FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant should submit yearly analyses from December 2017 to 2020 and the final CSR by December 2021.
Danish: Ansøgeren skal indsende årlige analyser fra december 2017 til 2020 og den endelige CSR i december 2021.
English: The apparent terminal half-life is approximately 26 hours.
Danish: Den tilsyneladende terminale halveringstid er ca. 26 timer.
English: Total daily dose
Danish: Total daglig dosis
English: Age, weight
Danish: Alder, vægt
English: White to off-white granules.
Danish: Hvidt til off-white granulat.
English: The worsening of liver function can be fatal.
Danish: Forværringen af leverfunktionen kan være dødelig.
English: These results were not considered statistically significant within the framework of the testing hierarchy for the individual studies.
Danish: Disse resultater blev ikke anset for at være statistisk signifikante inden for rammerne af testhierarkiet for de enkelte studier.
English: ** All patients had pancreatic insufficiency at baseline.
Danish: ** Alle patienter havde pankreasinsufficiens ved baseline.
English: The post-dose decline was resolved by Week 16.
Danish: Reduktionen postdosis var væk ved uge 16.
English: An alternative confirmatory method should be considered to verify results.
Danish: Der bør overvejes en alternativ bekræftelsesmetode til at verificere resultaterne.
English: Majority of patients discontinued for reasons other than safety.
Danish: Hovedparten af patienterne udgik af studiet af andre årsager end sikkerhed.
English: These results are presented in Table 7 below:
Danish: Disse resultater vises i tabel 7 nedenfor:
English: † 1 patient out of 738 ‡ 2 patients out of 738
Danish: † 1 patient ud af 738 ‡ 2 patienter ud af 738
English: † From Trials 1, 2 and 3.
Danish: † Fra studie 1, 2 og 3.
English: Juvenile animals
Danish: Unge dyr
English: In some instances, these elevations have been associated with concomitant elevations in total serum bilirubin.
Danish: I nogle tilfælde er disse forhøjelser blevet forbundet med samtidige forhøjelser i totalt serum-bilirubin.
English: If more than 6 hours have passed, the patient should be instructed to wait until the next scheduled dose.
Danish: Hvis der er gået over 6 timer, skal patienten instrueres i at vente til den næste planlagte dosis.
English: No dose adjustments are necessary based on gender.
Danish: Ingen dosisjustering er nødvendig baseret på køn.
English: (listed in section 6).
Danish: (angivet i punkt 6),
English: Patients from these trials were eligible to roll over into a blinded extension study.
Danish: Patienter fra disse studier var egnede til at overgå i et blindet forlængelsesstudie.
English: Following this period, the recommended daily dose should be continued.
Danish: Efter denne periode skal der fortsættes med den anbefalede daglige dosis.
English: Respiratory events
Danish: Respiratoriske hændelser
English: Changes in FEV1
Danish: Ændringer i FEV1
English: There are different strengths of Orkambi according to a child's age and weight.
Danish: Der er forskellige styrker af Orkambi i henhold til barnets alder og vægt.
English: Based on exposure and indicated doses, the interaction profile is considered to be the same for all strengths and pharmaceutical forms.
Danish: Baseret på eksponering og angivne doser anses interaktionsprofilen for at være den samme for alle styrker og lægemiddelformer.
English: † Indicates statistical significance confirmed in the hierarchical testing procedure.
Danish: †Indikerer bekræftet statistisk signifikans i den hierarkiske testprocedure.
English: Treatment of overdose consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling af en overdosis består af generel støttebehandling, herunder overvågning af vitale tegn og observation af patientens kliniske status.
English: Carmine (E120)
Danish: Carmin (E120)
English: Secondary endpoints*
Danish: Sekundære endepunkter*
English: OTHER Morning Evening
Danish: ANDET Morgen Aften
English: * Trial included key secondary and other secondary endpoints.
