FrancophonIA/ELRC3.0 huggingface dataset:
English: Some examples of soft foods include puréed fruits, flavoured yogurt, and milk or juice.
Danish: Eksempler på mosede fødevarer er pureret frugt, yoghurt med smag og mælk eller juice.
English: Among different age paediatric cohorts, in the 2 to 5 years old patients, transaminase elevations have been observed more frequently than in the 6 to 11 years old (see section 4.8).
Danish: Blandt de forskellige pædiatriske alderskohorter er der hyppigere blevet observeret forhøjede transaminaser hos patienter i alderen 2 til 5 år end hos patienter i alderen 6 til 11 år (se pkt.
English: Your child's doctor may monitor your child's blood pressure during treatment with Orkambi.
Danish: Dit barns læge vil evt. kontrollere dit barns blodtryk i løbet af behandlingen med Orkambi.
English: Secondary endpoints included absolute change from baseline in sweat chloride at Week 24 and absolute change in sweat chloride from Week 24 at Week 26 (see Pharmacodynamic effects) as well as the endpoints listed in Table 8.
Danish: Sekundære endepunkter omfattede en absolut ændring fra baseline i chloridindholdet i sved ved uge 24, og en absolut ændring i chloridindholdet i sved fra uge 24 ved uge 26 (se Farmakodynamisk virkning) samt endepunkterne anført i tabel 8.
English: Potential for lumacaftor/ivacaftor to affect other medicinal products CYP3A substrates
Danish: Mulighed for, at lumacaftor/ivacaftor påvirker andre lægemidler CYP3A4-substrater
English: NAME OF THE MARKETING AUTHORISATION HOLDER Vertex Pharmaceuticals (Ireland) Limited
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Vertex Pharmaceuticals (Ireland) Limited
English: In vitro studies suggest that lumacaftor has the potential to induce CYP2B6, CYP2C8, CYP2C9, and CYP2C19; however, inhibition of CYP2C8 and CYP2C9 has also been observed in vitro.
Danish: In vitro-studier tyder på, at lumacaftor har potentialet til at inducere CYP2B6, CYP2C8, CYP2C9 og CYP2C19.
English: Tell your doctor straight away if you have any of the following symptoms:
Danish: Fortæl det straks til lægen, hvis du får nogen af de følgende symptomer:
English: • if your child is allergic to lumacaftor, ivacaftor, or any of the other ingredients of this medicine
Danish: • hvis han/hun er allergisk over for lumacaftor, ivacaftor eller et af de øvrige indholdsstoffer i
English: After oral administration of ivacaftor 250 mg every 12 hours in combination with lumacaftor, the typical apparent volumes of distribution for the central and peripheral compartments [coefficient of variation as a percentage (CV)] were estimated to be 95.0 L (53.9%) and 201 L (26.6%), respectively.
Danish: Efter oral administration af ivacaftor 250 mg hver 12. time i kombination med lumacaftor blev de typiske tilsyneladende fordelingsvoluminer for de centrale og perifere compartments [variationskoefficient som procent (CV)] estimeret til at være hhv. 95,0 l (53,9 %) og 201 l (26,6 %).
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating treatment with lumacaftor/ivacaftor.
Danish: Baseline og opfølgende oftalmologiske undersøgelser anbefales hos pædiatriske patienter, der påbegynder behandling med lumacaftor/ivacaftor.
English: Talk to your doctor before taking Orkambi if you have been told you have liver or kidney disease as your doctor may need to adjust the dose of Orkambi.
Danish: Kontakt lægen, før du tager Orkambi, hvis du har fået at vide, at du har en lever- eller nyresygdom, da det kan være nødvendigt, at lægen justerer din dosis af Orkambi.
English: Tell your child's doctor straight away if your child has any of these symptoms, which may be a sign of liver problems:
Danish: Fortæl det straks til dit barns læge, hvis dit barn har nogen af disse symptomer, da de kan være tegn på leverproblemer:
English: There was negligible urinary excretion of lumacaftor as unchanged drug.
Danish: Der var en ubetydelig udskillelse af lumacaftor som uændret lægemiddel i urinen.
