FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, after weighing the risks and benefits of treatment, Orkambi should be used with caution at a reduced dose (see sections 4.4, 4.8, and 5.2).
Danish: Derfor bør Orkambi anvendes med forsigtighed efter en afvejning af risici og fordele ved behandlingen med en reduceret dosis (se pkt.
English: Nervous system disorders very common Headache, dizziness* uncommon Hepatic encephalopathy†
Danish: Hovedpine*, svimmelhed* ikke almindelig Hepatisk encefalopati†
English: • Mix the entire contents of a sachet with one teaspoon (5 mL) of age-appropriate soft food or liquid.
Danish: • Bland hele brevets indhold med en teskefuld (5 ml) ”alderssvarende” mosede fødevarer eller væske.
English: No dose adjustment of lumacaftor/ivacaftor is recommended when co-administered with fluconazole.
Danish: Ingen dosisjustering af lumacaftor/ivacaftor anbefales ved administration sammen med fluconazol.
English: Do not stop unless your child's doctor advises you to. You should keep giving the medicine as the doctor directs even if the child feels well.
Danish: Hvis du holder op med at give dit barn Orkambi Giv Orkambi til dit barn så længe dit barns læge anbefaler det. Du må ikke stoppe, medmindre dit barns læge fortæller dig det. Du skal blive ved med at give lægemidlet efter lægens anvisning, selv hvis dit barn har det godt.
English: Appropriate clinical monitoring should be employed, as is reasonable, when co-administered with lumacaftor/ivacaftor.
Danish: Der bør iværksættes passende klinisk overvågning, som det er hensigtsmæssigt, ved administration sammen med lumacaftor/ivacaftor.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/003 28 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1059/003 28 filmovertrukne tabletter
English: No dose adjustment of lumacaftor/ivacaftor is recommended when co-administered with erythromycin.
Danish: Ingen dosisjustering af lumacaftor/ivacaftor anbefales ved administration sammen med erythromycin.
English: No dose adjustment is recommended when used with moderate or weak CYP3A inhibitors.
Danish: Ingen dosisjustering er nødvendig ved anvendelse sammen med moderate eller svage CYP3Ahæmmere.
English: No dose adjustment of lumacaftor/ivacaftor is recommended when these antifungals are initiated in patients currently taking lumacaftor/ivacaftor.
Danish: Ingen dosisjustering af lumacaftor/ivacaftor anbefales, når disse antimykotika påbegyndes hos patienter, der aktuelt tager lumacaftor/ivacaftor.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/001 112 film-coated tablets EU/1/15/1059/002 56 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1059/001 112 filmovertrukne tabletter EU/1/15/1059/002 56 filmovertrukne tabletter
English: During a 24-week, open label, Phase 3b clinical study (Trial 5) in 46 patients aged 12 years and older with advanced lung disease (ppFEV1 < 40) [mean ppFEV1 29.1 at baseline (range: 18.3 to 42.0)], the incidence of respiratory events was 65.2%.
Danish: I løbet af et 24-ugers, åbent, fase IIIb klinisk studie (studie 5) hos 46 patienter i alderen 12 år og ældre med fremskreden lungesygdom (ppFEV1 < 40) [gennemsnitlig ppFEV1 29,1 ved baseline (interval: 18,3 til 42,0)] var forekomsten af respiratoriske hændelser 65,2 %.
English: The treatment difference between the combination of lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo evaluated as mean change in sweat chloride from baseline to Day 56 was statistically significant at -11 mmol/L (95% CI: -18, -4).
Danish: Forskellen i behandling mellem kombinationen af lumacaftor 400 mg/ivacaftor 250 mg hver 12. time og placebo evalueret som en gennemsnitlig ændring i chloridindholdet i sved fra baseline til dag 56 var statistisk signifikant på -11 mmol/l (95 % CI: -18, -4).
English: For patients aged 6 to 11 years 2 tablets of 100 mg/125 mg in the morning + 1 tablet of 100 mg/125 mg in the evening (12 hours later)
Danish: For patienter i alderen 6 til 11 år 2 tabletter med 100 mg/125 mg om morgenen + 1 tablet med 100 mg/125 mg om aftenen (12 timer senere)
English: St. John's wort (Hypericum perforatum)
Danish: Naturlægemidler: prikbladet perikon (Hypericum perforatum)
English: Gastrointestinal disorders very common Abdominal pain*, abdominal pain upper, diarrhoea, nausea common
Danish: Abdominalsmerter*, øvre abdominalsmerter, diarré, kvalme almindelig Flatulens, opkastning
English: Studies have not been conducted in patients with severe hepatic impairment (Child-Pugh Class C, score 10 to 15), but exposure is expected to be higher than in patients with moderate hepatic impairment (see sections 4.2, 4.4, and 4.8).
