FrancophonIA/ELRC3.0 huggingface dataset:
English: It is for inhalation use only and must not be administered by any other route.
Danish: Det er kun til inhalering og må ikke indtages på nogen anden måde.
English: In dogs an increased occurrence of coughing was observed both during and immediately post dose for low and high dose inhaled mannitol administration.
Danish: Hos hunde blev der observeret forhøjet forekomst af hoste både under og umiddelbart efter administration af både høj og lav dosis inhaleret mannitol.
English: - Take a steady deep breath in, to fill your lungs - then hold your breath for 5 seconds.
Danish: - Tag en rolig, dyb indånding for at fylde lungerne, - og hold derefter vejret i
English: In DPM-CF-303 imputation of missing data was performed using a baseline observation carried forward (BOCF) approach whereas no imputation was performed in DPM-CF-301 or DPM-CF-302.
Danish: I DPM-CF-303 blev imputation af manglende data udført ved anvendelse af en BOCF-tilgang (baseline observation carried forward), hvorimod ingen imputation blev udført i DPM-CF-301 eller DPM-CF-302.
English: In female patients, the adjusted mean change in FEV1 was 27ml for Bronchitol and 44ml for the control arm, suggesting potentially inferior benefit on lung function with Bronchitol compared to the control, although the difference was not statistically significant (p=0.480).
Danish: Hos kvindelige patienter var den justerede gennemsnitlige ændring i FEV1 på 27 ml for Bronkitol og 44 ml for kontrolgruppen, hvilket antyder en potentielt ringere fordel ved Bronkitol på lungefunktion sammenlignet med kontrolgruppen, skønt forskellen ikke var statistisk signifikant (p=0,480).
English: The rate and extent of absorption of mannitol after inhaled administration was very similar to that observed after oral administration.
Danish: Absorptionshastigheden og absorptionsomfang for mannitol efter inhaleret administration var meget lig den, der blev observeret efter peroral administration.
English: The initiation dose pack is used during the initiation dose assessment with your doctor.
Danish: Pakningen med initialdosen bruges under vurderingen af initialdosen hos din læge.
English: There is no evidence that mannitol is accumulated in the body, therefore distribution of inhaled mannitol was not examined in PK studies.
Danish: Der er ingen dokumentation for, at mannitol akkumuleres i kroppen, og derfor blev distributionen af inhaleret mannitol ikke undersøgt i PK-studie.
English: CARTON - 2-WEEK TREATMENT PACK
Danish: ÆSKE - 2-UGERS BEHANDLINGSPAKNING
English: After inhalation, each empty capsule is discarded before inserting the next capsule into the inhaler device with as little delay as possible between capsules.
Danish: Efter inhalation kasseres den tomme kapsel, før den næste indføres i inhalatoren med så lille forsinkelse mellem kapslerne som muligt.
English: The use of Bronchitol is not recommended in these patients.
Danish: Bronchitol anbefales ikke til disse patienter.
English: In a study of 18 healthy male adult volunteers, the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously was 0.59% ± 0.15.
Danish: I en studie af 18 raske, unge, mandlige, frivillige forsøgspersoner var den absolutte biotilgængelighed af mannitolpulver til inhalation sammenlignet med mannitol administreret intravenøst 0,59 % ± 0,15.
English: Check the capsule - Look to see if the capsule is empty - the capsule must spin in the inhaler in order to empty.
Danish: Kontrollér kapslen - Se efter, om kapslen er tom - kapslen skal rotere i inhalatoren for at blive tømt.
English: Clear colourless hard capsules marked with ‘PXS 40 mg' and containing white or almost white powder.
Danish: Klare, farveløse, hårde kapsler mærket med 'PXS 40 mg', som indeholder hvidt eller næsten hvidt pulver.
English: Cough which led to cessation of treatment was also commonly experienced and was observed in 4.0% of patients in the Bronchitol treatment arm.
Danish: Hoste, som førte til seponering af behandling, var også almindelig og blev observeret hos 4,0 % af patienterne i Bronchitol-behandlingsarmen.