English: * Adverse reactions and frequencies observed in patients in clinical studies with ivacaftor monotherapy (a component of
Danish: * Bivirkninger og hyppigheder observeret hos patienter i kliniske studier med ivacaftormonoterapi (en komponent i Orkambi).
English: Available pharmacokinetic data in animals have shown excretion of both lumacaftor and ivacaftor into the milk of lactating female rats.
Danish: De tilgængelige farmakokinetiske data fra dyreforsøg viser, at både lumacaftor og ivacaftor udskilles i mælken hos diegivende hunrotter.
English: Antidepressants: citalopram, escitalopram, sertraline
Danish: Antidepressiva: citalopram, escitalopram, sertralin
English: Patients with CF who have a gating (Class III) mutation in the CFTR gene Lumacaftor/ivacaftor has not been studied in patients with CF who have a gating (Class III) mutation in the CFTR gene on one allele, with or without the F508del mutation on the other allele.
Danish: Patienter med CF, som har en gating (klasse III)-mutation i CFTR-genet Lumacaftor/ivacaftor er ikke blevet undersøgt hos patienter med CF, som har en gating (klasse III)mutation i CFTR-genet på en allel med eller uden F508del-mutationen på den anden allel.
English: Your doctor may monitor your blood pressure during treatment with Orkambi.
Danish: Din læge vil evt. kontrollere dit blodtryk i løbet af behandlingen med Orkambi.
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Danish: Hvis dit barn oplever bivirkninger, bør du tale med dit barns læge eller apoteket.
English: Take the missed dose with fat-containing food if less than 6 hours have passed since the time you missed the dose.
Danish: Tag den glemte dosis sammen med fedtholdig mad, hvis der er gået under 6 timer fra den glemte dosis.
English: In this trial, 10 patients (homozygous for F508del-CFTR mutation) completed dosing with lumacaftor alone 400 mg q12h for 28 days followed by the addition of ivacaftor 250 mg q12h for an additional 28 days, and 25 patients (homozygous or heterozygous for F508del) completed dosing with placebo.
Danish: I dette studie gennemførte 10 patienter (som var homozygote med hensyn til F508del-CFTR-mutationen) dosering med lumacaftor alene 400 mg hver 12. time i 28 dage, efterfulgt af tilføjelse af ivacaftor 250 mg hver 12. time i yderligere 28 dage, og 25 patienter (homozygote eller heterozygote med hensyn til F508del) gennemførte dosering med placebo.
English: A transient decline in FEV1 has also been observed in some patients following initiation of lumacaftor/ivacaftor.
Danish: Der er også blevet observeret en forbigående reduktion i FEV1 hos nogle patienter, efter behandlingen med lumacaftor/ivacaftor blev iværksat.
English: Talk to your child's doctor or pharmacist before taking Orkambi.
Danish: Kontakt dit barns læge eller apotekspersonalet, før dit barn tager Orkambi.
English: Co-administration of lumacaftor/ivacaftor with itraconazole, a strong CYP3A inhibitor, did not impact the exposure of lumacaftor, but increased ivacaftor exposure by 4.3-fold.
Danish: Administration af lumacaftor/ivacaftor sammen med itraconazol, en potent CYP3A-hæmmer, påvirkede ikke eksponeringen for lumacaftor, men det øgede eksponeringen for ivacaftor 4,3 gange.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Vertex Pharmaceuticals (Ireland) Limited
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Vertex Pharmaceuticals (Ireland) Limited
English: INFORMATION IN BRAILLE Orkambi 150 mg, 188 mg
Danish: INFORMATION I BRAILLESKRIFT Orkambi 150 mg, 188 mg
English: The entire content of each sachet of granules should be mixed with one teaspoon (5 mL) of age-appropriate soft food or liquid and the mixture completely consumed.
Danish: Hele brevets indhold skal blandes med en teskefuld (5 ml) ”alderssvarende” mosede fødevarer eller væske, og hele blandingen skal indtages.
English: However, when initiating lumacaftor/ivacaftor in patients taking strong CYP3A inhibitors, the dose should be adjusted (see sections 4.2 and 4.4).
Danish: Når lumacaftor/ivacaftor påbegyndes hos patienter, der tager potente CYP3A-hæmmere, bør dosis imidlertid justeres (se pkt.
