FrancophonIA/ELRC3.0 huggingface dataset:
English: If a child experiences dizziness while taking Orkambi, it is advised that the child does not ride a bike or do anything else that needs their full attention, until their symptoms disappear.
Danish: Hvis et barn oplever svimmelhed, mens han/hun tager Orkambi, frarådes det, at barnet cykler eller gør andre ting, der kræver fuld opmærksomhed, indtil symptomerne forsvinder.
English: No meaningful changes in QTc interval or blood pressure were observed in a thorough QT clinical study evaluating either lumacaftor 600 mg once daily/ivacaftor 250 mg q12h or lumacaftor 1000 mg once daily/ivacaftor 450 mg q12h, demonstrating a lack of translation of these non-clinical findings to the clinic.
Danish: Ingen betydningsfulde ændringer i QTc-intervallet eller blodtrykket blev observeret i et grundigt klinisk studie af QT, der evaluerede enten lumacaftor 600 mg en gang dagligt/ivacaftor 250 mg hver 12. time eller lumacaftor 1000 mg en gang dagligt/ivacaftor 450 mg hver 12. time, hvilket viser en manglende overførsel af disse prækliniske fund til klinikken.
English: During the 24-week, placebo-controlled, Phase 3 studies, a maximum decrease in mean heart rate of 6 beats per minute (bpm) from baseline was observed on Day 1 and Day 15 around 4 to 6 hours after dosing.
Danish: I løbet af de 24-ugers, placebokontrollerede fase III-studier blev der observeret en maksimal reduktion i den gennemsnitlige puls på 6 slag pr. minut (bpm) fra baseline på dag 1 og dag 15 ca. 4 til 6 timer efter dosering.
English: The exposure of ivacaftor when given in combination with lumacaftor increased approximately 3-fold when given with fat-containing food in healthy volunteers.
Danish: Eksponeringen for ivacaftor, når det blev givet i kombination med lumacaftor, blev ca. forøget 3 gange, når det blev givet sammen med fedtholdig mad til raske frivillige.
English: The exposure of lumacaftor increased approximately 2.0-fold when given with fat-containing food relative to fasted conditions.
Danish: Eksponeringen for lumacaftor var ca. 2,0 gange forhøjet, når det blev givet sammen med fedtholdig mad, sammenlignet med fastende tilstande.
English: Increased blood pressure
Danish: Forhøjet blodtryk
English: • Moderate liver problems: the dose may be reduced to two tablets in the morning and one tablet in the evening.
Danish: • Moderate leverproblemer: dosis kan reduceres til to tabletter om morgenen og en tablet om aftenen
English: Seven patients who received lumacaftor/ivacaftor had liver-related serious adverse events with elevated transaminases, including 3 with concurrent elevation in total bilirubin.
Danish: Syv patienter, der fik lumacaftor/ivacaftor, havde leverrelaterede alvorlige uønskede hændelser med forhøjede transaminaser, herunder 3 med samtidigt forhøjet totalt bilirubin.
English: Hormonal contraceptives: ethinyl estradiol, norethindrone, and other progestogens
Danish: Hormonel kontraception: ethinyløstradiol, norethindron og andre progestogener
English: Clinical comment
Danish: Klinisk kommentar
English: • Anti-allergic medicines (used for the treatment of allergies and/or asthma) for example: montelukast, fexofenadine
Danish: • Antiallergika (anvendes til behandling af allergier og/eller astma), f.eks.: montelukast, fexofenadin
English: Examples of meals or snacks that contain fat are those prepared with butter or oils or those containing eggs.
Danish: Eksempler på fedtholdige måltider eller snacks er måltider eller snacks, der laves med smør eller olie eller indeholder æg.
English: Absolute change from baseline in weight (kg)
Danish: Absolut ændring fra baseline i vægt (kg)
English: Always give your child this medicine exactly as your child's doctor has told you.
Danish: Giv altid dit barn lægemidlet nøjagtigt efter dit barns læges anvisning.
English: • Anti-inflammatory medicines (used for the treatment of inflammation) for example: ibuprofen
Danish: • Antiinflammatoriske lægemidler (anvendes til behandling af betændelse), f.eks.: ibuprofen
English: Additionally, a clinical study with ivacaftor monotherapy showed that ivacaftor is a weak inhibitor of P-gp.