English: When you breathe in you should hear a ‘rattling' sound as the capsule spins in the inhaler.
Danish: Når du trækker vejret ind, skal du høre en 'raslende' lyd, når kapslen roterer i inhalatoren.
English: As a precautionary measure, it is preferable to avoid the use of Bronchitol during pregnancy.
Danish: Som en sikkerhedsforanstaltning bør Bronchitol undgås under graviditet.
English: Breathe out - Take the inhaler away from your mouth.
Danish: Pust ud - Tag inhalatoren ud af munden.
English: Patients should be trained to practice correct inhaler technique during treatment and advised to report persistent cough with the use of Bronchitol to their physician.
Danish: Patienterne skal uddannes i at benytte den korrekte inhalationsteknik under behandlingen og rådes til at rapportere vedvarende hoste i forbindelse med brug af Bronchitol til lægen.
English: Your doctor will help you take your first dose of Bronchitol and check your lung function before, during and after dosing.
Danish: Lægen hjælper dig med at tage den første dosis Bronchitol og kontrollerer din lungefunktion før, under og efter doseringen.
English: Cartons containing 10 or 280 capsules for initial dose and treatment use respectively.
Danish: Æsker med 10 eller 280 kapsler til henholdsvis initialdosis og behandling.
English: If there is evidence of therapy induced bronchospasm, the physician should carefully evaluate whether the benefits of continued use of Bronchitol outweigh the risks to the patient.
Danish: Hvis der er tegn på behandlingsfremkaldt bronkospasme, skal lægen omhyggeligt vurdere, om fordelene ved fortsat brug af Bronchitol opvejer risikoen for patienten.
English: Hyperresponsiveness to mannitol
Danish: Hyperreaktivitet over for mannitol
English: If the capsule has not emptied you may need to repeat steps 6 to 8.
Danish: Hvis kapslen ikke er tømt, kan det være nødvendigt at gentage trin
English: At the end of the initiation dose you will have taken 10 capsules (400 mg) which is the same as the usual dose.
Danish: Når du har fået hele initialdosis (den første dosis), har du taget 10 kapsler (400 mg), hvilket er den normale dosis.
English: The active substance is mannitol.
Danish: Aktivt stof: mannitol.
English: The following steps explain how to use the inhaler.
Danish: Følgende trin forklarer, hvordan inhalatoren bruges.
English: Before you are started on Bronchitol, your doctor will check whether your airways are too sensitive to mannitol.
Danish: Før du begynder på Bronchitol, undersøger din læge, om dine luftveje er for følsomme over for mannitol.
English: Patients with asthma may experience reversible temporary mild bronchospasm after passing the initiation dose assessment and therefore all patients should be monitored until their FEV1 has returned to baseline levels.
Danish: Patienter med astma kan midlertidigt opleve reversibel, mild bronkospasme efter bestået vurdering af initialdosis, og derfor skal alle patienter monitoreres, indtil FEV1 er tilbage på baselineniveau.
English: (See Table 1).
Danish: (setabel 1).
English: o The risk of bronchospasm during long term treatment even if the Bronchitol initiation dose assessment was initially passed and the need to reiterate it in case of doubt.
Danish: o Risikoen for bronkospasme under langvarig behandling, også selvom vurderingen af den initiale Bronchitol-dosis var bestået, og behovet for at gentage den i tvivlstilfælde.
English: Your doctor may ask you to use other medicines such as a bronchodilator before taking Bronchitol.
Danish: Lægen kan bede dig om at bruge anden medicin, f.eks. et bronkieudvidende lægemiddel, før du tager Bronchitol.
English: The number of subjects with at least one protocol defined pulmonary exacerbation (PDPE, defined by the presence of at least 4 symptoms and signs plus the use of intravenous antibiotics) was 18.1% in the mannitol arm and 28% in the control arm in study 301 (ITT population).
Danish: Antallet af forsøgspersoner med mindst en protokoldefineret pulmonal eksacerbation (PDPE, defineret af tilstedeværelse af mindst 4 symptomer og tegn plus anvendelse af intravenøse antibiotika) var 18,1 % i mannitolarmen og 28 % i kontrolarmen i studie 301 (ITT-population).
