderen 18 år og derover med cystisk fibrose (CF), som har en R117H-mutation i CFTR-genet (se pkt.
English: During the 24-week open-label Phase 3 clinical study of ivacaftor in 34 patients aged 2 to less than 6 years (study 7), the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 14.7% (5/34).
Danish: I løbet af det 24-ugers åbne kliniske fase 3-studie af ivacaftor hos 34 patienter i alderen 2 til under 6 år (studie 7) var forekomsten af patienter, der oplevede aminotransferaseforhøjelser (ALAT eller ASAT) >3 x ULN, 14,7 % (5/34).
English: Granules in sachet
Danish: Granulat i brev
English: Based on these results, a modified regimen of Kalydeco monotherapy is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Danish: Baseret på disse resultater anbefales et modificeret regime med Kalydeco-monoterapi til patienter med moderat nedsat leverfunktion (se tabel 2 i pkt.
English: Iron oxide black (E172) Propylene glycol (E1520)
Danish: Jernoxid, sort (E172) Propylenglycol (E1520) Ammoniakopløsning, koncentreret
English: If so, contact your doctor or pharmacist to ask for advice.
Danish: Hvis du gør det, skal du spørge lægen eller apotekspersonalet til råds.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS - 28-TABLET PACK
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER - PAKNING MED 28 TABLETTER
English: How to take Kalydeco
Danish: Sådan skal du tage Kalydeco
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating ivacaftor treatment, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor (see section 5.3).
Danish: Oftalmologiske undersøgelser ved start af behandlingen og som opfølgning anbefales hos pædiatriske patienter, der påbegynder behandling med ivacaftor enten som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor (se pkt.
English: During the 24-week open-label Phase 3 clinical study of ivacaftor monotherapy in 34 patients aged 2 to less than 6 years (study 7), the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 14.7% (5/34).
Danish: I løbet af det 24-ugers åbne, kliniske fase 3 studie af ivacaftor-monoterapi hos 34 patienter i alderen 2 til under 6 år (studie 7) var forekomsten af patienter, der oplevede aminotransferaseforhøjelser (ALAT eller ASAT) >3 x ULN, 14,7 % (5/34).
English: Use of ivacaftor is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks (see sections 4.2 and 5.2).
Danish: Ivacaftor bør ikke anvendes til patienter med svært nedsat leverfunktion, medmindre fordelene forventes at opveje risiciene (se pkt.
English: 6 months to less than 12 months (5 kg to < 7 kg) *
Danish: 6 måneder til under 12 måneder (5 kg til <7 kg) *
English: Caution is recommended for patients with severe renal impairment or end-stage renal disease (see section 5.2).
Danish: Der rådes til forsigtighed hos patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet (se pkt.
English: Dizziness very common
Danish: Udslæt meget almindelig
English: Food or drink containing grapefruit or Seville oranges should be avoided during treatment with Kalydeco (see section 4.2).
Danish: Mad og drikke, der indeholder grapefrugt eller Sevilla-appelsiner, bør undgås under behandlingen med Kalydeco (regimese pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER - 56-TABLET PACK
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE TIL BLISTER - PAKNING MED 56 TABLETTER
English: Starting dose: One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily.
Danish: Startdosis: En tablet med tezacaftor 100 mg/ivacaftor 150 mg en gang dagligt.
English: During the 48-week placebo-controlled studies 1 and 2 in patients aged 6 years and older, the incidence of maximum transaminase (ALT or AST) > 8, > 5 or > 3 x ULN was 3.7%, 3.7% and 8.3% in ivacaftor-treated patients and 1.0%, 1.9% and 8.7% in placebo-treated patients, respectively.
Danish: I løbet af de 48 ugers placebokontrollerede studier 1 og 2 hos patienter i alderen 6 år og derover, var forekomsten af maksimal aminotransferase (ALAT eller ASAT) >8, >5 eller >3 x øverste normal værdi (ULN) hhv. 3,7 %, 3,7 % og 8,3 % hos ivacaftor-behandlede patienter, og 1,0 %, 1,9 % og 8,7 % hos placebobehandlede patienter.
English: * Continue dosing with tezacaftor 100 mg/ivacaftor 150 mg or ivacaftor 150 mg tablets on alternate days.
