FrancophonIA/ELRC3.0 huggingface dataset:
English: Food or liquid should be at room temperature or below.
Danish: Maden eller væsken skal have stuetemperatur eller derunder.
English: Mean improvement in ppFEV1 was rapid in onset (Day 15) and sustained throughout the 24-week treatment period.
Danish: Der opstod hurtigt en gennemsnitlig forbedring i ppFEV1 (dag 15), som varede ved i løbet af hele den 24-ugers behandlingsperiode.
English: The incidence of these events was more common in patients with lower pre-treatment FEV1.
Danish: Forekomsten af disse hændelser var mere almindelig for patienter med en lavere FEV1 før behandling.
English: (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (frequency cannot be estimated using the available data).
Danish: MedDRA hyppighedsklassifikationen: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), og ikke kendt (hyppigheden kan ikke estimeres ud fra de forhåndenværende data).
English: Make sure that the mixture is consumed immediately and completely.
Danish: Sørg for, at barnet indtager hele blandingen straks.
English: Baseline BMI (kg/m2)‡ Absolute change from baseline in BMI (kg/m2)
Danish: Baseline BMI (kg/m2)‡ Absolut ændring fra baseline i BMI (kg/m2)
English: You can help by reporting any side effects your child may get.
Danish: Du kan hjælpe ved at indberette alle de bivirkninger, dit barn får.
English: Blister consisting of PolyChloroTriFluoroEthylene (PCTFE)/PolyVinyl Chloride (PVC) with a paper-backed aluminium foil lidding.
Danish: Blister bestående af PolyChlorTriFluorEthylen (PCTFE)/PolyVinylChlorid (PVC) med et aluminiumsfolielag med papir på bagsiden.
English: This extension trial was designed to evaluate the safety and efficacy of long-term treatment of lumacaftor/ivacaftor.
Danish: Dette forlængelsesstudie var udformet til at evaluere sikkerheden og virkningen af langvarig behandling med lumacaftor/ivacaftor.
English: It is not known if Orkambi is safe and effective in children under 2 years of age.
Danish: Det er ukendt, om Orkambi er sikkert eller effektivt til børn under 2 år.
English: Following this period, the recommended daily dose should be continued (see section 4.5).
Danish: Efter denne periode skal der fortsættes med den anbefalede daglige dosis (se pkt.
English: Pooled (Trial 1 and Trial 2)
Danish: Samlet (studie 1 og studie 2)
English: Therefore, use in transplanted patients is not recommended.
Danish: Derfor bør lægemidlet ikke anvendes til transplanterede patienter.
English: If you stop taking Orkambi You should keep taking the medicine as your doctor directs even if you feel well.
Danish: Hvis du holder op med at tage Orkambi Du skal blive ved med at tage lægemidlet efter lægens anvisning, selv hvis du har det godt.
English: The event rate per year, annualised to 48 weeks, was 0.70 in the lumacaftor/ivacaftor group and 1.14 in the placebo group.
Danish: Hyppigheden af hændelser pr. år, annualiseret til 48 uge, var 0,70 i gruppen med lumacaftor/ivacaftor og 1,14 i placebogruppen.
English: Lumacaftor is approximately 99% bound to plasma proteins, primarily to albumin.
Danish: Lumacaftor er ca. 99 % bundet til plasmaproteiner, primært til albumin.
English: Ivacaftor produced a dose-related but transient increase in the blood pressure parameters in dogs at single oral doses up to 60 mg/kg.
Danish: Ivacaftor udløste en dosisrelateret, men forbigående forhøjelse i blodtryksparametre hos hunde ved orale enkeltdoser op til 60 mg/kg.
English: Absolute change from baseline in percent predicted FEV1 at each visit†
Danish: Absolut ændring fra baseline i procent forventet FEV1 ved hvert besøg†
English: Antibiotics: clarithromycin, telithromycin
Danish: Antibiotika: clarithromycin, telithromycin
English: Since the exposure of ivacaftor is very significantly reduced when dosed in combination with lumacaftor, lumacaftor/ivacaftor should not be used in these patients.