English: 2-week treatment pack of 280 hard capsules and 2 inhalers
Danish: 2-ugers behandlingspakning med 280 hårde kapsler og 2 inhalatorer
English: The therapeutic dose regimen should not be prescribed until the initiation dose assessment has been performed.
Danish: Den terapeutiske dosisplan bør ikke ordineres, førend den indledende vurdering af dosis er foretaget.
English: If you think you have used too much medicine, tell your doctor or pharmacist straight away.
Danish: Hvis du mener, at du har brugt for meget medicin, skal du straks kontakte lægen eller apoteket.
English: This was observed in 7.8% of patients compared to 3.8% of patients in the control arm.
Danish: Det sås hos 7,8 % af patienterne sammenlignet med 3,8 % af patienterne i kontrolarmen.
English: Bronchitol is for use in adults 18 years of age and over.
Danish: Bronchitol anvendes til voksne på 18 år og derover.
English: For non-users the relative change was 4.30 (95% CI 0.53, 8.07).
Danish: For ikkebrugere var den relative ændring 4,30 (95 % CI 0,53, 8,07).
English: If you stop using Bronchitol
Danish: Hvis du holder op med at bruge Bronchitol
English: p value
Danish: p-værdi
English: - Then take out a capsule from the blister (only remove the capsule just before use).
Danish: - Tag derefter en kapsel ud af blisteren (tag først kapslen ud, lige før den skal bruges).
English: Use as directed by your doctor.
Danish: Anvendes efter lægens anvisninger.
English: - Then open it by turning the mouth-piece in the direction of the arrow on the inhaler.
Danish: - Derefter åbner du den ved at dreje mundstykket i pilens retning på inhalatoren.
English: Bronchitol is an inhaled hyperosmotic medicinal product.
Danish: Bronchitol er et hyperosmotisk inhalationslægemiddel.
English: Arvato distribution GmbH Gottlieb-Daimler Straβe 1 33428 Harsewinkel North Rhine-Westphalia Germany
Danish: Arvato distribution GmbH Gottlieb-Daimler Straβe 1 33428 Harsewinkel North Rhine-Westphalia Tyskland
English: The capsules must only be removed immediately before use.
Danish: Kapslerne må kun tages ud umiddelbart før brug.
English: If a therapy induced hyperresponsive reaction is suspected, Bronchitol should be discontinued.
Danish: Hvis der er mistanke om en behandlingsfremkaldt hyperreaktiv reaktion, skal Bronchitol seponeres.
English: A bronchodilator must be administered 5-15 minutes before each dose of Bronchitol.
Danish: En bronkodilator skal indgives 5-15 minutter før hver dosis Bronchitol.
English: Bronchitol has not formally been studied in patients with impaired renal and hepatic function.
Danish: Bronchitol er ikke formelt undersøgt hos patienter med nedsat nyre- og leverfunktion.
English: Bronchitol has no or negligible influence on the ability to drive and use machines.
Danish: Bronchitol påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Always take your bronchodilator before using Bronchitol.
Danish: Tag altid din bronkieudvidende medicin, før du bruger Bronchitol.
English: The proportion of patients who experienced haemoptysis including haemoptysis reported during exacerbation was 7.0% in the mannitol arm and 7.7% in the control arm (see section 4.4).
Danish: Andelen af patienter, der oplevede hæmoptyse, herunder hæmoptyse rapporteret under eksacerbation, var 7,0 % i mannitol-armen og 7,7 % i kontrolarmen (se pkt.
English: - Put the capsule into the capsule-shaped space in the bottom of the inhaler.
Danish: - Læg kapslen i det kapselformede rum i bunden af inhalatoren.
English: In male rats after 13 weeks of inhaled mannitol dosing, elevated circulating lymphocyte numbers and mandibular lymph node plasmacytosis was observed at doses greater than 9.3 fold the maximal dose.
Danish: Hos hanrotter blev der efter 13 ugers dosering med inhaleret mannitol observeret forhøjede cirkulerende lymfocytter og mandibulær lymfeknudeplasmacytose ved doser på over 9,3 gange den maksimale dosis.
