FrancophonIA/ELRC3.0 huggingface dataset:
English: Baseline ppFEV1‡ Absolute change from baseline ppFEV1 (percentage points)
Danish: Baseline ppFEV1‡ Absolut ændring fra baseline ppFEV1 (percentage point)
English: Anti-mycobacterials: rifabutin, rifampicin*, rifapentine
Danish: Antimykobakterielle midler: rifabutin, rifampicin*, rifapentin
English: The serum concentration of digoxin should be monitored and the dose should be titrated to obtain the desired clinical effect.
Danish: Serumkoncentrationen af digoxin bør overvåges, og dosis bør titreres for at opnå den ønskede kliniske virkning.
English: Results indicate no clinically relevant difference in pharmacokinetic parameters for lumacaftor or ivacaftor between males and females.
Danish: Resultaterne indikerer ingen klinisk relevant forskel i farmakokinetiske parametre for lumacaftor eller ivacaftor mellem mænd og kvinder.
English: In vitro studies indicate that lumacaftor is a substrate of Breast Cancer Resistance Protein (BCRP).
Danish: In vitro-studier indikerer, at lumacaftor er et substrat for brystcancerresistensprotein (BCRP).
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Danish: Ivacaftor er ca. 99 % bundet til plasmaproteiner, primært til alfa 1-syre-glykoprotein og albumin.
English: • Dark urine
Danish: • mørk urin
English: • Nipple changes or pain*
Danish: • ændringer eller smerter i brystvorter*
English: Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af genotoksicitet og karcinogenicitet.
English: It is unknown whether lumacaftor and/or ivacaftor and metabolites are excreted in human milk.
Danish: Det er ukendt, om lumacaftor og/eller ivacaftor og metabolitter udskilles i human mælk.
English: Other concomitant medicinal products of clinical relevance Antiarrhythmics: digoxin
Danish: Anden samtidig medicin med klinisk relevans Antiarytmika: digoxin
English: The exposures of ivacaftor and the anticonvulsant may be significantly decreased, which may reduce the efficacy of both active substances.
Danish: Eksponeringerne for ivacaftor og antikonvulsiva kan være signifikant nedsat, hvilket kan reducere virkningen af begge aktive stoffer.
English: Abnormality of the lens of the eye (cataract) without any effect on vision has been noted in some children and adolescents treated with Orkambi and ivacaftor alone (one of the components of Orkambi).
Danish: En unormal tilstand for linsen i øjet (grå stær) uden nogen påvirkning af synet er blevet bemærket hos nogle børn og unge i behandling med Orkambi og ivacaftor alene (en af komponenterne i Orkambi).
English: Findings of cataracts were observed in juvenile rats dosed with ivacaftor at 0.32 times the maximum recommended human dose based on systemic exposure of ivacaftor and its metabolites when co-administered with lumacaftor as Orkambi.
Danish: Katarakt blev observeret hos unge rotter doseret med ivacaftor ved 0,32 gange den maksimalt anbefalede humane dosis, baseret på systemisk eksponering for ivacaftor og dets metabolitter, når det blev administreret sammen med lumacaftor som Orkambi.
English: Table 6: Long-term effect of Lumacaftor/Ivacaftor in Trial 3*
Danish: Tabel 6: Langtidsvirkning af lumacaftor/ivacaftor i studie 3*
English: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving Orkambi.
Danish: Der har været rapporter om falsk positive urin-screeningstests for tetrahydrocannabinol (THC) hos patienter, der fik Orkambi.
English: What Orkambi contains
Danish: Orkambi indeholder:
English: Contents of the pack and other information What Orkambi contains
Danish: Pakningsstørrelser og yderligere oplysninger Orkambi indeholder:
English: The F508del mutation impacts the CFTR protein in multiple ways, primarily by causing a defect in cellular processing and trafficking that reduces the quantity of CFTR at the cell surface.
Danish: F508delmutationen påvirker CFTR-proteinet på flere måder, primært ved at forårsage en defekt i celleprocesser og strømninger, som reducerer mængden af CFTR på celleoverfladen.
