FrancophonIA/ELRC3.0 huggingface dataset:
English: In the compassionate-use programme, no blood clots were seen in the patients receiving ATryn.
Danish: I programmet for anvendelse med særlig udleveringstilladelse optrådte der ingen blodpropper hos de patienter, som fik ATryn.
English: The European Commission granted a marketing authorisation valid throughout the EU for ATryn on 28 July 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske
English: In studies, the most common side effects with ATryn (seen in between 1 and 10 patients in 100) were dizziness, headache, haemorrhage (bleeding, including bleeding at the site of the injection or after surgery), nausea (feeling sick) and wound secretion (discharge from the surgical wound).
Danish: I undersøgelserne var de hyppigste bivirkninger ved ATryn (som optræder hos mellem 1 og 10 ud af 100 patienter) svimmelhed, hovedpine, blødning (enten blødning på injektionsstedet eller blødning efter operation), kvalme og væskeudsivning fra operationssåret.
English: Taken together, the results support the effectiveness of ATryn in preventing blood clot development in patients having surgery.
Danish: Resultaterne som helhed understøtter virkningen af ATryn til forebyggelse af, at patienter udvikler blodpropper under operation.
English: In the study, among the 13 patients in whom the effectiveness of the treatment could be assessed, two had an episode of DVT, of which only one needed treatment.
Danish: To af de 13 patienter i undersøgelsen, hos hvem behandlingens virkning kunne vurderes, fik dyb venethrombose.
English: ATryn corrects the antithrombin deficiency, and gives temporary control of the clotting disorder.
Danish: ATryn retter op på manglen på antithrombin og korrigerer derved midlertidigt forstyrrelsen i blodets koagulation.
English: What benefit has ATryn shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved ATryn?
English: See the package leaflet for full instructions.
Danish: De fuldstændige anvisninger fremgår af indlægssedlen.
English: How does ATryn work?
Danish: Hvordan virker ATryn?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atryn have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af ATryn.
English: The active substance in ATryn, antithrombin alfa, is a copy of the natural blood protein antithrombin, which is produced by ‘recombinant DNA technology': it is extracted from the milk of goats that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Danish: Det fremstilles ved "rekombinant dna-teknologi": Det udvindes af mælken fra geder, der har fået indsat et gen (dna), der gør dem i stand til at danne det menneskelige protein i mælken.
English: It contains the active substance antithrombin alfa.
Danish: Det aktive stof i ATryn, antithrombin alfa, er en kopi af det naturlige protein antithrombin i blodet.
English: It contains important information about how to take these two medicines.
Danish: Den indeholder vigtige oplysninger om, hvordan disse to lægemidler skal tages.
English: * Statistical testing was not performed due to small numbers for individual mutations.
Danish: * Statistiske tests blev ikke udført på grund af små tal for de enkelte mutationer.
English: As such, a risk to the newborns/infants cannot be excluded.
Danish: Som sådan kan en risiko for nyfødte/spædbørn ikke udelukkes.
English: Lift here to open
Danish: Løft her for at åbne
English: Peri- and post-natal development
Danish: Peri- og postnatal udvikling
English: Cases suggestive of positive rechallenge were observed.
Danish: Der blev observeret tilfælde, der tydede på positiv rechallenge.
English: * Values based on data from a single patient; standard deviation not reported.
Danish: * Værdier baseret på data fra en enkelt patient; standardafvigelse ikke rapporteret.
English: Not all pack sizes may be marketed
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført
English: Use all 7 days' doses before starting a new wallet.
Danish: Brug doserne til alle 7 dage, inden du starter på en ny mappe.
English: For patients who rolled over from study 2 the number of events was, overall, low.
Danish: For patienter, som blev overført fra studie 2, var antallet af hændelser overordnet set lavt.
English: The potential relevance of these findings in humans is unknown.
Danish: Den mulige relevans af disse fund for mennesker er ukendt.
English: It may be better to avoid using Kalydeco during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
Danish: Det kan være bedst at undgå at anvende Kalydeco under graviditeten, hvis det er muligt, og din læge vil hjælpe dig med at beslutte, hvad der er det bedste for dig og dit barn.
English: Study 4: open-label extension study
Danish: Studie 4: åbent forlængelsesstudie
English: In such cases, the starting dose should be as above recommended, but administered every other day.