English: - Never leave a used capsule in your inhaler chamber.
Danish: - Lad aldrig en brugt kapsel sidde i inhalatorens kammer.
English: D18AY29
Danish: Dublin 18, D18AY29 Irland
English: Training the patient to practice correct inhaler technique during the initiation dose assessment is important.
Danish: Det er vigtigt at undervise patienten i at benytte den korrekte inhalationsteknik under vurderingen af initialdosis.
English: Inhaling medicines can cause chest tightness and wheezing and this can happen immediately after taking this medicine.
Danish: Inhalationsmedicin kan give strammen omkring brystet og hvæsende vejrtrækning, og det kan ske med det samme, når du har taget medicinen.
English: - Each of the ten capsules is put into the inhaler one at a time.
Danish: - De 10 kapsler lægges i inhalatoren en ad gangen.
English: Bronchitol has not been studied in patients with a history of significant episodes of haemoptysis (>60 ml) in the previous three months.
Danish: Bronchitol er ikke undersøgt hos patienter med signifikante episoder af hæmoptyse (>60 ml) i de foregående tre måneder.
English: - This allows the capsule to drop forward into the spinning chamber.
Danish: - På den måde kan kapslen falde frem i rotationskammeret.
English: Step 1 - 1 capsule (40 mg) Step 2 - 2 capsules (80 mg) Step 3 - 3 capsules (120 mg) Step 4 - 4 capsules (160 mg)
Danish: Trin 1 - 1 kapsel (40 mg) Trin 2 - 2 kapsler (80 mg) Trin 3 - 3 kapsler (120 mg) Trin 4 - 4 kapsler (160 mg)
English: Patients must be advised to report worsening signs and symptoms of asthma during therapeutic use to their physician.
Danish: Patienterne skal rådes til at rapportere tegn på forværring og symptomer på astma til deres læge, mens de er i behandling med lægemidlet.
English: Inhalation use only.
Danish: Kun til inhalation.
English: Initiation dose assessment
Danish: Vurdering af initialdosis
English: Patients with asthma must be carefully monitored for worsening signs and symptoms of asthma after the initiation dose of Bronchitol.
Danish: Patienter med astma skal monitoreres nøje for tegn på forværring og symptomer på astma efter initialdosen af Bronchitol.
English: Table 2: Frequency of adverse reactions with Bronchitol in the phase 3 studies (initiation dose assessment and/or treatment phase) - paediatric population (6 to 17 years of age) System organ class
Danish: Tabel 2: Frekvensen af bivirkninger ved Bronchitol i fase 3-studierne (vurderingen af startdosen og/eller behandlingsfasen) - pædiatrisk population (6 til 17 år).
English: In the third study (DPM-CF-303) 423 adult patients were randomised in a 1:1 ratio to inhaled mannitol 400 mg twice daily or to control.
Danish: I det tredje studie (DPM-CF-303) blev 423 voksne patienter randomiseret i forholdet 1:1 til inhaleret mannitol 400 mg to gange dagligt eller kontrol.
English: - Hold the inhaler upright and fully press in both ‘Piercing' buttons on the sides of the inhaler at the same time, then release them.
Danish: - Hold inhalatoren lodret, og tryk begge 'prikke'-knapper på siden af inhalatoren helt ind på samme tid, og slip dem igen.
English: Bronchospasm should be treated with a bronchodilator or as medically appropriate.
Danish: Bronkospasme behandles med bronkodilator eller efter medicinsk indikation.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke Bronchitol efter den udløbsdato, der står på pakningen (efter Exp).
English: Uncommon Initial insomnia, Morbid thoughts
Danish: Ikke almindelig Initial insomni, sygelig tankegang
English: Bronchitol is a powder for inhalation that is filled into hard capsules.
Danish: Bronchitol er et pulver til inhalation, som er fyldt i hårde kapsler.
English: CARTON - INITIATION DOSE PACK
Danish: ÆSKE - PAKNING MED INITIALDOSIS
English: Bronchitol 40 mg inhalation powder, hard capsules contain a white or almost white powder filled into clear, colourless, hard, capsules with “PXS 40 mg” imprinted on them.
