natgillin/translations-raw huggingface dataset:
Kalydeco i et kombinationsregime med tezacaftor/ivacaftor Ved administration sammen med potente hæmmere af CYP3A, må aftendosen af Kalydeco ikke administreres (se pkt.
Kalydeco in a combination regimen with tezacaftor/ivacaftor When co-administered with strong inhibitors of CYP3A, the Kalydeco evening dose should not be administered (see sections 4.4 and 4.5).
Reduktion af Kalydeco-dosis anbefales til patienter, der samtidig behandles med moderate CYP3A-hæmmere, såsom fluconazol og erythromycin (se pkt.
A reduction of the Kalydeco dose is recommended for patients taking concomitant moderate CYP3A inhibitors, such as fluconazole and erythromycin (see sections 4.2 and 4.4).
Ivacaftors virkning i den samlede population i studie 5 (herunder de sekundære endepunkter absolut ændring i BMI efter 8 ugers behandling og absolut ændring i CFQ-R-score for respirationssymptomer til og med 8 ugers behandling) og ved individuel mutation (absolut ændring i sved-chlorid og i procent af forventet FEV1 ved uge 8) vises i tabel 5.
The effect of ivacaftor in the overall population of study 5 (including the secondary endpoints absolute change in BMI at 8 weeks of treatment and absolute change in the respiratory domain score of the CFQ-R through 8 weeks of treatment) and by individual mutation (absolute change in sweat chloride and in percent predicted FEV1 at week 8) is shown in Table 5.
Aktivt stof: Ivacaftor.
The active substance is ivacaftor.
Sikkerhedsdata for ivacaftor som monoterapi er evalueret for 11 patienter i alderen 6 måneder til under 12 måneder, 19 patienter i alderen 12 måneder til under 24 måneder, 34 patienter i alderen 2 til under 6 år, for 61 patienter i alderen 6 til under 12 år og for 94 patienter i alderen 12 til under 18 år.
The safety data of ivacaftor monotherapy were evaluated in 11 patients between 6 months to less than 12 months of age, 19 patients between 12 months to less than 24 months of age, 34 patients between 2 to less than 6 years of age, 61 patients between 6 to less than 12 years of age and 94 patients between 12 to less than 18 years of age.
Ivacaftor i et kombinationsregime med tezacaftor/ivacaftor Hos patienter, der er homozygote for F508del-mutationen, var behandlingsforskellen mellem ivacaftor i kombination med tezacaftor/ivacaftor og placebo i gennemsnitlig absolut ændring fra baseline i svedchlorid til og med uge 24 -10,1 mmol/l (95 % CI: -11,4; -8,8).
Ivacaftor in a combination regimen with tezacaftor/ivacaftor In patients homozygous for the F508del mutation, the treatment difference between ivacaftor in combination with tezacaftor/ivacaftor and placebo in mean absolute change from baseline in sweat chloride through week 24, was -10.1 mmol/L (95% CI: -11.4, -8.8).
Kontakt dit barns læge, før dit barn tager dette lægemiddel, hvis dit barns læge har fortalt dig, at dit barn ikke tåler visse sukkerarter.
If you have been told by your child's doctor that your child has an intolerance to some sugars, contact your child's doctor before your child takes this medicine.
Studie 8: studie med pædiatriske patienter med CF i alderen under 24 måneder Ivacaftors farmakokinetiske profil, sikkerhed og virkninge hos patienter med CF i alderen 6 måneder til under 24 måneder blev vurderet i en kohorte af patienter med gennemført behandling i et igangværende 24-ugers, åbent, klinisk fase 3-studie hos patienter i alderen under 24 måneder (studie 8).
The pharmacokinetic profile, safety, and efficacy of ivacaftor in patients with CF aged 6 months to less than 24 months were assessed in a completed cohort of patients in an on-going 24-week, open-label, Phase 3 clinical study in patients aged less than 24 months (study 8).
Ved baseline var den gennemsnitlige forventede FEV1 63,6 % (interval: 31,6 % til 98,2 %), og gennemsnitsalderen var 26 år (interval: 12 til 53 år).
At baseline, mean predicted FEV1 was 63.6% (range: 31.6% to 98.2%) and mean age was 26 years (range: 12 to 53 years).
ved uge 8
Through week 8
Det skal du vide, før dit barn begynder at tage Kalydeco 3.
What you need to know before your child takes Kalydeco 3.
Ivacaftors virkning i den samlede population i studie 5 (herunder de sekundære endepunkter absolut ændring i BMI efter 8 ugers behandling og absolut ændring i CFQ-R-score for respirationssymptomer til og med 8 ugers behandling) og ved individuel mutation (absolut ændring i sved-chlorid og i procent af forventet FEV1 ved uge 8) vises i tabel 4.