Danish: Da eksponeringen for ivacaftor er meget signifikant reduceret, når der doseres i kombination med lumacaftor, bør lumacaftor/ivacaftor ikke anvendes til disse patienter.
English: The side effects reported with Orkambi and ivacaftor alone (one of the active substances of Orkambi) are listed below and may occur with the use of Orkambi.
Danish: De bivirkninger, der er rapporteret med Orkambi og ivacaftor alene (et af de aktive stoffer i Orkambi), er opstillet nedenfor og kan forekomme, når Orkambi anvendes.
English: • Nutritional bars or drinks
Danish: • energibarer eller -drikke
English: Following oral administration of lumacaftor, the majority of lumacaftor (51%) is excreted unchanged in the faeces.
Danish: Efter oral administration af lumacaftor udskilles størstedelen af lumacaftor (51 %) uændret i fæces.
English: The majority of events were mild or moderate in severity, non-serious and did not result in treatment discontinuation (see section 4.4).
Danish: De fleste hændelser var lette til moderate i sværhedsgrad, ikke alvorlige, og de førte ikke til behandlingsseponering (se pkt.
English: The Phase 3 trials of lumacaftor/ivacaftor included 81 patients with ppFEV1 < 40 at baseline.
Danish: Fase III-studier af lumacaftor/ivacaftor omfattede 81 patienter med ppFEV1 < 40 ved baseline.
English: Consume it completely.
Danish: Indtag det hele.
English: CYP2B6 and CYP2C substrates
Danish: CYP2B6- og CYP2C-substrater
English: Because an association with liver injury cannot be excluded, assessments of liver function tests (ALT, AST and bilirubin) are recommended before initiating lumacaftor/ivacaftor, every 3 months during the first year of treatment, and annually thereafter.
Danish: Da der ikke kan udelukkes en forbindelse med leverskade, anbefales det at vurdere leverfunktionsprøver (ALAT, ASAT og bilirubin), før behandlingen med lumacaftor/ivacaftor indledes, hver 3. måned i løbet af det første års behandling og derefter årligt.
English: PHARMACEUTICAL FORM Granules
Danish: LÆGEMIDDELFORM Granulat
English: For standard dosing recommendations see Table 1.
Danish: For standard-doseringsanbefalinger, se tabel 1.
English: Serious respiratory events were seen more frequently in patients with percent predicted FEV1 (ppFEV1) < 40, and may lead to discontinuation of the medicinal product.
Danish: Alvorlige respiratoriske hændelser blev hyppigere observeret hos patienter med procent forventet forceret eksspiratorisk volumen i det første sekund (ppFEV1) < 40 og kan føre til seponering af lægemidlet.
English: Specific studies to evaluate the phototoxic potential of lumacaftor were not conducted; however, evaluation of the available non-clinical and clinical data suggests no phototoxic liability.
Danish: Der er ikke udført specifikke studier for at evaluere det fototoksiske potentiale af lumacaftor, men evaluering af tilgængelige prækliniske og kliniske data tyder ikke på et fototoksisk potentiale.
English: Orkambi is not recommended in patients who have undergone an organ transplant.
Danish: Orkambi anbefales ikke til patienter, som har gennemgået en organstransplantation.
English: Effect on blood pressure
Danish: Virkning på blodtrykket
English: A decline in ppFEV1 at initiation of therapy was observed during serial post dose spirometry assessments.
Danish: En reduktion i ppFEV1 ved start af behandlingen blev observeret under serier af spirometrimålinger efter dosering.
English: Effects on sweat chloride
Danish: Virkning på chloridindholdet i sved
English: Respiratory events such as shortness of breath or chest tightness were seen in patients when starting Orkambi, especially in patients who have poor lung function.
Danish: Luftvejshændelser, såsom stakåndethed eller trykken for brystet, er set hos patienter, når de startede Orkambi, især hos patienter der har en dårlig lungefunktion.
English: If you experience dizziness, you should not drive or use machines until these symptoms disappear.
Danish: Hvis du oplever svimmelhed, bør du ikke føre motorkøretøj eller betjene maskiner, indtil disse symptomer er forsvundet.
