FrancophonIA/ELRC3.0 huggingface dataset:
English: During the 24-week, open-label Phase 3 clinical study (Trial 6) in 58 patients aged 6 to 11 years (mean baseline ppFEV1 was 91.4), the incidence of respiratory adverse reactions was 6.9% (4/58).
Danish: I løbet af det 24-ugers, åbne, fase III kliniske studie (studie 6) hos 58 patienter i alderen 6 til 11 år (gennemsnitlig ppFEV1 ved baseline var 91,4) var forekomsten af respiratoriske bivirkninger 6,9 %
English: Proton pump inhibitors: esomeprazole, lansoprazole, omeprazole
Danish: Protonpumpehæmmere: esomeprazol, lansoprazol, omeprazol
English: Due to inhibition of CYP3A by fluconazole
Danish: Da CYP3A hæmmes af fluconazol
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 sachet (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 2 to 5 years and weighing less than 14 kg; lumacaftor 150 mg/ivacaftor 188 mg for patients aged 2 to 5 years and weighing 14 kg or greater) every other day 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 ét brev (lumacaftor 100 mg/ivacaftor 125 mg for patienter i alderen 2 til 5 år, der vejer under 14 kg, lumacaftor 150 mg/ivacaftor 188 mg for patienter i alderen 2 til 5 år, der vejer 14 kg og derover) hver anden dag i den første uge, hvor behandlingen genoptages.
English: Due to potential induction or inhibition of CYP2C9 by LUM
Danish: Da CYP2C9 muligvis induceres eller hæmmes af LUM
English: LUM 200 mg/IVA 250 mg q12h (n = 103)
Danish: LUM 200 mg/IVA 250 mg hver 12. t (n = 103)
English: ↓ ethinyl estradiol, norethindrone, and other progestogens Due to induction of CYP3A/UGT by LUM
Danish: norethindron og andre progestogener Da CYP3A/UGT induceres af LUM
English: • Sore throat
Danish: • ondt i halsen
English: ‡ Baseline for the placebo transitioned to lumacaftor 400 mg q12h/ivacaftor 250 mg q12h group was the Trial 3 baseline.
Danish: ‡ Baseline for placebo, der overgik til lumacaftor 400 mg hver 12. time/ivacaftor 250 mg hver 12. time, var baseline for studie 3.
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 28 tabletter
English: Lumacaftor/ivacaftor may decrease the exposures of clarithromycin and telithromycin, which may reduce their efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for clarithromycin og telithromycin, hvilket kan nedsætte virkningen.
English: Patients who had 2 or more abnormal liver function tests (ALT, AST, AP, GGT ≥ 3 times the ULN), or ALT or AST > 5 times ULN, or total bilirubin > 2 times ULN were excluded.
Danish: Patienter, der havde 2 eller flere unormale leverfunktionsprøver (ALAT, ASAT, AP, GGT ≥3 gange ULN) eller ALAT eller ASAT
English: For patients aged 6 to 11 years 300 mg lumacaftor + 375 mg ivacaftor
Danish: For patienter i alderen 6 til 11 år 300 mg lumacaftor + 375 mg ivacaftor
English: Package leaflet: Information for the patient Orkambi 100 mg/125 mg granules in sachet Orkambi 150 mg/188 mg granules in sachet lumacaftor/ivacaftor
Danish: Indlægsseddel: Information til patienten Orkambi 100 mg/125 mg granulat i brev Orkambi 150 mg/188 mg granulat i brev lumacaftor/ivacaftor
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Orkambi 150 mg/188 mg granules lumacaftor/ivacaftor
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Orkambi 150 mg/188 mg granulat lumacaftor/ivacaftor
English: For patients aged 12 years and older 800 mg lumacaftor + 500 mg ivacaftor
Danish: For patienter i alderen 12 år og ældre 800 mg lumacaftor + 500 mg ivacaftor
English: Package leaflet: Information for the patient Orkambi 100 mg/125 mg film-coated tablets Orkambi 200 mg/125 mg film-coated tablets lumacaftor/ivacaftor
Danish: Indlægsseddel: Information til patienten Orkambi 100 mg/125 mg filmovertrukne tabletter Orkambi 200 mg/125 mg filmovertrukne tabletter lumacaftor/ivacaftor
English: • Enlargement of the breast*
Danish: • brystforstørrelse*
English: ↓ midazolam, triazolam
Danish: ↓ midazolam,
English: A higher dose of these proton pump inhibitors may be required to obtain the desired clinical effect.