Danish: Bronchitol 40 mg inhalationspulver, hårde kapsler, indeholder et hvidt eller næsten hvidt pulver, som er fyldt i klare, farveløse, hårde kapsler med ”PXS 40 mg” påtrykt.
English: All patients should be formally reviewed after approximately six weeks of Bronchitol treatment to assess for signs and symptoms suggestive of active substance induced bronchospasm.
Danish: Alle patienter skal evalueres formelt efter ca. 6 ugers behandling med Bronchitol for at vurdere, om der er tegn og symptomer, som tyder på bronkospasme fremkaldt af det aktive stof.
English: This requires the inhalation of the contents of ten capsules via the inhaler device twice a day.
Danish: Det betyder, at indholdet af 10 kapsler skal inhaleres via inhalatoren to gange dagligt.
English: This was observed in 8.3% of patients compared to 4.0% of patients in the control arm.
Danish: Det sås hos 8,3 % af patienterne sammenlignet med 4,0 % af patienterne i kontrolarmen.
English: Discard the inhaler and its cap 1 week after first use.
Danish: Inhalatoren og hætten kasseres 1 uge efter første brug.
English: However, studies with orally administered mannitol indicate no fertility effects (see section 5.3).
Danish: Studie med oralt administreret mannitol tyder imidlertid på, at der ikke er nogen indvirkning på human fertilitet (se pkt.
English: Therapeutic dose regimen
Danish: Terapeutisk dosisregime
English: Before you are prescribed Bronchitol your doctor will help you take your first dose of Bronchitol and test your lung function at each step to make sure you aren't sensitive to mannitol.
Danish: Før du får ordineret Bronchitol, hjælper lægen dig med at tage den første dosis Bronchitol og tester din lungefunktion ved hvert trin for at sikre sig, at du ikke er allergisk over for mannitol.
English: The excretion of mannitol in milk has not been studied in animals.
Danish: Udskillelse af mannitol i modermælken er ikke blevet undersøgt hos dyr.
English: What Bronchitol is Bronchitol contains a medicine called mannitol which is a mucolytic agent.
Danish: Hvad er Bronchitol Bronchitol indeholder et lægemiddel, som kaldes mannitol, og det er et slimløsende stof.
English: Average inhaled dose per capsule is 32.2 milligrams mannitol.
Danish: Den gennemsnitlige inhalerede dosis pr. kapsel er 32,2 mg mannitol.
English: Adult Population
Danish: Voksen population
English: You can carry on using your medicines for cystic fibrosis when you are using Bronchitol, this includes inhaled antibiotics such as tobramycin and colistimethate sodium.
Danish: Du kan fortsætte med din medicin for cystisk fibrose, når du bruger Bronchitol, herunder inhalationsantibiotika som f.eks. tobramycin og colistimethatnatrium.
English: Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland.
Danish: Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Irland.
English: Driving and using machines Bronchitol is not likely to affect your ability to drive or use any tools or machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Bronchitol påvirker din evne til at køre bil eller betjene værktøj eller maskiner.
English: In a study of 9 cystic fibrosis patients (6 adults, 3 adolescents), using 400 mg inhaled mannitol as a single dose (Day 1) then twice a day for 7 days (Days 2 - 7), pharmacokinetic parameters were similar for adults and adolescents, except for a longer average apparent terminal half life for adolescents (Day 1 = 7.29 hours, Day 7 = 6.52 hours) compared with adults (Day 1 = 6.10 hours, Day 7 = 5.42 hours).
Danish: I en studie af 9 patienter med cystisk fibrose (6 voksne, 3 unge), som brugte 400 mg inhalationsmannitol som enkeltdosis (Dag 1) og derefter to gange dagligt i 7 dage (Dag 2-7), var de farmakokinetiske parametre sammenlignelige for voksne og unge, dog undtaget en længere gennemsnitlig tilsyneladende terminalhalveringstid for unge (Dag 1 = 7,29 timer, Dag 7 = 6,52 timer) sammenlignet med voksne (Dag 1 = 6,10 timer, Dag 7 = 5,42 timer).
