FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common adverse reactions experienced by patients aged 12 years and older who received Symkevi in combination with ivacaftor in the pooled, placebo-controlled, Phase 3 studies were headache (14% versus 11% on placebo) and nasopharyngitis (12% versus 10% on placebo).
Danish: De mest almindelige bivirkninger, som patienter i alderen 12 år og derover oplevede, når de fik Symkevi i kombination med ivacaftor i de samlede, placebokontrollerede, fase III-studier, var hovedpine (14 % versus 11 % på placebo) og nasofaryngitis (12 % versus 10 % på placebo).
English: Symkevi in Combination with Ivacaftor N=161
Danish: Symkevi i kombination med ivacaftor N=161
English: No dose adjustment of CYP3A substrates is required when co-administered with Symkevi in combination with ivacaftor.
Danish: En dosisjustering af CYP3A-substrater er ikke nødvendig ved administration sammen med Symkevi i kombination med ivacaftor.
English: Ear pain, Ear discomfort, Tinnitus, Tympanic membrane hyperaemia, Vestibular disorder common
Danish: Øresmerter, øregener, tinnitus, hyperæmi i trommehinden, vestibulær sygdom almindelig
English: There were 23 patients with ppFEV1 <40 at baseline receiving Symkevi and 24 patients receiving placebo in Study 1.
Danish: Der var 23 patienter med ppFEV1<40 ved baseline, der fik Symkevi, og 24 patienter, der fik placebo, i studie 1.
English: Pulmonary exacerbations requiring hospitalizations were similar between treatment groups (RR: 0.78 [95% CI: 0.44, 1.36]; P=0.3801).
Danish: Lungeforværringer, der krævede indlæggelse, var sammenlignelige mellem behandlingsgrupperne (RR: 0,78 [95 % CI: 0,44; 1,36], P= 0,3801).
English: In a combination regimen with ivacaftor 150 mg tablets The recommended dose is one Symkevi (tezacaftor 100 mg/ivacaftor 150 mg) tablet taken in the morning and one ivacaftor 150 mg tablet taken in the evening, approximately 12 hours apart with fat-containing food (see Method of administration).
Danish: I et kombinationsprogram med ivacaftor 150 mg tabletter Den anbefalede dosis er én Symkevi (tezacaftor 100 mg/ivacaftor 150 mg) tablet, der skal tages om morgenen, og én tablet med 150 mg ivacaftor, der skal tages om aftenen, med ca. 12 timers mellemrum, sammen med fedtholdig mad (se Administration).
English: Pulmonary exacerbations
Danish: Lungeeksacerbationer
English: No dose adjustment is considered necessary for patients with mild hepatic impairment.
Danish: Ingen dosisjustering anses for nødvendig hos patienter med let nedsat leverfunktion.
English: Patients who were previously treated with placebo and received Symkevi in combination with ivacaftor in Study 3 showed an increase of 5.3 (0.7) percentage points.
Danish: Patienter, der tidligere blev behandlet med placebo og fik Symkevi i kombination med ivacaftor i studie 3 viste en stigning på 5,3 (0,7) procentpoints.
English: The No Observed Adverse Effect Level (NOAEL) for fertility findings provides an exposure level of approximately 5 times the systemic exposure of ivacaftor and its metabolites when administered as tezacaftor/ivacaftor in adult humans at the maximum recommended human dose (MRHD).
Danish: Niveaet for ingen observerede bivirkninger (no observed adverse effect level, NOAEL) for fertilitetsfund giver et eksponeringsniveau på ca. 5 gange den systemiske eksponering for ivacaftor og metabolitter heraf, når det administreres som tezacaftor/ivacaftor hos voksne mennesker ved den maksimalt anbefalede humane dosis (maximum recommended human dose, MRHD).
English: Table 4 reflects adverse reactions observed in clinical studies in patients treated with ivacaftor monotherapy.
Danish: Tabel 4 viser bivirkninger observeret i kliniske studier hos patienter behandlet med ivacaftor-monoterapi.
English: The NOAEL for viability and growth in the offspring provides an exposure level of approximately 4 times the systemic exposure of ivacaftor and its metabolites when administered as tezacaftor/ivacaftor in adult humans at the MRHD.
Danish: NOAEL for levedygtighed og vækst af afkommet giver et eksponeringsniveau på ca. 4 gange den systemiske eksponering for ivacaftor og metabolitter heraf, når det administreres som tezacaftor/ivacaftor hos mennesker ved MRHD.