Danish: * Studiet inkluderede de vigtigste sekundære og andre sekundære endepunkter.
English: Patients aged 12 to 17 years were included in Trials 1 and 2.
Danish: Patienter i alderen 12 til 17 år var inkluderet i studie 1 og 2.
English: Percent predicted FEV1 was also evaluated as a clinically meaningful other secondary endpoint.
Danish: Procent forventet FEV1 blev også evalueret som et klinisk meningsfyldt andet sekundært endepunkt.
English: * Based on clinical drug-drug interaction studies.
Danish: * Baseret på kliniske lægemiddelinteraktionsstudier.
English: Improvements in ppFEV1 were observed regardless of age, disease severity, sex and geographic region.
Danish: Der blev observeret forbedringer i ppFEV1 uanset alder, sygdommens sværhedsgrad, køn og geografisk område.
English: No patients had total bilirubin levels > 2 x ULN.
Danish: Ingen patienter havde totale bilirubinniveauer > 2 x ULN.
English: False Positive Urine Tests for THC
Danish: Falsk positive urintests for THC
English: These serious side effects are uncommon (may affect up to 1 in 100 people).
Danish: Disse alvorlige bivirkninger er ikke almindelige (kan forekomme hos op til 1 ud af 100 personer).
English: Drug interactions that have the most clinical relevance are listed first.
Danish: Lægemiddelinteraktioner med størst klinisk relevans er opstillet først.
English: No data are available (see section 5.1).
Danish: Der foreligger ingen data (se pkt.
English: Other forms of this medicine (granules in a sachet) are more suitable for children under 6 years of age, ask your doctor or pharmacist.
Danish: Andre former af dette lægemiddel (granulat i et brev) er bedre egnet til børn under 6 år, spørg lægen eller apotekspersonalet.
English: H2 blockers: ranitidine
Danish: H2-blokkere: ranitidin
English: Check you have been given the right tablet (below).
Danish: Kontroller, at du har fået den rigtige tablet (nedenunder).
English: M1 and M6 are the two major metabolites of ivacaftor in humans.
Danish: M1 og M6 er de to væsentligste metabolitter af ivacaftor hos mennesker.
English: Patients should be monitored closely for breakthrough fungal infections if such drugs are necessary.
Danish: Patienterne bør overvåges nøje for gennembruds-svampeinfektioner, hvis sådanne lægemidler er nødvendige.
English: Once mixed, the mixture has been shown to be stable for one hour.
Danish: Efter opblanding er det blevet vist, at blandingen er stabil i en time.
English: See section 4.5 for interactions with immunosuppressants.
Danish: 4.5 for interaktioner med immunosupprimerende midler.
English: 1 sachet per day or less frequently
Danish: 1 brev dagligt eller mindre hyppigt
English: *** The event rate per patient-year was annualised to 48 weeks.
Danish: *** Hyppigheden af hændelser pr. patientår blev annualiseret til 48 uger.
English: The information reported in Table 3 mostly derives from in vitro studies.
Danish: Informationerne i tabel 3 stammer primært fra in vitro-studier.
English: The significance of these findings for humans is unknown.
Danish: Betydningen af disse fund for mennesker er ukendt.
English: Orkambi should only be prescribed by physicians with experience in the treatment of CF.
Danish: Orkambi bør kun ordineres af læger med erfaring i behandling af CF.
English: Concomitant medicinal product class:
Danish: Klasse af samtidige lægemidler:
English: Side effects seen in children are similar to those seen in adults and adolescents.
Danish: Bivirkninger observeret hos børn svarer til de bivirkninger, der er observeret hos voksne og unge.
English: 6 to 11 years
Danish: 6 til 11 år
English: Final Report: December 2025
Danish: Endelig rapport: December 2025
English: That is a total of four tablets per day, to be taken with food containing fat.
Danish: Det er i alt fire tabletter om dagen, der skal tages sammen med fedtholdig mad.