English: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC - an active component in cannabis) in patients receiving Orkambi.
Danish: Der har været rapporter om falsk positive urin-screeningstests for tetrahydrocannabinol (THC - en aktiv komponent i cannabis) hos patienter, der fik Orkambi.
English: • Cheese, whole milk, whole-milk dairy products
Danish: • ost, sødmælk, sødmælksprodukter
English: Table 5: Summary of primary and key secondary outcomes in Trial 1 and Trial 2*
Danish: Tabel 5: Oversigt over primære og vigtigste sekundære udfald i studie 1 og studie 2*
English: Two patients in the lumacaftor/ivacaftor group and two patients in the placebo group discontinued treatment permanently due to transaminase elevations.
Danish: To patienter i lumacaftor/ivacaftor-gruppen og to patienter i placebogruppen seponerede behandlingen permanent på grund af transaminaseforhøjelser.
English: The impact of mild hepatic impairment (Child-Pugh Class A, score 5 to 6) on pharmacokinetics of lumacaftor given in combination with ivacaftor has not been studied, but the increase in exposure is expected to be less than 50%.
Danish: En let nedsat leverfunktions (Child-Pugh klasse A, score 5 til 6) påvirkning af lumacaftors farmakokinetik, når det gives i kombination med ivacaftor, er ikke undersøgt, men forhøjelsen i eksponeringen forventes at være under 50 %.
English: If you forget to take Orkambi
Danish: Hvis du har glemt at tage Orkambi
English: No specific antidote is available for overdose with lumacaftor/ivacaftor.
Danish: Der findes ingen specifikt antidot mod en overdosis af lumacaftor/ivacaftor.
English: Marketing Authorisation Holder Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper Dublin 2, D02 EK84
Danish: Indehaver af markedsføringstilladelsen Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper Dublin 2, D02 EK84
English: If you forget to give your child Orkambi
Danish: Hvis du har glemt at give dit barn Orkambi
English: There is no experience of the use of Orkambi in patients with severe hepatic impairment (Child-Pugh Class C), but exposure is expected to be higher than in patients with moderate hepatic impairment.
Danish: Der er ingen erfaring med anvendelsen af Orkambi til patienter med svært nedsat leverfunktion (Child-Pugh klasse C), men eksponeringen forventes at være højere end hos patienter med moderat nedsat leverfunktion.
English: Table 3: Established and other potentially significant drug interactions - dose recommendations for use of lumacaftor/ivacaftor with other medicinal products
Danish: Tabel 3: Klarlagte og andre potentielt signifikante lægemiddelinteraktioner - dosisanbefalinger for anvendelse af lumacaftor/ivacaftor sammen med andre lægemidler
English: Respiratory events (e.g., chest discomfort, dyspnoea, and respiration abnormal) were more common during initiation of lumacaftor/ivacaftor therapy.
Danish: Respiratoriske hændelser (f.eks. brystgener, dyspnø og unormal respiration) var mere almindelige i den indledende fase af behandlingen med lumacaftor/ivacaftor.
English: Proportion of patients with ≥5% relative change in ppFEV1 at Week 24
Danish: Andel patienter med ≥5 % relativ ændring i ppFEV1 ved uge 24
English: Following discontinuation of lumacaftor/ivacaftor, liver function tests returned to baseline or improved substantially in all patients (see section 4.4).
Danish: Efter seponering af lumacaftor/ivacaftor vendte leverfunktionsprøver tilbage til baseline, eller de blev betydeligt forbedret hos alle patienter (se pkt.
English: The MAH shall complete, within the stated timeframe, the following measure:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: These should not be relied upon as an effective method of birth control when given with Orkambi
Danish: Disse kan ikke betragtes som sikre præventionsmidler, når de gives sammen med Orkambi
English: An increase in blood pressure has been seen in some patients treated with Orkambi.
Danish: Der er blevet observeret forhøjet blodtryk hos nogle patienter i behandling med Orkambi.