English: Increased liver enzymes in the blood have been seen in patients with CF receiving Symkevi.
Danish: Forhøjede leverenzymer i blodet er blevet observeret hos patienter med CF, der fik Symkevi.
English: CFQ-R respiratory domain score
Danish: CFQ-R-score i respiratorisk domæne
English: In vitro and in vivo data indicate that ivacaftor is metabolized primarily by CYP3A4 and CYP3A5.
Danish: In vitro- og in vivo-data indikerer, at ivacaftor primært metaboliseres af CYP3A4 og CYP3A5.
English: Each film-coated tablet contains 100 mg of tezacaftor and 150 mg of ivacaftor.
Danish: Hver filmovertrukket tablet indeholder 100 mg tezacaftor og 150 mg ivacaftor.
English: Medicinal products affecting the pharmacokinetics of tezacaftor and ivacaftor CYP3A inducers
Danish: Lægemidler, der påvirker tezacaftors og ivacaftors farmakokinetik CYP3A-induktorer
English: A total of 244 patients aged 12 years and older (mean age 34.8 years) who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity were randomized to and received sequences of treatment that included Symkevi in combination with ivacaftor, ivacaftor, and placebo.
Danish: I alt 244 patienter i alderen 12 år og ældre (gennemsnitsalder 34,8 år), som var heterozygote for F508del-mutationen, og en anden mutation forbundet med resterende CFTR-aktivitet, blev randomiseret til og fik behandlingssekvenser, der inkluderede Symkevi i kombination med ivacaftor, ivacaftor og placebo.
English: In Study 2 treatment with Symkevi in combination with ivacaftor resulted in a statistically significant improvement in ppFEV1 (Table 6).
Danish: I studie 2 førte behandlingen med Symkevi i kombination med ivacaftor til en statistisk signifikant forbedring i ppFEV1 (tabel 6).
English: No dose adjustment of OATP1B1 substrates is required when coadministered with Symkevi.
Danish: Det er ikke nødvendigt at justere dosis af OATP1B1-substrater ved administration sammen med Symkevi.
English: Available pharmacokinetic/toxicological data in animals have shown excretion of tezacaftor and ivacaftor into the milk of lactating female rats (see section 5.3).
Danish: Tilgængelige farmakokinetiske/toksikologiske data fra dyrestudier viser, at både tezacaftor og ivacaftor udskilles i mælken hos diegivende hunrotter (se pkt.
English: In Study 1 treatment with Symkevi in combination with ivacaftor resulted in a statistically significant improvement in ppFEV1 (Table 5).
Danish: I studie 1 førte behandlingen med Symkevi i kombination med ivacaftor til en statistisk signifikant forbedring i ppFEV1 (tabel 5).
English: • In the evening, take one ivacaftor 150 mg tablet.
Danish: • Tag en ivacaftor 150 mg tablet om aftenen.
English: Elevated transaminases are common in patients with CF, and have been observed in some patients treated with Symkevi in combination with ivacaftor, as well as with ivacaftor monotherapy.
Danish: Forhøjede transaminaser er almindeligt hos patienter med CF, og det er blevet observeret hos nogle patienter i behandling med Symkevi i kombination med ivacaftor samt med ivacaftor-monoterapi.
English: M1-TEZ has similar potency to that of tezacaftor and is considered pharmacologically active.
Danish: M1-TEZ har en styrke, som er sammenlignelig med tezacaftor, og anses for at være farmakologisk aktiv.
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating treatment with Symkevi in combination with ivacaftor (see section 5.3).
Danish: Baseline og opfølgende oftalmologiske undersøgelser anbefales hos pædiatriske patienter, der påbegynder behandling med Symkevi i kombination med ivacaftor (se pkt.
English: Other fat-containing foods are:
Danish: Anden fedtholdig mad er:
English: Gender The pharmacokinetic parameters of tezacaftor and ivacaftor are similar in males and females.
Danish: Køn De farmakokinetiske parametre for tezacaftor og ivacaftor er sammenlignelige for mænd og kvinder.
English: sex, age group (<18, >=18 years) at screening, baseline value, and baseline value-by-visit interaction as fixed effect.