Danish: En større dosis af disse protonpumpehæmmere kan være påkrævet for at opnå den ønskede kliniske virkning.
English: Orkambi 200 mg/125 mg film-coated tablets 4 years
Danish: Orkambi 200 mg/125 mg filmovertrukne tabletter 4 år
English: However, when initiating Orkambi in patients taking strong CYP3A inhibitors, the dose should be reduced to one sachet (lumacaftor 100 mg/ivacaftor 125 mg for patients aged 2 to 5 years and weighing less than 14 kg; lumacaftor 150 mg/ivacaftor 188 mg for patients aged 2 to 5 years and weighing 14 kg or greater) every other day 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 ét brev (lumacaftor 100 mg/ivacaftor 125 mg for patienter i alderen 2 til 5 år, der vejer under 14 kg, lumacaftor 150 mg/ivacaftor 188 mg for patienter i alderen 2 til 5 år, der vejer 14 kg og derover) hver anden dag i den første behandlingsuge for at muliggøre lumacaftors induktionsvirkning ved steady-state.
English: Orkambi 200 mg/125 mg film-coated tablets Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Danish: Orkambi 200 mg/125 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 200 mg lumacaftor og 125 mg ivacaftor.
English: Lumacaftor/ivacaftor may decrease the exposure of hormonal contraceptives, which may reduce their efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for hormonel kontraception, hvilket kan nedsætte virkningen.
English: ↓ carbamazepine, phenobarbital, phenytoin Due to induction of CYP3A by LUM
Danish: phenobarbital, phenytoin Da CYP3A induceres af LUM
English: Two lumacaftor 200 mg/ivacaftor 125 mg tablets every 12 hours lumacaftor 800 mg/ ivacaftor 500 mg
Danish: To lumacaftor 200 mg/ivacaftor 125 mg tabletter hver 12. time lumacaftor 800 mg/ ivacaftor 500 mg
English: Dose adjustment of dabigatran may be required to obtain the desired clinical effect.
Danish: En dosisjustering af dabigatran kan være påkrævet for at opnå den ønskede kliniske virkning.
English: • Common cold*
Danish: • forkølelse*
English: Orkambi 200 mg/125 mg film-coated tablets (tablets) are pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed with “2V125” in black ink on one side.
Danish: Orkambi 200 mg/125 mg filmovertrukne tabletter (tabletter) er lyserøde, ovale tabletter (dimensioner 14 × 8,4 × 6,8 mm) præget med ”2V125” i sort blæk på den ene side.
English: Treatment with lumacaftor/ivacaftor significantly decreased the risk for exacerbations requiring hospitalisation versus placebo by 61% (rate ratio = 0.39, P < 0.0001; event rate per 48 weeks 0.17 for lumacaftor/ivacaftor and 0.45 for placebo) and reduced exacerbations requiring treatment with intravenous antibiotics by 56% (rate ratio = 0.44, P < 0.0001; event rate per 48 weeks 0.25 for lumacaftor/ivacaftor and 0.58 for placebo).
Danish: 48 uger 0,17 for lumacaftor/ivacaftor og 0,45 for placebo) og reducerede forværringer, der krævede behandling med intravenøst antibiotika med 56 % (rate ratio = 0,44, P < 0,0001, hyppigheden af hændelser pr. 48 uger 0,25 for lumacaftor/ivacaftor og 0,58 for placebo).
English: Orkambi 100 mg/125 mg film-coated tablets 3 years
Danish: Orkambi 100 mg/125 mg filmovertrukne tabletter 3 år
English: Lumacaftor/ivacaftor may alter the exposure of digoxin.
Danish: Lumacaftor/ivacaftor kan ændre eksponeringen for digoxin.