English: In vitro and in vivo data indicate that lumacaftor is mainly metabolised via oxidation and glucuronidation.
Danish: In vitro- og in vivo-data indikerer, at lumacaftor primært metaboliseres via oxidation og glukuronidation.
English: Orkambi should be taken with fat-containing food.
Danish: Orkambi skal tages sammen med fedtholdig mad.
English: Patients received either lumacaftor/ivacaftor (n = 62) or placebo (n = 63) in addition to their prescribed CF therapies.
Danish: Patienterne fik enten lumacaftor/ivacaftor (n = 62) eller placebo (n = 63) i tillæg til deres ordinerede CF-behandlinger.
English: The recommended dose for patients aged 6 years and over is two tablets in the morning, and two tablets in the evening (12 hours apart).
Danish: Den anbefalede dosis for patienter i alderen 6 år og derover er to tabletter om morgenen og to tabletter om aftenen (med 12 timers mellemrum).
English: Absolute change from baseline in body mass index (BMI)
Danish: Absolut ændring fra baseline i kropsmasseindeks (BMI)
English: Established and other potentially significant drug interactions Table 3 provides the established or predicted effect of lumacaftor/ivacaftor on other medicinal products or the effect of other medicinal products on lumacaftor/ivacaftor.
Danish: Klarlagte og andre potentielt signifikante lægemiddelinteraktioner Tabel 3 viser klarlagte eller forventede virkninger af lumacaftor/ivacaftor på andre lægemidler eller virkningen af andre lægemidler på lumacaftor/ivacaftor.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Instructions for use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Brugsanvisning
English: Additionally, in vitro studies suggest that ivacaftor may inhibit CYP2C9.
Danish: Desuden tyder in vitro-studier på, at ivacaftor kan hæmme CYP2C9.
English: Clinical experience in patients with ppFEV1 <40 is limited and additional monitoring of these patients is recommended during initiation of therapy (see section 4.8).
Danish: Klinisk erfaring hos patienter med ppFEV1 < 40 er begrænset, og der anbefales yderligere overvågning af disse patienter i løbet af den indledende fase af behandlingen (se pkt.
English: For patients aged 2 to 5 years and < 14 kg
Danish: For patienter i alderen 2 til 5 år og < 14 kg
English: In the subgroup of 28 patients who were initiated at the full dose of lumacaftor/ivacaftor (2 tablets every 12 hours), the incidence was 71.4%, and in the 18 patients who were initiated at a reduced dose of lumacaftor/ivacaftor (1 tablet every 12 hours for up to 2 weeks, and subsequently increased to the full dose), the incidence was 55.6%.
Danish: I undergruppen med 28 patienter, der blev startet på den fulde dosis af lumacaftor/ivacaftor (2 tabletter hver 12. time), var forekomsten 71,4 %, og hos de 18 patienter, der blev startet på en reduceret dosis af lumacaftor/ivacaftor (1 tablet hver 12. time i op til 2 uger og derefter øget til den fulde dosis), var forekomsten 55,6 %.
English: povidone (K30); sodium laurilsulfate; and magnesium stearate.
Danish: povidon (K30), natriumlaurilsulfat og magnesiumstearat.
English: Key Secondary Endpoints* Absolute change in BMI at Week 24 (kg/m2)
Danish: Vigtigste sekundære endepunkter* Absolut ændring i BMI ved uge 24 (kg/m2)
English: Table 1: Recommended dose of Orkambi in patients aged 6 years and older Age
Danish: Tabel 1: Anbefalet dosis af Orkambi hos patienter i alderen 6 år og ældre Alder
English: Additional adverse reactions from Trial 6 are included in Table 4.
Danish: Yderligere bivirkninger fra studie 6 er inkluderet i tabel 4.
English: Your doctor will do some blood tests to check your liver before and while you are taking Orkambi, particularly during the first year.
Danish: Din læge vil tage nogle blodprøver for at kontrollere din lever, før og mens du tager Orkambi, især i løbet af det første år.