Danish: **Blandet virkningsmodel for gentagne målinger med behandling, besøg, behandling pr. besøginteraktion, køn, aldersgruppe (<18; >=18 år) ved screening, baseline-værdi, og baseline-værdi pr. besøg-interaktion som en fikseret virkning.
English: In population pharmacokinetic analysis, data from 147 patients on tezacaftor or tezacaftor in combination with ivacaftor in Phase 2/3 clinical studies indicated that mild renal impairment (estimated glomerular filtration rate, estimated by the modification of diet in renal disease method, 60 to ≤89 mL/min/1.73 m2) did not affect the clearance of tezacaftor significantly.
Danish: I en populationsfarmakokinetisk analyse indikerede data fra 147 patienter for tezacaftor eller tezacaftor i kombination med ivacaftor i fase II/III kliniske studier, at let nedsat nyrefunktion (estimeret glomerulær filtrationshastighed, estimeret ved metoden med kostmodifikation under nyresygdom, 60 til ≤89 ml/min/1,73 m2) ikke påvirkede clearance af tezacaftor i signifikant grad. Ingen dosisjustering anbefales for let til moderat nedsat nyrefunktion.
English: Take both Symkevi and ivacaftor tablets with food that contains fat.
Danish: Tag både Symkevi- og ivacaftortabletterne sammen med fedtholdig mad.
English: Upper respiratory tract infection, Nasopharyngitis very common
Danish: Infektion i de øvre luftveje, nasofaryngitis meget almindelig
English: CFQ-R respiratory domain score Baseline value
Danish: CFQ-R-score i respiratorisk domæne Baseline-værdi
English: BMI Baseline value
Danish: BMI Baseline-værdi
English: A total of 504 patients aged 12 years and older (mean age 26.3 years) who were homozygous for the F508del mutation in the CFTR gene were randomized (1:1 randomization: 248 Symkevi in combination with ivacaftor, 256 placebo).
Danish: I alt 504 patienter i alderen 12 år og ældre (gennemsnitsalder 26,3 år), som var homozygote for F508del-mutationen i CFTR-genet, blev randomiseret (1:1 randomisering: 248 Symkevi i kombination med ivacaftor, 256 placebo).
English: The mean treatment difference between ivacaftor and placebo-treated patients was 4.4 percentage points (95% CI: 0.9,
Danish: Den gennemsnitlige behandlingsforskel mellem ivacaftor- og placebobehandlede patienter var 4,4 procentpoint (95 % CI:
English: Exposure to tezacaftor and ivacaftor may be reduced by the concomitant use of CYP3A inducers, potentially resulting in reduced efficacy of Symkevi and ivacaftor.
Danish: Eksponering for tezacaftor og ivacaftor kan være nedsat under samtidig anvendelse af CYP3Ainduktorer, hvilket potentielt kan føre til en nedsat virkning af Symkevi og ivacaftor.
English: Symkevi in combination with 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: Symkevi i kombination med ivacaftor bør 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: Absolute change from baseline at Week 24 (kg/m2)**
Danish: Absolut ændring i BMI fra baseline til uge 24 (kg/m2)**
English: Patients who were previously treated with ivacaftor and placebo and received Symkevi in combination with ivacaftor in Study 3 showed an increase of 1.6 (1.6) percentage points and 7.2 (1.2) percentage points, respectively.
Danish: Patienter, der tidligere blev behandlet med ivacaftor og placebo og fik Symkevi i kombination med ivacaftor i studie 3 viste en stigning på hhv. 1,6 (1,6) procentpoints og 7,2 (1,2) procentpoints.
English: 28 film-coated tablets
Danish: 28 tabletter
English: During the placebo-controlled Phase 3 studies (up to 24 weeks), the incidence of maximum transaminase (ALT or AST) >8, >5, or >3 x ULN were similar between Symkevi in combination with ivacaftor- and placebo-treated patients; 0.2%, 1.0%, and 3.4% in Symkevi in combination with ivacaftor-treated patients, and 0.4%, 1.0%, and 3.4% in placebo-treated patients.
Danish: I løbet af de placebokontrollerede fase III-studier (op til 24 uger) var forekomsten af maksimale transaminaseniveauer (ALAT eller ASAT) >8, >5 eller >3 x ULN sammenlignelig mellem Symkevi i kombination med ivacaftor- og placebo-behandlede patienter: 0,2 %, 1,0 % og 3,4 % hos patienter behandlet med Symkevi i kombination med ivacaftor og 0,4 %, 1,0 % og 3,4 % hos patienter behandlet med placebo.
English: Caution is recommended when administering Symkevi in combination with ivacaftor to patients with severe renal impairment or end-stage renal disease.
Danish: Der rådes til forsigtighed, når Symkevi administreres i kombination med ivacaftor til patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet.
English: The treatment difference between ivacaftor alone- and placebo-treated patients was 4.7 percentage points (95% CI: 3.7, 5.8; P<0.0001) and 2.1 percentage points (95% CI: 1.2, 2.9) between Symkevi in combination with ivacaftor- and ivacaftor alone-treated patients.
Danish: Behandlingsforskellen mellem ivacaftor alene og placebobehandlede patienter var 4,7 procentpoint (95 % CI: 3,7; 5,8, P<0,0001) og 2,1 procentpoint (95 % CI: 1,2; 2,9) mellem patienter behandlet med Symkevi i kombination med ivacaftor og ivacaftor alene.
English: There were 16 patients with ppFEV1 <40 at baseline receiving Symkevi, 13 receiving ivacaftor and 15 receiving placebo in Study 2.
Danish: Der var 16 patienter med ppFEV1<40 ved baseline, der fik Symkevi, 13 fik ivacaftor, og 15 fik placebo, i studie 2.
English: Table 3: Adverse reactions in patients treated with Symkevi in combination with ivacaftor MedDRA System Organ Class
Danish: Tabel 3: Bivirkninger hos patienter behandlet med Symkevi i kombination med ivacaftor MedDRA-systemorganklasse
English: ppFEV1: percent predicted forced expiratory volume in 1 second; SD: Standard Deviation; LS mean: least squares mean; CI: confidence interval; NA: not applicable; IVA: ivacaftor; CFQ-R: Cystic Fibrosis Questionnaire-Revised.
Danish: Ikke relevant ppFEV1: procent forventet forceret eksspiratorisk volumen i løbet af 1 sekund, IVA: ivacaftor, SD: standarddeviation, LS-gennemsnit: mindste kvadraters (least squares) gennemsnit, CI: konfidensinterval, IVA: ivacaftor, CFQ-R: Cystic Fibrosis Questionnaire-Revised.
English: • Herbal medicines.
Danish: • Naturlægemidler.
English: When co-administered with moderate CYP3A inhibitors (e.g., fluconazole, erythromycin), the dose should be adjusted according to Table 1 (see sections 4.4 and 4.5).
Danish: Ved administration sammen med moderate CYP3A-hæmmere (f.eks. fluconazol, erythromycin) skal dosis justeres i henhold til tabel 1 (se pkt.
English: Contents of the pack and other information What Symkevi contains
Danish: Pakningsstørrelser og yderligere oplysninger Symkevi indeholder:
English: The use of Symkevi in patients with severe hepatic impairment is therefore not recommended unless the benefits outweigh the risks (see Table 2 in section 4.2).
Danish: Symkevi bør derfor ikke anvendes til patienter med svært nedsat leverfunktion, medmindre fordelene opvejer risiciene (se tabel 2, pkt.
English: After steady-state dosing of tezacaftor in combination with ivacaftor in CF patients, the mean (SD) terminal half-lives of tezacaftor and ivacaftor were approximately 156 (52.7) and 9.3 (1.7) hours, respectively.
Danish: Efter steady-state-dosering af tezacaftor i kombination med ivacaftor hos CF-patienter var de gennemsnitlige (SD) terminale halveringstider for tezacaftor og ivacaftor hhv. ca. 156 (52,7) og 9,3 (1,7) timer.
English: Patients who received placebo in both Study 1 and Study 2 demonstrated improvements in ppFEV1 when treated with Symkevi in combination with ivacaftor in Study 3 [Study 1: within-group change=4.2 (0.5) percentage points, Study 2: within-group change=4.9 (0.6) percentage points].
Danish: Patienter, der fik placebo i både studie 1 og studie 2 viste forbedringer i ppFEV1, efter de blev behandlet med Symkevi i kombination med ivacaftor i studie 3 [studie 1: ændring inden for gruppen = 4,2 (0,5) procentpoint, studie 2: ændring inden for gruppen = 4,9 (0,6) procentpoint].