English: In order to evaluate off drug effects, patients had a safety follow-up visit following a 2-week washout period.
Danish: For at evaluere virkningen uden lægemiddel, havde patienten en sikkerhedsopfølgning efter en 2-ugers udvaskningsperiode.
English: Meals and snacks recommended in CF guidelines or meals recommended in standard nutritional guidelines contain adequate amounts of fat.
Danish: Måltider og snacks, der anbefales i retningslinjerne for CF, eller måltider, der anbefales i generelle retningslinjer for ernæring, har et tilstrækkeligt fedtindhold.
English: • Usual dose: Take one sachet of ORKAMBI granules every 12 hours.
Danish: • Sædvanlig dosis: Tag et brev med ORKAMBI granulat hver 12. time.
English: After Day 15, heart rate was not monitored in the period after dosing in these studies.
Danish: Efter dag 15 blev pulsen ikke målt i perioden efter dosering i disse studier.
English: • Abnormal periods, including the absence or infrequent menses, or more frequent or heavier menstrual bleeding
Danish: • unormal menstruation, herunder udebleven eller sjælden menses, eller hyppigere eller kraftigere menstruationsblødning
English: All other drug interactions shown are predicted.
Danish: Alle andre viste lægemiddelinteraktioner er forventede.
English: Interim Analysis: December 2022
Danish: Interimanalyse: December 2022
English: Most of these reactions were mild or moderate in severity and non-serious.
Danish: De fleste af disse reaktioner var lette til moderate i sværhedsgrad og ikke alvorlige.
English: An alternative to these antibiotics, such as azithromycin, should be considered.
Danish: Alternativer til disse antibiotika bør overvejes, såsom azithromycin.
English: There are different strengths of Orkambi tablet for different age groups.
Danish: Der er forskellige styrker af Orkambi-tabletter til forskellige aldersgrupper.
English: Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to ivacaftor cannot be excluded (see section 5.3).
Danish: Selvom andre risikofaktorer var til stede i nogle tilfælde (såsom brug af kortikosteroider og eksponering for stråling), kan en mulig risiko, som kan tilskrives ivacaftor, ikke udelukkes (se pkt.
English: At Week 24, 16% of children had a reduction in sweat chloride below 60 mmol/L, and none below 30 mmol/L.
Danish: Ved uge 24 havde 16 % af børnene en reduktion i chloridindholdet i sved under 60 mmol/l, og ingen under 30 mmol/l.
English: No dose adjustment for montelukast is recommended.
Danish: Ingen dosisjustering anbefales for montelukast.
English: * In each study, a hierarchical testing procedure was performed within each active treatment arm for primary and secondary endpoints vs. placebo; at each step, P ≤ 0.0250 and all previous tests also meeting this level of significance was required for statistical significance.
Danish: *I hvert studie blev der udført en hierarkisk testprocedure inden for hver arm med aktiv behandling for primære og sekundære endepunkter vs. placebo, ved hvert trin var P ≤ 0,0250 og alle tidligere tests, som også opfyldte dette signifikansniveau, påkrævet for statistisk signifikans.
English: The recommendations provided under “Clinical comment” in Table 3 are based on drug interaction studies, clinical relevance, or predicted interactions due to elimination pathways.
Danish: Anbefalingerne under ”Klinisk kommentar” i tabel 3 er baseret på lægemiddelinteraktionsstudier, klinisk relevans eller forventede interaktioner fra eliminationsveje.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: Once mixed, the product has been shown to be stable for one hour, and therefore should be ingested during this period.
Danish: Det er påvist, at præparatet efter opblandingen er stabilt i en time, og det skal derfor indtages i løbet af denne periode.
English: 2 tablets in the morning 2 tablets in the evening
Danish: 2 tabletter om morgenen 2 tabletter om aftenen
English: For patients with a history of ALT, AST, or bilirubin elevations, more frequent monitoring should be considered.
Danish: For patienter med tidligere forhøjelser af ALAT, ASAT eller bilirubin bør en hyppigere overvågning overvejes.
English: • Obligation to conduct post-authorisation measures:
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse:
English: Lift here to open
Danish: Oral anvendelse Løft her for at åbne
English: Approximately three-quarters of the events began during the first week of treatment, and in most patients the events resolved without dosing interruption.
Danish: Ca. tre-fjerdedele af hændelserne begyndte i løbet af den første behandlingsuge og gik hos de fleste patienter væk uden dosisafbrydelse.
English: Blood pressure should be monitored periodically in all patients during treatment (see section 4.8).
Danish: Blodtrykket skal kontrolleres periodisk hos alle patienterne under behandlingen (se pkt.
English: Active substance name Effect
Danish: Navn på det aktive stof Virkning
English: The clinical relevance of the magnitude of these changes in children 2 to 5 years with cystic fibrosis has not been clearly ascertained in longer-term treatment.
Danish: Den kliniske relevans af størrelsesordenen af disse ændringer hos børn i alderen 2 til 5 år med cystisk fibrose er ikke blevet helt klarlagt ved behandling i længere tid.
English: The primary efficacy analysis of this extension study included data up to Week 72 of Trial 3 with a sensitivity analysis that included data up to Week 96 of Trial 3.
Danish: Den primære virkningsanalyse for dette forlængelsesstudie inkluderede data op til uge 72 fra studie 3 med en følsomhedsanalyse, der inkluderede data op til uge 96 fra studie 3.
English: • Increase of an enzyme in your blood (blood creatine phosphokinase)
Danish: • forhøjet niveau af et enzym i blodet (kreatinphosphokinase)
English: Results from Trial 3 are presented in Figure 1 and Table 6.
Danish: Resultater fra studie 3 er vist i figur 1 og tabel 6.
English: ↓ itraconazole,
Danish: ↓ itraconazol,
English: *Side effects seen for ivacaftor alone.
Danish: *Bivirkninger observeret for ivacaftor alene.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 November 2015
Danish: Dato for første markedsføringstilladelse: 19. november 2015
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of lumacaftor/ivacaftor in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af lumacaftor/ivacaftor til gravide kvinder.
English: The safety profile in these paediatric patients is generally consistent with that in adult patients.
Danish: Sikkerhedsprofilen hos disse pædiatriske patienter svarer generelt til profilen hos voksne patienter.
English: Benzodiazepines: midazolam, triazolam ↔ LUM, IVA
Danish: Benzodiazepiner: midazolam, triazolam ↔ LUM, IVA
English: Orkambi tablets should not be used in children under the age of 6 years.
Danish: Orkambi tabletter bør ikke anvendes til børn under 6 år.
English: • Yellowing of the skin or the white part of the eyes
Danish: • Gulfarvning af huden eller af det hvide i øjnene
English: • Avocados, hummus, soy-based products (tofu)
Danish: • avocado, hummus, soyabaserede produkter (tofu)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Orkambi in one or more subsets of the paediatric population in cystic fibrosis.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Orkambi i en eller flere undergrupper af den pædiatriske population med cystisk fibrose (se pkt.
English: The recommended dose for patients aged 2 years and over is indicated in the table below.
Danish: Den anbefalede dosis for patienter i alderen 2 år og derover er angivet i tabellen nedenfor.
English: Note: ↑ = increase, ↓ = decrease, ↔ = no change; LUM = lumacaftor; IVA = ivacaftor.
Danish: Bemærk: ↑ = forhøjelse, ↓ = reduktion, ↔ = ingen ændring, LUM = lumacaftor, IVA = ivacaftor.
English: An alternative to erythromycin, such as azithromycin, should be considered.
Danish: Alternativer til erythromycin bør overvejes, såsom azithromycin.
English: Swallow the tablets whole.
Danish: Slug tabletterne hele.