English: The initiation dose assessment must be performed according to the following steps:
Danish: Vurdering af initialdosis udføres i følgende trin:
English: Take out the used capsule - Turn the inhaler upside down, tap the bottom and throw the empty capsule away.
Danish: Tag den brugte kapsel ud - Vend inhalatoren på hovedet, bank på bunden, og smid den tomme kapsel væk.
English: Table 1: Frequency of adverse reactions with Bronchitol in the phase 3 studies (initiation dose assessment and/or treatment phase)
Danish: Tabel 1: Frekvensen af bivirkninger ved Bronchitol i fase 3-studierne (vurderingen af startdosen og/eller behandlingsfasen)
English: The patient must complete and pass the initiation dose assessment before starting treatment with Bronchitol.
Danish: Patienten skal gennemføre og bestå den indledende dosis vurdering, inden behandling med Bronchitol påbegyndes.
English: Common (May affect up to 1 in 10 people) - Cough - Chest discomfort - Headache - Pain in the back of your mouth and throat and discomfort when swallowing - Vomiting, vomiting after coughing
Danish: Almindelige (kan ramme op til 1 ud af 10 personer) - Hoste - Brystubehag - Hovedpine - Smerter bagest i munden og svælget og ubehag, når du synker - Opkastning, opkastning efter hoste
English: The MAH shall complete, within the stated timeframe, the below measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger/tiltag:
English: Open the inhaler - Hold the bottom of the inhaler firmly with one hand.
Danish: Åbn inhalatoren - Hold bunden af inhalatoren fast med den ene hånd.
English: - If you do not hear the rattling, hold the inhaler with the mouth-piece facing downwards, and tap the bottom firmly.
Danish: - Hvis du ikke hører den raslende lyd, skal du holde inhalatoren med mundstykket nedad og banke hårdt på bunden.
English: However, Bronchitol has been used in clinical studies in conjunction with standard cystic fibrosis therapies such as mucolytics, antibiotics (including tobramycin and colistimethate sodium), bronchodilators, pancreatic enzymes, vitamins, inhaled and systemic corticosteroids, and analgesics.
Danish: Bronchitol er imidlertid anvendt i kliniske studie i forbindelse med standardbehandlinger for cystisk fibrose, f.eks. mucolytika, antibiotika (herunder tobramycin og colistimethatnatrium), bronkodilatorer, pancreasenzymer, vitaminer, inhalationskortikoider, systemiske kortikoider og analgetika.
English: Summary of Product Characteristics and Patient Information Leaflet Educational material for Healthcare Professionals
Danish: Undervisningspakken skal indeholde følgende: Produktresumé og indlægsseddel Undervisningsmateriale til sundhedspersonale
English: This helps your lungs to clear mucus more easily.
Danish: Det hjælper lungerne med lettere at få slimen op.
English: - For the best results, inhale each capsule one after another, so there is as little delay as possible between capsules.
Danish: - Du opnår det bedste resultat, hvis du inhalerer kapslerne en efter en med så lille forsinkelse mellem kapslerne som muligt.
English: If you are not sure, talk to your doctor or pharmacist before using Bronchitol.
Danish: Er du i tvivl, så spørg lægen eller på apoteket, inden du bruger Bronchitol.
English: The proportion of patients who experienced haemoptysis as an adverse reaction was 7.3%, 3.3% and 3.4% in the Bronchitol arms for studies 301, 302 and 303 respectively vs. 3.4%, 0% and 5.6% in the control arms.
Danish: Andelen af patienter, der oplevede hæmoptyse som bivirkning, var henholdsvis 7,3 %, 3,3 % og 3,4 % i Bronchitol-armene i studie 301,302 og 303 versus 3,4 %, 0 % og 5,6 % i kontrolarmene.
English: The metabolic pathway of inhaled mannitol was not examined in pharmacokinetic studies.
Danish: Metaboliseringsvejen for inhaleret mannitol er ikke undersøgt i farmakokinetiske studie.