Danish: Der er ikke foretaget studier af patienter med svært nedsat leverfunktion (Child-Pugh klasse C, score 10 til 15), men eksponeringen forventes at være højere end for patienter med moderat nedsat leverfunktion (se pkt.
English: ketoconazole, voriconazole Due to induction of CYP3A by LUM
Danish: ketoconazol, voriconazol Da CYP3A induceres af LUM
English: ↑ or ↓ digoxin Due to potential induction or inhibition of P-gp
Danish: fexofenadin På grund af den mulige induktion eller hæmning af P-gp
English: Cells contain two copies of the CFTR gene; Orkambi is used in patients in whom both copies are affected by the F508del mutation.
Danish: Orkambi anvendes til patienter, hvor begge kopier er påvirket af F508del-mutationen.
English: Menstruation irregular, dysmenorrhoea, metrorrhagia, breast mass* uncommon Menorrhagia, amenorrhoea, polymenorrhoea, breast inflammation*, gynaecomastia*, nipple disorder*, nipple pain*, oligomenorrhoea
Danish: Det reproduktive system og mammae almindelig Uregelmæssig menstruation, dysmenorré, metroragi, knude i brystet* ikke almindelig Menoragi, amenorré, polymenorré, brystbetændelse*, gynækomasti*, sygdom i brystvorter*, smerter i brystvorter*, oligomenorré
English: ↓ fluconazole Due to induction by LUM; fluconazole is cleared primarily by renal excretion as unchanged drug; however, modest reduction in fluconazole exposure has been observed with strong inducers
Danish: På grund af LUM's induktion: fluconazol fjernes primært via nyreudskillelse af det uændrede lægemiddel.
English: Appropriate clinical monitoring should be employed when co-administered with lumacaftor/ivacaftor.
Danish: Der bør iværksættes passende klinisk overvågning ved administration sammen med lumacaftor/ivacaftor.
English: Mean lumacaftor (SD) AUCss
Danish: Gennemsnitlig lumacaftor (SD)
English: During the 24-week, placebo-controlled Phase 3 clinical study in 204 patients aged 6 to 11 years (Trial 7), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 1.0%, 4.9%, and 12.6% in the lumacaftor/ivacaftor patients, and 2.0%, 3.0%, and 7.9% in the placebo-treated patients.
Danish: I løbet af det 24-ugers, placebokontrollede fase III kliniske studie hos 204 patienter i alderen 6 til 11 år (studie 7), var forekomsten maksimale transaminaseniveauer (ALAT eller ASAT) > 8, > 5 og > 3 x ULN 1,0 %, 4,9 % og 12,6 % hos patienter, der fik lumacaftor/ivacaftor, og 2,0 %, 3,0 % og 7,9 % hos placebobehandlede patienter.
English: The other ingredients are: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; povidone (K30); and sodium laurilsulfate.
Danish: Øvrige indholdsstoffer: cellulose, mikrokrystallinsk; croscarmellosenatrium, hypromelloseacetatsuccinat, povidon (K30) og natriumlaurilsulfat (Se sidst i punkt 2 - Vigtige oplysninger om indholdet af Orkambi).
English: No dose adjustment of lumacaftor/ivacaftor is recommended when clarithromycin or telithromycin are initiated in patients currently taking lumacaftor/ivacaftor.
Danish: Ingen dosisjustering af lumacaftor/ivacaftor anbefales, når clarithromycin eller telithromycin påbegyndes hos patienter, der aktuelt tager lumacaftor/ivacaftor.
English: Orkambi 150 mg/188 mg granules in sachet One sachet in the morning; One sachet in the evening
Danish: Orkambi 150 mg/188 mg granulat i brev Et brev om morgenen Et brev om aftenen
English: Trial 1 evaluated 549 patients with CF who were aged 12 years and older (mean age 25.1 years) with percent predicted FEV1 (ppFEV1) at screening between 40-90 (mean ppFEV1 60.7 at baseline [range: 31.1 to 94.0]).
Danish: Studie 1 evaluerede 549 patienter med CF i alderen 12 år og ældre (gennemsnitsalder 25,1 år) med procent forventet FEV1 (ppFEV1) ved screening fra 40-90 (gennemsnitlig ppFEV1 60,7 ved baseline [interval: 31,1 til 94,0]).