Danish: I sådanne tilfælde bør startdosis være som anbefalet ovenfor, men administreret hver anden dag.
English: Treatment differencea (95% CI)
Danish: Behandlingsforskela (95 % CI)
English: Patients should be instructed to swallow the tablets whole.
Danish: Patienterne skal instrueres i at sluge tabletterne hele.
English: • Yellowing of the skin or the white part of the eyes
Danish: • gulfarvning af huden eller af det hvide i øjnene
English: Side effects seen in children and adolescents are similar to those observed in adults.
Danish: Bivirkninger, der observeres hos børn og unge, svarer til dem, der observeres hos voksne.
English: Date of first authorisation: 23 July 2012 Date of latest renewal: 28 April 2017
Danish: Dato for første markedsføringstilladelse: 23. juli 2012 Dato for seneste fornyelse: 28. april 2017
English: Sodium laurilsulfate (E487)
Danish: Natriumlaurilsulfat (E487)
English: * Treatment occurred during blinded, controlled, 48-week Phase 3 study.
Danish: * Behandlingen fandt sted i løbet af et blindet, kontrolleret 48-ugers fase 3-studie.
English: Take the tablets approximately 12 hours apart.
Danish: Tag tabletterne med ca. 12 timers mellemrum.
English: An open-label, rollover, 96 week study is on-going to evaluate the long-term safety and efficacy of the combination regimen in both patient populations.
Danish: Et åbent, 96-ugers rollover-studie er i gang for at evaluere sikkerheden og virkningen på langt sigt af kombinationsregimet i begge patientpopulationer.
English: Therefore, no dose adjustment of oral contraceptives is necessary.
Danish: Derfor er dosisjustering af oral kontraception ikke nødvendig.
English: Median (min, max)
Danish: Median (min; maks)
English: See the end of section 2 - Important information about the contents of Kalydeco.
Danish: Se sidst i punkt 2 - Vigtige oplysninger om Kalydecos indhold.
English: Kalydeco is for oral use.
Danish: Kalydeco er til oral anvendelse.
English: See section 4.5 for interactions with ciclosporin or tacrolimus.
Danish: 4.5 for interaktioner med ciclosporin eller tacrolimus.
English: Treatment of overdose consists of general supportive measures including monitoring of vital signs, liver function tests and observation of the clinical status of the patient.
Danish: Behandling af en overdosis består af generel støttebehandling, herunder monitorering af vitale tegn, leverfunktionsprøver og observation af patientens kliniske status.
English: Therefore, liver function tests are recommended for all patients prior to initiating ivacaftor, every 3 months during the first year of treatment and annually thereafter.
Danish: Derfor anbefales leverfunktionsprøver for alle patienter, før ivacaftor påbegyndes, hver 3. måned i løbet af det første års behandling og derefter årligt.
English: Potential for ivacaftor to interact with transporters
Danish: Ivacaftors potentiale til at interagere med transportører
English: Each sachet is for single use only.
Danish: Hvert brev er kun til engangsbrug.
English: Tertiary endpoints included efficacy measures such as Faecal Elastase-1 and growth parameters.
Danish: Tertiære endepunkter omfattede virkningsmålinger, såsom fækal elastase-1 og vækstparametre.
English: However, increased liver enzymes in the blood are more frequently seen in young children.
Danish: Forhøjede niveauer af leverenzymer i blodet observeres dog hyppigere hos små børn.
English: 25 kg or more
Danish: 25 kg eller mere
English: Tel: +353 (0)1 761 7299
Danish: Tlf.: +353 (0)1 761 7299
English: There were no additional improvements in study 4 (week 48 through week 144).
Danish: Der var ingen yderligere forbedring i studie 4 (uge 48 til og med uge 144).
English: A total of 36 patients continued into part 2 (18 per treatment sequence).
Danish: I alt 36 patienter fortsatte i del 2 (18 i hver behandlingssekvens).
English: Relative risk of pulmonary exacerbation
Danish: Relativ risiko for lungeforværring
English: The effect of food on ivacaftor absorption is similar for both formulations, i.e., tablets and granules.
Danish: Virkningen af mad på absorptionen af ivacaftor er tilsvarende for begge formuleringer, dvs. tabletter og granulat.
English: Some medicines can affect how Kalydeco works, or make side effects more likely.
Danish: Nogle lægemidler kan påvirke den måde, Kalydeco virker på, eller gøre bivirkninger mere sandsynlige.
English: Absolute change at week 24
Danish: Absolut ændring ved uge 24
English: At the start of the study, patients in the placebo group used some medicinal products at a higher frequency than the ivacaftor group.
Danish: Ved starten af studiet anvendte patienterne i placebogruppen nogle lægemidler med en større hyppighed end i ivacaftor-gruppen.
English: †† n = 3 for the analysis of absolute change in sweat chloride.
Danish: †† n=3 for analysen af den absolutte ændring i sved-chlorid.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of ivacaftor in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af ivacaftor til gravide kvinder.
English: Adults (≥ 18 years old)
Danish: Voksne (≥ 18 år)
English: • Moderate liver problems: the dose may be reduced to one half of the indicated dose in the table above, that is one sachet once daily.
Danish: • Moderate leverproblemer: dosis kan reduceres til halvdelen af den dosis, der er angivet i den ovenstående tabel, dvs. ét brev en gang dagligt.
English: The use of inhaled hypertonic saline was not permitted.
Danish: Anvendelse af inhaleret hypertonisk saltvand var ikke tilladt.
English: Patients continued on their prescribed standard-of-care CF therapies.
Danish: Patienterne fortsatte med deres ordinerede standardbehandling af CF.
English: An appropriate dose for children under 6 years of age and weighing less than 25 kg cannot be achieved with Kalydeco tablets.
Danish: En passende dosis for børn under 6 år, der vejer under 25 kg, kan ikke opnås med Kalydeco tabletterne.
English: No statistical analysis was conducted for subjects 12 to 17 years of age because only 2 patients were enrolled in this study.
Danish: Der blev ikke udført en statistisk analyse af personer i alderen 12 til 17 år, fordi der kun indgik 2 patienter i dette studie.
English: Otherwise, wait until your next scheduled dose as you normally would.
Danish: Ellers skal du vente indtil den næste planlagte dosis, som du normalt ville gøre.
English: Kalydeco has minor influence on the ability to drive or use machines.
Danish: Kalydeco påvirker i mindre grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og karcinogent potentiale.
English: The safety profile is generally consistent among paediatric patients aged 6 months and older and adult patients.
Danish: Sikkerhedsprofilen stemmer generelt overens for pædiatriske patienter i alderen 6 måneder og ældre og voksne patienter.
English: • Nipple changes or pain
Danish: • ændring af brystvorter eller smerter
English: Kalydeco is available in the following pack sizes:
Danish: Kalydeco findes i de følgende pakningsstørrelser:
English: Patients in study 7 were aged 2 to less than 6 years (mean age 3 years).
Danish: Patienterne i studie 7 var i alderen 2 til under 6 år (gennemsnitsalder 3 år).
English: If your child feels dizzy, it is advised that your child does not ride his/her bike or do anything else that needs his/her full attention.
Danish: Hvis dit barn føler sig svimmel, tilrådes det, at dit barn ikke cykler eller gør andre ting, der kræver barnets fulde opmærksomhed.
English: Total daily dose
Danish: Samlet daglig dosis
English: If you feel dizzy, do not drive, cycle or use machines.
Danish: Hvis du føler dig svimmel, må du ikke føre motorkøretøj, cykle eller betjene maskiner.
English: Infants aged at least 6 months, toddlers, children, adolescents and adults should be dosed according to Table 1.
Danish: Dosering Spædbørn i alderen mindst 6 måneder, småbørn, børn, unge og voksne skal doseres ifølge tabel 1.
English: In study 5, four patients with the G970R mutation were included.
Danish: I studie 5 var fire patienter med G970R-mutationen inkluderet.
English: The magnitude of increase in exposure in these patients is unknown but is expected to be higher than that observed in patients with moderate hepatic impairment.
Danish: Størrelsesordenen af den øgede eksponering hos disse patienter er ukendt, men den forventes at være højere end den observerede størrelsesorden hos patienter med moderat nedsat leverfunktion.
English: Following oral administration in healthy volunteers, the majority of ivacaftor (87.8%) was eliminated in the faeces after metabolic conversion.
Danish: Efter oral administration hos raske frivillige blev størstedelen af ivacaftor (87,8 %) elimineret i fæces efter metabolisk konvertering.
English: Kalydeco with food and drink
Danish: Brug af Kalydeco sammen med mad og drikke
English: • Once mixed, give the product to your child immediately.
Danish: • Efter opblandingen skal du straks give det til barnet.
English: Ivacaftor was permanently discontinued in one patient.
Danish: Ivacaftor blev seponeret permanent hos én patient.
English: M1 and M6 are the two major metabolites of ivacaftor in humans.
Danish: M1 og M6 er to af ivacaftors hovedmetabolitter hos mennesker.
English: Patients grouped under mutation types (n)
Danish: Patienter grupperet under mutationstype (n)
English: Ivacaftor does not bind to human red blood cells.
Danish: Ivacaftor bindes ikke til røde blodlegemer hos mennesker.
English: Kalydeco should only be prescribed by physicians with experience in the treatment of cystic fibrosis.
Danish: Kalydeco bør kun ordineres af læger med erfaring i behandling af cystisk fibrose.
English: If more than 6 hours have passed since the time the dose is usually taken, the patient should be told to wait until the next scheduled dose.
Danish: Hvis der er gået over 6 timer fra det tidspunkt, dosen normalt tages på, skal patienten instrueres i at vente til den næste planlagte dosis.
English: Similar results to part 1 were seen in part 2 of the study.
Danish: Resultaterne i del 2 af studiet svarede til resultaterne i del 1.
English: Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to treatment cannot be excluded.
Danish: Selvom andre risikofaktorer var til stede i nogle tilfælde (såsom anvendelse af kortikosteroider og eksponering for stråling), kan det ikke udelukkes, at en mulig risiko kan tilskrives behandlingen.
English: Digoxin and other P-gp substrates
Danish: Digoxin og andre P-gp-substrater
English: Currently available data are described in sections 4.4, 4.8 and 5.1, but no recommendation on a posology can be made.
Danish: 4.4, 4.8 og 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: In part 2, all patients received ivacaftor as indicated in part 1 for 16 additional weeks.
Danish: I del 2 fik alle patienter ivacaftor som angivet i del 1 i yderligere 16 uger.
English: For all patients with a history of transaminase elevations, more frequent monitoring of liver function tests should be considered.
Danish: For alle patienter med tidligere forhøjede aminotransferaser bør der overvejes en hyppigere monitorering af leverfunktionsprøverne.
English: • Pain or discomfort in the upper right stomach (abdominal) area
Danish: • smerter eller ubehag i den øvre højre del af maven
English: Insert tab below to close
Danish: Indsæt flig nedenfor for at lukke Åbn
English: Table 1: Dosing recommendations for concomitant use with moderate CYP3A inhibitors Day 1 Day 2 Day 3 Day 4*
Danish: Tabel 1: Doseringsanbefalinger for anvendelse sammen med moderate CYP3A-hæmmere Dag 1 Dag 2 Dag 3 Dag 4*
English: The exact mechanism leading ivacaftor to potentiate the gating activity of normal and some mutant CFTR forms in this system has not been completely elucidated.
Danish: Den nøjagtige mekanisme, der får ivacaftor til at potensere gating-aktiviteten for normale og visse muterede CFTR-former i dette system, er ikke blevet fuldstændigt belyst.
English: † Reflects results from the one patient with the G551S mutation with data at the 8-week time point.
Danish: † Afspejler resultater fra den ene patient med G551S-mutation med data ved 8-ugers tidspunktet.
English: Your child's doctor will determine the correct dose for your child.
Danish: Dit barns læge vil fastsætte den korrekte dosis til dit barn.
English: Use within one hour after mixing, just before or after a fat-containing meal or snack.
Danish: Anvendes inden for en time efter blanding, umiddelbart før eller efter et fedtholdigt måltid eller en fedtholdig snack.
English: If not immediately consumed, the mixture has been shown to be stable for one hour and therefore should be ingested during this period.
Danish: Hvis blandingen ikke indtages straks, er det påvist, at den vil være stabil i en time, derfor skal den indtages inden for denne periode.
English: Dosing intervals should be modified according to clinical response and tolerability.
Danish: Doseringsintervallerne bør modificeres i henhold til klinisk respons og tolerabilitet
English: Your doctor may perform some eye examinations prior to and during treatment.
Danish: Din læge kan udføre nogle øjenundersøgelser før og under behandlingen.
English: Co. Armagh BT63 5UA United Kingdom
Danish: Co. Armagh BT63 5UA Storbritannien
English: Animals studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
English: Pharmacotherapeutic group: Other respiratory system products, ATC code: R07AX02
Danish: Farmakoterapeutisk klassifikation: Andre midler med virkning på respirationssystemet, ATC-kode: R07AX02
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Do not use this medicine after the expiry date which is stated on the package after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The use of inhaled hypertonic sodium chloride was not permitted.
Danish: Brugen af inhaleret hypertonisk natriumchlorid var ikke tilladt.
English: The major metabolites M1 and M6 accounted for approximately 65% of the total dose eliminated with 22% as M1 and 43% as M6.
Danish: Hovedmetabolitterne M1 og M6 udgjorde ca. 65 % af den totale eliminerede dosis, hvoraf 22 % var M1 og 43 % var M6.
English: Juvenile animal studies
Danish: Forsøg med unge dyr
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Danish: Ca. 99 % af ivacaftor er bundet til plasmaproteiner, primært til alfa-1-syre glycoprotein og albumin.
English: Ivacaftor and its metabolites are substrates of BCRP in vitro.
Danish: Ivacaftor og dets metabolitter er substrater for BCRP in vitro.
English: 12- to 17-year-olds n = 97
Danish: 12 til 17 år n=97
English: Six patients with initial levels below 200 µg/g achieved, at week 24, a level of ≥ 200 µg/g.
Danish: -Seks patienter med indledende niveau under 200 µg/g opnåede et niveau på ≥ 200 µg/g i uge 24.
English: Meals or snacks that contain fat include those prepared with butter or oils or those containing eggs.
Danish: Måltider eller snacks, der indeholder fedt, omfatter måltider og snacks fremstillet med smør eller olie, eller som indeholder æg.
English: Study 1
Danish: Studie 1
English: Placental transfer of ivacaftor was observed in pregnant rats and rabbits.
Danish: Der blev observeret placental overførsel af ivacaftor hos drægtige rotter og kaniner.
English: In both studies, improvements in FEV1 were rapid in onset (day 15) and durable through 48 weeks.
Danish: I begge studier sås der hurtigt forbedringer i FEV1 (dag 15), og de varede ved til og med 48 uger.
English: Duration of ivacaftor treatment (weeks)
Danish: Behandlingsvarighed med ivacaftor (uger)
English: • Avocados, hummus, soy-based products (tofu)
Danish: • avocadoer, hummus, sojabaserede produkter (tofu)
English: The mean overall post-baseline value was 76.0% and 83.7%, respectively.
Danish: Den gennemsnitlige samlede værdi efter baseline var hhv. 76,0 % og 83,7 %.
English: d Hazard ratio for time to first pulmonary exacerbation e In subjects under 20 years of age (CDC growth charts)
Danish: d Hazard ratio for tid til første lungeforværring e Hos personer under 20 år (CDC vækstkurver)
English: No specific antidote is available for overdose with ivacaftor.
Danish: Der findes ingen specifik antidot for en overdosis af ivacaftor.
English: After every 12-hour dosing, steady-state plasma concentrations of ivacaftor were reached by days 3 to 5, with an accumulation ratio ranging from 2.2 to 2.9.
Danish: Efter dosering hver 12. time blev steady-state plasmakoncentrationer af ivacaftor opnået ved dag 3 til 5, med et akkumulationsforhold fra 2,2 til 2,9.
English: Important information about the contents of Kalydeco
Danish: Vigtige oplysninger om Kalydecos indhold
English: # Causes a splicing defect resulting in little-to-no CFTR protein at the cell surface
Danish: # Forårsager en splicing-defekt, der fører til kun lidt eller intet CFTR-protein på celleoverfladen.
English: The phase of the poly-T variant identified with the R117H mutation should be determined in accordance with local clinical recommendations.
Danish: Hvilken fase af poly-T-varianten, der er identificeret sammen med R117H-mutationen, skal bestemmes i henhold til lokale kliniske anbefalinger.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Danish: Ma. Ti. On. To. Fr. Lø.
English: There was negligible urinary excretion of ivacaftor as unchanged parent (less than 0.01% following a single oral dose of 500 mg).
Danish: Der var en ubetydelig udskillelse af ivacaftor i urinen som uændret udgangsstof (under 0,01 % efter en enkelt oral dosis med 500 mg).