English: Repeat-dose toxicity studies involving the co-administration of lumacaftor and ivacaftor revealed no special hazard for humans in terms of potential for additive and/or synergistic toxicities.
Danish: Toksicitetsstudier med gentagne doser, der omfattede administration af lumacaftor sammen med ivacaftor, viste ingen speciel risiko for mennesker med hensyn til muligheden for additive og/eller synergistiske toksiciteter.
English: Clinical comment erythromycin
Danish: Klinisk kommentar erythromycin
English: Anticoagulants: dabigatran
Danish: Antikoagulantia: dabigatran
English: • Pain or discomfort in the upper right stomach (abdominal) area
Danish: • Smerter eller ubehag i den øvre højre del af maven
English: Patients took the study drug with fat-containing food for 24 weeks in addition to their prescribed CF therapies (e.g., bronchodilators, inhaled antibiotics, dornase alfa, and hypertonic saline).
Danish: Patienterne tog studielægemidlet med fedtholdig mad i 24 uger i tillæg til deres ordinerede CF-behandlinger (f.eks. bronkodilatatorer, inhalerede antibiotika, dornase alfa og hypertonisk saltvand).
English: Adverse events that occurred at an increased incidence of ≥ 5% in the supratherapeutic dose period compared with the therapeutic dose period were headache, generalised rash, and increased transaminase.
Danish: Uønskede hændelser, der opstod med en øget forekomst på ≥5 % i den supraterapeutiske doseringsperiode, sammenlignet med den terapeutiske dosisperiode var hovedpine, generaliseret udslæt og forhøjet transaminase.
English: 1 sachet every morning and 1 sachet in the evening every other day.
Danish: 1 brev hver morgen og 1 brev om aftenen hver anden dag.
English: If the patient's genotype is unknown, an accurate and validated genotyping method should be performed to confirm the presence of the F508del mutation on both alleles of the CFTR gene.
Danish: Hvis patientens genotype er ukendt, skal der udføres en akkurat og valideret genotype-metode, så tilstedeværelsen af F508delmutationen i begge alleler af CFTR-genet bekræftes.
English: If this is not possible, give it within the hour after mixing.
Danish: Hvis dette ikke er muligt, skal barnet have blandingen inden for en time.
English: Usual dose: Take 2 tablets whole every 12 hours (morning and evening) with fat-containing food.
Danish: Sædvanlig dosis: Tag 2 hele tabletter hver 12. time (morgen og aften) sammen med fedtholdig mad.
English: Contact your doctor or pharmacist for advice.
Danish: Kontakt lægen eller apotekspersonalet for rådgivning.
English: For patients with moderate hepatic impairment (Child-Pugh Class B), a dose reduction is recommended.
Danish: For patienter med moderat nedsat leverfunktion (Child-Pugh klasse B) anbefales en dosisreduktion.
English: Lumacaftor/ivacaftor dosing was maintained or successfully resumed after interruption in all patients with transaminase elevations, except 1 patient who discontinued treatment permanently.
Danish: Doseringen med lumacaftor/ivacaftor blev opretholdt eller genoptaget med succes efter afbrydelse hos alle patienter med transaminaseforhøjelser undtagen hos 1 patient, der seponerede behandlingen permanent.
English: • Inner ear disorder (feeling dizzy or spinning)*
Danish: • sygdom i det indre øre (svimmelhed eller følelse af at snurre rundt)*
English: Lumacaftor inhibits the organic anion transporter (OAT) 1 and 3.
Danish: Lumacaftor hæmmer den organiske aniontransporter (OAT) 1 og 3.
English: Instructions for Use
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: Ivacaftor is not an inhibitor of OAT1 and OAT3.
Danish: Ivacaftor er ikke en hæmmer af OAT1 og OAT3.
English: Due to potential induction or inhibition of P-gp
Danish: På grund af den mulige induktion eller hæmning af P-gp
English: Tablets
Danish: Tabletkerne
English: Concomitant medicinal products of most clinical relevance Anti-allergics: montelukast
Danish: Samtidig medicin med størst klinisk relevans Antiallergisk medicin: montelukast
English: Therefore, concomitant use of lumacaftor/ivacaftor may alter (i.e., either increase or decrease) the exposure of CYP2C8 and CYP2C9 substrates, decrease the exposure of CYP2C19 substrates, and substantially decrease the exposure of CYP2B6 substrates.
Danish: Derfor kan samtidig anvendelse af lumacaftor/ivacaftor ændre (dvs. enten øge eller reducere) eksponeringen for CYP2C8- og CYP2C9-substrater, reducere eksponeringen for CYP2C19-substrater og væsentligt reducere eksponeringen for CYP2B6-substrater.
English: • Oral hypoglycaemics (used for the management of type 2 diabetes): repaglinide
Danish: • Orale hypoglykæmiske midler (anvendes til behandling af type 2-diabetes): repaglinid
English: Post-Authorization Safety Study (PASS) The applicant should conduct a 5-year long-term observational study with lumacaftor/ivacaftor in patients with cystic fibrosis, including also microbiological and clinical endpoints (e.g. exacerbations) according to an approved protocol.
Danish: Sikkerhedsundersøgelser efter tilladelse til markedsføring (PASS) Ansøgeren skal udføre et 5-års langtids-observationsstudie med lumacaftor/ivacaftor hos patienter med cystisk fibrose, der også indbefatter mikrobiologiske og kliniske endepunkter (f.eks. forværringer) i henhold til en godkendt protokol.
English: Abnormal blood tests of the liver have been commonly seen in some people receiving Orkambi.
Danish: Unormale blodprøver af leverfunktionen er blevet observeret med en hyppighed på almindelig hos nogle personer, der har fået Orkambi.
English: The effect of gender on lumacaftor pharmacokinetics was evaluated using a population pharmacokinetics analysis of data from clinical studies of lumacaftor given in combination with ivacaftor.
Danish: Kønnets indvirkning på lumacaftors farmakokinetik blev evalueret ved hjælp af en populationsfarmakokinetisk analyse af data fra kliniske studier med lumacaftor givet i kombination med ivacaftor.
English: Orkambi contains two active substances, lumacaftor and ivacaftor.
Danish: Orkambi indeholder to aktive stoffer, lumacaftor og ivacaftor.
English: Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden dit barn begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: If you plan to breast-feed, ask your doctor for advice before taking Orkambi.
Danish: Hvis du planlægger at amme, skal du spørge din læge til råds, før du tager Orkambi.
English: At maternally toxic doses in rats, ivacaftor produced reductions in foetal body weight; an increase in the incidence of variations in cervical ribs, hypoplastic ribs, and wavy ribs; and sternal irregularities, including fusions.
Danish: Ved doser, der var toksiske for moderdyret hos rotter, forårsagede ivacaftor reduktioner i føtal legemsvægt, en stigning i forekomsten af variationer i cervikale ribben, hypoplastiske ribben og takkede ribben og sternale uregelmæssigheder, herunder fusioner.
English: Dizziness has been reported in patients receiving ivacaftor, a component of Orkambi, which could influence the ability to drive or use machines.
Danish: Der er blevet rapporteret om svimmelhed hos patienter, der har fået ivacaftor, som er en af Orkambis komponenter, hvilket kunne påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Adverse reactions are ranked under the
Danish: Bivirkningerne er klassificeret i henhold til
English: • Anticoagulants (used to prevent blood clots from forming or growing larger in blood and blood vessels) for example: warfarin, dabigatran
Danish: • Antikoagulantia (anvendes til at forhindre, at der dannes blodpropper, eller at de vokser sig større i blodet og blodårene), f.eks.: warfarin, dabigatran
English: Therefore, Orkambi should not be used in children under the age of 2 years.
Danish: Derfor bør Orkambi ikke anvendes til børn under 2 år.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Extension Week 96
Danish: Uge 96
English: However, no ivacaftor-induced QT prolongation was observed in a dog telemetry study at single doses up to 60 mg/kg or in ECG measurements from repeat-dose studies of up to 1 year duration at the 60 mg/kg/day dose level in dogs (Cmax after 365 days = 36.2 to 47.6 μM).
Danish: Der blev imidlertid ikke observeret nogen ivacaftor-induceret QT-forlængelse i et telemetristudie med hunde ved enkeltdoser op til 60 mg/kg eller i EKG-målinger fra studier med gentagne doser på op til 1 års varighed ved et dosisniveau på 60 mg/kg/dag hos hunde (Cmax efter 365 dage = 36,2 til 47,6 μM).
English: Animal studies with lumacaftor and ivacaftor do not indicate direct or indirect harmful effects with respect to developmental and reproductive toxicity, whereas effects were noted with ivacaftor only at maternally toxic doses (see section 5.3).
Danish: Dyreforsøg med lumacaftor og ivacaftor indikerer hverken direkte eller indirekte skadelige virkninger hvad angår udviklings- og reproduktionstoksicitet, hvorimod der blev bemærket virkninger med ivacaftor alene ved doser, der var toksiske for moderdyret (se pkt.
English: Lumacaftor and ivacaftor
Danish: Lumacaftor og ivacaftor
English: Lumacaftor increases the amount of CFTR available and ivacaftor helps the abnormal protein to work more normally.
Danish: Lumacaftor øger mængden af tilgængeligt CFTR, og ivacaftor hjælper det unormale protein med at virke mere normalt.
English: Interaction with CYP2B6 and CYP2C substrates has not been investigated in vivo.
Danish: Interaktion med CYP2B6- og CYP2C-substrater er ikke undersøgt in vivo.
English: For patients who transitioned from placebo to active treatment similar changes as those observed in patients treated with lumacaftor/ivacaftor in Trial 1 or Trial 2 were seen (see Table 5).
Danish: For patienter, som overgik fra placebo til aktiv behandling, blev der observeret ændringer som dem, der blev observeret hos patienter i behandling med lumacaftor/ivacaftor i studie 1 eller studie 2 (se tabel 5).
English: Ivacaftor is a CFTR potentiator that facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein at the cell surface.
Danish: Ivacaftor er en CFTR-potentiator, der faciliterer en øget chloridtransport ved at potensere sandsynligheden for, at kanalen er åben (eller gating) for CFTR-proteinet på celleoverfladen.
English: A fat-containing meal or snack should be consumed just before or just after taking Orkambi.
Danish: Der skal indtages et fedtholdigt måltid eller en fedtholdig snack lige før eller lige efter Orkambi tages.
English: In a human pharmacokinetic study with ivacaftor alone, there was minimal elimination of ivacaftor and its metabolites in urine (only 6.6% of total radioactivity was recovered in the urine).
Danish: I et farmakokinetisk studie hos mennesker med ivacaftor alene var der minimal elimination af ivacaftor og dets metabolitter i urinen (kun 6,6 % af den totale radioaktivitet blev genfundet i urinen).
English: Lumacaftor is not extensively metabolised in humans, with the majority of lumacaftor excreted unchanged in the faeces.
Danish: Lumacaftor metaboliseres ikke i udtalt grad hos mennesker, og størstedelen af lumacaftor udskilles uændret i fæces.
English: Lumacaftor and ivacaftor are not inhibitors of OATP1B1, OATP1B3, and organic cation transporter (OCT) 1 and 2.
Danish: Lumacaftor og ivacaftor er ikke hæmmere af OATP1B1, OATP1B3 og organisk kationtransporter (OCT) 1 and 2.
English: Of the patients who were initiated lumacaftor/ivacaftor at the full dose, one patient had a serious respiratory event, three patients subsequently had their dose reduced, and three patients discontinued treatment.
Danish: Ud af de patienter, der blev startet på den fulde dosis af lumacaftor/ivacaftor, havde 1 patient en alvorlig respiratorisk hændelse, 3 patienter fik efterfølgende deres dosis nedsat, og 3 patienter seponerede behandlingen.
English: • Food containing fat should be given to your child just before or just after dosing (some examples are provided below).