English: 1 tablet of 200 mg/125 mg in the evening (12 hours later)
Danish: 1 tablet med 200 mg/125 mg om aftenen (12 timer senere)
English: Patients aged 12 to less than 18 years lumacaftor 400 mg/ivacaftor 250 mg every 12 hours
Danish: Patienter i alderen 12 til under 18 år lumacaftor 400 mg/ivacaftor 250 mg hver 12. time
English: Due to inhibition of CYP3A by erythromycin
Danish: Da CYP3A hæmmes af erythromycin
English: ↔ LUM, IVA ↑ or ↓ ranitidine
Danish: ↔ LUM, IVA ↑ eller ↓ ranitidin
English: rifapentine
Danish: rifapentin
English: Absolute change from baseline in BMI-for-age-z-score n = 57 95% CI: 0.14, 0.45; P = 0.0003
Danish: Absolut ændring fra baseline i BMI-for-alder-z-score n = 57 95 % CI: 0,14; 0,45; P = 0,0003
English: Uncommon may affect up to 1 in 100 people:
Danish: Ikke almindelig kan forekomme hos op til 1 ud af 100 personer:
English: A higher dose of these systemic corticosteroids may be required to obtain the desired clinical effect.
Danish: Det kan være nødvendigt med en større dosis af disse systemiske kortikosteroider for at opnå den ønskede kliniske virkning.
English: • if you are allergic to lumacaftor, ivacaftor, or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for lumacaftor, ivacaftor eller et af de øvrige indholdsstoffer i Orkambi
English: Trials in patients with CF aged 6 to 11 years old who are homozygous for the F508del mutation in the CFTR gene
Danish: Studier hos patienter med CF i alderen 6 til 11 år, som er homozygote med hensyn til F508del-mutationen i CFTR-genet
English: Orkambi 100 mg/125 mg granules in sachet One sachet in the morning; One sachet in the evening
Danish: Orkambi 100 mg/125 mg granulat i brev Et brev om morgenen Et brev om aftenen
English: No dose adjustment is necessary when CYP3A inhibitors are initiated in patients currently taking lumacaftor/ivacaftor.
Danish: Ingen dosisjustering er nødvendig, når behandling med CYP3A-hæmmere påbegyndes hos patienter, der aktuelt tager lumacaftor/ivacaftor.
English: Orkambi 200 mg/125 mg is available in the following pack sizes:
Danish: Orkambi 200 mg/125 mg fås i de følgende pakningsstørrelser:
English: Ear pain*, ear discomfort*, tinnitus*, tympanic membrane hyperaemia*, vestibular disorder* uncommon Ear congestion*
Danish: Øre og labyrint almindelig Øresmerter*, øregener*, tinnitus*, hyperæmi i trommehinden*, vestibulær sygdom* ikke almindelig Propper i ørerne*
English: # of events (rate per 48 wks)
Danish: Antal hændelser (hyppighed pr. 48 uger)
English: During the 24-week, placebo-controlled Phase 3 clinical study (Trial 7) in patients aged 6 to 11 years (mean baseline ppFEV1 was 89.8), the incidence of respiratory adverse reactions was 18.4% in lumacaftor/ivacaftor patients and 12.9% in placebo patients.
Danish: I løbet af det 24-ugers, placebokontrollerede fase III kliniske studie (studie 7) hos patienter i alderen 6 til 11 år (gennemsnitlig ppFEV1 ved baseline var 89,8) var forekomsten af respiratoriske bivirkninger 18,4 % hos patienter i behandling med lumacaftor/ivacaftor og 12,9 % hos placebopatienter.
English: Orkambi 100 mg/125 mg film-coated tablets Pack containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Danish: Orkambin 100 mg/125 mg filmovertrukne tabletter Pakning indeholdende 112 filmovertrukne tabletter (4 pakninger med 28 filmovertrukne tabletter).
English: INFORMATION IN BRAILLE Orkambi 200 mg, 125 mg
Danish: INFORMATION I BRAILLESKRIFT Orkambi 200 mg, 125 mg
English: For patients aged 12 years and older 400 mg lumacaftor + 250 mg ivacaftor or a reduced daily dose
Danish: For patienter i alderen 12 år og ældre 400 mg lumacaftor + 250 mg ivacaftor eller en nedsat daglig dosis
English: • Nausea
Danish: • kvalme
English: Due to induction of CYP3A by these anticonvulsants
Danish: Da CYP3A induceres af disse antikonvulsiva
English: Absolute change from baseline in weight-for-age z-score n = 57 95% CI: 0.15, 0.38; P < 0.0001
Danish: Absolut ændring fra baseline i vægt-for-alder z-score n = 57 95 % CI: 0,15; 0,38; P < 0,0001
English: Trial 2 evaluated 559 patients aged 12 years and older (mean age 25.0 years) with ppFEV1 at screening between 40-90 (mean ppFEV1 60.5 at baseline [range: 31.3 to 99.8]).
Danish: Studie 2 evaluerede 559 patienter i alderen 12 år og ældre (gennemsnitsalder 25,0 år) med ppFEV1 ved screening fra 40-90 (gennemsnitlig ppFEV1 60,5 ved baseline [interval: 31,3 til 99,8]).
English: Following resolution of transaminase elevations, the benefits and risks of resuming dosing should be considered (see sections 4.2, 4.8, and 5.2).
Danish: Efter transaminaseforhøjelserne er vendt tilbage til normalen, bør fordele og risici ved at genoptage doseringen overvejes (se pkt.
English: For patients aged 2 to 5 years and < 14 kg lumacaftor 200 mg + ivacaftor 250 mg
Danish: For patienter i alderen 2 til 5 år og < 14 kg lumacaftor 200 mg + ivacaftor 250 mg
English: Due to induction of CYP3A by antimycobacterials
Danish: Da CYP3A induceres af antimykobakterielle midler
English: Baseline for the lumacaftor 400 mg q12h/ivacaftor 250 mg q12h group was the Trial 1 and 2 baseline.
Danish: Baseline for gruppen med lumacaftor 400 mg hver 12. time/ivacaftor 250 mg hver 12. time var baseline for studie 1 og 2.
English: During the 24-week, open-label Phase 3 clinical study in 60 patients aged 2 through 5 years (Trial 8), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and > 3 x ULN was 8.3% (5/60), 11.7% (7/60), and 15.0% (9/60).
Danish: I løbet af det 24-ugers, åbne, fase III kliniske studie hos 60 patienter i alderen 2 til og med 5 år (studie 8) var forekomsten af maksimale transaminaseniveauer (ALAT eller ASAT) > 8, > 5 og > 3 x ULN hhv. 8,3 % (5/60), 11,7 % (7/60) og 15,0 % (9/60).
English: The primary efficacy endpoint was absolute change in LCI2.5 from baseline through Week 24.
Danish: Det primære endepunkt for virkning var en absolut ændring fra baseline i LCI2.5 til og med uge 24.
English: 1 tablet of 100 mg/125 mg in the evening (12 hours later) or a reduced daily dose
Danish: 1 tablet med 100 mg/125 mg om aftenen (12 timer senere) eller en nedsat daglig dosis
English: For patients aged 6 to 11 years 1 tablet of 100 mg/125 mg in the morning +
Danish: For patienter i alderen 6 til 11 år 1 tablet med 100 mg/125 mg om morgenen +
English: Patients aged 6 to 11 years lumacaftor 200 mg/ivacaftor 250 mg every 12 hours
Danish: Patienter i alderen 6 til 11 år lumacaftor 200 mg/ivacaftor 250 mg hver 12. time
English: fexofenadine
Danish: fexofenadin
English: Trials in patients with CF aged 12 years and above who are homozygous for the F508del mutation in the CFTR gene
Danish: Studier hos patienter med CF i alderen 12 år og derover, som er homozygote med hensyn til F508delmutationen i CFTR-genet
English: Concomitant use of lumacaftor/ivacaftor with these benzodiazepines is not recommended.
Danish: Administration af lumacaftor/ivacaftor sammen med disse benzodiazepiner anbefales ikke.
English: Presentation of the lumacaftor 400 mg q12h/ivacaftor 250 mg q12h dose group is consistent with recommended posology.
Danish: Præsentationen af dosisgruppen med lumacaftor 400 mg hver 12. time/ivacaftor 250 mg hver 12. time er i overensstemmelse med den anbefalede dosering.
English: For patients aged 2 to 5 years and ≥ 14 kg lumacaftor 300 mg + ivacaftor 376 mg
Danish: For patienter i alderen 2 til 5 år og ≥ 14 kg lumacaftor 300 mg + ivacaftor 376 mg
English: Orkambi 100 mg/125 mg granules in sachet:
Danish: Orkambi 100 mg/125 mg granulat i brev:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - SINGLE PACK
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE - ENKELTPAKNING
English: Absolute change in CFQ-R Respiratory Domain Score (points)
Danish: Absolut ændring i CFQ-R-score for respiratorisk domæne (point)
English: GGT ≥ 3 times the ULN or total bilirubin ≥ 2 times the ULN) were excluded.
Danish: > 5 gange ULN eller totalt bilirubin > 2 gange ULN, blev ekskluderet.
English: A higher dose of these antidepressants may be required to obtain the desired clinical effect.
Danish: Det kan være nødvendigt med en større dosis af disse antidepressiva for at opnå den ønskede kliniske virkning.
English: At Day 15, the treatment difference between lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo for the mean absolute change (95% CI) in ppFEV1 from baseline was 2.51 percentage points in the pooled Trials 1 and 2 (P < 0.0001).
Danish: Ved dag 15 var behandlingsforskellen mellem lumacaftor 400 mg/ivacaftor 250 mg hver 12. time og placebo for den gennemsnitlige absolutte ændring (95 % CI) i ppFEV1 fra baseline 2,51 procentpoint i de samlede studier 1 og 2 (P < 0,0001).
English: INFORMATION IN BRAILLE Orkambi 100 mg, 125 mg
Danish: INFORMATION I BRAILLESKRIFT Orkambi 100 mg, 125 mg
English: 1 tablet of 200 mg/125 mg in the evening (12 hours later) or a reduced daily dose
Danish: 1 tablet med 200 mg/125 mg om aftenen (12 timer senere) eller en nedsat daglig dosis
English: If Orkambi is interrupted for more than one week and then re-initiated while taking strong CYP3A inhibitors, the Orkambi dose should be reduced to one tablet daily (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 6 to 11 years; lumacaftor 200 mg/ivacaftor 125 mg for patients aged 12 years and older) for the first week of treatment re-initiation.
Danish: Hvis Orkambi afbrydes i over en uge og dernæst genoptages, mens der tages potente CYP3A-hæmmere, skal Orkambi-dosis reduceres til én tablet dagligt (lumacaftor 100 mg/ivacaftor 125 mg for patienter i alderen 6 til 11 år, lumacaftor 200 mg/ivacaftor 125 mg for patienter i alderen 12 år og ældre) i den første uge, hvor behandlingen genoptages.
English: Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 2 years and older who are homozygous for the F508del mutation in the CFTR gene (see sections 4.2, 4.4 and 5.1).
Danish: Orkambi granulat er indiceret til behandling af cystisk fibrose (CF) hos børn i alderen 2 år og ældre, som er homozygote med hensyn til F508del-mutationen i CFTR-genet (se pkt.
English: ↓ bupropion Due to induction of CYP2B6 by LUM
Danish: Da CYP2B6 induceres af LUM
English: Placebo transitioned to Lumacaftor 400 mg q12h/ Ivacaftor 250 mg q12h (n = 176)**
Danish: Placebo, overgik til lumacaftor 400 mg hver 12. time/ ivacaftor 250 mg hver 12. time (n = 176)**
English: Lumacaftor/ivacaftor may decrease the exposures of methylprednisolone and prednisone, which may reduce their efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for methylprednisolon og prednison, hvilket kan nedsætte virkningen.
English: Caution is recommended while using lumacaftor/ivacaftor in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Danish: Der rådes til forsigtighed, når lumacaftor/ivacaftor anvendes til patienter med svært nedsat nyrefunktion eller nyresygdom i slutstadiet (se pkt.
English: Inducers of CYP3A
Danish: Inducere af CYP3A
English: One lumacaftor 150 mg/ivacaftor 188 mg sachet every 12 hours lumacaftor 300 mg/ ivacaftor 376 mg
Danish: Et brev med lumacaftor 150 mg/ivacaftor 188 mg hver 12. time lumacaftor 300 mg/ ivacaftor 376 mg
English: Orkambi 200 mg/125 mg film-coated tablets Pack containing 28 film-coated tablets.
Danish: Orkambin 200 mg/125 mg filmovertrukne tabletter Pakning indeholdende 28 filmovertrukne tabletter.