English: • Once mixed, give the product to your child immediately.
Danish: • Efter opblanding skal du straks give blandingen til barnet.
English: If less than 6 hours have passed since the missed dose, the scheduled dose of Orkambi should be taken with fat-containing food.
Danish: Hvis der er gået under 6 timer siden den glemte dosis, skal den planlagte dosis Orkambi tages sammen med fedtholdig mad.
English: Side effects in children
Danish: Bivirkninger hos børn
English: Absolute change from baseline in faecal elastase-1 (FE-1) levels (µg/g)**
Danish: Absolut ændring fra baseline i fækal elastase-1 (FE-1)niveauer (µg/g)**
English: The treatment difference in this subgroup was comparable to that observed in patients with ppFEV1 ≥ 40.
Danish: Forskellen i behandlingen i denne undergruppe svarede til den observerede forskel hos patienter med ppFEV1 ≥40.
English: Use all 7 days' doses before starting a new wallet.
Danish: Oral anvendelse Morgen Aften Brug doserne til alle 7 dage, inden du starter på en ny mappe.
English: People with the mutation will produce an abnormal CFTR protein.
Danish: Personer med mutationen vil danne et unormalt CFTR-protein.
English: These menstrual events occurred more frequently in the subset of female patients who were taking hormonal contraceptives (25.0%) versus patients who were not taking hormonal contraceptives (3.5%) (see section 4.5).
Danish: Disse menstruationshændelser opstod hyppigere hos en undergruppe af kvindelig patienter, der tog hormonal kontraception (25,0 %), versus patienter, der ikke tog hormonal kontraception (3,5 %) (se pkt.
English: Your doctor may request another test to verify results.
Danish: Din læge kan anmode om en anden test til at verificere resultaterne.
English: Check your child has been given the right dose (below).
Danish: Kontroller, at dit barn har fået den rigtige dosis (nedenunder).
English: Your child's doctor may request another test to verify results.
Danish: Dit barns læge kan anmode om en anden test til at verificere resultaterne.
English: Pharmacotherapeutic group: Other respiratory system products; ATC code: R07AX30
Danish: Farmakoterapeutisk klassifikation: Andre midler mod sygdomme i respirationssystemet, ATC-kode: R07AX30
English: Worsening of liver function in patients with advanced liver disease has been reported.
Danish: Forværring af leverfunktionen hos patienter med fremskreden leversygdom er blevet rapporteret.
English: Your child must keep using all other medicines, unless your child's doctor tells you to stop using any.
Danish: Dit barn skal blive ved med at bruge alle andre lægemidler, medmindre lægen fortæller dit barn, at han/hun skal holde op med at bruge et eller flere af dem.
English: Orkambi has to be taken in the morning and in the evening (12 hours apart) with food containing fat.
Danish: Orkambi skal tages om morgenen og om aftenen (med 12 timers mellemrum) sammen med fedtholdig mad.
English: Children under 2 years old
Danish: Børn under 2 år
English: Method of administration Orkambi is for oral use.
Danish: Indgivelsesmåde Orkambi er til oral anvendelse.
English: Examples of other fat-containing foods are:
Danish: Eksempler på andre fedtholdige fødevarer:
English: Oral hypoglycemics: repaglinide
Danish: Orale hypoglykæmiske midler: repaglinid
English: No serious respiratory events, dose reductions or discontinuations were seen in patients who were initiated at the half dose (see section 4.4).
Danish: Ingen alvorlige respiratoriske hændelser, dosisreduktioner eller seponeringer blev observeret hos patienter, der blev startet på den halve dosis (se pkt.
English: Children under 6 years old
Danish: Børn under 6 år
English: * A total of 82% (421 of 516 eligible patients) completed 72 weeks of this study; 42% completed 96 weeks.
Danish: *I alt 82 % (421 ud af 516 egnede patienter) gennemførte 72 uger af dette studie.