Danish: • Barnet skal have fedtholdig mad lige før eller lige efter indtagelse af medicinen (se eksempler nedenfor).
English: In the event of significant elevation of ALT or AST, with or without elevated bilirubin (either ALT or AST > 5 x the upper limit of normal [ULN], or ALT or AST > 3 x ULN with bilirubin > 2 x ULN), dosing with lumacaftor/ivacaftor should be discontinued and laboratory tests closely followed until the abnormalities resolve.
Danish: I tilfælde af en signifikant forhøjelse af ALAT eller ASAT med eller uden forhøjet bilirubin (enten ALAT eller ASAT > 5 x den øvre normalgrænse [ULN], eller ALAT eller ASAT > 3 x ULN med bilirubin > 2 x ULN) bør doseringen med lumacaftor/ivacaftor seponeres, og laboratorieprøverne skal følges nøje, indtil anomalierne har fortaget sig.
English: In healthy subjects, the half-life of ivacaftor when given with lumacaftor is approximately 9 hours.
Danish: Hos raske personer er halveringstiden for ivacaftor, når det gives sammen med lumacaftor, ca. 9 timer.
English: Orkambi granules are packaged in a foil laminate [biaxially-oriented polyethylene terephthalate/polyethylene/foil/polyethylene (BOPET/PE/Foil/PE)] sachet.
Danish: 6.5 Emballagetype og pakningsstørrelser Orkambi granulat er pakket i et brev af folielaminat [biaksialt orienteret polyethylenterephthalat/polyethylen/folie/polyethylen (BOPET/PE/folie/PE)].
English: Ivacaftor did not cause developmental defects in the offspring of pregnant rats dosed orally from pregnancy through parturition and weaning at 100 mg/kg/day.
Danish: Ivacaftor forårsagede ikke udviklingsdefekter i afkommet fra drægtige rotter, der blev doseret oralt fra drægtighed til fødsel og afvænning ved 100 mg/kg/dag.
English: In vitro studies indicated that lumacaftor has the potential to both inhibit and induce P-gp.
Danish: In vitro-studier indikerede, at lumacaftor har potentialet til både at hæmme og inducere P-gp.
English: The CFTR protein is a chloride channel present at the surface of epithelial cells in multiple organs.
Danish: CFTR-proteinet er en chloridkanal, der findes på overfladen af epitelceller i flere organer.
English: Co-administration with sensitive CYP3A substrates or CYP3A substrates with a narrow therapeutic index is not recommended (see section 4.5).
Danish: Administration sammen med følsomme CYP3Asubstrater eller CYP3A-substrater med et snævert terapeutisk indeks anbefales ikke (se pkt.
English: Patients treated with lumacaftor/ivacaftor in Trial 1 or Trial 2 showed an effect that was maintained with respect to baseline after an additional 96 weeks through Trial 3.
Danish: Patienter i behandling med lumacaftor/ivacaftor i studie 1 eller studie 2 viste en virkning, der blev opretholdt i forhold til baseline efter yderligere 96 uger gennem hele studie 3.
English: • Tablet coating: polyvinyl alcohol; titanium dioxide (E171); macrogol 3350; talc; carmine (E120);
Danish: • Tabletovertræk: polyvinylalkohol, titandioxid (E171), macrogol 3350, talcum, carmin (E120),
English: Serious adverse reactions occurring in at least 0.5% of patients included hepatobiliary events, e.g., transaminase elevations, cholestatic hepatitis and hepatic encephalopathy.
Danish: Alvorlige bivirkninger, der opstod hos mindst 0,5 % af patienterne, omfattede lever- og galdevejshændelser, f.eks. transaminaseforhøjelser, kolestatisk hepatitis og hepatisk encefalopati.
English: There is potential for other medicinal products to affect lumacaftor/ivacaftor when administered concomitantly, and also for lumacaftor/ivacaftor to affect other medicinal products.
Danish: Der er mulighed for, at andre lægemidler påvirker lumacaftor/ivacaftor, når de administreres samtidigt, samt for at lumacaftor/ivacaftor også påvirker andre lægemidler.