English: Caution is recommended while using Orkambi in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.4 and 5.2).
Danish: Der rådes til forsigtighed, når Orkambi anvendes til patienter med svært nedsat nyrefunktion (kreatininclearance under eller lig med 30 ml/min) eller med nyresygdom i slutstadiet (se pkt.
English: Therefore, co-administration with strong CYP3A inducers (e.g., rifampicin, St. John's wort [Hypericum perforatum]) is not recommended (see section 4.5).
Danish: Derfor anbefales administration sammen med potente CYP3A-inducere (f.eks. rifampicin, prikbladet perikon [Hypericum perforatum]) ikke (se pkt.
English: Tell your doctor straight away if you have any of these symptoms, which may be a sign of liver problems:
Danish: Fortæl det straks til lægen, hvis du har nogen af disse symptomer, da de kan være tegn på leverproblemer:
English: If lumacaftor/ivacaftor is used in these patients, they should be closely monitored after the initiation of treatment and the dose should be reduced (see sections 4.2, 4.8, and 5.2).
Danish: Hvis lumacaftor/ivacaftor anvendes til disse patienter, skal de overvåges nøje efter behandlingen indledes, og dosis bør reduceres (se pkt.
English: • Antidepressant medicines (used for the treatment of depression) for example: citalopram, escitalopram, sertraline, bupropion
Danish: • Antidepressiva (anvendes til behandling af depression), f.eks.: citalopram, escitalopram, sertralin, bupropion
English: • Upper respiratory tract infection
Danish: • infektion i de øvre luftveje
English: In patients who received placebo (mean baseline 114 mmHg systolic and 69 mmHg diastolic), the maximum increase from baseline in mean systolic and diastolic blood pressure was 0.9 mmHg and 0.9 mmHg, respectively.
Danish: Hos patienter, der fik placebo (gennemsnit ved baseline 114 mmHg systolisk og 69 mmHg diastolisk), var den maksimale forhøjelse fra baseline i gennemsnitligt systolisk og diastolisk blodtryk hhv. 0,9 mmHg og 0,9 mmHg.
English: Lumacaftor is a CFTR corrector that acts directly on F508del-CFTR to improve its cellular processing and trafficking, thereby increasing the quantity of functional CFTR at the cell surface.
Danish: Lumacaftor er et CFTR-korrigerende stof, der virker direkte på F508del-CFTR for at forbedre celleprocesser og strømninger, og derved øge mængden af funktionelt CFTR på celleoverfladen.
English: Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with Orkambi (see section 4.5).
Danish: Der bør ikke stoles på hormonel kontraception, herunder oral, injicerbar, transdermal og implanterbar kontraception, som en sikker kontraceptionsmetode ved administration sammen med Orkambi (se pkt.
English: Therefore, concomitant use of lumacaftor/ivacaftor with CYP3A substrates may decrease the exposure of these substrates (see section 4.4).
Danish: Derfor kan anvendelse af lumacaftor/ivacaftor sammen med CYP3Asubstrater nedsætte eksponeringen for disse substrater (se pkt.
English: Pharmacokinetic studies have not been performed with lumacaftor/ivacaftor in patients with renal impairment.
Danish: Der er ikke udført farmakokinetiske studier med lumacaftor/ivacaftor hos patienter med nedsat nyrefunktion.
English: • Printing ink: shellac; iron oxide black (E172); propylene glycol; and ammonium hydroxide.
Danish: • Prægeblæk: shellac, jernoxid, sort (E172), propylenglycol og ammoniumhydroxid.
English: • Pack containing 28 film-coated tablets.
Danish: • Pakning indeholdende 28 filmovertrukne tabletter.
English: Changes in ppFEV1 in response to lumacaftor alone or in combination with ivacaftor were also evaluated in the double-blind, placebo-controlled, Phase 2 trial in patients with CF age 18 years and older.
Danish: Ændringer i ppFEV1 som respons på lumacaftor alene eller i kombination med ivacaftor blev også evalueret i det dobbeltblindede, placebokontrollerede fase II-studie hos patienter med CF i alderen 18 år og ældre.
English: In the lumacaftor/ivacaftor patients, the treatment difference for absolute change in ppFEV1 from baseline through Week 24 was 2.4 (P = 0.0182).
Danish: Hos patienter i behandling med lumacaftor/ivacaftor var behandlingsforskellen for absolut ændring i ppFEV1 fra baseline til og med uge 24 2,4 (P = 0,0182).
English: ↔ LUM, IVA ↑ or ↓ warfarin
Danish: ↔ LUM, IVA ↑ eller ↓ warfarin
English: Tell your child's doctor straight away if he/she gets any of these:
Danish: Fortæl det straks til dit barns læge, hvis han/hun får nogen af disse symptomer:
English: During Trials 1 and 2, adverse reactions related to increased blood pressure (e.g., hypertension, blood pressure increased) were reported in 0.9% (7/738) of patients treated with lumacaftor/ivacaftor and in no patients who received placebo.
Danish: I løbet af studie 1 og 2 blev der rapporteret bivirkninger med relation til forhøjet blodtryk (f.eks. hypertension, forhøjet blodtryk) hos 0,9 % (7/738) af patienterne i behandling med lumacaftor/ivacaftor og ikke hos nogen patienter, der fik placebo.
English: Description of selected adverse reactions for paediatric patients aged 2 to 11 years Hepatobiliary events
Danish: Beskrivelse af udvalgte bivirkninger for pædiatriske patienter i alderen 2 til 11 år Lever- og galdevejshændelser
English: The safety data from 1029 patients aged 12 years and older who were homozygous for the F508del mutation in the CFTR gene treated with lumacaftor/ivacaftor for up to an additional 96 weeks in the long-term safety and efficacy rollover study (Trial 3) were similar to the 24-week, placebo-controlled studies (see section 5.1).
Danish: Sikkerhedsdata fra 1029 patienter i alderen 12 år og ældre, som var homozygote for F508delmutationen i CFTR-genet, i behandling med lumacaftor/ivacaftor i op til yderligere 96 uger i det langvarige rolloverstudie af sikkerhed og virkning (studie 3) svarede til de 24-ugers, placebokontrollerede studier (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - MULTIPACK - WITH BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE - MULTIPAKNING - MED BLÅ BOKS
English: Severe hepatic impairment (Child-Pugh Class C)
Danish: Svært nedsat leverfunktion (Child-Pugh klasse C)
English: No effects on male or female fertility and reproductive performance indices were observed at ≤100 mg/kg/day
Danish: Der blev ikke observeret nogen virkning på indeksværdier for fertiliteten og reproduktionsevnen hos hanner og hunner ved ≤ 100 mg/kg/dag (se pkt.
English: Orkambi 150 mg/188 mg granules in sachet are white to off-white granules.
Danish: Orkambi 150 mg/188 mg granulat i brev er et hvidt til off-white granulat.
English: • Increase in blood pressure
Danish: • forhøjet blodtryk
English: 14 sachets
Danish: 14 breve
English: Lumacaftor is a strong inducer of CYP3A and ivacaftor is a weak inhibitor of CYP3A when given as monotherapy.
Danish: Lumacaftor er en potent inducer af CYP3A, og ivacaftor er en svag hæmmer af CYP3A, når de gives som monoterapi.
English: The incidence of transaminase-related adverse reactions was 5.1% and 4.6% in lumacaftor/ivacaftor-treated patients and those who received placebo, respectively.
Danish: Forekomsten af transaminaserelaterede bivirkninger var 5,1 % og 4,6 % hos hhv. lumacaftor/ivacaftor-behandlede patienter og patienter, der fik placebo.
English: Safety data were evaluated in 60 patients aged 2 to 5 years, 161 patients aged 6 to 11 years (Trials 6, 7 and 8) and in 194 patients aged 12 to 17 years with CF who are homozygous for the F508del mutation and who received lumacaftor/ivacaftor in clinical studies.
Danish: Sikkerhedsdata blev evalueret hos 60 patienter i alderen 2 til 5 år, 161 patienter i alderen 6 til 11 år (studie 6, 7 og 8) og hos 194 patienter i alderen 12 til 17 år med CF, som er homozygote med hensyn til F508del-mutationen, og som fik lumacaftor/ivacaftor i kliniske studier.
English: Lumacaftor had no effects on fertility and reproductive performance indices in male and female rats.
Danish: Lumacaftor havde ingen virkning på indeksværdier for fertiliteten og reproduktionsevnen hos han- og hunrotter.
English: Number of events requiring intravenous antibiotics per patient-year (95% CI) (rate per 48 wks)
Danish: Antal hændelser, der krævede intravenøse antibiotika, pr. patientår (95 % CI) (hyppighed pr. 48 uger)
English: Talk to your child's doctor before taking Orkambi if you have been told your child has liver or kidney disease as the doctor may need to adjust the dose of Orkambi.
Danish: Kontakt dit barns læge, før dit barn tager Orkambi, hvis du har fået at vide, at dit barn har en levereller nyresygdom, da det kan være nødvendigt, at lægen justerer dosis af Orkambi.
English: • Anticonvulsant medicines (used for the treatment of fits [epileptic seizures]) for example: phenobarbital, carbamazepine, phenytoin
Danish: • Antikonvulsiva (anvendes til behandling af krampeanfald (epileptiske krampeanfald)), f.eks.: phenobarbital, carbamazepin, phenytoin
English: No effects on male or female fertility and reproductive performance indices were observed at ≤ 100 mg/kg/day (yielding exposures approximately 8 and 5 times, respectively, those obtained with the maximum recommended human dose of the ivacaftor component of Orkambi based on summed AUCs of ivacaftor and its metabolites extrapolated from Day 90 exposures at 100 mg/kg/day in the 6-month repeat-dose toxicity study and gestation Day 17 exposures in the embryofoetal development study in this species).
Danish: Der blev ikke observeret nogen virkning på indeksværdier for fertilitet og reproduktionsevne hos hanner og hunner ved ≤ 100 mg/kg/dag (hvilket giver eksponeringer på hhv. ca. 8 og 5 gange eksponeringerne opnået med den maksimalt anbefalede humane dosis af ivacaftorkomponenten af Orkambi, baseret på summen af AUC'er for ivacaftor og dets metabolitter ekstrapoleret fra eksponeringer ved dag 90 ved 100 mg/kg/dag i 6-måneders toksicitetsstudiet med gentagne doser og eksponering på gestationsdag 17 i studiet af embryoføtal udvikling for denne dyreart).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON FOR MULTIPACK NO BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE ÆSKE TIL MULTIPAKNING INGEN BLÅ BOKS
English: • Mix entire content of sachet with 5 mL of age-appropriate soft food or liquid that is at or below room temperature.
Danish: • Bland hele indholdet af et brev med 5 ml ”alderssvarende” mosede fødevarer eller væske, der er ved eller under stuetemperatur.
English: While taking Orkambi, you may notice that your child's breathing is easier, that they do not get ill as often, and/or that it is easier to gain weight.
Danish: Mens dit barn tager Orkambi, oplever du måske, at det bliver lettere for dit barn at trække vejret, at hun/han ikke så ofte bliver syg, og/eller at hun/han lettere tager på i vægt.
English: In patients treated with lumacaftor/ivacaftor (mean baseline 114 mmHg systolic and 69 mmHg diastolic), the maximum increase from baseline in mean systolic and diastolic blood pressure was 3.1 mmHg and 1.8 mmHg, respectively.
Danish: Hos patienter i behandling med lumacaftor/ivacaftor (gennemsnit ved baseline 114 mmHg systolisk og 69 mmHg diastolisk) var den maksimale forhøjelse fra baseline i gennemsnitligt systolisk og diastolisk blodtryk hhv. 3,1 mmHg og 1,8 mmHg.
English: Ivacaftor is a weak inhibitor of CYP3A when given as monotherapy.
Danish: Ivacaftor er en svag hæmmer af CYP3A, når det gives som monoterapi.
English: Moderate hepatic impairment (Child-Pugh Class B)
Danish: Moderat nedsat leverfunktion (Child-Pugh klasse B)
English: Do not use this medicine after the expiry date which is stated on the carton/blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken/blisteren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The primary endpoint was improvement in lung function as determined by the mean absolute change from baseline at Day 56 in ppFEV1.