English: Your doctor will decide whether to recommend that you stop breast-feeding or for you to stop lumacaftor/ivacaftor therapy.
Danish: Din læge vil beslutte, om det kan anbefales, at du stopper med at amme, eller om du skal stoppe behandlingen med lumacaftor/ivacaftor.
English: Anticonvulsants: carbamazepine, phenobarbital, phenytoin
Danish: Antikonvulsiva: carbamazepin, phenobarbital, phenytoin
English: Co-administration of Orkambi with medicinal products that inhibit BCRP may increase plasma lumacaftor concentration.
Danish: Administration af Orkambi sammen med lægemidler, der hæmmer BCRP, kan øge plasmakoncentrationen af lumacaftor.
English: Component of a multipack, cannot be sold separately
Danish: Kan ikke sælges separat
English: Lumacaftor is a strong inducer of CYP3A.
Danish: Lumacaftor er en potent inducer af CYP3A.
English: At week 24, the proportion of patients who remained free from pulmonary exacerbations was significantly higher for patients treated with lumacaftor/ivacaftor compared with placebo.
Danish: Ved uge 24 var andelen af patienter, som var fri for lungeforværringer, signifikant højere for patienter i behandling med lumacaftor/ivacaftor, sammenlignet med placebo.
English: Therefore, concomitant use of lumacaftor/ivacaftor with P-gp substrates (e.g., digoxin) may alter the exposure of these substrates.
Danish: Derfor kan anvendelse af lumacaftor/ivacaftor sammen med P-gp-substrater (f.eks. digoxin) ændre eksponeringen for disse substrater.
English: The safety and efficacy of Orkambi in patients aged 65 years or older have not been evaluated.
Danish: Orkambis sikkerhed og virkning hos patienter i alderen 65 år og ældre er ikke evalueret.
English: Post-Authorisation Efficacy Study (PAES) Based on an agreed protocol, the Applicant should conduct a long-term effectiveness study to compare disease progression among children with CF homozygous for F508del-CFTR and are aged 2 through 5 years at the time of Orkambi treatment initiation versus disease progression among concurrent matched cohort of children with CF who have never received Orkambi treatment, in addition to a longitudinal historical cohort.
Danish: Virkningsundersøgelse efter tilladelse til markedsføring (PAES) Baseret på en godkendt protokol skal ansøgeren udføre et studie af langvarig virkning for at sammenligne sygdomsprogression blandt børn med CF homozygot for F508del-CFTR og som er i alderen 2 til og med 5 år på tidspunktet for påbegyndelse af Orkambi-behandlingen versus sygdomsprogression blandt samtidige matchede kohorter af børn med CF, som aldrig har fået Orkambi-behandling, i tillæg til en longitudinal historisk kohorte.
English: Do not give your child a double dose to make up for the forgotten dose.
Danish: Du må ikke give dit barn en dobbeltdosis som erstatning for den glemte dosis.
English: Potential for lumacaftor/ivacaftor to interact with transporters In vitro experiments show that lumacaftor is a substrate for Breast Cancer Resistance Protein (BCRP).
Danish: Mulighed for, at lumacaftor/ivacaftor påvirker transportere In vitro-eksperimenter viser, at lumacaftor er et substrat for brystcancerresistensprotein (BCRP).
English: While taking Orkambi, you may notice that your breathing is easier, that you do not get ill as often, and/or that it is easier to gain weight.
Danish: Mens du tager Orkambi, oplever du måske, at det bliver lettere at trække vejret, at du ikke så ofte bliver syg, og/eller at du måske lettere tager på i vægt.
English: In a human pharmacokinetic study with lumacaftor alone, there was minimal elimination of lumacaftor and its metabolites in urine (only 8.6% of total radioactivity was recovered in the urine with 0.18% as unchanged parent).
Danish: I et farmakokinetisk studie hos mennesker med lumacaftor alene var der minimal elimination af ivacaftor og dets metabolitter i urinen (kun 8,6 % af den totale radioaktivitet blev genfundet i urinen, med 0,18 % som uændret udgangsstof).