Danish: Desuden viste et klinisk studie med ivacaftor som monoterapi, at det er en svag hæmmer af P-gp.
English: ** For patients rolled over from Trials 1 and 2 (placebo-to-lumacaftor/ivacaftor group) total exposure was up to 96 weeks.
Danish: ** For patienter, der overgik fra studie 1 og 2 (gruppen med placebo til lumacaftor/ivacaftor), var den totale eksponering op til 96 uger.
English: Trial 7 was a 24-week, placebo-controlled, Phase 3 clinical study in 204 patients with CF aged 6 to 11 years old (mean age 8.8 years).
Danish: Studie 7 var et 24-ugers, placebokontrolleret, fase III klinisk studie hos 204 patienter med CF i alderen 6 til 11 år (gennemsnitlig alder 8,8 år).
English: Lumacaftor and ivacaftor work together to improve the function of the abnormal CFTR protein.
Danish: Lumacaftor og ivacaftor arbejder sammen for at forbedre funktionen af det unormale CFTR-protein.
English: Following multiple doses of lumacaftor/ivacaftor for 10 days, subjects with moderately impaired hepatic function (Child-Pugh Class B, score 7 to 9) had higher exposures (AUC0-12hr by approximately 50% and Cmax by approximately 30%) compared with healthy subjects matched for demographics.
Danish: Efter flere doser af lumacaftor/ivacaftor i 10 dage havde personer med moderat nedsat leverfunktion (Child-Pugh klasse B, score 7 til 9) højere eksponeringer (AUC0-12t med 50 % og Cmax med ca. 30 %), sammenlignet med raske personer med demografisk match.
English: If your child has poor lung function your child's doctor may monitor your child more closely when she/he starts Orkambi.
Danish: Hvis dit barn har en dårlig lungefunktion, kan dit barns læge overvåge dit barn nøjere, når hun/han begynder med Orkambi.
English: Three patients discontinued lumacaftor/ivacaftor treatment permanently due to transaminase elevations.
Danish: 3 patienter fik seponeret behandlingen med lumacaftor/ivacaftor permanent på grund af transaminaseforhøjelser.
English: • Benzodiazepines (used for the treatment of anxiety or sleeplessness [insomnia], agitation, etc.) for example: midazolam, triazolam
Danish: • Benzodiazepiner (anvendes til behandling af angst, søvnløshed, ophidselse osv.), f.eks.: midazolam, triazolam
English: Your child's doctor will do some blood tests to check your child's liver before and while she/he is taking Orkambi, particularly during the first year.
Danish: Dit barns læge vil tage nogle blodprøver for at kontrollere dit barns lever, før og mens hun/han tager Orkambi, især i løbet af det første år.
English: The international normalised ratio (INR) should be monitored when warfarin co-administration with lumacaftor/ivacaftor is required.
Danish: Den internationale normaliserede ratio (INR) bør overvåges, når det er nødvendigt at administrere warfarin sammen med lumacaftor/ivacaftor.
English: (μg/mL*h)
Danish: AUCss (μg/ml*t)
English: Due to the induction effect of lumacaftor on CYP3A, at steady-state, the net exposure of ivacaftor when co-administered with a CYP3A inhibitor is not expected to exceed that when given in the absence of lumacaftor at a dose of 150 mg every 12 hours, the approved dose of ivacaftor monotherapy.
Danish: På grund af lumacaftors induktionsvirkning på CYP3A ved steady-state forventes nettoeksponeringen for ivacaftor ved administration sammen med en CYP3A-hæmmer ikke at overskride eksponeringen ved administration uden lumacaftor ved en dosis på 150 mg hver 12. time, den godkendte dosis for monoterapi med ivacaftor.
English: Your child's doctor may perform some eye examinations prior to and during treatment with Orkambi.
Danish: Dit barns læge kan udføre nogle øjenundersøgelser før og under behandlingen med Orkambi.
English: Lumacaftor/ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Danish: Lumacaftor/ivacaftor er ikke blevet undersøgt hos patienter med CF, som har gennemgået organtransplantation.
English: • Immunosuppressants (used after an organ transplantation) for example: ciclosporin, everolimus, sirolimus, tacrolimus
Danish: • Immunosuppressive midler (anvendes efter en organtransplantation), f.eks.: ciclosporin, everolimus, sirolimus, tacrolimus
English: Ivacaftor produced concentration-dependent inhibitory effect on hERG (human ether-à-go-go related gene) tail currents, with an IC15 of 5.5 µM, compared to the Cmax (1.5 µM) for ivacaftor at the therapeutic dose for lumacaftor/ivacaftor.
Danish: Ivacaftor udløste en koncentrationsafhængig hæmmende virkning på hERG (humant ether-à-go-gorelateret gen) tilbageløbsstrøm med en IC15 på 5,5 µM, sammenlignet med Cmax (1,5 µM) for ivacaftor ved den terapeutiske dosis for lumacaftor/ivacaftor.
English: • Severe liver problems: the dose may be reduced to one tablet every 12 hours.
Danish: • Svære leverproblemer: dosis kan reduceres til en tablet hver 12. time
English: • Severe liver problems: the dose may be reduced to one sachet per day, or less often.
Danish: • Svære leverproblemer: dosis kan reduceres til et brev pr. dag, eller mindre hyppigt.
English: Effects in repeated dose studies were observed only at exposures considered sufficiently in excess (> 25-, > 45-, and > 35-fold for mice, rats, and dogs, respectively) of the maximum human exposure of ivacaftor when administered as Orkambi, indicating little relevance to clinical use.
Danish: I studier med gentagne doser blev der kun iagttaget virkninger ved doser, der anses for at overstige den maksimale humane eksponering i væsentlig grad (> 25, > 45 og > 35 gange for hhv. mus, rotter og hunde), når det administreres som Orkambi.
English: † For patients rolled over from Trials 1 and 2 (lumacaftor/ivacaftor-to-lumacaftor/ivacaftor group) total exposure was up to 120 weeks.
Danish: † For patienter, der overgik fra studie 1 og 2 (gruppen med lumacaftor/ivacaftor til lumacaftor/ivacaftor), var den totale eksponering op til 120 uger.
English: After oral administration of 400 mg every 12 hours in patients with CF in a fed state, the typical apparent volumes of distribution for the central and peripheral compartments (CV) were estimated to be 23.5 L (48.7%) and 33.3 L (30.5%), respectively.
Danish: Efter oral administration af 400 mg hver 12. time hos patienter med CF efter indtagelse af mad blev de typiske tilsyneladende fordelingsvoluminer for de centrale og perifere compartments (CV) estimeret til at være hhv. 23,5 l (48,7 %) og 33,3 l (30,5 %).
English: From Week 4, the change in mean heart rate at pre-dose ranged from 1 to 2 bpm below baseline among patients treated with lumacaftor/ivacaftor.
Danish: Fra uge 4 var ændringen i gennemsnitlig puls før doseringen fra 1 til 2 bpm under baseline blandt patienter i behandling med lumacaftor/ivacaftor.
English: The net effect of lumacaftor/ivacaftor therapy is expected to be strong CYP3A induction.
Danish: Nettovirkningen ved behandling med lumacaftor/ivacaftor forventes at være en potent CYP3A-induktion.
English: The exact mechanisms by which lumacaftor improves cellular processing and trafficking of F508del-CFTR and ivacaftor potentiates F508del-CFTR are not known.
Danish: Den nøjagtige mekanisme, hvorved lumacaftor forbedrer celleprocesser og strømninger for F508del-CFTR, og ivacaftor potenserer F508del-CFTR, er ukendt.
English: Very common may affect more than 1 in 10 people:
Danish: Meget almindelig kan forekomme hos flere end 1 ud af 10 personer:
English: Clinical comment fluconazole
Danish: Klinisk kommentar fluconazol
English: Corticosteroids, systemic: methylprednisolone, prednisone
Danish: Kortikosteroider, systemiske: methylprednisolon, prednison
English: Orkambi dose
Danish: Orkambi-dosis
English: Trial 3 was a Phase 3, parallel-group, multicentre, rollover extension study in patients with CF that included patients aged 12 years and older from Trial 1 and Trial 2.