Danish: Det primære endepunkt var en forbedring i lungefunktionen, bestemt ved den gennemsnitlige absolutte ændring fra baseline ved dag 56 i ppFEV1.
English: Absolute change in ppFEV1 at Week 24 (percentage points)
Danish: Absolut ændring i ppFEV1 ved uge 24 (procentpoint)
English: Taking Orkambi with fat-containing food is important to get the right levels of medicine in the body.
Danish: Det er vigtigt at tage Orkambi sammen med fedtholdig mad, så barnet opnår det rigtige niveau af lægemidlet i kroppen.
English: Due to inhibition of CYP3A by clarithromycin, telithromycin
Danish: Da CYP3A hæmmes af clarithromycin, telithromycin
English: Ivacaftor impaired fertility and reproductive performance indices in male and female rats at 200 mg/kg/day (yielding exposures approximately 11 and 7 times, respectively, those obtained with the maximum recommended human dose of the ivacaftor component of Orkambi based on summed AUCs of ivacaftor and its metabolites extrapolated from Day 90 exposures at 150 mg/kg/day in the 6-month repeat-dose toxicity study and gestation Day 17 exposures in the pilot embryofoetal development study in this species) when dams were dosed prior to and during early pregnancy.
Danish: Ivacaftor reducerede indeksværdier for fertilitet og reproduktionsevne hos han- og hunrotter ved 200 mg/kg/dag (hvilket giver eksponeringer på ca. hhv. 11 og 7 gange eksponeringerne opnået med den maksimalt anbefalede humane dosis af ivacaftorkomponenten af Orkambi, baseret på summen af AUC'er for ivacaftor og dets metabolitter ekstrapoleret fra eksponeringer ved dag 90 ved 150 mg/kg/dag i 6-måneders toksicitetsstudiet med gentagne doser og eksponering på gestationsdag 17 i pilotstudiet af embryoføtal udvikling for denne dyreart), når hunnerne blev doseret før og i løbet af den tidlige drægtighedsperiode.
English: Therefore, lumacaftor/ivacaftor should be administered with fat-containing food.
Danish: Derfor skal lumacaftor/ivacaftor administreres sammen med fedtholdig mad.
English: Transaminase elevations have been observed more frequently in paediatric patients than in adult patients (see section 4.8).
Danish: Transaminaseforhøjelser er blevet observeret hyppigere hos pædiatriske patienter end hos voksne patienter (se pkt.
English: It is unknown if lumacaftor or ivacaftor are found in human milk.
Danish: Det er ukendt, om lumacaftor eller ivacaftor kan genfindes i modermælk.
English: The exposure (AUC) of lumacaftor is approximately 2-fold higher in healthy adult volunteers compared to exposure in patients with CF.
Danish: Eksponeringen (AUC) for lumacaftor er ca. 2 gange større hos raske, voksne frivillige sammenlignet med eksponeringen hos patienter med CF. Eksponeringen for ivacaftor er tilsvarende for raske, voksne frivillige og patienter med CF.
English: Common may affect up to 1 in 10 people:
Danish: Almindelig kan forekomme hos op til 1 ud af 10 personer:
English: The most common adverse reactions experienced by patients aged 12 years and older who received lumacaftor/ivacaftor in the pooled, placebo-controlled, Phase 3 studies were dyspnoea (14.0% versus 7.8% on placebo), diarrhoea (11.0% versus 8.4% on placebo), and nausea (10.2% versus 7.6% on placebo).
Danish: De mest almindelige bivirkninger, som patienter i alderen 12 år og derover oplevede med lumacaftor/ivacaftor i de samlede, placebokontrollerede, fase III-studier, var dyspnø (14,0 % versus 7,8 % på placebo), diarré (11,0 % versus 8,4 % på placebo) og kvalme (10,2 % versus 7,6 % på placebo).
English: A fat-containing meal or snack should be consumed just before or just after dosing (see section 5.2).
Danish: Et fedtholdigt måltid eller en snack skal indtages umiddelbart før eller umiddelbart efter dosering (se pkt.
English: How to take Orkambi
Danish: Sådan skal du tage Orkambi
English: Do not use this medicine after the expiry date which is stated on the carton/sachet after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken/brevet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.