Danish: * Doseringen med tezacaftor 100 mg/ivacaftor 150 mg eller ivacaftor 150 mg tabletter skal fortsætte hver anden dag.
English: 12 months to less than 24 months (≥ 14 kg to < 25 kg)
Danish: 12 måneder til under 24 måneder (≥14 kg til <25 kg)
English: Only patients with CF who had a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R gating (class III) or G970R mutation in at least one allele of the CFTR gene were included in studies 1, 2, 5 and 7 (see section 5.1).
Danish: Kun patienter med CF, som havde en G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N eller S549R gating (klasse III) eller G970R-mutation i mindst én allel på CFTR-genet, blev inkluderet i studie 1, 2, 5 og 7 (se pkt.
English: Kalydeco 75 mg granules
Danish: Kalydeco 75 mg granulat
English: Pharyngeal erythema common
Danish: Faryngealt erytem almindelig
English: The NOAEL for viability and growth in the offspring provides an exposure level approximately 3 times the systemic exposure of ivacaftor and its metabolites when administered as ivacaftor monotherapy in adult humans at the MRHD.
Danish: NOAEL for levedygtighed og vækst af afkommet giver et eksponeringsniveau ca. 3 gange den systemiske eksponering for ivacaftor og dets metabolitter, når det administreres som ivacaftormonoterapi hos voksne mennesker ved MRHD.
English: Caution is recommended when administering ivacaftor, either as monotherapy or in combination with tezacaftor, to patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.2 and 4.4).
Danish: Der rådes til forsigtighed, når ivacaftor administreres, enten som monoterapi eller i kombination med tezacaftor, til patienter med svært nedsat nyrefunktion (kreatininclearance under eller lig med 30 ml/min), eller med nyresygdom i slutstadiet (se pkt.
English: Vestibular disorder common
Danish: Vestibulær sygdom almindelig
English: 2- to 5-year-olds (≥ 14 kg to < 25 kg)
Danish: 2- til 5-årige (≥14 kg til <25 kg)
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET FOR SACHET
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN MELLEMSTE EMBALLAGE MAPPE TIL BREVE
English: Kalydeco 25 mg granules in sachet Each sachet contains 25 mg of ivacaftor.
Danish: Kalydeco 25 mg granulat i brev Hvert brev indeholder 25 mg ivacaftor.
English: Only patients with CF who had a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R gating (class III), G970R or R117H mutation in at least one allele of the CFTR gene were included in studies 1, 2, 5 and 6 (see section 5.1).
Danish: Kun patienter med CF, som havde en G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R gating-mutation (klasse III), G970R eller R117H-mutation i mindst én allel på CFTRgenet, blev inkluderet i studie 1, 2, 5 og 6 (se pkt.
English: Study 2 evaluated 52 patients who were 6 to 11 years of age at screening; mean (SD) body weight was 30.9 (8.63) kg; 42 (80.8%) patients had the F508del mutation in the second allele.
Danish: Den gennemsnitlige (SD) kropsvægt var 30,9 (8,63) kg. 42 (80,8 %) patienter havde F508del-mutationen i den anden allel.
English: Two patients with elevations of ALT or AST > 8 x ULN interrupted treatment and subsequently resumed ivacaftor successfully (see section 4.4 for management of elevated transaminases).
Danish: To patienter med forhøjelser af ALAT eller ASAT >8 x ULN afbrød behandlingen og genoptog efterfølgende ivacaftor med godt resultat (se pkt.
English: Upper respiratory tract infection very common
Danish: Infektion af de øvre luftveje meget almindelig
English: The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 in patients 12 to 17 years of age in study 1 was 11.9 percentage points (5.9, 17.9).
Danish: Behandlingsforskellen mellem ivacaftor og placebo for den gennemsnitlige absolutte ændring (95 % CI) i procent af forventet FEV1 fra baseline til og med uge 24 hos patienter fra 12 til 17 år i studie 1 var 11,9 procentpoint (5,9; 17,9).
English: The two patients with elevations of ALT or AST > 8 x ULN interrupted treatment and subsequently resumed ivacaftor successfully (see section 4.4 for management of elevated transaminases).
Danish: De to patienter med forhøjelser af ALAT eller ASAT >8 x ULN afbrød behandlingen og genoptog efterfølgende ivacaftor med godt resultat (se pkt.