Danish: Langvarigt rollover-studie af sikkerhed og virkning Studie 3 var et fase III multicenter-rollover forlængelsesstudie med parallelle grupper hos patienter med CF, der omfattede patienter i alderen 12 år og ældre fra studie 1 og studie 2.
English: Among 7 patients with pre-existing cirrhosis and/or portal hypertension who received lumacaftor/ivacaftor in the placebo-controlled, Phase 3 studies, worsening liver function with increased ALT, AST, bilirubin, and hepatic encephalopathy was observed in one patient.
Danish: Blandt 7 patienter med eksisterende cirrose og/eller hypertension i vena porta, der fik lumacaftor/ivacaftor i de placebokontrollerede fase III-studier, blev der observeret forværret leverfunktion med øget ALAT, ASAT, bilirubin og leverencefalopati hos en patient.
English: Taking Orkambi with fat-containing food is important to get the right levels of medicine in your body.
Danish: Det er vigtigt at tage Orkambi sammen med fedtholdig mad, så du opnår det rigtige niveau af lægemidlet i din krop.
English: Especially tell your doctor if you take any of the following medicines:
Danish: Du skal især fortælle det til lægen, hvis du tager nogen af de følgende lægemidler:
English: The median (range) tmax of lumacaftor is approximately 4.0 hours (2.0; 9.0) in the fed state.
Danish: Median (interval) tmax for lumacaftor er ca. 4,0 timer (2,0; 9,0) efter indtagelse af mad.
English: The use of lumacaftor/ivacaftor in organ transplant patients has not been studied.
Danish: Anvendelsen af lumacaftor/ivacaftor til organtransplanterede patienter er ikke blevet undersøgt.
English: The median (range) tmax of ivacaftor is approximately 4.0 hours (2.0; 6.0) in the fed state.
Danish: Median (interval) tmax for ivacaftor er ca. 4,0 timer (2,0; 6,0) efter indtagelse af mad.
English: This medicine contains less than 1 mmole sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: For dose adjustments for patients with hepatic impairment see Table 2.
Danish: For dosisjusteringer for patienter med nedsat leverfunktion, se tabel 2.
English: Final CSR December 2021
Danish: Endelig CSR december
English: Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with lumacaftor/ivacaftor.
Danish: Der bør ikke stoles på hormonel kontraception, herunder oral, injicerbar, transdermal og implanterbar kontraception, som en sikker kontraceptionsmetode ved administration sammen med lumacaftor/ivacaftor.
English: The percentage of patients with heart rate values < 50 bpm on treatment was 11% for patients who received lumacaftor/ivacaftor, compared to 4.9% for patients who received placebo.
Danish: Procentdelen af patienter med en puls på < 50 bpm under behandlingen var 11 % for patienter, der fik lumacaftor/ivacaftor, sammenlignet med 4,9 % for patienter, der fik placebo.
English: As a precautionary measure, it is preferable to avoid the use of lumacaftor/ivacaftor during pregnancy unless the clinical condition of the mother requires treatment with lumacaftor/ivacaftor.
Danish: For en sikkerheds skyld bør lumacaftor/ivacaftor undgås under graviditeten, medmindre moderens kliniske tilstand kræver behandling med lumacaftor/ivacaftor.
English: There is no experience of initiating treatment with lumacaftor/ivacaftor in patients having a pulmonary exacerbation and initiating treatment in patients having a pulmonary exacerbation is not advisable.
Danish: Der er ingen erfaring med iværksættelse af behandling med lumacaftor/ivacaftor til patienter med lungeforværringer, og det anbefales ikke at iværksætte behandling hos patienter med lungeforværringer.
English: There was negligible urinary excretion of ivacaftor as unchanged drug.
Danish: Der var en ubetydelig udskillelse af ivacaftor i urinen som uændret stof.
English: Giving Orkambi granules to your child:
Danish: Sådan giver du Orkambi granulat til dit barn
English: Absolute change in BMI at Week 24 (kg/m
Danish: Absolut ændring i BMI ved uge 24 (kg/m2)
English: Anti-inflammatories: ibuprofen
Danish: Antiinflammatoriske midler: ibuprofen
English: Patients with a history of colonisation with organisms such as Burkholderia cenocepacia, Burkholderia dolosa, or Mycobacterium abscessus or who had 3 or more abnormal liver function tests (ALT, AST, AP, GGT ≥ 3 times the ULN or total bilirubin ≥ 2 times the ULN) were excluded.