English: If you have poor lung function your doctor may monitor you more closely when you start Orkambi.
Danish: Hvis du har en dårlig lungefunktion, kan din læge overvåge dig nøjere, når du begynder med Orkambi.
English: Immunosuppressants: ciclosporin, everolimus, sirolimus, tacrolimus (used after organ transplant)
Danish: Immunosupprimerende midler: ciclosporin, everolimus, sirolimus, tacrolimus (anvendes efter organtransplantation)
English: • Tear or cut sachet open along the line.
Danish: • Riv eller klip langs klippelinjen for at åbne brevet.
English: The safety and efficacy of lumacaftor/ivacaftor in patients age 65 years or older have not been evaluated.
Danish: Ældre Lumacaftor/ivacaftors sikkerhed og virkning hos patienter i alderen 65 år og ældre er ikke evalueret.
English: A population pharmacokinetic analysis of clearance versus creatinine clearance shows no trend for subjects with mild and moderate renal impairment (see section 4.2).
Danish: En populationsfarmakokinetisk analyse af clearance over for kreatininclearance viser ingen tendens for personer med let til moderat nedsat nyrefunktion (se pkt.
English: Cataracts were not observed in foetuses derived from rat dams treated during the organogenesis stage of foetal development, in rat pups exposed to a certain extent through milk ingestion prior to weaning, or in repeated dose toxicity studies with ivacaftor.
Danish: Der blev ikke observeret katarakt hos fostre fra hunrotter behandlet i løbet af organogenesestadiet af fosterudvikling, hos rotteafkom eksponeret i en vis grad via mælkeindtagelsen før afvænning eller i toksicitetsstudier med gentagne doser med ivacaftor.
English: Following multiple oral doses of lumacaftor, the exposure of lumacaftor generally increased proportional to dose over the range of 50 mg to 1000 mg every 24 hours.
Danish: Efter flere orale dosisadministrationer af lumacaftor øgedes eksponeringen af lumacaftor generelt proportionelt med dosen i intervallet fra 50 mg til 1000 mg hver 24. time.
English: Brilliant blue FCF aluminium lake (E133) Indigo carmine aluminium lake (E132)
Danish: Brilliant blue FCF aluminium lake (E133) Indigocarmin aluminium lake (E132)
English: Name and address of the manufacturer responsible for batch release Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
English: Important information about the contents of Orkambi This medicine contains less than 1 mmol sodium (23 mg) per dose, so it is essentially ‘sodium-free'.
Danish: Vigtige oplysninger om indholdet af Orkambi Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natrium-frit.
English: Transaminase elevations have been observed more frequently in paediatric patients than in adult patients.
Danish: Transaminaseforhøjelser er blevet observeret hyppigere hos pædiatriske patienter end hos voksne patienter.
English: The recommended dose
Danish: Den anbefalede dosis
English: Ivacaftor was not teratogenic when dosed orally to pregnant rats and rabbits during the organogenesis stage of foetal development at doses approximately 7 times (ivacaftor and metabolite exposure) and 46 times the ivacaftor exposure in humans at the therapeutic lumacaftor/ivacaftor dose, respectively.
Danish: Ivacaftor var ikke teratogent ved oral dosering til drægtige rotter og kaniner i løbet af organogenesestadiet af føtal udvikling ved doser, der var ca. hhv. 7 gange (ivacaftor- og metaboliteksponering) og 46 gange eksponeringen for ivacaftor hos mennesker ved den terapeutiske dosis af lumacaftor/ivacaftor.
English: * For the endpoints listed, absolute change from baseline is the mean absolute change from baseline at Week 24.
Danish: * For de anførte endepunkter er den absolutte ændring fra baseline den gennemsnitlige absolutte ændring fra baseline ved uge 24.
English: The combined effect of lumacaftor and ivacaftor is increased quantity and function of F508del-CFTR at the cell surface, resulting in increased chloride ion transport.