English: Absolute change from baseline in stature-for-age z-score n = 57 95% CI: 0.02, 0.15; P = 0.0104
Danish: Absolut ændring fra baseline i højde-for-alder z-score n = 57 95 % CI: 0,02; 0,15; P = 0,0104
English: During the 24-week, open-label Phase 3 clinical study in 58 patients aged 6 to 11 years (Trial 6), the incidence of maximum transaminase (ALT or AST) levels > 8, > 5, and >3 x ULN was 5.3%, 8.8%, and 19.3%.
Danish: I løbet af det 24-ugers, åbne, fase III kliniske studie hos 58 patienter i alderen 6 til 11 år (studie 6) var forekomsten af maksimale transaminaseniveauer (ALAT eller ASAT) > 8, > 5 og > 3 x ULN 5,3 %, 8,8 % og 19,3 %.
English: Hypromellose acetate succinate
Danish: Hypromelloseacetatsuccinat
English: Absolute change in CFQ-R Respiratory Domain Score at Week 24 (points)
Danish: Absolut ændring i CFQ-R-score i respiratorisk domæne ved uge 24 (point)
English: Lumacaftor/ivacaftor will decrease the exposures of midazolam and triazolam, which will reduce their efficacy.
Danish: Lumacaftor/ivacaftor vil nedsætte eksponeringen for midazolam og triazolam, hvilket kan nedsætte virkningen.
English: Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene (see sections 4.2, 4.4 and 5.1).
Danish: Orkambi tabletter er indiceret til behandling af cystisk fibrose (CF) hos patienter i alderen 6 år og ældre, som er homozygote med hensyn til F508del-mutationen i CFTR-genet (se pkt.
English: At Week 24, the treatment difference between lumacaftor 400 mg/ivacaftor 250 mg q12h and placebo for the mean absolute change (95% CI) in ppFEV1 from baseline in the pooled Trials 1 and 2 were 3.39 percentage points (P = 0.0382) for patients with ppFEV1 < 40 and 2.47 percentage points (P < 0.0001) for patients with ppFEV1 ≥ 40.
Danish: Ved uge 24 var behandlingsforskellen mellem lumacaftor 400 mg/ivacaftor 250 mg hver 12. time og placebo for den gennemsnitlige absolutte ændring (95 % CI) i ppFEV1 fra baseline i de samlede studier 1 og 2 3,39 procentpoint (P = 0,0382) for patienter med ppFEV1 < 40 og 2,47 procentpoint (P < 0,0001) for patienter med ppFEV1 ≥40.
English: ↔ LUM, IVA ↑ or ↓ dabigatran
Danish: ↔ LUM, IVA ↑ eller ↓ dabigatran
English: However, when initiating Orkambi in patients taking strong CYP3A inhibitors, the dose should be reduced to one tablet daily (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 6 to 11 years; lumacaftor 200 mg/ivacaftor 125 mg for patients aged 12 years and older) for the first week of treatment to allow for the steady state induction effect of lumacaftor.
Danish: Når Orkambi påbegyndes hos patienter, der tager potente CYP3A-hæmmere, bør dosis imidlertid reduceres til én tablet dagligt (lumacaftor 100 mg/ivacaftor 125 mg for patienter i alderen 6 til 11 år, lumacaftor 200 mg/ivacaftor 125 mg for patienter i alderen 12 år og ældre) i den første behandlingsuge for at muliggøre lumacaftors induktionsvirkning ved steady-state.
English: PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets (4 packs of 28 tablets) 56 film-coated tablets (2 packs of 28 tablets)
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 112 tabletter (4 pakninger med 28 tabletter i hver) 56 tabletter (2 pakninger med 28 tabletter i hver)
English: Orkambi 150 mg/188 mg granules in sachet Each sachet contains 150 mg of lumacaftor and 188 mg of ivacaftor.
Danish: Orkambi 150 mg/188 mg granulat i brev Hvert brev indeholder 150 mg lumacaftor og 188 mg ivacaftor.
English: For patients aged 6 to 11 years
Danish: For patienter i alderen 12 år og ældre
English: For patients aged 6 to 11 years 200 mg lumacaftor + 250 mg ivacaftor or a reduced daily dose
Danish: For patienter i alderen 6 til 11 år 200 mg lumacaftor + 250 mg ivacaftor eller en nedsat daglig dosis
English: Ivacaftor, which is one of the active components of Orkambi, has a minor influence on the ability to drive or use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Ivacaftor, som er en af de aktive komponenter i Orkambi, påvirker evnen til at føre motorkøretøj eller betjene maskiner i mindre grad. Ivacaftor kan forårsage svimmelhed (se pkt.
English: • Redness inside the ear*
Danish: • propper i ørerne*