English: Absolute change in CFQ-R Respiratory Domain Score through Week 24 (points)
Danish: Absolut ændring i CFQ-R-score i respiratorisk domæne til og med uge 24 (point)
English: A higher dose of repaglinide may be required to obtain the desired clinical effect.
Danish: En større dosis af repaglinid kan være påkrævet for at opnå den ønskede kliniske virkning.
English: For patients aged 12 years and older 600 mg lumacaftor + 375 mg ivacaftor
Danish: For patienter i alderen 12 år og ældre 600 mg lumacaftor + 375 mg ivacaftor
English: STATEMENT OF ACTIVE SUBSTANCE Each sachet of granules contains 150 mg of lumacaftor and 188 mg of ivacaftor.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev med granulat indeholder 150 mg lumacaftor og 188 mg ivacaftor.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1059/006
English: NAME OF THE MEDICINAL PRODUCT Orkambi 150 mg/188 mg granules in sachet lumacaftor/ivacaftor
Danish: LÆGEMIDLETS NAVN Orkambi 150 mg/188 mg granulat i brev lumacaftor/ivacaftor
English: Two lumacaftor 100 mg/ivacaftor 125 mg tablets every 12 hours lumacaftor 400 mg/ ivacaftor 500 mg
Danish: To lumacaftor 100 mg/ivacaftor 125 mg tabletter hver 12. time lumacaftor 400 mg/ ivacaftor 500 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1059/007
English: A higher dose of ibuprofen may be required to obtain the desired clinical effect.
Danish: En større dosis af ibuprofen kan være påkrævet for at opnå den ønskede kliniske virkning.
English: Dose adjustment of fexofenadine may be required to obtain the desired clinical effect.
Danish: En dosisjustering af fexofenadin kan være påkrævet for at opnå den ønskede kliniske virkning.
English: Day 1: lumacaftor 200 mg + ivacaftor 250 mg Day 2: lumacaftor 100 mg + ivacaftor 125 mg
Danish: Dag 2: lumacaftor 100 mg + ivacaftor 125 mg
English: Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Danish: Titandioxid (E171)
English: A higher dose of fluconazole may be required to obtain the desired clinical effect.
Danish: En større dosis af fluconazol kan være påkrævet for at opnå den ønskede kliniske virkning.
English: Lumacaftor/ivacaftor may decrease the exposure of erythromycin, which may reduce its efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for erythromycin, hvilket kan nedsætte virkningen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1059/005
English: ↓ esomeprazole, lansoprazole, omeprazole Due to induction of CYP3A/2C19 by LUM
Danish: lansoprazol, omeprazol Da CYP3A/2C19 induceres af LUM
English: If you take more Orkambi than you should
Danish: Hvis du har taget for meget Orkambi
English: Due to induction of CYP3A/2C19 by LUM
Danish: Da CYP3A/2C19 induceres af LUM
English: 6.4 Special precautions for storage This medicinal product does not require any special storage conditions.
Danish: 6.6 Regler for bortskaffelse Ingen særlige forholdsregler.
English: PHARMACEUTICAL FORM AND CONTENTS 112 film-coated tablets (4 packs of 28 tablets).
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 112 tabletter (4 pakninger med 28 tabletter i hver).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Orkambi Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Lumacaftor/ivacaftor may alter the exposure of warfarin.
Danish: Lumacaftor/ivacaftor kan ændre eksponeringen for warfarin.
English: You may start taking Orkambi on any day of the week.
Danish: Du kan begynde at tage Orkambi på en vilkårlig ugedag.
English: • Multipacks containing 56 film-coated tablets (2 packs of 28 film-coated tablets).
Danish: • Multipakninger indeholdende 56 filmovertrukne tabletter (2 pakninger med 28 filmovertrukne tabletter).
English: Lumacaftor/ivacaftor may alter the exposure of fexofenadine.
Danish: Lumacaftor/ivacaftor kan ændre eksponeringen for fexofenadin.
English: A higher dose of rifabutin may be required to obtain the desired clinical effect.
Danish: En større dosis af rifabutin kan være påkrævet for at opnå den ønskede kliniske virkning.
English: What Orkambi looks like and contents of the pack Orkambi 100 mg/125 mg granules in sachet are white to off-white granules.
Danish: Orkambi 100 mg/125 mg granulat i brev er et hvidt til off-white granulat.
English: Lumacaftor/ivacaftor may alter the exposure of dabigatran.
Danish: Lumacaftor/ivacaftor kan ændre eksponeringen for dabigatran.
English: Multipacks containing 56 film-coated tablets (2 packs of 28 film-coated tablets).
Danish: Multipakninger indeholdende 56 filmovertrukne tabletter (2 pakninger med 28 filmovertrukne tabletter).
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg granules in sachet Orkambi 150 mg/188 mg granules in sachet
Danish: Orkambi 100 mg/125 mg granulat i brev Orkambi 150 mg/188 mg granulat i brev
English: Lumacaftor 400 mg q12h/ Ivacaftor 250 mg q12h (n = 369)†
Danish: Lumacaftor 400 mg hver 12. time/ ivacaftor 250 mg hver 12. time (n = 369)†
English: Check with the doctor if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: • If you have any further questions, ask your child's doctor or pharmacist.
Danish: • Spørg dit barns læge eller apotekspersonalet, hvis der er mere, du vil vide.
English: Lumacaftor/ivacaftor will decrease the exposure of these immunosuppressants, which may reduce the efficacy of these immunosuppressants.
Danish: Lumacaftor/ivacaftor vil nedsætte eksponeringen for disse immunosupprimerende midler, hvilket kan nedsætte virkningen af dem.
English: Lumacaftor/ivacaftor may decrease the exposures of these antidepressants, which may reduce their efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for disse antidepressiva, hvilket kan nedsætte virkningen.
English: Lumacaftor/ivacaftor may decrease the exposure of montelukast, which may reduce its efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for montelukast, hvilket kan nedsætte virkningen.
English: Due Date
Danish: Tidsfrist
English: Concomitant use of lumacaftor/ivacaftor with these immunosuppressants is not recommended.
Danish: Administration af lumacaftor/ivacaftor sammen med disse immunosupprimerende midler anbefales ikke.
English: Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor.
Danish: Hver filmovertrukket tablet indeholder 200 mg lumacaftor og 125 mg ivacaftor.
English: Lumacaftor/ivacaftor may alter the exposure of ranitidine.
Danish: Lumacaftor/ivacaftor kan ændre eksponeringen for ranitidin.
English: Due to induction of CYP3A by LUM
Danish: Da CYP3A induceres af LUM
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Orkambi 100 mg/125 mg granules lumacaftor/ivacaftor
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Orkambi 100 mg/125 mg granulat lumacaftor/ivacaftor
English: 6 years and older
Danish: 6 år og derover
English: Lumacaftor/ivacaftor may decrease the exposures of these proton pump inhibitors, which may reduce their efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for disse protonpumpehæmmere, hvilket kan nedsætte virkningen.
English: Orkambi 200 mg/125 mg film-coated tablets:
Danish: Orkambi 200 mg/125 mg filmovertrukne tabletter:
English: • Multipacks containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Danish: • Multipakninger indeholdende 112 filmovertrukne tabletter (4 pakninger med 28 filmovertrukne tabletter).
English: Multipacks containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Danish: Multipakninger indeholdende 112 filmovertrukne tabletter (4 pakninger med 28 filmovertrukne tabletter).
English: ↓ posaconazole Due to induction of UGT by LUM
Danish: Da UGT induceres af LUM
English: Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Danish: Hver filmovertrukket tablet indeholder 100 mg lumacaftor og 125 mg ivacaftor.
English: Decrease in heart rate
Danish: Nedsat nyrefunktion
English: A higher dose of bupropion may be required to obtain the desired clinical effect.
Danish: En større dosis af bupropion kan være påkrævet for at opnå den ønskede kliniske virkning.
English: One lumacaftor 100 mg/ivacaftor 125 mg sachet every 12 hours lumacaftor 200 mg/ ivacaftor 250 mg
Danish: Et brev med lumacaftor 100 mg/ivacaftor 125 mg hver 12. time lumacaftor 200mg/ ivacaftor 250 mg
English: Orkambi 100 mg/125 mg film-coated tablets:
Danish: Orkambi 100 mg/125 mg filmovertrukne tabletter:
English: LUM 400 mg q12h/IVA 250 mg q12h (n = 369)
Danish: LUM 400 mg hver 12. t/ IVA 250 mg hver 12. t (n = 369)
English: Each sachet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Danish: Hvert brev indeholder 100 mg lumacaftor og 125 mg ivacaftor.
English: Trial 8: Safety and tolerability study in pediatric patients with CF aged 2 to 5 years homozygous for the F508del mutation in the CFTR gene
Danish: Studie 8: Sikkerheds- og tolerabilitetsstudie hos pædiatriske patienter med CF i alderen 2 til 5 år, som var homozygote for F508del-mutationen i CFTR-genet Studie 8 evaluerede 60 patienter i alderen 2 til 5 år ved screening (gennemsnitsalder ved baseline 3,7 år).
English: The dose of lumacaftor/ivacaftor should be reduced to one tablet daily for the first week of treatment when initiating lumacaftor/ ivacaftor in patients currently taking clarithromycin or telithromycin.
Danish: Dosis af lumacaftor/ivacaftor bør reduceres til en tablet dagligt i løbet af den første uges behandling, når lumacaftor/ivacaftor påbegyndes hos patienter, der aktuelt tager clarithromycin eller telithromycin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Orkambi 100 mg/125 mg film-coated tablets Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Danish: Orkambi 100 mg/125 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 100 mg lumacaftor og 125 mg ivacaftor.
English: Lumacaftor/ivacaftor may decrease the exposure of repaglinide, which may reduce its efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for repaglinid, hvilket kan nedsætte virkningen.
English: Lumacaftor/ivacaftor may decrease the exposure of fluconazole, which may reduce its efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for fluconazol, hvilket kan nedsætte virkningen.
English: Dose adjustment of ranitidine may be required to obtain the desired clinical effect.
Danish: En dosisjustering af ranitidin kan være påkrævet for at opnå den ønskede kliniske virkning.
English: ↔ LUM
Danish: Sø.
English: Respiration abnormal, oropharyngeal pain, sinus congestion*, rhinorrhoea, pharyngeal erythema*
Danish: Tilstoppet næse, dyspnø, produktiv hoste, øget spytproduktion almindelig Unormal respiration, orofaryngeale smerter, tilstoppede bihuler*, rhinorré, faryngealt erytem*
English: LUM 400 mg q12h/IVA 250 mg q12h (n = 187)
Danish: LUM 400 mg hver 12. t/ IVA 250 mg hver 12. t (n = 187)
English: Concomitant use of lumacaftor/ivacaftor with these anticonvulsants is not recommended.
Danish: Administration af lumacaftor/ivacaftor sammen med disse antikonvulsiva anbefales ikke.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING WALLET FOR SACHET
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MAPPE TIL BREV
English: The dose of lumacaftor/ivacaftor should be reduced to one tablet daily for the first week of treatment when initiating lumacaftor/ ivacaftor in patients currently taking these antifungals.
Danish: Dosis af lumacaftor/ivacaftor bør reduceres til en tablet dagligt i løbet af den første uges behandling, når lumacaftor/ivacaftor påbegyndes hos patienter, der aktuelt tager disse antimykotika.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg film-coated tablets Orkambi 200 mg/125 mg film-coated tablets
Danish: Orkambi 100 mg/125 mg filmovertrukne tabletter Orkambi 200 mg/125 mg filmovertrukne tabletter
English: Lumacaftor/ivacaftor may decrease the exposure of rifabutin, which may reduce its efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for rifabutin, hvilket kan nedsætte virkningen.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet of granules contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev med granulat indeholder 100 mg lumacaftor og 125 mg ivacaftor.
English: LUM 400 mg q12h/ IVA 250 mg q12h (n = 182)
Danish: LUM 400 mg hver 12. t/ IVA 250 mg hver 12. t (n = 182)
English: Tablet core
Danish: Nedsat puls
English: See Orkambi tablets SmPC for further details
Danish: Se produktresuméet for Orkambi tabletter for flere oplysninger Orkambi skal tages sammen med fedtholdig mad.
English: Orkambi 100 mg/125 mg film-coated tablets and Orkambi 200 mg/125 mg film-coated tablets: The other ingredients are:
Danish: Orkambi 100 mg/125 mg filmovertrukne tabletter og Orkambi 200 mg/125 mg filmovertrukne tabletter:
English: Concomitant use of lumacaftor/ivacaftor with these anti-mycobacterials is not recommended.
Danish: Administration af lumacaftor/ivacaftor sammen med disse antimykotika anbefales ikke.
English: Due to inhibition of CYP3A by these antifungals
Danish: Da CYP3A hæmmes af disse antimykotika
English: Lumacaftor/ivacaftor may decrease the exposure of bupropion, which may reduce its efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for bupropion, hvilket kan nedsætte virkningen.
English: It may be better to avoid using Orkambi during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
Danish: Hvis det er muligt, kan det være bedst helt at undgå at tage Orkambi under graviditet.
English: What Orkambi looks like and contents of the pack Orkambi 100 mg/125 mg film-coated tablets (tablets) are pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed with “1V125” in black ink on one side.
Danish: Orkambi 100 mg/125 mg filmovertrukne tabletter (tabletter) er lyserøde, ovale tabletter (dimensioner 14 × 7,6 × 4,9 mm) præget med ”1V125” i sort blæk på den ene side.
English: • Stuffy or runny nose
Danish: • tilstoppet eller rindende næse
English: Ear and labyrinth disorders common
Danish: Luftveje, thorax og mediastinum meget almindelig
English: ↓ erythromycin Due to induction of CYP3A by LUM
Danish: telithromycin Da CYP3A induceres af LUM
English: For patients aged 2 to 5 years and < 14 kg lumacaftor 100 mg + ivacaftor 125 mg For patients aged 2 to5 years and ≥ 14 kg lumacaftor 150 mg + ivacaftor 188 mg
Danish: For patienter i alderen 2 til 5 år og ≥ 14 kg lumacaftor 150 mg + ivacaftor 188 mg
English: Lumacaftor/ivacaftor may decrease the exposure of ibuprofen, which may reduce its efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for ibuprofen, hvilket kan nedsætte virkningen.
English: ↓ ibuprofen Due to induction of CYP3A/2C8/2C9 by LUM
Danish: CYP3A/2C8/2C9 induceres af LUM
English: Baseline CFQ-R
Danish: Behandlingsfo rskel
English: Number of Pulmonary exacerbations (events) ** † *** Number of events per patient- year (95% CI) (rate per 48 wks)
Danish: Antal hændelser pr. patientår (95 % CI) (hyppighed pr. 48 uger)
English: 4.7 Effects on ability to drive and use machines
Danish: Oversigt over indlægssedlen Virkning og anvendelse
English: • Sinus congestion*
Danish: • tilstoppede bihuler*
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Orkambi 100 mg/125 mg granules in sachet Each sachet contains 100 mg of lumacaftor and 125 mg of ivacaftor.
Danish: Orkambi 100 mg/125 mg granulat i brev Hvert brev indeholder 100 mg lumacaftor og 125 mg ivacaftor.
English: Respiratory Domain Score (points)‡
Danish: Baseline CFQ-R-score for respiratorisk domæne (point)‡
English: Lumacaftor/ivacaftor may decrease the exposures of these antifungals, which may reduce their efficacy.
Danish: Lumacaftor/ivacaftor kan nedsætte eksponeringen for disse antimykotika, hvilket kan nedsætte virkningen.
English: NAME OF THE MEDICINAL PRODUCT Orkambi 200 mg/125 mg tablets lumacaftor/ivacaftor
Danish: LÆGEMIDLETS NAVN Orkambi 200 mg/125 mg tabletter lumacaftor/ivacaftor
English: NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg tablets lumacaftor/ivacaftor
Danish: LÆGEMIDLETS NAVN Orkambi 100 mg/125 mg tabletter lumacaftor/ivacaftor
English: ↓ clarithromycin, telithromycin Due to induction of CYP3A by LUM
Danish: everolimus, sirolimus, tacrolimus Da CYP3A induceres af LUM