Danish: Den kombinerede virkning af lumacaftor og ivacaftor er en øget mængde og funktion af F508del-CFTR på celleoverfladen, hvilket fører til en øget transport af chloridioner.
English: Other medicines and Orkambi
Danish: Brug af anden medicin sammen med Orkambi
English: Patients experiencing dizziness while taking Orkambi should be advised not to drive or use machines until symptoms abate.
Danish: Patienter, der oplever svimmelhed, mens de tager Orkambi, bør rådes til ikke at føre motorkøretøj eller betjene maskiner, før symptomerne klinger af.
English: The steady-state exposure of ivacaftor is lower than that of Day 1 due to the CYP3A induction effect of lumacaftor (see section 4.5).
Danish: Steady-stateeksponeringen for ivacaftor er lavere end eksponeringen ved dag 1 på grund af CYP3Ainduktionsvirkningen af lumacaftor (se pkt.
English: Co-administration of lumacaftor/ivacaftor with rifampicin, a strong CYP3A inducer, had minimal effect on the exposure of lumacaftor, but decreased ivacaftor exposure (AUC) by 57%.
Danish: Administration af lumacaftor/ivacaftor sammen med rifampicin, en potent CYP3A-hæmmer, havde en minimal virkning på eksponeringen for lumacaftor, men det reducerede eksponeringen for ivacaftor (AUC) med 57 %.
English: The exposures are similar between adults and the paediatric population based on population (PK) analyses as presented in Table 8 below:
Danish: Eksponeringerne er sammenlignelige mellem voksne og den pædiatriske population baseret på populationsanalyser (farmakokinetiske) som vist i tabel 8 nedenfor:
English: Table 1: Recommended dose of Orkambi in patients aged 2 years and older
Danish: Tabel 1: Anbefalet dosis af Orkambi hos patienter i alderen 2 år og ældre
English: Antifungals: itraconazole*, ketoconazole, posaconazole, voriconazole
Danish: Antimykotika: itraconazol*, ketoconazol, posaconazol, voriconazol
English: Your doctor will take into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Danish: Lægen vil opveje barnets fordel ved amningen og din fordel ved behandlingen.
English: The typical apparent clearance, CL/F (CV), of lumacaftor was estimated to be 2.38 L/hr (29.4%) for patients with CF.
Danish: Den typiske tilsyneladende clearance, CL/F (CV), for lumacaftor blev estimeret til at være 2,38 l/t (29,4 %) for patienter med CF.
English: A double dose should not be taken to make up for the forgotten dose.
Danish: Der må ikke tages en dobbeltdosis som erstatning for den glemte dosis.
English: The event occurred within 5 days of the start of dosing and resolved following discontinuation of lumacaftor/ivacaftor (see section 4.4).
Danish: Hændelsen opstod inden for 5 dag efter doseringen blev startet og gik væk efter seponering af lumacaftor/ivacaftor (se pkt.
English: Table 4: Adverse reactions in lumacaftor/ivacaftor-treated patients and in patients treated with ivacaftor alone
Danish: Tabel 4: Bivirkninger hos patienter behandlet med lumacaftor/ivacaftor og hos patienter behandlet med ivacaftor alene
English: The typical CL/F (CV) of ivacaftor when given in combination with lumacaftor was estimated to be 25.1 L/hr (40.5%) for patients with CF.
Danish: Den typiske CL/F (CV) for ivacaftor, når det blev givet i kombination med lumacaftor, blev estimeret til at være 25,1 l/t (40,5 %) for patienter med CF.
English: If you have moderate or severe problems with liver function, your doctor may need to reduce the dose of Orkambi as your liver will not clear Orkambi as fast as in people who have normal liver function.
Danish: Hvis du har moderate eller svære problemer med leverfunktionen, kan det være nødvendigt, at din læge reducerer din dosis af Orkambi, da din lever ikke vil udskille Orkambi så hurtigt som hos personer med normal leverfunktion.
English: Especially tell the doctor if your child takes any of the following medicines:
Danish: Du skal især fortælle det til lægen, hvis dit barn tager nogen af de følgende lægemidler: