FrancophonIA/ELRC3.0 huggingface dataset:
English: - Breathe out, and then breathe normally again.
Danish: - Pust ud, og træk vejret normalt igen.
English: No formal interaction studies have been conducted.
Danish: Der er ikke udført formelle interaktions studie.
English: The suggested order is as follows, unless otherwise advised by your doctor:
Danish: Den foreslåede rækkefølge er som følger, medmindre lægen har sagt noget andet:
English: Do not stop using your Bronchitol without talking to your doctor first, even if you feel better.
Danish: Du må ikke holde op med at bruge Bronchitol uden at tale med lægen først, også selvom du har det bedre.
English: The applicant is requested to submit periodic analysis of the CF study every 6 months for 3 years and annually for 2 years.
Danish: Ansøgeren bedes indsende periodiske analyser af CF-studie hver 6. måned i 3 år og derefter en gang om året i 2 år.
English: Talk to your doctor if the cough won't go away or worries you.
Danish: Tal med lægen, hvis hosten ikke forsvinder, eller den bekymrer dig.
English: Repeat steps 3 to 10 for each capsule - Perform these steps for each of the ten capsules.
Danish: Gentag trin 3-10 for hver kapsel - Udfør disse trin for hver af de 10 kapsler.
English: Repeat the inhalation to get your dose.
Danish: Gentag inhalationen for at få din dosis.
English: A risk to the newborns/infants cannot be excluded.
Danish: Det er derfor ikke muligt at udelukke en risiko for nyfødte/spædbørn.
English: If this does not happen, the capsule may be stuck.
Danish: Hvis det ikke sker, sidder kapslen måske fast.
English: o The need for monitoring and when to withhold treatment.
Danish: o Behovet for at monitorere behandlingen, og hvornår behandling skal seponeres.
English: Physiotherapy/exercise 4.
Danish: Fysioterapi/motion 4.
English: Aluminium/polyamide/PVC/aluminium blisters.
Danish: Aluminium/polyamid/PVC/aluminiumsblistere.
English: The Tmax after inhaled administration was 1.5 ± 0.5 hours.
Danish: Tmax efter inhaleret administration var 1,5 ± 0,5 timer.
English: Treatment dose (2-week packs) - You must use Bronchitol every day.
Danish: Behandlingsdosis (2-ugers-pakninger) - Du skal bruge Bronchitol hver dag.
English: An additional 2.8% (n=34) of patients from the three studies had incomplete MTTs and were not randomised.
Danish: Yderligere 2,8 % (n=34) af patienterne fra de tre studie havde ufuldstændige MTT'er og blev ikke randomiseret.
English: Put in the capsule - First make sure your hands are dry.
Danish: Læg kapslen i - Kontrollér først, at dine hænder er tørre.
English: Productive cough can contribute to sputum clearance.
Danish: Produktiv hoste kan bidrage til clearance af sputum.
English: All patients should be monitored until their FEV1 has returned to baseline levels.
Danish: Alle patienter skal overvåges, indtil deres FEV1 er vendt tilbage til baseline-niveauet.
English: - Coughing up blood or blood in your sputum.
Danish: - Du hoster blod op eller har blod i spyttet.
English: - Do not use a double dose to make up for a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Danish: Før lancering af lægemidlet i de enkelte medlemsstater skal indehaveren af markedsføringstilladelsen aftale indholdet af og formatet for undervisningsmaterialet med den nationale kompetente myndighed.
English: If you stop using Bronchitol your symptoms may get worse.
Danish: Hvis du holder op med at bruge Bronchitol, kan symptomerne blive værre.
English: Order of using this medicine
Danish: Rækkefølge for brug af denne medicin
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data).
Danish: 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 (≥1/100.000 til 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene om fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs webportal.
English: There are limited data from the use of mannitol in pregnant women.
Danish: Der foreligger begrænsede data vedrørende brug af mannitol til gravide kvinder.
English: A massive/serious haemoptysis is considered to be:
Danish: Svær/alvorlig hæmoptyse er:
English: The mean terminal half-life in adults was approximately 4 to 5 hours from serum and approximately 3.66 hours from urine.
Danish: Middelterminalhalveringstiden hos voksne var omkring 4-5 timer i serum og omkring 3,66 timer i urin.
English: It also helps improve the condition of your lungs and your breathing.
Danish: Det er også med til at forbedre lungernes tilstand og din vejrtrækning.
English: The 2-week treatment pack is for treatment use.
Danish: Pakningen med 2 ugers behandling er til behandlingsbrug.
English: If you forget to use Bronchitol - If you forget a dose, use it as soon as you remember it and carry on as usual.
Danish: Hvis du har glemt at bruge Bronchitol - Hvis du glemmer at tage en dosis af medicinen, skal du tage den, så snart du husker det, og fortsætte som normalt.
English: Use Bronchitol as part of your normal daily treatment routine.
Danish: Brug Bronchitol som en del af din normale daglige behandlingsrutine.
English: A small percentage of systemically absorbed mannitol undergoes hepatic metabolism to glycogen and carbon dioxide.
Danish: En lille procentdel af systemisk absorberet mannitol gennemgår metabolisering til glykogen og kuldioxid i leveren.
English: Do not try to loosen the capsule by pressing the piercing buttons again.
Danish: Du må ikke forsøge at løsne kapslen ved at trykke på prikkeknapperne igen.
English: This happens commonly.
Danish: Det er almindeligt.
English: The recommended dose of Bronchitol is 400 mg twice a day.
Danish: Den anbefalede dosis af Bronchitol er 400 mg to gange dagligt.
English: Cleaning the inhaler - Usually your inhaler will give you the correct dose of medicine for 7 days without needing cleaning.
Danish: Rengøring af inhalatoren - Inhalatoren vil normalt give den korrekte dosis medicin i 7 dage, uden at du behøver at rengøre den.
English: If excessive coughing and bronchoconstriction occurs, a beta2 agonist should be given, and oxygen if necessary.
Danish: Hvis der forekommer overdreven hoste og bronkokonstriktion, skal der gives en beta2-agonist og desuden ilt, hvis det er nødvendigt.
English: - Then twist the mouth-piece into the closed position - when it is closed you will hear a ‘click'.
Danish: - Drej derefter mundstykket til lukket position - du hører et 'klik', når den er lukket.
English: What Bronchitol contains:
Danish: Bronchitol indeholder:
English: The safety profile of Bronchitol has been evaluated in clinical studies involving more than 1200 patients.
Danish: Bronchitols sikkerhedsprofil er blevet evalueret i kliniske studier med mere end 1200 patienter.
English: The elevated lymphocyte count was within historical control values, did not progress and was essentially resolved by the end of the in life phase of the study and following withdrawal of treatment.
Danish: Det forhøjede lymfocyttal lå inden for historiske kontrolværdier, progredierede ikke og var stort set forsvundet ved afslutningen af studie levende fase og efter seponering af behandling.
English: Overall, the comparison of AUCs between Day 1 and Day 7 showed a time independence of pharmacokinetics, indicating linearity at the dose level administered in this study.
Danish: Totalt set viste sammenligningen af AUC'er mellem Dag 1 og Dag 7 en tidsuafhængighed af farmakokinetik, hvilket tydede på linearitet ved det dosisniveau, som blev administreret i denne studie.
English: There are no data on concomitant use of hypertonic saline with Bronchitol as it was excluded from the Phase 3 studies.
Danish: Der er ingen data vedrørende samtidig brug af hypertonisk saltopløsning med Bronchitol, da det var udelukket fra fase 3-studierne.
English: The doses should be taken morning and night with the evening dose taken 2-3 hours before bedtime.
Danish: Doserne skal tages morgen og aften, idet aftendosis tages 2-3 timer før sengetid.
English: Inhaled antibiotics (if applicable)
Danish: Inhalationsantibiotika (hvis relevant)
English: As a result you may get a ‘productive cough', which also helps to remove mucus from your lungs.
Danish: Du kan derfor få en såkaldt "produktiv hoste", som også hjælper med at fjerne slim fra lungerne.
English: As well as using Bronchitol you will normally keep using the other medicines you take for cystic fibrosis.
Danish: Ud over Bronchitol vil du normalt også anvende de andre lægemidler, du tager for cystisk fibrose.
English: Inhale - Tilt your head back slightly.
Danish: Inhaler - Læg hovedet lidt tilbage.
English: Table 3 - Change in FEV1 from baseline over 26 weeks in the mITT and adult populations
Danish: Tabel 3 - Ændring i FEV1 i forhold til baseline over 26 uger i mITT-populationen og den voksne population
English: Lung deposition studies have demonstrated a 24.7% deposition of inhaled mannitol confirming its distribution to the target organ.
Danish: Lungeaflejrings studie har vist en aflejring på 24,7 % af inhaleret mannitol, hvilket bekræfter dets distribution til målorganet.
English: The doctor may give you oxygen and medicines to help you breathe.
Danish: Lægen kan give dig ilt og medicin, så du bedre kan trække vejret.
English: Wash your inhaler in warm water with the mouth-piece open.
Danish: Vask inhalatoren i varmt vand med mundstykket åbent.
English: When administered intravenously, mannitol is eliminated largely unchanged by glomerular filtration and 87% of the dose is excreted in the urine within 24 hours.
Danish: Når mannitol administreres intravenøst, elimineres det stort set uændret ved glomerulær filtration, og 87 % af dosis udskilles i urinen inden for 24 timer.
English: Do not use Bronchitol - if you are allergic to mannitol - if you are sensitive to mannitol.
Danish: Brug ikke Bronchitol - hvis du er allergisk over for mannitol - hvis du er følsom over for mannitol.
English: All FEV1 measurements and SpO2 monitoring should be performed 60 seconds after dose inhalation.
Danish: Alle FEV1målinger og al SpO2-monitorering udføres 60 sekunder efter dosisinhalation.
English: Mannitol was shown not to be an irritant in an isolated bovine eye assay or when introduced into rabbit eyes.
Danish: Mannitol blev vist ikke at være irriterende i en isoleret bovin øjentest, eller når det blev indført i kaninøjne.
English: Studies in rats, mice and humans have demonstrated that mannitol has no toxic metabolites.
Danish: Studie med rotter, mus og mennesker har vist, at mannitol ikke har toksiske metabolitter.
English: Tell your doctor straight away if you notice any of the following side effects: - Severe cough.
Danish: Fortæl det straks til lægen, hvis du bemærker en eller flere af følgende bivirkninger: - Kraftig hoste.
English: Concomitant administration with hypertonic saline was not permitted in these trials.
Danish: Samtidig administration med hypertont saltvand var ikke tilladt i disse studie.
English: The inhaler device is to be replaced after one week of use.
Danish: Inhalatoren skal udskiftes efter en uges brug.
English: No treatment-related adverse effect occurred greater than 13 fold the maximal therapeutic dose.
Danish: Der forekom ingen behandlingsrelateret bivirkning ved mere end 13 gange den maksimale terapeutiske dosis.
English: • recurrent bleeding ≥100 ml/day over several days The reinstitution or withholding of Bronchitol following smaller episodes of haemoptysis should be based on clinical judgement.
Danish: • recidiverende blødning ≥100 ml/dag over flere dage Genoptagelse eller seponering af Bronchitol efter mindre episoder med hæmoptyse skal ske efter en klinisk vurdering.
English: Safety and efficacy have not been demonstrated in patients with a FEV1 of less than 30% of predicted (see section 5.1).
Danish: Sikkerhed og virkning er ikke vist hos patienter med en FEV1 på mindre end 30 % af den forventede værdi (se pkt.
English: Available data from studies DPM-CF-301 and 302 suggest that no dose adjustments are required for these patient populations.
Danish: Data fra studie DPM-CF-301 og 302 tyder på, at dosisjustering ikke er nødvendig for disse patientpopulationer.
English: If you are too sensitive to mannitol, your airways will become narrower, and you may find it harder to breathe.
Danish: Hvis du er for følsom over for mannitol, bliver luftvejene forsnævret, og du kan få sværere ved at trække vejret.
English: Leave it to dry in the air - lay it on its side with the mouth-piece open.
Danish: Lad den lufttørre - læg den på siden med mundstykket åbent.
English: You may: - feel that you cannot breathe; - become wheezy; - cough a lot.
Danish: Du kan: - føle, at du ikke kan trække vejret - få hvæsende vejrtrækning - hoste meget
English: Therefore, treatment with Bronchitol is not recommended.
Danish: Derfor anbefales behandling med Bronchitol ikke.
English: Paediatric population (6 to 17 years of age) Frequency, type and severity of adverse reactions in children are similar to those observed in adults.
Danish: Pædiatrisk population (6-17 år) Hyppighed, type og sværhedsgrad af bivirkninger hos børn svarer til det, der ses hos voksne.
English: - Keep the inhaler tilted in this way and breathe out completely (away from the inhaler).
Danish: - Hold inhalatoren vippet på denne måde, og pust helt ud (væk fra inhalatoren).
English: The limited data available in adolescents aged 12 to 17 years indicate the pharmacokinetic parameters of inhaled mannitol are similar to the adult population.
Danish: De begrænsede data, der foreligger for unge i alderen 12-17 år, tyder på, at de farmakokinetiske parametre for inhaleret mannitol er sammenlignelige med den voksne populations.
English: Bronchitol helps by increasing the amount of water on the surface of your airways and in your mucus.
Danish: Bronchitol hjælper ved at øge mængden af vand på overfladen af luftvejene og i slimen.
English: 10 hard capsules and 1 inhaler
Danish: 10 hårde kapsler og 1 inhalator
English: No evidence of carcinogenicity was observed when dietary mannitol (≤5%) was administered to mice and rats for 2 years.
Danish: Der blev ikke observeret nogen tegn på karcinogenicitet, når mannitol blev administreret i kosten (≤5 %) hos mus og rotter i 2 år.
English: Uncommon Initial insomnia
Danish: Ikke almindelig Initial insomni
English: Below is a diagram that shows what the inhaler looks like.
Danish: Nedenfor viser et diagram, hvordan inhalatoren ser ud.
English: Extra information on how to look after your inhaler - Keep your inhaler dry and always make sure your hands are dry before using it. - Never breathe or cough into your inhaler.
Danish: Yderligere oplysninger om, hvordan du passer din inhalator - Hold inhalatoren tør, og kontrollér altid, at dine hænder er tørre, før du bruger den. - Pust aldrig ud, og host aldrig i inhalatoren.
English: - If your inhaler breaks, use your second inhaler and talk to your doctor.
Danish: - Hvis inhalatoren går i stykker, skal du bruge den anden inhalator og kontakte din læge.
English: This leaflet was last revised in MM/YYYY.
Danish: Denne indlægsseddel blev senest ændret i MM/AAAA.
English: Therapeutic dose regimen(6 to 17 years of age)
Danish: Terapeutisk dosisregime (6-17 år)
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Shake it until there are no large water droplets left in the inhaler.
Danish: Ryst den, indtil der ikke er flere store dråber vand tilbage i inhalatoren.
English: Effect size estimate
Danish: Estimat af virkning
English: - The usual dose is 10 capsules (400 mg) inhaled in the morning, and 10 capsules inhaled in the evening.
Danish: - Den normale dosis er 10 kapsler (400 mg) inhaleret om morgenen og 10 kapsler inhaleret om aftenen.
English: No mutagenic or genotoxic effect has been revealed when mannitol was assayed in a standard battery of genotoxicity tests.
Danish: Der har ikke vist sig nogen mutagen eller genotoksisk virkning, når mannitol blev analyseret i et standardbatteri af genotoksicitetstest.
English: Inhaling medicines can also cause cough and this can happen with Bronchitol.
Danish: Inhalation af medicin kan også give hoste, og det kan også ske med Bronchitol.
English: Susceptible persons may suffer bronchoconstriction in the event of an inhaled overdose.
Danish: Modtagelige personer kan opleve bronkokonstriktion i tilfælde af en inhaleret overdosis.
English: Bronchitol should not be used by children and adolescents under the age of 18.
Danish: Bronchitol bør ikke bruges af børn og teenagere under 18 år.
English: Study 303 did not show a superior treatment effect of Bronchitol on FEV1 for female patients, in whom the underlying cystic fibrosis disease course may be worse than males for reasons that are not fully understood.
Danish: Studie 303 viste ikke en bedre behandlingseffekt af Bronkitol på FEV1 for kvindelige patienter, for hvem den underliggende cystiske fibrose kan være mere udtalt i forhold til mænd på grund af årsager, som ikke er fuldt forstået.
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to use and/or prescribe Bronchitol are provided with an educational pack.
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal sikre sig, at alt sundhedspersonale, som forventes at anvende og/eller ordinere Bronchitol, ved lanceringen bliver forsynet med en undervisningspakke.
English: You must let it fully dry, this can take up to 24 hours.
Danish: Det kan tage op til 24 timer.
English: However, studies conducted with orally administered mannitol indicated no teratogenic effects in mice or rats, at doses of up to 1.6 g/kg, or in hamsters at 1.2 g/kg.
Danish: Studie med mannitol administreret peroralt viste imidlertid ingen teratogen virkning hos mus eller rotter ved doser på op til 1,6 g/kg eller hos hamstere ved 1,2 g/kg.
English: Stop using Bronchitol and see a doctor straight away if you notice the following serious side effects: - Difficulty breathing, which may be due to narrowing of the airways, worsening of asthma symptoms or wheezing.
Danish: Stop med at bruge Bronchitol, og søg straks læge, hvis du bemærker nogle af følgende alvorlige bivirkninger: - Problemer med vejrtrækningen, som kan skyldes en forsnævring af luftvejene, forværring af astmasymptomer eller hvæsende vejrtrækning.
English: This is because piercing the capsule more than once may make it split or break-up.
Danish: Det er, fordi kapslen kan brække eller gå i stykker, hvis du gennemborer den mere end én gang.
English: Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
Danish: Bronchitol er indiceret til behandling af cystisk fibrose (CF) hos voksne på 18 år og derover som tillægsbehandling til bedste behandlingsstandard.
English: Pregnancy and breast-feeding - If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Graviditet og amning - Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: However, studies conducted with mannitol administered via other routes indicated no effect on foetal survival in mice, rats and hamsters and on embryo and foetal development in rats and rabbits.
Danish: Studie med mannitol administreret via andre veje viste imidlertid ingen virkning på fosteroverlevelsen hos mus, rotter og hamstere og på fosterudviklingen hos rotter og kaniner.
English: The safety/efficacy of Bronchitol in patients with asthma has not been formally studied.
Danish: Sikkerheden/virkningen af Bronchitol hos patienter med astma er ikke formelt undersøgt.
English: The safety profile of Bronchitol is based on the safety data from Phase III clinical studies (including data from the initiation dose assessment).
Danish: Sikkerhedsprofilen for Bronchitol er baseret på sikkerhedsdata fra kliniske fase 3-studier (herunder data fra vurderingen af startdosen).
English: Initiation dose must be used under medical supervision and include monitoring of lung function.
Danish: Initialdosis skal anvendes under medicinsk overvågning og inkludere monitorering af lungefunktion.
English: While the exact mechanism of action is unknown, inhaled mannitol may change the viscoelastic properties of mucus, increase the hydration of the periciliary fluid layer and contribute to increased mucus clearance of the retained secretions through mucociliary activity.
Danish: Den præcise virkningsmekanisme er ukendt, men inhaleret mannitol kan ændre de viskoelastiske egenskaber i mucus, øge hydreringen af det periciliære væskelag og bidrage til øget mucusclearance af de retinerede sekreter gennem mucociliær aktivitet.
English: It is not known if this medicine passes into the breast milk.
Danish: Det vides ikke, om dette lægemiddel udskilles i modermælk.
English: As a consequence, these patients should be carefully monitored, and Bronchitol should be withheld in the event of massive haemoptysis.
Danish: Derfor skal disse patienter monitoreres nøje, og Bronchitol skal tilbageholdes i tilfælde af svær hæmoptyse.
English: The cumulative amount of mannitol filtered into the urine over the 24 hour collection period was similar for inhaled (55%) and oral (54%) mannitol.
Danish: Den kumulative mængde mannitol, som blev filtreret til urinen over den 24-timers indsamlingsperiode, var sammenlignelig for inhaleret (55 %) og peroral (54 %) mannitol.
English: As the effects of a possible hyperresponsive reaction on the mother and/or foetus are unknown, caution should be exercised when prescribing Bronchitol to pregnant women.
Danish: Da virkningen af en eventuel hyperreaktiv reaktion på moderen og/eller fosteret ikke er kendt, bør der udvises forsigtighed ved ordination af Bronchitol til gravide.
English: Nonclinical toxicology studies indicate that mannitol inhaled into the lungs is absorbed into the bloodstream, with the maximum serum concentration being achieved occurring at 1 hour.
Danish: Ikke-kliniske toksikologiske studie tyder på, at mannitol, som inhaleres i lungerne, absorberes i blodet, og den maksimale serumkoncentration nås efter 1 time.
English: It must not be administered by any other route or using any other inhaler.
Danish: Det må ikke administreres på anden måde eller med en anden inhalator.
English: Initiation dose (6 to 17 years of age)
Danish: Initialdosis (6-17 år)
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: If either of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using this medicine.
Danish: Hvis et af ovenstående gælder for dig (eller hvis du ikke er sikker), skal du tale med lægen eller apotekspersonalet, før du begynder at bruge medicinen.
English: It is unknown whether mannitol is excreted in human milk.
Danish: Det er ukendt, om mannitol udskilles i human mælk.