The effect of ivacaftor in the overall population of study 5 (including the secondary endpoints absolute change in BMI at 8 weeks of treatment and absolute change in the respiratory domain score of the CFQ-R through 8 weeks of treatment) and by individual mutation (absolute change in sweat chloride and in percent predicted FEV1 at week 8) is shown in Table 4.
Den estimerede forskel i behandlingen med ivacaftor versus placebo var -6,3 procentpoint (95 % CI -12,0, -0,7).
The treatment difference for ivacaftor versus placebo was -6.3 percentage points (95% CI -12.0, -0.7).
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.
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).
Reduktion af Kalydeco-dosisanbefales ved administration sammen med potente CYP3A-hæmmere, såsom ketoconazol, itraconazol, posaconazol, voriconazol, telithromycin og clarithromycin (se pkt.
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).
Administration sammen med (oral) midazolam, et følsomt CYP3A-substrat, øger eksponeringen for midazolam 1,5 gange, i overensstemmelse med ivacaftors svage CYP3A-hæmning.
Co-administration with (oral) midazolam, a sensitive CYP3A substrate, increased midazolam exposure 1.5-fold, consistent with weak inhibition of CYP3A by ivacaftor.
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).
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).
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.
Each sachet contains 73.2 mg of lactose (as monohydrate) Kalydeco 75 mg granules in sachet Each sachet contains 75 mg of ivacaftor.
Tabel 3: Ivacaftors virkning på andre endepunkter for virkning i studie 1 og 2 Studie 1
Table 3: Effect of ivacaftor on other efficacy endpoints in studies 1 and 2
Der er ikke udført farmakokinetiske studier med ivacaftor hos patienter med nedsat nyrefunktion, hverken som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor.
Pharmacokinetic studies have not been performed with ivacaftor in patients with renal impairment, either as monotherapy or in a combination regimen with tezacaftor/ivacaftor.
Ved administration sammen med potente CYP3A-hæmmere bør Kalydeco-dosen reduceres til 150 mg to gange ugentligt (se pkt.
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).
Kalydeco 25 mg granulat i brev Kalydeco 50 mg granulat i brev Kalydeco 75 mg granulat i brev
Kalydeco 25 mg granules in sachet Kalydeco 50 mg granules in sachet Kalydeco 75 mg granules in sachet
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).
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).
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.
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.
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.
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).
En tablet med ivacaftor 150 mg en gang dagligt
One tablet of ivacaftor 150 mg once daily
Derfor bør det ikke anvendes til patienter, der har gennemgået en transplantation.
Therefore, use in transplanted patients is not recommended.
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.
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.
Pædiatrisk population Kalydecos sikkerhed og virkning hos børn under 6 måneder er ikke klarlagt.
The safety and efficacy of Kalydeco in children aged less than 6 months have not been established.
Tabel 4: Ivacaftors virkning på andre endepunkter for virkning i studie 1 og 2 Studie 1
Table 4: Effect of ivacaftor on other efficacy endpoints in studies 1 and 2
Granulat i brev 14 breve
Granules in sachet 14 sachets
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER - PAKNING MED 56 TABLETTER
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS - 56-TABLET PACK
Administration af Kalydeco sammen med potente CYP3A-induktorer, såsom rifampicin, rifabutin, phenobarbital, carbamazepin, phenytoin og perikon (Hypericum perforatum), bør undgås (se pkt.
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).
Tabletterne må ikke knækkes, tygges eller opløses.
Do not break, chew or dissolve the tablets.
Sådan skal du tage Kalydeco 4.
How to store Kalydeco 6.
Ingen dosisjustering er nødvendig, når Kalydeco (som monoterapi eller i et kombinationsregime med tezacaftor/ivacaftor) anvendes sammen med moderate eller svage CYP3A-induktorer.
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.
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.
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.
Startdosis: En tablet med ivacaftor 150 mg hver anden dag.
Starting dose: One tablet of ivacaftor 150 mg every other day.
Til og med uge 48
Through week 48
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.
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).
Derfor kan administration af Kalydeco (monoterapi eller i kombinationregime med tezacaftor/ivacaftor) sammen med potente CYP3A-induktorer ikke anbefales (se pkt.
Therefore, co-administration of Kalydeco (monotherapy or in combination with tezacaftor/ivacaftor) with strong CYP3A inducers is not recommended (see section 4.5).
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).
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).
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.
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).
Administration sammen med fluconazol, en moderat CYP3A-hæmmer, øgede eksponeringen for ivacaftor 3 gange og øgede M1 i mindre grad end ivacaftor.
Co-administration with fluconazole, a moderate inhibitor of CYP3A, increased ivacaftor exposure by 3-fold and increased M1 to a lesser extent than ivacaftor.
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.
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).
Kalydeco 150 mg tabletter
Kalydeco 150 mg tablets
Se indlægssedlen for Kalydeco tabletter
Please refer to Kalydeco tablets Package Leaflet
Til og med uge 24 Til og med uge 48
Through week 24 Through week 48
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.
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.
• Tabletkerne: cellulose, mikrokrystallinsk, lactosemonohydrat, hypromelloseacetatsuccinat, croscarmellosenatrium, natriumlaurilsulfat (E487), silica, kolloid vandfri, og magnesiumsterat.
• Tablet core: cellulose microcrystalline, lactose monohydrate, hypromellose acetate succinate, croscarmellose sodium, sodium laurilsulfate (E487), silica, colloidal anhydrous, and magnesium stearate.
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.
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).
CYP3A-induktorer
CYP3A inducers
4.8), og patienter, der oplever svimmelhed, bør rådes til ikke at føre motorkøretøj eller betjene maskiner, før symptomerne aftager.
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.
Ingen patienter seponerede behandlingen med ivacaftor på grund af aminotransferaseforhøjelser.
No patients discontinued ivacaftor treatment due to transaminase elevations.
Den estimerede forskel i behandlingen med ivacaftor versus placebo var 2,1 procentpoint (95 % CI -1,1, 5,4).
The estimated treatment difference for ivacaftor versus placebo was 2.1 percentage points (95% CI -1.1, 5.4).
Ved administration sammen med moderate CYP3A-hæmmere bør Kalydeco-dosen reduceres til 150 mg en gang dagligt (se pkt.
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).
Cellulose, mikrokrystallinsk Lactosemonohydrat Hypromelloseacetatsuccinat Croscarmellosenatrium Natriumlaurilsulfat (E487) Silica, kolloid vandfri Magnesiumstearat
Cellulose, microcrystalline Lactose monohydrate Hypromellose acetate succinate Croscarmellose sodium Sodium laurilsulfate (E487) Silica, colloidal anhydrous Magnesium stearate
• Kontakt dit barns læge, hvis du har fået at vide, at dit barn har nyreproblemer eller har haft det tidligere.
• Talk to your child's doctor if you have been told your child has kidney problems, or has previously had them.
Hver filmovertrukket tablet indeholder 150 mg ivacaftor.
Each film-coated tablet contains 150 mg of ivacaftor.
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.
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.
• Kontakt dit barns læge, hvis dit barn har leverproblemer eller har haft det tidligere.
• Talk to your child's doctor if your child has liver problems, or has had them previously.
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.
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).
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).
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).
Granulat i brev
Granules in sachet
Baseret på disse resultater anbefales et modificeret regime med Kalydeco-monoterapi til patienter med moderat nedsat leverfunktion (se tabel 2 i pkt.
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).
Jernoxid, sort (E172) Propylenglycol (E1520) Ammoniakopløsning, koncentreret
Iron oxide black (E172) Propylene glycol (E1520)
Hvis du gør det, skal du spørge lægen eller apotekspersonalet til råds.
If so, contact your doctor or pharmacist to ask for advice.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER - PAKNING MED 28 TABLETTER
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS - 28-TABLET PACK
Sådan skal du tage Kalydeco
How to take Kalydeco
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.
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).
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).
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).
Ivacaftor bør ikke anvendes til patienter med svært nedsat leverfunktion, medmindre fordelene forventes at opveje risiciene (se pkt.
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).
6 måneder til under 12 måneder (5 kg til <7 kg) *
6 months to less than 12 months (5 kg to < 7 kg) *
Der rådes til forsigtighed hos patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet (se pkt.
Caution is recommended for patients with severe renal impairment or end-stage renal disease (see section 5.2).
Udslæt meget almindelig
Dizziness very common
Mad og drikke, der indeholder grapefrugt eller Sevilla-appelsiner, bør undgås under behandlingen med Kalydeco (regimese pkt.
Food or drink containing grapefruit or Seville oranges should be avoided during treatment with Kalydeco (see section 4.2).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE TIL BLISTER - PAKNING MED 56 TABLETTER
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER - 56-TABLET PACK
Startdosis: En tablet med tezacaftor 100 mg/ivacaftor 150 mg en gang dagligt.
Starting dose: One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily.
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.
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.
* Doseringen med tezacaftor 100 mg/ivacaftor 150 mg eller ivacaftor 150 mg tabletter skal fortsætte hver anden dag.
* Continue dosing with tezacaftor 100 mg/ivacaftor 150 mg or ivacaftor 150 mg tablets on alternate days.
12 måneder til under 24 måneder (≥14 kg til <25 kg)
12 months to less than 24 months (≥ 14 kg to < 25 kg)