English: No ivacaftor 150 mg dose
Danish: Ingen ivacaftor 150 mg dosis
English: The rate ratio versus placebo was 0.53 (95% CI: 0.34, 0.82; nominal P= 0.0042).
Danish: Hyppighedsratio (rate ratio, RR) versus placebo var 0,53 (95 % CI: 0,34; 0,82, nominel P=0,0042).
English: Mean (SD) tezacaftor and ivacaftor exposure by age group Age group
Danish: Gennemsnitlig (SD) tezacaftor- og ivacaftoreksponering pr. aldersgruppe Aldersgruppe
English: The safety and efficacy of Symkevi in children aged less than 12 years has not yet been established.
Danish: Symkevis sikkerhed og virkning hos børn i alderen under 12 år er endnu ikke klarlagt.
English: Evening No dose adjustment No ivacaftor 150 mg dose
Danish: Aften Ingen dosisjustering Ingen ivacaftor 150 mg dosis
English: Adolescent patients with CF who were heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity
Danish: Unge patienterne med CF, som var heterozygote for F508del-mutationen og en anden mutation forbundet med residuel CFTR-aktivitet
English: Therefore, co-administration with strong CYP3A inducers is not recommended (see section 4.5).
Danish: Derfor bør administration sammen med potente CYP3A-induktorer ikke anvendes (se pkt.
English: The mean absolute change (SE) from baseline in ppFEV1 was 11.7 (1.2) percentage points in the Symkevi in combination with ivacaftor group, 7.6 (1.2) percentage points in the ivacaftor group and -0.4 (1.2) percentage points in the placebo group in Study 2.
Danish: Den gennemsnitlige absolutte ændring (SE) fra baseline i ppFEV1 var 11,7 (1,2) procentpoints i gruppen med Symkevi i kombination med ivacaftor, og 7,6 (1,2) procentpoints i ivacaftorgruppen og -0,4 (1,2) procentpoints i placebogruppen i studie 2.
English: The mean absolute change (SE) from baseline in BMI z-value was 0.24 (0.07) kg/m2 in the Symkevi in combination with ivacaftor group, 0.20 (0.07) kg/m2 in the ivacaftor group and 0.04 (0.07) kg/m2 in the placebo group in Study 2.
Danish: Den gennemsnitlige absolutte ændring (SE) fra baseline i BMI z-værdi var 0,24 (0,07) kg/m2 i gruppen med Symkevi i kombination med ivacaftor, 0,20 (0,07) kg/m2 i ivacaftorgruppen og 0,04 (0,07) kg/m2 i placebogruppen i studie 2.
English: Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with Symkevi in combination with ivacaftor, as well as with ivacaftor monotherapy.
Danish: Der er blevet rapporteret tilfælde af ikke medfødte linseuklarheder uden påvirkning af synet hos pædiatriske patienter behandlet med Symkevi i kombination med ivacaftor samt i monoterapi med ivacaftor.
English: Tezacaftor Mean (SD)
Danish: Tezacaftor gennemsnitlig (SD)
English: • Redness inside the ear
Danish: • rødme inden i øret
English: After oral administration of tezacaftor 100 mg once daily in combination with ivacaftor 150 mg every 12 hours in patients with CF in the fed state, the mean (±SD) for apparent clearance values of tezacaftor and ivacaftor were 1.31 (0.41) and 15.7 (6.38) L/h, respectively.
Danish: Efter oral administration af tezacaftor 100 mg en gang dagligt i kombination med ivacaftor 150 mg hver 12. time til patienter med CF i den ikke-fastende tilstand var gennemsnittet (±SD) for de tilsyneladende udskillelsesværdier for tezacaftor og ivacaftor hhv. 1,31 (0,41) og 15,7 (6,38) l/t.
English: Study in patients with CF who were homozygous for the F508del mutation in the CFTR gene (Study 1)
Danish: Studie hos patienter med CF, som var homozygote med hensyn til F508del-mutationen i CFTRgenet (studie 1)
English: • Changes in the type of bacteria in mucus
Danish: • ændrede bakterietyper i dit slim
English: Tezacaftor exposures can also be expected to decrease significantly during co-administration with strong CYP3A inducers; therefore, co-administration with strong CYP3A inducers is not recommended.
Danish: Tezacaftor-eksponeringer kan også forventes at falde signifikant under administration sammen med potente CYP3A-induktorer.