English: Serious side effects for Orkambi include raised levels of liver enzymes in the blood, liver injury and worsening of pre-existing severe liver disease.
Danish: Alvorlige bivirkninger for Orkambi omfatter forhøjede niveauer af leverenzymer i blodet, leverskader og forværring af eksisterende svær leversygdom.
English: 12 years and older
Danish: 12 år og ældre
English: Adverse reactions observed with ivacaftor alone are also provided in Table 4.
Danish: Bivirkninger, der er observeret med ivacaftor alene, er også angivet i tabel 4.
English: Doses above 100 mg/kg/day resulted in survival and lactation indices that were 92% and 98% of control values, respectively, as well as reductions in pup body weights.
Danish: Doser over 100 mg/kg/dag førte til overlevelses- og laktationsindeksværdier, der var hhv. 92 % og 98 % af kontrolværdierne, samt reduktioner i afkommets kropsvægt.
English: Following oral administration of ivacaftor alone, the majority of ivacaftor (87.8%) is eliminated in the faeces after metabolic conversion.
Danish: Efter oral administration af ivacaftor alene elimineres størstedelen af ivacaftor (87,8 %) i fæces efter metabolisk konvertering.
English: Table 8: Summary of secondary outcomes in Trial 8
Danish: Tabel 8: Oversigt over sekundære udfald i studie 8
English: In both trials, treatment with lumacaftor/ivacaftor resulted in a statistically significant improvement in ppFEV1 (Table 5).
Danish: I begge studier førte behandlingen med lumacaftor/ivacaftor til en statistisk signifikant forbedring i ppFEV1 (tabel 5).
English: Number of pulmonary exacerbations through Week 24
Danish: Antal lungeforværringer til og med uge 24
English: In lumacaftor/ivacaftor-treated patients, approximately two-thirds of these reactions resolved, and the median duration was 10 days.
Danish: Hos lumacaftor/ivacaftor-behandlede patienter gik ca. to-tredjedele af disse reaktioner væk, og medianvarigheden var 10 dage.
English: Patients with advanced liver disease
Danish: Patienter med fremskreden leversygdom
English: Placental transfer of ivacaftor was observed in pregnant rats and rabbits.
Danish: Der blev observeret placentaoverførsel af ivacaftor hos drægtige rotter og kaniner.
English: Lumacaftor/ivacaftor should be used with caution in patients with advanced liver disease and only if the benefits are expected to outweigh the risks.
Danish: Lumacaftor/ivacaftor bør anvendes med forsigtighed hos patienter med fremskreden leversygdom, og kun hvis det forventes, at fordelene opvejer risici.
English: Each sachet is for single use only.
Danish: Hvert brev er beregnet til en enkelt anvendelse.
English: The small amount of F508del-CFTR that reaches the cell surface has low channel-open probability (defective channel gating).
Danish: Den lille mængde F508del-CFTR, der når til celleoverfladen, har en lav sandsynlighed for, at kanalen er åben (defekt gating af kanalen).
English: Baseline and Endpoint
Danish: Baseline og endepunkt
English: • Irregular periods (menses) or pain with menses
Danish: • uregelmæssig menstruation (menses) eller menstruationssmerter
English: Co-administration of Orkambi with medicinal products that are substrates for OAT1/3 and BCRP transport may increase plasma concentrations of such medicinal products.
Danish: Administration af Orkambi sammen med lægemidler, der er substrater for OAT1/3- og BCRP-transport kan øge plasmakoncentrationerne af sådanne lægemidler.
English: Patients should not chew, break, or dissolve the tablets.
Danish: Patienterne må ikke tygge, knække eller opløse tabletterne.
English: Cellulose, microcrystalline
Danish: Cellulose, mikrokrystallinsk
English: Abnormalities in liver function, including advanced liver disease, can be present in patients with CF.
Danish: Unormal leverfunktion, herunder fremskreden leversygdom, kan være til stede hos patienter med CF.