Danish: Patienter med tidligere kolonisering af organismer som Burkholderia cenocepacia, Burkholderia dolosa eller Mycobacterium abscessus, eller som havde 3 eller flere unormale leverfunktionsprøver (ALAT, ASAT, AP, GGT ≥3 gange ULN eller totalt bilirubin ≥2 gange ULN),
English: brilliant blue FCF aluminium lake (E133); and indigo carmine aluminium lake (E132).
Danish: brilliant blue FCF aluminuim lake (E133) og indigocarmin aluminium lake (E132).
English: Following multiple oral dose administration of ivacaftor in combination with lumacaftor, the exposure of ivacaftor generally increased with dose from 150 mg every 12 hours to 250 mg every 12 hours.
Danish: Efter flere orale dosisadministrationer af ivacaftor i kombination med lumacaftor øgedes eksponeringen af ivacaftor generelt med dosis fra 150 mg hver 12. time til 250 mg hver 12. time.
English: • Antibiotic medicines (used for the treatment of bacterial infections) for example: telithromycin, clarithromycin, rifampicin, rifabutin, rifapentine, erythromycin
Danish: • Antibiotika (anvendes til behandling af bakterieinfektioner), f.eks.: telithromycin, clarithromycin, rifampicin, rifabutin, rifapentin, erythromycin
English: The exposure of ivacaftor will be decreased, which may reduce the efficacy of lumacaftor/ivacaftor.
Danish: Eksponeringen for ivacaftor vil være nedsat, hvilket kan reducere virkningen af lumacaftor/ivacaftor.
English: Patients received either lumacaftor 200 mg/ivacaftor 250 mg every 12 hours (n = 103) or placebo (n = 101) in addition to their prescribed CF therapies.
Danish: Patienterne fik enten lumacaftor 200 mg/ivacaftor 250 mg hver 12. time (n = 103) eller placebo (n = 101) i tillæg til deres ordinerede behandlinger mod CF.
English: The efficacy of lumacaftor/ivacaftor in patients with CF who are homozygous for the F508del mutation in the CFTR gene was evaluated in two randomised, double-blind, placebo-controlled clinical trials of 1108 clinically stable patients with CF, in which 737 patients were randomised to and dosed with lumacaftor/ivacaftor.
Danish: Lumacaftor/ivacaftors virkning hos patienter med CF, som er homozygote med hensyn til F508delmutationen i CFTR-genet, blev evalueret i to randomiserede, dobbeltblindede, placebokontrollerede kliniske studier med 1108 klinisk stabile patienter med CF, hvor 737 patienter blev randomiseret til og doseret med lumacaftor/ivacaftor.
English: Treatment with lumacaftor/ivacaftor resulted in no significant improvement in ppFEV1 relative to placebo in patients with CF heterozygous for the F508del mutation in the CFTR gene (treatment difference 0.60 [P = 0.5978]) and no meaningful improvements in BMI or weight (see section 4.4).
Danish: Behandling med lumacaftor/ivacaftor førte ikke til nogen signifikant forbedring i ppFEV1 i forhold til placebo hos patienter med CF, der var heterozygote med hensyn til F508del-mutationen i CFTR-genet (en behandlingsforskel på 0,60 [P = 0,5978]) og ingen betydelige forbedringer i BMI eller vægt (se pkt.
English: The proportion of patients who experienced a systolic blood pressure value > 140 mmHg or a diastolic blood pressure > 90 mmHg on at least two occasions was 3.4% and 1.5% in patients treated with lumacaftor/ivacaftor, respectively, compared with 1.6% and 0.5% in patients who received placebo (see section 4.4).
Danish: Andelen af patienter, der oplevede et systolisk blodtryk > 140 mmHg eller et diastolisk blodtryk > 90 mmHg ved mindst to målinger, var hhv. 3,4 % og 1,5 % hos patienter i behandling med lumacaftor/ivacaftor, sammenlignet med 1,6 % og 0,5 % hos patienter, der fik placebo (se pkt.
English: Iron oxide black (E172) Propylene glycol Ammonium hydroxide
Danish: Jernoxid, sort (E172) Propylenglycol Ammoniumhydroxid
English: The safety and efficacy of Orkambi in children aged less than 2 years have not yet been established.
Danish: Orkambis sikkerhed og virkning hos børn i alderen under 2 år er endnu ikke klarlagt.
English: Extension Week 72
Danish: Forlængelsesuge 72
English: In addition, the mean absolute change in sweat chloride from Week 24 at Week 26 following the 2-week washout period (to evaluate off-drug response) was an increase of 33.0 mmol/L (95% CI: 28.9, 37.1; nominal P < 0.0001), representing a return to baseline after treatment washout.
Danish: Desuden var den gennemsnitlige absolutte ændring i chloridindholdet i sved fra uge 24 ved uge 26 efter den 2-ugers udvaskningsperiode (for at evaluere responset uden lægemiddel) en stigning på 33,0 mmol/l (95 % CI: 28,9; 37,1; nominel P < 0,0001), hvilket repræsenterer en tilbagevenden til baseline efter udvaskning af behandlingen.
English: Table 7: Summary of primary and key secondary outcomes in Trial 7
Danish: Tabel 7: Oversigt over primære og vigtigste sekundære udfald i studie 7
English: However, increased liver enzymes in the blood have been seen more frequently in younger children than in adults.
Danish: Der er imidlertid hyppigere blevet observeret forhøjede leverenzymer hos yngre børn end hos voksne.
English: Vascular disorders uncommon Hypertension
Danish: Vaskulære sygdomme ikke almindelig Hypertension
English: Increased blood pressure has been observed in some patients treated with lumacaftor/ivacaftor.
Danish: Der er blevet observeret forhøjet blodtryk hos nogle patienter i behandling med lumacaftor/ivacaftor.
English: Patients may start taking Orkambi on any day of the week.
Danish: Patienterne kan begynde at tage Orkambi på en vilkårlig ugedag.
English: Talk to your doctor or pharmacist before taking Orkambi.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Orkambi.
English: Skin and subcutaneous tissue disorders common
Danish: Hud og subkutane væv almindelig Udslæt
English: The exposures are similar between adults and the paediatric population based on population (PK) analyses as presented in Table 9.
Danish: Eksponeringerne er sammenlignelige mellem voksne og den pædiatriske population baseret på populationsanalyser (farmakokinetiske) som vist i tabel 9 nedenfor:
English: • Cardiac glycosides (used for the treatment of mild to moderate congestive heart failure and an abnormal heart rhythm called atrial fibrillation) for example: digoxin
Danish: • Hjerteglykosider (anvendes til behandling af let til moderat kongestivt hjertesvigt og en unormal hjerterytme, der kaldes atrieflimren), f.eks.: digoxin
English: Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Danish: Fortæl altid dit barns læge eller apotekspersonalet, hvis dit barn tager anden medicin eller har gjort det for nylig.
English: If your child has moderate or severe problems with liver function, your child's doctor may need to reduce the dose of Orkambi as your child's liver will not clear Orkambi as fast as in children who have normal liver function.
Danish: Hvis dit barn har har moderate eller svære problemer med leverfunktionen, kan det være nødvendigt, at dit barns læge reducerer dosis af Orkambi, da dit barns lever ikke vil udskille Orkambi så hurtigt som hos børn med normal leverfunktion.
English: • H2 Antagonist medicines (used to reduce stomach acid) for example: ranitidine
Danish: • H2-antagonistiske lægemidler (anvendes til reduktion af mavesyre), f.eks.: ranitidin
English: Blood creatine phosphokinase increased uncommon Blood pressure increased
Danish: Bakterier i sputum* almindelig Forhøjet niveau af kreatinphosphokinase i blodet ikke almindelig Forhøjet blodtryk
English: No dose adjustment is necessary when CYP3A inhibitors are initiated in patients currently taking Orkambi.
Danish: Ingen dosisjustering er nødvendig, når behandling med CYP3A-hæmmere påbegyndes hos patienter, der aktuelt tager Orkambi.
English: Lumacaftor and ivacaftor are inhibitors of BCRP.
Danish: Lumacaftor og ivacaftor er hæmmere af BCRP.
English: 2 to 5 years and weighing less than 14 kg
Danish: 2 til 5 år, der vejer under 14 kg