English: Ivacaftor Mean (SD)
Danish: Ivacaftor gennemsnitlig (SD)
English: • Your doctor will do some blood tests to check your liver before and during treatment with
Danish: • Lægen vil tage nogle blodprøver for at kontrollere din lever før og under behandlingen med Symkevi, især hvis dine blodprøver tidligere har vist høje leverenzymer.
English: Table 4: Adverse reactions in patients treated with ivacaftor monotherapy MedDRA System Organ Class
Danish: Tabel 4: Bivirkninger hos patienter behandlet med ivacaftor-monoterapi MedDRA-systemorganklasse
English: ppFEV1 Baseline value
Danish: ppFEV1 Baseline-værdi
English: The use of Symkevi 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: Symkevi anbefales ikke til patienter med svært nedsat leverfunktion, medmindre fordelene forventes at opveje risiciene (se pkt.
English: Tezacaftor 100 mg once daily/ivacaftor 150 mg every 12 hours
Danish: Tezacaftor 100 mg en gang dagligt/ivacaftor 150 mg hver 12. time
English: The evening dose of ivacaftor should not be taken (see sections 4.4 and 4.5).
Danish: Der bør ikke tages en aftendosis af ivacaftor (se pkt.
English: Patients who received Symkevi in combination with ivacaftor in Study 1 and Study 2, and continued on treatment, showed sustained improvements in ppFEV1 through 48 weeks (Week 24 Study 3) and through 24 weeks (Week 16 Study 3), respectively.
Danish: Patienter, der fik Symkevi i kombination med ivacaftor i studie 1 og studie 2 og fortsatte med behandlingen viste vedvarende forbedringer i ppFEV1 til og med hhv. 48 uger (uge 24 studie 3) og til og med 24 uger (uge 16 studie 3).
English: In Study 2 (patients heterozygous for the F508del mutation and a second mutation associated with residual CFTR activity), the treatment difference in mean absolute change from baseline in sweat chloride through Week 8 was -9.5 mmol/L (95% CI: -11.7, -7.3; nominal P<0.0001*) between Symkevi in combination with ivacaftor and placebo, and -4.5 mmol/L (95% CI: -6.7, -2.3; nominal P<0.0001*) between ivacaftor and placebo.
Danish: I studie 2 (patienter, der var heterozygote for F508del-mutationen og en anden mutation forbundet med resterende CFTR-aktivitet) var behandlingsforskellen i gennemsnitlig absolut ændring fra baseline i svedchlorid til og med uge 8, -9,5 mmol/l (95 % CI: -11,7; -7,3, nominel P<0,0001*) mellem Symkevi i kombination med ivacaftor og placebo og -4,5 mmol/l (95 % CI: -6,7; -2,3, nominel P<0,0001*) mellem ivacaftor og placebo.
English: • Ringing in the ears
Danish: • propper i ørerne
English: − Tablet core: Hypromellose acetate succinate, sodium laurilsulfate (E487), hypromellose (E464), microcrystalline cellulose (E460(i)), croscarmellose sodium (E468), and magnesium stearate (E470b).
Danish: − Tabletkerne: Hypromelloseacetatsuccinat, natriumlaurilsulfat (E487), hypromellose (E464), mikrokrystallinsk cellulose (E460(i)), croscarmellosenatrium (E468) og magnesiumstearat (E470b).
English: NA 2.1 (1.2, 2.9)
Danish: 4.2 og 5.2).
English: Ivacaftor 150 mg tablet *Continue dosing with tezacaftor 100 mg/ivacaftor 150 mg or ivacaftor 150 mg tablets on alternate days.
Danish: Ivacaftor 150 mg tablet *Doseringen med tezacaftor 100 mg/ivacaftor 150 mg eller ivacaftor 150 mg tabletter skal fortsættes skiftevis hver anden dag.
English: Findings of cataracts were observed in juvenile rats dosed from postnatal Day 7 through 35 at ivacaftor exposure levels of 0.25 times the MRHD based on systemic exposure of ivacaftor and its metabolites when administered as tezacaftor/ivacaftor.
Danish: Der blev observeret fund af katarakt hos unge rotter doseret ved eksponeringsniveauer for ivacaftor på 0,25 gange den maksimale anbefalede humane dosis (MRHD) baseret på systemisk eksponering af ivacaftor og metabolitter heraf ved administration som tezacaftor/ivacaftor).